chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Syncope
Clinical narrative: Pt lying in mom's arms after vaccines given and fainted after 3rd vaccine. Patient recovered after ammonia ampoule held under nose. Pulse was 88. Color did not change. Recovered fully after 5 minutes.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Heart rate normal, Ventilation/perfusion scan
Clinical narrative: dizzy in 5 minutes after Gardasil injection and PPD placement
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Irritability
Clinical narrative: Cranky x2 days.  Red area of induration L upper outer thigh.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Nausea, Rash, Swelling
Clinical narrative: allergic reaction, red rash (R) upper arm, swelling and nausea.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Received pneumovax on 12/11/07. Patient reports that same evening left arm extremely painful and unable to raise arm at all. The next morning left arm was reddened "from lymph nodes to elbow". Pain improved over the next few days and by 12/14/07 she was able to raise her arm. Mild ache remains occasionally but reports she has "98%" recovered *see back; Patient also reported chest pain at onset of symptoms on 12/11/07 afternoon took aspirin, chest pain lasted < 1 1/2 hrs. She was seen by PCP, who agreed she should not receive any further pneumovax vaccinations.  He told her that the adverse affects were "not serious." She had another cortisone injection on 1/14/08 and reported that she became "fire engine red", and broke out in hives on 1/15/08. Symptoms improved today (1/16/08)
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Severe shoulder pain at site of injection
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood culture, Full blood count, Injection site cellulitis
Clinical narrative: (L) arm with cellulitis
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Infectious mononucleosis, Injection site erythema, Injection site swelling, Meningitis viral
Clinical narrative: Increased temp (103.9), swelling, redness (L) deltoid area - injection site extending down to elbow.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Colon cancer, Disorientation, Erythema
Clinical narrative: Developed pain, swelling redness and limited mobility of (L) arm 4 hours after vaccination. 24 hours after vaccination chills, disorientation/continued pain in (L) arm with weakness of (L) arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Developed pain, swelling redness and limited mobility of (L) arm 4 hours after vaccination. 24 hours after vaccination chills, disorientation/continued pain in (L) arm with weakness of (L) arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Swelling
Clinical narrative: red, Swelling, Swollen
Age: 53.0
Sex: M
Vaccine: TYP
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: 12/21/07 Patient received Typhoid V.  12/28/07 complained of neck and shoulder soreness and pain.  ER visit for pain relief.  Received steroid injection, muscle relaxant and dose pack steroid with relief.  Pain returned and called 1/15/08, advised flu with PCP.
Age: 10.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large red, warm, tender area 12cm diameter around vaccine site.
Age: 10.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Large red, warm, tender area 12cm diameter around vaccine site.
Age: 9.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large, red, warm, tender area 11cm drain around vaccine site
Age: 9.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Large, red, warm, tender area 11cm drain around vaccine site
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Headache, Hypoaesthesia, Nausea, Pain
Clinical narrative: Severe headache, fever, body aches, arm pain, numbness in hand extremity, dizziness, nausea and sometimes blurry vision.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: Severe headache, fever, body aches, arm pain, numbness in hand extremity, dizziness, nausea and sometimes blurry vision.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Varicella vaccination given 1-8-08 - 2hr next day child had erythema with noted at site of injection of about 2 1/2 x 2 1/2 reports by mother. Examination of site on 11/10/08 erythema of 4 1/8 x 3 3/4, hot and tender to touch - Tx of Benadryl, Motrin, ice and heat packs to area; 01/16/08 Follow-up call to mother to check on child. Mother reports that they had taken child to "hospital" on Friday the 11th because the swelling and redness had spread almost up to the shoulder and down to the elbow and almost circled the upper arm. She also stated that the fingers on that side were a different color. That doctor at "hospital" diagnosed her with cellulitis and placed the child on clindamycin because the medication that the primary physician had placed her on was not for skin infections. Mother reports that the arm was much improved by the next day and looks good now. Child had twisted her ankle just prior to receiving the vaccination. Apparently the physicians had wondered if maybe the child had a minor abrasion or had possibly scratched the injection site. Mom did not know.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: 2 cm mild swelling/induration around injection site shortly after vaccination. No symptoms. Monitored 10 min - improved. On repeat exam in office 10 minutes later.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Swelling face
Clinical narrative: Complained of face swelling and redness.  Swelling at injection site 1 hour after injection.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Left arm erythema, warm.
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Faint rash upper left arm approx 2" from sight of injection - No other complaints or concerns
Age: 89.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Insomnia, Night sweats, Serology positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of positive hepatitis B serology in a 89-year-old female subject who was vaccinated with  Engerix B (GlaxoSmithKline) for prophylaxis.  The subject suffers from renal impairment and undergoes hemodialysis three times a week.  On an unspecified date the subject received 2nd dose of Engerix B at 0.5 ml.  The first dose of the series was given in January 2007.  At an unspecified time after the 2nd vaccination with Engerix B, the subject experienced positive hepatitis B serology (tested on 20 March 2007), trouble sleeping and night sweats.  The positive hepatitis B serology was unresolved and the outcome of the other events was unspecified at the time of reporting.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, FLU3, HEPA, MNQ
Symptoms: Dyspnoea, Stridor, X-ray normal
Clinical narrative: Seriousness criteria: other-medically significant.  Initial report received on 11 January 2008 from a health care professional.  A 16-year-old male patient, with no illness at the time of vaccination, had received a left arm injection of Menactra, lot number U2420AA; a left arm injection of Fluzone SV 2007-2008, lot number U2508AA; and a right arm injection of hepatitis A vaccine, manufacturer GSK, lot number AHAVB17AA; on 17 December 2007.  Two days post-vaccination, the patient began to experience trouble breathing at night with stridor lasting for a few seconds.  The patient did not have a past medical history of asthma.  He experienced these episodes two to three times per week.  Lateral X-ray of the neck was normal.  The patient was examined by an ENT specialist (findings not provided) and was scheduled to see an allergist.  Treatment provided was not reported.  The patient had received a prior dose of Menomune, but the year of administration was not provided.  Recovery status was not reported.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bronchitis, Dyspnoea, Fluid retention, Surgery, X-ray abnormal
Clinical narrative: Initial and follow-up information has been received from a physician's office technician and a 64 year old female with high cholesterol and high blood pressure and a history of hysterectomy and no drug allergies who on 29-NOV-2007 was vaccinated with a one time 0.5 ml dose of Zostavax (Oka/Merck) (lot #688083/0885U).  Concomitant drug therapy included ezetimibe (MSD) 20 mg, atorvastatin calcium (Lipitor) 20 mg and amlodipine besylate (+) benazepril hydrochloride 5/20 mg.  On approximately 07-DEC-2007 8 to 10 days after vaccination, the patient experienced shortness of breath.  The patient went to a walk-in clinic and was treated with azithromycin HCl (Zithromax/Z-Pak).  The patient did not feel better and went to see the physician who found on a chest X-ray that there was water in her right lung.  The patient was then taken to the hospital where tests were done which showed a virus around the heart and lungs.  On 11-DEC-2007 the patient was admitted to the hospital for 4 days into the "ICU" and underwent emergency surgery for the water in her lungs and around her heart.  The patient was discharged from the hospital on 14-DEC-2007.  On 18-DEC-2007 the patient still had some water in the right lung upon examination at the physician's office and went for a follow-up exam (date and specified results unknown).  It was noted that the diagnosis had not yet been determined.  On approximately 24-DEC-2007 1 to 1 & 1/2  weeks after discharge from the hospital, the patient fully recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chest X-ray abnormal, Dyspnoea, Intensive care, Laboratory test abnormal
Clinical narrative: Initial and follow-up information has been received from a physician's office technician and a 64 year old female with high cholesterol and high blood pressure and a history of hysterectomy and no drug allergies who on 29-NOV-2007 was vaccinated with a one time 0.5 ml dose of Zostavax (Oka/Merck) (lot #688083/0885U).  Concomitant drug therapy included ezetimibe (MSD) 20 mg, atorvastatin calcium (Lipitor) 20 mg and amlodipine besylate (+) benazepril hydrochloride 5/20 mg.  On approximately 07-DEC-2007 8 to 10 days after vaccination, the patient experienced shortness of breath.  The patient went to a walk-in clinic and was treated with azithromycin HCl (Zithromax/Z-Pak).  The patient did not feel better and went to see the physician who found on a chest X-ray that there was water in her right lung.  The patient was then taken to the hospital where tests were done which showed a virus around the heart and lungs.  On 11-DEC-2007 the patient was admitted to the hospital for 4 days into the "ICU" and underwent emergency surgery for the water in her lungs and around her heart.  The patient was discharged from the hospital on 14-DEC-2007.  On 18-DEC-2007 the patient still had some water in the right lung upon examination at the physician's office and went for a follow-up exam (date and specified results unknown).  It was noted that the diagnosis had not yet been determined.  On approximately 24-DEC-2007 1 to 1 & 1/2  weeks after discharge from the hospital, the patient fully recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pulmonary oedema, Surgery, Viral infection
Clinical narrative: Initial and follow-up information has been received from a physician's office technician and a 64 year old female with high cholesterol and high blood pressure and a history of hysterectomy and no drug allergies who on 29-NOV-2007 was vaccinated with a one time 0.5 ml dose of Zostavax (Oka/Merck) (lot #688083/0885U).  Concomitant drug therapy included ezetimibe (MSD) 20 mg, atorvastatin calcium (Lipitor) 20 mg and amlodipine besylate (+) benazepril hydrochloride 5/20 mg.  On approximately 07-DEC-2007 8 to 10 days after vaccination, the patient experienced shortness of breath.  The patient went to a walk-in clinic and was treated with azithromycin HCl (Zithromax/Z-Pak).  The patient did not feel better and went to see the physician who found on a chest X-ray that there was water in her right lung.  The patient was then taken to the hospital where tests were done which showed a virus around the heart and lungs.  On 11-DEC-2007 the patient was admitted to the hospital for 4 days into the "ICU" and underwent emergency surgery for the water in her lungs and around her heart.  The patient was discharged from the hospital on 14-DEC-2007.  On 18-DEC-2007 the patient still had some water in the right lung upon examination at the physician's office and went for a follow-up exam (date and specified results unknown).  It was noted that the diagnosis had not yet been determined.  On approximately 24-DEC-2007 1 to 1 & 1/2  weeks after discharge from the hospital, the patient fully recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death
Clinical narrative: Information has been received from the FDA concerning a two month male who was vaccinated with Rotateq (Lot # 657670/1108U). Concomitant therapy included three other vaccines unspecified (dose, duration and indication not provided). The manufacturer of these vaccines were being contacted. Subsequently, the patient died. Although there was no definitive diagnosis, SIDS was suspected. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: Information has been received from the FDA concerning a two month male who was vaccinated with Rotateq (Lot # 657670/1108U). Concomitant therapy included three other vaccines unspecified (dose, duration and indication not provided). The manufacturer of these vaccines were being contacted. Subsequently, the patient died. Although there was no definitive diagnosis, SIDS was suspected. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Dizziness, Dyspnoea, Headache, Influenza like illness
Clinical narrative: HEADACHE; SHORTNESS OF BREATH; WHEEZING; COUGHING; SWOLLEN THROAT; DIZZINESS; FLU LIKE SYMPTOMS; PALENESS; REACTIONS BEGAN WITHIN 30 MINUTES OF VACCINE.  FLU LIKE SYMPTOMS LASTED 2 DAYS.  OTHER SYMPTOMS ARE STILL PRESENT.  TWO DAYS AFTER RECEIVING THE SHOT, PATIENT CALLED DOCTORS OFFICE AND LEFT MESSAGE ABOUT REACTION. AT THE END OF THE DAY (AFTER 5PM) DOCTOR RETURNED CALL. DOCTOR ADVISED PATIENT TO GO TO URGENT CARE.  SHE WAS ALSO TOLD 'NOT' TO TELL URGENT CARE PHYSICIAN SHE HAD RECEIVED A VACCINE, BECAUSE SHE WOULD GET NO TREATMENT IF SHE DID.  PATIENT WENT TO URGENT CARE.  PATIENT DID TELL DOCTOR ON CALL AT URGENT CARE ABOUT GETTING THE VACCINE, BECAUSE SHE WAS AFRAID IF SHE DIDN'T, THE DOCTOR MIGHT GIVE HER SOMETHING THAT COULD REACTION WITH IT.  DOCTOR AT URGENT CARE DIDN'T WANT TO DISCUSS PATIENT HAVING A PNEUMONIA VACCINE, SAID HER SYMPTOMS WERE NOT A REACTION TO VACCINE.  DOCTOR LISTENED TO PATIENTS CHEST, AND TOLD HER SHE WAS HAVING AN ASTHMA ATTACK.  PATIENT TOLD DOCTOR SHE HAS HAD ASTHMA SINCE SHE WAS 6 WEEKS OLD, AND THIS WAS NOT AN ASTHMA ATTACK.  DOCTOR DID NO TESTING. DOCTOR DID NOT EVEN TAKE A CHEST X-RAY.  PATIENT WAS GIVEN A BREATHING TREATMENT AND RELEASED.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pallor, Pharyngeal oedema, Wheezing
Clinical narrative: HEADACHE; SHORTNESS OF BREATH; WHEEZING; COUGHING; SWOLLEN THROAT; DIZZINESS; FLU LIKE SYMPTOMS; PALENESS; REACTIONS BEGAN WITHIN 30 MINUTES OF VACCINE.  FLU LIKE SYMPTOMS LASTED 2 DAYS.  OTHER SYMPTOMS ARE STILL PRESENT.  TWO DAYS AFTER RECEIVING THE SHOT, PATIENT CALLED DOCTORS OFFICE AND LEFT MESSAGE ABOUT REACTION. AT THE END OF THE DAY (AFTER 5PM) DOCTOR RETURNED CALL. DOCTOR ADVISED PATIENT TO GO TO URGENT CARE.  SHE WAS ALSO TOLD 'NOT' TO TELL URGENT CARE PHYSICIAN SHE HAD RECEIVED A VACCINE, BECAUSE SHE WOULD GET NO TREATMENT IF SHE DID.  PATIENT WENT TO URGENT CARE.  PATIENT DID TELL DOCTOR ON CALL AT URGENT CARE ABOUT GETTING THE VACCINE, BECAUSE SHE WAS AFRAID IF SHE DIDN'T, THE DOCTOR MIGHT GIVE HER SOMETHING THAT COULD REACTION WITH IT.  DOCTOR AT URGENT CARE DIDN'T WANT TO DISCUSS PATIENT HAVING A PNEUMONIA VACCINE, SAID HER SYMPTOMS WERE NOT A REACTION TO VACCINE.  DOCTOR LISTENED TO PATIENTS CHEST, AND TOLD HER SHE WAS HAVING AN ASTHMA ATTACK.  PATIENT TOLD DOCTOR SHE HAS HAD ASTHMA SINCE SHE WAS 6 WEEKS OLD, AND THIS WAS NOT AN ASTHMA ATTACK.  DOCTOR DID NO TESTING. DOCTOR DID NOT EVEN TAKE A CHEST X-RAY.  PATIENT WAS GIVEN A BREATHING TREATMENT AND RELEASED.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Scab
Clinical narrative: Pt. received smallpox vaccination 1/08/08 R arm.  On 1/20/08 Pt. noted a reddened raised area located on R temporal area of head. Pt. thought this was a acne pimple and a topical prep containing benzoyl peroxide.  Evening of 1/20 Pt. noted reddened area developed a blister.  Pt. denied any C/O drainage from site and denied any other lesions on any other part of her body.  Pt. presented to Medical Group 1/22.  Area on temple measures 5mm x 2mm.  The area is scabbed over and no drainage noted.  Advised pt to keep this area covered and to treat area as if it were vaccine related.  Further advised pt. to see her PMD for evaluation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: CRYING FOR 6 HOURS WITHIN THE FIRST 48 HOURS AFTER RECEIVING VACCINES.
Age: 1.56
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Painful left thigh swelling to approximately twice normal diameter. No impairment of walking and no signs of infection, improving at time of office visit 1/23/08 at 9:30am.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Respiratory tract congestion, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 5 month old male with a history of "reflux" who in approximately October 2007, was vaccinated orally with a second dose of Rotateq. Two weeks post vaccination, on 08 NOV 2007, the patient was seen "in the office" at which time the patient was "congested with on an off vomiting". The patient presented with "a good bowel movement" and was given amoxicillin and sent home. Approximately 16 hours later the patient was taken to the emergency room (ER). "The child passed away on 10 NOV 2007". The patient's status was not recovered. The reported cause of death was "necrotic bowel". The adverse events reported were considered to be, Disabling, immediately life threatening by the reporter. Additional information has been requested.  1/25/08 Received vax record which reveal patient also received Pediarix #2 AC21B133AA, Hib #2 Merck lot # 0436U, Prevnar #2 B54007H & Rotateq #2 0670U..  1/29/08 Reviewed ER medical records of 11/9/07 which reveal patient arrived in cardiopulmonary arrest having been brought to hospital by parent.  Had voided & had bloody stool, possibly vomited & had been lethargic prior to coding.  Was in severe acidosis, shock, dehydration, hypercarbia, arrhythmia, infection.  Resuscitated & transferred to higher level of care ER. FINAL Initial ER DX: abdominal castrophe; respiratory/cardiac arrest; and septic shock. 2/1/08 Reviewed hospital med records which reveal patient transferred from outlying hospital in critical shock condition.  Admitted 11/9-11/10/2007 to ICU.  Had 36 hour hx of poor feeding, increased crying & developed bilious emesis & bloody stools. Intubated & emergent laparotomy & ileocecectomy was performed in ICU.  Finding at surgery: IS extending to hepatic flexure w/small area of necrosis in cecum & entire small bowel w/diffusely involved ischemia thought likely secondary to shock & cardiac arrest.  Bowel remained dusky at end of procedure & abdomen left open w/bowel wrapped in order to visulize recovery. developed compartment syndrome of bilateral legs.  Deteriorated, developed hepatic failure, DIC, fixed & dilated pupils, seizures & absent reflexes.  Defibrillated numerous times & expired 11/10/07.  Preliminary autopsy report included w/medical records reveals COD as Intussusception leading to ischemic bowel resulting in sepsis complicated by prolonged cardiac arrest & multiorgan failure.  Findings included: ischemic bowel; diffuse alveolar damage,mild; sepsis; hepatic failure; DIC; renal petechiae; gastric mucosal petechiae; bilateral lower extremity ischemic damage; hyperemic lower extremities.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Physical examination normal
Clinical narrative: Information has been received from a physician concerning a 17 week old female with no pertinent medical history or drug allergies who on 02-NOV-2007 and 28-DEC-2007 was vaccinated PO with her first and second doses of RotaTeq (lot# 657459/0509U, 656387/0971U). There was no concomitant medication. On 28-DEC-2007 the patient experienced intussusception and was hospitalized on 03-JAN-2008. The intussusception was resolved with a barium enema. The patient did not require surgical interventions. On approximately 06-JAN-2008 2-3 days after hospitalization, the patient was discharged home and was noted to be recovered. On 14-JAN-2008 the patient was seen for a follow-up visit with the physician and her exam was normal. On that same day after the exam, therapy with RotaTeq was discontinued by the physician. There was no product quality complaint. Additional information has been requested.  01/25/2008 Vax record received and data entered. 01/29/2008 MR received for ER visit 1/3/08. Infant to ER with screaming, vomiting, and listlessness. No po intake that day.  Impression: Viral syndrome.  Vomiting. Child transfered to another facility for further care. 03/27/2008 MR received for DOS 01/4-6/2008 with D/C DX: Intussusception. Infant presented to local hospital with lethargy, decreased po intake and vomiting. Pt later had a bloody stool. IS noted on Abd US. Air contrast enema successful in reducing IS. Pt began taking PO well and became more alert and was d/c home.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Paraesthesia oral
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse (LPN) concerning a 17 year old female student with long standing not controlled asthma, perennial allergic rhinoconjunctivitis, and acute sinusitis who on 04-JAN-2008 at 3:00 p.m. was vaccinated IM in left deltoid with her first dose of Gardasil, lot# 659439/1267U. Concomitant therapy included beclomethasone dipropionate (QVAR). On 04-JAN-2008 at 8:00 p.m. the patient experienced tingling of the lips and facial flushing. The patient was prescribed diphenhydramine hcl (BENADRYL). On 05-JAN-2008, the patient recovered. The reporter felt that the events were other important medical events. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Convulsion, Head injury, Inappropriate schedule of drug administration, Skin laceration, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female who on 10-JAN-2008 was vaccinated with Gardasil (Lot # 659653/1448U). Concomitant therapy included MICROGESTIN FE and on the same day received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 10-JAN-2008, 10-15 minutes after receiving the vaccines, the patient fainted. She immediately had an innocuous seizure, and sustained a bump, an "egg," on her head and laceration on forehead. Dermabond was applied to the laceration. The nurse attempted to sit the patient up and the patient had another seizure. The seizures lasted 10-15 seconds. She was placed on an exam table for an hour and was better. The patient's blood pressure was fine and the patient was sent home. Subsequently, the patient recovered. Upon review, the seizures were upgraded to serious due to an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood test, Computerised tomogram, Drug exposure during pregnancy, Electroencephalogram
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 female with a penicillin allergy and a history of a fractured nose. The nurse practitioner reported that the patient completed the Gardasil series and then miscarried. The patient received her first dose of Gardasil (Lot #655503/0012U) on 05-MAR-2007, her second dose on 05-MAY-2007 (Lot #657621/0387U) and her third dose on 07-SEP-2007 (Lot #658488/0930U). The patient miscarried 3-4 weeks after receiving the last dose approximately 28-SEP-2007. The mother of the patient said the miscarried fetus had developed for about 3 months. The patient went to the emergency room for the miscarriage and was treated there for bleeding post-miscarriage. The patient had also been treated at an unspecified OBGYN post-miscarriage for bleeding and presently vertigo and headaches. The patient has been to the emergency room twice for treatment post-miscarriage and an unspecified neurologist. It was unclear if the patient was ever hospitalized. There was no testing on the miscarried fetus, because it was "flushed" and not recovered. There was no other information to report. Upon internal review a miscarriage was considered an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Headache, Laboratory test, Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 female with a penicillin allergy and a history of a fractured nose. The nurse practitioner reported that the patient completed the Gardasil series and then miscarried. The patient received her first dose of Gardasil (Lot #655503/0012U) on 05-MAR-2007, her second dose on 05-MAY-2007 (Lot #657621/0387U) and her third dose on 07-SEP-2007 (Lot #658488/0930U). The patient miscarried 3-4 weeks after receiving the last dose approximately 28-SEP-2007. The mother of the patient said the miscarried fetus had developed for about 3 months. The patient went to the emergency room for the miscarriage and was treated there for bleeding post-miscarriage. The patient had also been treated at an unspecified OBGYN post-miscarriage for bleeding and presently vertigo and headaches. The patient has been to the emergency room twice for treatment post-miscarriage and an unspecified neurologist. It was unclear if the patient was ever hospitalized. There was no testing on the miscarried fetus, because it was "flushed" and not recovered. There was no other information to report. Upon internal review a miscarriage was considered an other important medical event. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Allergy test positive, Blood immunoglobulin E, Diagnostic procedure, Hypersensitivity, Intensive care
Clinical narrative: Information was received from a literature article, titled as stated above, concerning a 15-month-old adopted male with a history of eczema, asthma, and a prior adverse reaction to Varivax was referred for further allergic evaluation. Upon initial allergic evaluation, the infant was able to tolerate eggs, milk, wheat, fish, and pork. No medication allergy was documented. His medications included fluticasone 44 mcg 2 puffs daily in the morning for asthma maintenance, and multivitamins. Skin prick testing was positive for Varivax (Oka/Merck) and histamine and negative for egg and MMR II, gelatin, and normal saline solution. The patient's mother described a previous allergic reaction to Varivax (Oka/Merck) as a rash, suggestive of generalized urticaria, for which the patient was prescribed oral prednisone for two days. Intradermal testing revealed a positive reaction to the MMR II as well as histamine, but not to saline. Subsequently the patient received diphenhydramine topical cream to control the itching. When the patient was 18 months old he was admitted to the pediatric intensive care unit for an MMR II graded challenge. The dosing protocol included an initial dose of MMR II of 0.5 ml with a 1:100 dilution, followed at 5 minutes with 0.05 ml with a 1:10 dilution. At 30 minutes 0.5 ml of MMR II was administered at full strength, followed by 0.10 ml full strength at 45 minutes, 0.15 ml full strength at 60 minutes and a final dose of 0.20 ml full strength at 75 minutes. The patient tolerated the procedure without any adverse reaction. It was also noted that the patient had tolerated subsequent vaccinations (unspecified) well. Research suggests that immediate and some non-immediate type reactions to Varivax are caused by anti-gelatin IgG or IgE immune reactions. Most individuals with IgE antibodies to gelatin and type I hypersensitivity to gelatin containing vaccines have not reported allergic reactions to gelatin prior to vaccination. Sensitization to gelatin during infancy may be attributed to prior ingestion of precooked infant food for administration of gelatin containing vaccines. The patient's history suggested the presence of serum IgE antibodies to gelatin. Hypersensitivity after vaccination warrants consideration of gelatin allergy as a potential cause. In the opinion of the reporters hypersensitivity to gelatin, a stabilizing vaccine constituent is associated with anaphylaxis to MMR and varicella vaccines. Adverse reactions to these vaccines are commonly related to gelatin allergy. Individuals with prior hypersensitivity to gelatin-containing vaccines are more likely to experience future adverse reaction to vaccines, and therefore may benefit from a safe and rapid approach, such as a graded-dose protocol. This is one of two reports received from the same source. A copy of this published article is attached as further documentation of the patient's experienced.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Information was received from a literature article, titled as stated above, concerning a 15-month-old adopted male with a history of eczema, asthma, and a prior adverse reaction to Varivax was referred for further allergic evaluation. Upon initial allergic evaluation, the infant was able to tolerate eggs, milk, wheat, fish, and pork. No medication allergy was documented. His medications included fluticasone 44 mcg 2 puffs daily in the morning for asthma maintenance, and multivitamins. Skin prick testing was positive for Varivax (Oka/Merck) and histamine and negative for egg and MMR II, gelatin, and normal saline solution. The patient's mother described a previous allergic reaction to Varivax (Oka/Merck) as a rash, suggestive of generalized urticaria, for which the patient was prescribed oral prednisone for two days. Intradermal testing revealed a positive reaction to the MMR II as well as histamine, but not to saline. Subsequently the patient received diphenhydramine topical cream to control the itching. When the patient was 18 months old he was admitted to the pediatric intensive care unit for an MMR II graded challenge. The dosing protocol included an initial dose of MMR II of 0.5 ml with a 1:100 dilution, followed at 5 minutes with 0.05 ml with a 1:10 dilution. At 30 minutes 0.5 ml of MMR II was administered at full strength, followed by 0.10 ml full strength at 45 minutes, 0.15 ml full strength at 60 minutes and a final dose of 0.20 ml full strength at 75 minutes. The patient tolerated the procedure without any adverse reaction. It was also noted that the patient had tolerated subsequent vaccinations (unspecified) well. Research suggests that immediate and some non-immediate type reactions to Varivax are caused by anti-gelatin IgG or IgE immune reactions. Most individuals with IgE antibodies to gelatin and type I hypersensitivity to gelatin containing vaccines have not reported allergic reactions to gelatin prior to vaccination. Sensitization to gelatin during infancy may be attributed to prior ingestion of precooked infant food for administration of gelatin containing vaccines. The patient's history suggested the presence of serum IgE antibodies to gelatin. Hypersensitivity after vaccination warrants consideration of gelatin allergy as a potential cause. In the opinion of the reporters hypersensitivity to gelatin, a stabilizing vaccine constituent is associated with anaphylaxis to MMR and varicella vaccines. Adverse reactions to these vaccines are commonly related to gelatin allergy. Individuals with prior hypersensitivity to gelatin-containing vaccines are more likely to experience future adverse reaction to vaccines, and therefore may benefit from a safe and rapid approach, such as a graded-dose protocol. This is one of two reports received from the same source. A copy of this published article is attached as further documentation of the patient's experienced.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Adenosine deaminase deficiency, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, CD4 lymphocytes decreased, CD8 lymphocytes
Clinical narrative: It was reported in a published article, title as stated above that: "Rational" Immunodeficiency should be considered in children with severe failure-to-thrive prior to administration of live vaccines. Methods: A 17 month old male with failure-to-thrive presented to the allergy consult service 14 days after a presentation to the ED with prolonged fever (Tmax 103F) and erythematous papules on his face. A respiratory infection had been diagnosed in the ED and treated with amoxicillin. Fevers persisted, and the rash evolved into grouped papules, vesicles, and crusting lesions over the face and abdomen. Past medical history revealed a growth curve below the 3rd percentile for height and weight, but no prior hospitalization or serious infection. The live attenuated varicella vaccine had been given approximately 14 days before the ED presentation. Results: Varicella infection was confirmed by direct immunofluorescence assay, and a Tzank stain showed multinucleated giant cells. Severe lymphopenia was evident, with 1% lymphocytes (57/mm3), along with decreased immunoglobulins (152 (IgG), 25 (IgM) and 10 (IgA) mg/dL) and T, B and NK cells (CD3: 27.4%, CD4: 14.7% (6/mm3), CD8: 10.3% (4/mm3), CD19 6.3%, CD16: 32.5%). The patient was transferred to a hospital after initiation of acyclovir and IVIG. Expanded lymphocyte enumeration confirmed markedly decreased T (CD3 (55/mm3), CD4 (51/mm3), CD8 (7/mm3)), B (CD19 0/mm3), and CD3+CD56+ NKT cells (6/mm3), and slightly decreased CD3-CD56+ NK cells (150/mm3). SCID was diagnosed. After RBC transfusion, lab tests revealed low levels of adenosine deaminase (ADA) (16.8 nmol/h/mg, normal 63) and increased levels of deoxyadenosine nucleotides (0.056 imol/mL, normal <0.002) in the hemosylate. Lymphocyte proliferation to PHA was decreased but present (21,377 CPM, background 189; Control 188.330, background 126). Pegylated-ADA was started at 187.5 IU IM twice weekly. Levels of ADA, lymphocyte subsets and IgG are being monitored, and after two weeks of therapy the lymphocyte count increased to 560/mm3. Conclusion: This case demonstrates the consequence following administration of a live vaccine to a child with severe failure-to-thrive who had undiagnosed SCID. To the author's knowledge, this is the first published report of disseminated cutaneous varicella infection after vaccination as the presenting symptoms of SCID-ADA deficiency, and shows the need to consider immunodeficiency in such patient's." A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal, Lymphocyte count decreased, Pyrexia, Rash papular, Rash vesicular
Clinical narrative: It was reported in a published article, title as stated above that: "Rational" Immunodeficiency should be considered in children with severe failure-to-thrive prior to administration of live vaccines. Methods: A 17 month old male with failure-to-thrive presented to the allergy consult service 14 days after a presentation to the ED with prolonged fever (Tmax 103F) and erythematous papules on his face. A respiratory infection had been diagnosed in the ED and treated with amoxicillin. Fevers persisted, and the rash evolved into grouped papules, vesicles, and crusting lesions over the face and abdomen. Past medical history revealed a growth curve below the 3rd percentile for height and weight, but no prior hospitalization or serious infection. The live attenuated varicella vaccine had been given approximately 14 days before the ED presentation. Results: Varicella infection was confirmed by direct immunofluorescence assay, and a Tzank stain showed multinucleated giant cells. Severe lymphopenia was evident, with 1% lymphocytes (57/mm3), along with decreased immunoglobulins (152 (IgG), 25 (IgM) and 10 (IgA) mg/dL) and T, B and NK cells (CD3: 27.4%, CD4: 14.7% (6/mm3), CD8: 10.3% (4/mm3), CD19 6.3%, CD16: 32.5%). The patient was transferred to a hospital after initiation of acyclovir and IVIG. Expanded lymphocyte enumeration confirmed markedly decreased T (CD3 (55/mm3), CD4 (51/mm3), CD8 (7/mm3)), B (CD19 0/mm3), and CD3+CD56+ NKT cells (6/mm3), and slightly decreased CD3-CD56+ NK cells (150/mm3). SCID was diagnosed. After RBC transfusion, lab tests revealed low levels of adenosine deaminase (ADA) (16.8 nmol/h/mg, normal 63) and increased levels of deoxyadenosine nucleotides (0.056 imol/mL, normal <0.002) in the hemosylate. Lymphocyte proliferation to PHA was decreased but present (21,377 CPM, background 189; Control 188.330, background 126). Pegylated-ADA was started at 187.5 IU IM twice weekly. Levels of ADA, lymphocyte subsets and IgG are being monitored, and after two weeks of therapy the lymphocyte count increased to 560/mm3. Conclusion: This case demonstrates the consequence following administration of a live vaccine to a child with severe failure-to-thrive who had undiagnosed SCID. To the author's knowledge, this is the first published report of disseminated cutaneous varicella infection after vaccination as the presenting symptoms of SCID-ADA deficiency, and shows the need to consider immunodeficiency in such patient's." A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Respiratory tract infection, Scab, Selective IgA immunodeficiency, T-lymphocyte count decreased, Transfusion
Clinical narrative: It was reported in a published article, title as stated above that: "Rational" Immunodeficiency should be considered in children with severe failure-to-thrive prior to administration of live vaccines. Methods: A 17 month old male with failure-to-thrive presented to the allergy consult service 14 days after a presentation to the ED with prolonged fever (Tmax 103F) and erythematous papules on his face. A respiratory infection had been diagnosed in the ED and treated with amoxicillin. Fevers persisted, and the rash evolved into grouped papules, vesicles, and crusting lesions over the face and abdomen. Past medical history revealed a growth curve below the 3rd percentile for height and weight, but no prior hospitalization or serious infection. The live attenuated varicella vaccine had been given approximately 14 days before the ED presentation. Results: Varicella infection was confirmed by direct immunofluorescence assay, and a Tzank stain showed multinucleated giant cells. Severe lymphopenia was evident, with 1% lymphocytes (57/mm3), along with decreased immunoglobulins (152 (IgG), 25 (IgM) and 10 (IgA) mg/dL) and T, B and NK cells (CD3: 27.4%, CD4: 14.7% (6/mm3), CD8: 10.3% (4/mm3), CD19 6.3%, CD16: 32.5%). The patient was transferred to a hospital after initiation of acyclovir and IVIG. Expanded lymphocyte enumeration confirmed markedly decreased T (CD3 (55/mm3), CD4 (51/mm3), CD8 (7/mm3)), B (CD19 0/mm3), and CD3+CD56+ NKT cells (6/mm3), and slightly decreased CD3-CD56+ NK cells (150/mm3). SCID was diagnosed. After RBC transfusion, lab tests revealed low levels of adenosine deaminase (ADA) (16.8 nmol/h/mg, normal 63) and increased levels of deoxyadenosine nucleotides (0.056 imol/mL, normal <0.002) in the hemosylate. Lymphocyte proliferation to PHA was decreased but present (21,377 CPM, background 189; Control 188.330, background 126). Pegylated-ADA was started at 187.5 IU IM twice weekly. Levels of ADA, lymphocyte subsets and IgG are being monitored, and after two weeks of therapy the lymphocyte count increased to 560/mm3. Conclusion: This case demonstrates the consequence following administration of a live vaccine to a child with severe failure-to-thrive who had undiagnosed SCID. To the author's knowledge, this is the first published report of disseminated cutaneous varicella infection after vaccination as the presenting symptoms of SCID-ADA deficiency, and shows the need to consider immunodeficiency in such patient's." A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: It was reported in a published article, title as stated above that: "Rational" Immunodeficiency should be considered in children with severe failure-to-thrive prior to administration of live vaccines. Methods: A 17 month old male with failure-to-thrive presented to the allergy consult service 14 days after a presentation to the ED with prolonged fever (Tmax 103F) and erythematous papules on his face. A respiratory infection had been diagnosed in the ED and treated with amoxicillin. Fevers persisted, and the rash evolved into grouped papules, vesicles, and crusting lesions over the face and abdomen. Past medical history revealed a growth curve below the 3rd percentile for height and weight, but no prior hospitalization or serious infection. The live attenuated varicella vaccine had been given approximately 14 days before the ED presentation. Results: Varicella infection was confirmed by direct immunofluorescence assay, and a Tzank stain showed multinucleated giant cells. Severe lymphopenia was evident, with 1% lymphocytes (57/mm3), along with decreased immunoglobulins (152 (IgG), 25 (IgM) and 10 (IgA) mg/dL) and T, B and NK cells (CD3: 27.4%, CD4: 14.7% (6/mm3), CD8: 10.3% (4/mm3), CD19 6.3%, CD16: 32.5%). The patient was transferred to a hospital after initiation of acyclovir and IVIG. Expanded lymphocyte enumeration confirmed markedly decreased T (CD3 (55/mm3), CD4 (51/mm3), CD8 (7/mm3)), B (CD19 0/mm3), and CD3+CD56+ NKT cells (6/mm3), and slightly decreased CD3-CD56+ NK cells (150/mm3). SCID was diagnosed. After RBC transfusion, lab tests revealed low levels of adenosine deaminase (ADA) (16.8 nmol/h/mg, normal 63) and increased levels of deoxyadenosine nucleotides (0.056 imol/mL, normal <0.002) in the hemosylate. Lymphocyte proliferation to PHA was decreased but present (21,377 CPM, background 189; Control 188.330, background 126). Pegylated-ADA was started at 187.5 IU IM twice weekly. Levels of ADA, lymphocyte subsets and IgG are being monitored, and after two weeks of therapy the lymphocyte count increased to 560/mm3. Conclusion: This case demonstrates the consequence following administration of a live vaccine to a child with severe failure-to-thrive who had undiagnosed SCID. To the author's knowledge, this is the first published report of disseminated cutaneous varicella infection after vaccination as the presenting symptoms of SCID-ADA deficiency, and shows the need to consider immunodeficiency in such patient's." A copy of the published article is attached as further documentation of the patient's experience.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Patient given an expired dose of Flumist. Dose expired on 1-10-08. Given on 01-23-08.
Age: 1.23
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Mother noted small red bumpy rash on both legs and few days after vaccinations.
Age: 41.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient recieved influenza vaccination on 12-21-2007 Sanofi U2509AA 06-30-2008 in the R deltoid. Good site location was noted when complaint was stated.  Pt. c/o of local site pain/discomfort on 01-22-2008.  Client stated that after 2-3 weeks of injection pt. presented to same clinic and saw LVN and stated she still had site pain and discomfort with movement that radiated to the tricep area on the right arm.  LVN told her to stop taking ASA and start taking acetaminophen for the discomfort/pain.  No report was filed to lead nurse at the time.  On 01-22-2008 pt presented to R.N. and restated symptoms with c/o of "lightening pain" when she lifts her right arm over the height of her shoulder.  Client has no insurance and wants pmd evaluation.  I directed her to my supervisor with instructions to file her complaints/expectations in writing with a copy of a picture her husband took 2 weeks after the injection, ASAP.  I also gave her my supervisor name/address/phone, my name, nurses names.  I asked if she had tried any NSAIDs for the discomfort and asked if she has any allergies/stomach ulcers/liver or kidney disease.  She stated no, I recommended ibuprofen 200mg tabs ii po q8hrs x 3 days with meals and outlined possible stomach problems that may occur and to stop if they occur. I also stated that if no relieve or lessing of discomfort was noted after 3 days to stop the NSAIDs. pt. stated understanding and left with that information. The next day I called the immunization coordinator for the county and left a message for her to contact me regarding this patient then I completed the VAERS form via email while I awaited her response.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 16 week old female who was vaccinated with Rotateq.  Subsequently, the patient experienced bloody stool.  The patient sought unspecified medical attention.  Upon internal review, bloody stool was determined to be an other important medical event.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Lethargy, Vomiting
Clinical narrative: Information has been received from a nurse concerning an 8 month old female who on 06-JUN-2007 was vaccinated with the first dose of Rotateq (Lot # 656393/0240U). On 19-SEP-2007, the patient was vaccinated with the second dose of Rotateq (Lot # 657522/0769U). On 09-JAN-2008 the patient came into the office lethargic and spitting up. The patient was sent to a local hospital and was transferred to another hospital where she was admitted. The patient had surgery on 09-JAN-2008 for intussusception. As of 10-JAN-2008, the patient was "stabilized". The nurse felt that the intussusception was life-threatening and an other important medical event. A lot check has been requested. Additional information has been requested. 3/14/08-records received for DOS 1/9-1/11/08-DC DX: Intussusception. Hx of 1 bloody stool, vomiting and lethargy. Refused to eat.  Exploratory laparotomy with reduction of intussusception and appendectomy.