chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5 1/2 X 12 cm redness warm @ sight of injection; no tender
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Convulsion, Injection site erythema, Pyrexia
Clinical narrative: Patient experienced a 5 minute generalized seizure with fever, 24 hours following DTAP, IPV, HBV and PCV7. By time patient, age 7 month, arrived at the ER temperature was only 102 degrees F. A zone of 7mm redness noted about the PCV7 injection site, right thigh.
Age: 0.2
Sex: M
Vaccine: DTAP, HBPV, IPV, PNC
Symptoms: Crying, Somnolence
Clinical narrative: Excessive crying- "a different cry" after vaccine 1/7/02;  Excessive sleeping 1/8/02 & went 12 hours without nursing.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Screaming
Clinical narrative: Crying for 24 hours. Given Tylenol.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Convulsion, Ear disorder, Infection, Pyrexia
Clinical narrative: The day after immunizations, the pt developed fever to 103F and had a 3-4 minute, generalized seizure. Nine days, post vax, she had recurrent otitis, fever to 102F and a seizure for 2-3 hours, on and off. Started seizure med and given antibiotics.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Insomnia, Nausea, Pain
Clinical narrative: "Since receiving the vaccine, the enrollee reports a sore arm, consistent headache, nausea and trouble sleeping. No rash or swelling.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Left upper thigh was swollen and erythematous. Dx'd with cellulitis. Treated with Keflex (250/5ml) 4 ml q 6 hours X 10 days. Follow-up tomorrow.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: The client complained of a sore spot and can't lift arm. She has had a history of shoulder problems. She was advised to apply heat and ice. On 11/16/01, the client stated her was better.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: The client complained of a sore spot and can't lift arm. She has had a history of shoulder problems. She was advised to apply heat and ice. On 11/16/01, the client stated her was better.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: Client complained of sore arm and unable to lift arm. Applied ice packs and was instructed to see a physician if not better. Had no swelling or redness.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Client complained of sore arm and unable to lift arm. Applied ice packs and was instructed to see a physician if not better. Had no swelling or redness.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: The client complained of redness and swelling on 11/01/01 which got bigger than at the time of the injection. The client was seen by a physician and was prescribed an antibiotic for cellulitis. On 1/8/02, the cellulitis was completely resolved.
Age: 1.4
Sex: M
Vaccine: PNC
Symptoms: Asthenia, Coordination abnormal, Crying, Febrile convulsion
Clinical narrative: The child received vaccine at 17:30. Mom then found child at 23:15 screaming with a temperature of 105F and convulsing. She placed the child in the bathtub and then brought to ER. The pt was treated with ibuprofen. Mom reports symptoms of irritability, ataxia and weakness for 5 days. She says the physician determined it to be a febrile seizure related to the vaccine. The pt had a reaction of fever and hives to DTAP/COMVAX/PREVNAR at 1.25 years of age.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Muscular weakness, Myalgia
Clinical narrative: The pt developed multiple myalgias, arthralgias, lower extremity weakness and swollen and painful joints.
Age: 1.2
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Suspect rash on chin on the day of the vaccination. No temperature. On Thanksgiving, she had a rash around the site and then on her stomach and back. She had a temperature last night, inside ear and around mouth.
Age: 79.0
Sex: F
Vaccine: TD, TD
Symptoms: Cellulitis, Hypokinesia, Injection site pain, Injury, Pain
Clinical narrative: This 78 year old female presented to the ER complaining of pain and redness to her right cheek for the past 2 days. She was apparently stung by a bee and this is how the redness started. It has grown since that time. She has some pain and swelling. She was started on Keflex for cellulitis to the right cheek secondary to a bee sting.  I appreciate your asking me to examine your pt who suffered from severe left arm pain which began following a tetanus injection in the left deltoid area after she was stung by a bee in her face on 8/5/01. The pain was initially localized but gradually spread to the hand, particularly the 1st and 2nd digits. The pain was unrelenting and prevented the pt from using her arm. In particular, she could not place her arm behind her back or raise it above 90 degrees horizontal. The pain began to subside after 1 month to 6 weeks. The pt underwent physical therapy X 5 and had an orthopedic evaluation. The neurological exam was unremarkable with preservation of strength and reflexes as well as sensation. Cervical spine movements were intact as well. Cranial nerves were intact. The most important finding was one of focal pain over the anterior edge over the deltoid toward its insertion on the humerus. This area was very tender and reproduced the pt's pain. There was a minimal ache over the posterior shoulder area, perhaps in the supraspinatus tendon. There was very slight tenderness at times with range of motion of the shoulder, which cannot explain the pt's primary complaint and may simply relate to the MRI findings. Discussion: The history made me suspicious that the pt might have suffered a post vaccination brachial plexitis, but based on my exam, this appears to be unlikely. The pain lasted much too long and unless the syndrome has fully recovered, there are no residual findings. I rather believe that the injection took place in the tendinous part of the deltoid. I felt that a local infiltration might be of benefit, which was performed with Xylocaine 2 percent and abolished the localized pain. The pt should apply heat for the next several days and engage in range of motion exercises to eliminate any contributing factor from the shoulder. This procedure may need to be repeated, perhaps with local steroids. I anticipate that it can further improve, although such entity can sometimes linger for quite some time.
Age: 79.0
Sex: F
Vaccine: TD, TD
Symptoms: Tendon disorder
Clinical narrative: This 78 year old female presented to the ER complaining of pain and redness to her right cheek for the past 2 days. She was apparently stung by a bee and this is how the redness started. It has grown since that time. She has some pain and swelling. She was started on Keflex for cellulitis to the right cheek secondary to a bee sting.  I appreciate your asking me to examine your pt who suffered from severe left arm pain which began following a tetanus injection in the left deltoid area after she was stung by a bee in her face on 8/5/01. The pain was initially localized but gradually spread to the hand, particularly the 1st and 2nd digits. The pain was unrelenting and prevented the pt from using her arm. In particular, she could not place her arm behind her back or raise it above 90 degrees horizontal. The pain began to subside after 1 month to 6 weeks. The pt underwent physical therapy X 5 and had an orthopedic evaluation. The neurological exam was unremarkable with preservation of strength and reflexes as well as sensation. Cervical spine movements were intact as well. Cranial nerves were intact. The most important finding was one of focal pain over the anterior edge over the deltoid toward its insertion on the humerus. This area was very tender and reproduced the pt's pain. There was a minimal ache over the posterior shoulder area, perhaps in the supraspinatus tendon. There was very slight tenderness at times with range of motion of the shoulder, which cannot explain the pt's primary complaint and may simply relate to the MRI findings. Discussion: The history made me suspicious that the pt might have suffered a post vaccination brachial plexitis, but based on my exam, this appears to be unlikely. The pain lasted much too long and unless the syndrome has fully recovered, there are no residual findings. I rather believe that the injection took place in the tendinous part of the deltoid. I felt that a local infiltration might be of benefit, which was performed with Xylocaine 2 percent and abolished the localized pain. The pt should apply heat for the next several days and engage in range of motion exercises to eliminate any contributing factor from the shoulder. This procedure may need to be repeated, perhaps with local steroids. I anticipate that it can further improve, although such entity can sometimes linger for quite some time.
Age: 79.0
Sex: F
Vaccine: TD, TD
Symptoms: Nerve injury, Pain
Clinical narrative: This 78 year old female presented to the ER complaining of pain and redness to her right cheek for the past 2 days. She was apparently stung by a bee and this is how the redness started. It has grown since that time. She has some pain and swelling. She was started on Keflex for cellulitis to the right cheek secondary to a bee sting.  I appreciate your asking me to examine your pt who suffered from severe left arm pain which began following a tetanus injection in the left deltoid area after she was stung by a bee in her face on 8/5/01. The pain was initially localized but gradually spread to the hand, particularly the 1st and 2nd digits. The pain was unrelenting and prevented the pt from using her arm. In particular, she could not place her arm behind her back or raise it above 90 degrees horizontal. The pain began to subside after 1 month to 6 weeks. The pt underwent physical therapy X 5 and had an orthopedic evaluation. The neurological exam was unremarkable with preservation of strength and reflexes as well as sensation. Cervical spine movements were intact as well. Cranial nerves were intact. The most important finding was one of focal pain over the anterior edge over the deltoid toward its insertion on the humerus. This area was very tender and reproduced the pt's pain. There was a minimal ache over the posterior shoulder area, perhaps in the supraspinatus tendon. There was very slight tenderness at times with range of motion of the shoulder, which cannot explain the pt's primary complaint and may simply relate to the MRI findings. Discussion: The history made me suspicious that the pt might have suffered a post vaccination brachial plexitis, but based on my exam, this appears to be unlikely. The pain lasted much too long and unless the syndrome has fully recovered, there are no residual findings. I rather believe that the injection took place in the tendinous part of the deltoid. I felt that a local infiltration might be of benefit, which was performed with Xylocaine 2 percent and abolished the localized pain. The pt should apply heat for the next several days and engage in range of motion exercises to eliminate any contributing factor from the shoulder. This procedure may need to be repeated, perhaps with local steroids. I anticipate that it can further improve, although such entity can sometimes linger for quite some time.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: The pt developed a fever of 103F, cough, runny nose and a rash.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Around 13:30, the pt complained of "throat felt tight, closing; breathing difficult". She was taken to ER and given "5 shots and O2" and sent home after 1 hour.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Headache, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: The pt was seen in the doctor's office on 1/11/02 for complaints of joint pain, general malaise, fever and sweats since 1/7/02. Pt also had a headache. Dx'd with serum sickness due to Hep-B injection.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The pt developed a 17cm X 10cm area of erythema, edema and warmth to left proximal arm to elbow over primarily exterior.
Age: 7.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This 7 year old pt was given Prevnar on 1/14/02 due to a history of recurrent pneumonia. That evening he developed a fever of 103.5F and a red and sore vaccine site on his right deltoid. He was seen on 1/15/02 for increased red and sore area. On exam, it was consistent with a local rxn; not cellulitis. The entire area had blanching erythema; not indurated or intense erythema.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Erythema nodosum, Pain, Pharyngolaryngeal pain, Swelling, Urticaria
Clinical narrative: The pt developed ankle pain and swelling, erythema nodosum, hives on legs and inside elbows and a mild sore throat which occurred at the end of November.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Myalgia, Pain, Rash, Swelling
Clinical narrative: Local reaction to MMR. left arm swelling erythema, pain, tenderness & rash. Ice pack applied. taking Advil. Local reaction resolved 1-14-02
Age: 32.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Arm swelled up, knot on right arm hot moist heat, antiflammatories
Age: 1.0
Sex: M
Vaccine: HBPV, MMR
Symptoms: Otitis media, Screaming
Clinical narrative: Fine until midnight-woke up and screamed for 3 hours. Was on antibiotics for 1 week because of ear infections so used ear drops but they didn't help. Shrill scream continued until 3 am "next day acted fine"
Age: 1.0
Sex: F
Vaccine: HBPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: 1 hr after MMR & Hib, slight rash where immunization was given-started breaking out more. next am was completely covered with hives-Benadryl helped for few hours lasted for 3 days. She had been on antibiotics but mom did not discontinue them-3 days later hives with itching finally went away. Still taking antibiotics.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Otitis media, Pyrexia, Rash
Clinical narrative: MMR given 1-3-02 Fever and rash began to 1-12-02 pt. seen 1-14-02, low grade temperature unresolved. O M still noted. Patient was on amoxicillin. Rash appeared to be measles and not drug eruptions.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Vaccines received on Monday 10-22-01, pt. c/o soreness. Tues p.m., Wed. am 10/24/01 left arm swollen, red and warm to touch from shoulder to elbow. Child responsive but didn't want to get out of bed. Mom state "didn't want to be bothered' Child feverish, temperature not taken, but given Motrin and warm compresses. seen by MD Wed. am. No other treatment prescribed. Better Wed. pm 10/24/01, Recovered and return to school 10/26/01
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema
Clinical narrative: Twenty-four hours after vaccine given large red patch on left upper arm. Pt. says its tender but doesn't seem to mind palpitation if distracted no swelling/edema or fevers. Uses arm without limitation. Has been present  for twenty-four hours
Age: 1.51
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: small erythematous non-tender papule @ injection site-raised wheel & flare looking areas. Hives over body-possibly secondary  to DTaP
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site warmth
Clinical narrative: 4 X 5 area of erythema warm to touch around site of DTaP right thigh
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling
Clinical narrative: Mother returned to clinic for evaluation of injection site on 1/11/02, injection given 1/8/02-Erythema & slightly raised area of deltoid approximately 40 mm X 30 mm-no complaints from patient. Discussed Benadryl should area itch, cool compressions.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema
Clinical narrative: Erythema lesions of right anterior thigh area 14 cm (width) X 11 cm (height). Treatment-benadryl
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Erythema, Pain, Swelling
Clinical narrative: 1/4/02 Received DTaP injection Right upper arm 1/5/02 right arm red swollen, tendser at injection site 1/6/02 blisters develop @ injection site, increased swelling  & pain. Child seen in emergency room, started on cephalaxin antibiotic. 1/7/02 seen at our clinic-Rx pedrapred zyrtec 1.9.02 F/u visit-blisters healed, minimal redness, swelling, no pain 1/14/2002 Resolved
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Pt. received MMR on 1/8/02. Rash on head than body 8 days after MMR Vd with corza. Resolving by 1/21/02- Measles reaction (possibly)
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Pain
Clinical narrative: Patient with left arm pain starting after injections of Hepatitis A. No improvement after 2 months.
Age: 5.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthma, Pyrexia
Clinical narrative: A report was received from French R agency on 01/10/2002, concerning a 5 year old female pt who experienced asthma crisis resolution in hospitalizations 5 days after receiving the second dose injection of fluvirin on 10/27/2001; the first having been on 10/03/2001. The pt had a medical history of cyctic fibrosis. During the night of 11/01/2001-11/02/2001, the pt experienced on asthma crisis. The pt was hospitalized in the Pediatric dept with fever (37.8 deg. C) and congestion. The pt recovered without sequelae following IV antibiotic and corticosteroid treatment.
Age: 5.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthma, Pyrexia, Upper respiratory tract infection
Clinical narrative: A report was received from French R agency on 01/10/2002, concerning a 5 year old female pt who experienced asthma crisis resolution in hospitalizations 5 days after receiving the second dose injection of fluvirin on 10/27/2001; the first having been on 10/03/2001. The pt had a medical history of cyctic fibrosis. During the night of 11/01/2001-11/02/2001, the pt experienced on asthma crisis. The pt was hospitalized in the Pediatric dept with fever (37.8 deg. C) and congestion. The pt recovered without sequelae following IV antibiotic and corticosteroid treatment.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction
Clinical narrative: Report 20010046361 describes burning (sensation) at the injection site in a 50 year old female who received hep B vaccine (recombinant) Engerix-B for prophylaxis of hep B. The vaccinee is allergic to sulfa. Reportedly, she has no medical history and takes no concomitant medications. On 01/08/2001, the vaccinee received her first "pediatric" left deltoid dose of Engerix-B. Post vaccination, in the "pm" of 01/08/2001, the vaccinee experienced nausea and diarrhea. these adverse events resolved within 24 hours. On 02/20/2001, the vaccinee received her second "pediatric" left deltoid dose of Engerix B. Two hours later, she experienced itching and burning at the injection site. As of 02/20/2001, the itching and burning at the injection site are unresolved.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Heart rate decreased, Respiratory disorder
Clinical narrative: Information has been received from a health professional concerning a 12 year old male with no personal history or allergies, but a family history of anaphylactic shock (mother), contact allergies (father), drug allergies (mother) and asthma (siblings) who on 01/24/2002 was vaccinated with a first dose of hepatitis b vaccine recombinant. On 01/24/2002, 2 mins after vaccination, the pt experienced an anaphylactic reaction. He presented with respiratory problems and nearly no pulse. Adrenalin was immediately adminsitered. No additional dose waas needed but the pt was immediately transferred to the hospital where NaCl and hydrocortisone were also administered. The pt was discharge on 01/25/2002 in the afternoon. No more information is expected. The case is closed.
Age: 0.9
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Feeling hot, Injection site erythema, Pyrexia
Clinical narrative: On 17 January 2001 12:00, the vaccinee received her first intramuscular left thigh dose of Engerix-B, her second intramuscular right thigh dose of diphtheria, tetanus, and acellular pertussis vaccine (Tripedia), her second intramuscular left thigh dose of poliomyelitis vaccine inactivated (IPOL), and her second intramuscular right thigh dose of hemophilus influenzae B vaccine (HibTiter). On 17 January 2001 12:15, the patient developed redness at the right vastus lateralis immunization site and slight redness at the left vastus lateralis immunization site. The patient was observed for thirty minutes. No distress was noted; patient was happy. Ice pack was applied bilaterally and the mother was instructed to give the patient diphenhydramine hydrochloride (Benadryl). On 17 January 2001, 14:00, the mother stated that the patient was doing well. On 18 January 2001, the father stated that the patient's legs were still red. That day, the patient was seen by the physician in his office. No redness or swelling was noted in the left leg. Right leg vastus lateralis redness noted and was warm to touch. Physician instructed parents to continue giving Benadryl 1/2 tsp every 4 to 6 hours and to take the patient to the ER if breathing problems or any change in status was noted. On 22 January 2001, the mother stated that the patient was not laughing today and temperature was 103 starting today. Mother was instructed to take patient to ER. On 23 January 2001, mother stated that patient was seen by doctor yesterday who treated her for an ear infection. As of 6 March 2001, the outcome of the immunization site redness was resolved. The outcome of the fever and ear infection was unknown.
Age: 0.9
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site warmth, Otitis media, Pyrexia
Clinical narrative: On 17 January 2001 12:00, the vaccinee received her first intramuscular left thigh dose of Engerix-B, her second intramuscular right thigh dose of diphtheria, tetanus, and acellular pertussis vaccine (Tripedia), her second intramuscular left thigh dose of poliomyelitis vaccine inactivated (IPOL), and her second intramuscular right thigh dose of hemophilus influenzae B vaccine (HibTiter). On 17 January 2001 12:15, the patient developed redness at the right vastus lateralis immunization site and slight redness at the left vastus lateralis immunization site. The patient was observed for thirty minutes. No distress was noted; patient was happy. Ice pack was applied bilaterally and the mother was instructed to give the patient diphenhydramine hydrochloride (Benadryl). On 17 January 2001, 14:00, the mother stated that the patient was doing well. On 18 January 2001, the father stated that the patient's legs were still red. That day, the patient was seen by the physician in his office. No redness or swelling was noted in the left leg. Right leg vastus lateralis redness noted and was warm to touch. Physician instructed parents to continue giving Benadryl 1/2 tsp every 4 to 6 hours and to take the patient to the ER if breathing problems or any change in status was noted. On 22 January 2001, the mother stated that the patient was not laughing today and temperature was 103 starting today. Mother was instructed to take patient to ER. On 23 January 2001, mother stated that patient was seen by doctor yesterday who treated her for an ear infection. As of 6 March 2001, the outcome of the immunization site redness was resolved. The outcome of the fever and ear infection was unknown.
Age: 16.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Convulsion, Headache, Loss of consciousness, Nausea
Clinical narrative: Report 20010050971 describes a possible seizure in a 16 year old female who received an injection of hep B vaccine. Medical history included feeling "sick secondary to needles and injections." The pt had no cardiac history and no history of seizure or syncope. There were no concurrent medications. On 02/20/2001, the pt received an injection of tetanus and diphtheria toxoids in her right arm; she tolerated the injection well. A few mins later, she received an injection of Engerix B in her left arm. Within "a few seconds" of receiving Engerix B, the pt reported feeling "sick" (NOS). Her eyes then shut, she slumped forward, and was unresponsive. As she was lowered to the floor, the nurse who administered the vaccine noticed that the pt's left arm was drawn up to her anterior chest, with the elbow and wrist flexed. The pt spontaneously regained consciousness within 45 seconds. Her heart rate was 80 beats per min. and her blood pressure was 120/80 mmHg. There was no incontinence or post event disorientation. Within a few minutes, the pt was alert, but complained of a headache and nausea. The nurse who witnessed the event was unwilling to describe it as a seizure. The nurse reported that the pt ha dnothing to eat or drink that morning. After an unspecified period of observation, the pt left the clinic. She was examined later that day by her primary physician. At the time of the examination, the pt was alert, oriented, and had normal findings on physical examination. The physician made a diagnosis of "possible seizure" and "reaction to hep B vaccine" and prescribed Medrol and Allegra. The pt was sent home. The pt's physician considered the events to be possibly associated with pt's medical history of feeling "sick secondary to needles and injections." On 03/27/2001, the nurse who administered the vaccines reported that the vaccinee had no illness at the time of immunization. The vaccinee was reportedly nervous at the time of immnization, and the nurse indicated that the event could be related to this nervousness. Possible seizure is considered SB medically serious.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, MEN, PNC
Symptoms: Diarrhoea, Haematochezia, Nasal congestion, Pyrexia, Sleep disorder
Clinical narrative: Report 20010091431 described bloody stool in a two month old male who received hep B vaccine. Allergies, medical history, and illness at time of vaccination were unknown. It was not known whether the vaccinee had illness at the time of vaccination. On 02/16/2001, the vaccinee received his second intramuscular right thigh dose of Engerix-B, his first intramuscular left thigh dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix), his first intramuscular right thigh dose of 7-valent pneumococcal conjugate vaccine, his first intramuscular left thigh dose of Haemophilusb conjugate vaccine, and his first subcutaneous left arm dose of inactivated poliomyelitis virus vaccine. On 02/17/2001, the child developed congestion (NOS), a "slight" fever, vomited one time, and was sleeping "a lot." The child was seen by a local pediatrician and was noted to have clear lungs, soft abdomen, and a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk. On 02/18/2001, the child was noted to have a yellow stool; additional physical findings were normal. On 02/22/2001, the child's pediatrician noted "mucoid stools and blood noted. child acts fine. 6-7 stools/day with blood, appear not as green." The vaccinee's mother received "Keflex two weeks ago for mastitis." On 05/01/2001, the vaccinee's pediatrician stated that the vaccinee "continues to have diarrhea stools with mucous and further blood." Further evaluation was pending with a pedicatric gastrointestinal physician. No drugs were used to treat the adverse events. The reporter stated that the adverse events were moderate in intensity. As of 09/05/2001, the events had resolved.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, MEN, PNC
Symptoms: Vomiting
Clinical narrative: Report 20010091431 described bloody stool in a two month old male who received hep B vaccine. Allergies, medical history, and illness at time of vaccination were unknown. It was not known whether the vaccinee had illness at the time of vaccination. On 02/16/2001, the vaccinee received his second intramuscular right thigh dose of Engerix-B, his first intramuscular left thigh dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix), his first intramuscular right thigh dose of 7-valent pneumococcal conjugate vaccine, his first intramuscular left thigh dose of Haemophilusb conjugate vaccine, and his first subcutaneous left arm dose of inactivated poliomyelitis virus vaccine. On 02/17/2001, the child developed congestion (NOS), a "slight" fever, vomited one time, and was sleeping "a lot." The child was seen by a local pediatrician and was noted to have clear lungs, soft abdomen, and a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk. On 02/18/2001, the child was noted to have a yellow stool; additional physical findings were normal. On 02/22/2001, the child's pediatrician noted "mucoid stools and blood noted. child acts fine. 6-7 stools/day with blood, appear not as green." The vaccinee's mother received "Keflex two weeks ago for mastitis." On 05/01/2001, the vaccinee's pediatrician stated that the vaccinee "continues to have diarrhea stools with mucous and further blood." Further evaluation was pending with a pedicatric gastrointestinal physician. No drugs were used to treat the adverse events. The reporter stated that the adverse events were moderate in intensity. As of 09/05/2001, the events had resolved.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, MEN, PNC
Symptoms: Diarrhoea, Faeces pale, Haematochezia, Nasal congestion, Pyrexia
Clinical narrative: Report 20010091431 described bloody stool in a two month old male who received hep B vaccine. Allergies, medical history, and illness at time of vaccination were unknown. It was not known whether the vaccinee had illness at the time of vaccination. On 02/16/2001, the vaccinee received his second intramuscular right thigh dose of Engerix-B, his first intramuscular left thigh dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix), his first intramuscular right thigh dose of 7-valent pneumococcal conjugate vaccine, his first intramuscular left thigh dose of Haemophilusb conjugate vaccine, and his first subcutaneous left arm dose of inactivated poliomyelitis virus vaccine. On 02/17/2001, the child developed congestion (NOS), a "slight" fever, vomited one time, and was sleeping "a lot." The child was seen by a local pediatrician and was noted to have clear lungs, soft abdomen, and a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk. On 02/18/2001, the child was noted to have a yellow stool; additional physical findings were normal. On 02/22/2001, the child's pediatrician noted "mucoid stools and blood noted. child acts fine. 6-7 stools/day with blood, appear not as green." The vaccinee's mother received "Keflex two weeks ago for mastitis." On 05/01/2001, the vaccinee's pediatrician stated that the vaccinee "continues to have diarrhea stools with mucous and further blood." Further evaluation was pending with a pedicatric gastrointestinal physician. No drugs were used to treat the adverse events. The reporter stated that the adverse events were moderate in intensity. As of 09/05/2001, the events had resolved.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, MEN, PNC
Symptoms: Somnolence, Vomiting
Clinical narrative: Report 20010091431 described bloody stool in a two month old male who received hep B vaccine. Allergies, medical history, and illness at time of vaccination were unknown. It was not known whether the vaccinee had illness at the time of vaccination. On 02/16/2001, the vaccinee received his second intramuscular right thigh dose of Engerix-B, his first intramuscular left thigh dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix), his first intramuscular right thigh dose of 7-valent pneumococcal conjugate vaccine, his first intramuscular left thigh dose of Haemophilusb conjugate vaccine, and his first subcutaneous left arm dose of inactivated poliomyelitis virus vaccine. On 02/17/2001, the child developed congestion (NOS), a "slight" fever, vomited one time, and was sleeping "a lot." The child was seen by a local pediatrician and was noted to have clear lungs, soft abdomen, and a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk. On 02/18/2001, the child was noted to have a yellow stool; additional physical findings were normal. On 02/22/2001, the child's pediatrician noted "mucoid stools and blood noted. child acts fine. 6-7 stools/day with blood, appear not as green." The vaccinee's mother received "Keflex two weeks ago for mastitis." On 05/01/2001, the vaccinee's pediatrician stated that the vaccinee "continues to have diarrhea stools with mucous and further blood." Further evaluation was pending with a pedicatric gastrointestinal physician. No drugs were used to treat the adverse events. The reporter stated that the adverse events were moderate in intensity. As of 09/05/2001, the events had resolved.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, MEN, PNC
Symptoms: Diarrhoea, Haematochezia, Laboratory test abnormal, Nasal congestion, Pyrexia
Clinical narrative: Report 20010091431 described bloody stool in a two month old male who received hep B vaccine. Allergies, medical history, and illness at time of vaccination were unknown. It was not known whether the vaccinee had illness at the time of vaccination. On 02/16/2001, the vaccinee received his second intramuscular right thigh dose of Engerix-B, his first intramuscular left thigh dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix), his first intramuscular right thigh dose of 7-valent pneumococcal conjugate vaccine, his first intramuscular left thigh dose of Haemophilusb conjugate vaccine, and his first subcutaneous left arm dose of inactivated poliomyelitis virus vaccine. On 02/17/2001, the child developed congestion (NOS), a "slight" fever, vomited one time, and was sleeping "a lot." The child was seen by a local pediatrician and was noted to have clear lungs, soft abdomen, and a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk. On 02/18/2001, the child was noted to have a yellow stool; additional physical findings were normal. On 02/22/2001, the child's pediatrician noted "mucoid stools and blood noted. child acts fine. 6-7 stools/day with blood, appear not as green." The vaccinee's mother received "Keflex two weeks ago for mastitis." On 05/01/2001, the vaccinee's pediatrician stated that the vaccinee "continues to have diarrhea stools with mucous and further blood." Further evaluation was pending with a pedicatric gastrointestinal physician. No drugs were used to treat the adverse events. The reporter stated that the adverse events were moderate in intensity. As of 09/05/2001, the events had resolved.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, MEN, PNC
Symptoms: Abnormal faeces, Pyrexia, Rhinitis, Somnolence, Vomiting
Clinical narrative: Report 20010091431 described bloody stool in a two month old male who received hep B vaccine. Allergies, medical history, and illness at time of vaccination were unknown. It was not known whether the vaccinee had illness at the time of vaccination. On 02/16/2001, the vaccinee received his second intramuscular right thigh dose of Engerix-B, his first intramuscular left thigh dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix), his first intramuscular right thigh dose of 7-valent pneumococcal conjugate vaccine, his first intramuscular left thigh dose of Haemophilusb conjugate vaccine, and his first subcutaneous left arm dose of inactivated poliomyelitis virus vaccine. On 02/17/2001, the child developed congestion (NOS), a "slight" fever, vomited one time, and was sleeping "a lot." The child was seen by a local pediatrician and was noted to have clear lungs, soft abdomen, and a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk. On 02/18/2001, the child was noted to have a yellow stool; additional physical findings were normal. On 02/22/2001, the child's pediatrician noted "mucoid stools and blood noted. child acts fine. 6-7 stools/day with blood, appear not as green." The vaccinee's mother received "Keflex two weeks ago for mastitis." On 05/01/2001, the vaccinee's pediatrician stated that the vaccinee "continues to have diarrhea stools with mucous and further blood." Further evaluation was pending with a pedicatric gastrointestinal physician. No drugs were used to treat the adverse events. The reporter stated that the adverse events were moderate in intensity. As of 09/05/2001, the events had resolved.
Age: 0.5
Sex: M
Vaccine: HEP, PNC
Symptoms: Decreased appetite, Insomnia, Irritability, Rash erythematous
Clinical narrative: Report 20010104591 desceibed rash in a 6 month old male who received hep B vaccine (Engerix-B). Allergies and medical history were unknown. There was no illness at the time of vaccination. On 03/23/2001, the vaccinee received his second intramuscular left thigh dose of Engerix B, and his second intramuscular right thigh dose of 7-valen pneumococcal conjugate vaccine (Prevnar). Within 12 hours post immunization, on 03/23/2001, the vaccinee developed a generalized erythematous rash, irritability, sleeplessness, and a decreased appetite. The reporter indicated that the infant did not sleep for three nights. As of 04/25/2001, the outcome of the events is unknown.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Optic neuritis
Clinical narrative: On an unspecified date, the vaccinee received injections of Engerix-B and Havrix for "re-vaccination". The number of previous injections of Engerix-B and Havrix were not specified. On 9/28/01, the vaccinee was seen in the physician's office and in the ER. He was hospitalized with a dx of second nerve bilateral optic papillitis. As of 10/3/01, the event was ongoing.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dyspnoea, Feeling hot, Pain
Clinical narrative: Report 20010244311 describes difficulty breathing in an 18 year old female who received an injection of hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. On 10/02/2001, the pt received her first injection of Engerix-B. Two to three hours post immunization, the pt experienced difficulty breathing, body aches, chest pain, and stated that her whole body felt warm. The events persisted as of 10/03/2001.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Report 20010047761 describes injection site pain in a 34 year old female who received hep B vaccine for prophylaxis of hep B. This report was received from a person of unspecified professional identity and has not been verified by a physician or other healthcare professional. Allergies, medical history, and concomitant medications were not specified. On 02/06/2001, the vaccinee received her first IM dose of Engerix-B. Post vaccination, on 02/06/2001, she experienced "severe" pain at the injection site. The vaccinee complained of soreness for two days after the immunization. No treatment was given. Engerix B was not discontinued. As of 02/12/2001, " the pt is ok."
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Contusion, Feeling hot, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: The vaccinee had seasonal allgeries and took no concomitant medications. There was no illness at the time of the vaccination. No adverse events were reported following dose 1 of Engerix-B. On 6 February 2001, the vaccinee received her second IM-left deltoid dose of Engerix-B. 30 minutes later, she developed a hard lump (at the injection site). The lump was warm at bedtime and felt al ittle itchy. The vaccinee had "blood in arm the size of a fifty cent piece and the site was kind of blue." On 7 February 2001, the vaccinee still had a blue bruise. At noon, severe itching began and the area got redder and the "hard spot" grew to 1 to 1.5 inches in diameter.  In the evening, the area was 6 to 8 inches long and three inches wide. The area was red, hard and hot. She experienced "swelling/pain in deltoid" (injection site). She treated herself with cool compresses and ibuprofen. On 8 February 2001, she was seen by a physician, who treated her with amoxicillin trihydrate/clavulanic acid (Augmentin). As of 27 March 2001, the outcome of the events was unknown.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: The vaccinee had seasonal allgeries and took no concomitant medications. There was no illness at the time of the vaccination. No adverse events were reported following dose 1 of Engerix-B. On 6 February 2001, the vaccinee received her second IM-left deltoid dose of Engerix-B. 30 minutes later, she developed a hard lump (at the injection site). The lump was warm at bedtime and felt al ittle itchy. The vaccinee had "blood in arm the size of a fifty cent piece and the site was kind of blue." On 7 February 2001, the vaccinee still had a blue bruise. At noon, severe itching began and the area got redder and the "hard spot" grew to 1 to 1.5 inches in diameter.  In the evening, the area was 6 to 8 inches long and three inches wide. The area was red, hard and hot. She experienced "swelling/pain in deltoid" (injection site). She treated herself with cool compresses and ibuprofen. On 8 February 2001, she was seen by a physician, who treated her with amoxicillin trihydrate/clavulanic acid (Augmentin). As of 27 March 2001, the outcome of the events was unknown.
Sex: U
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: Report 20010054981 described elevated liver function tests (NOS) in a vaccinee of unspecified age and gender who received hep B vaccine recombinant (engerix-B). Allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received the second dose of Engerix-B. Subsequently, the vaccinee experienced elevated liver function tests (NOS). As of 02/22/2001, the outcome of the event was unknown.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Report 20010058221 described itching and rash in a 41 year old male who received hep B vaccine recombinant (Engerix-B) for the prophylaxis of hep B. The vaccinee lived with a hep B carrier. Reportedly, the vaccinee had no known drug allergies or medical history. Concomitant medication: Gamma globulin. On 01/19/2001, the vaccinee received his first "adult" left deltoid dose of Engerix-B and a dose of gamma globulin without adverse event. On 02/19/2001, the vaccinee received his second "adult" left deltoid dose of Engerix-B. Post vaccination, in the evening of 02/19/2001, the vaccinee experienced itching and a full body rash. The adverse events resolved without treatment. As of 02/27/2001, the outcome of the events is resolved.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Report 20010058291 described a 30 year old female who received hep B vaccine recombinant (Engerix-B) for prophylaxis of hep B. Allergies, medical history, and concomitant medications were not specified. On 02/05/2001, the vaccinee received her first intramuscular dose of Engerix-B. At the time of injection, the vaccinee complained of severe pain and "burning." No treatment was given. As of 02/28/2001, the outcome of the event is unresolved.
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Palpitations
Clinical narrative: Report 20010058381 described palpitations in a female vaccinee of unspecified age who received hep B vaccine. The vaccinee had no known drug allergies. She had hypertension. She tok unspecified concomitant medications. On 02/28/2001, the vaccinee received her first left deltoid "adult" dose of Engerix-B. Three hours later, she experienced palpitations, weakness, and dizziness. The vaccinee contacted her physician, who did not feel that a doctor visit was medically necessary. As of 03/01/2001, the outcome of the events was unresolved.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Report 20010058451 described itching in a 36 year old female who received hep B vaccine recombinant for prophylaxis of hep B. The vaccinee's husband is "positive" for hep B. Reportedly, the vaccinee had no known durg alleriges, no medical history, and took no concomitant medications. On 08/30/2000, the vaccinee received her first right deltoid "adult" dose of Engerix-B. Post vaccination on 08/30/2000, she experienced itching and a "slight" rash. These adverse events resolved.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: On 21 June 2000, 22, July 2000, and 15 December 2000, the vaccinee received his first, second, and third doses of Engerix-B, respectively. Routes/sites were unspecified. Subsequently he was found to be a ronresponder. As of 6 March 2001, the outcome of the event is unknown.
Sex: U
Vaccine: HEP
Symptoms: Nonspecific reaction
Clinical narrative: On 21 June 2000, 21 July 2000, and 15 December 2000, the vaccinee received the first, second, and third doses of Engerix-B (routes and sites not specified). Subsequently, the vaccinee was found to be a nonresponder. As of 27 March 2001, the outcome of the event was unknown.
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Pain
Clinical narrative: On 23 February 2001, the vaccinee received her first left deltoid "adult"dose of Engerix-B. Within one hour post-vaccination, on 23 February 2001, the vaccinee experienced numbness and pain in her left arm. As of 6 March 2001, the outcome of the event was resolved.
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: On 26 February 2001, the vaccinee received her first left deltoid "adult" dose of Engerix-B. Post-vaccination, on 26 February 2001, the vaccinee experienced numbness and cold sensation in her left arm. As of 6 March 2001, the outcome of the events was resolved.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Report 20010066361 describes tingling and numbness (fingers) in a 14 year old female who received hepatitis B vaccine recombinant (Engerix-B). reportedly, the vaccinee had no allergies or medical history. Reportedly she had no illness at the time of vaccination. Concomitant vaccine: tetanus toxoid administered within four weeks of Engerix-B. On an unspecified date, the vaccinee received her unspecified dose of Engerix-B. subsequently, she experienced tingling and numbness in her fingers. Her symptoms resolved in two weeks. As of 03/13/2001, the vaccinee recovered.
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Report 20010070641 described dizziness in a male vaccinee of unspecified age who received hepatitis B vaccine recombinant (Engerix-B). The vaccinee is a physician. The vaccinee's allergies are unspecified. He had "some reflux" and took Prilosec. In December 2000, the vaccinee received his 1st dose of Engerix-B without adverse event. In January 2001, the vaccinee received his 2nd dose of Engerix-B. Approx. two months later, he experienced dizziness, nausea, numbness and tingling in his legs and hands. He was seen by a neurologist. Nerve conduction studies were within normal limits. As of 03/016/2001, the outcome of the events was ongoing.