chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt's father called and said child had Hep-B shot  on 2/22/02 and on 2/23/02, he had a red rash all over his body. It was raised and red with white centers and itchy. It's the first time this has happened. Father denies any previous allergic reactions. MD was notified and states this could be an allergic rash to IZ. States should not get. Father called family doctor and he ordered Benadryl.
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pain
Clinical narrative: IM DTaP was given in right deltoid area on 3-5-02 By evening 3-6-02 had developed 2 area, each about 1 cm in diameter (one centered at the shot puncture area) which were painful and indurated. This was more intense and well demarcated than usual local soreness.
Age: 59.0
Sex: F
Vaccine: RUB
Symptoms: Lymphadenopathy
Clinical narrative: Sub occipital lymph nodes-one; large one on the left, 2 smaller ones on right.
Age: 5.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Drug ineffective, Infection
Clinical narrative: Approx. 3 weeks after oldest brother broke out with chickenpox, 2 younger brothers now showing rash symptoms. Red rash, fluid filled vesicles, popping and itching. No fever.
Sex: M
Vaccine: HIBV, MMR, OPV
Symptoms: Drug ineffective, Infection
Clinical narrative: Approx. 3 weeks after older brother broke out with chickenpox (exposure at school), 2 younger brothers now have red rash, fluid filled vesicles not popping; no fever; no itching.
Age: 8.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Development of chickenpox despite previous IZ. Pt had a red rash begin; 1 noted on 11/19/01; 3 noted on 11/20/01 and numerous over body on 11/23/01 with blisters starting and itching. Mother states exposure at school.
Age: 2.9
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Strabismus
Clinical narrative: Left esotropia-refractive error ? following vaccine administration.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Pyrexia, Vision blurred
Clinical narrative: Dizziness, blurred vision, increased temperature and chills.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness
Clinical narrative: Dizziness and chills
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at left deltoid.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Hypersensitivity, Pyrexia, Rash
Clinical narrative: Thursday pm pt started having rash to cheeks and fever. Friday broke out with full bodied rash, went to ER, was told it was vaccine allergic reaction. Given rx for benadryl and to F/U with PCP if not better. Called incident in this AM still noted
Sex: F
Vaccine: HEPA
Symptoms: Rash, Tenderness
Clinical narrative: Redness within 24 hrs, tenderness. ? reaction VS cellulitis.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2/6/02 within 2 hrs, L arm had swelling, pain, redness and warmth to area, size of swelling 3x3" approx, - mom gave Advil and ice compress to arm.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Face oedema, Injection site rash
Clinical narrative: Rash on injection site, chest face. Face swelling. No resp difficulty. (Still has face swelling).
Age: 4.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Rt deltoid and upper arm with erythema, tenderness given DTaP on 2/1/02. Seen in urgent care with symptoms on 2/3/02. given Cephalexin 250m/5ml syrup 1 tsp tid x 10 days.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Pyrexia, Rash, Skin burning sensation
Clinical narrative: Rash on upper right side of back, under R arm, across R breast. Red, tender, fever, burned, first few days it itched.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Rash
Clinical narrative: Hep B #1 given L deltoid on 5/15/01, the next morning fever X 2 days and rash on face. Mom treated the fever with fever rx, mom states he really felt sick.
Age: 1.08
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Warmth, erythema, edema L upper extremity to elbow.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varicella - many, many lesions. Full blown case, despite immunization.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Agitation, Pyrexia, Screaming
Clinical narrative: Between 13:30 to 18:00 on the same day, began crying/screaming and couldn't be comforted. On 1/22/02, began a fever of 103F and not coming down with Tylenol. On 1/24/02, between 16:30 until 20:30, began high-pitched scream again. Seen by MD on 1/25/02. No signs or symptoms at that time. MD has recommended no more pertussis.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Injection site pain, Pain, Pruritus, Speech disorder
Clinical narrative: Developed right arm pain, several hours, post vax. Arm (up to neck and down to waist) became very painful and sore. Woke up during the night in a cold sweat. This morning, feels itchy all over and her "skin hurts". States she is having difficulty speaking although she was able to be interviewed for this report. Instructed to take ibuprofen 200 mg q 6 hours X 24 hours and apply ice to right arm and call if not improved.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Pain
Clinical narrative: Total body pain, severe "felt like body was shattering", about 18 hours, after receiving day 7 shot and lasted for  about 1 day.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Influenza, Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no known allergies who on 08/21/2001 was vaccinated with a first dose of hep b vaccine recombinant IM. Approximately twelve hours post vaccination on 08/22/2001, the pt developed a fever of 104 deg. F, general malaise, and aches. She went to the ER and was diagnosed with the flu. She was given IV fluids, antibiotics and a pain killer. According to the nurse, the pt felt sick for two more days and had a decreased appetite for one week. Subsequently, the pt recovered. No additional info is expected.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site inflammation, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female who on 09/15/2001 was vaccinated with a third dose of hep b vaccine recombinant IM in the arm. On 09/15/2001, the pt experienced a localized reaction which involved a large area of the injection site and below which was quiet inflammed. The pt was treated with hiphendydramino hydrochloride and warm compresses. Additional info has been received from a registered nurse. The nurse reported that the pt had a large induration around, above and below the injection site. No further info is expected.
Sex: M
Vaccine: HEP
Symptoms: Flushing, Malaise
Clinical narrative: Information has been received on 20 Sep 2001 from a licensed practical nurse concerning a male (age unspecified) with no known allergies who "one month ago" was vaccinated with a first dose of hepatitis b vaccine recombinant (yeast). The patient had hot flushing and malaise post vaccination. There was no other information. The patient sought unspecified medical attention. Follow-up information indicated that when the patient arrived at the community occupational health center for his second dose of hepatitis b vaccine recombinant (yeast) it was not administered. It was noted that the patient has since quit his job. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: Information has been received from a pharmacist concerning a female who on 09/18/2001 was vaccinated with a dose of hep b vaccine recombinant. On 09/20/2001, labs were drawn and an elevated liver function test was observed. No other info was available. Unspecified medical attention was sought. Additional info has been requested. Follow up info received from the pharmacist indicated that she was stopped in the hallway by a physician who asked her if she was aware of the hep B vaccine causing an elevation in AST liver function tests. The pharmacist indicated that she did not know which brand of hep B vaccine was administered to the pt. No further info is available.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Eye swelling, Headache, Hyperhidrosis
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old male who on 08/20/2001 and 09/21/2001 was vaccinated with the first and second dose of hep b vaccine recombinant. On 09/21/2001 the mother called the doctor's office to report that about three hours after he received the vaccine he experienced sweating, headache, and his pupils were dilated. Unspecified medical attention was sought. The symptoms lasted about an hour and were relieved without any medical management. The nurse reported that the pt is very anxious when he receives a shot. The mother told the nurse that when he received his first dose on 08/20/2001 he developed similar symptoms. Additional info has been requested.
Sex: U
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of hepatitis b vaccine recombinant (yeast). Subsequently, the patient experienced hair loss. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 18 day old female who on 10/17/1994 was vaccinated with the first dose of hep b vaccine recombinant. Post vaccination, on 10/17/1994, the pt developed a large swollen area at injection site and had hives. The RN stated that the child's reaction was from thimerosal and the child will be revaccinated with thimerosal free vaccine. The pt sought unspecified medical attention. No further info is available.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Information has been received form a pharmacist concerning an adult female who in April 2001 was vaccinated with third dose of hepatitis b vaccine recombinant (yeast). Since then, in April 2001, the patient experienced low grade fever, arthralgia and myalgia. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of hep b vaccine recombinant. The physician reported that the pt's mother stated that the pt had swelling and fever of 102 deg. F. following the injection. At the time of this report, the pt had not received medical attention for her experience. Additional info has been requested.
Age: 0.8
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician's assistant concerning a 10 month old male with no past medical history who was vaccinated with hepatitis b vaccine recombinant (yeast) and varicella virus vaccine live (MSD) on the same day. There was no other concomitant therapy. Subsequently, the patient developed a rash post vaccination. It was noted that the patient was being tested for vaccination. It was noted that the patient was being tested for allergies. The patient had received medical attention for his experience. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: Information has been received from a consumer concerning her 21 year old son, with a history of acne and no known allergies, who on either 05/11/2001 or 05/18/2001 and either 06/11/2001 or 06/18/2001 was vaccinated with the first and second doses of hep b vaccine recombinant, respectively. Concomitant therapy included minocycline. Following the second dose, the pt went home and lifted weights for 45 mins. The next day, he developed forearm, hand, and shoulder swelling, "three times the normal size." It was reported tat the arm returned to normal within 5-7 days. The pt did not seek medical attention. Additional info has been requested.
Sex: M
Vaccine: HEP
Symptoms: Candidiasis, Constipation, Hyperbilirubinaemia, Jaundice
Clinical narrative: Initial and follow-up info has been received from a physician concerning a 2 day old male with no known allergies, who on 06/16/2001 at birth was vaccinated with the first dose of hep b vaccine recombinant. Assessment documented on 06/17/2001 indicated that the infant was jaundiced. It was noted that the baby was being fed every 2-3 hrs with iron. Three wet diapers and one bowel movement were noted in 24 hrs. He made eye contact with and smiled at his mother. During a visit to the pediatrician, on 06/20/2001, physical exam and developmental screen were normal, with the exception of mild jaundice. There was no organomegaly. At that time, it was reported that he was having 3-6 bowel movements per day. On 06/22/2001, total bilirubin was 11.8 and direct bilirubin was 0.3. At this time, it was documented that no follow-up needed and keep near natural light. The physician noted that the pt did have a mild bout of hyperbilirubinemia in the newborn period, but that no therapy was required. On 07/05/2001 the pt was seen by the pediatrician for complaints of constipation. It was noted that he was having "pellet like stools" once a day, but that they were non-bloody. The physician reported that he had some mild constipation "as he was a formula fed baby." At that time, his appetite was good and he had no fever. The remainder of his assessment was normal. He was treated with Kavo syrup. On 08/23/2001, the child was seen for his 2 month visit. At that time, bowel movements were noted to be soft. He had a sore mouth, for one week, no fever, and was diagnosed with thrush. He was placed on Tylenol prn and nystatin PO QID for 14 days. Otherwise healthy was documented. It was also documented that on unspecified dates, the child received a dose of the following vaccinations. diphtheria toxoid pertussis vaccine tetanus toxoid, haemophilus b conjugate vaccine, poliovirus vaccine, streptococcus pneumoniae vaccine, and  hep b vaccine recombinant. The child's state newborn screen results were al normal and it was noted that he had no previous vaccine reactions. The child's mother was vaccinated with varicella virus vaccine and subsequently found out she was pregnant. Upon internal review, thrush was considered to be an incidental finding. No further info is available.
Sex: U
Vaccine: HEP
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a pharmacist who received a telephone call from a nurse concerning a patient who was vaccinated with hepatitis b vaccine recombinant (yeast) (manufacturer unknown). Subsequently the patient reacted to recombinant hepatitis b vaccine. The pharmacist did not know any details of the reaction or the manufacturer of the vaccine. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with hep b vaccine recombinant. Subsequently the pt developed a local reaction. The info was given to the pharmacist by a nurse. Additional info has been requested.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Angioneurotic oedema
Clinical narrative: Information has been received from an approximately 28 year old female consumer with no past medical history and a sulfa allergy, and photosensitivity who in approximately 1991 was vaccinated with hep b vaccine recombinant and experienced large hives from her nipples to her knees. It was reported that concomitant medication at the time of this report 10/23/2001 included Synthroid. Unspecified medical attention was sought. No further info was provided. Additional info has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with hep b vaccine recombinant. Subsequently the pt experienced a positive hep core antigen titer. Additional info has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 35 year old female who on 10/18/2001 was vaccinated with the first dose hep b vaccine recombinant IM in the right deltoid. On 10/20/2001, the pt developed a rash on her chest and upper arms. The pharmacist indicated that on 10/23/2001, the pt recovered from the rash on her chest and upper arms. Additional info is not expected.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Pyrexia
Clinical narrative: Information has been received from an employee in a physician's office concerning a 13 year old female who on approximately 10/22/2001 was vaccinated with a second dose of hep b vaccine recombinant. On approx. 10/27/2001 the pt was taken to an ER by her mother for a fever and dizziness. The pt received unspecified treatment, was released from the ER and was reported as not hospitalized. The physician's office employee further reported that the pt's mother felt that the reaction was due to "thimerosal" despite having received a thimerosal free hep b vaccine recombinant vaccination. Additional info has been requested.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Aggression, Agitation, Irritability
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old male with down's syndrome and an atrial ventricular septal defect who was vaccinated with hep b vaccine recombinant. The pt was on concomitant therapy with Depakote. On 10/25/2001, a divalproex sodium drug level was drawn, and the pt's dose of divalproex sodium had been doubled to 750 mg twice daily. On 10/26/2001, the pt was vaccinated with a first dose of hep b vaccine recombinant IM in the left arm. On 10/27/2001, the pt became highly agitated, irritable, combative/physically aggressive, and did not respond to redirection. The pt had been responding well to medication and was pretty calm prior to the weekend of 10/27/2001. The pt received medical attention for his experience. On 10/30/2001, the pt was still agitated. Additional info received indicated that the outcome of the pt's experience was unknown. No additional info is expected.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia, Pain, Tongue discolouration
Clinical narrative: Information has been received from a physician concerning a 49 year old male pt with a chronic white coated tongue who in May 2000, was vaccinated with hep b vaccine recombinant. In July 2000, the pt was vaccinated with a second dose of hep b vaccine recombinant. There was no concomitant medication. The physician reported that in July 2000, the pt complained of achiness in his arms and sometimes in his legs. In September 2000 the pt experienced an obnoxious taste in his mouth and his tongue was white-coated which the physician stated was a chronic condition. Unspecified medical attention was sought. He also noted that the symptoms were present everyday and the pt has had no relief. The pt had no difficulty swallowing and no heartburn present on a regular basis. In November 2000, the pt was vaccinated with a third dose of hep b vaccine recombinant. Additional info is not expected.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hyperaesthesia, Laboratory test abnormal, Pain, Pyrexia, Viral infection
Clinical narrative: Information has been received from a physician concerning a 41 year old female who in June 2001 was vaccinated with hep b vaccine recombinant. The pt received the first dose in May 2001. In approx. June 2001, the pt experienced fever, body aches and became sensitive to touch. The pt underwent an examination and liver function tests, which revealed a serum alanine aminotransferase test of 252 and serum aspartate aminotransferase test of 161. Two weeks later the pt's serum alanine aminotransferase test was 20 and serum aspartate aminotransferase test was 19. Additional info has been requested. The follow up states info has been received from a physician concernign a 40 year old female with a Celcor allergy, described as rash, whoon 6/6/01 at 10am was vaccinated IM in the left deltoid with a second dose of hep B vaccine (637173/1264K). The pt received the first dose in May 2001. There was no illness at the time of vaccination. On 6/8/01 at 10am, 48 hrs after vaccination, the pt experienced fever, body aches and became sensitive to touch. The pt underwent an examination and liver function tests, which revealed a serum alanine aminotransferase tet of 252 and serum aspartate amiotransferase test of 161. The health care facility also reported that the pt experienced elevated liver function studies and viral type symptoms. Two weeks later the pt's serum alanine aminotransferase test was 20 and serum aspartate aminotransferase test was 19. Follow-up info from the health care facility indicated that the pt also experienced viral type symptoms. It was also reported that a hepatitis panel was performed, however results were not reported. Subsequently the pt recovered. No further info is available.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 2 year old child who was vaccinated with the first dose of hep b vaccine recombinant. Subsequently the pt developed hives. It was reported that the rash resolved on it's own. Additional info has been requested.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 59 year old male who on 10/02/2001 at 10:15am and 11/07/2001 at 11am was vaccinated with the first and second dose of hep b vaccine recombinant IM. Five days after the first dose the pt developed chills, fever, and headache. It was reported that the pt "took hot shower" and the symptoms disappeared by the next day. Four days after the second dose the pt experienced the same symptoms. The pt sought unspecified medical attention. It was reported that the pt recovered. No further info is expected.
Age: 1.3
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 month old female with a pcn allergy, amoxicillin allergy and a diptheria toxoid vaccine allergy who on 05/17/1993 was vaccinated with a dose of hep b vaccine recombinant IM. Several hours after receiving the vaccine, the pt developed hives. The pt sought unspecified medical attention. Additional info has been requested.
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Information has been received from a health professional concerning a male with no known allegies who was vaccinated with a dose of hep b vaccine recombinant. Subsequently, after the dose, the pt experienced shortness of breath and dizziness. The pt was administered Benadryl and taken to the ER for observation. No other treatment was given. It was noted that another pediatrician administered the vaccine. Upon internal review, shortness of breath was determined to be an other important medical event. Additional info has been requested.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a 47 year old male who was vaccinated with hep b vaccine recombinant. Subsequently the pt experienced fatigue aproximately 2-3 days after receiving therapy. The pt reported that he falls asleep without warning. 10 days after therapy was administered the pt was still experiencing fatigue. On 12/04/2001 the pt was seen by a physician and there was no change in his condition. Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Rheumatoid arthritis
Clinical narrative: Information has been received from a consumer concerning an adult female who on 04/05/1997 was vaccinated with a first dose and on 05/17/1997 was vaccinated with a second dose of hep b vaccine recombinant. The pt's son reported that subsequently at an unspecified time post immunization, his mother "developed rheumatoid arthritis and other autoimmune disease." Additional info has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from the mother of a 12 year old female with systemic lupus erythematosus and penicillin allergy and a history of tonsillectomy who in May, June and November 1997, was vaccinated with Hepatitis B vaccine recombinant (yeast). The lot numbers for the Hepatitis B vaccine recombinant (yeast) were 622695/0049E; 622633/1628D: and 623489/0609E respectively. In May 1997, the child was also vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(lot #619798/0996D). There was no other concomitant medication following the November vaccination with hepatitis B vaccine recombinant (yeast), the child was "swollen and rashy from head to toe". The child's mother reported that in 1998, the child had braces for 2 years and she subsequently broke out the whole time she wore the braces. The mother also reported that "now the child frequently breaks out in rashes" Unspecified medical attention was sought. at the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a 29 year old female with an allergy to horse serum who on 05-DEC-2001 was vaccinated with a dose of Hepatitis B vaccine recombinant (yeast). There was no concomitant medications. In December 2001, the patient developed swelling at the injection site in left arm, redness, and it was described as the size of an quarter, tender to touch and he experienced shoulder pain. The patient applied ice to the site. unspecified medical attention was sought.  Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Cardiac disorder, Crying, Lethargy, Listless
Clinical narrative: Information has been received from a pharmacist concerning an 11 year old male family member who on 28-2001 was vaccinated with Hepatitis B vaccine recombinant (yeast). On approximately 01-DEC-2001, the patient became tired and listless, he had a loss of appetite, he became depressed, he cried a lot, was afraid to go to school and mentioned that his heart felt funny. Unspecified medical attention was sought.  Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic enzyme abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 39 year old female patient with a thyroid disorder and no known drugs allergies who on 30-Nov-2001 was vaccinated with the second dose of hepatitis B vaccine recombinant (yeast) (Pl:30-Oct-2001) Concomitant therapy included levothyroxine NA (synthroid). Liver function tests done shortly after the second dose returned at almost double normal values. Unspecified medical attention was sought. Additional information has been requested. On 12/13/01 at 9:53 the pt experineced elevated ALT (151U/L), elevated AST (130U/L), and elevated LDH (289U/L) levels. It was reported that the values were almost double normal values. The pt was asymptomatic. Unspecified medical attention was sought. An ultrasound of the gallbladder was performed on 1/3/02 and it was noted that the gallbaldder was well demonstrated and that no shadowing gallstones were observed within it. The common bile duct was not dialated, and no gallstones were identified. An ultrasound of the liver was also performed on 1/3/02 and it was reported that the liver was homogenous and that no lesions were observed within the liver and there was no evidence of intraheatic bile duct dilation. Both tests were within normal limits. Repeat liver function tests were scheduled in April 2002 to determine if the pt could receive the third dose of hep B vaccine. On 4/3/02, repeat AST (41U/L), and ALT (40U/L) tests were performed, and the nurse practitioner reported that the liver function tests were normal. She reported that they were proceeding with the third dose. The pt recovered.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Face oedema, Rash, Urticaria
Clinical narrative: Information has been received from a physicians assistant concerning a 13 year old male with no known drug allergies who on 03-Jan-2002 was vaccinated with the second dose of hepatitis B vaccine recombinant (yeast). There was no concomitant medications. On 04-Jan-2002, the patient seen in the emergency room with a hive-like rash on his trunk, arms and neck and was also noted to have some facial edema At the time of this report, the outcome of the events was unknown.   Additional information has been requested. The pt was treated with Benadryl. Follow up info was received from the physician's assistant on 2/22/02. It was determined that the rash was "probably not related to the vaccine." The pt was referred to his primary care physician. Additional info has been requested.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Enzyme abnormality, Liver function test abnormal
Clinical narrative: Information has been received from a pharmacist concerning a male who was vaccinated with four 10 mcg doses of Hepatitis B vaccination was received on 05-Jun-2000, and the fourth dose of the Hepatitis B vaccine recombinant (yeast) vaccination was on 03-Aug-2001. It was reported that the patient subsequently experienced generalized arthralgia on occasion, and was noted to have elevation of his liver enzymes (lab. date not provided). Unspecified medical attention was sought, and at the time of this report the outcome of the events was unknown. Additional information has been requested. Follow up information was received on 2/28/02. The pharmacist reported that the reactions were not due to vaccination with hepatitis B vaccine recombinant (yeast) (MSD). Additional follow up information was received on 6/10/02. It was reported that the patient did recovered shortly following. No further information is available.
Age: 1.0
Sex: M
Vaccine: HEP, UNK, DTP, HIBV, OPV
Symptoms: Cognitive disorder, Drug toxicity, Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: An attorney alleges that a 12 month old male received his 4th dose of Hib-Titer, 3rd dose of Orimune and Tri-Immunol (dose unknown) vaccines on 1/6/97. In 1997, at 18 to 24 months of age, the reporter stated that the child developed symptoms of neurological damage consistent with mercury poisoning. Those symptoms included regression of language skills, developmental delays, lack of fine motor skills, limited attention span and diminished cognitive ability. Sometime in 2001, the attorney alleges that the child was dx'd with mercury poisoning. The reporter attributes these events to the presence of thimerosal which has resulted in severe mental and physical injuries. The reporter indicated that the child is receiving an unspecified treatment and alleges that the child's parents have noted "modest" improvement as the mercury levels have decreased.
Age: 1.0
Sex: M
Vaccine: HEP, UNK, DTP, HIBV, OPV
Symptoms: Cognitive disorder, Disturbance in attention, Drug toxicity, Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: An attorney alleges that a 12 month old male received his 4th dose of Hib-Titer, 3rd dose of Orimune and Tri-Immunol (dose unknown) vaccines on 1/6/97. In 1997, at 18 to 24 months of age, the reporter stated that the child developed symptoms of neurological damage consistent with mercury poisoning. Those symptoms included regression of language skills, developmental delays, lack of fine motor skills, limited attention span and diminished cognitive ability. Sometime in 2001, the attorney alleges that the child was dx'd with mercury poisoning. The reporter attributes these events to the presence of thimerosal which has resulted in severe mental and physical injuries. The reporter indicated that the child is receiving an unspecified treatment and alleges that the child's parents have noted "modest" improvement as the mercury levels have decreased.
Age: 1.0
Sex: M
Vaccine: HEP, UNK, DTP, HIBV, OPV
Symptoms: Speech disorder
Clinical narrative: An attorney alleges that a 12 month old male received his 4th dose of Hib-Titer, 3rd dose of Orimune and Tri-Immunol (dose unknown) vaccines on 1/6/97. In 1997, at 18 to 24 months of age, the reporter stated that the child developed symptoms of neurological damage consistent with mercury poisoning. Those symptoms included regression of language skills, developmental delays, lack of fine motor skills, limited attention span and diminished cognitive ability. Sometime in 2001, the attorney alleges that the child was dx'd with mercury poisoning. The reporter attributes these events to the presence of thimerosal which has resulted in severe mental and physical injuries. The reporter indicated that the child is receiving an unspecified treatment and alleges that the child's parents have noted "modest" improvement as the mercury levels have decreased.
Age: 2.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR
Symptoms: Autism
Clinical narrative: This report, received on 2/27/02, is concerning an approx. 28 month old male (DOB 8/5/99) who on 12/12/00 was vaccinated with a 3rd dose of Hib + Hep-B (lot 634690/1977J). Concomitant therapy that same day included the 1st dose of Infanrix (lot DTPA961A2), a 3rd dose of IPOL and the 1st dose of MMRII (lot 630637/1062K) (also reported as Pluserix). It was reported, "just recently" the pt had received a dx of autism. As of 2/8/02, the pt's autism had not resolved. The pt's autism was considered as an "Other Important Medical Event". It was noted that the pt's vax history included: the 1st and 2nd dose of Hib + Hep-B on 10/27/99 (lot 629770/0610J) and 12/29/99 (lot 631247/0549J); the 1st and 2nd dose of IPOL on 10/27/99 and 12/29/99; 1st, 2nd and 3rd dose of Tripedia on 10/27/99 (lot 7389AA), 12/29/99 (lot 7389AA) and 3/1/00 (lot 7387AA); 1st dose of Hib on 3/1/00. This report was originally reported by an RN. Follow-up information from an RN on 3/6/02, noted that the pt had been dx'd with autism "within the last 6 weeks", approx. 1/02. The mother of the child called the RN to obtain information on the thimerosal content within the vaccines that the child had received. Additional information has been requested.
Age: 2.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR
Symptoms: Autism, Schizophreniform disorder
Clinical narrative: This report, received on 2/27/02, is concerning an approx. 28 month old male (DOB 8/5/99) who on 12/12/00 was vaccinated with a 3rd dose of Hib + Hep-B (lot 634690/1977J). Concomitant therapy that same day included the 1st dose of Infanrix (lot DTPA961A2), a 3rd dose of IPOL and the 1st dose of MMRII (lot 630637/1062K) (also reported as Pluserix). It was reported, "just recently" the pt had received a dx of autism. As of 2/8/02, the pt's autism had not resolved. The pt's autism was considered as an "Other Important Medical Event". It was noted that the pt's vax history included: the 1st and 2nd dose of Hib + Hep-B on 10/27/99 (lot 629770/0610J) and 12/29/99 (lot 631247/0549J); the 1st and 2nd dose of IPOL on 10/27/99 and 12/29/99; 1st, 2nd and 3rd dose of Tripedia on 10/27/99 (lot 7389AA), 12/29/99 (lot 7389AA) and 3/1/00 (lot 7387AA); 1st dose of Hib on 3/1/00. This report was originally reported by an RN. Follow-up information from an RN on 3/6/02, noted that the pt had been dx'd with autism "within the last 6 weeks", approx. 1/02. The mother of the child called the RN to obtain information on the thimerosal content within the vaccines that the child had received. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Convulsion, Fall, Fracture
Clinical narrative: On 10/17/01, the pt received Fluvirin and Pneumovax II and 12 hours later, he experienced a convulsion. During this episode, the pt fell down and fractured his ankle. He was subsequently hospitalized. The pt was treated with Phenytoin for the convulsions. There was insufficient information to determine the reporter's causality assessment.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: A report was received from a regulatory authority on 3/6/02, concerning a 25 year old male pt who had been enrolled in a (non-company clinical trial) who experienced vertigo, which was considered disabling after receiving a Fluvirin vaccine on 10/20/95 which (was not part of the clinical trial). The pt (a helicopter pilot) had received adsorbed tetanus-diphtheria vaccine (reduced dose) and a poliomyelitis booster on 9/26/95. Since 2/01, the pt had experienced paroxymal vertigo approx. once a week, lasting between 30 seconds and a minute. A full exam was performed which was normal, including ENT/neurological and psychiatric assessment and MRI evoked potentials. Further investigations are planned to rule out migraine. At the time of reporting, the pt had not yet recovered. There was insufficient information to determine the reporter's causality assessment.
Sex: U
Vaccine: LYME
Symptoms: Hearing impaired, Pain
Clinical narrative: On unspecified dates, the vaccinee completed "a series of injections" of Lymerix. One year later, the vaccinee experienced hearing loss, "vibrations" and pain. The vaccinee underwent an unspecified surgical procedure. As of 2/28/02, the outcomes of the events were unknown.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Cold sweat, Dizziness, Hypertension, Hypokinesia
Clinical narrative: On 11/27/01, the pt received her 1st injection of Engerix-B. At 07:00, on 11/28/01, the pt presented to the clinic stating that she did not feel well and her left arm was painful. She stated that she felt "extremely weak in the evening on 11/29/01. She stated that she woke up at 03:00 on 11/28/01, feeling cold and clammy. She went to work on 11/28/01, still feeling weak. She was diaphoretic and complained of feeling cold and clammy. She was "barely able to move", and felt like she was "going to fall". She was transported to the ER for evaluation. The ER physician made a dx of "viral illness versus reaction/adverse effect and instructed her to stay out of work for 2 days. Her physician instructed her not to receive any more doses of the vaccine. The reporter considered the events to be moderate in intensity and possibly related to Engerix-B administration. The reporter considered the events disabling/incapacitating. The events resolved on 11/30/01.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Hypothermia, Injection site pain, Malaise, Viral infection
Clinical narrative: On 11/27/01, the pt received her 1st injection of Engerix-B. At 07:00, on 11/28/01, the pt presented to the clinic stating that she did not feel well and her left arm was painful. She stated that she felt "extremely weak in the evening on 11/29/01. She stated that she woke up at 03:00 on 11/28/01, feeling cold and clammy. She went to work on 11/28/01, still feeling weak. She was diaphoretic and complained of feeling cold and clammy. She was "barely able to move", and felt like she was "going to fall". She was transported to the ER for evaluation. The ER physician made a dx of "viral illness versus reaction/adverse effect and instructed her to stay out of work for 2 days. Her physician instructed her not to receive any more doses of the vaccine. The reporter considered the events to be moderate in intensity and possibly related to Engerix-B administration. The reporter considered the events disabling/incapacitating. The events resolved on 11/30/01.
Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Hypoacusis
Clinical narrative: The pt reported that he received his 1st injection of Lymerix in 5/99; exact date of IZ was not provided. On 6/23/99, a dx of "sensory motor hearing loss" was reportedly made. The pt stated that he underwent "several" unidentified procedures to correct the hearing loss, but "it has reverted back to the way it was in the beginning". The pt stated that he received the second injection of Lymerix 3 to 6 months following the 1st injection. The Lymerix IZ series was then discontinued. The hearing loss in this report is considered to be an "Other Important Medical Event".
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Atelectasis, Cardiomegaly, Irritability, Oral intake reduced
Clinical narrative: An investigator reported that a 6 month old male received a 2nd dose of Prevnar vaccine on 11/23/01, as "Post marketing Evaluation of Prevnar Pneumococcal 7-Valent conjugate vaccine (CRM197 protein conjugate); Safety of Prevnar Administered Concurrently with Routine Infant Vaccinations  at 2,4 ,6, and 12 to 15 Months of Age."  Concomitant medication included Infanrix, Polio vaccine and Hib-Titer. The coroner's office reported that the infant "hadn't been feeling good" for 2-3 days, was not eating and fussy while at "sitter's" house. Sitter said he ate very little. The infant was put down to sleep and 1/2 hours later, was fine. In another 1/2 hour, a blanket was found around the infant's face and he was found not breathing but with a heartbeat. "911" was called, resuscitation was attempted and the infant was pronounced dead. The pathologist that handled the case, determined the cause of death as SIDS. The investigator noted that a MD at the hospital said he sent the final report to the coroner's office; however, the coroner's office said that the hospital would have the workup. The investigator is still attempting to track down the documentation. The investigator and the medical monitor agree that sudden infant death syndrome (expected per local package insert) as "not related" to study vaccine. Additional information received 03/29/02 from investigator. The infant was described as previously healthy, except for recent fussiness related to teething. He was dropped off at the babysitter's residence at approximately 0700 on 01/24/02. He was not eating well.At 09:00 he took four ounces of Enfamil in the car seat. he was then put to bed in a portable crib and asleep at approximately 09:15. Two months ago he took antibiotics for an ear infection which has now cleared. At approximately 1000 he was checked and seemed to be fine, supine position.At 10:30-1100, he was found with the quilt over his face and unresponsive. 911 was called, He was in full cardiac arrest upon arrival of the paramedics. Coroners' autopsy report confirmed cause of death as SIDS.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Petechiae, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome, Thymus hypertrophy
Clinical narrative: An investigator reported that a 6 month old male received a 2nd dose of Prevnar vaccine on 11/23/01, as "Post marketing Evaluation of Prevnar Pneumococcal 7-Valent conjugate vaccine (CRM197 protein conjugate); Safety of Prevnar Administered Concurrently with Routine Infant Vaccinations  at 2,4 ,6, and 12 to 15 Months of Age."  Concomitant medication included Infanrix, Polio vaccine and Hib-Titer. The coroner's office reported that the infant "hadn't been feeling good" for 2-3 days, was not eating and fussy while at "sitter's" house. Sitter said he ate very little. The infant was put down to sleep and 1/2 hours later, was fine. In another 1/2 hour, a blanket was found around the infant's face and he was found not breathing but with a heartbeat. "911" was called, resuscitation was attempted and the infant was pronounced dead. The pathologist that handled the case, determined the cause of death as SIDS. The investigator noted that a MD at the hospital said he sent the final report to the coroner's office; however, the coroner's office said that the hospital would have the workup. The investigator is still attempting to track down the documentation. The investigator and the medical monitor agree that sudden infant death syndrome (expected per local package insert) as "not related" to study vaccine. Additional information received 03/29/02 from investigator. The infant was described as previously healthy, except for recent fussiness related to teething. He was dropped off at the babysitter's residence at approximately 0700 on 01/24/02. He was not eating well.At 09:00 he took four ounces of Enfamil in the car seat. he was then put to bed in a portable crib and asleep at approximately 09:15. Two months ago he took antibiotics for an ear infection which has now cleared. At approximately 1000 he was checked and seemed to be fine, supine position.At 10:30-1100, he was found with the quilt over his face and unresponsive. 911 was called, He was in full cardiac arrest upon arrival of the paramedics. Coroners' autopsy report confirmed cause of death as SIDS.
Age: 0.7
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: An investigator reported that an 8 month old male received a 3rd dose of Prevnar as a post-marketing safety study. Concomitant vaccines included a 3rd dose of Infanrix, Recombivax-HB and Hib-Titer vaccines. On 12/29/01, the pt expired. The coroner's office is investigating the death as SIDS; however, confirmation of dx is "still pending receipt of results from toxicology, pathology, etc". The investigator assessed SIDS (expected per local package insert) as "not related" to study vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cognitive disorder, Disturbance in attention, Drug toxicity, Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: An attorney alleges that a 4 year old male received an injection of Acel-Immune on 10/25/99. Sometime in 1998, at 30 months of age, the reporter stated that the child began to display symptoms of neurological damage consistent with mercury poisoning. Those symptoms included regression of language skills, developmental delays, lack of fine motor control, limited attention span and diminished cognitive ability. In 2002, the attorney alleges that the child was dx'd with mercury poisoning which has caused him to suffer permanent injuries. The reporter attributed these events to the presence of thimerosal. The child received unspecified treatments and his parents allege that they have noted "modest" improvement as mercury levels decrease.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder
Clinical narrative: An attorney alleges that a 4 year old male received an injection of Acel-Immune on 10/25/99. Sometime in 1998, at 30 months of age, the reporter stated that the child began to display symptoms of neurological damage consistent with mercury poisoning. Those symptoms included regression of language skills, developmental delays, lack of fine motor control, limited attention span and diminished cognitive ability. In 2002, the attorney alleges that the child was dx'd with mercury poisoning which has caused him to suffer permanent injuries. The reporter attributed these events to the presence of thimerosal. The child received unspecified treatments and his parents allege that they have noted "modest" improvement as mercury levels decrease.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Petechiae, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: Information has been received from an investigator regarding a 2 month old female who received her 1st doses of Prevnar, Hib-Titer, Infanrix, IPV and her 2nd dose of Engerix-B as part of a post-marketing safety study. On 10/21/01, at 3 months of age, the infant died. Autopsy results showed the cause of death to be SIDS. The investigator believed that SIDS (expected per package insert) was not related to study vaccine administration. The medical monitor's assessment of relatedness in unknown. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA. Follow-up info received on 03/13/2002 indicated that the medical monitor agreed with the investigator's assessment that the event was not related to vaccine administration. Per F/U 4/1/02 autopsy states: The pt has apparent healed rib fractures on the lateral aspect of left ribs 6,7 and 8 and rib 6 on the lateral right chest. The thymus has occasional petechial hemorrhages on both the anterior and posterior surfaces. Sectioning of the lungs reveals moderate congestion and edema.