chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Cold sweat, Convulsion, Gait disturbance, Malaise
Clinical narrative: 5:30PM 3/4/11 Child was clammy and complaining that he felt sick like he was going to throw up. 6:30PM 3/4/11 Child was extremely weak and not able to walk real well so he sat down. Child burning up, parent not sure how high fever was they were away from home and did not have access to thermometer. Mother medicated child with ibuprofen.  10:30PM 3/4/11 Sibling alarmed parents that something was wrong with his brother in bed. Mother ran to him to find him convulsing and not responding to her. They were getting ready to go to ER and she picked up the child and he vomited. After that child spoke to the parents and he fell asleep. Child the next morning was otherwise sleepy, but more himself. To this date, child has been fine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Somnolence, Unresponsive to stimuli, Vomiting
Clinical narrative: 5:30PM 3/4/11 Child was clammy and complaining that he felt sick like he was going to throw up. 6:30PM 3/4/11 Child was extremely weak and not able to walk real well so he sat down. Child burning up, parent not sure how high fever was they were away from home and did not have access to thermometer. Mother medicated child with ibuprofen.  10:30PM 3/4/11 Sibling alarmed parents that something was wrong with his brother in bed. Mother ran to him to find him convulsing and not responding to her. They were getting ready to go to ER and she picked up the child and he vomited. After that child spoke to the parents and he fell asleep. Child the next morning was otherwise sleepy, but more himself. To this date, child has been fine.
Age: 10.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient's right upper arm developed swelling and redness the evening of 3/2/11. By 3/4/11 patient had developed a 12cm x 6cm area of erythema with a 6cm x 4 cm area of darker red in the center. The injection site was within the center. Area was warm to touch and itched.  Patient was seen at Walk In Clinic by PA-C. Patient was told to use oral Benadryl for itching.
Age: 22.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site vesicles
Clinical narrative: blister at near sight near probable hep a injection
Age: 1.46
Sex: M
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: PATIENT HAS HX OF SEIZURE DISORDER. RECEIVED MMR VACCINE ON AM OF 03/08/2011. TO THE EMERGENCY ROOM APPROXIMATELY 90 MINUTES LATER WITH SEIZURES.  DIAGNOSIS: SEIZURE ACTIVITY WITH SEIZURE DISORDER.  LAST REPORTED SEIZURE PRIOR TO THIS WAS 02/19/2011.  KEPPRA WAS INCREASED FROM 5.5 BIB TO TID AFTER DISCUSSING CASE WITH PEDIATRIC NEUROLOGIST AND ALSO OTHER DR.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia, Vomiting
Clinical narrative: Shots given 12/15/10 child's arm was warm, red and causing pain 2 days after vaccine was administered. Mother states child had fever of 101.3 at home and vomiting. Fever and vomiting began the night vaccines were given and continued the day after. Child temp now 97.1 oral. Called on 12/20/10 child is better no fever, no redness, no pain, according to mother.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture negative, CSF test abnormal, Pyrexia, White blood cell count increased
Clinical narrative: 3/4 - 8 hours after vaccines pt seen for fever sent to ER - hydrated - continued to run fever - admitted 3/6 - WBC 21,000 CSF sl. cloudy - neg cultures so far possible viral meningitis.
Age: 24.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Chills, Disturbance in attention, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Received PPSV23, Hep B, Tdap 3-8-11; Hep B- rt deltoid, Tdap - left deltoid, PPSV23- left upper arm SC. Soon after injections pt c/o pain left arm, took 2 ALEVE (3-8-11); swelling & redness onset 3-9-11, chills/warmth; 3-10-11 nauseated, poor concentrations, vomited x1. Office visit 3-10-11 Temp 102.8, 70cm x 110cm area of erythema/swelling mid/upper left upper arm at PPSV23 inj site. Painful to touch. Had a PE 3-8-11 & was ordered PCN 250 qid/10 days for dental caries. 3-10-11 Ibuprofen 60mg TID & BENADRYL 25mg, 2, qid prn. 3-11-11 spoke with pt afebrile, better ROM Lt arm, less swelling. Recheck 3-14-11.
Age: 24.0
Sex: M
Vaccine: HEP, PPV, TDAP
Symptoms: Nausea, Pain, Pain in extremity, Swelling, Vomiting
Clinical narrative: Received PPSV23, Hep B, Tdap 3-8-11; Hep B- rt deltoid, Tdap - left deltoid, PPSV23- left upper arm SC. Soon after injections pt c/o pain left arm, took 2 ALEVE (3-8-11); swelling & redness onset 3-9-11, chills/warmth; 3-10-11 nauseated, poor concentrations, vomited x1. Office visit 3-10-11 Temp 102.8, 70cm x 110cm area of erythema/swelling mid/upper left upper arm at PPSV23 inj site. Painful to touch. Had a PE 3-8-11 & was ordered PCN 250 qid/10 days for dental caries. 3-10-11 Ibuprofen 60mg TID & BENADRYL 25mg, 2, qid prn. 3-11-11 spoke with pt afebrile, better ROM Lt arm, less swelling. Recheck 3-14-11.
Age: 1.28
Sex: F
Vaccine: MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever to 105 x 3 days.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives developed approx 5 hours after administration of Hepatitis A, first dose. The hives were located on abdomen, top of thighs, & back.
Age: 1.21
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Convulsion, Gaze palsy, Pallor, Pyrexia, Tremor
Clinical narrative: Developed fever 101.2 on the day of vaccination. Next day, on 03/05/2011, developed seizure: eyes rolled up, shaking movement of the body, pallor, nonresponsive. Seizure lasted less than 5 minutes. Seen at ER the same day, observed and discharged home the same day.
Age: 1.21
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: Developed fever 101.2 on the day of vaccination. Next day, on 03/05/2011, developed seizure: eyes rolled up, shaking movement of the body, pallor, nonresponsive. Seizure lasted less than 5 minutes. Seen at ER the same day, observed and discharged home the same day.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling, hot to touch.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Ear infection, Rash
Clinical narrative: Severe rash & left ear infection.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain at injection site with and without touch, soreness with arm movement, difficulty using the arm due to pain.
Age: 39.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pyrexia, Skin warm
Clinical narrative: Patient stated that at the time of the vaccination she had some stinging in her arm, and then a fever of 100.00 to 101.00 that evening with redness, swelling and warmth.  Swelling continued through 03/09/2011 but fever subsided
Age: 39.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: Patient stated that at the time of the vaccination she had some stinging in her arm, and then a fever of 100.00 to 101.00 that evening with redness, swelling and warmth.  Swelling continued through 03/09/2011 but fever subsided
Age: 39.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: Patient stated that at the time of the vaccination she had some stinging in her arm, and then a fever of 100.00 to 101.00 that evening with redness, swelling and warmth.  Swelling continued through 03/09/2011 but fever subsided
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Headache, Pain in extremity, Syncope
Clinical narrative: Two minutes after pt received immunization, a thud was heard and pt was found sitting on the floor. Pt says she felt pain in her arm, was standing & texting on her phone & fell. Next thing she remembered is sitting on floor. Denied nausea, dizziness, neck pain, back pain, numbness. (+) headache. Vitals: pulse 60, BP 110/70 supine; pulse 76, BP 110/60 sitting up. Pt had fainted. She was monitored about 20 minutes. No treatment.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Arthralgia, Arthritis, Blood uric acid normal, Bone cyst
Clinical narrative: Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein increased, Cervical spinal stenosis, Chronic obstructive pulmonary disease, Condition aggravated, Disability
Clinical narrative: Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dyspnoea, Infection, Joint dislocation, Joint swelling
Clinical narrative: Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Labyrinthitis, Lymphocyte count decreased, Mean cell haemoglobin increased, Mean cell volume increased, Musculoskeletal discomfort
Clinical narrative: Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Osteoarthritis, Pain, Red blood cell sedimentation rate increased, Rheumatoid arthritis
Clinical narrative: Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rheumatoid factor increased, Skin warm, Spinal X-ray, Tenderness, X-ray abnormal
Clinical narrative: Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: X-ray limb, X-ray limb abnormal
Clinical narrative: Noted about 1 week after vaccinated. Swelling of hands which comes and goes put on tapering doses of Prednisone which was not effective. Another doctor said he didn't think it was due to vaccine.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site extravasation, Injection site induration
Clinical narrative: About 6cm area of redness, induration, oozing on left arm.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Patient experienced localized redness, swelling, and tenderness that started evening of 3/6/11. Swelling got 5cm in diameter so patient went to see her MD.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Patient received Tdap & PNEUMOVAX (R) upper extremity on 3/9/11 - had immediate onset redness, pain & swelling.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Severe pain and swelling with limited movement of left arm
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Injection site erythema, Vomiting
Clinical narrative: 15 MINUTES AFTER LEAVING THE CLINIC, APPROX 25 MINUTES AFTER RECEIVING VACCINATIONS PT VOMITED AND FELT FAINT.  DEVELOPED 1" REDNESS IN LEFT ARM - DELTOID REGION.  REDNESS LASTED APPROX 24 HOURS.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: ABOUT 3 OR 4 DAYS POST VACCINE ADMINISTRATION, PATIENT REPORTED RED SWOLLEN WELP AT ADMINISTRATION SITE. NO ITCHING OR ANY OTHER SIDE EFFECTS. PATIENT SAYS WELP IS GETTING SMALLER AND DOES NOT BOTHER HER.
Age: 63.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Asthenia, Bedridden, Laboratory test, Muscular weakness, Pain
Clinical narrative: At a very rapid pace, I went from healthy & strong to losing use of arms (pain/weakness), legs (weakness), shoulder/neck/arm/hand extreme pain/burning. Dropped 30 pounds in 3 mos. and bedridden w/in 2 mos. Surgery on spine (fused several vertebra) eventually to find answer & relief. 2-3 year rehab. to gain upper body muscle & weight lost in 3 mos.  Continued chronic pain & shoulder/neck/arm/hand pain and weakness.
Age: 63.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Pain in extremity, Spinal fusion surgery, Weight decreased
Clinical narrative: At a very rapid pace, I went from healthy & strong to losing use of arms (pain/weakness), legs (weakness), shoulder/neck/arm/hand extreme pain/burning. Dropped 30 pounds in 3 mos. and bedridden w/in 2 mos. Surgery on spine (fused several vertebra) eventually to find answer & relief. 2-3 year rehab. to gain upper body muscle & weight lost in 3 mos.  Continued chronic pain & shoulder/neck/arm/hand pain and weakness.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Convulsion, Laboratory test normal, Loss of consciousness, Movement disorder
Clinical narrative: Child passed out and seized for 3 minutes, followed by 2 minutes of unconsciousness. When waking up he was unable to speak or move. Temp of 102.8 when EMS arrived. Appropriate Tylenol dose given in ambulance. 1 hour later at hospital temp was 102.6. Urine tox and labs drawn. All negative. Motrin given at hospital. 1 hour later temp 99.6. Pediatric neuorologist consulted. Sent home with instructions to give meds Q 3 hours until fevers subsided. *****(Child has identical twin that recieved MMR shot at the same time. Twin had fever of 103.2 with one hour of first childs seizures. Both children continue to have temps of 99 to 102 around the clock even with constant meds.)
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Child passed out and seized for 3 minutes, followed by 2 minutes of unconsciousness. When waking up he was unable to speak or move. Temp of 102.8 when EMS arrived. Appropriate Tylenol dose given in ambulance. 1 hour later at hospital temp was 102.6. Urine tox and labs drawn. All negative. Motrin given at hospital. 1 hour later temp 99.6. Pediatric neuorologist consulted. Sent home with instructions to give meds Q 3 hours until fevers subsided. *****(Child has identical twin that recieved MMR shot at the same time. Twin had fever of 103.2 with one hour of first childs seizures. Both children continue to have temps of 99 to 102 around the clock even with constant meds.)
Age: 0.34
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Gastritis, Gastrointestinal inflammation, Haematemesis, Haematochezia, Viral test negative
Clinical narrative: Severe Vomiting after eating a grain that had been introduced numerous times before w/out difficulty.  Inflammation of the stomach. Two other occurrances happened after the first bout of Vomiting...all within a month. Virus was ruled out.  Blood in spit up and stool occured 30 days after vaccine was given.  Inflammation of the stomach and small intestine was diagnosed.
Age: 0.34
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Severe Vomiting after eating a grain that had been introduced numerous times before w/out difficulty.  Inflammation of the stomach. Two other occurrances happened after the first bout of Vomiting...all within a month. Virus was ruled out.  Blood in spit up and stool occured 30 days after vaccine was given.  Inflammation of the stomach and small intestine was diagnosed.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Rash occurred (B) thighs with (R) worse than (L) 3 days after vaccine administration. Rash is erythematous with <1 mm papules.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Oedema peripheral, Paraesthesia, Pharyngeal oedema
Clinical narrative: Pt. called 2 days after immunization to say she had stiff neck, throat felt swollen on left side, gland felt swollen, & pt. had tingling in fingers left hand, with numbness in one finger. Pt. was advised to use pain reliever and to schedule office visit if no improvement by next day.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Pt. states she had aches, chills & fever of 102.5 - evening with aches, chills persisting; injection site sore w/o redness. Pt advised to take ibuprofen for aches/chills/fever.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Dizziness, Dysphagia, Pallor, Tachycardia
Clinical narrative: Feeling faint, pale, wheezing, difficulty swallowing, tight throat, tachycardia. Elevated B/P.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Throat tightness, Wheezing
Clinical narrative: Feeling faint, pale, wheezing, difficulty swallowing, tight throat, tachycardia. Elevated B/P.
Age: 26.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Induration, Pyrexia, Tachycardia, Tenderness
Clinical narrative: 5cm induration and erythema, tenderness, fever, tachycardia.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Blood glucose normal, Blood pressure increased, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Immediately after receiving Hep A she said she "felt funny". She moved from Imms room to waiting room. She hadn't eaten so ate her sub. We used ammonia inhalant & gave her 4 tsp BENADRYL. She started improving & talking etc. Then 15 min later she started going downhill. We laid her on floor with feet elevated & started O2. With no improvement we called 911 - In ER till 7pm.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Sensation of foreign body, Throat irritation
Clinical narrative: Initial report received from a physician on 02 Mar 2011: This patient was vaccinated with second dose of RABIPUR (batch number 486011A) on 17 Feb 2011. The patient had tolerated first dose. Ten minutes after second dose, the patient developed globus pharyngis and had compulsive throat clearing. One hour after vaccination, the patient developed exanthema which led to hospitalization. Final event outcome was reported as completely recovered.
Age: 19.0
Sex: M
Vaccine: HEPAB, RAB
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Initial health care professional report received on 02 Mar 2011: This patient received first dose of RABIPUR (batch number 468013A) intramuscularly into the upper arm on 21 Jun 2010. The patient also received co-suspect, TWINRIX, (batch number AHABB191AC, other manufacturer) intramuscularly into the upper arm on 21 Jun 2010. On 22 Jun 2010 at 5 am, the patient developed thoracal syndrome with dyspnea. The patient was hospitalized on the same day. On 15 Jul 2010, the patient received the next vaccination with RABIPUR (batch number 474011A) without any complications. On 22 Jun 2010, the patient recovered from the events. No causality assessment was reported. Following internal review on 10 Mar 2011 of the information received on 02 Mar 2011, it was noted that the event verbatim term "thoracal syndrome" was incorrectly reported as thoracic outlet syndrome. Therefore, it was corrected to thorax pain.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Central nervous system lesion, Demyelination, Hypoaesthesia, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: [[address]]a ruling released Nov. 17. "The undersigned cannot based an onset on a chimera of transient toe tingling and numbness", special master said. "The onset here is not one month, not three months, far too [[name]] to be medically appropriate for a causative link with hepatitis B vaccine." Only acceptable diagnosis: "The only acceptable diagnosis of onset in this [[name]] is in 1996, two years after petitioner's third hepatitis B vaccination when she did see doctors and complained of recent onset (not numbness and tingling intermittently occurring over two years) and for which there was objective testing, and evidence of lesions occurring over space and time," the special master said. "This objective testing and evidence of lesions occurring over space and time is consonant with the [[name]] criteria, created by the most notable international neurologists as a template for the diagnosis of MS." According to the special master, the 47 year old patient said she had experienced tingling of the toes after her third hepatitis B vaccination on [[name]] 31, 1994. She mentioned it to a physician during a visit on 07-Sep-1994 which would in any [[name]] have been outside the two-month window special master set for MS causation in the omnibus proceeding. In September 1996, the patient consulted neurologist. A magnetic resonance imaging test showed multiple [[name]] white matter lesions consistent with demyelinating disease. Contrast enhancement of two [[name]] lesions was consistent with active lesions. Upon internal review, the multiple sclerosis (MS) was considered to be an other important medical event. No further information is expected.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: [[address]]a ruling released Nov. 17. "The undersigned cannot based an onset on a chimera of transient toe tingling and numbness", special master said. "The onset here is not one month, not three months, far too [[name]] to be medically appropriate for a causative link with hepatitis B vaccine." Only acceptable diagnosis: "The only acceptable diagnosis of onset in this [[name]] is in 1996, two years after petitioner's third hepatitis B vaccination when she did see doctors and complained of recent onset (not numbness and tingling intermittently occurring over two years) and for which there was objective testing, and evidence of lesions occurring over space and time," the special master said. "This objective testing and evidence of lesions occurring over space and time is consonant with the [[name]] criteria, created by the most notable international neurologists as a template for the diagnosis of MS." According to the special master, the 47 year old patient said she had experienced tingling of the toes after her third hepatitis B vaccination on [[name]] 31, 1994. She mentioned it to a physician during a visit on 07-Sep-1994 which would in any [[name]] have been outside the two-month window special master set for MS causation in the omnibus proceeding. In September 1996, the patient consulted neurologist. A magnetic resonance imaging test showed multiple [[name]] white matter lesions consistent with demyelinating disease. Contrast enhancement of two [[name]] lesions was consistent with active lesions. Upon internal review, the multiple sclerosis (MS) was considered to be an other important medical event. No further information is expected.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a health professional concerning a 68 year old female patient who was vaccinated with series of RECOMBIVAX HB from September 1998 to April 1999. Blood work was obtained on 19-DEC-2009 and results obtained on 23-DEC-2009 were "not immune". At the time of the report the status of the patient was unspecified. It was unspecified if the patient sought medical attention. Follow up information has been received from a health professional who reported that the patient would be given again the series of 3 shots of RECOMBIVAX HB and probably in the summer (July 2010 or August 2010). The patient would be sent for testing to make sure immunity took. This is one of several reports received from the same source. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Influenza like illness
Clinical narrative: Information has been received from a pharmacist concerning an adult patient how on 12-JAN-2010 was vaccinated intramuscularly with 2 doses of adult formulation (1 mL) RECOMBIVAX HB (LOT# not reported). No adverse effect was reported. No further information is available at this time of the reporting. Follow-up information has been received which reported that the 44 year old male patient with an illness of hepatitis C at time of vaccination who on 12-JAN-2010 at 16:01 PM was vaccinated intramuscularly with 2 doses of adult formulation RECOMBIVAX HB (1 mL per dose, one on left deltoid (LOT# 660951/0398X) and another dose on right deltoid (LOT# 660951/0398X)). It was reported that in 12-JAN-2010 at 10:00 PM, the patient experienced flu-like symptoms. The patient's outcome was unknown at this time of reporting. Follow-up information has been received which reported that the patient got the RECOMBIVAX HB (unspecified) on each arm rather than a RECOMBIVAX HB (unspecified) and hepatitis A virus vaccine (unspecified). The patient possible experienced flu-like symptoms. The patient's outcome was unknown at this time of reporting. No further information is available.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Exercise tolerance decreased, Polyuria, Thirst, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: Information has been received from a case in litigation from a consumer concerning her son who on 15-SEP-1998 at the age of 11 year old was vaccinated with the first dose of RECOMBIVAX HB. The patient was also vaccinated with the second dose on 17-NOV-1998. The mother believed that his stamina decreased during the autumn months, which became more pronounced after the second vaccination. He had also developed such classic diabetes symptoms as weight loss and excessive thirst and urination. At the time of reporting the patient's outcome was unknown. The petitioner alleged that the Hep B vaccine had caused type I (juvenile) diabetes. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dermatomyositis, Gait disturbance, Juvenile arthritis, Lupus-like syndrome, Mixed connective tissue disease
Clinical narrative: Information has been received from a case in litigation from a physician concerning a 20 year old female patient who in 2001 at the age of 12 year old was vaccinated with the first dose of RECOMBIVAX HB. The patient was also vaccinated in 2001 with the second and third doses. The reporter mentioned that in the following weeks after the first vaccination the patient had intermittent hives. Similar outbreaks followed subsequent vaccinations. After the third vaccination, she developed pain in her upper legs, which grew worse over the following months until she had trouble walking across the room. The physician had diagnosed the patient with a lupus-like illness. The patient's rheumatologist said the development of arthritis after the vaccine "is well recognized". Although the vaccine's connection to lupus is "less clearly demonstrated". In May 2003, the patient consulted rheumatologist who attributed her symptoms to dermatomyositis, juvenile rheumatoid arthritis, lupus or mixed connective tissue disease. At the time of reporting the patient's outcome was unknown. The petitioner alleged that the RECOMBIVAX HB had caused systemic lupus erythematosus. Upon internal review systemic lupus erythematosus (SLE) was considered to be an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Systemic lupus erythematosus, Urticaria
Clinical narrative: Information has been received from a case in litigation from a physician concerning a 20 year old female patient who in 2001 at the age of 12 year old was vaccinated with the first dose of RECOMBIVAX HB. The patient was also vaccinated in 2001 with the second and third doses. The reporter mentioned that in the following weeks after the first vaccination the patient had intermittent hives. Similar outbreaks followed subsequent vaccinations. After the third vaccination, she developed pain in her upper legs, which grew worse over the following months until she had trouble walking across the room. The physician had diagnosed the patient with a lupus-like illness. The patient's rheumatologist said the development of arthritis after the vaccine "is well recognized". Although the vaccine's connection to lupus is "less clearly demonstrated". In May 2003, the patient consulted rheumatologist who attributed her symptoms to dermatomyositis, juvenile rheumatoid arthritis, lupus or mixed connective tissue disease. At the time of reporting the patient's outcome was unknown. The petitioner alleged that the RECOMBIVAX HB had caused systemic lupus erythematosus. Upon internal review systemic lupus erythematosus (SLE) was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning the mother of a patient who mentioned that on an unspecified date, she received an adult dose of RECOMBIVAX HB (manufacturer unknown). It was reported that the titers were low. It was also stated that the mother had to be revaccinated. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female patient with no known drug allergies and no pertinent medical history who on 08-APR-2003, 05-AUG-2004 and 16-JUN-2005 was vaccinated with the first, second and third doses of adult RECOMBIVAX HB. There was no concomitant medication. Subsequently, the patient was found to have anti-HBs concentration of <5mIU/mL after the primary vaccine series with RECOMBIVAX HB. The patient sought unspecified medical attention and the serum hepatitis B surface antibody screen was performed. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a registered nurse who reported that the 24 year old female patient was not a smoker. On 01-FEB-2010, the patient had a serum hepatitis B surface antibody screen performed which showed that the anti-HBs concentration was less than 5mIU/mL. The patient had a lack of seroconversion. On 22-FEB-2010 and 24-MAR-2010, the patient had unspecified booster vaccines (lot# AHBVBB34AA). At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient with no known drug allergies or pertinent medical history who on 01-OCT-1998 was vaccinated with a first dose of RECOMBIVAX HB, 1 ml IM. Subsequently, on 10-DEC-2002 the patient was vaccinated with a second dose of RECOMBIVAX HB 1 ml IM and on 24-JUN-2004 the patient was vaccinated with a third dose of RECOMBIVAX HB 1 ml IM. The nurse reported that the patient's titers were negative. Afterwards, the patient was given another series of RECOMBIVAX HB. On 04-SEP-2009 the patient was vaccinated with a fourth dose of RECOMBIVAX HB (Lot number 662115/1263X) 1 ml IM, on 09-NOV-2009 the patient was vaccinated with a fifth dose of RECOMBIVAX HB (Lot number 662115/1263X) 1 ml IM and on 22-MAR-2010 the patient was vaccinated with a sixth dose of RECOMBIVAX HB (Lot number 0727X) 1 ml IM. The patient's titers were taken on 23-APR-2010 and they were negative. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from the licensed practical nurse concerning the four year old female patient with no illness at the time of vaccination. On 31-AUG-2009, a hepatitis B surface antibody test was performed to the patient, the quantity was 0.0. Afterwards, the patient was given another series of RECOMBIVAX HB. On 23-APR-2010, a hepatitis B surface antibody test was performed to the patient, the quantity was 0.0 again. On 03-MAY-2010, another hepatitis B surface antibody test was performed to the patient, the result was negative. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Injection site vesicles, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 14 month old female patient with no pertinent medical history or drug reactions/allergies, who on 03-MAR-2010 was vaccinated with RECOMBIVAX HB (lot number 665366/0890Y). Concomitant therapy included VARIVAX (WAES 1003USA00607). It was reported that on 03-MAR-2010, after receiving RECOMBIVAX HB the patient developed injection site reactions. The arm which got RECOMBIVAX HB developed tiny blisters at injection site. At the time of the report the patient was recovering. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from the Registered Nurse who reported that the welts were resolved before the patient left the office. Follow up information has been received from the Registered Nurse who reported that on 03-MAR-2010 at 15:30, the baby with no illness at the time of vaccination, was vaccinated intramuscularly in the left arm with a dose of RECOMBIVAX HB (lot number 665366/0890Y). Concomitantly the patient was vaccinated subcutaneously in the right arm with a dose of VARIVAX (WAES 665193/1049Y). It was reported that the same day at 15:30 the patient developed an area of erythema at both injection sites with a small hive. Ice was applied. The reaction lasted approximately 15 minutes then resolved. The patient was referred to the allergist. No further information is available.
Age: 0.98
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 month old female with no pertinent medical history reported or drug reactions or allergies reported as none who on 22-APR-1993 was vaccinated with first adult dose of RECOMBIVAX HB (lot # not reported). On 19-JUN-1993 she received second adult dose of RECOMBIVAX HB (lot # not reported). On 11-OCT-1993 she received third adult dose of RECOMBIVAX HB (lot # not reported). There was no concomitant medication. On 03-MAY-2010 the patient was found to have negative hepatitis B antibody titers. The patient sought unspecified medical attention. The outcome of negative hepatitis B antibody titers was unknown. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a registered nurse concerning an actually 20 year old female patient with no known drug reaction or allergies or pertinent medical history who was vaccinated with the first, second and third dose of RECOMBIVAX HB (manufacturer unknown) on 20-MAY-1998, 30-JUL-1998 and 18-JAN-1999 respectively. There was no concomitant medication. The registered nurse reported that the patient had negative hepatitis B surface antibodies. The patient sought medical attention by an office visit. At the time of the report, the patient hepatitis B titers were negative. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Muscle disorder
Clinical narrative: Information has been received from a physician concerning a male patient who an unknown date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Subsequently the patient developed unspecified muscle problems. The physician stated that the muscle problem was not Guillain Barre Syndrome. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Anti-HBc IgM antibody positive, Hepatitis B, Hepatitis B antibody negative, Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a registered nurse concerning a 9 month old male patient with no pertinent medical history or allergies who on 22-MAY-2009 was vaccinated intramuscularly with a 0.5 ml dose of RECOMBIVAX HB (663314/0089Y) (thimerosal free)). Concomitant therapy included hepatitis B immune globulin. It was reported that the patient also received two doses of ENGERIX B followed by RECOMBIVAX HB. On 01-MAR-2010 the patient was diagnosed with hepatitis B. On 01-MAR-2010, hepatitis B antibody testing was negative; hepatitis B surface antigen and hepatitis B core IgM testing were positive. Unspecified medical attention was sought. The patient had been referred for evaluation. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B DNA assay negative, Hepatitis B core antigen, Hepatitis B surface antigen negative
Clinical narrative: Information has been received from a physician concerning a 41 year old male who "20 years ago" (in 1990) was vaccinated with 2 three dose series of RECOMBIVAX HB (lot number not reported). The patient "now" (in 2010) had negative surface antigen, negative DNA levels but had positive core antibodies. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HEP
Symptoms: Full blood count normal, HIV test negative, Hepatitis B antibody negative, Hepatitis C antibody negative, Treponema test negative
Clinical narrative: Information has been received from a nurse concerning a 65 days old male patient with no pertinent medical history reported who on 20-DEC-2004 was vaccinated with a first dose of RECOMBIVAX HB (route and lot number not reported) (manufacturer unknown). On 18-FEB-2005 and 22-APR-2005 the patient was vaccinated with a second and third dose respectively of RECOMBIVAX HB (routes and lot numbers not reported) (manufacturer unknown). It was reported that on 22-JUN-2005 the patient received a fourth dose of RECOMBIVAX HB (route and lot number not reported) (manufacturer unknown). The nurse reported that the patient had a negative hepatitis B surface antigen after 4 doses of unknown hepatitis B vaccine. Hepatitis B titer was performed on 10-MAY-2010 and the result was negative. At the time of the report the outcome of the patient was not recovered. It was unspecified if the patient sought medical attention. Follow-up information was received from the registered nurse who reported that the 5 years old patient, with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions, on 10-MAY-2010 was stuck with a needle that has been contaminated while he was receiving a MMR II (Merck). Laboratories were done on the employee involved on the incident and also in the patient. The patient's labs revealed negative hepatitis B surface antigen and negative hepatitis B surface antibody, complete blood count were within normal limits. RPR with reflex titer was non-reactive and HIV 1/2 screen reflex WB was not reactive. No further information is available.
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (route and lot # unknown) and with a dose of PEDVAXHIB (manufacturer unknown) (route and lot # unknown). Other concomitant therapy included PEDIARIX. Subsequently, on an unspecified date, the patient experienced side effects after receiving the vaccines. It was unspecified if the patient sought medical attention. At the time of the report the patient's outcome was unknown. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a patient who "in the past" was vaccinated with a pediatric/adolescent (0.5 ml) dose of RECOMBIVAX HB. Recently the titer was checked and found to be low. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning a 34 year old male patient with no drug reactions/allergies and with no pertinent medical history reported who was vaccinated with three "standard doses" of RECOMBIVAX HB (dates, routes and lot numbers not reported). There was no concomitant medication. The nurse reported that the patient failed to have antibody titer several years after receiving three "standard doses" of RECOMBIVAX HB. "Titer tested last month" (approximately in April 2010). The patient sought unspecified medical attention. No adverse effect reported. Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: FLU3, HEP
Symptoms: Convulsion, Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her approximately 16 month old son who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) and a dose of influenza virus vaccine (unspecified). Subsequently the patient developed a fever and seizure. On an unspecified date the patient recovered from fever and seizure. Upon internal review, seizure was determined to be an other important medical event. The patient subsequently experienced diarrhea while on therapy with ROTATEQ (MSD, WAES # 1006USA00596). No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Seroconversion test negative
Clinical narrative: Information has been received from a female physician who in 1993 was vaccinated with RECOMBIVAX HB series. Recently the titer draw showed she failed to seroconvert. The physician also stated she would probably get a "booster" dose of RECOMBIVAX HB. At the time of the report, the patient's status was unknown. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Chills, Pyrexia
Clinical narrative: Information has been received from a female medical technologist with penicillin allergy and ulcerative colitis who on an unspecified date was vaccinated with one dose of RECOMBIVAX HB (manufacturer unknown) (route, dose and lot number not reported). Concomitant therapy included tuberculin purified protein derivative ("PPD") and "medication for ulcerative colitis". The patient reported that she received RECOMBIVAX HB and tuberculin purified protein derivative ("PPD") that made her ill with fever and chills. No laboratory tests were performed. At the time of the report the outcome of the patient was recovered (date unspecified). The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning at least 2 or 3 patients who on unspecified dates completed series of RECOMBIVAX HB (adult) when they were young. But they had negative titer when they were tested for their college admission. In telephone follow-up, the registered nurse stated she did not remember the names of the patients involved, but would continue checking. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a Health Care Department concerning 7 patients who over the past two months were vaccinated with a fourth dose of RECOMBIVAX HB (lot number 603895/0748V). It was unspecified if the patient's sought medical attention. Follow up information has been received from an office manager concerning an approximately 17 year old male patient who after his third dose of RECOMBIVAX HB presented with hepatitis B surface antibody test negative, "not immune". Laboratory test was less than 5. The patient was administered at least one dose of RECOMBIVAX HB, lot# 603895/0748V. On an unspecified date, the patient was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The hepatitis B surface antibody test was repeated a month after the fourth dose and the results was 301. The patient did not develop hepatitis B. No the adverse experience was reported. At the time of report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 19-NOV-1992 (at the age of 8 weeks) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V) (adult dose), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information has been received from a physician who reported that a 9 week male who on 19-NOV-1992 was vaccinated with a second dose of RECOMBIVAX HB in the left leg. On the same day the patient received the first dose of ACEL-IMUNE (lot number 3030-910) in the right leg, ORIMUNE (lot number 334-9500667E) orally and HIBTITER (lot number MOZOJE) in the left leg. On 22-APR-2010 the patient underwent a hepatitis B surface antibody which was <5 mIU/L (not have immunity to hepatitis B virus). On 28-JUN-2010, the patient's hepatitis B surface antibody which was 301 mIU/L (immunity to hepatitis B virus). This is an amended report. The code overdose was deleted since the actual dose of vaccine was not provided. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a physician concerning a patient who on 27-MAY-2010 was vaccinated with a 10mcg (adult) dose of RECOMBIVAX HB. On 29-MAY-2010 the patient tested positive for surface antigen for hepatitis B infection. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. No further information is available.