chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: CSF test abnormal, Febrile convulsion, Rhinorrhoea, White blood cell count increased
Clinical narrative: Febrile seizure within 24 hours, post vax. Also with a 2 hour history of clear rhinorrhea prior to seizure. WBC of >25,000. Hospitalized for observation and IV antibiotics. The 60 day follow-up states that the pt's final diagnosis is febrile seizure. Pt received additonal doses of all vaccines on 06/04/2001 since any any adverse event. Notes- great aunt notes that child, dad and sib all have large heads but MD's are not concernred. Dx with febrile seizures
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Choking, Dyspnoea, Hypersensitivity, Pallor, Pyrexia
Clinical narrative: Pt slept for 3 hours, post vax, and woke up with a fever of 102F and vomiting when she woke up and had choking, difficulty breathing. Lips and face turned white. Took to hospital ER. Advised it was a possible reaction to a vaccination and to call PCP. The doctor in the office stated it was a definite reaction to pneumococcal vaccine.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Somnolence, Vomiting
Clinical narrative: Pt slept for 3 hours, post vax, and woke up with a fever of 102F and vomiting when she woke up and had choking, difficulty breathing. Lips and face turned white. Took to hospital ER. Advised it was a possible reaction to a vaccination and to call PCP. The doctor in the office stated it was a definite reaction to pneumococcal vaccine.
Age: 1.0
Sex: M
Vaccine: HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Injection site rash
Clinical narrative: Mom noted rash at site of injections, left thigh, per phone call. Seen at another facility on 2/25/01.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Mother called stating child had hives 1-1 1/2 hours, post vax. Treated with Benadryl. Subsided by the next AM. Not seen by physician.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site rash, Pruritus
Clinical narrative: Itchy rash below vaccine site. Rx desonide.
Age: 1.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cyanosis, Hypotonia, Rash papular, Skin discolouration, Somnolence
Clinical narrative: Pt cried, turned blue, developed cyanotic colored rash on thighs and then turned limp. Afterwards, had vesicular papular rash and was very dazed and sleepy. Symptoms resolved in 24-36 hours.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Injection site induration, Rash papular
Clinical narrative: Localized reaction with induration at site of injection. Diffuse papular rash over back, thighs and chest. Rash started, 2 days, post vax. No treatment.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Rash macular
Clinical narrative: Pt had received vaccines and 10 minutes, post vax, as family was leaving clinic, they returned because pt became red with hive-like blotches on face, neck and back of arms. No respiratory distress. Doctor was notified and ordered Benadryl and cool compresses. 24 hours later there were no hives.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Nasal congestion, Urticaria
Clinical narrative: This patient developed hives after 2 month shots. Got Prevnar, DTaP, IPV, and HIB. She also had a stuffy nose for 2 weeks.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, HEP, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: 11:00 mom brought child for immunizations. She was given vaccines and waited 15 minutes without reactions noted. Pt left town with mom for vacation X 1 month. Not able to contact mom due to her being out of town but grandma contacted on 2/23/01 and she has no way to contact daughter.
Age: 46.0
Sex: F
Vaccine: LYME
Symptoms: Paraesthesia
Clinical narrative: A report 2001009913-1 described tingling and loss of feeling (hands and feet) in a female of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). Allergies, medical history, and concomitant medications were unspecified. On an unspecified date, the vaccinee received her second dose of Lymerix. Subsequently, she experienced "severe" tingling in her fingers and toes which lasted  for several months. Because her general physician could not pinpoint the problem, he sent her to a neurologist who came to the conclusion that "the Lymerix shots caused minor loss of feeling in (her) hands and feet." The tingling resolved after "several months".  the adverse events of "tingling" and "loss of feeling" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash vesicular
Clinical narrative: Pt broke out in a rash on 12/21/00. Started on ankle area and then spread to rest of body. Rash is red, itchy, flat, and round areas, sometimes ooze. Clears some and then returns. Went to MD and then referred to dermatologist and may see allergist. Still has rash.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Injection site erythema, Injection site inflammation
Clinical narrative: Noted around injection site; redness, erythema, inflammation and general weakness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm is swollen and redness and states it feels numb on 4/17/01 at 10:55 PM. Treated with Zithromax, Atarax and follow-up with MD.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site swelling, Nasal congestion
Clinical narrative: Right arm with redness and swelling, headache and stomachache and fever of 101F. Nauseated and with congestion.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Nausea, Pyrexia
Clinical narrative: Right arm with redness and swelling, headache and stomachache and fever of 101F. Nauseated and with congestion.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Pyrexia, Stomach discomfort
Clinical narrative: Fever, upset stomach, swelling of arm at injection site. Came to ER.
Age: 4.08
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Cellulitis of left leg (thigh). Treatment: antibiotics. Redness on thigh started the day after shots. Still being treated.
Age: 18.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Joint swelling, Urticaria
Clinical narrative: Pt states on 4/4/01 at 8-9 PM, noticed hives on arms. By 4/5/01 AM, pt awoke with hives over entire body. Went to ER and was given cortisone injection. Pt states all joints were swollen. Given po Zyrtec and prednisone. Pt states that on 3/27/01, went to PCP with sore throat and fluid in ears. Given generic amoxicillin and guaifenesin.
Age: 14.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Pyrexia
Clinical narrative: Temperature 102.9F, within 24 hours, post vax, lasting 6-8 hours.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Cyanosis, Dyspnoea, Urticaria
Clinical narrative: On 1/15/01, child had slight cough. On 1/16/01, lips blue and difficulty breathing and mother gave albuterol and Benadryl that she had at home from previous asthma events. Stated has a history of asthma since 18 months old. Child then developed hives on 1/18/01 and has had hives almost daily since then. MD called 2-3 weeks later to renew meds. The doctor's office told the mother that she needed to be seen at that time so she took the child to the doctor on 2/12/01. The child had a rash on his groin and buttocks area at that time. The mother stated that the child continued to have allergy related events and was having hives almost daily. She stated that since the MMR was given, her son seems to have more allergies now. She was referred to an allergy specialist who will be doing some allergy testing on 2/26/01. The mother stated the child was dx'd with an egg allergy when he was about 18 months old but did not test positive for any other allergies at that time. The mother was told to call PCHD and let us know if the child tested positive for other allergies.
Age: 36.0
Sex: F
Vaccine: MMR, TD
Symptoms: Laboratory test abnormal, Viral infection
Clinical narrative: Developed case of Rubella after receiving MMR on 2/2/01, due to negative titer.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diabetes mellitus, Hyperglycaemia, Hyperhidrosis, Injection site erythema
Clinical narrative: Approx. 2 hours, post vax, sweats, chills, nausea. Developed hyperglycemia (pt is diabetic). In 2 days, pain through upper arm and in 3 days, noted erythema and pain at injection site.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nausea
Clinical narrative: Approx. 2 hours, post vax, sweats, chills, nausea. Developed hyperglycemia (pt is diabetic). In 2 days, pain through upper arm and in 3 days, noted erythema and pain at injection site.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Received 5 immunizations on 3/27/01. Left thigh with erythema 8cm X 10cm diameter at injection site.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Developed fever of 104.5F (ax) 24 hours, post vax. Addendum: Child had temperature of 103.3F, post vax, and we gave Motrin, immediately, within 5 minutes.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Cyanosis, Face oedema
Clinical narrative: Pt began to cough with edema and blueness under eyes. No SOB or tightening of throat. Epinephrine was given SC in left deltoid. Signs and symptoms cleared in 10-15 minutes.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cough, Ear disorder, Infection, Pyrexia
Clinical narrative: Child had slight cough before vaccines given. He developed a fever about 3 hours, post vax. Had had a fever "on and off" since going as high as "almost 103F". Cough has become worse. Mother is giving both children's Tylenol and Motrin together since 3/7/01. Told to call doctor. He was dx'd with earl infection.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Injection site atrophy, Pigmentation disorder, Skin disorder
Clinical narrative: Pt received vaccines on 9/29/00. Today on 2/15/01, complaining of area of tissue atrophy and hypo-pigmentation 2" X 1" over injection site.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Conjunctivitis, Cough, Headache, Hypertension, Hypoventilation
Clinical narrative: Seen today, after vaccination on 3/13/01 into left deltoid for local erythema, edema, tenderness, generalized body aches, headache, low-grade fever, chills, dry hack-like cough and bilateral conjunctivitis.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pain, Pyrexia
Clinical narrative: Seen today, after vaccination on 3/13/01 into left deltoid for local erythema, edema, tenderness, generalized body aches, headache, low-grade fever, chills, dry hack-like cough and bilateral conjunctivitis.
Age: 14.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Rash
Clinical narrative: Non-itchy rash on neck, trunk, arms and legs, starting on 2/9/01. Reported from pt's mother on 2/16/01. States she hasn't noticed the rash since 2/14/01.
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3" X 5" red, swollen area on thigh.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Urticaria
Clinical narrative: Hives on thighs, extending to lower extremities and lower torso. Treated with Benadryl.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Urticaria
Clinical narrative: Hives on face, limbs, torso; lasting 2 weeks. Treated with Benadryl X 2 days prior to vaccinations given. Continue Benadryl.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site warmth, White blood cell disorder
Clinical narrative: Reddened, hot and hard area the size of a softball. Cellulitis dx'd at Urgent Care.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Rash
Clinical narrative: Onset of generalized rash and joint pain, 12 days, post vax of MMR vaccine. Pt sought medical care from her private physician.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: The pt experienced a red rash the size of a grapefruit which was warm to the touch (10x8cm) slightly hard to feel, no tenderness, no pruritis, no fever. Onset was within 24 hours of administration. Given Benadryl and observed.
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: The pt experienced a possible low grade fever and morbilliform rash.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 24 hours post vax, the pt developed a red and swollen arm which was warm to the touch.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Infection
Clinical narrative: On 2/23/01, the pt noticed chicken pox has approximately 7 blisters.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Pruritus, Skin ulcer
Clinical narrative: On 2/23/01, the pt noticed chicken pox has approximately 7 blisters.
Age: 1.55
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced a large amount of swelling to the thigh beginning 36 hours post vax and lasting 3 days which was approximately the size of an orange and 3/4 around the thigh and was very red and hot to the touch. The child was fussy and did not feel good. Temp is normal. Treated with Tylenol every 4 hours.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: On 1/6/01, the pt noticed that her left arm was extremely red, swollen and hurting. On 1/7/01 went to employee health and a prescription was given for Amoxicillin for 10 days.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Pharyngolaryngeal pain, Rash
Clinical narrative: This report is from a physician referring to a 49 year old male. No known drug allergies. The vaccinee has type II diabetes and takes Glucophage, Sinemet, Serzone and Univasc. On 2/18/00, the pt received his 1st IM, left deltoid dose of Havrix. 90 minutes later, on 2/18/00, the pt experienced a rash. Outcome: ongoing. 2-3 days, post vax, the pt experienced a sore throat. Outcome: ongoing. A doctor visit was required and the vaccinee was treated with Benadryl and steroids (NOS). The most recent information, received on 2/24/00, reports the condition of the vaccinee as ongoing.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphagia, Erythema, Flushing, Hypersensitivity, Pharyngitis
Clinical narrative: This report is from a nurse referring to a 49 year old male pt and follow-up from his personal physician. The pt has an allergy to poison ivy. The pt has a medical history of left shoulder impingement, type II diabetes, high blood pressure, obesity and restless legs. At the time of the event, he was taking Glucophage, Univasc, Sinemet, Serzone, Amaryl, Novocaine and cortisone. On 2/18/00, the pt received his 1st injection with Havrix 1440 Elisa units for prophylaxis. Approx. 1.5 hours later, the pt experienced a rash over his whole body with erythema, flatness and flushed face, without itchiness. The rash was treated with Benadryl 25mg 2X/day and resolved but reappeared later. Also, within 24 hours of the injection, the pt experienced pharyngitis with a severe sore throat and difficulty swallowing. On 2/21/00, during an office visit, it was noted the pt had 2 pustules on his tonsils. Penicillin VK 250mg every 6 hours for 10 days was begun. The pt saw a dermatologist and had a biopsy performed. The dermatologist dx'd an allergic reaction to Havrix. The pt was treated with an unspecified medication. The information received on 3/29/00 reports the pharyngitis improved, and the rash is not well dissipated after treatment.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Pharyngolaryngeal pain, Rash
Clinical narrative: This report is from a nurse referring to a 49 year old male pt and follow-up from his personal physician. The pt has an allergy to poison ivy. The pt has a medical history of left shoulder impingement, type II diabetes, high blood pressure, obesity and restless legs. At the time of the event, he was taking Glucophage, Univasc, Sinemet, Serzone, Amaryl, Novocaine and cortisone. On 2/18/00, the pt received his 1st injection with Havrix 1440 Elisa units for prophylaxis. Approx. 1.5 hours later, the pt experienced a rash over his whole body with erythema, flatness and flushed face, without itchiness. The rash was treated with Benadryl 25mg 2X/day and resolved but reappeared later. Also, within 24 hours of the injection, the pt experienced pharyngitis with a severe sore throat and difficulty swallowing. On 2/21/00, during an office visit, it was noted the pt had 2 pustules on his tonsils. Penicillin VK 250mg every 6 hours for 10 days was begun. The pt saw a dermatologist and had a biopsy performed. The dermatologist dx'd an allergic reaction to Havrix. The pt was treated with an unspecified medication. The information received on 3/29/00 reports the pharyngitis improved, and the rash is not well dissipated after treatment.
Age: 42.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Erythema, Rash, Swelling
Clinical narrative: The pt was vaccinated with Engerix-B at the same time as he was vaccinated with Havrix; 1 vaccine in each arm. On 3/27/00, the pt received his 1st dose of Havrix. On 3/29/00, he experienced a red and swollen rash from the armpit down body. An ER or doctor visit was required. The most recent information, received on 3/29/00, reports the condition of the vaccinee as unknown.
Sex: F
Vaccine: HEPA
Symptoms: Pain
Clinical narrative: On an unspecified date, the pt received her 1st dose of Havrix. A "few" days later, the pt reported axilla pain. Physician is not "even sure the pain is related to the injection". The most recent information, received on 4/3/00, reports the condition of the pt is unknown.
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Chest discomfort, Hyperhidrosis, Paraesthesia
Clinical narrative: This is a spontaneous report from a paramedic referring to a 42 year old male. The pt had a cold (illness) at time of vaccination. On 4/4/00, the pt received his 1st IM left deltoid dose of Havrix. One hour later, he experienced chest tightness, tingling, and sweaty palms. Pulse oximetry was required. On room air, BP 120/88, oxygen saturation 95%, HB 66 and normal rhythm. The most recent information, received on 4/4/00, reports the condition of the vaccinee as ongoing.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a pharmacist/mother referring to her 15 year old daughter. On 4/11/00 at 13:00, the pt received her 1st IM, right deltoid, dose of Havrix. One day later, on 4/12/00, the pt was feverish and achy with fatigue. On 4/13/00, her fever was higher 102F and symptoms were persisting. No treatment was given. The most recent information, received on 4/13/00, reports the condition of the vaccine as ongoing.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Balance disorder, Chest discomfort, Disorientation, Disturbance in attention, Dizziness
Clinical narrative: On 4/17/00, the pt received his 1st IM, left deltoid dose of Havrix. Subsequently, on 4/17/00, he felt like fainting, he felt as if he could not breathe, he experienced pallor, red ears, palpitations, chest tightness, light-headedness, difficulty concentrating and fatigue. His BP was 140/90 (high for him). Physician thought it might be a vasovagal reaction. The pt noticed that his beard was growing more slowly; he shaved every day, but since yesterday, he didn't have his usual 5 o'clock shadow. After the initial events, the pt reported feeling generally unwell with episodic palpitations and "disequilibrium". This latter symptom was described as a feeling of spatial disorientation that lasted for "a second" after a rapid change in head position; there was no sensation of the room spinning, loss of consciousness or diplopia. This symptom gradually resolved approx. 10 days, post vax. The pt also reported developing a sore throat and fever on 4/22/00. He reportedly, experienced episodes of sweating and palpitations. The fatigue and malaise continued and were accompanied by an episodic, pounding headache. The pt denied myalgias, rhinitis, otalgia, fever or chills, and was reportedly, examined by his PCP on 4/26/00. The pt's physician did not obtain an ECG or 24 hour Holter study. No treatment was given. The pt stayed out of work during the week of 4/24/00. His symptoms largely abated by the end of the week and he was back at work by 5/1/00. He was able to drive. The most recent information, received on 5/1/00, reports the condition of the vaccinee as resolved.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Erythema, Fatigue, Hair disorder, Headache
Clinical narrative: On 4/17/00, the pt received his 1st IM, left deltoid dose of Havrix. Subsequently, on 4/17/00, he felt like fainting, he felt as if he could not breathe, he experienced pallor, red ears, palpitations, chest tightness, light-headedness, difficulty concentrating and fatigue. His BP was 140/90 (high for him). Physician thought it might be a vasovagal reaction. The pt noticed that his beard was growing more slowly; he shaved every day, but since yesterday, he didn't have his usual 5 o'clock shadow. After the initial events, the pt reported feeling generally unwell with episodic palpitations and "disequilibrium". This latter symptom was described as a feeling of spatial disorientation that lasted for "a second" after a rapid change in head position; there was no sensation of the room spinning, loss of consciousness or diplopia. This symptom gradually resolved approx. 10 days, post vax. The pt also reported developing a sore throat and fever on 4/22/00. He reportedly, experienced episodes of sweating and palpitations. The fatigue and malaise continued and were accompanied by an episodic, pounding headache. The pt denied myalgias, rhinitis, otalgia, fever or chills, and was reportedly, examined by his PCP on 4/26/00. The pt's physician did not obtain an ECG or 24 hour Holter study. No treatment was given. The pt stayed out of work during the week of 4/24/00. His symptoms largely abated by the end of the week and he was back at work by 5/1/00. He was able to drive. The most recent information, received on 5/1/00, reports the condition of the vaccinee as resolved.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Hypertension, Pallor, Palpitations, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: On 4/17/00, the pt received his 1st IM, left deltoid dose of Havrix. Subsequently, on 4/17/00, he felt like fainting, he felt as if he could not breathe, he experienced pallor, red ears, palpitations, chest tightness, light-headedness, difficulty concentrating and fatigue. His BP was 140/90 (high for him). Physician thought it might be a vasovagal reaction. The pt noticed that his beard was growing more slowly; he shaved every day, but since yesterday, he didn't have his usual 5 o'clock shadow. After the initial events, the pt reported feeling generally unwell with episodic palpitations and "disequilibrium". This latter symptom was described as a feeling of spatial disorientation that lasted for "a second" after a rapid change in head position; there was no sensation of the room spinning, loss of consciousness or diplopia. This symptom gradually resolved approx. 10 days, post vax. The pt also reported developing a sore throat and fever on 4/22/00. He reportedly, experienced episodes of sweating and palpitations. The fatigue and malaise continued and were accompanied by an episodic, pounding headache. The pt denied myalgias, rhinitis, otalgia, fever or chills, and was reportedly, examined by his PCP on 4/26/00. The pt's physician did not obtain an ECG or 24 hour Holter study. No treatment was given. The pt stayed out of work during the week of 4/24/00. His symptoms largely abated by the end of the week and he was back at work by 5/1/00. He was able to drive. The most recent information, received on 5/1/00, reports the condition of the vaccinee as resolved.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope vasovagal
Clinical narrative: On 4/17/00, the pt received his 1st IM, left deltoid dose of Havrix. Subsequently, on 4/17/00, he felt like fainting, he felt as if he could not breathe, he experienced pallor, red ears, palpitations, chest tightness, light-headedness, difficulty concentrating and fatigue. His BP was 140/90 (high for him). Physician thought it might be a vasovagal reaction. The pt noticed that his beard was growing more slowly; he shaved every day, but since yesterday, he didn't have his usual 5 o'clock shadow. After the initial events, the pt reported feeling generally unwell with episodic palpitations and "disequilibrium". This latter symptom was described as a feeling of spatial disorientation that lasted for "a second" after a rapid change in head position; there was no sensation of the room spinning, loss of consciousness or diplopia. This symptom gradually resolved approx. 10 days, post vax. The pt also reported developing a sore throat and fever on 4/22/00. He reportedly, experienced episodes of sweating and palpitations. The fatigue and malaise continued and were accompanied by an episodic, pounding headache. The pt denied myalgias, rhinitis, otalgia, fever or chills, and was reportedly, examined by his PCP on 4/26/00. The pt's physician did not obtain an ECG or 24 hour Holter study. No treatment was given. The pt stayed out of work during the week of 4/24/00. His symptoms largely abated by the end of the week and he was back at work by 5/1/00. He was able to drive. The most recent information, received on 5/1/00, reports the condition of the vaccinee as resolved.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: On 4/13/00, the pt received her 2nd dose of Havrix. Four days later, on 4/17/00, the pt experienced abdominal pain, diarrhea and nausea. The most recent information, received on 4/19/00, reports the condition of the pt as ongoing.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Diarrhoea
Clinical narrative: On 4/20/00, the pt received his 1st dose of Havrix. Physician reported that he was experiencing severe fatigue, epigastric discomfort and diarrhea. Physician reported that the pt had severe eosinophilia and that he could not be sure it was not present prior to the Havrix. Additionally, he was not sure that the fatigue developed after the Havrix. The gastrointestinal discomfort has improved. The diarrhea occurred for 1 day only, then resolved. On 5/19/00, physician visit: Physician noted that the pt had a 1 month history of unusual fatigue and eosinophilia noted on peripheral blood counts. No fever was noted with the pt's recent symptoms, but the pt did complain of abdominal discomfort and a sense of abdominal fullness and nausea after completing 1/2 of his meal. He had diarrhea for 1 day in early May, 2000, with normal stools since that time. He had been so fatigued that he had been unable to participate in his usual tennis competition and had missed some school. There is no history of unusual exposure to illness or toxins and no travel to exotic sites. He did receive a routine Hep-A vaccine. Physical exam was normal. On 5/19/00, Allergist visit: It is unclear whether the pt's symptoms began before or after receiving the Havrix on 4/20/00. However, his parents contacted physician on 4/27/00 with at least a 1 week history of fatigue, malaise and epigastric discomfort. He had no other GI symptoms (except for car sickness) prior to this episode. Allergist had no explanation for the pt's significant eosinophilia. The fact that he has had prior normal eosinophil percentages on his hemograms suggested that this was an acute event (which was hoped was resolving) rather than something related to his prior peanut allergy or mild allergic rhinitis. It is possible that he experienced an idiosyncratic reaction to the Hep-A vaccine. It is possible that he may have eosinophilic gastroenteritis. Hypereosinophilic syndrome would require absolute eosinophil count, 1500 per micro liter for more than 6 months. Current eosinophil count was 1458. He had no signs or symptoms of specific organ involvement other than mild epigastric pain and severe fatigue. Physician reports that the fatigue and the eosinophilia are still resolving and are definitely better. He had a "complete work-up" and all tests were "normal". Physician reported that the pt had prior CBC with differential that was normal. WBC-6,000 on 4/27/00. The vaccinee has regained 6 of the 10 pounds that he lost. Current WBC count is 12,000 with 2% eosinophils. The elevated SGOT and SGPT values resolved by 6/1/00. The most recent information, received on 8/9/00, reports the outcome of the event as improving.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Eosinophilia, Fatigue, Malaise, Nausea, Oral intake reduced
Clinical narrative: On 4/20/00, the pt received his 1st dose of Havrix. Physician reported that he was experiencing severe fatigue, epigastric discomfort and diarrhea. Physician reported that the pt had severe eosinophilia and that he could not be sure it was not present prior to the Havrix. Additionally, he was not sure that the fatigue developed after the Havrix. The gastrointestinal discomfort has improved. The diarrhea occurred for 1 day only, then resolved. On 5/19/00, physician visit: Physician noted that the pt had a 1 month history of unusual fatigue and eosinophilia noted on peripheral blood counts. No fever was noted with the pt's recent symptoms, but the pt did complain of abdominal discomfort and a sense of abdominal fullness and nausea after completing 1/2 of his meal. He had diarrhea for 1 day in early May, 2000, with normal stools since that time. He had been so fatigued that he had been unable to participate in his usual tennis competition and had missed some school. There is no history of unusual exposure to illness or toxins and no travel to exotic sites. He did receive a routine Hep-A vaccine. Physical exam was normal. On 5/19/00, Allergist visit: It is unclear whether the pt's symptoms began before or after receiving the Havrix on 4/20/00. However, his parents contacted physician on 4/27/00 with at least a 1 week history of fatigue, malaise and epigastric discomfort. He had no other GI symptoms (except for car sickness) prior to this episode. Allergist had no explanation for the pt's significant eosinophilia. The fact that he has had prior normal eosinophil percentages on his hemograms suggested that this was an acute event (which was hoped was resolving) rather than something related to his prior peanut allergy or mild allergic rhinitis. It is possible that he experienced an idiosyncratic reaction to the Hep-A vaccine. It is possible that he may have eosinophilic gastroenteritis. Hypereosinophilic syndrome would require absolute eosinophil count, 1500 per micro liter for more than 6 months. Current eosinophil count was 1458. He had no signs or symptoms of specific organ involvement other than mild epigastric pain and severe fatigue. Physician reports that the fatigue and the eosinophilia are still resolving and are definitely better. He had a "complete work-up" and all tests were "normal". Physician reported that the pt had prior CBC with differential that was normal. WBC-6,000 on 4/27/00. The vaccinee has regained 6 of the 10 pounds that he lost. Current WBC count is 12,000 with 2% eosinophils. The elevated SGOT and SGPT values resolved by 6/1/00. The most recent information, received on 8/9/00, reports the outcome of the event as improving.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Weight decreased
Clinical narrative: On 4/20/00, the pt received his 1st dose of Havrix. Physician reported that he was experiencing severe fatigue, epigastric discomfort and diarrhea. Physician reported that the pt had severe eosinophilia and that he could not be sure it was not present prior to the Havrix. Additionally, he was not sure that the fatigue developed after the Havrix. The gastrointestinal discomfort has improved. The diarrhea occurred for 1 day only, then resolved. On 5/19/00, physician visit: Physician noted that the pt had a 1 month history of unusual fatigue and eosinophilia noted on peripheral blood counts. No fever was noted with the pt's recent symptoms, but the pt did complain of abdominal discomfort and a sense of abdominal fullness and nausea after completing 1/2 of his meal. He had diarrhea for 1 day in early May, 2000, with normal stools since that time. He had been so fatigued that he had been unable to participate in his usual tennis competition and had missed some school. There is no history of unusual exposure to illness or toxins and no travel to exotic sites. He did receive a routine Hep-A vaccine. Physical exam was normal. On 5/19/00, Allergist visit: It is unclear whether the pt's symptoms began before or after receiving the Havrix on 4/20/00. However, his parents contacted physician on 4/27/00 with at least a 1 week history of fatigue, malaise and epigastric discomfort. He had no other GI symptoms (except for car sickness) prior to this episode. Allergist had no explanation for the pt's significant eosinophilia. The fact that he has had prior normal eosinophil percentages on his hemograms suggested that this was an acute event (which was hoped was resolving) rather than something related to his prior peanut allergy or mild allergic rhinitis. It is possible that he experienced an idiosyncratic reaction to the Hep-A vaccine. It is possible that he may have eosinophilic gastroenteritis. Hypereosinophilic syndrome would require absolute eosinophil count, 1500 per micro liter for more than 6 months. Current eosinophil count was 1458. He had no signs or symptoms of specific organ involvement other than mild epigastric pain and severe fatigue. Physician reports that the fatigue and the eosinophilia are still resolving and are definitely better. He had a "complete work-up" and all tests were "normal". Physician reported that the pt had prior CBC with differential that was normal. WBC-6,000 on 4/27/00. The vaccinee has regained 6 of the 10 pounds that he lost. Current WBC count is 12,000 with 2% eosinophils. The elevated SGOT and SGPT values resolved by 6/1/00. The most recent information, received on 8/9/00, reports the outcome of the event as improving.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: This report was received from a nurse concerning the occurrence of a rash in a male aged 34 years who was vaccinated with Havrix. On 4/14/00, the pt received his 1st vaccination with Havrix. After 6 days, 4/20/00, he experienced a full body rash. The most recent information received on 4/27/00, reported the symptoms resolved.
Sex: F
Vaccine: HEPA
Symptoms: Anorexia, Dizziness, Faeces pale, Headache, Lymphadenopathy
Clinical narrative: On 12/22/99, the pt received her 1st dose of Havrix. "Right after the injection", she experienced headache, dizziness and was "hyper". Additionally, she lost her appetite and lost 20 pounds, experienced swollen lymph nodes and occasional yellow stools and muscle aches. Her feeling "hyper" subsided, but she still had loss of appetite, continued to lose weight, and had muscle aches. A doctor or ER visit was required. No treatment was given. Multiple tests were performed (NOS) but no dx was arrived at. The most recent information received on 5/10/00, reports the outcome of the event is unknown.
Sex: F
Vaccine: HEPA
Symptoms: Myalgia, Psychomotor hyperactivity, Weight decreased
Clinical narrative: On 12/22/99, the pt received her 1st dose of Havrix. "Right after the injection", she experienced headache, dizziness and was "hyper". Additionally, she lost her appetite and lost 20 pounds, experienced swollen lymph nodes and occasional yellow stools and muscle aches. Her feeling "hyper" subsided, but she still had loss of appetite, continued to lose weight, and had muscle aches. A doctor or ER visit was required. No treatment was given. Multiple tests were performed (NOS) but no dx was arrived at. The most recent information received on 5/10/00, reports the outcome of the event is unknown.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Lymphadenopathy, Rash maculo-papular
Clinical narrative: This report describes the occurrence of maculopapular rash in a 21 year old female who received her 1st dose of Havrix on 5/24/00 and 24 hours later, she experienced an erythematous maculopapular rash and lymphadenopathy (occipital and left clavicular). She had mildly swollen lymph nodes prior to the vaccination. She was without headache, photophobia, chills, myalgia, nausea, vomiting or itching. She was treated with Benadryl po on 5/25/00, after which her rash worsened. The most recent information, received on 5/26/00, reports the outcome of the event is ongoing.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Migraine
Clinical narrative: The pt received his 1st IM, right deltoid, dose of Havrix on 6/22/00. Three days later, on 6/25/00, he experienced a severe migraine. No treatment was given. The most recent information, received on 6/26/00, reports the outcome of the event as resolving.
Sex: M
Vaccine: HEPA
Symptoms: Hepatic enzyme abnormal
Clinical narrative: On an unspecified date, the pt received the unspecified dose of Havrix. Subsequently, he developed elevated liver enzymes. Vaccinee reported that, per his physician, the elevated liver enzymes were related to Havrix. The most recent information, received on 6/26/00, reports the outcome of the event as unknown. No further information is available.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administration error
Clinical narrative: On 6/6/00, the vaccinee received his 1st adult dose of Havrix. This was described as a mal-administration (wrong dose). The most recent information, received on 6/29/00, reports the outcome of the event as unknown.
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Myalgia
Clinical narrative: On 3/13/00, the pt received her 1st IM, left deltoid dose of Havrix. On 3/22/00, 9 days later, the pt experienced swollen lymph nodes, muscle pain and a stiff neck. On 4/5/00, the pt self-treated with ibuprofen (Advil) and methyl salicylate/menthol (Ben-Gay) with "some relief". As of 5/18/00, the reporter noted that the pt had significant muscle tightness throughout her shoulders, neck and chest. She was treated with ibuprofen and physical therapy. As of 12/28/00, the outcome of the events is unknown.
Age: 67.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Injection site hypersensitivity, Pruritus, Rash
Clinical narrative: Immediately post vax, the pt experienced a 3 X 3 rash, redness, itching and swelling at the injection site. the pt reported that he was seen by a physician in Guatemala who provided antibiotics (NOS) for 4 days and topical ointment without results. The outcome of the event is ongoing.
Sex: U
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Three days post vax, the pt experienced hives. The outcome of the event is unknown.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Depression, Fatigue
Clinical narrative: Two weeks post vax, the pt experienced increased fatigue and depression. No treatment was given. These events resolved after two weeks. The outcome of the event is resolved.
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Within hours post vax, the pt experienced pain in the injection arm down to the elbow and then down into his fingers. No treatment was given. The outcome of the event is ongoing.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash
Clinical narrative: On 2/18/00 and 8/18/00, the pt received her 1st and 2nd doses of Havrix, respectively. The pt had no adverse event after the 1st injection. Two days after the 2nd dose of Havrix, on 8/20/00, the vaccinee experienced a rash without fever. The rash began on her back and was very itchy. She was treated with Medrol Dose-Pak on 8/21/00 and 8/29/00. She was also treated with Elocon creme on 8/29/00. As of 9/1/00, there was no improvement in the rash. She was still breaking out. As of 9/1/00, the outcome of the event in unresolved.
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: On 8/4/00, the pt received the 1st dose of Havrix. Five days later, on 8/9/00, he experienced fever, malaise, fatigue, myalgia and nausea. As of 8/16/00, the outcome of the events in unresolved.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Immunoglobulins increased
Clinical narrative: On 5/4/98, the vaccinee received his 1st dose of Havrix. On 8/17/99, he was found to have an AST of 192 U/L. He was found to have an ALT of 157 on 8/24/99. On 8/8/00, the pt received his 2nd dose of Havrix. Subsequent AST values were 173 U/L on 8/24/99 and 43 U/L on 3/23/00. Physician stated that the increased liver function tests were possibly related to alcohol consumption. The vaccinee was never symptomatic, reported the RN. As of 10/5/00, the pt's lab values were improving.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Dysgeusia
Clinical narrative: On 9/8/00, the pt received her second dose of hepatitis A vaccine. Ten minutes post vax, she experienced a metallic taste in her mouth which overwhelmed her. As of 9/22/00, the outcome of the event is resolved.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administration error, Injection site pain
Clinical narrative: On 9/15/00, the pt received her 1st dose of Havrix and experienced mal-administration (expired vaccine). Additionally, she experienced whole arm pain (injection site). The reporter was told by the CDC that they consider this Havrix dose to be a "non-vaccination". As of 9/21/01, the outcome of the events is resolved.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: On 9/23/00, th pt experienced a fever of 103. He was treated with ibuprofen (Motrin). As of 10/05/00, the outcome of the event is unknown.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Syncope
Clinical narrative: On 3/22/00, the pt received her first adult IM dose of Havrix. Within seconds, post vax, she became severely pale and fainted. Her loss of consciousness lasted a few seconds and the episode resolved in 5-10 minutes. No treatment was given. As of 9/21/00, the outcome of the event was resolved.
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: On 3/2/00 the pt contracted a severe case of poison ivy, which was treated with prednisone. On 9/1/00 she was found to be seronegative. No treatment was given. As of 9/21/00 the outcome of the event is ongoing.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: On approximately 9/2/00, the pt received her third adult IM dose of Havrix. No treatment was given. As of 10/2/00, no adverse events were reported.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatitis A
Clinical narrative: Subsequently the pt experienced an elevated SGOT and SGPT with normal alkaline phosphatase and bilirubin. A hepatitis screen showed her to be positive for Hepatitis A. As of 10/5/00, the outcome of the events is ongoing.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: On 10/18/00, the pt received his first dose of Havrix. On 10/18/00 he experienced malaise, myalgia, arthralgias, fever of 102 and tingling body. He was treated with acetaminophen and rest. Symptoms resolved on 10/20/00. Havrix was discontinued. As of 10/20/00, the outcome of the events is resolved.
Age: 0.4
Sex: M
Vaccine: HEPA
Symptoms: Injection site mass, Pyrexia, Vomiting
Clinical narrative: Subsequently following vaccination, the pt experienced a slight fever, which resolved within two days with treatment with acetaminophen. The infant did vomit and had decreased intake for two to three days also. The reporting physician attributed the vomiting to the mother giving the infant prune juice and increasing his Enfamil feeding from 4 ounces to 6 ounces. A dime-size lump remained at the injection site as of 10/20/00. All events resolved within three days. As of 1/23/01, the outcome of the events was resolved.
Sex: U
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: On 4/24/00, the pt received the first dose of Havrix, one month later, on 5/24/00, the pt experienced fainting. As of 10/24/00, the outcome of the event is unknown.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Influenza like illness, Vomiting
Clinical narrative: Within 24 hours, the pt experienced flu-like symptoms. Reportedly, the pt's sister also was home with flu-like symptoms. The pt's sister and nephew had the flu last week. The son started vomiting at 20:00 last night and the pt at 3:00. The nurse felt that the pt's symptoms were not related to Havrix. As of 11/14/00, the outcome of the events is ongoing.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Shoulder pain
Clinical narrative: Immediately post vax, the pt experienced pain in his left shoulder, Havrix had been injected into the left deltoid. The pt reported that the pain persisted as of 11/21/2000. The physician reported that the pain resolved without treatment, on 02/15/2000. The physician considered the injection site pain to be related to Havrix administration.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea
Clinical narrative: On 10/30/2000 and 11/30/2000, the pt received first and second doses of Havrix.  On 12/10/2000, the pt experienced diarrhea. The reported stated that the adverse event was moderate in severity and possibly related to Havrix (but doubt). As of 01/02/2001, the outcome of the event is resolved.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Laboratory test abnormal, Nausea
Clinical narrative: Approximately 6 weeks post vax, the pt experienced nausea and fatigue. She was seen by her physician who performed a hepatitis profile and hepatitis A antibody titer. The hepatitis profile was negative; the hepatitis A titer was positive. The pt recovered after two weeks.
Age: 57.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Erythema, Musculoskeletal stiffness, Oedema peripheral, Pain, Pharyngeal oedema
Clinical narrative: 24 hours post vax, the pt experienced the sensation of a knot in her throat. 30 hours post vax the pt experienced pain in both great toes. 48 hours post vax, the pt developed redness, stiffness and swelling of the fingers on both hands. The redness, stiffness and swelling migrated from finger to finger. She was seen by her primary care physician. An arthritis panel and Lyme titer performed were negative. The physician prescribed a 5 week course of Vioxx. The sensation of a knot in the throat resolved one week after onset. The toe pain resolved one to two weeks after onset. The finger redness, stiffness and swelling resolved after an unspecified period of time.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Liver function test abnormal
Clinical narrative: Subsequent to receiving vax, the pt was determined to have elevated liver function test results. Medical history is significant for household exposure to hepatitis A, the the pts father.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Subsequent to receiving an unspecified dose of hepatitis A vaccine, the pt experienced injection site swelling and redness. As of 01/19/2001, the outcome of the event is unknown.
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Subsequent to receiving the first dose of Havrix, the pt experienced a rash. As of 01/23/2001, the outcome of the event is unknown.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash
Clinical narrative: 36 hours post vax, the pt developed a fine, non-pruritic, pinkish rash on his back, arms, groin and buttocks. Three days post vax, the rash began to spread to his legs and began to itch. He was seen by a physician. A throat culture was negative to Streptococcus. The pt was treated with Benadryl. The rash and itch persisted as of 01/25/2001.
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A
Clinical narrative: Subsequent to receiving first and second doses of Havrix, the pt was sent to Central America to do missionary work and contracted Hepatitis A. As of 02/06/2001 the outcome of the event is unknown.