chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: M
Vaccine: HIBV, PNC
Symptoms: Rash
Clinical narrative: Pt was hoarse the morning after receiving vax. He had severe diaper rash and congestion noted in the morning 4 days post vax. He had a double ear infection and was treated with Amoxicillin 6 days post vax. He developed a yeast infection.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt developed erythema and induration of 4-5 cm in anterior right thigh.
Age: 6.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Oedema peripheral, Skin nodule
Clinical narrative: Mother called around 4 PM one day post vax stating that pt's right arm was swollen, red, hot and had a huge lump. Mother instructed to start pt on Benadryl and apply cold compresses.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Pt experienced 2 days of morbilliform rash.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Pt developed a 10 x 8 cm local reaction with tenderness of the left thigh.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Injection site abscess, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Pt developed a suspected sterile abscess on right deltoid area with 3" of redness, warmth, tenderness and inflammation at site.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child had his first DTAP on 7/20/01. Child's mother called on 7/22/01 and said that her son's leg was swollen, red and was the size of a grapefruit. The child had no fever. Mom was instructed to use cold compresses and use Benadryl and to call us if symptoms worsened.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Chickenpox breakout
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Had vaccine on 9/17 in right upper arm. Reaction noticed on 7/20 described as enlarging area of induration, erythema and warm and tenderness especially to the tricep area.
Age: 19.0
Sex: F
Vaccine: HEP, MEN
Symptoms: Chills, Headache, Hyperhidrosis, Somnolence
Clinical narrative: Pt had chills, sweaty and a headache. She went home and went to bed and slept off and on most of the day. Symptoms lasted until that evening (7/9/01).
Age: 57.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Hypokinesia, Joint stiffness, Laboratory test abnormal, Rash
Clinical narrative: MMR vaccine administered on 7/2/01. On 7/15/01, pt states she had a rash on her face and stiffness in her joints. By today, she is virtually unable to use her hands, her knees are stiff and sore, as well as, ankles, elbows, wrists and shoulders.
Age: 57.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Rash
Clinical narrative: MMR vaccine administered on 7/2/01. On 7/15/01, pt states she had a rash on her face and stiffness in her joints. By today, she is virtually unable to use her hands, her knees are stiff and sore, as well as, ankles, elbows, wrists and shoulders.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Bursitis, Pain
Clinical narrative: Pt developed pain in shoulder, the afternoon, post vax. Because of pain in left shoulder and even the right shoulder that intensified, pt made multiple ER visits and was evaluated by orthopedist. Gradual improvement over 1 month. Still hurting but no weakness.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling to injection site, developed 24 hours later and progressed over the next 24 hours. He was started on Atarax.
Age: 0.6
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site induration
Clinical narrative: Areas of injection 1 cm below injection site with area of induration around 2 cm x1.5 cm
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administration on 3/20 PM, reaction on 3/21 PM; deltoid area below elbow red, swollen, warm, no pus, non tender; saw pt on 3/22 and symptoms still present.
Age: 2.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine administration on 3/20 PM, reaction on 3/21 PM; deltoid area below elbow red, swollen, warm, no pus, non tender; saw pt on 3/22 and symptoms still present.
Sex: F
Vaccine: HEP
Symptoms: Cyanosis neonatal, Neonatal apnoeic attack
Clinical narrative: Pt became apneic and turned blue approximately 4 hours after immunization.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Arthropathy, Bone pain, Chills, Fatigue, Headache
Clinical narrative: Pt developed headaches, leg aches, right hand tiredness, chills, and aching all over.  Diagnosed with degenerative joint dx. The follow up received on 9/27/01 states fatigue, flu-like symptoms, bone pain persist. Symptoms worse in cold weather. Feels "like I'm 80 years old when I get up in the morning: none of these symptoms were presnt pre-vaccination.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Muscular weakness, Pain
Clinical narrative: Pt developed headaches, leg aches, right hand tiredness, chills, and aching all over.  Diagnosed with degenerative joint dx. The follow up received on 9/27/01 states fatigue, flu-like symptoms, bone pain persist. Symptoms worse in cold weather. Feels "like I'm 80 years old when I get up in the morning: none of these symptoms were presnt pre-vaccination.
Age: 0.9
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria, Wheezing
Clinical narrative: Generalized urticaria began 1 week after vaccine administration and lasted 1 week
Age: 0.3
Sex: M
Vaccine: DTAP, HBPV, IPV, PNC
Symptoms: Crying
Clinical narrative: Started crying non stop when Mom got home from PE. Was settled in office after shots.
Age: 1.2
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: PCCV given 7/17/01 in left thigh, noted redness on7/1//01 around 2.50 cm to 5 cm medial to injection site.
Sex: F
Vaccine: FLUX
Symptoms: Arthropathy
Clinical narrative: A nurse reported that a female received an injection of 1985-1986 formula influenza virus vaccine, manufacturer unknown, in 1985 and subsequently developed terrible joint problems. No further information was available at the date of this report.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: The patient experienced fever and varicella rash.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Post vax the patient developed redness and swelling at the immunization site and complained of itching.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Dyspnoea, Fatigue, Pruritus
Clinical narrative: The patient experienced itching, tiredness, and some shortness of breath about 1-2 days post-vax.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Hyperglycaemia, Sinus bradycardia, Syncope
Clinical narrative: The patient experienced a syncopal episode 30-40 minutes post vax. The ER findings showed a normal physical exam. The patient is to follow up with non-invasive cardiology. It is not known if there  is any causal agent with the vaccine.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Within 5 minutes post vax the injection site swelled to the size of a softball. The injection area was very hot and swollen. A second red area was noticed south of the injection site down the right thigh. This area was swollen, hot and the size of a half dollar. The patient was given Benadryl immediately.
Age: 1.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Diarrhoea, Viral infection, Vomiting
Clinical narrative: Post vax the patient developed diarrhea and vomiting. The patient went to the doctor on 06/26/2001 and was told symptoms were viral and had nothing to do with the immunization.
Age: 0.5
Sex: M
Vaccine: DTAP, HBPV, IPV
Symptoms: Tic, Tremor
Clinical narrative: Following 4/17/01 IZ's  pt had tremors and tics. No fever, no crying or fussiness per Mom. Tremors lasted for 1 month.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Eyelid oedema, Rash, Skin exfoliation, Swelling face
Clinical narrative: The patient developed swollen lips, a rash on his forehead and on both lower lids and both lower lids were swollen. The skin had a scaly appearance. The family has been treating symptomatically with 1% steroid cream.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: The patient developed a large welt on the left arm at the injection site with erythema of the surrounding area. The patient was treated with Benadryl and ice was applied.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Conjunctivitis, Lacrimal disorder, Nasal congestion, Tachycardia
Clinical narrative: Within 15 minutes of receiving the vaccine, the patient began having conjunctival suffusion, lacrimation, nasal stuffiness, and tachycardia. The patient was treated with epinephrine and Benadryl.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Patient's hair started falling out a few months after her last shot. The patient has lost 60% of her hair and is still losing hair, though it is growing back in some areas.
Age: 23.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 24 hours after the injection the patient's right arm became swollen, painful, red and warm.
Age: 1.3
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: The patient's right thigh became red, warm and firm to the touch.
Age: 15.0
Sex: M
Vaccine: HEP, TTOX
Symptoms: Asthenia, Face oedema, Oedema peripheral, Pyrexia
Clinical narrative: The patient developed chills, a fever of 103F, swelling of lips and hands and general weakness post vax. The patient was treated with Benadryl and Tylenol.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Neck pain, Pyrexia
Clinical narrative: Post vax patient experienced chills, fever, headache and neck pain.
Age: 22.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Cartilage development disorder, Cyst, Hypokinesia
Clinical narrative: On 02/16/2000 and 03/22/2000, the patient received his first and second doses of Lymerix. On approximately 05/22/2000, the patient began to experience right knee pain. There was no swelling. There was pain with walking and running and with getting out of bed in the morning. As of 05/22/2001 the event was unresolved. On follow-up received on 06/15/2001, the physician indicated that "no adverse reactions were reported to me." The adverse event of "knee pain" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/2000 letter.
Age: 22.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Cyst, Difficulty in walking
Clinical narrative: On 02/16/2000 and 03/22/2000, the patient received his first and second doses of Lymerix. On approximately 05/22/2000, the patient began to experience right knee pain. There was no swelling. There was pain with walking and running and with getting out of bed in the morning. As of 05/22/2001 the event was unresolved. On follow-up received on 06/15/2001, the physician indicated that "no adverse reactions were reported to me." The adverse event of "knee pain" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/2000 letter.
Age: 40.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema, Feeling hot, Injection site hypersensitivity, Oedema, Pruritus
Clinical narrative: Pt stated her upper arm became very swollen, warm to the touch and a little red. She applied ice and took Ibuprofen with relief. The arm reswelled the next evening. When ice was not used, the swelling lasted until Monday 5/21/01. At present, 5/24/01, she only has itching at the site.
Age: 40.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pt stated her upper arm became very swollen, warm to the touch and a little red. She applied ice and took Ibuprofen with relief. The arm reswelled the next evening. When ice was not used, the swelling lasted until Monday 5/21/01. At present, 5/24/01, she only has itching at the site.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: The pt died on 10/14/00. Autopsy results were reported as consistent with sudden infant death syndrome. The investigator and medical monitor did not consider the event to be related to immunization.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: The patient states the injection site became reddened and with a hard lump under the surface. The erythema area was reported as softball size.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Cerebral haemorrhage, Convulsion, Rash, Screaming, Swelling
Clinical narrative: Pt recvd first Hepatitis B shot at 1 wk old. Within 1 month, his head circumference was noticeably larger. On 10/25/00, pt recvd polio, DPT, HIB and #2 Hepatitis B. Pt developed sessions of high pitched screaming. A full body rash developed. On 12/27/00, he received more polio, DPT and HIB vax. 1/3/01 CT scan showed blood on brain. 1/5/01 he had head surgery to relieve pressure and blood matter. Seizures followed. Doctors deny vaccine adverse event once again. Diagnosed with subdural hemetoma
Age: 1.08
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Infection, Pneumonia
Clinical narrative: Pt received his varicella vaccine on 6-11-01. One week prior to hospitalization, he was exposed to a second cousin with chickenpox. The pt developed chickenpox and pneumonia on 7/5/01 and was admitted to the hospital. He was discharged from the hospital on 7/7/01.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Dehydration, Diabetes mellitus, Ketosis
Clinical narrative: Pt developed Type I Diabetes, dx'd on 12/31/99. Onset of symptoms was approx. 1 month following 2nd shot (given on 4/3/99). "My son developed Type I Diabetes in the few months following his 1st 2 shots in the Hep-B series. I have talked with several doctors, nurses and others, who believe this is directly related to his vaccinations. He did not have any flu or illness prior to getting his dx. He was healthy and active until his Diabetes started. I hope that you use this information and can prevent other children from having the same reaction. I could not get this form from my own pediatrician. I had to go to a doctor we don't know. (It was very difficult to finally get a form)."
Age: 85.0
Sex: M
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Pt was receiving dialysis and transfusion of 1 unit of blood when he had a seizure lasting 2 minutes, tonic-clonic in nature.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Diffuse urticarial rash developed on morning after vaccinations. First appeared at umbilical region then spread over body. Treated with Benadryl 5mg/kg for 24 hours.
Age: 1.75
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Erythema, Oedema peripheral, Rash, Urticaria
Clinical narrative: Pt developed rash to both arms and chest. Pt developed edema to left arm. Pt developed erythema to right arm. Chest had fine, urticarial lesions. Pt was seen in ER and given Benadryl IM on 5/5/01.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pt returned to clinic complaining of left deltoid with 5cm X 8cm erythema, non-tender, (+) induration over 3cm X 4cm. Seen by PA and rx'd with Tylenol po every 4 to 6 hours for pain; Benadryl 1/2 tsp po every 4 to 6 hours. Return to clinic prn.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Fever to 104F for 2-3 days.
Age: 0.7
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Convulsion, Dyskinesia, Eye disorder, Hypotonia, Muscle contractions involuntary
Clinical narrative: Pt experienced facial clenching, eyes bulging, shoulder shrugging and right arm abduction for 10-15 seconds and then hypotonic collapse. Pt then returned to normal state before recurrence of symptoms. There was a decrease in frequency of the symptoms after 1-2 hours. Pt taken to ER. She had no cyanosis or breathing problems. Symptoms resolved by 12:30 AM. Afebrile seizure lasted about 4 hours with no treatment recvd at ER.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Developed 1cm X 2cm area of erythema overlying 2cm X 3cm area of induration on anterio-lateral aspect of right thigh at site of Hep/Hib vaccine injection.
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Tooth disorder
Clinical narrative: The pt received her 1st dose of Lymerix in 5/00. One week later, she experienced right elbow pain and muscle pain. These symptoms resolved after an unspecified period of time. The pt received her 2nd dose of Lymerix in 6/00. The next day, she began to experience "extreme" pain in "every joint in her body". She was seen by a rheumatologist, who reportedly told her that she had "arthritis from vaccine". The pt also mentioned that she has an "impingement problem" in her shoulder, which will require surgery. It was unclear if the "impingement problem" developed before or after immunization. Treatment and outcome of the arthritis and "impingement problem" were not provided. The pt declined to provide contact information for herself and she declined to provide authorization for GSK to contact her physician. Therefore, no additional information will be available. The adverse events of "arthritis", "elbow pain" and "impingement problem" do not meet ICM serious criteria, but are being submitted as an expedited report by special request per the 6/28/00 letter.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Difficulty in walking, Guillain-Barre syndrome, Pain
Clinical narrative: On AM of 6/13/01, could not bend or put weight on knees. Pain down shin and up back of thigh and was unable to walk. Doctor visit on 6/14/01 and was referred to Orthopedists. Pt stated Orthopedist dx'd her with Guillain-Barre Syndrome. The annual follow up states that, "pt states that she has permanent disability. Extent of disability is unknown." 60-day and Annual Follow up on 11/17/2003: "It is unknown whether the vaccine recipient recovered from the adverse events that was reported for this vaccination."
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site inflammation
Clinical narrative: Inflammatory reaction on left thigh, 2 days, post vax.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: Mother complained of child crying about 3 hours after shots given. Had temperature of 103F that night, was irritable from 6/21/01 to 6/26/01. No fever since 6/21/01. She did not consult with physician yet but encouraged mother to do so.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Hypoaesthesia, Hypotension
Clinical narrative: Pt returned to clinic at 12:00 one day post vax stating he had begun experiencing numbness in face and top of head within 10-20 minutes after receiving vax. He pointed to his cheek and jaw area bilaterally. Pt also c/o dizziness. He was accompanied by wife who stated she had stayed up all night with him because they were both worried. Injection site appeared normal, neuro signs were intact, pt was alert and oriented with no deficits noted.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Dizziness, Headache, Lethargy
Clinical narrative: Pt given 1st in series of Hep-B (3 doses) and 20 minutes, post vax, student felt "dizzy" and became lethargic. Complained of abdominal pain and a headache. Went to ER where he was given Benadryl.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Pt and mother came to clinic today for Hep-B and pt asked if any concerns. Pt stated she fainted in her car after she left the clinic on 6/7/01. Mom stated she "came to" less than 1 minute and felt nauseous. She vomited 3 times that evening and felt fine the next day. Pt stayed at clinic for 20 minutes, post vax, with no complaints on 6/7/01. Hep-B #2 not given today.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Later in the day of recving vax, pt was exercising on a treadmill which was a new activity for her. About 9-9:30 PM she noticed a fine, red rash on back, across shoulders and a little on chest. It was a little itchy. Rash remained as of 3/28/01. Pt had no other complaints. On 4/4/01, PMD recommended Benadryl with next dose and to continue series.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous
Clinical narrative: Pt developed a pimple-like, non-pruritic, red rash over shoulder blades, both sides of abdomen, both legs and arms. It started 5 days post vax. Mother advised to call PMD, but she did not. She used topical Benadryl for rash and stated pt was fine. Mother encouraged to call PMD for further instructions. No further info obtained. Parent did not return calls.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: Pt developed hives within 24 hours of vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Gravitational oedema, Injection site erythema, Injection site induration, Injection site pain, Rash morbilliform
Clinical narrative: Local redness, tenderness, induration, morbilliform rash, dependent edema from mid-triceps to elbow.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Pt's mother stated pt's father contracted Ramsey Hunt Syndrome after pt recvd Varivax immunization. Pt's father was seen by another MD for diagnosis.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Dyskinesia, Screaming
Clinical narrative: Infant received 3 vaccines about 11:30. Was given acetaminophen and woke up screaming at 14:30; shuddering with jerking of head and shoulder girdle (mild). Parents relate he did this up to 2 weeks of age. By the time he was seen by me, his condition had lessened, considerably at 17:30. Referred to pediatric neurology.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed swelling, pain and redness over entire left anterior thigh. He had no generalized rash or systemic symptoms.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Pyrexia, Rash macular, Swelling face
Clinical narrative: Four hours post vax, pt developed big blotches over entire body, on soles of feet and palms. Her face became swollen and she had a temp of 103. She was treated in the ER with oral Benadryl and the blotches began to subside.
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Difficulty in walking, Eye disorder, Hypotonia, Movement disorder
Clinical narrative: Tuesday afternoon, onset of hypotonia like muscle control. falls from walking would result in hitting head because he would be unable to control the forward movement of the head. Drooping eyes, unable to sit, to stand. Unable to look up while in crawling position, has to roll to his side. No ? symptoms as of 7/23/01.
Age: 1.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Within 1-2 minutes of receiving vax, an area approximately 1-1.5 cm diameter that was pink and warm developed. By 11 AM, area had decreased redness and warmth.
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Pt called on 7/12/01 to report that she has had left arm pain since her hepatitis A injection. She describes the pain as continuous like a toothache. It's zapping me. Pt has not sough any medical follow up. PHN recommended she see a physician asap.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness.
Age: 1.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Convulsion
Clinical narrative: Left clinic feeling great. No noted problems noted in client until seizure. Ambulance called and taken to ER for observation. No further seizure or treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right leg 9 cm X 9 cm hardened red area.
Age: 28.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Night sweats
Clinical narrative: Report 2001007581-1 describes night sweats in a pt who rec'd Lyme disease vaccine (Lymerix) for the prevention of Lyme disease. Reportedly the pt had no known drug allergies or medical history. He took no concomitant medications. In November 2000, the pt rec'd his 1st dose in L deltoid of Lymerix without adverse event. In December 2000, the pt rec'd his 2nd dose L deltoid of Lymerix. In January 2001 he became to experience night sweats and fatigue. These adverse events resolved after 3-4 months. As of 6/8/01 the adverse events had resolved.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Injection site mass, Injection site pain
Clinical narrative: On an unspecified date, the patient received her second dose of Lymerix. On the injection date, she experienced soreness in the injection arm which lasted 24 hours and resolved. On 04/17/2001, the patient received her third vaccine. On 04/22/2001, the patient noticed a dime-size lump on her left arm approx 1/4 inch above the injection site. The patient was advised to "wait one week" and to treat the lump with warm compresses. As of 04/24/2001, the outcome of the event was ongoing.
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Hypokinesia, Injection site pain, Pain, Sensation of heaviness
Clinical narrative: Beginning on 01/26/2001, post-vax, the patient experienced general arm pain which localized to the injection site and increased with movement. Additionally, she experienced heaviness of the arm that was injected. There was no joint pain. No treatment was given. As of 04/27/2001 the adverse events were unresolved. The follow-up states the pt's medical history included osteoarthritis for which was received rofecoxib. She had no history of Lyme disease. On 07/28/2000, 09/01/2000, adn 01/10/2001, the vaccinee  received her first, second, and third .5ml left deltoid doses of LYMErix. There were no adverse events associated with dose 1 and dose 2 of LYMErix. She was treated with Vioxx from 05/03/2001 to 05/07/2001, and Darvocet N-100 one tablet three times daily as needed orally from 05/07/2001. Both MRI and X-rays were negative. The reporting physician indicated that the adversee vents were moderate in severity and were possibly related to LYMErix. He also stated that the adverse events could be associated with administration by chance injuring the sensory nerve. As of 06/29/2001, the adverse events were unresolved. On 10/11/2001m the physician stated that the vacinee had persistent but diminished pain in the area of the injection site. Some relief was obtained with Vioxx. She has seen an orthopedist but was not diagnosed. The physician stated that "it is questionalbe if related to injection or just related in time." The vaccinee had not contacted the physician about this pain for several months but it was reported by the husband one month ago. As of 10/11/2001, the adverse events were unresolved.
Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Rash
Clinical narrative: On unspecified dates, the patient received her first and second doses of Lymerix. Two weeks after dose 2, the patient experienced a left popliteal fossa rash. As of 05/08/2001, the adverse event had resolved.
Age: 34.0
Sex: M
Vaccine: LYME
Symptoms: Rash erythematous
Clinical narrative: On 04/24/2001, the patient received his first right deltoid dose of Lymerix. Ten days later, on 05/04/2001, the patient experienced raised, red bumps on the hands and wrists. The patient was not seen by a physician and no treatment was received. No laboratory tests were performed. As of 05/08/2001, the adverse event was unresolved.
Age: 67.0
Sex: F
Vaccine: LYME
Symptoms: Chest pain
Clinical narrative: The patient experienced chest pain post vax. This report was received from the patient and has not been confirmed by a physician or other health care professional.
Age: 20.0
Sex: M
Vaccine: LYME
Symptoms: Anxiety, Malaise, Nausea, Skin discolouration
Clinical narrative: Following the third dose of Lymerix, the patient experienced nausea, was "ill at ease" and "turning green",  and was anxious. An emergency room visit was required. As of 05/14/2001, the outcome was unknown.
Age: 34.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Chills, Cold sweat, Pallor, Pyrexia
Clinical narrative: In May and June of 2000 and approximately 5/22/01, pt recvd first, second, and third doses of Lymerix. Two to three days after dose 3, the pt had fever, chills/shakes, general weakness, and was pale and clammy. He was seen in the ER where labs were drawn and IV fluids and Toradol were administered. The pt seemed to recover until 6/4/01 when symptoms began to return. All symptoms have returned. The pt was seen by an MD on 6/4/01. He was treated with Ceftin for 20 days. As of 6/5/01, the outcome of the events was unresolved. The follow-up states that a motor vehicle accident with unspecified fracture and an unspecified surgical procedure. The vaccinee smoked one pack of cigarettes per day. The vaccinee had no adverse experience following receipt of the firs two doses of LYMErix. The vaccinee was seen by his primary physician on 05/29/2001. This physician noted that a small tick was found on the vaccinee when he was in the ER. The primary physician prescribed a 30 day course of the Ceftinl 500 mg twice daily. As of 07/24/2001, the outcome of the events was unknown. The follow up states that the vaccinee had no adverse experienced following receipt of the first two doses of LYMErix. The vaccinee was seen by his primary physician on 05/29/2001. This physician noted that a small tick was found on the vaccinee when he was inthe ER. The primary physician prescribed a 20 day course of Ceftin. As of 07/24/2001, the outcome of the events was unknown.
Age: 34.0
Sex: M
Vaccine: LYME
Symptoms: Tremor
Clinical narrative: In May and June of 2000 and approximately 5/22/01, pt recvd first, second, and third doses of Lymerix. Two to three days after dose 3, the pt had fever, chills/shakes, general weakness, and was pale and clammy. He was seen in the ER where labs were drawn and IV fluids and Toradol were administered. The pt seemed to recover until 6/4/01 when symptoms began to return. All symptoms have returned. The pt was seen by an MD on 6/4/01. He was treated with Ceftin for 20 days. As of 6/5/01, the outcome of the events was unresolved. The follow-up states that a motor vehicle accident with unspecified fracture and an unspecified surgical procedure. The vaccinee smoked one pack of cigarettes per day. The vaccinee had no adverse experience following receipt of the firs two doses of LYMErix. The vaccinee was seen by his primary physician on 05/29/2001. This physician noted that a small tick was found on the vaccinee when he was in the ER. The primary physician prescribed a 30 day course of the Ceftinl 500 mg twice daily. As of 07/24/2001, the outcome of the events was unknown. The follow up states that the vaccinee had no adverse experienced following receipt of the first two doses of LYMErix. The vaccinee was seen by his primary physician on 05/29/2001. This physician noted that a small tick was found on the vaccinee when he was inthe ER. The primary physician prescribed a 20 day course of Ceftin. As of 07/24/2001, the outcome of the events was unknown.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Cellulitis, Laboratory test abnormal, Oedema peripheral
Clinical narrative: In May and June of 2000, pt recvd first and second doses of Lymerix without adverse event. On 5/31/01, pt recvd his third dose of Lymerix. On 6/1/01, pt stated that his right arm puffed up about 14-15 inches long and that he had cellulitis. That day he went to the ER and was treated with antibiotics which did not agree with him. He was given another antibiotic treatment at a secondary emergency visit one week later. The pt stated that the injection messed up his INR which measured 1.2. As of 6/11/01, the cellulitis had not resolved.
Sex: U
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: This report described arthralgia in a vaccinee of unspecified age and gender who received Lyme disease vacicne recombinant. Allergies, medical history, and concomitant medications were not specified. On unspecified dates, the vaccinee recieved an unspecified number of doses of LYMErix. Six months after receiving vaccines, the patient reportedly complained of arthralgia. As of 6/13/01, the outcome of the event was unknown. The adverse event arthralgia does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Blood pressure increased, Fatigue, Flushing, Heart rate increased, Irritability
Clinical narrative: About 12:00, I began to have a bad head itch. Rash appeared around the front rim of hairline. Sunday, face was flushed with small bumps and neck was hives. The hives itched. Monday, called MD. Rash had moved to trunk and back. The old hives on face and neck began to widen and turn dark red and began to move to my lips and ears. Tuesday, limbs were covered with itching and unable to sleep at night. Wednesday, blood evaluated. Thursday, had chills, fatigue, itching all over body, nervousness and irritability. Friday, doctor's office. Treated with antibiotic (Prednisone, anti-histamine and creams for external and internal use for itching. Saturday, had high blood pressure, heart rate and temperature of 101.7F. Went to ER and admitted into the hospital and is still being treated.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Nervousness, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: About 12:00, I began to have a bad head itch. Rash appeared around the front rim of hairline. Sunday, face was flushed with small bumps and neck was hives. The hives itched. Monday, called MD. Rash had moved to trunk and back. The old hives on face and neck began to widen and turn dark red and began to move to my lips and ears. Tuesday, limbs were covered with itching and unable to sleep at night. Wednesday, blood evaluated. Thursday, had chills, fatigue, itching all over body, nervousness and irritability. Friday, doctor's office. Treated with antibiotic (Prednisone, anti-histamine and creams for external and internal use for itching. Saturday, had high blood pressure, heart rate and temperature of 101.7F. Went to ER and admitted into the hospital and is still being treated.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Antinuclear antibody positive, Hepatic enzyme abnormal, Immunoglobulins increased, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: About 12:00, I began to have a bad head itch. Rash appeared around the front rim of hairline. Sunday, face was flushed with small bumps and neck was hives. The hives itched. Monday, called MD. Rash had moved to trunk and back. The old hives on face and neck began to widen and turn dark red and began to move to my lips and ears. Tuesday, limbs were covered with itching and unable to sleep at night. Wednesday, blood evaluated. Thursday, had chills, fatigue, itching all over body, nervousness and irritability. Friday, doctor's office. Treated with antibiotic (Prednisone, anti-histamine and creams for external and internal use for itching. Saturday, had high blood pressure, heart rate and temperature of 101.7F. Went to ER and admitted into the hospital and is still being treated.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pyrexia, Rash, Rheumatoid factor
Clinical narrative: About 12:00, I began to have a bad head itch. Rash appeared around the front rim of hairline. Sunday, face was flushed with small bumps and neck was hives. The hives itched. Monday, called MD. Rash had moved to trunk and back. The old hives on face and neck began to widen and turn dark red and began to move to my lips and ears. Tuesday, limbs were covered with itching and unable to sleep at night. Wednesday, blood evaluated. Thursday, had chills, fatigue, itching all over body, nervousness and irritability. Friday, doctor's office. Treated with antibiotic (Prednisone, anti-histamine and creams for external and internal use for itching. Saturday, had high blood pressure, heart rate and temperature of 101.7F. Went to ER and admitted into the hospital and is still being treated.
Age: 0.3
Sex: M
Vaccine: DTAP, HBPV, IPV
Symptoms: Cyst, Hypotonia, Vomiting
Clinical narrative: Child vomited X 4 on 7/18/01-Brought to PCP's office on 7/19. Had a hypotonic response while waiting to see PCP. Transported to hospital and diagnosed with arachnoid cyst.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Dyspnoea, Pallor
Clinical narrative: About 4 hrs post vax, pt cried very hard, couldn't breathe well and turned pale. She was taken to the ER, given a breathing treatment, and sent home. She was much better when she left the hospital. MD said the problem was from Prevnar.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Rash, Urticaria
Clinical narrative: Vaccine (Hib) was given at 10:18 and pt had rash with mild hives that started at 10:23. At 10:38, the rash was still only mild (scant) and at 10:45, the rash and hives were gone except on the bottom of pt's feet and slight on his back. At 11:50, the rash came back on front of his chest, back and legs. At 11:55, the doctor ordered Benadryl X 2 days. At 12:45, the rash almost gone. Pt discharged home with instructions to go to ER or call 911, if the baby becomes worse with rash of if any respiratory problems occur. On 7/30/01 at 08:30, the parent of the baby stated that his rash and hives have been all gone since Sunday.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Cough, Pruritus
Clinical narrative: The child complained of itching of the arms and body and she had a constant dry cough. No difficulty breathing. Epinephrine was given and itching and cough cleared. EMS was called. The child was taken to hospital ER. As per ER doctor, she was discharged on Prednisone.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Swelling face, Throat tightness, Tremor, Urticaria
Clinical narrative: Approx. 12 hours, post vax, the pt developed facial tightness, hives behind knees, throat tightness and shakiness. At injection site, she had local reaction with swelling and tightness. VSS, afebrile. She was given 50mg po Benadryl. Recovered uneventfully.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia
Clinical narrative: Fever of 105F, the evening after vaccines vaccines given (same day).
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, HEP, HEPA
Symptoms: Fatigue, Headache, White blood cell count increased, Yellow skin
Clinical narrative: The 1st day, pt became very sleepy; a few day later, he had a headache and then he became faint, weak, almost passed out twice, turned yellow, nauseous, had diarrhea, body aches all over, over 100F temperature, dizzy and very, very ill. I took him to the doctor twice. One doctor said, this probably was a reaction to immunizations. He will not have any other immunizations. His heart also beat very funny.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, HEP, HEPA
Symptoms: Diarrhoea, Dizziness, Headache, Irritability, Nausea
Clinical narrative: The 1st day, pt became very sleepy; a few day later, he had a headache and then he became faint, weak, almost passed out twice, turned yellow, nauseous, had diarrhea, body aches all over, over 100F temperature, dizzy and very, very ill. I took him to the doctor twice. One doctor said, this probably was a reaction to immunizations. He will not have any other immunizations. His heart also beat very funny.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, HEP, HEPA
Symptoms: Pain, Pyrexia, Somnolence, Syncope, Yellow skin
Clinical narrative: The 1st day, pt became very sleepy; a few day later, he had a headache and then he became faint, weak, almost passed out twice, turned yellow, nauseous, had diarrhea, body aches all over, over 100F temperature, dizzy and very, very ill. I took him to the doctor twice. One doctor said, this probably was a reaction to immunizations. He will not have any other immunizations. His heart also beat very funny.
Age: 5.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Approx. 2cm red and slightly tender to the touch area on left upper leg.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Blood pressure increased, Fatigue, Flushing, Heart rate increased, Irritability
Clinical narrative: Lymphadenopathy, rash, elevated liver enzymes and fever.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Nervousness, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Lymphadenopathy, rash, elevated liver enzymes and fever.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Antinuclear antibody positive, Hepatic enzyme abnormal, Immunoglobulins increased, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: Lymphadenopathy, rash, elevated liver enzymes and fever.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pyrexia, Rash, Rheumatoid factor
Clinical narrative: Lymphadenopathy, rash, elevated liver enzymes and fever.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Murder
Clinical narrative: Infant died on 1/19/99. Autopsy report states cause of death to be traumatic head injuries, homicide. Death certificate states: craniocerebral trauma.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Bone development abnormal, Injection site pain, Pain, Paraesthesia
Clinical narrative: Information has been received from an RN concerning a 44 year old white female who on 7/19/00 was vaccinated with Hep-B. On 7/19/00, the pt experienced sore left arm, 5" below injection site. The pt was instructed to use a warm compress and Tylenol. As of 7/31/00, the pt continued to have pain and soreness in the left arm below the injection site. On 5/12/01, the pt developed severe pain in left arm that included tingling in the digits of the left hand and numbness in the left hand. In follow-up, the RN reported that on 7/12/01, the pt was dx'd with "spurring". The physician felt that the spurring was not related to the vaccination with Hep-B. Upon internal review, spurring was considered to be an "Other Medical Event". No further information is expected.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Abnormal behaviour, Autism, Cognitive disorder, Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received from a lawyer concerning an 11 year old male pt who allegedly received 16 injections of thimerosal-laden vaccines between 5/6/98 and 4/12/00. On 5/6/98, the pt was vaccinated in the hospital with a 1st dose of Hep-B. On 5/12/99, the pt was vaccinated, IM, in the left thigh with MMRII and a dose, in the left thigh of varicella virus vaccine. It is alleged that prior to completing the schedule of vaccinations, the pt developed normally and demonstrated social language, cognitive, behavioral and physical skills appropriate for his age. Beginning in approx. 9/99, he began to display symptoms of neurological damage consistent with mercury poisoning including losing his language skills, engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn. It is also alleged that the pt has been dx'd as suffering from mercury poisoning and disintegrative (or "late onset", "degenerative" or "regressive") autism. The pt is receiving medical treatment to remove mercury from his body. As the mercury levels in his body have decreased, he has noted some improvement in his symptoms. Upon internal review, disintegrative autism was determined to be an "Other Important Medical Event". No further information is available.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Social avoidant behaviour, Speech disorder
Clinical narrative: Information has been received from a lawyer concerning an 11 year old male pt who allegedly received 16 injections of thimerosal-laden vaccines between 5/6/98 and 4/12/00. On 5/6/98, the pt was vaccinated in the hospital with a 1st dose of Hep-B. On 5/12/99, the pt was vaccinated, IM, in the left thigh with MMRII and a dose, in the left thigh of varicella virus vaccine. It is alleged that prior to completing the schedule of vaccinations, the pt developed normally and demonstrated social language, cognitive, behavioral and physical skills appropriate for his age. Beginning in approx. 9/99, he began to display symptoms of neurological damage consistent with mercury poisoning including losing his language skills, engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn. It is also alleged that the pt has been dx'd as suffering from mercury poisoning and disintegrative (or "late onset", "degenerative" or "regressive") autism. The pt is receiving medical treatment to remove mercury from his body. As the mercury levels in his body have decreased, he has noted some improvement in his symptoms. Upon internal review, disintegrative autism was determined to be an "Other Important Medical Event". No further information is available.
Age: 1.25
Sex: M
Vaccine: DTP, HEP, HIBV, MMR, VARCEL
Symptoms: Abasia, Arthralgia, Difficulty in walking, Pain, Pyrexia
Clinical narrative: On 7/13/01, the pt had difficulty walking and as of 7/16/01 was reported as being unable to walk. The pt also has joint pain, arm pain and a fever of 102-103F. It was noted that the pt had taken Cedax for a few days prior to the vax for an unspecified condition. The MD reported that the pt's inability to walk was secondary to his generalized arthralgias and not secondary to any type of neurological gait abnormality. The pt is recovering. Upon internal review, "difficulty walking and now unable to walk" was determined to be an other important medical event. Addtl info has been requested.
Age: 6.0
Sex: F
Vaccine: DTPHIB
Symptoms: Abnormal behaviour, Febrile convulsion, Hearing impaired, Neurodevelopmental disorder, Speech disorder
Clinical narrative: Mom gave Tylenol prior to vax and another dose at 4 PM. Pt went to bed at 8 PM. She awoke at between 9 and 10 PM acting strange, eyes crossing, seizing with a temperature of 105-106. She was taken to the ER. She had multiple seizures in ER. She was admitted for 2 days and treated with Phenobarbital. She was diagnosed as having febrile seizures. She was diagnosed with central auditory processing disorder, severe learning disability and language and speech disorder.
Age: 6.0
Sex: F
Vaccine: DTPHIB
Symptoms: Strabismus
Clinical narrative: Mom gave Tylenol prior to vax and another dose at 4 PM. Pt went to bed at 8 PM. She awoke at between 9 and 10 PM acting strange, eyes crossing, seizing with a temperature of 105-106. She was taken to the ER. She had multiple seizures in ER. She was admitted for 2 days and treated with Phenobarbital. She was diagnosed as having febrile seizures. She was diagnosed with central auditory processing disorder, severe learning disability and language and speech disorder.
Age: 0.62
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Blister
Clinical narrative: Pt developed blisters and bullae on legs and body 2 days post vax. She was seen at ER and transferred to a hospital where she stayed for 3 days.
Age: 0.62
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Dermatitis bullous
Clinical narrative: Pt developed blisters and bullae on legs and body 2 days post vax. She was seen at ER and transferred to a hospital where she stayed for 3 days.
Age: 0.62
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Crying, Erythema, Injection site erythema, Injection site pain, Skin exfoliation
Clinical narrative: Pt developed blisters and bullae on legs and body 2 days post vax. She was seen at ER and transferred to a hospital where she stayed for 3 days.