chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Erythema, Face oedema, Irritability, Vomiting
Clinical narrative: On 8/25/00, the pt received her 1st dose of Engerix-B. Within 1 hour, post vax, she developed "redness around her eyes and nose". On 8/26/00, she developed redness on her cheeks and extremities and she vomited. On 8/27/00, she awoke with "her face puffy and her eyes almost shut and her extremities bright red". She was also very irritable. She was seen in ER and recovered. As of 12/12/00, the outcome of the events is recovered.
Age: 0.8
Sex: F
Vaccine: HEP, PNC
Symptoms: Otitis media, Pyrexia
Clinical narrative: The pt received Prevnar on 6/14/00 and 7/11/00. On 7/13/00, she developed a fever of 104F. The pt's mother treated her with acetaminophen and gave her cool baths. The pt was seen in the physician's office on 7/14/00, where a dx of acute otitis media was made. The pt was treated with amoxicillin/clavulanate and recovered. As of 12/10/00, the outcome of the events is recovered.
Age: 1.0
Sex: M
Vaccine: HEP, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Reprot 20010010401 describes fever wit elevated white blood cell count in a 12 month old male who received Engerix-B. The vaccinee's allergies and medical history are unknown. The vaccinee had no illness  at the time of vaccination. Concomitant vaccines received on 08/10/2000 were : Prevnar (first dose IM/left thigh), and Varivax (first dose SC/right thigh). On 08/10/2000, the vaccinee received his third IM/right leg dose of Engerix-B. "Within hours" of vaccine administration, the vaccinee developed a fever of 104 "plus" degrees F. That evening he was seen in the ER, where a complete blood count was done. His white blood cell count was found to be 16,000 u/l. Blood and urine culture results were negative. He was treated with ceftriaxone (Rocephin). On 08/11/2000, the vaccinee was seen by the physician and also treated himwith ceftriaxone (Rocephin). Another blood count was done with white blood cell counts remaining at 16,000 u/l. The mother treated the vaccinee with ibuprofen (Motrin). As of 01/15/2001, the outcome of the events is unknown.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: On 9/29/00, the pt received his 1st IM dose of Engerix-B. Subsequently, on 9/29/00, the pt experienced rash, urticaria and pruritus. He was treated with Benadryl 25mg q 5 h po, starting on 9/29/00 for the urticaria and with Zyrtec 10mg q 6 h po, starting on 1/4/01 for the pruritus. He was seen by the physician on 11/13/00. Engerix-B was discontinued. The reporter stated that the adverse events were possibly related to Engerix-B. As of 2/8/01, the outcome of the adverse events is unresolved.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Dizziness, Nausea
Clinical narrative: Report 2000035298-1 describes dizziness in a 43 year old female who received Engerix-B for prophylaxis of hepatitis B.  Reportedly, the vaccinee had no known drug allergies or medical history. She received PPD on 11/11/2000, and takes diphenhyramine hydrochloride (Benadryl) prn.  On 13-NOV-00, the vaccinee received her first 1cc IM dose of Engerix-B. On 20-NOV-00, the vaccinee began to experience daily nausea without vomiting, dizziness and hair loss. The vaccinee had to buy a wig. the physician assistant did not feel that these events were directly related to Engerix-B. As of 05-DEC-00, the outcome of the events is unknown.
Age: 13.0
Sex: M
Vaccine: HEP, TTOX
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea, Pallor
Clinical narrative: Report 20010027821 describes pallor in a 13 year old male who received Engerix-B. The vaccinee's allergies are unspecified. His medical history includes otitis externa (nos). On 07/10/2000 he received the unspecified IM right arm dose of Tetanus and Diphtheria Toxoide adsorbed, Ultrafined, in addition to Engerix-B. On 07/10/2000, the vaccinee received the unspecified IM left arm dose of Engerix-B. On 07/11/2000, the vaccinee awoke with an injection site reaction characterized by redness, swelling, and tenderness at the site of the Tetanus and Diphtheria absorbed, Ultrafined, administration. He was also nauseous. He then became dizzy and pale and had blurred vision; these symptoms lasted approx. 5 minutes. He felt feverish, but did not take his temperature. His mother treated him with diphenhydramine, acetaminophen, and applications of ice to the injection site. by 07/12/2000, only the injection site swelling and tenderness remained. As of 02/02/2001, the outcome of the events is resolved.
Age: 13.0
Sex: M
Vaccine: HEP, TTOX
Symptoms: Tenderness, Vision blurred
Clinical narrative: Report 20010027821 describes pallor in a 13 year old male who received Engerix-B. The vaccinee's allergies are unspecified. His medical history includes otitis externa (nos). On 07/10/2000 he received the unspecified IM right arm dose of Tetanus and Diphtheria Toxoide adsorbed, Ultrafined, in addition to Engerix-B. On 07/10/2000, the vaccinee received the unspecified IM left arm dose of Engerix-B. On 07/11/2000, the vaccinee awoke with an injection site reaction characterized by redness, swelling, and tenderness at the site of the Tetanus and Diphtheria absorbed, Ultrafined, administration. He was also nauseous. He then became dizzy and pale and had blurred vision; these symptoms lasted approx. 5 minutes. He felt feverish, but did not take his temperature. His mother treated him with diphenhydramine, acetaminophen, and applications of ice to the injection site. by 07/12/2000, only the injection site swelling and tenderness remained. As of 02/02/2001, the outcome of the events is resolved.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Report 20000368922 describes headaches in a 21 year old female who received Engerix-B. Allerigies and medical history are unknown. The vaccinee had no illness at the time of vaccination. She received typhoid vaccine and Havrix on 02/22/2000. She received Tatanus toxoid adsorbed, purogenated on 01/20/2000. On 02/22/2000, the vaccinee received her first IM-left deltoid dose of Engerix-B. Within 24 hours, she developed a fever of 101.1 degrees F., headaches, and generalized body aches. As of 12/28/2000, the outcome of the events is unknown.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Report 20010039031 described nausea and stomach pain in a 25 year old vaccinee who received hepatitis B vaccine recombinant (Enterix-B) for prophylaxis of hepatitis B. The vaccinee is allergic to penicillin Reportedly, she had no medical history and took no concomitant medications. On 01/04/2001, the vaccinee received her first 20 mcg IM dose of Engerix-B. This was a "one time dose." Post-vaccination, on 02/04/2001, the vaccinee experienced severe nausea and stomach pain. These adverse events resolved on 01/04/2001. They were considered by the reporter to be possibly related to Engerix-B. As of 03/13/2001, the outcome of the events is resolved. The reporter has reported these adverse events directly to VAERS.
Age: 11.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site erythema, Rash
Clinical narrative: The pt received his 1st injection of Engerix-B on 8/4/00. On that date, he also received an injection of tetanus and diphtheria toxoids adsorbed. Two days, post vax, he developed a rash on both hands and a 3" to 4" area of redness at the site of the tetanus and diphtheria toxoid administration. He was reportedly improving on 8/8/00.
Age: 11.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Arthritis, Feeling cold, Insomnia, Pyrexia
Clinical narrative: Pt reports one day after she was feeling extremely cold and the next morning throwing up, fever, insomnia, after 2 days pain in her hand and then pain in different joints and rash, these symptoms came off and on different days since 9/15/01.
Age: 11.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash, Vomiting
Clinical narrative: Pt reports one day after she was feeling extremely cold and the next morning throwing up, fever, insomnia, after 2 days pain in her hand and then pain in different joints and rash, these symptoms came off and on different days since 9/15/01.
Age: 11.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Chest pain, Pyrexia
Clinical narrative: Pt reports one day after she was feeling extremely cold and the next morning throwing up, fever, insomnia, after 2 days pain in her hand and then pain in different joints and rash, these symptoms came off and on different days since 9/15/01.
Age: 1.5
Sex: M
Vaccine: DTAP, OPV
Symptoms: Aphasia, Autism, Balance disorder, Colitis, Constipation
Clinical narrative: The child developed autism; started toe walking, episodes of diarrhea, constipation, altered immune system, multiple food allergies, colitis, hypotonia, visual issues, motor issues, balance issues, brain auto-antibodies, gluten and casein sensibilities, abnormal EEG activity, lost language and auto-immune encephalopathy. (Also was given MMR and HIB on 8/7/98)
Age: 1.5
Sex: M
Vaccine: DTAP, OPV
Symptoms: Diarrhoea, Electroencephalogram abnormal, Encephalopathy, Gait disturbance, Hypokinesia
Clinical narrative: The child developed autism; started toe walking, episodes of diarrhea, constipation, altered immune system, multiple food allergies, colitis, hypotonia, visual issues, motor issues, balance issues, brain auto-antibodies, gluten and casein sensibilities, abnormal EEG activity, lost language and auto-immune encephalopathy. (Also was given MMR and HIB on 8/7/98)
Age: 1.5
Sex: M
Vaccine: DTAP, OPV
Symptoms: Hypotonia, Immune system disorder, Laboratory test abnormal, Visual disturbance
Clinical narrative: The child developed autism; started toe walking, episodes of diarrhea, constipation, altered immune system, multiple food allergies, colitis, hypotonia, visual issues, motor issues, balance issues, brain auto-antibodies, gluten and casein sensibilities, abnormal EEG activity, lost language and auto-immune encephalopathy. (Also was given MMR and HIB on 8/7/98)
Sex: F
Vaccine: DTP, HIBV, OPV
Symptoms: Convulsion, Tremor
Clinical narrative: Seizure; pt brought in when she woke up shaking on 3/12/92 at 16:30.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt got chickenpox after having had Varivax on 2/1/99.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Ocular hyperaemia, Skin exfoliation, Vaginal infection
Clinical narrative: The pt reported on 1/16/02 of experiencing redness and swelling of orbits of eyes and eyelids which resolved in 2 weeks. The redness and swelling and eventual flaking of skin around mouth resolved in 3 weeks. Vaginitis resolved in 3 days. Did not seek medical help. No meds.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: On 1/1/02, developed inability to smile; left facial Bell's Palsy and drooping eyelids. Saw doctor on 1/2/02 and was placed on Prednisone 80mg po and decreasing dose and acyclovir 800mg po 5 X ?. Sees MD on 1/16/02. Said Bell's Palsy unrelated to flu shot but pt said the F/U sheet said to report anything unusual.
Age: 57.0
Sex: M
Vaccine: LYME
Symptoms: Joint swelling, Pain
Clinical narrative: Joint swelling & pain following vaccine arthritis following vaccine
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Sensation of heaviness
Clinical narrative: Felt heaviness in feet, knees, hips and joint pain. Sought evaluation with lab work done. This vaccine was given as part of a wellness program for employees.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Shingles with no clinical disease, currently.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Irritability, Screaming
Clinical narrative: Baseball-sized area of redness and erythema at left thigh injection site X 48 hours; inconsolable crying and fussiness X over 8 hours, following injection.
Age: 1.8
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Pt was brought in by grandmother on 1/4/02, complaining of swelling and itching to vaccine site on left thigh. Seen per doctor and given RX for Benadryl. Grandmother was instructed that if pt started to have a fever, to start RX of Keflex antibiotic and return to clinic.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema, Pruritus
Clinical narrative: Erythema, warm to touch, mild edema, full ROM, mildly pruritic (19 1/2 cm length x 14 cm circ. gone by 1/12
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: As described by mother, child was seen in ER 11/22/01 9 days after MMR, varivax for complained of fever & rash.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Redness, swelling, hot to touch, itching and sore, tender to touch, approximately 115 mm in length of area redness. put on Keflex 500 mg BID x 10 days
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: erythema over left deltoid on 1/11/02 where #4 DTaP given on 1/08/02
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Received immunizations early afternoon (12:50 appt.) parent called @ 4:23 pm. to report hives scattered over body (started 2 1/2 hrs after immunizations) seen 01-09-02-resolved. Unsure if secondary to vaccines or not.
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema
Clinical narrative: 8 X 6 area of erythema @ injection site
Age: 4.0
Sex: F
Vaccine: DTP, HEP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: My daughter ran a high temperature 104 for 3 days. we called the hospital and the nurse said it was normal after receiving the MMR vaccine
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Pyrexia
Clinical narrative: Ran a low-grade temperature from the DTAP.
Age: 1.25
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Gingival bleeding, Petechiae, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: ITP; platelet count 1000. Presented as petechiae and gingival bleeding on 12/26/01. Hospitalized on 12/26/01 until 12/27/01. Rx'd with Winrho.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Injection site erythema, Injection site pain
Clinical narrative: Less than 12 hours, post vax, the pt developed a local left arm pain, redness and tenderness that progressed over 36 hours, then began to improve. At 48 hours, she had chest tightness that began without wheezing. At 72 hours, local arm symptoms responding nicely to ice/heat. Lungs clear on exam.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Asthma, Dyskinesia, Dysphonia, Hypersensitivity
Clinical narrative: This 7 month old infant was seen by me for the 1st time on 7/5/01 for what appeared to be chronologically related vaccine reactions. He had 4 shots on 7/3/01 at your health unit and that night he developed fever to as high as 103.8F that persisted to a low-grade fever the following day. Baby was teething. Mother took him to ER, the morning of 7/4/01 for fever, hoarseness and wheezing and was sent home after receiving an antibiotic shot. She returned to the same ER, that evening, for baby was crying for 2 hours straight that was high-pitched and he was inconsolable. By the time he got to the ER, he had stopped crying and was sent home, since nothing wrong was found with him. I admitted him on 7/5/01 to Peds at the medical center for wheezing, tachypnea and head bobbing and treated him for asthma. He did well overnight without any fever or prolonged crying and was discharged home with follow-up with his pulmonologist in 4 days. Mother gives a history of high fever and crankiness for 3 days with his previous set of shots. Thus, it appears to me, that he had vaccine reactions on both occasions that may be ameliorated with giving DTAP instead of DTP and see his response. Mother should keep a close watch on him with his next set of shots and report to you any related vaccine reactions as soon as possible.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Screaming, Tachypnoea, Tooth disorder, Vaccine positive rechallenge
Clinical narrative: This 7 month old infant was seen by me for the 1st time on 7/5/01 for what appeared to be chronologically related vaccine reactions. He had 4 shots on 7/3/01 at your health unit and that night he developed fever to as high as 103.8F that persisted to a low-grade fever the following day. Baby was teething. Mother took him to ER, the morning of 7/4/01 for fever, hoarseness and wheezing and was sent home after receiving an antibiotic shot. She returned to the same ER, that evening, for baby was crying for 2 hours straight that was high-pitched and he was inconsolable. By the time he got to the ER, he had stopped crying and was sent home, since nothing wrong was found with him. I admitted him on 7/5/01 to Peds at the medical center for wheezing, tachypnea and head bobbing and treated him for asthma. He did well overnight without any fever or prolonged crying and was discharged home with follow-up with his pulmonologist in 4 days. Mother gives a history of high fever and crankiness for 3 days with his previous set of shots. Thus, it appears to me, that he had vaccine reactions on both occasions that may be ameliorated with giving DTAP instead of DTP and see his response. Mother should keep a close watch on him with his next set of shots and report to you any related vaccine reactions as soon as possible.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Wheezing
Clinical narrative: This 7 month old infant was seen by me for the 1st time on 7/5/01 for what appeared to be chronologically related vaccine reactions. He had 4 shots on 7/3/01 at your health unit and that night he developed fever to as high as 103.8F that persisted to a low-grade fever the following day. Baby was teething. Mother took him to ER, the morning of 7/4/01 for fever, hoarseness and wheezing and was sent home after receiving an antibiotic shot. She returned to the same ER, that evening, for baby was crying for 2 hours straight that was high-pitched and he was inconsolable. By the time he got to the ER, he had stopped crying and was sent home, since nothing wrong was found with him. I admitted him on 7/5/01 to Peds at the medical center for wheezing, tachypnea and head bobbing and treated him for asthma. He did well overnight without any fever or prolonged crying and was discharged home with follow-up with his pulmonologist in 4 days. Mother gives a history of high fever and crankiness for 3 days with his previous set of shots. Thus, it appears to me, that he had vaccine reactions on both occasions that may be ameliorated with giving DTAP instead of DTP and see his response. Mother should keep a close watch on him with his next set of shots and report to you any related vaccine reactions as soon as possible.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Cough, Drooling, Eye swelling, Urticaria
Clinical narrative: Dad called approx. 17:00 to state that pt had immunizations 1 1/2 hours ago and now has a rash, hives, eyes swollen shut, coughing and drooling. The RN instructed parent to call 911 immediately. The pt went to the Medical Center.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Pharyngitis, Pyrexia
Clinical narrative: A temperature of 105F (axillary) noted in the evening, post vax. Antipyretic give and pt was seen in an ER. No physical findings or associated symptoms were present. Symptomatic care was recommended. Fever is present still, on 1/7/02. Pharyngitis was noted on 1/7/02.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The pt complained of left upper arm pain with redness and swelling. Time course was about 24 hours. The treatment was ibuprofen/APAP.
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Cyanosis, Injection site induration
Clinical narrative: Acrocyanosis without fever less than twenty-four hours after moderate induration at the site.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Influenza like illness, Pyrexia, Rash papular
Clinical narrative: Approx. 10 fluid-filled papules located on face, head and chest; flu-like symptoms and fever.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Tension
Clinical narrative: Got the flu shot around 08:20 and then 30-40 minutes later, pt "felt funny"; like she had taken something too strong for her. She was lightheaded and could not drive. She called the health dept. about 10:00 and was advised to see MD. MD placed her on Depo-Medrol and instructed that if she was not better by night, to go to the ER.
Age: 0.5
Sex: F
Vaccine: DTAP, HBPV, HEP, IPV, PNC
Symptoms: Cough, Eye movement disorder, Pulmonary congestion
Clinical narrative: Rec'd Immunization 11/27/01 no fever; mother administered Tylenol every six hours for the first thirty-six hours after Immunization. Developed cough and low grade fever 12/03/2002. Mother administered Robitussin infant drops for cough and increased chest congestion. Had poor appetite until 12/06/2001. On 12/06/2001  late in evening, pt. threw her head back, eyes rolled back & mouth was contorted. She had several episodes of this, Mother took her to the hospital-brain scan-negative and plans to schedule EEG soon. Pt. was not observed having seizure activity in the hospital and was not placed on any medication.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain, Pyrexia, Swelling
Clinical narrative: Arm reddened, hot to touch same day of injection; increased temperature of 102.6 degrees F; asking and N/V same day after shot. 12/05/01 arm continuing to hurt like swollen muscle and pain shooting to elbow when using or lifting objects.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Swelling, Viral infection, Vomiting
Clinical narrative: Numbness and tingling in face, lips, tongue, arm and fingers: also swelling of tongue and lips: vomiting :HA all s/s started early am 12-04-1: saw RNP @ the doctor's office-she (per pt's gm) stated that pt had a stomach virus, probably unrelated to the flu shot.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Hypersensitivity, Inflammation, Oedema
Clinical narrative: Pt stated she had a flu shot 11/27/2001 and had an allergic reaction to shot. Left upper arm reddened, inflamed, swollen and itching since shot on Tuesday. Pt's states she is now having breathing difficulty at this time, that she is allergic to latex and when comes in contact to latex, had to go to ER for breathing difficulties.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt stated she had a flu shot 11/27/2001 and had an allergic reaction to shot. Left upper arm reddened, inflamed, swollen and itching since shot on Tuesday. Pt's states she is now having breathing difficulty at this time, that she is allergic to latex and when comes in contact to latex, had to go to ER for breathing difficulties.
Age: 1.0
Sex: F
Vaccine: DTAP, HBPV, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Four days after vaccine, pt developed fine rash on left thigh. Rash has slowly spread to right thigh, calf, both arms and trunk has some itching. On 11/10/2001 Mom took child to ER with temperature of 103. Diagnosed with ear infection, took 4 day course of Cefzil. Rash still present now (11/19/2001). Has MD appointment tomorrow for ear infection follow up, will have rash evaluated.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Mother called 12/03/2001 states child's arm is red. Nurse states red with scab. Augmentin 400 mg PO BID times 10 days. Nurse states area appeared red with apparent scratched marks on left arm. Spoke with Mom 12/05/2001. Pt is better, but still on meds.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Telephone call from mother 11 AM 12/13/2001, states child has his white bumps all over his body. Denies any elevated temp or other health problems. History of eczema. 12/14/2001 Temperature confirmed with mother. Took child to quick care 12/13/2001. States MD advised not a reaction to MMR.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis right arm due to 3 injections given in same arm. Has been given 2 antibiotic PO for cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MER
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Red, swollen, tight, hot left deltoid area where DTaP was administered.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis
Clinical narrative: Report #2000026283-1 describes hepatitis B core positive in a 61 year old pt who rec'd Engerix-B. The pt's allergies are not specified. Her medical history includes hepatitis C, hypothyroidism, and diskectomy and fusion. she takes levothyroxine sodium (Synthoid) and an omega series interferon (Isis) as an experimental treatment for hepatitis C. On unspecified dates, the pt rec'd  her first, second,and third doses of Engerix-B, respectively. 31 days after receiving dose 3 of Engerix-B, she was found to have hepatitis B core positive. As of 8/28/00, the outcome of the event is ongoing.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Eye oedema
Clinical narrative: Report # 2000026339-1 describes eye swelling in a pt who rec'd Engerix-B. Allergies, medical history, and concomitant medications are not specified. On an unspecified date, the pt received his first dose of Engerix-B. On 8/29/00, he experienced eyelid swilling in one eye, and the eyelid closed shut. As of 8/29/00, the outcome of the event is ongoing.
Age: 14.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Report #200002456-1 describes numbness in a pt who rec'd Engerix-B for the prophylaxis of hepatitis B. No known allergies, or medical history, reportedly. The pt rec'd tetanus vaccine on 8/14/00. On 5/14/00 the pt rec'd her first IM-L deltoid dose of Engerix-B. On 8/15/00, the pt experienced numbness and tingling in the left ring finger and left pinky. a doctor visit was required. Symptoms resolved  in 2 weeks. As of 9/5/00, the outcome of the event is resolved.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Crying, Injection site swelling
Clinical narrative: Report number 2000027554-1 describes crying in an 11 year old pt who rec'd Engerix-B. Allergies, medical history, and concomitant medications are not specified. On 6/13/00, the pt rec'd the unspecified dose of Engerix-B. Following the vaccination the pt cried for 48 hrs, and her arm was swollen 2 inches larger than the other. Unspecified medical attention was provided. As of 9/7/00, the outcome of the swollen arm is unknown.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Dry mouth, Hallucination, Lethargy, Listless, Mydriasis
Clinical narrative: Report #2000027563-1 describes the occurrence of hallucinations in a child who rec'd Engerix-B. The report was from a physician. Allergies are unspecified. The pt has a pervasive developmental disorder (NOS) and a mood disorder. He takes clonidine (Catapres), fluvoxamine maleate (Luvox), and diphendydramine hydrochloride (Benadryl) On 9/1/00, the pt rec'd his first dose of Engerix-B. Four days later, on 9/5/00, he experienced hallucinations and screamed. The pt felt that he was being attacked by skeletons. He was then listless and lethargic for 3-4 additional days. Per the pt's mother, the pt had dilated pupils and dry mouth. The physician was unsure if the adverse events were related to Engerix-B. No treatment was given. As of 8/11/00, the outcome of the events is resolved.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Screaming
Clinical narrative: Report #2000027563-1 describes the occurrence of hallucinations in a child who rec'd Engerix-B. The report was from a physician. Allergies are unspecified. The pt has a pervasive developmental disorder (NOS) and a mood disorder. He takes clonidine (Catapres), fluvoxamine maleate (Luvox), and diphendydramine hydrochloride (Benadryl) On 9/1/00, the pt rec'd his first dose of Engerix-B. Four days later, on 9/5/00, he experienced hallucinations and screamed. The pt felt that he was being attacked by skeletons. He was then listless and lethargic for 3-4 additional days. Per the pt's mother, the pt had dilated pupils and dry mouth. The physician was unsure if the adverse events were related to Engerix-B. No treatment was given. As of 8/11/00, the outcome of the events is resolved.
Age: 18.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Arthralgia
Clinical narrative: Report #2000027818-1 describes knee pain in a pt who rec'd Engerix-B. This report was rec'd from a medical student and has not been verified by a physician or other HCP. Allergies and medical history, concomitant vaccines includes: measles-mumps-rubella ad diphtheria-tetanus. On 8/11/00, the pt rec'd his first dose of Engerix-B. On the evening on 8/11/00, he experienced severe knee pain which lasted that night only. As of 9/19/00, the outcome of the event is resolved.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness
Clinical narrative: Report #2000028145-1 describes dizziness in a pt who rec'd Engerix-B. Allergies, concomitant medications, and medical history are not specified. On 9/23/99, the pt rec'd his first dose of Engerix-B. 10-20 minutes post vaccination, he became weak and dizzy. subsequently, he recovered. On an unspecified date, the pt rec'd his second dose of Engerix-B. The reporter was unable to find out if there were any adverse events following the second dose. As of 9/22/00, the outcome of the events is resolved.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Asthenia, Back pain, Injection site pain
Clinical narrative: Report # 20000281531 describes arthritic symptoms in a pt who rec'd Engerix-B. The pt is allergic to sulfa and adhesive tape. Concomitant medications were not specified. The pt had no illness at the time of vaccination. On 11/10/99, the pt rec'd a booster 1ml IM-R deltoid dose of Engerix-B. One hour following vaccination, on 11/10/99, the pt experienced severe pain radiating from the injection site and decreased strength. She also experienced back arthritic symptoms. The pain persisted on 5/17/00  and was not relieved by ibuprofen (Motrin) or acetaminophen (Tylenol). The pt also continued with decreased strength in the injection arm. As of 10/16/00, the pain in her R arm continued. It throbbed at times and hurt up into her shoulder if she lifted something heavy.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Report #2000028194-1 describes hives in a pt who rec'd Engerix-B for the prophylaxis of hepatitis B. The pt is allergic to commercial fabric softeners (skin irritation) and is obese. She takes over the counter weight reduction medication NOS). On 4/27/00 (IM), 5/25/00 (IM), and 9/14/00 (IM L deltoid), the pt rec'd her first, second, and third adult pre fill doses of Engerix-B, respectively. Two days after the third dose of Engerix-B, in the afternoon of 9/16/00, the pt experienced itching, burning (sensation), and hives on her abdomen, chest, arms, and legs. An emergency room visit was required. She missed four days of work. She was treated with epinephrine, diphenhydramine hydrochloride (Benadryl) PO. and Prednisone (from 9/16/00 to 9/20/00). the pt reported that the hives continued. The pt's symptoms resolved as of 9/21/00. this case is considered serious due to the medical intervention required. As of 12/14/00, the outcome of the event is resolved.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Report #2000028285-1 describes vomiting in a pt who rec'd Engerix-B for the prophylaxis of hepatitis B. The pt has no known allergies. She has arthritis and has been taking rofecoxib (Vioxx) for 6 months. On 3/24/00 (IM) and 9/15/00 at 15:30 (IM-L-deltoid), the pt rec'd her first and second adult doses (pre filled syringe) of Engerix-B.  On 9/17/00 at 12:00 she experienced loose stools, vomiting, nausea, and a slight headache. As of 9/20/00, the outcome of the events in ongoing.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Report #20000228319-1 describes lack of response in a pt unspecified age who rec'd Engerix-B for prophylaxis of hepatitis B. Allergies, medical history and concomitant medications are not specified. In 1/00, 2/00, and 8/00, the pt rec'd her subsequently, she was found to be a non-responder. No antibodies were found on titer. As of 9/21/00, the outcome of the event is unknown.
Sex: M
Vaccine: HEP
Symptoms: Arthropathy, Pain in jaw, Paraesthesia
Clinical narrative: Report #2000028594-1 describes the inability to open the mouth of a child who rec'd Engerix-B. Allergies, medical history and concomitant medications are not specified. On an unspecified date the pt rec'd his first dose of Engerix-B. One day later, he experienced tingling in the jaw which became painful. The pt was unable to open his mouth for approximately one hr. As of 9/21/00, the inability to open the mouth resolved and the outcome of the tingling/ pain in the jaw is unknown.
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Report # 2000028600-1 describes urticaria in a child of unspecified gender who rec'd Engerix-B. Allergies, medical history, and concomitant medications are unknown. The pt is currently being evaluated for allergies. The pt rec'd the first pediatric dose of Engerix-B on an unspecified date. In 1995, the pt rec'd the second pediatric dose of Engerix-B, 1-2 hrs post vaccination, the pt experienced urticaria on the back. symptoms resolved in 1-2 days. As of 9/25/00, the outcome of the event is resolved.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis
Clinical narrative: Report #2000028611-1 describes hepatitis B surface antigenemia in a pt who rec'd Engerix-B. Allergies, medical history, and concomitant medications are not specified. On 9/11/00, the pt rec'd his first dose of Engerix-B, on 9/12/00, he was found to have hepatitis B surface antigenemia. As of 9/25/00, the outcome of the event is unresolved.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Erythema, Heart rate increased, Skin burning sensation
Clinical narrative: Report#2000028756-1 describes burning (skin sensation) in a pt who rec'd Engerix-B for prophylaxis of hepatitis B. This report was rec'd from a pt and has not been verified by a physician or other hlth professional. Allergies are not specified. Concomitant medications are denied. The pt has Charcot-Marie-Tooth disease II. On 8/26/00 and 9/14/00, the pt rec'd her first and second L arm doses of Engerix-B, respectively. By 21:00 on 9/14/00 the pt's skin was red all over the body. the pt stated that it was not a rash or raised just red. It burned and stung. She was seen in the ER and was found to have an elevated heart rate ad blood pressure. She was given unspecified treatment and released. The pt was OK from 9/15/00 to 9/18/00. On 9/19/00, the pt had a recurrence of the same symptoms and returned to the ER. she was treated with Benadryl and Prednisone and released. On 9/19/00, in the evening she had another episode and returned to the ER again. She was given unspecified treatment and released. The pt reports that the redness resolved, but her heart rate and blood pressure are still elevated. As of 9/26/00, the outcome of the events in ongoing.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Syncope, Vomiting
Clinical narrative: Report #20000030115-2 describes fainting in a pt who rec'd Engerix-B for the prophylaxis of hepatitis B. This report was rec'd from the pt's mother and has not been verified by a physician or other hlth professional. The pt has no known allergies. The pt is very fearful of injections. At age 4-5, the pt rec'd diphtheria-tetanus-pertussis and passed out (1988-89). In 10/93 she experienced a closed head injury (MVA). There was no loss of consciousness she had a laceration only. The pt has no history of seizure disorder. She passed out while sitting watching a film on 12/21/99. The pt rec'd Havrix on 3/22/00 and diptheria-tetanus on 3/30/00 (no adverse event). On 3/22/00 (IM-L deltoid) and 4/20/00 (IM) the pt rec'd her first and second adult doses of Engerix-B, within seconds after receiving dose 2 of Engerix-B, she became lightheaded, fainted, was revived with smelling slats and vomited. The adverse events resolved within 10 minutes of the injection.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Swelling face
Clinical narrative: Report 20000301501 describes facial rash in a 25 year old female who received Engerix-B for prophylaxis of hepatitis B. The vaccinee has no known allergies, medical history, or concomitant medications. On 01/01/1995 (IM), 03/01/1995 (IM), 01/01/1996 (IM), and 09/25/2000 AM (two pediatric doses, IM-left deltoid), and vaccinee received her first, second third, and fourth doses of Engerix-B, respectively. On 09/25/2000, in the late evening, the vaccinee experienceed "a severe facial rash." The vaccinee reported that the rash was red, raised, and itching. Her face felt hot, but she was afebrile. A doctor visit was required on 09/26/2000, and she was treated with diphenhydramine hycrochloride 25 mg PO HS. As of 09/27/2000, the outcome of the event is ongoing.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Report 20000301551 describes viral looking rash in an eight year old female who received Engerix-B for prophylaxis of hepatitis B. Allergies are not specified. The vaccinee's medical history includes several viral rashes. She takes no concomitant medications. On 06/26/2000, the vaccinee received her first IM right deltoid dose of Engerix-B. 24-72 hours later, she developed a "viral looking rash" and fever. Her symptoms resolved. On 08/01/2000, the vaccinee received her second IM right deltoid dose of Engerix-B. 24-72 hours later, she again developed a "viral looking rash" and fever. Her symptoms resolved. No treatment was given. As of 09/29/2000, the outcome of the events is resolved.
Sex: M
Vaccine: HEP
Symptoms: Pain, Pyrexia
Clinical narrative: Report 20000301591 describes body aches in a male of unspecified age (birth date 11/19/1985) who received Engerix-B for prophylaxis of hepatitis B. This report was received from the vaccinee's mother and has not been verified by a physician or other health care professional. The vaccinee is allergic to Ceclor. His medical history is unspecified. He takes amphetamine sulfate/dextroamphetamine sulfate/dextroamphetamine sacchrate/ amphetamine aspartate (Adderall). On an unspecified date, the vaccinee received his unspecified dose of Engerix-B. Post-vaccination, he developed a fever of 101 degrees and body aches. The vaccinee's symptoms resolved "within one day or so." As of 09/29/2000, the outcome of the events is resolved.
Age: 8.0
Sex: U
Vaccine: HEP
Symptoms: Injection site oedema
Clinical narrative: Report 200000302261 describes injection arm swelling in an 8 year old vaccinee of unspecified sex who received Engerix-B. Allergies, medical history, and concomitant medications are not specified. On an unspecified date, the vaccinee received the unspecified dose of Engerix-B. Subsequently, the vaccinee experienced injection arm swelling. Symptoms resolved. As of 09/29/2000, the outcome of the event is resolved.
Sex: M
Vaccine: HEP
Symptoms: Hallucination, Pyrexia
Clinical narrative: Report 20000302321 describes hallucinations in a male "child" who received Engerix-B. Allergies, medical history, and concomitant medications are not specified. In October 1999, the vaccinee received his first dose of Engerix-B. In December 1999, the vaccinee experienced hallucinations and high fever. The vaccinee's mother does not wish the vaccinee to receive additional doses of Engerix-B because the vaccinee's pediatrician was relating the adverse events to Engerix-B. As of 10/02/2000, the outcome of the events is unknown.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Diabetes mellitus, Diarrhoea, Gastrooesophageal reflux disease, Hepatitis, Hypertension
Clinical narrative: Report 2000030253-1 describes gastroparesis in a 41 year old male who received the hepatitis-B vaccine for prophylaxis of hepatitis-b.  The vaccinee is allergic to pork, Vancoled (?) and Compazine. His medical history includes end stage renal disease, type 1 diabetes, hypertension, and gastroesophageal reflux disease. He had positive hepatitis B antibodies before his first dose of the hepatitis-b vaccine. He has been a dialysis patient since 1994. His concomitant medications include erythromycin elixir, metaprolol, dilatiazem chydrochloride, omeprazole, ascorbic acid/folic acid and insulin 70/30  On 01-Sep-00, the vaccinee received his forth dose of the hepatitis-b vaccine. Approximately two weeks later on 15-Sep-00, he experienced vomiting and diarrhea. His primary nephrologist and an associate felt that the vaccinee's  symptoms were related to gastroparesis. The vaccinee was subsequently seen by a gastroenterologist who specialized in hepatology who suggested a casual relationship between the vaccinee's symptoms and the hepatitis-B vaccine. Stool culture were ordered but a stool speicman was never collected. The vaccinee was started on metronidazole (Flagyl) 250 mg bid or qid for approximately 7-10 days. The vaccinee's vomiting and diarrhea resolved sometimes during the course of Flagyl. As of 02-SEP-00, the outcome of the event is resolved
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Renal failure, Vomiting
Clinical narrative: Report 2000030253-1 describes gastroparesis in a 41 year old male who received the hepatitis-B vaccine for prophylaxis of hepatitis-b.  The vaccinee is allergic to pork, Vancoled (?) and Compazine. His medical history includes end stage renal disease, type 1 diabetes, hypertension, and gastroesophageal reflux disease. He had positive hepatitis B antibodies before his first dose of the hepatitis-b vaccine. He has been a dialysis patient since 1994. His concomitant medications include erythromycin elixir, metaprolol, dilatiazem chydrochloride, omeprazole, ascorbic acid/folic acid and insulin 70/30  On 01-Sep-00, the vaccinee received his forth dose of the hepatitis-b vaccine. Approximately two weeks later on 15-Sep-00, he experienced vomiting and diarrhea. His primary nephrologist and an associate felt that the vaccinee's  symptoms were related to gastroparesis. The vaccinee was subsequently seen by a gastroenterologist who specialized in hepatology who suggested a casual relationship between the vaccinee's symptoms and the hepatitis-B vaccine. Stool culture were ordered but a stool speicman was never collected. The vaccinee was started on metronidazole (Flagyl) 250 mg bid or qid for approximately 7-10 days. The vaccinee's vomiting and diarrhea resolved sometimes during the course of Flagyl. As of 02-SEP-00, the outcome of the event is resolved
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Report 20000302771 describes hives in a male of unspecified age who received Engerix-B. Allergies, medical history, and concomitant medications are unspecified. On an unspecified date, the vaccinee received his first dose of Engerix-B. Subsequently, he experienced hives. As of 10/03/2000, the outcome of event is resolved.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Headache, Pyrexia
Clinical narrative: Report 20000303341 describes dizziness in a 13 year old female who received Engerix-B for prophylaxis of hepatitis B. This report was received from the vaccinee's father and has not been verified by a physician or other health professional. Allergies, medical history, and concomitant medications were denied by the reporter. On 09/01/2000, the vaccinee received her third dose of Engerix-B. Subsequently, the vaccinee experienced fever, chills, headache, dizziness, and was required and unspecified treatment was given. As of 10/05/2000, the outcome of the events is unresolved.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Report 20000307171 describes fever in a 26 year old male who received Engerix-B for prophylaxis of hepatitis B. Allergies, medical history, and concomitant medications are unknown. On 09/01/2000, the vaccinee received his first IM left deltoid dose of Engerix-B. Subsequently, he experienced a fever of 103 degrees F which lasted two weeks. No treatment was given. As of 10/05/2000, the outcome of the event is resolved.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Coma, Convulsion, Drooling, Dyskinesia
Clinical narrative: On 15-May-00, the vaccinee received his first dose of Engerix-B. Fifteen days later, on 30-May-00, and, in addition, on an unknown date, he experienced a total of two seizures. The seizures were not witnessed by medical personnel. The vaccinee's cell-mate described mild clonic seizures, post-ictal, with droolong. Outcome: unresolved. On 20-Jul-00, the vaccinee received his second dose of Engerix-B. On 03-AUG-00, 25-AUG-00, and 17-OCT-00, he experienced a total of three seizures. THe vaccinee was unresponsive and drooling. His cell-mate describes jerking movements while sleeping. Outcome: unresolved. Engerix-B was discontinued. This case is considered medically serious. As of 19-OCT-00, the outcome of the event is unresolved.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Erythema
Clinical narrative: On 09-OCT-00, the vaccinee received her first right deltoid dose of hepatitis B vaccine (brand unknown). On 10-OCT-00, she experienced a fever blister and a red neck. No treatment was given. As of 11-OCT-00, the outcome of the events is improving.
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: On 26-Sep-00, the vaccinee received her first right arm dose of Engerix-B. Sixteen days later, on 12-OCT-00, she experienced warmth, redness, and swelling at the injection site. As of 10-OCT-00, the outcome of the events is resolved.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Urticaria
Clinical narrative: Report 2000031133-1 describes wheal (injection site) in a 43 year old female who rec'd Engerix-B for prophylaxis of hepatitis B. The pt is intolerant of erythromycin  (gastrointestinal problems NOS). On 9/7/00 and 10/12/00 the pt rec'd her first and second IM L deltoid doses of Engerix-B, respectively. Immediately after receiving dose 2 of Engerix-B she experienced wheal and flare  (hard edema the size of fifty cent piece) at the injection site. Symptoms resolved in one day. She was treated with cetirizine hydrochloride (Zyrtec) for 2 days. As of 10/17/00 the outcome of the events is resolved.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Joint stiffness, Rheumatoid arthritis
Clinical narrative: 10 year old male who received hepathis B recombinant (Engerix-B) for the prophylaxis of hep B. This report was received from the vaccinee's mother and has been verified by a physician. Allergies were not specified, and concomitant medications were denied. The vaccinee's medical history included "adenoids", ear tubes and Lyme disease at age 5. On 08/31/2000, the vaccinee received his first 0.5 ml IM dose of Engerix-B. "A few days later", he experienced joint pain which did not resolve, according to the mother. The physician stated that the onset date of "transient arthritis with morning stiffness" was late sept, 2000. A doctor visit was required. Starting on 10/26/2000, the vaccinee was treated with ibuprofen (Advil) 100 mg orally as needed. Additionally, the vaccinee was treated with acetaminophen (Tylenol). The vaccinee's mother stated that the vaccinee was recently diagnosed with polyarticular juvenile rheumatoid arthritis. The physician stated that the vaccinee's diagnosis was "arthritis", and that this adverse event was moderate in intensity and possibly related to Engerix-B. The physician stated that the adverse events were disabling/incapaciting. As of April 18 2001, the patient was complaining of arthralgias, but had no objective swelling. As of 12/27 2001, the patient had not been seen in follow-up. His mother reported that he had intermittent joint pains but no swelling or stiffness.