chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, DTAP, IPV, PNC
Symptoms: Laboratory test abnormal, Pyrexia, Viral infection
Clinical narrative: This subject is a 16 week old male, who was admitted to the hospital due to viral syndrome while enrolled in a Immnogenicity Assessment of Daptacel Co-administered with a pneumococcal conjugate vaccine. The subject received the study vaccine on 8/1/03. The subject developed a high fever of 103.5 deg F 33 days post-immunization and was admitted to the hospital on the same day. Treatment included 500mg of Rocephin given IM. The subject was discharged from the hospital on the following day. The subject recovered and continued the trial. The event of viral syndrome was reported by the investigator as unrelated to the study vaccine.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, DTAP, IPV, PNC
Symptoms: Pyrexia, Viral infection
Clinical narrative: This subject is a 16 week old male, who was admitted to the hospital due to viral syndrome while enrolled in a Immnogenicity Assessment of Daptacel Co-administered with a pneumococcal conjugate vaccine. The subject received the study vaccine on 8/1/03. The subject developed a high fever of 103.5 deg F 33 days post-immunization and was admitted to the hospital on the same day. Treatment included 500mg of Rocephin given IM. The subject was discharged from the hospital on the following day. The subject recovered and continued the trial. The event of viral syndrome was reported by the investigator as unrelated to the study vaccine.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Febrile convulsion
Clinical narrative: This case was considered medically important (OMIC). Info regarding Flumist was received from a physician regarding a 4 year old male pt who experienced a seizure approximately 26 hrs after receiving Flumist. The pt received a dose on 1/5/04. The physician reported that the child was a "walk-up pt" and had no history at his office. The physician did not see the child post-immunization, but learned of the seizure after receiving a telephone call from the child's mother. No additional info was available at the time of this report. Follow-up information received from the physician provided a "likely" diagnosis of febrile seizure and recovery status (patient recovered). The child recovered without sequelae, and was discharged from the emergency room on the same day as admission. The physician spoke with the father the following day, and was told that all was well with the child. Follow up information received from the physician provided a likely diagnosis of febriel seizure and recovery status (patient recovered).
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Condition aggravated, Headache, Medication error, Myalgia, Pharyngolaryngeal pain
Clinical narrative: Follow up information received from the physician provided patient information, test results and additional events with serious criteria (OMIC). Information regarding Flumist nasal solution was received from a healthcare professional regarding a 14 year old male patient who experienced status asthmaticus, rhinitis, wheezing, headache, sore throat, myalgia and fever. At 14 years of age, the patient received a dose of 12/9/03. The patient's concurrent illness includes asthma. Indication for Flumist was immunization. Product was administered on 12/9/03. Dose regimen was 1 dose (IN). Concomitant therapy included Advair, Singulair, and albuterol. The patient experienced rhintiis, wheezing, myalgia, sore throat, and headache on the night of 12/11/03. On 12/12/03, he was sent home from school with a fever of 101.8 degrees F. He was seen by the physician later that same day with a fever of 102.8 and appeared to have active influenza. He was treated with Advil. Later that same day, he was hospitalized for status asthmaticus. He was treated with prednisone, albuterol, and Tamiflu. On 12/14/03, he was discharged. As of 12/15/03, he was still weak and wheezing but no longer toxic or short of breath. The physician indicated that the patient had been out of albuterol for a few days prior to immunization.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinitis, Status asthmaticus, Wheezing
Clinical narrative: Follow up information received from the physician provided patient information, test results and additional events with serious criteria (OMIC). Information regarding Flumist nasal solution was received from a healthcare professional regarding a 14 year old male patient who experienced status asthmaticus, rhinitis, wheezing, headache, sore throat, myalgia and fever. At 14 years of age, the patient received a dose of 12/9/03. The patient's concurrent illness includes asthma. Indication for Flumist was immunization. Product was administered on 12/9/03. Dose regimen was 1 dose (IN). Concomitant therapy included Advair, Singulair, and albuterol. The patient experienced rhintiis, wheezing, myalgia, sore throat, and headache on the night of 12/11/03. On 12/12/03, he was sent home from school with a fever of 101.8 degrees F. He was seen by the physician later that same day with a fever of 102.8 and appeared to have active influenza. He was treated with Advil. Later that same day, he was hospitalized for status asthmaticus. He was treated with prednisone, albuterol, and Tamiflu. On 12/14/03, he was discharged. As of 12/15/03, he was still weak and wheezing but no longer toxic or short of breath. The physician indicated that the patient had been out of albuterol for a few days prior to immunization.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis, Viral infection
Clinical narrative: Follow up info received from the physician provided vaccination date, lot number, admitting diagnosis, test results, and outcome. Info regarding Prevnar was received from an infectious disease physician regarding a 5 month old male who developed a respiratory syncytial virus infection and pneumococcal bacteremia. The infant received his first dose of Prevnar on 9/10/03, at 2 months of age. The infant was hospitalized on an unspecified date with a respiratory syncytial virus infection and then developed pneumococcal disease. Blood cultures performed on 12/7/03 and 12/9/03 were positive for Streptococcus pneumoniae serotype 19. The lab reported that they did not specifically test for serotype 19F. The physician indicated that a sample will be sent to CDC for serotyping. An immunologic workup was negative. The infant was admitted to the ICU and intubated. The physician reported the infant "survived and is doing well."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea, Gastroenteritis, Hypotonia, Lethargy, Stupor
Clinical narrative: Hyporesponsive-hypotonic event within 12 hours of aDPT, IPV, Hep B-HIB, and PCV7 immunizations. Afebrile. Medical Records received on 1/20/2004 states loose stools, lethargy and gastroenteritis.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, PPV
Symptoms: Bacterial infection, Dehydration, Diarrhoea, Drug ineffective, Dyspnoea
Clinical narrative: 20 mo old male takent o ER and admitted to ICU. Admitting diagnosis: pneumonia. Culture positive for Strep. pneumo. The hospital discharge summary received on 3/23/04 states dehydration, hyponatremia, empyema w/o fistual, pleural effusion, pneumothrorax, influenza, diarrhea, and difficulty breathing.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, PPV
Symptoms: Hyponatraemia, Infection, Influenza, Pleural effusion, Pneumonia
Clinical narrative: 20 mo old male takent o ER and admitted to ICU. Admitting diagnosis: pneumonia. Culture positive for Strep. pneumo. The hospital discharge summary received on 3/23/04 states dehydration, hyponatremia, empyema w/o fistual, pleural effusion, pneumothrorax, influenza, diarrhea, and difficulty breathing.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, PPV
Symptoms: Pneumothorax, Sepsis
Clinical narrative: 20 mo old male takent o ER and admitted to ICU. Admitting diagnosis: pneumonia. Culture positive for Strep. pneumo. The hospital discharge summary received on 3/23/04 states dehydration, hyponatremia, empyema w/o fistual, pleural effusion, pneumothrorax, influenza, diarrhea, and difficulty breathing.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Urinary tract infection
Clinical narrative: A report was received from a health care professional on 1/5/03, concerning an 18 month old female vaccinee who experienced a seizure 15 minutes after, and a urinary tract infection an unspecified length of time after inadvertently receiving Fluvirin on an unspecified date. The events were considered medically significant. The vaccinee had a previous history of a seizurre, bronchitis, and mild respiratory distress. On an unspecified date the vaccinee experienced a seizure 15 minutes after receiving Fluvirin at her mother's request on an unspecified date. The vaccinee was taken to an ER for treatment and was diagnosed as having a urinary tract infection. The outcome of the event was not reported. There was insufficient info to determine the reporter's causality assessment. The reporter also commented: "doubt seizure was caused by vaccine due to history given by mother."  Follow up on 06/25/04 states: "Vaccinee had experienced a seizure prior to Fluvirin administration, was taken to ER and found to have a urinary tract infection and fever. Pt was also found to be developing a fever with the urinary tract infection after vaccination with Fluvirin. The pt is currently being investigated for a seizure disorder unrelated to the Fluvirin event. Reporter's causality-possible, but unlikely."
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt received flu shot at pharmacy and was told to stay in store 10-15 minutes in case of adverse reaction.  Pt returned about 20 min later; they had left store and pt was passenger in car driving home when pt passed out, but came to almost right away.  Returned to pharmacy for observation.  No further problems.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Noted redness and swelling surrounding injection site which decreased over next few hours.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Muscular weakness, Pain
Clinical narrative: Severe left arm pain and weakness with muscle bulging-unremitting-sent to neurology. The medical record received on 4/2/04 states decreased range of motion. No further calls or complaints from the patient.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash, Urticaria
Clinical narrative: Had Typhoid, Anthrax, and smallpox shot on 08/09/03.  On 08/12/03 had rash on my entire body.  Spoke to clinic and she said could to to ER if I wished.  Found out to be hives.
Age: 46.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Coronary artery disease, Coronary artery occlusion, Myocardial infarction, Skin ulcer
Clinical narrative: Developed chest pain on 1/6/04 resulting in cardiac cath and angioplasty with stenting. RCA proximal and distal lesions; will have CABG in 6 weeks. Medical records reviewed. Please add COSTARTS of CORONARY ART DIS, OCCLUS CORONARY, INFARCT MYOCARD.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Lacrimation increased, Pruritus
Clinical narrative: 20 min after 3rd vaccine, pt developed itchy, watery eyes right with erythema.  Slightly relieved with IM Benadryl lasting 3-4 days.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: High-pitched crying, Musculoskeletal stiffness
Clinical narrative: High-pitched cry, body stiffening in intermittent episodes over several hours.  Arms held out over front or overhead.  Recovered following day, no fever.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV
Symptoms: High-pitched crying, Musculoskeletal stiffness
Clinical narrative: High-pitched cry and body stiffening in intermittent episodes, over several hours.  Arm held out in front or overhead.  Recovered the following day, no fever.
Age: 0.8
Sex: M
Vaccine: IPV
Symptoms: Chills, High-pitched crying, Musculoskeletal stiffness
Clinical narrative: High-pitched cry and body stiffening lasting several hours.  Arm held out or overhead several episodes of shuddering followed.  NO fever fully recovered following day.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Headache, Urticaria
Clinical narrative: Pt went to ER with complaints of headache, hives, slight shortness of breath.  Please review attached ED report.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Right thigh red, itchy, painful.  10-15 cm in diameter.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Blister
Clinical narrative: Small blister to right thigh.  No redness, no edema, no fever.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Pt developed redness, swelling and soreness and a small hematoma at injection site.  Also experienced fever: 100-101 and pain in upper arm.  Symptoms lasted approx 36-48 hours.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness around arm below injection site; prescribed Keflex 500mg per mouth ever 6 hours for 7 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Rash
Clinical narrative: Red rash/swelling around right arm 3cm below injection site. Prescribed Keflex 500mg per mouth ever 6 hours for 7 days.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Crying
Clinical narrative: 12/09/2003 @ 10:00: Vaccines given.  12/09/03 @ 15:00: Pt's grandmother called to report aht child have been crying for greater than 2 hours.  Stated child did not have fever.  Infant Tylenol had been given at 14:45.  Nurse to check with pt in 1 hour 12/09/03 @ 16:00: Telephone call, grandmother stated parents took child to ER after observing a "small seizure".  12/10/03@ 07:45: Telephone call, grandmother stated child is doing better-was not admitted to hospital.  Was advised by ER staff to continued prescribing Tylenol.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Oedema, Pain
Clinical narrative: Pt received injection on 01/09/2004-client complained of progressive pain and swelling which she reported to our clinic on 01/12/04, advised client to seek medical care to rule out cellulitis/infection.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Torticollis
Clinical narrative: Stiff neck developed for few days after initial flu vaccine. Booster dose given, pt developed torticollis  worsening over 5 days.
Age: 21.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Overall body aches and pains.  Slight fever, exhaustion.  Called MD: take 3 advil at HS; Called ER: bring pt to ER if symptoms became worse.
Age: 9.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Chills, Cough, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Chills, body aches, high fever, runny nose, cough.  Treated with Triaminic flu cold and cough.
Age: 1.6
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Contusion, Face oedema
Clinical narrative: Facial edema and bruising.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Eye swelling, Face oedema, Flushing
Clinical narrative: Mom called MD office on 01/07/04 at about 16:00 and reported that pt woke up with swelling to eyes at about 13:00 and as time went by, pt's upper lip swelled and became redness to face and spreading to entire body by 16:00.  Mother was advised to take pt to ER ASAP.  Pt seen at ER that afternoon and treated and released.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Coordination abnormal
Clinical narrative: Ataxia starting about 7 hours after immunizations given. Pt afebrile, otherwise normal exam. No bruising, edema, erythema at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash
Clinical narrative: Mom noted red rash at left deltoid 2 days after receiving vaccines. No history of fevers, breathing problems.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Somnolence
Clinical narrative: Prolonged crying continued 24 hours, started immediately after giving vax, increased sleeping day after immunizations.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Hypersensitivity, Irritability, Oedema
Clinical narrative: Swelling of groin and both legs from umbilicus to feet 2 days after vaccines given. Increased fussiness and crying, treated with Tylenol. Diagnosis: local vs allergic reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Oedema peripheral
Clinical narrative: LD to left elbow red, swollen, warm to touch.
Age: 1.17
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Papular rash without symptoms of other illness 13 days after varicella vaccine. Fever controlled with Tylenol. T max 103.0.
Age: 1.33
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Cough, Dyspnoea, Pyrexia, Urticaria
Clinical narrative: Fever >101. Urticaria like rash x2 days, brief difficulties of breathing 1 day after vaccines given; cough x2 days.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: The case was reported by a physician and describes the occurrence of fever in a 6-month-old female who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The pt's medical history, concurrent conditions, and concurrent medications were not reported. The pt had no adverse events following 2 previous doses with Haemophilus influenzae type b conjugate vaccine and 7-valent pneumococcal conjugate vaccine. On 09/20/2003, the pt received her 1st dose of Pediarix in her right leg. Concurrently, she received her 3rd dose of  with Haemophilus influenzae type b conjugate vaccine (manufacturer unknown) and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs). Approx 5 days post-immunization, on 09/25/2003, the pt developed a fever of 102.8 degrees F. The event was unresolved as of 09/26/2003. The physician considered the event probably related to vaccination with Pediarix.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Petechiae
Clinical narrative: This case was reported by a nurse and described the occurrence of petechial rash in a 2-month-old pt who received diptheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. Concurrent vaccines/medications, concurrent medical conditions and medical history were not provided. On an unknown date, the pt received the 2nd dose of Pediarix (lot 21882B2). On an unspecified date post-immunization, the pt experienced a petechial rash on the lower legs which spread to the arms. The event was unresolved as of 10/03/2003.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Petechiae
Clinical narrative: This case was reported by a nurse and described the occurrence of generalized petechial rash in a 2-month-old pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. Concurrent vaccines/medications, concurrent medical conditions and medical history were not provided. On an unknown date, the pt received the 2nd dose of Pediarix (lot 21882B2). On an unspecified date post-immunization, the pt experienced a generalized petechial rash. The events were unresolved as of 10/03/2003.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, DTAPHEPBIP, HIBV, IPV
Symptoms: Crying, Medication error
Clinical narrative: This case was reported by a physician and described a 2-month-old female pt who inadvertently received diphtheria and tetanus toxoids and acellular perrtussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) plus a separate injection of poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 10/13/2003, the pt received her 1st dose of Pediarix. The pt then inadvertently received an injection of IPOL. The pt also received Haemophilus influenzae type b conjugate vaccine (Hib-Titer, Lederle Labs). At an unspecified time following the immunizations, on 10/13/2003, the pt experienced crying.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC, DTAPHEPBIP, PNC
Symptoms: Flatulence, Oedema peripheral, Pyrexia, Rash, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of the leg of an 8-month-old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On unspecified dates, the pt received 2 previous doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (unknown manufacturer), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and combination Haemophilus influenzae type b conjugate vaccine/hepatitis B vaccine (Comvax, Merck). On 10/22/2003, the pt received his 1st dose of Pediarix which was given as the 3rd dose in the DTPa, poliomyelitis, and hepatitis B immunization series. The dose of Pediarix was administered in the left leg. One day later, on 10/23/2003, the pt experienced a rash on his leg "which covered one-fourth of his thigh," swelling of the leg, fever, vomiting and gas pains. The fever, vomiting and gas pains resolved on 10/24/2003. The leg rash and leg swelling were unresolved. The nurse considered the events were probably related to vaccination with Pediarix. The nurse considered the leg rash and leg swelling to be related to vaccination with Pediatrix and the fever, vomiting and gas pain to possibly be related to Pediarix and Prevnar.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC, DTAPHEPBIP, PNC
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site oedema, Injection site rash
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of the leg of an 8-month-old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On unspecified dates, the pt received 2 previous doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (unknown manufacturer), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and combination Haemophilus influenzae type b conjugate vaccine/hepatitis B vaccine (Comvax, Merck). On 10/22/2003, the pt received his 1st dose of Pediarix which was given as the 3rd dose in the DTPa, poliomyelitis, and hepatitis B immunization series. The dose of Pediarix was administered in the left leg. One day later, on 10/23/2003, the pt experienced a rash on his leg "which covered one-fourth of his thigh," swelling of the leg, fever, vomiting and gas pains. The fever, vomiting and gas pains resolved on 10/24/2003. The leg rash and leg swelling were unresolved. The nurse considered the events were probably related to vaccination with Pediarix. The nurse considered the leg rash and leg swelling to be related to vaccination with Pediatrix and the fever, vomiting and gas pain to possibly be related to Pediarix and Prevnar.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC, DTAPHEPBIP, PNC
Symptoms: Pyrexia, Rash, Rash macular, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of the leg of an 8-month-old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On unspecified dates, the pt received 2 previous doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (unknown manufacturer), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and combination Haemophilus influenzae type b conjugate vaccine/hepatitis B vaccine (Comvax, Merck). On 10/22/2003, the pt received his 1st dose of Pediarix which was given as the 3rd dose in the DTPa, poliomyelitis, and hepatitis B immunization series. The dose of Pediarix was administered in the left leg. One day later, on 10/23/2003, the pt experienced a rash on his leg "which covered one-fourth of his thigh," swelling of the leg, fever, vomiting and gas pains. The fever, vomiting and gas pains resolved on 10/24/2003. The leg rash and leg swelling were unresolved. The nurse considered the events were probably related to vaccination with Pediarix. The nurse considered the leg rash and leg swelling to be related to vaccination with Pediatrix and the fever, vomiting and gas pain to possibly be related to Pediarix and Prevnar.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC, DTAPHEPBIP, PNC
Symptoms: Flatulence, Injection site oedema, Injection site rash, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of the leg of an 8-month-old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On unspecified dates, the pt received 2 previous doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (unknown manufacturer), inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and combination Haemophilus influenzae type b conjugate vaccine/hepatitis B vaccine (Comvax, Merck). On 10/22/2003, the pt received his 1st dose of Pediarix which was given as the 3rd dose in the DTPa, poliomyelitis, and hepatitis B immunization series. The dose of Pediarix was administered in the left leg. One day later, on 10/23/2003, the pt experienced a rash on his leg "which covered one-fourth of his thigh," swelling of the leg, fever, vomiting and gas pains. The fever, vomiting and gas pains resolved on 10/24/2003. The leg rash and leg swelling were unresolved. The nurse considered the events were probably related to vaccination with Pediarix. The nurse considered the leg rash and leg swelling to be related to vaccination with Pediatrix and the fever, vomiting and gas pain to possibly be related to Pediarix and Prevnar.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying, Dyspnoea, Erythema, Hyperhidrosis, Injection site mass
Clinical narrative: This case was reported by a consumer and described the occurrence of uncontrollable crying in an 8-week-old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. A physician or other health care professional has not verified this report. The pt received hepatitis B vaccine (unknown manufacturer) at birth. On 11/18/2003, when the pt was 8 weeks of age, he received the 1st dose of Pediarix in his right leg and "immediately started crying." Pediarix was administered as the 2nd dose of hepatitis B vaccine. The same day, the pt received an injection of Haemophilus influenzae type b conjugate vaccine (unknown manufacturer). Approx 30 minutes post-immunization at 3:00 PM, the mother reported that she fed her son and was able to calm him down. Approx 90 minutes later, at 4:00 PM, the pt "started crying uncontrollably and would shake his right leg like it was hurting and scream." The mother noted that her son cried "so hard that he started sweating and would gasp for breath between sobs." She contacted the physician via telephone and was instructed to treat him with acetaminophen and a bath. Approx 2 hours later at 6:00 PM she stated her son "calmed down, but did not sleep well that same night." Approx 12 hours later, on 11/19/2003, the pt had an axially fever of 100 degrees F and developed 2 red spots on his leg and "two hard balls under his skin," at the injection site. The injection site reaction resolved 2 days post-immunization. At the time of reporting, 11/21/2003, all other events were unresolved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pyrexia, Sleep disorder, Tremor
Clinical narrative: This case was reported by a consumer and described the occurrence of uncontrollable crying in an 8-week-old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. A physician or other health care professional has not verified this report. The pt received hepatitis B vaccine (unknown manufacturer) at birth. On 11/18/2003, when the pt was 8 weeks of age, he received the 1st dose of Pediarix in his right leg and "immediately started crying." Pediarix was administered as the 2nd dose of hepatitis B vaccine. The same day, the pt received an injection of Haemophilus influenzae type b conjugate vaccine (unknown manufacturer). Approx 30 minutes post-immunization at 3:00 PM, the mother reported that she fed her son and was able to calm him down. Approx 90 minutes later, at 4:00 PM, the pt "started crying uncontrollably and would shake his right leg like it was hurting and scream." The mother noted that her son cried "so hard that he started sweating and would gasp for breath between sobs." She contacted the physician via telephone and was instructed to treat him with acetaminophen and a bath. Approx 2 hours later at 6:00 PM she stated her son "calmed down, but did not sleep well that same night." Approx 12 hours later, on 11/19/2003, the pt had an axially fever of 100 degrees F and developed 2 red spots on his leg and "two hard balls under his skin," at the injection site. The injection site reaction resolved 2 days post-immunization. At the time of reporting, 11/21/2003, all other events were unresolved.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Report 2001027133-1 describes a sore throat in a 32-year-old female who received an injection of hepatitis B vaccine recombinant (Engerix-B). This report was received from the pt and has not been verified by a physician or other healthcare professional. Medical history and concurrent conditions were not specified. There were no concurrent medications. On 06/30/2001, the pt received an injection of Engerix-B; it was not specified if the pt had received prior injections of Engerix-B. On 09/01/2001, 63 days post-immunization, the pt experienced a sore throat and "feeling that food was coming out of her mouth." The pt was seen by a physician. The events persisted as of 11/14/2001.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Psoriasis, Skin disorder
Clinical narrative: Report 2001027603-1 describes decreased T cells in a male approx 50 years of age who received hepatitis B recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. "Four years ago", the pt received his 2nd injection of Engerix-B. Subsequently, "four years ago", the pt experienced skin changes, psoriasis, and decreased T-cells. As of 11/20/2001, the outcome of the events was unknown.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Bradycardia, Hyperhidrosis
Clinical narrative: Report 2001027635-1 describes bradycardia in a 32-year-old male who received hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent medications and concurrent conditions were not specified. On 10/01/2001, the pt received his 1st injection of Engerix-B. Two to 3 hours post-immunization, he experienced bradycardia and broke out into a cold sweat. He recovered, without treatment. On 11/01/2001, the pt received his 2nd injection of Engerix-B. Approx 5 minutes post-immunization, he broke out into a cold sweat. Additionally, he experienced bradycardia. Medical attention was required at the occupational health clinic. His heart rate rose gradually from 48 to 51 to 61 beats/minute. As of 11/20/2001, the events had resolved.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Report 2001028372-1 describes a 54-year-old female who did not respond to the hepatitis B recombinant vaccine (Engerix-B) immunization series. Medical history, concurrent conditions and concurrent medications were not specified. The pt received injections of Engerix-B (lot ENG3212A4) on 01/03/1999, 02/03/1999 and 06/02/199, On an unspecified date, the pt "tested negative for any hepatitis B antibodies."
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Report 2001028659-1 describes dizziness in an 18-year-old female who received hepatitis B vaccine recombinant (Engerix-B). The pt had a seizure disorder and received carbamazepine (Tegretol). On 12/03/2001, the pt received her 1st injection of Engerix-B. Post-vaccination, on 12/03/2001, the pt experienced dizziness. As of 12/03/2001, the outcome of the event was unknown.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: Report 2001028667-1 describes headache in a 47-year-old female who received hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the pt received her 1st injection of Engerix-B. Subsequently, she experienced injection site pain, headache, fever, nausea, and malaise. As of 12/03/2001, the outcomes of the events were unknown.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Report 2001028862-1 describes hives in a 19 year old female who received hep B vaccine. Medical history, concurrent conditions, and concurrent medications were not specified. On unspecified dates, the vaccinee received her first and second injections of hep B vaccine. Following her second vaccination with hep B vaccine, she experienced hives. As of 12/4/01, the hives had resolved.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Report 2001028958-1 describes urticaria in a 14 year old female who received hep B vaccine recombinant (Engerix B). Medical history and concurrent conditions were not specified. She received no concurrent medications. On 7/31/01, the vaccinee received her second 10mcg injection of Engerix B. Within 24 hrs post-vaccination, she experienced urticaria. No medical attention was required. As of 12/4/01, she had recovered.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: Report 2001029378-1 describes fever in a 27 year old female who received an injection of hep B vaccine recombinant (Engerix B). This report was received from the vaccinee's sister, who is a nurse. Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no adverse experience following receipt of her first injection of Engerix B. On 12/6/01, the pt received her second injection of Engerix B. An unspecified time post-immunization, she experienced fever, chills, sweats, and flu-like symptoms.
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Back pain, Chills, Hyperhidrosis
Clinical narrative: Report 2001029402-1 describes back pain in a female (age not specified) who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no adverse experiences following receipt of her first injection of Engerix B. On 12/6/01, the pt received her second injection of Engerix B. An unspecified time post-vaccination, she experienced back pain, abnormal cramping, weakness, sweating, chills, and nausea. The pt was seen by a physician. The outcomes of the events were unknown.
Sex: F
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: Report 2001029402-1 describes back pain in a female (age not specified) who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no adverse experiences following receipt of her first injection of Engerix B. On 12/6/01, the pt received her second injection of Engerix B. An unspecified time post-vaccination, she experienced back pain, abnormal cramping, weakness, sweating, chills, and nausea. The pt was seen by a physician. The outcomes of the events were unknown.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pain
Clinical narrative: Report 2001029413-1 describes leg pain in a female in her 50's who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. On 12/4/01, the pt received her first injection of Engerix B. For 20 minutes following the injection, the pt experienced nausea, which resolved without treatment. On 12/7/01, three days post-vaccination, the pt experienced pain in her legs and was seen by the reporter. She had no difficulty walking. The pt talked to her physician via the telephone. The pt indicated that she thought the leg pain was related to Engerix B administration.
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Fungal infection, Muscular weakness
Clinical narrative: Report 2001029705-1 describes a yeast infection in an adult female of unspecified age who received an injection of hep B vaccine. This report was received from the vaccinee's co-worker, and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date during the summer of 2001, the vaccinee received an injection of hep B vaccine. It was not known if she had received previous injections of hep B vaccine. "Right after the shot," the vaccinee reportedly experienced an unspecified yeast infection. The reporter stated," she is now complaining of SOB, muscle weakness, and numerous other things." The vaccinee "claimed to have all of the side effects listed in the package insert." The vaccinee reportedly had sought medical attention for these events. Outcomes of the events were not known by the reporter. The reporter declined to provide additional info.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Tic
Clinical narrative: Report 2001029903-1 describes motor tics in a 9 year old male who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee received no concomitant vaccines. In March 2001, the vaccinee received his third injection of Engerix B. One day post-vaccination, he experienced motor tics which "come and go." As of 12/13/01. the motor tics have not resolved.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Report 2001029990-1 describes an adult female of unspecified age who did not respond to the hep B immunization series. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee allegedly received injectoins of Engerix B on 9/16/98, 10/14/98, and 3/10/99. Lot numbers of vaccine administered were not provided. Her attorney alleged that "on or about 11/18/99, plaintiff received a letter from her employer which stated "there may have been a problem with a particular batch of hep B vaccinations" from which she received one of her injections and that she "should receive a lab test, known as a titer, to determine if she has a positive immunity to hep B or if she needed a booster injection." The vaccinee allegedly received an injection of Engerix B on 12/2/99. An unspecified hep B titer, measured on 1/13/00, was reportedly <2mIU/mL. The vaccinee then allegedly received injections of Engerix B on 2/25/00, 3/24/00 and 8/23/00; lot numbers of vaccine administered were not provided.  An unspecified hep B titer, measured on 9/25/00, was reportedly <2mIU/mL.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Report 2001030201-1 describes an allergic reaction in a 6 year old female who received hep B vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not specified. In September 1996, the vaccinee received her first injection of Engerix B. Subsequently, the vacinee had an allergic reaction. As of 12/20/01, the outcomes of the event was unknown.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Paraesthesia
Clinical narrative: Report 2001030432-1 describes tingling in a 24 year old female who received hep B vaccine recombinant (Engerix B). The vaccinee's medical history, concurrent conditions and concurrent medications were not specified. She received no concomitant vaccines. On 11/16/01, the vaccinee received her second 20mcg right deltoid injection of Engerix B. Two weeks later, on 11/30/01, she started to experience tingling in her right fingertips, followed by shooting pains down the right arm. As of 12/14/01, the vaccinee was also experiencing tingling in her left arm. A doctor visit was required. As of 12/21/01, the adverse events had not resolved.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Unevaluable event
Clinical narrative: Report 2002000693-1 describes a 34-year-old female who did not respond to the hepatitis B recombinant vaccine (Engerix-B) immunization series. Medical history, concurrent conditions, and concurrent medications were not specified. On 11/12/2001, the pt received her 3rd injection of Engerix-B. In January 2002, approx 2 months post-vaccination, "titers" revealed that the pt had not seroconverted.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Paraesthesia, Somnolence
Clinical narrative: Report 2002000816-1 describes dizziness in a 33-year-old male who received hepatitis B vaccine recombinant (Engerix-B). This report was received from the pt and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. On 01/15/2002, in the morning, the pt reportedly received his 1st 20 mcg subcutaneous injection of Engerix-B. "By early afternoon", he was experiencing dizziness, sweating and tingling in his hand. He slept from 17:30 to the next morning without waking. As of 01/16/2002, the events were ongoing.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis
Clinical narrative: Report 2002000935-1 describes dermatitis around the injection site in an approx 30-year-old female pt who received hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent conditions and concurrent medications were not specified. On 09/18/2001, the pt received her 1st injection of Engerix-B (lot ENG5186C6). Subsequently, she had a "dermatitis reaction" around the area of the vaccination. The pt was seen by a dermatologist, who reportedly made a diagnosis of dermatitis related to the hepatitis B vaccination. As of 01/11/2001, the outcome of the event was unknown.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Depressed level of consciousness, Dizziness, Fall, Fatigue
Clinical narrative: Report 2002001243-1 describes fainting in an 11-year-old male who received hepatitis B vaccine recombinant (Engerix-B). This report was received from the mother of the pt and has not been verified by a physician or other healthcare professional. Medical history and concurrent conditions were not specified. The pt did not receive any other vaccinations on 01/22/2002, but he did have the tuberculosis skin test performed. Reportedly, on 01/22/2002, the pt received his 1st injection of Engerix-B. The mother reported that within 5 minutes of getting in the car, her son "was out cold". She said that it was very difficult to wake him and they had to help him out of the car and into the house. She stated that his condition was "like he was going in and out of consciousness". Reportedly, he had no interest in food, felt dizzy and nauseated, and had "some" muscle weakness. Reportedly, he went to go down the hall to his bedroom and fell down in the hall and went to sleep. Mother said he "was just unable to function". The pt was taken to the ER where, reportedly, the physician said that the pt had "fainted" and sent him home. Mother and pt went to the pediatrician's office on 01/23/2002 and, reportedly, the physician stated that the pt "seemed fine". Mother reported that on 01/23/2002, her son was throwing up and was very nauseated. She said that he has not had this type of reaction with any other vaccines he has had in the past. As of 01/24/2002, the pt was "still fatigued".
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Muscular weakness, Nausea, Syncope, Vomiting
Clinical narrative: Report 2002001243-1 describes fainting in an 11-year-old male who received hepatitis B vaccine recombinant (Engerix-B). This report was received from the mother of the pt and has not been verified by a physician or other healthcare professional. Medical history and concurrent conditions were not specified. The pt did not receive any other vaccinations on 01/22/2002, but he did have the tuberculosis skin test performed. Reportedly, on 01/22/2002, the pt received his 1st injection of Engerix-B. The mother reported that within 5 minutes of getting in the car, her son "was out cold". She said that it was very difficult to wake him and they had to help him out of the car and into the house. She stated that his condition was "like he was going in and out of consciousness". Reportedly, he had no interest in food, felt dizzy and nauseated, and had "some" muscle weakness. Reportedly, he went to go down the hall to his bedroom and fell down in the hall and went to sleep. Mother said he "was just unable to function". The pt was taken to the ER where, reportedly, the physician said that the pt had "fainted" and sent him home. Mother and pt went to the pediatrician's office on 01/23/2002 and, reportedly, the physician stated that the pt "seemed fine". Mother reported that on 01/23/2002, her son was throwing up and was very nauseated. She said that he has not had this type of reaction with any other vaccines he has had in the past. As of 01/24/2002, the pt was "still fatigued".
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Unevaluable event
Clinical narrative: Report 2002001269-1 describes a 53-year-old female who did not respond to a 4-injection series of hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. On 03/08/2001, 04/10/2001 and 09/12/2001, the pt received her 1st, 2nd and 3rd injections of Engerix-B (all from lot #ENG3375A4; expiry 04/20/2003) respectively. Antibody titer against hepatitis B surface antigen (HBsAg) was measured on 11/20/2001 and was negative. On 11/30/2001 the pt received her 4th injection of Engerix-B (lot ENG3375A4), expiry 04/20/2003). Anti-HBsAg titer was negative on 01/17/2002.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Unevaluable event
Clinical narrative: Report 2002001273-1 describes a 36-year-old female who failed to respond to a 3-injection series of hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent conditions and concurrent medications were not specified. The pt received injections of hepatitis B vaccine (Recombivax-HB, Merck) on 05/23/2000 (lot 1960J, expiry 02/04/2002), 06/28/2000 (lot 0488K, expiry 03/12/2002) and 01/03/2001 (lot 0488K, expiry 03/12/2001). Antibody titer against hepatitis B surface antigen (HBsAg) was measured on 03/01/2001 and was negative. The pt received her 1st injection of Engerix-B on 03/12/2001 (lot ENG3375A4, expiry 04/20/2003). Anti-HBsAg titer measured on 05/02/2001 was negative. She received her 2nd injection of Engerix-B on 05/24/2001 (lot ENG 3375A4, expiry 04/20/2003). Anti-HBsAg titer was negative on 08/29/2001. The pt received her 3rd injection of Engerix-B on 09/24/2001 (lot ENG3375A4, expiry 04/20/2003). Anti-HBsAg titer measured on 11/27/2001 was negative.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Unevaluable event
Clinical narrative: A pharmacist reported an occurrence of non-response to the hepatitis B vaccine recombinant (Engerix-B) immunization series in a 47-year-old female. Concurrent medical conditions included an allergy to penicillin. Concurrent medications were not provided. On 01/16/1998, the pt received a 6th injection of hepatitis B vaccine recombinant (Engerix-B). Sometime after the injections, the pharmacist reported that the pt "never seroconverted."