chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Malaise, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 4/14/2006 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). On 4/17/2006, the patient presented with a rash which was all over the child's body. The physician noted that the child had not been feeling well on the date of vaccination, but did not have a fever. The physician did not thing that the rash was related to therapy with measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Information has been received from a nurse concerning a 12 month old female with no allergies who on 4/14/2006 was vaccinated SC with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot 651815/0950R). There was no concomitant medications. On 4/24/2006 the patient presented with a perfuse erythematous papular rash all over her whole body including in her mouth. She also had a fever. There were no labs or diagnostics per. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 6 year old male who was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Subsequently the patient developed cellulitis. Unspecified medical attention was sought. The patient was treated with unspecified antibiotics and subsequently recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a physician concerning a patient who on approximately 4/12/2006 was vaccinated with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Subsequently, approximately 4/12/2006, the patient developed an eraser like bump at the injection site. At the time of the report the patient had not yet recovered. Unspecified medical attention was sought. No lab diagnostic tests were preformed. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-month-old male with no medical history or allergies, who on 11-APR-2006 was vaccinated subcutaneously in the left thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine (+) varicella virus vaccine live.  Concomitant vaccination given on that same day, included a dose of Hib conj vaccine.  On the same day of vaccination, 11-APR-2006, the patient developed a "red spot" at the injection site.  Medical attention was sought and no treatment was recommended and no laboratory or diagnostic tests were performed.  At the time of the report the "red spot" at the injection site persisted.  No product quality complaint was involved.  Additional information has been requested
Age: 1.85
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a child who recently, in approximately April 2006 was vaccinated with a dose of MMR II.  In approximately April 2006, the child experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information is not expected.
Age: 1.05
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a child who recently, in approximately April 2006, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/29/2006. Information has been received from a registered nurse concerning a 12 month old female who on 01-MAY-2006, was vaccinated SC in the "left" with a first dose of PROQUAD (Merck upgrade process) (lot #652545/0926R). On 02-MAY-2006, the patient experienced a fever of 103.5 for 48 hours. Unspecified medical attention was sought. The patient's outcome was recovered. A product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Agency abd was rekeased by the regulatory agency. No further information is expected.
Age: 1.13
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a child who recently, in approximately April 2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot# 652545/0926R).  In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a child who recently, in approximately April 2006, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  In approximately April 2006, the patient experienced a fever equal to greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements was released.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a child who recently, in approximately April 2006, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a child who recently, in approximately April 2006, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was releases.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a child who recently, in approximately April 2006, was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot 652545/0926R). In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees F. A product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 5/1/06 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot 652231/0773R). 24 hours later, on 5/2/06, the patient experienced a fever of 104 degrees F. At the time of the report the fever had persisted. it was noted that the physician had ordered blood studies. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 2 year old male who was vaccinated in the thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Subsequently the patient experienced a rash across the injection site on his thigh. Unspecified medical attention was sought. The patient was treated with Benadryl and his rash improved. At the time of the report, the patient was recovering. There was no product quality complaint involved. Additional information has been requested. The patient's rash was considered to be an other important medical event. (OMIC)
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female with no allergies, who was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Subsequently, seven days after receiving the vaccination, the patient developed a fever and eleven days post vaccination she developed a measles like rash. Unspecified medical attention was sought. The child was treated with diphenhydramine hydrochloride Benadryl. The outcome was reported as recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old female twin who was vaccinated on an unspecified date with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). On 5/10/2006, the patient developed a measles like rash. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The reporter indicated that the patients twin sister experienced an adverse event following vaccination WAES0606USA00914. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Body temperature normal, Pyrexia, Rash, Rash erythematous, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 4/28/06 was vaccinated SC with a 0.5mL dose of MMR and varicella virus vaccine live. On approximately 4/28/06, shortly after the dosing, the patient developed a rash of about 5 to 10 lesions on the feet. Diphenhydramine hydrochloride was given. Unspecified medical attention was sought. There was no product quality complaint involved. The physician considered the event to be an other important medical event (OMIC). Additional information has been requested. There was no illness at the time of vaccination. On 09-MAY-2006. "shortly after the dosing", the patient developed a rash of about 5 to lesions on the feet. BENADRYL was given. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that on 09-MAY-2006, 11 days post vaccination, the patient was seen for fever to 101-102 degrees and a maculopapular rash. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Subsequently, following vaccination, the patient developed a stiff neck. It was unspecified if medical attention was sought. It was reported that the patient still has a stiff neck at the time of this report. No product quality complaint was involved. No further information is available.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 1 year old patient who in the middle of March 2006 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Two days after being vaccinated, the patient developed a fever of 103 degrees. medical attention was sought. The high fever lasted for four days. Six days after being vaccinated, the child's temperature returned to normal. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Subsequently, the patient developed swelling at the injection site. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of MMR II/ varicella Virus Vaccine live (upgrade process). Subsequently, the patient developed swelling at the injection site. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old female twin who was vaccinated on an unspecified date with a 0.5 ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). On 5/10/2006, the patient developed a varicella like rash. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The reporter indicated that the patients twin sister experienced an adverse event following vaccination WAES0605USA02016. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a patient with a birth twin who was vaccianted subcutaneously on an unspecified date with a 0.5 ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot unknown). Subsequently, the patient developed an elevated white blood cell count of 19. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The physician reported that the patients sibling experienced an adverse reaction following vaccination WAES0606USA01411. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who on 5/31/2006 was vaccinated subcutaneously with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot 652234/0951R). On an unspecified date following vaccination, the patient developed a rash. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who on 6/2/06 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot 652234/0951R). On 6/2/2006, as soon as the needle was inserted in  the injection site the patient experienced an injection site red raised hive the size of a silver dollar. Medical attention was sought. The hive continued to increase in size and the patient was given an injection of diphenhydramine hydrochloride Benadryl which stopped the reaction. Subsequently, the patient recovered as of 6/5/2006. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a patient with a birth twin who was vaccinated subcutaneously on an unspecified date with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot unknown).  Subsequently, the patient developed an elevated white blood cell count of 16.2.  Unspecified medical attention was sought.   No outcome was reported.  No product quality complaint was involved.  The physician also reported that the patient's twin experience an adverse event following vaccination.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: The child's arm is hot, red and swollen, put ice on it today.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Injection site pain, Nausea, Tongue oedema, Vomiting
Clinical narrative: Client very apprehensive and anxious prior to adm of vaccine. Shortly after adm of Td client c/o lightheadedness, nauseated. Verbalized vomiting when she arrived home. Client verbalized that "my tongue started to swell", says she took Benadryl 2 capsules and slept for a while, verbalizes her arm is sore. After she awoke tongue normal.
Age: 10.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain upper, Headache, Listless, Pyrexia
Clinical narrative: IM injection on 06/27/06 by evening pt was c/o stomach ache and ran low grade temp. By next morning 6/25/06 was listless, still with low grade temp and associated HA. No skin reaction at site of injection. By evening 6/28/06 no fever.
Age: 35.0
Sex: M
Vaccine: MMR, TD
Symptoms: Unintended pregnancy
Clinical narrative: Pt positive pregnancy not known at time of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received MMR vaccine on 5/24/06. Presents today with swelling and redness around injection site.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site rash, Rash vesicular, Tenderness
Clinical narrative: H/o varicella vaccine given 6/21/06 to Left arm. C/o left arm redness, reddened area one inch in diameter, tender to touch, and warm to touch and mild rash. Dx'd chickenpox mild.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: H/o varicella vaccine given 6/21/06 to Left arm. C/o left arm redness, reddened area one inch in diameter, tender to touch, and warm to touch and mild rash. Dx'd chickenpox mild.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Urticaria, wheel, c/o R deltoid approx 4cm diameter.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Mother noticed 6/29/06 at approx 11:00AM that child was breaking out all over stomach, legs and arms. At first thought was bug bite, but noticed was acting bigger and spreading. Child brought into clinic and notice whelps on arms and stomach. Child constantly scratching and c/o itching. Mother stated put on anti itching cream that made child feel better.
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Scrotum, stomach, legs, back, buttock, head 50 lesions.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Pain, Rash, Throat tightness
Clinical narrative: Swelling of arm, pain, rash as well as swelling of her throat. ER 6/28.Tx with ?? and Benadryl. Treated with Keflex 500 mg QID for 1 week begining 6/30.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Ten minutes after injection patient complained of severe itching.  Dime sized redness noted at injection site.  Patient was provided with an ice pack and instructed to use some Benadryl.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash developed around injection site.  Hot to touch, raised.  Rapidly developed (with in one hour of injection).
Age: 1.02
Sex: M
Vaccine: HEP, HIBV, MMR, OPV
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with Shingles by Dr.
Age: 1.27
Sex: F
Vaccine: HBHEPB, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: Injection site reaction, brought to the clinic 2 days post vaccination with varivax, Hepatitis A vaccine (Vaqta), and Comvax given in right thigh.  Pt has 4 cm area of redness  and induration, warm to touch at injection site. Injection given 7/3/06. Low grade temp (99.5) Instructed to give Motrin, use cool compresses and tea bags on site. To follow up if not better in the next 2-3 days.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Last night mom noticed redness and swelling on the patient's left leg. less swollen and red today. on exam today splotchy redness on nearly the entire anterior left thigh. not painful. slightly warm and raised.
Age: 1.26
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with Shingles on 06-30-2006.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema multiforme, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician and described the occurrence of erythema multiforme in a female subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On an unspecified date, the subject received an unspecified dose of Pediarix (unk). After an unspecified time after vaccination with Pediarix, the subject experienced erythema multiforme. The physician reported that this erythema has occurred always with Pediarix. The physician reported that the subject is an allergy pt of his. He also reported that the only other times the subject had experienced this reaction was with Poli Vi Flor and other Pediarix immunizations. This case was assessed as medically serious by manf (OMIC). At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with Pediarix.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Abortion spontaneous, Laboratory test abnormal, Pelvic pain, Thrombosis, Vaginal haemorrhage
Clinical narrative: This 20-year-old female subject was enrolled in a blinded study (580299 099) for the prophylaxis of cervical intraepithelial neoplasia (CINII) associated with human papillomavirus (HPV); 16 and/or HPV-18 in health young females. The subject received intramuscular investigational product single dose on 09/21/2005, 11/01/2005 and 03/01/2006 after negative urine pregnancy test. Site of injection was the left deltoid. On 09/21/2005, 11/01/2005 and 03/01/2006, the subject received the first, second and third intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of Havrix vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug AL (OH) 3. Lot number was not provided.  On 05/22/2006, 82 days after the third dose of Blinded vaccine, this 20-year-old subject developed abundant vaginal bleeding with clots associated with pelvic pain. (last menstrual period: 03/15/2006, the subject was exposed to the vaccine before conception). On 05/28/2006, the vaginal bleeding stopped. On 05/09/2006, the subject performed a blood pregnancy test which was positive. the microbiologist indicated that the result was only slightly positive and recommended her to visit a doctor because it could be a miscarriage. The subject didn't consult a doctor because the vaginal bleeding stopped on 05/28/2006 and she felt well. On 06/05/2006, she was evaluated by the study doctor. He documented a closed, formed cervix, without vaginal bleeding, an uterus with normal height and doubtful urine pregnancy test (non serous adverse event). On 06/09/2006, when she was 12+1 weeks pregnant according to the date of last menstrual period, a quantified HCG test was performed. On 06/20/2006, the result of this test was received: 96 UI/L (normal values after 3-4 weeks pregnancy: 15-150 UI/L). The subject was finally diagnosed as having had a complete spontaneous miscarriage since she presented with vaginal bleeding and a positive blood pregnancy test with decreased HCG. The event resolved on 05/28/2006. The subject will continue in the study. The investigator reported the complete spontaneous abortion as possibly related to investigational product due to the temporal association between the last vaccine dose administration and the date of the last menstrual period. This event has been considered to be medically important. (OMIC)
Age: 23.0
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Cellulitis, Dehydration, Erythema, Fatigue, Influenza like illness
Clinical narrative: Pt was inoculated with primary SPV on 6/8/06. He developed flu-like sxs 7-10 days later and went to after hours clinic who diagnosed him with dehydration and eventually cellulitis. He was admitted to hospital on 06/22/06. Symptom: fever -start: 06/16/06, end: 06/20/06. Comment: started about 1 wk after SPV inoculation. Symptom: Flu-like symptoms>96 hrs. Start: 06/16/06, end: 06/22/06 comment: see HPI. Symptom: Muscle pain start: 6/18/06, end: 06/22/06 comment: reported diffuse muscle aches. Symptom: erythema start: 06/16/06, end: 06/22/06 comment: increased erythema over the left shoulder. Medical records state fatigue, malaise. msv
Age: 23.0
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Laboratory test abnormal, Malaise, Myalgia, Pyrexia
Clinical narrative: Pt was inoculated with primary SPV on 6/8/06. He developed flu-like sxs 7-10 days later and went to after hours clinic who diagnosed him with dehydration and eventually cellulitis. He was admitted to hospital on 06/22/06. Symptom: fever -start: 06/16/06, end: 06/20/06. Comment: started about 1 wk after SPV inoculation. Symptom: Flu-like symptoms>96 hrs. Start: 06/16/06, end: 06/22/06 comment: see HPI. Symptom: Muscle pain start: 6/18/06, end: 06/22/06 comment: reported diffuse muscle aches. Symptom: erythema start: 06/16/06, end: 06/22/06 comment: increased erythema over the left shoulder. Medical records state fatigue, malaise. msv
Age: 1.02
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Decreased appetite, Diarrhoea, Irritability, Pyrexia, Rash
Clinical narrative: Fever between 101 and 102, fussy, decreased appetite, no URI, no cough, no vomit and diarrhea, no rash, no stomatitis, urine clear as per ER, CXR said to be clear, temp increased to 105 rect., went transported in air conditioned car. Pt came into office 7/1/06 with diarrhea, then 7/2/06 with body rash.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Hypokinesia, Injection site pain, Insomnia, Pain
Clinical narrative: When injected vaccine hurt going in left arm, became very sore just below injection site to just above the elbow. Could not sleep on that side nor could I raise that arm above my head without it hurting. This went on until the following Sunday (1 wk) 6/18/06.  It started feeling better and I am now able to sleep on that arm. However, it still is minimally sore up on vaccination site.
Age: 1.48
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Anorexia, Diarrhoea, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Severe diarrhea, anorexia, irritability, fever 100.2, runny nose
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Bacterial infection, Diarrhoea, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Local reaction, erythema, 1/4cm, swelling size of a grape. 3 episodes vomiting, 2 of diarrhea. Pt had unconfirmed case of Pertussis after 2nd round of Pediarix, Pedvax Hib and Prevnar. Neg PCR essay for pertussis. Lab questioned verocity of given length sample which caused it and that it was taken after initiating abx therapy.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Increased redness, swelling at injection site, systemic symptoms of chills/sweats, malaise.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Left arm swollen, red, streaked, tender, given 7/3/06 reaction started 7/4/06 Cefzil 250 bid x 10 days. Benadryl, cold compress.
Sex: U
Vaccine: MMRV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Subsequently, the patient developed swelling at the injection site.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Diabetes mellitus, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient in her mid 60's with diabetes who was on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot unknown). The patient could not remember getting a previous vaccination.  However, after the vaccination, the office personnel discovered that the patient had received it 3 months earlier.  Concomitantly she was on several medications ( therapy unspecified).  Subsequently, on an unknown date, the patient developed a severe local reaction involving the entire deltoid region which was hot hard, and swollen.  The patient was treated with (ZYRTEC) and with anti-inflammatory mediation.  Within three days of treatment the patient improved.  Patient's present status was reported as recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Bone disorder, Gastrointestinal disorder, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 90 year old female patient with osteoarthritis, osteopenia, gastroesophageal reflux disease, psoriasis, and no known allergies, who on 10-NOV-2005 was vaccinated (route unknown) with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included calcium (unspecified), vitamins (unspecified) and propranolol HCL (Inderal).  On 10-NOV-2005, the patient had a reaction at the injection site which included redness with a discoloration, swelling, hardness and pain. On 16-NOV-2005 the patient was treated with ice, acetaminophen (TYLENOL), and diphenhydramine hydrochloride (BENADRYL).  The patient's present status was reported as not recovered.  No product quality complaint was involved.  No additional information is expected.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Skin discolouration, Skin disorder
Clinical narrative: Information has been received from a certified medical assistant concerning a 90 year old female patient with osteoarthritis, osteopenia, gastroesophageal reflux disease, psoriasis, and no known allergies, who on 10-NOV-2005 was vaccinated (route unknown) with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included calcium (unspecified), vitamins (unspecified) and propranolol HCL (Inderal).  On 10-NOV-2005, the patient had a reaction at the injection site which included redness with a discoloration, swelling, hardness and pain. On 16-NOV-2005 the patient was treated with ice, acetaminophen (TYLENOL), and diphenhydramine hydrochloride (BENADRYL).  The patient's present status was reported as not recovered.  No product quality complaint was involved.  No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered respiratory therapist concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced an adverse event.  The patient's outcome was unknown.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a 65 year old female, with unknown medical history, history and unknown drug reactions/allergies, who on  04-APR-2006 was vaccinated (route unknown) with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 14-APR-2006 the patient experienced pain at the injection site, fever, chills and fatigue after receiving the vaccination.  The patient's status was reported as not recovered.  Unspecified medical attention was sought.  No product quality compliant was involved.  Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: FLUX, SMALL, FLUX, SMALL
Symptoms: Fatigue, Injection site pain, Laboratory test abnormal, Myocarditis, Pulmonary oedema
Clinical narrative: Initial report received on 26Jun06 from a newspaper article, which was printed in the 24Jun06 edition of the newspaper. A 26 yr old male pt, who was a soldier, received a dose of influenza vaccine and a dose of smallpox vaccine on 18Nov05. The trade names, manufacturers, lot numbers, routes and site of admin were not reported. 16 days after receiving the vaccines, the soldier died. Autopsy tests showed inflammation of the heart muscle. The military physicians who reviewed the pt's case did not find the vaccinia virus, the main ingredient of smallpox vaccine, in the soldier's heart muscle, however they did find evidence of parvovirus B19 and concluded that the vaccines might have caused (the soldier's) death. No other information was available at the time of this report. Follow up information was received from a health care professional on 27Jun06. The smallpox vaccine that was administered was Dryvax. The lot number was not reported, but per the reporter was one lot number for all. The trade name, manf and lot number for the influenza vaccine was not reported. At the time of vaccination, the pt was taking Motrin (one dose from prescription for vaccine side effects) and an alternative medication supplement known as NitroT3, which the reporter states did not appear to contain any active ingredients associated with cardiac effects. The pt had no past medical history of immune problems, anemia, HIV or cancer. He had no history of joint problems. He did have a history of boils on the back as per his mother, but they were never seen by anyone and were not evident at the time of autopsy. The pt presented as dead on arrival and no blood was available for IgM for parvovirus B19. The military is working on obtaining historical sera for serologies. The histology was not consistent with parvovirus B19 and PCR testing will need to be repeated per lab recommendation. The possibility of specimen contamination cannot be ruled out. Additional testing of the liver is planned. As per the reporter, the final autopsy findings was eosinophilic myopericarditis consistent with vaccinia associated myopericarditis.
Age: 26.0
Sex: M
Vaccine: FLUX, SMALL, FLUX, SMALL
Symptoms: Pyrexia, Shoulder pain, Sleep disorder, Sudden death
Clinical narrative: Initial report received on 26Jun06 from a newspaper article, which was printed in the 24Jun06 edition of the newspaper. A 26 yr old male pt, who was a soldier, received a dose of influenza vaccine and a dose of smallpox vaccine on 18Nov05. The trade names, manufacturers, lot numbers, routes and site of admin were not reported. 16 days after receiving the vaccines, the soldier died. Autopsy tests showed inflammation of the heart muscle. The military physicians who reviewed the pt's case did not find the vaccinia virus, the main ingredient of smallpox vaccine, in the soldier's heart muscle, however they did find evidence of parvovirus B19 and concluded that the vaccines might have caused (the soldier's) death. No other information was available at the time of this report. Follow up information was received from a health care professional on 27Jun06. The smallpox vaccine that was administered was Dryvax. The lot number was not reported, but per the reporter was one lot number for all. The trade name, manf and lot number for the influenza vaccine was not reported. At the time of vaccination, the pt was taking Motrin (one dose from prescription for vaccine side effects) and an alternative medication supplement known as NitroT3, which the reporter states did not appear to contain any active ingredients associated with cardiac effects. The pt had no past medical history of immune problems, anemia, HIV or cancer. He had no history of joint problems. He did have a history of boils on the back as per his mother, but they were never seen by anyone and were not evident at the time of autopsy. The pt presented as dead on arrival and no blood was available for IgM for parvovirus B19. The military is working on obtaining historical sera for serologies. The histology was not consistent with parvovirus B19 and PCR testing will need to be repeated per lab recommendation. The possibility of specimen contamination cannot be ruled out. Additional testing of the liver is planned. As per the reporter, the final autopsy findings was eosinophilic myopericarditis consistent with vaccinia associated myopericarditis.
Age: 26.0
Sex: M
Vaccine: FLUX, SMALL, FLUX, SMALL
Symptoms: Cardiac disorder, Eosinophilia, Medication error, Pericarditis, Viral infection
Clinical narrative: Initial report received on 26Jun06 from a newspaper article, which was printed in the 24Jun06 edition of the newspaper. A 26 yr old male pt, who was a soldier, received a dose of influenza vaccine and a dose of smallpox vaccine on 18Nov05. The trade names, manufacturers, lot numbers, routes and site of admin were not reported. 16 days after receiving the vaccines, the soldier died. Autopsy tests showed inflammation of the heart muscle. The military physicians who reviewed the pt's case did not find the vaccinia virus, the main ingredient of smallpox vaccine, in the soldier's heart muscle, however they did find evidence of parvovirus B19 and concluded that the vaccines might have caused (the soldier's) death. No other information was available at the time of this report. Follow up information was received from a health care professional on 27Jun06. The smallpox vaccine that was administered was Dryvax. The lot number was not reported, but per the reporter was one lot number for all. The trade name, manf and lot number for the influenza vaccine was not reported. At the time of vaccination, the pt was taking Motrin (one dose from prescription for vaccine side effects) and an alternative medication supplement known as NitroT3, which the reporter states did not appear to contain any active ingredients associated with cardiac effects. The pt had no past medical history of immune problems, anemia, HIV or cancer. He had no history of joint problems. He did have a history of boils on the back as per his mother, but they were never seen by anyone and were not evident at the time of autopsy. The pt presented as dead on arrival and no blood was available for IgM for parvovirus B19. The military is working on obtaining historical sera for serologies. The histology was not consistent with parvovirus B19 and PCR testing will need to be repeated per lab recommendation. The possibility of specimen contamination cannot be ruled out. Additional testing of the liver is planned. As per the reporter, the final autopsy findings was eosinophilic myopericarditis consistent with vaccinia associated myopericarditis.
Age: 27.0
Sex: F
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site erythema, Latex allergy, Pruritus
Clinical narrative: Pt was administered the hep A and yellow fever vaccines on 6/21/06 at approx 9:45AM. She had no rxn at this time and when she left our office she was fine. Pt called at approx 11 AM with c/o rash and difficulty breathing (SOB). Pt advised to go to the ER.
Age: 27.0
Sex: F
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Rash, Urticaria, Vaccination complication
Clinical narrative: Pt was administered the hep A and yellow fever vaccines on 6/21/06 at approx 9:45AM. She had no rxn at this time and when she left our office she was fine. Pt called at approx 11 AM with c/o rash and difficulty breathing (SOB). Pt advised to go to the ER.
Age: 27.0
Sex: F
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Dyspnoea, Rash
Clinical narrative: Pt was administered the hep A and yellow fever vaccines on 6/21/06 at approx 9:45AM. She had no rxn at this time and when she left our office she was fine. Pt called at approx 11 AM with c/o rash and difficulty breathing (SOB). Pt advised to go to the ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt arm has soft ball sized swollen area that is red and warm to touch.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Quarter size reddened and warm to touch area Lt upper outer thigh area.
Age: 1.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Convulsion, Influenza, Pneumonia, Pyrexia
Clinical narrative: 105 temp, seizure-seen in ER, also diagnosed with stomach flu, 2 weeks later had pneumonia seizure with high fever, seen at hospital
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: On L arm where DTAP and Hib were administered, there is redness, induration and is warm to the touch.
Age: 21.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Rt upper arm redness, swelling and warm to the touch. Pt reports some itching feelings. Started 7/4/06 evening around the injection site. Reports to clinic 7/5/06 at 08:00 AM for evaluation.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Redness, swelling, warm to touch and increasing pain radiating up neck Lt upper arm. Increased temperature and feels sick.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pyrexia
Clinical narrative: Redness, swelling, warm to touch and increasing pain radiating up neck Lt upper arm. Increased temperature and feels sick.
Age: 60.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Two days after TDAP, pt states her arm swelled, that it was very hot, burning and red. States that she had a lot of pain and a moderate (?) fever for the 3 days that the symptoms were present. The correlation of symptoms lasted for approximately 3 days.
Age: 18.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Dehydration, Infection, Lethargy, Nausea, Pyrexia
Clinical narrative: Onset 6/18/06 low-grade temp (100), lethargy, nausea. 6/19/06-6/20/06-To ER, Re-hydrated, given K+ tablets, continued low-grade temp, nausea. Rash developed on 6/22/06. To ER for re-hydration after seen by MD; To MD (Dermatologist) for biopsy of back lesion 6/26/06. MD confirmed DX: "chickenpox". To see MD on 6/29/06 for follow-up. Recovering per mother 6/28/06.
Age: 6.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Medication error
Clinical narrative: Pt was given TDAP (Adacel) instead of DTAP to complete primary series accidentally. Will need to follow-up for DTAP. No adverse event. Pt given wrong vaccine and must return for correct one.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Injection site reaction, Malaise, Pyrexia, Vomiting
Clinical narrative: TDAP 6/28/06 about six hours later, c/o not feeling well, fever, dizzy and vomited a few times that evening. 24 hours later, symptoms resolved; left only with large local reaction at injection site.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: TDAP to right deltoid on 6/13/06. Swelling next day; then swelling decreased 6/16 but worsened 6/17/06-6/18/06. On 6/19/06, had marked induration 60mm X 80mm with hardened tender center of 2 1/2cm.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: C/o redness, swelling and extremely tender to touch.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: Pain to left deltoid; swelling to left neck on set 24 hours after injection, no temp, swelling is painful.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Noticed redness to site 72 hours after injection. Site today is sized as 40mmx32mm, warm to touch; site mildly sore.