chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Nausea
Clinical narrative: Injection painful at time of administration with bleeding and bruising occurring immediately. Shortly thereafter, site observed to be hot to touch with silver-dollar sized redness and swelling at site. In ensuing days, starting very soon, experienced muscle and joint aching. Heat persisted until 12/09/02. Some nausea, intermittently. Redness and swelling persisted for about 5 days and associated soreness at site.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Rash
Clinical narrative: Pruritic rash lasting 7 days. No difficulty breathing.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Tinnitus
Clinical narrative: Since 3rd Anthrax shot, has had ringing/hum sound in left ear (2 years duration). Evaluated by local MD with neg physical findings.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Muscle spasms, Muscular weakness
Clinical narrative: Delayed anaphylactic reaction with severe hives, difficulty breathing, fever, nausea, dizziness, neck pain and spasms, shakiness, weakness in both arms and blurred vision. Made 3 trips to ER for Epinephrine and several meds; eye drops; and physical therapy is still on-going.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Neck pain, Pyrexia, Tremor, Urticaria
Clinical narrative: Delayed anaphylactic reaction with severe hives, difficulty breathing, fever, nausea, dizziness, neck pain and spasms, shakiness, weakness in both arms and blurred vision. Made 3 trips to ER for Epinephrine and several meds; eye drops; and physical therapy is still on-going.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Delayed anaphylactic reaction with severe hives, difficulty breathing, fever, nausea, dizziness, neck pain and spasms, shakiness, weakness in both arms and blurred vision. Made 3 trips to ER for Epinephrine and several meds; eye drops; and physical therapy is still on-going.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Pain, Pyrexia
Clinical narrative: Cough, congestion, low-grade fever and body aches. Recovery in progress.
Age: 1.3
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Pt had hives and hand swelling of both hands.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: 12/26/02 (02:00) numbness on right side of face and about midnight went to ER. Face paralyzed on right side speech and eyes. Prescribed Prednisone (30 of them) 10mg for 12 days. Dx: Bell's Palsy. No recovery yet. Would not have taken the Flu shot if I had known there was mercury preservative in it because my nephew has autism after childhood vaccinations.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal, Viral infection
Clinical narrative: Child developed mild case of chickenpox with small vesicles and many (about 50) ? lesions-junk papules.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Herpes zoster
Clinical narrative: Pt received a vaccination for combined Hep-A and Hep-B in preparation for a trip to China. Typical herpes zoster developed in the same arm, 14 days later.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: 1 day, post vax, in the left arm, pt had swelling and violatous discoloration at site of shot plus surrounding erythema and induration.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Mouth ulceration, Nausea, Swelling face
Clinical narrative: On 1/8/03, pt complained of nausea and extreme fatigue, approx. 3 hours after Typhoid oral administration. On 1/9/03, pt complained of lip swelling and bumps on mouth upon awaking in AM.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 7cm X 11cm erythema and induration at injection site. Also, tender and warm to touch on 1/10/03. Injection given 48 hours earlier. TX: Benadryl 50mg bid X 2 days, ice on and off X 24 hours.
Age: 5.5
Sex: M
Vaccine: HIBV, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Child developed chickenpox.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Skin irritation
Clinical narrative: Pt had swelling, irritation from MMR, area of cellulitis and it was delineated red/white.
Age: 3.5
Sex: M
Vaccine: PPV
Symptoms: Febrile convulsion
Clinical narrative: Temperature 104F within 3 hours of vaccine and possible febrile seizure.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Ear disorder, Pyrexia
Clinical narrative: Crying for 2 hours. Woke up at 17:30 and crying on and off until 23:00; fell asleep. Fever of 101 (ax) on the night of 1/8/03. Gave Tylenol on 1/7/03 PM, twice on 1/8/03 AM and PM. Crying on and off until 06:00 this morning with only cat naps. Slight red left ear at 17:30 on 1/9/03.
Sex: F
Vaccine: IPV
Symptoms: Injection site rash
Clinical narrative: Vaccine site rash.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Multiple papular lesions, some vesicular, some crusted and some pink papules on scalp, back and trunk. No fever.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and hives on abdomen and back. Benadryl 50mg po, Prednisone 60mg po and Zantac 150mg po were given in ED and a prescription. Still has rash and itching.
Age: 30.0
Sex: M
Vaccine: TTOX
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgia and headache.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Acne, Asthenia, Myalgia, Night sweats
Clinical narrative: Report 2001028489-1 describes weakness in a 28 year old male who received hepatitis B vaccine recombinant (Engerix-b). Medical history and concurrent conditions were not specified. Concurrent medications included hepatitis B immunoglobulin administered on 11/11/01. On 11/27/01 the vaccinee received his first injection of Engerix B. At approximately 20:00 on 11/27/01, the vaccinee experienced a very sore and tender arm. Additionally, he stated that the night of the vaccination he experienced mild generalized weakness and noted some night sweats. He also noted a small painful bump on his left shoulder/back. He reported back to the clinic the next day, stating that he could hardly lift his arm. He returned to the clinic on 11/29/01 feeling better but concerned. The nurse assessed the bump on his back which appeared to be a pimple. He did not require treatment and did not miss any work. The reporter stated that the events were mild in intensity and possibly related to Engerix B or HBIG. As of 11/29/01, the events had resolved.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Gastrointestinal disorder, Pyrexia, Viral infection, Vomiting
Clinical narrative: On 9/21/01, the infant received his 1st 10mcg dose of Engerix-B (lot ENG5144A2). On 9/27/01, 6 days post vax, the infant developed fever. He was seen by the physician and hospitalized on 9/28/01. The infant receive IV ampicillin and cefotaxime for 2 days. The fever resolved on 9/30/01 and the infant was discharged from the hospital. Discharge DX was neonatal fever. Discharge medication included cefprozil (Cefzil). The infant was seen by the physician for follow-up on 10/01/01. On 10/24/01, the infant received injections of DTAP vaccine adsorbed (see report 20010288362), 7-valent pneumococcal conjugate vaccine (Prevnar) and Hib. The infant experienced emesis on 10/30/01. On 11/27/01, when the infant was 2 months old, he received his 2nd 10mcg dose of Engerix-B (lot ENG5156A2) and an injection of IPOL. Two days later, on 11/29/01, the infant again experienced emesis. He was seen in the physician's office and blood was drawn for unspecified lab analysis. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/01 and 1/3/02. As of 1/7/02, the infant was being evaluated for possible malrotation or volvulus of the stomach. The most recent info was received on 1/11/02. The fever resolved on 9/30/01. The vaccine provider considered the fever to be moderate in intensity and possibly related to either Engerix-B administration or to a possible viral illness. The intermittent emesis was ongoing. The vaccine provider considered it to be moderate in intensity and possibly related to either Engerix-B administration, malrotation or volvulus of the stomach.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis
Clinical narrative: Report 2001029746-1 describes an adult female of unspecified age who received hepatitis B vaccine recombinant and contracted hepatitis B. 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's spouse is also infected with the hepatitis B virus. The spouse was allegedly tested after the vaccinee found that she had contracted hepatitis B; it is not known if the spouse contracted hepatitis B before or after the vaccinee allegedly did. The vaccinee's job responsibilities placed her in direct contact with bodily fluids from a patient with known hepatitis B infection. The vaccinee allegedly received injections of Engerix B on 8/31/98, 9/30/98, and 3/1/99. Lot numbers of vaccine administered were not reported. It was alleged that on or about 11/18/99, plaintiff.....received a letter from her employer stating that there may have been a problem with a particular batch of hepatitis B vaccinations from which she received on of her injections and that she should receive a lab test, known as a titer, to determine if she has a positive immunity to hepatitis B or if she needed a booster injection. The vaccinee received a booster injection of Engerix B on 12/3/99. The attorney stated as directed by the aforementioned letter, plaintiff.....was tested by her local physician on or about 1/7/00.....on 1/11/02, plaintiff.....learned that she had contracted the hepatitis B virus. It is not known if she had contracted hepatitis B before, during or after completing the Engerix B immunization series. Treatment and outcome of the hepatitis B infection were not reported. Hepatitis B is considered medically serious.
Age: 65.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Injection site haemorrhage, Laboratory test abnormal, Myalgia
Clinical narrative: Report 2002001333-1 describes sore arms in a 65 year old male who received hepatitis B vaccine recombinant (Engerix-B). Concurrent medications were not specified. The vaccinee had no major illnesses and no known allergies. On an unspecified date, the vaccinee received his first injection of hepatitis A vaccine inactivated. In July 2001, the vaccinee received injections of inactivated poliomyelitis virus vaccine and typhoid vaccine. In June 2001, and in July 2001, the vaccinee received his first and second injections of Engerix B, respectively. It was reported that in October 2001, he underwent a routine physical at a tertiary care center. An unspecified clotting study was performed. The vaccinee reported that the clotting study showed prolonged clotting in one arm, but that the other arm was normal. To the nurse practitioner's understanding, the test was repeated and the results then were normal. An electrophoresis was performed that showed an immunoglobulin G spike. The electrophoresis value was 2.3 dL on 10/1/01. On 1/18/02, the vaccinee received his third dose of Engerix B. He received two injections of the 10mcg pediatric formulation, to provide the adult dose of 20mcg. On that date, he also received his second injection of Havrix. On 1/21/02, the vaccinee developed a moderate-size hematoma at the Havrix injection site. The reporter stated that the hematoma was possibly related to Havrix. The vaccinee also complained of sore arms, tiredness, and vague myalgia; the exact onset of these symptoms was unknown. As of 2/22/02, the outcomes of the myalgia, sore arms, and tiredness were unknown. The outcome of the immunoglobulin G spike was not reported.
Age: 65.0
Sex: F
Vaccine: HEP, HEPA, HEP, HEPA
Symptoms: Fatigue, Myalgia
Clinical narrative: Report 2002001621-1 describes sore arms in a 65 year old female who received hepatitis B vaccine recombinant (Engerix B). Concurrent medical conditions included menopause and Barrett's esophagus (starting in 1999) which was treated with omeprazole. On 1/18/02, the vaccinee received her third dose of Engerix B. She received two injections of the 10mcg pediatric formulation (lot ENG5252A2; expiry 4/10/03), to provide the adult dose of 20 mcg. On that date, she also received her second injection of hepatitis A vaccine inactivataed. On 1/20/02, she experienced tiredness, sore arms, and generalized myalgias. Medical attention at the clinic was required. The vaccinee was treated with acetaminophen. The vaccinee did not have the same side effects with previous doses. The reporter stated that the events were mild in intensity, and possibly related to Engerix B. As of 2/25/02, the events had resolved.
Age: 65.0
Sex: F
Vaccine: HEP, HEPA, HEP, HEPA
Symptoms: Asthenia, Myalgia
Clinical narrative: Report 2002001621-1 describes sore arms in a 65 year old female who received hepatitis B vaccine recombinant (Engerix B). Concurrent medical conditions included menopause and Barrett's esophagus (starting in 1999) which was treated with omeprazole. On 1/18/02, the vaccinee received her third dose of Engerix B. She received two injections of the 10mcg pediatric formulation (lot ENG5252A2; expiry 4/10/03), to provide the adult dose of 20 mcg. On that date, she also received her second injection of hepatitis A vaccine inactivataed. On 1/20/02, she experienced tiredness, sore arms, and generalized myalgias. Medical attention at the clinic was required. The vaccinee was treated with acetaminophen. The vaccinee did not have the same side effects with previous doses. The reporter stated that the events were mild in intensity, and possibly related to Engerix B. As of 2/25/02, the events had resolved.
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chills, Dermatitis contact, Hyperhidrosis
Clinical narrative: The vaccinee worked with cleaning products (NOS) as a housekeeper. On 1/23/02, the vaccinee received her 1st dose of Engerix-B. She received 2 injections of the 10mcg pediatric formulation, to provide the adult dose of 20mcg. On 1/24/02, the vaccinee was seen at the ER for treatment of burning back pain, chills and sweats around her left upper back. At the ER, the vaccinee was told that her bra was too tight or she "was having a reaction to a chemical". The vaccinee was given Keflex by the ER physician. The vaccinee returned and showed the NP her back. The NP described the area as a linear burn on the left lower portion of her back near the bra strap. The area extended to the left underarm. The NP described the burn as resembling skin that had been peeled off and underneath was deep red. The NP was unsure if there were any blisters. The vaccine site looked "fine". The vaccinee had not had any complaints about her left arm. The vaccinee was seen by 3 physicians. They were reportedly were in agreement, that her dx was contact dermatitis and that there was "no connection to the vaccine". The NP did not think that the event was due to the Engerix-B administration. However, the cause of the event was unknown. As of 3/6/02, the outcome of the events were unknown.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Visual disturbance
Clinical narrative: This report describes the occurrence of the vision being affected in a 39 year old female who received Hep-B vaccine recombinant (Engerix-B). The vaccinee required corrective eye lenses at the time of IZ. Concurrent medications were not specified. On 12/7/01, the vaccinee received her 1st injection of Engerix-B. That same day, the vision in  her left eye was affected (NOS). Two days later, she experienced the same symptoms. The vaccinee reportedly changed her eye glass prescription after this event. As of 2/5/01, the event was "partially resolved". On 1/18/02, the vaccinee received her 2nd injection of Engerix-B. There were no reported adverse events related to this injection.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: In 1999 (specific date not provided), the vaccinee received her 2nd injection of Engerix-B (lot ENG3090A6). On 11/17/99, post vax, she experienced generalized hives. She was seen by a physician and the event resolved with unspecified sequelae on approx. 11/23/99. The Engerix-B immunization series was discontinued. The reporter indicated the event was probably related to the thimerosal in vaccine.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Laboratory test abnormal, Lethargy, Nausea, Pharyngitis
Clinical narrative: The vaccinee is not allergic to yeast. He had reactions to past IZ's. On 1/3/02, the vaccinee received his 1st dose of Engerix-B. He received 2 injections of the 10mcg pediatric dose (lot ENG5205A2) to provide the adult dose of 20mcg. Subsequently, on 1/3/02, he experienced nausea, vomiting, lethargy and diarrhea. In addition, he developed a cold on 1/5/02. The vaccinee did not receive medical attention for the events. As of 1/12/02, the events resolved.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Rhinitis, Vomiting
Clinical narrative: The vaccinee is not allergic to yeast. He had reactions to past IZ's. On 1/3/02, the vaccinee received his 1st dose of Engerix-B. He received 2 injections of the 10mcg pediatric dose (lot ENG5205A2) to provide the adult dose of 20mcg. Subsequently, on 1/3/02, he experienced nausea, vomiting, lethargy and diarrhea. In addition, he developed a cold on 1/5/02. The vaccinee did not receive medical attention for the events. As of 1/12/02, the events resolved.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: At birth, the vaccinee received his 1st injection of Hep-B vaccine (mfr unk). At 1, 6 and 12 months, the vaccinee received Recombivax-HB. "A couple of months ago", a Hep-B antibody test was negative. The results of this test "suggested that the vaccinee was not sero-protected."
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: The subject had no adverse experiences following receipt of prior Hep-B vaccine series (9/95 and 11/95 and 4/96). She subsequently, received Engerix-B on 7/23/01, 9/4/01 and 2/5/02. Ten hours after her 3rd injection of the 2nd series of Engerix-B, the subject experienced a fever of 103F and "severe" chills. She was seen in the ER, where UA and "flu test" ruled out both the "flu" and a UTI. She was told by the physician on call, that she had "a reaction to the Hep-B vaccination". The subject returned to the vaccine provider on 2/6/02. Reportedly, WBC and eosinophil count were normal. The events were reported to have resolved, 1 month later on 3/5/02. The reporter considered the events to be possibly related to the 3rd injection of Engerix-B.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: The subject received injections of Engerix-B on 3/8/01 (lot ENG3374A4), 4/9/01 (lot ENG3383A4), and 9/10/01 (lot ENG5239A4). On 11/2/01, a Hep-B surface antigen titer showed a value less than 2 (values more than 10.0 being considered protective). On 11/9/02, the vaccinee received a booster injection of Engerix-B (lot ENG5239A4). A Hep-B surface antibody titer drawn on 1/29/02, showed a value of less than 2. The subject refused to receive further immunizations.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Face oedema, Pruritus, Tongue oedema
Clinical narrative: As per pt, received a flu shot on Thursday 11/14/02. Pt noted hives on the back of neck and hands the next afternoon. She took Benadryl for the itching. On 11/16/02 she continued to take Benadryl x 2 for hives. 11/17/02 pt woke up with welts all over her body and legs. She had facial swelling-face was twice its normal size and tongue started to swell. Pt went to ER-received Epinephrine, steroids and Tagamet. Monday 11/18 she feel better but then noted hives-lips started to swell-pt went back to ER got Benadryl injection. She experienced chest pressure and received Nrg without relief. Cardiac w/u was negative. The medical record states dizzy.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: As per pt, received a flu shot on Thursday 11/14/02. Pt noted hives on the back of neck and hands the next afternoon. She took Benadryl for the itching. On 11/16/02 she continued to take Benadryl x 2 for hives. 11/17/02 pt woke up with welts all over her body and legs. She had facial swelling-face was twice its normal size and tongue started to swell. Pt went to ER-received Epinephrine, steroids and Tagamet. Monday 11/18 she feel better but then noted hives-lips started to swell-pt went back to ER got Benadryl injection. She experienced chest pressure and received Nrg without relief. Cardiac w/u was negative. The medical record states dizzy.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pain and swelling in the left arm for 5 days. He did yard work after episode.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Post vax, pt states his right arm started hurting and swelling. He has been taking some aspirin for the pain and swelling is getting worse. He called to report the problems this morning, 1/16/03. I have sent him to his PMD stat for DX and TX.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: 4 days of crops of bumps, 1cm, and itchy. First noted on forehead, neck and then everywhere. 15 lesion in all. Seen in office on 1/16/03.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Diarrhoea, Irritability, Pyrexia, Rash, Vomiting
Clinical narrative: Extreme irritability, inconsolable X 8-10 hours beginning several hours after DTAP. Had a fine rash, diarrhea and some vomiting. Irritability persisted X 4 days. Fever X 36 hours.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Rash papular
Clinical narrative: On 2/13/02, the vaccinee received her 1st injection of Engerix-B. On 2/15/02, she developed a red, papular rash on her left lateral flank. The rash resolved on 2/20/02. The reporter stated that the rash was possibly related to Engerix-B.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis
Clinical narrative: On 2/6/02, the vaccinee received his 1st injection of Engerix-B. On 2/11/02, 5 days post vax, he tested positive for Hep-B surface antigen.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis, Laboratory test abnormal
Clinical narrative: On 2/6/02, the vaccinee received his 1st injection of Engerix-B. On 2/11/02, 5 days post vax, he tested positive for Hep-B surface antigen.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: On 1/21/02, the vaccinee received her 1st injection of Engerix-B. She immediately experienced soreness of the injection site, which persisted as of 2/21/02. She also experienced injection site swelling and a bump at the injection site. The reporting physician considered the events to be probably related to Engerix-B administration and discontinued the Engerix-B vaccine series. Information received on 4/16/02, indicated the outcome of the events were unknown.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Wheezing
Clinical narrative: On 8/13/01, the vaccinee received her 2nd injection of Hep-B vaccine. In mid 9/01, approx. 1 month post vax, the vaccinee experienced difficulty breathing and was unable to "catch her breath" when playing soccer and exercising. She had wheezing on 2 occasions. The most recent information received on 2/25/02, indicated the events resolved "around the end of December or the beginning of January".
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pigmentation disorder
Clinical narrative: On 9/17/01, the vaccinee received her 2nd injection of Engerix-B. On the day of the injection, the vaccinee experienced a change in the skin pigment at the injection site described as a ring "about the size of a quarter" that was lighter than the rest of her skin color. The vaccinee was seen by a physician. The most recent information received on 2/26/02, reported the event as unresolved.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Ecchymosis, Injection site reaction
Clinical narrative: In February, 2002, the vaccinee received her 1st injection of Engerix-B. Two days, post vax, she experienced bruising at the injection site measuring 2" in diameter. As of 2/27/02, the bruise was resolving, but still present. The reporter considered the event to be probably related to Engerix-B administration.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: The vaccinee received injections of Engerix-B on 5/1/01 (lot ENG5178A4), 6/17/01 (lot ENG5178A4) and 11/20/01 (lot ENG5239A4). On 2/11/02, a "titer" (NOS) was "0". The reporter considered the negative titer to be probably related to Engerix-B administration.
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: She had no adverse experiences following receipt of the 1st 2 Engerix-B injections. On 2/28/02, the vaccinee received her 3rd injection of Engerix-B. On 2/28/02, immediately after the injection, she experienced tingling. Later that day, she developed a "severe" rash and itching all over her body. As of 3/5/02, the tingling and rash had improved; however, the itching persisted.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Headache, Pruritus, Skin exfoliation
Clinical narrative: On 2/28/02, the subject received her 1st injection of Engerix-B. On 3/2/02, 2 days post vax, she noticed "a lot" of her hair came out from her temples and the back of her head while in the shower. On 4/29/02, a 2nd injection of Engerix-B was administered and the subject again experienced the recurrence of hair loss, which she described as "hair falling out with flaky, itchy scalp". Additionally, the subject developed "headaches at times". A Hep-B surface antibody (HBsAb) was performed following receipt of the 2nd injection and was reported to have responded (greater that 150). On 5/30/02, the subject reported "less hair loss", however, the symptom persisted. The immunization series was discontinued after the 2nd injection of Engerix-B. The event of alopecia was reported to have improved as of 6/20/02, however, the outcome of other events was not specified. The reporter considered alopecia to be related to Engerix-B.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: On 2/3/99, the vaccinee received her 2nd injection of Engerix-B. On 2/18/99, the vaccinee received her 3rd injection of Engerix-B, 2 weeks after the 2nd injection rather that the recommended interval of 6 months. On an unspecified date, the vaccinee's hair "fell out in clumps". The hair grew back after an unspecified period of time.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis, Laboratory test abnormal
Clinical narrative: Prior to initiating the Engerix-B immunization series, and after the 1st and 2nd injection of Engerix-B, the vaccinee tested negative for Hep-B surface antigen (HBsAg). On 1/8/02, the vaccinee received his 3rd injection of Engerix-B. On 1/15/02, 7 days post vax, the vaccinee tested positive for HBsAg. Tests for HBsAg on 1/16/2002 and 2/7/02 were also positive. Liver function tests were "within normal limits", and he was not exhibiting signs of Hep-B infection. Two donors for the vaccinee's previous blood transfusions were re-tested for the Hep-B virus; both were negative for HBsAg. The reporter considered the positive HBsAg tests to be possibly related to Engerix-B administration.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: On 3/1/02, the vaccinee received her 1st injection of Engerix-B. On 3/1/02, at an unspecified time post vax, she experienced headache, stiff neck muscles, body aches, and "stiffness all over". The vaccinee was seen in the ER on 3/4/02. The headache resolved "after several weeks". As of 4/22/02, the other events had resolved.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: On unspecified dates, the vaccinee received the series of Engerix-B injections. On an unspecified date post vax, it was determined that the vaccinee "did not respond to the vaccination series". The reporter indicated that 11 adults were immunized, using lots ENG5178A4, ENG3232A4, ENG3382A4 and ENG3374A4. Five of the 11, "did not respond". These 5 individuals (presently unidentified) received the same lots of vaccine as the 6 individuals who did respond.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: The pt had a positive reaction to purified protein derivative (PPD) in 11/00. On 11/3/00 (lot ENG3359A4), 12/3/00 (lot ENG3232A4) and 5/3/01 (lot unk), the vaccinee received his 1st, 2nd and 3rd injections of Engerix-B, respectively. One month following his 3rd injection, the vaccinee was tested using a "new machine" for "immunity threshold". The results of this test indicated the vaccinee was a non-responder to the vaccine series. On 3/6/02, Hep-B surface antibodies were "non-reactive". The reporter stated that the lack of efficacy could have been associated with erroneous administration ("did not shake bottle"). As of 4/22/02, the outcome of the event was unknown. The reporter indicated that there were an unspecified number of pts who also experienced the same event, however, they could not be identified.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Report A0364078A describes fever in a 4 week old male who received hepatitis B vaccine recombinant (Engerix B). The treating physician submitted this report directly to VAERS. Medical history, concurrent conditions, and concurrent medications were not specified. On 3/19/02, the vaccinee received his first injection of Engerix B (lot ENG5217A2). On 3/21/02, the vaccinee experienced a fever of 38.5 degrees C. On that date, he was admitted to the hospital to investigate the cause of his fever. The treating physician considered the fever to be possibly related to Engerix B administration. As of 3/22/02, the fever was ongoing.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Convulsion, Pyrexia
Clinical narrative: Report A0364090A describes seizure in a 10 year old female who received hepatitis B vaccine recombinant (Engerix-B). The medical history included a seizure disorder since the vaccinee was 6 months old. Concomitant medications included carbemazapine and valproic acid for a few years for seizure control, and clonazepam for two years for seizure control. On 2/3/02, the vaccinee received her first injection of Engerix B. On 2/6/02, the vaccinee experienced fever and seizure. She was hospitalized for three days due to the seizure. The reporting physician stated that the seizure jeopardized the patient or required intervention. The events resolved after an unspecified period of time. The Engerix B immunization series was discontinued. The physician stated that the events were possibly related to Engerix B administration, or to the pre-existing seizure disorder.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Multiple sclerosis
Clinical narrative: On unspecified dates, the subject received the 1st and 2nd injections of Hep-B vaccine (mfr unk). Subsequent to the 2nd injection of Hep-B, the subject experienced an exacerbation of multiple sclerosis. The Hep-B immunization series was discontinued. Additional info was received from the spouse on 11/8/02. He stated that he considered the exacerbation of multiple sclerosis to have resulted in "severe or permanent disability". He considered the event to be possibly related to "Hep-B and Hep-C vaccination". As of 11/8/02, the exacerbation of MS had "improved".
Sex: U
Vaccine: HEP
Symptoms: Constipation
Clinical narrative: On an unspecified date, the vaccinee received an injection of Engerix-B. An unspecified time, post immunization, the vaccinee experienced constipation. Treatment and outcome were not provided. The reporter wished to remain anonymous. Therefore, no additional information will be available.
Age: 25.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: The vaccinee was not immunocompromised. On an unspecified date, the vaccinee received a 3rd dose of Engerix-B (lot ENG5213A2; expiry 11/23/02). At that time, the vaccinee received 2 injections of the 10 mcg pediatric formulation to provide the adult dose of 20 mcg. Subsequently, the vaccinee's antibody titer against Hep-B surface antigen (HBsAg) was found to be "too low". As of 4/4/02, the outcome of the event was unknown.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: The vaccinee was not immunocompromised. On an unspecified date, the vaccinee received the 3rd dose of Engerix-B (lot ENG5213A2; expiry 11/23/02). At that time, the vaccinee received 2 injections of the 10 mcg pediatric formulation to provide the adult dose of 20 mcg. Subsequently, the vaccinee's antibody titer against Hep-B surface antigen (HBsAg) was found to be "too low". As of 4/4/02, the outcome of the event was unknown.
Age: 45.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: The vaccinee was not immunocompromised. On an unspecified date, the vaccinee received the 3rd dose of Engerix-B (lot ENG5213A2; expiry 11/23/02). At that time, the vaccinee received 2 injections of the 10 mcg pediatric formulation to provide the adult dose of 20 mcg. Subsequently, the vaccinee's antibody titer against Hep-B surface antigen (HBsAg) was found to be "too low". As of 4/4/02, the outcome of the event was unknown.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: The vaccinee was a hemodialysis pt. On unspecified dates, the vaccinee received his 1st, 2nd, 3rd and 4th 40 mcg injections of Engerix-B. He was found to be a non-responder on an unspecified date, following his 4 injection with Engerix-B. As of 3/15/02, the outcome of the event was unknown.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, PNC
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: In 3/01, (when the pt was a neonate in the hospital), the vaccinee received his 1st injection of Hep-B vaccine (mfr unk). On 4/12/01, the vaccinee received his 2nd injection of Hep-B vaccine (Engerix-B, lot ENG5166A2). On 9/12/01, the vaccinee received his 3rd injection of Hep-B vaccine (Recombivax-HB, lot 0318K). On 3/12/02, the pt was found to be a non-responder. As of 3/19/02, the outcome of the event was unknown.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Hypoventilation, Tremor, Vision blurred
Clinical narrative: On 9/18/01, the vaccinee received his 1st injection of Engerix-B. Thirty minutes later, he had problems focusing, shallow breathing and shakiness. The events lasted 30 minutes. On 10/19/01, the vaccinee received his 2nd injection of Engerix-B (lot ENG5255B6). No adverse events were reported at that time. On 3/21/02, the vaccinee was seen in the office to receive his 3rd injection of Engerix-B. At that time, he reported that 30 minutes after receiving his 2nd injection of Engerix-B, on 10/19/01, he experienced nausea, vomiting, tingling sensation in his right hand, blurred vision, shakiness, weakness and anxiety. The nausea resolved on 10/19/01. As of 3/21/02, the outcome of the vomiting, tingling sensation in his right hand, blurred vision, shakiness, weakness and anxiety were unknown. The 3rd injection of Engerix-B was not administered.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Reportedly, the vaccinee had received "a complete Hep-B vaccination series years ago". The vaccinee had "recently" obtained "a Hep-B titer test" (NOS) and was found to have "no antibodies to Hep-B antigen".
Sex: M
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: On 3/24/02, the vaccinee received his 1st injection of Engerix-B. On 3/25/02, 1 day post immunization, he experienced nausea. The nausea persisted on 3/27/02.  Follow up on 01/16/04: "On 04/07/03, the physician indicated that the subject was lost to follow up .  No further information is available."
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: On 3/24/02, the vaccinee received her 1st injection of Engerix-B. On 3/26/02, 2 days post immunization, she experienced nausea. The nausea persisted on 3/27/02. Follow up on 01/16/04: "The subject's medical history included a "very mild form" of sickle cell disease diagnosed in 1984.  The physician reported, "usually she is stable without any symptoms."  There were no concurrent medications.  On 03/25/02, the subject received her first injection of Engerix-B (Lot # ENG5262A4).  On 03/26/02, she developed a rash.  The physician made a diagnosis of allergic reaction and considered it to be related to Engerix-B administration.  The allergic reaction resolved on 03/28/03.  The subject received her second injection of Engerix-B on an unspecified date.  No adverse experiences were reported.  On 10/09/02, the subject received her third injection of Engerix-B (Lot # ENG5303A4).  "A few hours" post-immunization, she developed "severe" nausea and emesis.  The physician made a diagnosis of allergic reaction and considered it to be related to Engerix-B administration. The second allergic reaction resolved on 10/13/02.
Age: 72.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis
Clinical narrative: In 1998, the vaccinee received "a series" of Engerix-B. Subsequently, he "had" unspecified antibodies and then "lost them". On 3/19/02, the vaccinee received his 4th dose of Engerix-B (lot ENG5270A4; expiry 8/17/03). On 8/21/02, he was found to have Hep-B surface antigen positive. The reporter stated that the event was probably related to Engerix-B. As of 3/29/02, the event was unresolved. The pt was hospitalized for an unrelated, unspecified reason.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: On 4/4/02, the vaccinee received a booster dose of Engerix-B (lot ENG5272B2; expiry 8/29/03). The dose number in the series was unspecified. Two days later, she experienced rash on her trunk, but not at the vaccine site. The pt had been taking Benadryl "with no relief". As of 4/15/02, the event was ongoing.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: On 8/25/00 (lot ENG3359A4), 10/25/00 (lot ENG3359A4), 3/9/01 (lot ENG3360A4), 4/12/01 (lot ENG3383A4), 5/23/01 (ENG3382A4) and 10/23/01 (lot ENG5235A4), the vaccinee received his 1st, 2nd, 3rd, 4th, 5th and 6th injections of Engerix-B, respectively. On 3/6/02, 19 weeks after his 6th injection of Engerix-B, Hep-B surface antibodies were found to be "nonreactive". The reporter stated that the lack of efficacy could have been associated with erroneous administration ("did not shake bottle"). As of 4/22/02, the outcome of the event was unknown.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: On 4/12/01, 05/15/01 and 10/15/01, the vaccinee received his 1st, 2nd and 3rd injections of Engerix-B, respectively. On 3/6/02, 142 days following the 3rd injection of Engerix-B, Hep-B surface antibodies were found to be "nonreactive". The reporter stated that this lack of efficacy could have been associated with erroneous administration ("did not shake bottle"). As of 4/22/02, the outcome of the event was unknown.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: On 11/17/00 (lot ENG3359A4), 12/15/00 (lot ENG3232A4) and 5/17/01 (lot unk), the vaccinee received her 1st, 2nd and 3rd injections of Engerix-B, respectively. On 3/6/02, 10 months after her 3rd injection of Engerix-B, Hep-B surface antibodies were found to be "nonreactive". The reporter stated that this lack of efficacy could have been associated with erroneous administration ("did not shake bottle"). As of 4/22/02, the outcome of the event was unknown.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis, Laboratory test abnormal
Clinical narrative: On an unspecified date, the vaccinee received the 2nd Engerix-B injection. Subsequently, the vaccinee was found to have a positive Hep-B surface antigen result. As of 4/22/02, the outcome of the event was unknown.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Pyrexia, Urticaria
Clinical narrative: On 3/19/02, the vaccinee received his 2nd injection of Engerix-B. On 4/1/02, 13 days post immunization, he experienced total body urticaria and low-grade fever. On 4/4/02, he experienced arthralgia. He was seen in the ER twice. During the 2nd ER visit, the events were treated with IV Solu-Medrol and Benadryl, 50mg IV push. The events resolved on 4/12/02. On 10/22/02, the subject's Allergist reported that the events were possibly related to Engerix-B administration. The Engerix-B immunization series was discontinued. This report was initially considered GSK medically serious. On follow-up, it was reclassified as non-serious.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: On an unspecified date, the vaccinee received her 2nd dose of Engerix-B. Subsequently, she experienced a rash at the injection site. As of 4/23/02, the outcome of the event was unknown.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Syncope, Syncope vasovagal
Clinical narrative: On 4/23/02, the vaccinee received her 1st injection of Engerix-B. On 4/23/02, at an unspecified time post vax, the vaccinee experienced a vasovagal response; she fainted. The reporter stated that when the vaccinee fell, she hit her head. The mother "was hysterical" and insisted that the "rescue squad" be called. The physician provided unspecified treatment at the office. The reporter stated that the vasovagal reaction was probably related to Engerix-B. As of 4/23/02, the event had resolved.
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: On an unspecified date, the vaccinee received an injection of Engerix-B; it was not known if she had received previous injections of Engerix-B. On 4/23/02, she experienced nausea, vomiting and abdominal cramps. As of 4/23/02, the events were ongoing.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Headache, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: The vaccinee was feeling "fine" at the time of his 1st IZ with Engerix-B. On 3/19/02, the vaccinee received his 1st injection of Engerix-B. The next morning, he woke up with a "severe" headache, congestion (NOS), cough and a sore throat. His mother treated him with unspecified over-the-counter products. The symptoms lasted for about 4 days. On an unspecified date, the vaccinee received his 2nd injection of Engerix-B. That evening, he again experienced a "severe" headache and sore throat, but no cough or congestion. Mother treated him with Dimetapp, Triaminic and Advil. The Advil helped the headache, but "once the dose wears off, the headache returns". The reporter stated that "no medical attention was required". As of 4/23/02, the headache and sore throat were ongoing.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Joint swelling, Oedema peripheral
Clinical narrative: The Pt had no adverse experiences following receipt of prior immunizations. and no known drug allergies. There were no concurrent medications. On 4/17/02, the pt rec'd his 1st injection of Engerix-B. On 4/18/02, the pt experienced swelling in his R thumb. On 4/19/02, the swelling in his thumb had subsided, but he had swelling in his L ankle. On 4/20/02, the swelling in his L ankle subsided, but he had swelling in his R knee. On 4/21/200, all swelling had subsided
Sex: F
Vaccine: HEP
Symptoms: Injection site hypersensitivity
Clinical narrative: On an unspecified date, the pt rec'd her 1st injection of Engerix-B. An unspecified time post immunization, the pt experienced a hypersensitivity reaction (NOS). Treatment and outcome were not specified.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Depression, Fibromyalgia, Headache, Injection site swelling
Clinical narrative: Pt was reportedly in very good health prior to vaccination". Concurrent conditions, and concurrent medications were not provided. reportedly the pt rec'd her 1st injection of hepatitis B vaccine in 1993 pr 194. the pt's mother reported that 10 minutes after receiving the injection the pt experienced swelling at the injection site. The swelling resolved after an unspecified period of time. She then reportedly experienced headaches for the next 4 days. The pt then experienced "joint pain in arms and legs that progressed over the next couple of years". She also reportedly experienced depression and blurred vision. The pt's mother reported that a diagnosis of fibromyalgia was made. The hepatitis B immunization series was discontinued. As of 4/30/02, the injection site swelling and headaches had resolved. The outcome of the fibromyalgia was not specified.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: Pt was reportedly in very good health prior to vaccination". Concurrent conditions, and concurrent medications were not provided. reportedly the pt rec'd her 1st injection of hepatitis B vaccine in 1993 pr 194. the pt's mother reported that 10 minutes after receiving the injection the pt experienced swelling at the injection site. The swelling resolved after an unspecified period of time. She then reportedly experienced headaches for the next 4 days. The pt then experienced "joint pain in arms and legs that progressed over the next couple of years". She also reportedly experienced depression and blurred vision. The pt's mother reported that a diagnosis of fibromyalgia was made. The hepatitis B immunization series was discontinued. As of 4/30/02, the injection site swelling and headaches had resolved. The outcome of the fibromyalgia was not specified.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: On Mar 20, 2002, the pt rec'd his 2nd injection of Engerix-B. On 3/22/02, the pt experienced experienced joint pain, headache, tiredness, muscle aches, and nasal congestion. Treatment was not provided. The pt reported that he "coped" with the discomfort and that all events resolved in 3 weeks. The reporting person did not specify the relationship between the Engerix-B administration and join pain, headache, tiredness, muscle aches and nasal congestion.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: In 1994, the vaccinee received an injection of Engerix-B. An unspecified time, post vax, the vaccinee experienced fever greater than 100.5F and an injection site reaction characterized by swelling. She was reportedly confined to bed for 4 days. She was not hospitalized; treatment was not specified. The IZ series was discontinued. The reporter stated that currently, the vaccinee's immune status is negligible. The events resolved after an unspecified period of time. The reporter stated that the events were probably related to Engerix-B administration.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: The vaccinee received his 1st injection of Engerix-B on 3/26/02, without adverse experience. On 4/25/02, the vaccinee received his 2nd injection (20mcg rather than the recommended 10mcg) of Engerix-B. On 5/1/02, he experienced fever, achiness and flu-like symptoms. He was seen by a physician. Treatment was not specified.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: On an unspecified date, the vaccinee received his 1st injection of Engerix-B. Within 1 hours, he experienced nausea and vomiting. As of 5/2/02, the nausea and vomiting had "improved".