chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DT, DTAP, IPV
Symptoms: Agitation, Injection site erythema
Clinical narrative: Approximately 2 hours after this infant had his vaccines, the child had redness at the site of injection on his left leg (0 contraindication). the infant had inconsolable crying for 2 hours. The parent put ice on site and the infant continued crying. The infant has no history of crying for a long period of time or any other problem.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Fatigue, Malaise, Pyrexia, Vomiting
Clinical narrative: This patient's father reports onset of fever between 10 AM - 11 AM this morning. He also reports vomiting 3 times, fatigue, malaise, and a stomach ache. The patient temperature was not measured. The nurse consulted the physician and advised the family to monitor his sickness. Seek medical care if fever increases of sickness continues or worsens.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Amnesia, Eye disorder, Eye movement disorder, Hypertonia, Hypotonia
Clinical narrative: One minute after the vaccine was given to this patient, she lost consciousness for 5 seconds, involuntary clonic tonic movements of arms and legs, her eyes rolled back and fluttering. Inhalation and exhalation throughout. Skin moist and warm face and trunk. Hands moist and cool, lips pink. No paleness and memory of what happened, no history of seizure disorder.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Skin warm
Clinical narrative: One minute after the vaccine was given to this patient, she lost consciousness for 5 seconds, involuntary clonic tonic movements of arms and legs, her eyes rolled back and fluttering. Inhalation and exhalation throughout. Skin moist and warm face and trunk. Hands moist and cool, lips pink. No paleness and memory of what happened, no history of seizure disorder.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: The mother of this patient was concerned about the persistant swelling at the site of injection on 10/30/00. Swelling noted the day after immunizations received. The mother feels it has gotten "larger", firm, moveable swelling (4cm x 4cm) anterolateral aspect left thigh. No erythema, no tenderness, full range of motion, no medical evaluation sought to date.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: The father reports a 3" long x 4" wide area where vaccine was given to be red, swollen, hard to the touch, and warm. Advised to contact health department. Recommended ibuprofen and ice.
Age: 12.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Abdominal pain, Vomiting
Clinical narrative: The pt experienced vomiting, abdominal pain. Mother states "never ever vomits".
Age: 0.4
Sex: U
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: The pt experienced a fever of 104.4 for 2 days with Tylenol, went to ER and told to use "tepid baths"; unconsolable crying for 2 days and then "became well".  Follow up:  According to MA who filled out the form, adverse event onset is unknown.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Dermatitis allergic, Injection site erythema, Injection site reaction, Pruritus
Clinical narrative: The pt experienced pruritis, allergic dermatitis at the site of injection (left deltoid) with redness and itching.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Dermatitis allergic, Injection site erythema, Injection site reaction, Pyrexia
Clinical narrative: The pt experienced allergic dermatitis at the site of injection with redness and fever.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pain, Paraesthesia, Pruritus
Clinical narrative: Approximately 1/2 hour post vax. the pt started experiencing tingling around her mouth, face then turned red and started itching, tingling went to the arms and continued off and on for about a week. Pain in the hand and feet started the following day.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Muscle rigidity, Staring, Stupor
Clinical narrative: The child became rigid, stared into space and did not respond to verbal stimuli for about 2-3 seconds. Child responded as soon as placed in supine position.
Age: 1.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: The pt experienced redness at the injection site beginning the evening of the vax. Increased redness over the next 48 hours to 12 x 12 cm, was warm and swollen. Fever to 101.0 for 2 days.
Age: 0.2
Sex: F
Vaccine: HEP
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: The pt experienced a rash. Petechiae was noted. Platelets were less than 1,000. Bone marrow consistent with ITP. Admitted of IVIG.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Coma, Dizziness, Musculoskeletal stiffness, Tooth disorder
Clinical narrative: Approximately 10 minutes post vax, the pt was in the car and began clenching teeth, arm flexing, non-responsive for approximately 20 seconds. Then immediately became responsive and alert. Complained of feeling dizzy, and lightheaded. Examined within 10 minutes and had normal exam including vital signs and neurologic exam.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: 24 hours post vax, the pt experienced swelling, erythema, warmth and induration was noted at the injection site, erythema 6cm x 13 cm. Non-tender, induration approximately 1 cm in diameter. Area affected is the left thigh.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Feeling hot, Lacrimation increased, Pyrexia, Rash erythematous
Clinical narrative: On 12/28/00 at 4:30AM to 12/30/00 9:00am the pt experienced a fever of up to 104-105 with Tylenol every 4 hours. The fever would drop to 102 but then spike back up to 104/105. On 12/30/00 at 9:00 am to 12/30/00 8:00pm the pt experienced a fever of 102, treated with Tylenol. On 12/29/00 the skin around the eyes were red and eyes were watery. On 12/30/00 at 6:00pm the pt had a head to toe rash - red dots, some raised and most hot. No discomfort was noted with rash.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: The pt experienced a severe pruritic maculo-papular rash for 1 week. Started on trunk and proximal extremities spread distally to involve entire body except palms and soles and face. Minimal relief with antihistamines or topical steroids.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Eye movement disorder, Loss of consciousness
Clinical narrative: 10 minutes post vax, the pt complained of stomach hurting then a couple of minutes later the child's eyes rolled back in head and the child passed out.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt experienced chicken pox on 1/1/01 through 1/10/01.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Exactly one week posit vax, the pt experienced hives covering the entire body lasting 2-3 days.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced swelling, redness. No fever was noted. At an evaluation the following day, the right thigh was warm, erythematous with marked swelling of entire right thigh. Parent applied compresses with com improvement. The pt took Benadryl.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Headache, Malaise, Nausea
Clinical narrative: The morning after the vax, the pt felt ill when she went to work. She felt progressively worse until she left work early. She had an itchy sore throat, chills, headache, nausea and generalized joint soreness. The pt also states that some of her co-workers have missed work due to illness recently.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngolaryngeal pain, Pruritus
Clinical narrative: The morning after the vax, the pt felt ill when she went to work. She felt progressively worse until she left work early. She had an itchy sore throat, chills, headache, nausea and generalized joint soreness. The pt also states that some of her co-workers have missed work due to illness recently.
Age: 1.9
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urticaria, Vomiting
Clinical narrative: The same day as vax, the pt experienced hives and was sick. He experienced one episode of vomiting,  and appeared a little clingy. He was treated with Benadryl with some relief. He was referred to a clinic.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: The pt experienced a rash and itchiness. Rash was noted on arms, legs, chest and some of the abdominal areas. Pt complained of itching. Treated with Benadryl and hydrocortisone cream for itching.
Age: 11.0
Sex: M
Vaccine: HEP, TTOX
Symptoms: Injection site erythema, Injection site pain, Rash macular
Clinical narrative: The pt experienced a 6.5 x 2 cm erythemic, tender, macular area to the left deltoid.
Age: 1.2
Sex: M
Vaccine: DTAP, IPV
Symptoms: Convulsion
Clinical narrative: The pt experienced a seizure like episode after the vax was given.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Hypertension, Hypoaesthesia
Clinical narrative: Before leaving the doctors office, the pt told the clerk that her chest felt tight and the clerk notified the RN. The pt stated that the tightening occurred suddenly. They loosened clothing and had the pt lie down. The tightness continued and her throat began to feel numb. Her color remained pink. 911 was called. Treated with epinephrine and transported to the hospital.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Coma, Hypertension, Hypokinesia, Nausea
Clinical narrative: Approximately 8:40 the school nurse was called to the auditorium, the pt was unresponsive, staring, (not unconscious). At 8:45 her BP was 180/94, pulse 104 and respirations were 20. She seemed unable to speak, unresponsive to painful stimulation. No difficulty breathing was noted. The pt complained of heaviness of of arm and legs. The pt was unable to move legs, and felt a "little tightness in chest". The ambulance arrived and the pt complained of nausea and she started staring and became unresponsive again. She was transported to the ER. She was then discharged home.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory rate increased, Sensation of heaviness, Speech disorder, Staring
Clinical narrative: Approximately 8:40 the school nurse was called to the auditorium, the pt was unresponsive, staring, (not unconscious). At 8:45 her BP was 180/94, pulse 104 and respirations were 20. She seemed unable to speak, unresponsive to painful stimulation. No difficulty breathing was noted. The pt complained of heaviness of of arm and legs. The pt was unable to move legs, and felt a "little tightness in chest". The ambulance arrived and the pt complained of nausea and she started staring and became unresponsive again. She was transported to the ER. She was then discharged home.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Patient developed a raised, red rash on her chest, neck, groin, and inner arms. This was not itchy. There were no respiratory symptoms. Patient made a telephone call and visited her physician. She was treated with prednisone. The rash was fading as of 11/13/00.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: On 11/16/00, at 3 AM the patient was experiencing itchiness to the groin, stomach, legs, progressing to the neck and chest; no rash. On 11/20/00, the itching continues. Calamine lotion and Benadryl over the counter items will provide temporary relief. On 11/21/00, the physician prescribed over the phone  Hydroxycine HCL, good relief provided.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Lung disorder, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: A call was received from a medical examiner stating the child had died of SIDS on 1/12/01. Autopsy states pulmonary congestion and edema. Final cause of death given as sudden death associated with bronchopulmonary dysplasia.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: The pt experienced a high fever of 104 for 2 hours following vax. Severe joint pain and headache. Joint pain has continued over the past eight years worsening 3 years ago. This has been reported to a doctor but no treatment has been recommended. 60 day follow-up states the pt continues to get worse every year.
Age: 38.0
Sex: M
Vaccine: TTOX
Symptoms: Coordination abnormal, Diplopia, Dizziness, Dysarthria, Dysphagia
Clinical narrative: Pt developed Guillain-Barre' Syndrome approx. 6 weeks, post vax. He received plasma-phoresis. He has developed Bell's Palsy which began about 1/3/01. He has some paralysis in progress. Per F/U 6/19/01: Pt speech is thick and he has dizziness. He awoke with numbness to bilateral fingers, mouth and slowly progressing now to bilateral feet, too. He also has double vision. He has no reflexes on all 4 extremities. Seen earlier that day for same symptoms but is progressively worsening. 800mg Motrin/ibuprofen. Addendum: Did not have flu vaccine this year (historically, some reports of association of GBS with anticedent vaccinations); would not give flu vaccine at this point. Hospitalized. He has ataxia. Palate paralysis with nasal voice (hoarseness) ; has swallowing difficulty and respiratory insufficiency. Follow-up with Neurology and speech pathology.  Follow up on 06/19/2001: "Patient has had a history of cough for about a week and had an episode of diarrhea last week prior to admisison.  Chronic illnesses before onset of GBS: 2.5 years ago had back surgery 2* to pain in left leg.  Ruptured disc. Another time patient received influenza was two years ago."
Age: 38.0
Sex: M
Vaccine: TTOX
Symptoms: Dysphonia, Facial palsy, Guillain-Barre syndrome, Heart rate increased, Hypertension
Clinical narrative: Pt developed Guillain-Barre' Syndrome approx. 6 weeks, post vax. He received plasma-phoresis. He has developed Bell's Palsy which began about 1/3/01. He has some paralysis in progress. Per F/U 6/19/01: Pt speech is thick and he has dizziness. He awoke with numbness to bilateral fingers, mouth and slowly progressing now to bilateral feet, too. He also has double vision. He has no reflexes on all 4 extremities. Seen earlier that day for same symptoms but is progressively worsening. 800mg Motrin/ibuprofen. Addendum: Did not have flu vaccine this year (historically, some reports of association of GBS with anticedent vaccinations); would not give flu vaccine at this point. Hospitalized. He has ataxia. Palate paralysis with nasal voice (hoarseness) ; has swallowing difficulty and respiratory insufficiency. Follow-up with Neurology and speech pathology.  Follow up on 06/19/2001: "Patient has had a history of cough for about a week and had an episode of diarrhea last week prior to admisison.  Chronic illnesses before onset of GBS: 2.5 years ago had back surgery 2* to pain in left leg.  Ruptured disc. Another time patient received influenza was two years ago."
Age: 38.0
Sex: M
Vaccine: TTOX
Symptoms: Paraesthesia, Paralysis, Respiratory failure
Clinical narrative: Pt developed Guillain-Barre' Syndrome approx. 6 weeks, post vax. He received plasma-phoresis. He has developed Bell's Palsy which began about 1/3/01. He has some paralysis in progress. Per F/U 6/19/01: Pt speech is thick and he has dizziness. He awoke with numbness to bilateral fingers, mouth and slowly progressing now to bilateral feet, too. He also has double vision. He has no reflexes on all 4 extremities. Seen earlier that day for same symptoms but is progressively worsening. 800mg Motrin/ibuprofen. Addendum: Did not have flu vaccine this year (historically, some reports of association of GBS with anticedent vaccinations); would not give flu vaccine at this point. Hospitalized. He has ataxia. Palate paralysis with nasal voice (hoarseness) ; has swallowing difficulty and respiratory insufficiency. Follow-up with Neurology and speech pathology.  Follow up on 06/19/2001: "Patient has had a history of cough for about a week and had an episode of diarrhea last week prior to admisison.  Chronic illnesses before onset of GBS: 2.5 years ago had back surgery 2* to pain in left leg.  Ruptured disc. Another time patient received influenza was two years ago."
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Influenza like illness, Malaise, Myalgia
Clinical narrative: The pt experienced flu symptoms, shortness of breath, chest congestion, runny nose, constant cough, muscle aches etc. Still very sick.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: The pt experienced flu symptoms, shortness of breath, chest congestion, runny nose, constant cough, muscle aches etc. Still very sick.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Abscess, Furuncle, Pruritus, Rash, Skin burning sensation
Clinical narrative: The evening of the vax, while lying down to sleep, the pt noticed itching on buttocks and feet were burning. The next day around 2:00 pm, the pt complained of feet were burning and parts of my skin all over my body was itching. She called the MD for advice. She was told to take 2 Benadryl and drink lots of water and to lay her feet on frozen bags with towels around them. The pt complied but still had itchy whelps and rashes that were huge. The follow day, the breakout began in different places on the body. The pt then experienced a swollen tongue. She called her MD, but was placed on hold for a long period of time and then decided to call an ambulance and was taken to the hospital. She was given steroids, after which the intense itching stopped. The pt then experienced boils between her legs where she sits. The boil turned into a huge abscess which had to be lanced and packed twice (different days) in which she received no medication to relieve the pain. The abscess covered a large area between her legs, about the size of a naval orange. The pain traumatized the pt. She has been a diabetic for about 2 years and has never experienced anything like this before. The pt has never had adverse reactions to vaccinations prior to this. The pt believes the flu shot was a large part of her pain because the smell of the abscess was like rotten eggs plus the MD who performed the lancing told her that the steroids would have produced the boil. In conclusion, the pt will never take the flu vaccine again.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Tongue oedema, Urticaria
Clinical narrative: The evening of the vax, while lying down to sleep, the pt noticed itching on buttocks and feet were burning. The next day around 2:00 pm, the pt complained of feet were burning and parts of my skin all over my body was itching. She called the MD for advice. She was told to take 2 Benadryl and drink lots of water and to lay her feet on frozen bags with towels around them. The pt complied but still had itchy whelps and rashes that were huge. The follow day, the breakout began in different places on the body. The pt then experienced a swollen tongue. She called her MD, but was placed on hold for a long period of time and then decided to call an ambulance and was taken to the hospital. She was given steroids, after which the intense itching stopped. The pt then experienced boils between her legs where she sits. The boil turned into a huge abscess which had to be lanced and packed twice (different days) in which she received no medication to relieve the pain. The abscess covered a large area between her legs, about the size of a naval orange. The pain traumatized the pt. She has been a diabetic for about 2 years and has never experienced anything like this before. The pt has never had adverse reactions to vaccinations prior to this. The pt believes the flu shot was a large part of her pain because the smell of the abscess was like rotten eggs plus the MD who performed the lancing told her that the steroids would have produced the boil. In conclusion, the pt will never take the flu vaccine again.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Pruritus, Urticaria
Clinical narrative: 5 minutes post vax, the pt developed hives in the right groin area and upper body with itching. Treated with Benadryl. The pt was observed for 15 minutes. Hives decreased and pt went home.
Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Oedema peripheral, Pain, Pruritus, Rash
Clinical narrative: The pt experienced swelling of fingers on both hands, fingers had red sore like spots. They itch and were very painful.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Diarrhoea, Insomnia
Clinical narrative: The pt was unable to sleep and developed diarrhea. No treatment was given.
Age: 1.08
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Rash
Clinical narrative: The pt experienced a knot with redness one day post vax. The pt also experienced a 3cm area of induration. The pt developed redness to the anterior right thigh. The pt also had a rash behind the neck. Was seen in clinic on 2nd day.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: The pt experienced a fever of 104 and was fussy. Symptoms resolved the following day.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Dry skin, Haematochezia, Immune system disorder, Injection site pain, Lymphocytosis
Clinical narrative: On 6/25/99 following vax, the pt had a sore arm. On 7/9/99 following 2nd dose the pt experienced soreness in arm again. On 7/23/99 following 3rd dose the pt experienced blood in the stool. On 1/28/00 following dose 4, the pt experienced hives all over the body, continuous dryness of skin, blood in stool and low immune system. Blood in stool, drynes of skin, rash, low immune system. Stopped the vaccination of the Anthrax shot. Broke out in hives.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: On 6/25/99 following vax, the pt had a sore arm. On 7/9/99 following 2nd dose the pt experienced soreness in arm again. On 7/23/99 following 3rd dose the pt experienced blood in the stool. On 1/28/00 following dose 4, the pt experienced hives all over the body, continuous dryness of skin, blood in stool and low immune system. Blood in stool, drynes of skin, rash, low immune system. Stopped the vaccination of the Anthrax shot. Broke out in hives.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced a localized reaction to the right thigh injection site. The site was slightly red, swollen, and warm to the touch.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Difficulty in walking, Dizziness, Hypokinesia, Oedema peripheral
Clinical narrative: Shortly after vax the pt felt lightheaded, became pale and nearly fainted. She sat in a chair with her head between knees for about 10 minutes then went back to work. A couple hours later it was reported that she felt much better and that it had happened last year when she got  her flu shot. She also stated she was having joint pain and swelling in her right hand and could hardly use it. She stated she could bare get up and down from sitting and had difficulty walking. It was advised that she doesn't take the vaccine again.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pallor, Similar reaction on previous exposure to drug, Vaccine positive rechallenge
Clinical narrative: Shortly after vax the pt felt lightheaded, became pale and nearly fainted. She sat in a chair with her head between knees for about 10 minutes then went back to work. A couple hours later it was reported that she felt much better and that it had happened last year when she got  her flu shot. She also stated she was having joint pain and swelling in her right hand and could hardly use it. She stated she could bare get up and down from sitting and had difficulty walking. It was advised that she doesn't take the vaccine again.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Nausea, Parosmia
Clinical narrative: 24 hours post vax the pt noticed a ver foul odor much like rotten eggs. Nothing would eradicate this nauseating odor 24 hours a day. After 24 more hours the pt experienced a severe headache and general muscle aches. These symptoms lasted about 2 weeks. The pt had a reoccurrence of the foul odor occasionally for 1 month following the vax.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Feeling hot, Pruritus, Urticaria
Clinical narrative: One day post vax, the pt started itching which lasted most of the day. It itched like dry skin, the pt used lotion. The next day, the pt woke up with itching with hives on the buttocks, sides and back, abdomen and top of legs and waist line. Ears were hot and swollen. Took Benadryl. Hives lightened. Was taken to the ER.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Rash maculo-papular
Clinical narrative: The pt experienced a blotchy raised rash on chest only, with itchiness. It was irritated by clothing. No respiratory symptoms. The rash faded but did not disappear. It reoccurred on 11/26/00. The pt took Benadryl for some relief. On 12/11 the rash faded.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Neck pain, Pain, Vaccine positive rechallenge
Clinical narrative: The pt complained of pain in his neck approximately 20 minutes post vax as he was getting into his car. 24 hours later he still experienced pain associated with movement of his head. Has had similar pain in the past, but not this bad.
Age: 4.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Gaze palsy
Clinical narrative: The pt experienced 8-10 episodes of blinking eyes and upward eyebrow movements without loss of consciousness without staring and without loss of continence.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance, Hypersensitivity, Nausea, Skin burning sensation
Clinical narrative: 5 minutes following vax while driving, the pt felt a hot burning sensation go up her arm ant hen throughout her whole body. The pt complained of a loss of peripheral vision. When getting out of her car she became dizzy and nauseated and began stumbling. The pt went to the ER by ambulance. The pt was diagnosed with an adverse flu shot reaction. No further problems as of this date.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Visual field defect
Clinical narrative: 5 minutes following vax while driving, the pt felt a hot burning sensation go up her arm ant hen throughout her whole body. The pt complained of a loss of peripheral vision. When getting out of her car she became dizzy and nauseated and began stumbling. The pt went to the ER by ambulance. The pt was diagnosed with an adverse flu shot reaction. No further problems as of this date.
Age: 17.0
Sex: M
Vaccine: TD
Symptoms: Neck pain
Clinical narrative: The pt complained of neck pain one day post vax. The pt went to the ER. MD wasn't sure if reaction was related to the vaccine. No redness at the site of injection was noted.
Age: 6.0
Sex: F
Vaccine: DTAP, OPV
Symptoms: Blister, Pruritus, Rash papular
Clinical narrative: The pt experienced scattered vesicles and papules on chest, arms and forehead. Itching that lasted for 2 days.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Skin nodule
Clinical narrative: On 1/9/01 the pt experienced a knot in neck. On 1/11/01 a rash was experienced on back and on the abdomen. The pt was afebrile.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying
Clinical narrative: The mom states the baby cried non-stop for 2 hours from 7:00 pm - 9:00 pm on the day of vaccine.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: The pt experienced cellulitis to the right deltoid with redness, induration and warmth to the touch. It was initially treated with ice, ibuprofen and Benadryl. Keflex was prescribed but never given. By 12/31/00 the pt's symptoms had resolved.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Dyspnoea, Pyrexia
Clinical narrative: On 1/7/01 the pt had a fever of 102, trouble breathing, ataxia. Was seen by a doctor at 1/11/01. Fever has resolved. The pt was still slightly ataxic, no stagmus.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Myalgia
Clinical narrative: The pt states that he has an ache in left deltoid muscle area when he stretches arm back (similar to motion of putting on coat). Noted this within 1st week after shot and it has remained since. Believed this is slightly worse. Can lift hay bales without discomfort, but it hurts to sleep on that arm. No heat, redness or swelling.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: The pt experienced itching all over body, mother applied calamine lotion.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: The pt experienced itching all over the body. Mother applied calamine lotion.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Eyelid oedema, Urticaria
Clinical narrative: 1 hour post vax, the pt experienced hives from head to toe, mostly on trunk. The pt also experienced swollen eyelids the next day. The hives lasted 1.5 weeks.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Anaphylactic reaction, Eyelid oedema, Nasal congestion, Urticaria
Clinical narrative: The pt received the vaccines at 9:00 am. at 9:40 the pt experienced an anaphylactic reaction. upper eye lid edema and facial hives, nasal congestion. Treated with epinephrine and chlortrimeton.
Age: 10.0
Sex: M
Vaccine: MMR, TD
Symptoms: Contusion, Cyanosis, Face oedema
Clinical narrative: Approximately 6 months post vax, the pt's lips became swollen and his chin turned cyanotic. The pt was taken to the ER and given Benadryl and held for observation. Swelling reduced the following day, but the chin appeared bruised. MD thought it was a reaction to one of the vaccines.
Age: 1.2
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: The child received the vax on 10/2/00. Returned to the clinic on 11/27/00. Mother said 1 week after the vaccine the child had a rash and fever of 103.9 axillary. Mother notified the physician. The child was treated with Tylenol and the fever began to come down.
Age: 12.0
Sex: F
Vaccine: HEP, IPV, HEP, IPV
Symptoms: Pain, Paraesthesia
Clinical narrative: The pt was seen in the ER on 11/7/00 at 11:32am, complaining of left arm pain, tingling and numbness. Treated with Advil/Motrin.
Age: 12.0
Sex: F
Vaccine: HEP, IPV, HEP, IPV
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: The pt was seen in the ER on 11/7/00 at 11:32am, complaining of left arm pain, tingling and numbness. Treated with Advil/Motrin.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: The pt experienced a fever of 102, and was given Tylenol. Fever decreased to 101 and then increased back to 104.
Age: 0.44
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site mass, Irritability, Pyrexia, Rash
Clinical narrative: A mother reported that the child has a rash on abdomen, arms and legs, was fussy. The pt had a temp of 99.6, raised lump at left leg injection site. The pt is eating ok. On 1/5/01 the mother reports that the rash has improved and the lump on left thigh is smaller and the pt is less fussy.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site induration
Clinical narrative: The pt experienced a 6 x 4 inch induration, no discharge. (Enlarged leg syndrome.)
Age: 52.0
Sex: M
Vaccine: TD
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Type III immune complex mediated reaction
Clinical narrative: Within 24 hours the pt developed a 10 cm area of erythema, edema and tenderness at the injection site. Mild Arthus-type hypersensitivity was diagnosed. 8 weeks later developed a mild reoccurrence and shooting pains at the site. Resolved with symptomatic therapy.
Age: 20.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dysphagia, Dyspnoea, Hypoaesthesia, Pharyngeal oedema, Tongue oedema
Clinical narrative: About 12 hours post vax, the pt complained of tongue and throat swelling and states it felt like it was all numb. She states she could hardly breath or swallow. She took an Atarax pill and it helped but her tongue and mouth are still numb.
Age: 12.0
Sex: M
Vaccine: MMR, TD
Symptoms: Face oedema
Clinical narrative: The pt experienced swelling of the face 1 day post vax. Returned to the clinic and was placed on Prednisone, but swelling increased. Presented to the ER 2 days post vax and treated with Benadryl.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Erythema, Irritability, Swelling face, Vomiting
Clinical narrative: Within one hour post vax, the pt developed redness around her eyes and nose. The next day she developed redness on her cheeks and extremities, and she vomited. Two days post vax, the pt awoke with her face puffy and her eyes almost shut and her extremities bright red. She was also very irritable. The pt was seen in the ER. She recovered. A copy of this report has been forwarded to SKB, manufacturer of Engerix B.
Age: 0.25
Sex: M
Vaccine: IPV, PNC
Symptoms: Agitation
Clinical narrative: A 3 month old male received an injection of Prevnar and IPV on 9/14/00 and 3 hours later, experienced inconsolable crying. He was seen by a physician and his crying abated approx. within 3 hours. The pt recovered.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, OPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain, Irritability
Clinical narrative: A few hours post vax, the pt became very irritable and difficult to settle. He also developed an injection site reaction characterized by swollen, red, tender and warm lower extremities.  The pt was treated with Advil and recovered. The administration sites of concomitant vaccines were not specified. A copy of this report was forwarded to Merck, manufacturer of Comvax. The lot number for Acel-Imune was reported as 9970A2; however, this is not a valid Lederle lot number.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, OPV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: A few hours post vax, the pt became very irritable and difficult to settle. He also developed an injection site reaction characterized by swollen, red, tender and warm lower extremities.  The pt was treated with Advil and recovered. The administration sites of concomitant vaccines were not specified. A copy of this report was forwarded to Merck, manufacturer of Comvax. The lot number for Acel-Imune was reported as 9970A2; however, this is not a valid Lederle lot number.
Age: 1.0
Sex: M
Vaccine: HEP, PNC, VARCEL, HEP, PNC, VARCEL
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Within hours of the vax, the child developed a fever of 104 +. That evening, he was seen in an ER where a complete blood count was done. His white blood cell count was found to 16,000. Blood and urine culture results were negative. He was treated with Rocephin. The next day, the child was seen by the physician who also treated him. Another blood count was done and the WBC remained at 16,000. The mother treated the child with Motrin. This is in follow-up to  report(s) previously submitted on 05/15/2001.This report was received from Wyeth-Ayerst Research for streptococcus pneumoniae vaccine (Prevnar) and was assigned manufacturer report number HQ161629SEP2000. This was originally reported by a registered nurse. The pt has no pre-existing allergies, birth defects, medical conditions or adverse events with prior vaccination. information has been received from a registered nurse concerning a 12-mth old Caucasian male with no past medical history who on 10-AUG-2000 was vaccinated with the first dose of varicella virus vaccine live (lot # 634502/0538K)subcutaneously in the right thigh. Concomitant therapy included the first dose of streptococcus pneumoniae vaccine (Prevnar) (lot number 471651) intramuscularly in his left thigh and third dose of hepatitis B vaccine recombinant (Engerix-B) (lot number 3084A2) intramuscularly in the right thigh. There was no other concomitant medications.The child had no illness at the time of the vaccination. On 10-Aug.2000, at 1400 (previously reported as 2100) hours, the child developed a fever of 102.3 F at night and at 2200 hours the temp. increased to 104+ degrees F. Upon internal review fever of 104 plus degrees F was determined to be Other Medical Event. At 2200 hours, that evening, the pt was seen in the ER and was given ceftriaxone (Rocephin) 500mg intravenous. On 11-Aug-2000, at 0025 hours, laboratory evaluation revealed white blood cell count (WBC) of 16,600/cumm. At 0030 hours, a blood culture was drawn which revealed no growth to date (as of 1045 on 12-Aug-2000). Microscopic urinalysis revealed 5-10 WBC/high powered field (HPF) and urobilinogen 0.2. A urine culture was obtained and the results was negative. On 11-Aug-2000, the child was again seen by the physician. his temp was 100.7 degrees F. A repeat blood count was performed that revealed the WBC's remained elevated at 16,000 u/l. the pt was again treated with ceftrianxone 500mg and placed on drug therapy with amoxicillin (Augmentin) two times daily. The mother treated the child with ibuprofen (Motrin). On 11-Aug-2000, the pt recovered from fever. no further information is expected.
Age: 1.0
Sex: M
Vaccine: HEP, PNC, VARCEL, HEP, PNC, VARCEL
Symptoms: Infection, Pyrexia, White blood cell count increased
Clinical narrative: Within hours of the vax, the child developed a fever of 104 +. That evening, he was seen in an ER where a complete blood count was done. His white blood cell count was found to 16,000. Blood and urine culture results were negative. He was treated with Rocephin. The next day, the child was seen by the physician who also treated him. Another blood count was done and the WBC remained at 16,000. The mother treated the child with Motrin. This is in follow-up to  report(s) previously submitted on 05/15/2001.This report was received from Wyeth-Ayerst Research for streptococcus pneumoniae vaccine (Prevnar) and was assigned manufacturer report number HQ161629SEP2000. This was originally reported by a registered nurse. The pt has no pre-existing allergies, birth defects, medical conditions or adverse events with prior vaccination. information has been received from a registered nurse concerning a 12-mth old Caucasian male with no past medical history who on 10-AUG-2000 was vaccinated with the first dose of varicella virus vaccine live (lot # 634502/0538K)subcutaneously in the right thigh. Concomitant therapy included the first dose of streptococcus pneumoniae vaccine (Prevnar) (lot number 471651) intramuscularly in his left thigh and third dose of hepatitis B vaccine recombinant (Engerix-B) (lot number 3084A2) intramuscularly in the right thigh. There was no other concomitant medications.The child had no illness at the time of the vaccination. On 10-Aug.2000, at 1400 (previously reported as 2100) hours, the child developed a fever of 102.3 F at night and at 2200 hours the temp. increased to 104+ degrees F. Upon internal review fever of 104 plus degrees F was determined to be Other Medical Event. At 2200 hours, that evening, the pt was seen in the ER and was given ceftriaxone (Rocephin) 500mg intravenous. On 11-Aug-2000, at 0025 hours, laboratory evaluation revealed white blood cell count (WBC) of 16,600/cumm. At 0030 hours, a blood culture was drawn which revealed no growth to date (as of 1045 on 12-Aug-2000). Microscopic urinalysis revealed 5-10 WBC/high powered field (HPF) and urobilinogen 0.2. A urine culture was obtained and the results was negative. On 11-Aug-2000, the child was again seen by the physician. his temp was 100.7 degrees F. A repeat blood count was performed that revealed the WBC's remained elevated at 16,000 u/l. the pt was again treated with ceftrianxone 500mg and placed on drug therapy with amoxicillin (Augmentin) two times daily. The mother treated the child with ibuprofen (Motrin). On 11-Aug-2000, the pt recovered from fever. no further information is expected.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Injection site erythema
Clinical narrative: A nurse practitioner reported that the patient received Prevnar, Infanrix (SKB), IPV (Aventis Pasteur SA), and Comvax (Merck) on 10/24/00. Immediately post vaccination, she developed "uncontrollable" crying for 6 hours. She also developed erythema at an unspecified injection site which resolved. Follow up information received 12/28/2000 indicated the patient developed the erythema on her left anterior thigh.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Screaming
Clinical narrative: A nurse practitioner reported that the patient received Prevnar, Infanrix (SKB), IPV (Aventis Pasteur SA), and Comvax (Merck) on 10/24/00. Immediately post vaccination, she developed "uncontrollable" crying for 6 hours. She also developed erythema at an unspecified injection site which resolved. Follow up information received 12/28/2000 indicated the patient developed the erythema on her left anterior thigh.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Torticollis
Clinical narrative: A nurse reported that a 2 month old female received Prevnar, Tripedia, Hib and IPV vaccines on 9/28/00. That evening, the infant developed "torticollis". She was treated with Advil. The infant recovered. This is 1 of 2 pts from this facility who experienced this event following receipt of 2 different lots of Prevnar.
Age: 0.7
Sex: F
Vaccine: HEP, PNC
Symptoms: Torticollis
Clinical narrative: A nurse reported that an 8 month old female received Prevnar and Engerix B vaccines on 9/27/00 and within 24 hours, the infant developed torticollis. She was seen by a physician and treated with Advil. A neck x-ray was normal. The infant recovered. This is 1 of 2 pts from this facility who experienced this event following receipt of 2 different lots of Prevnar.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Laboratory test abnormal, Lymphadenopathy
Clinical narrative: A company representative reported that a 14 month old female received Prevnar, MMR II and Varivax vaccines and subsequently, developed swollen lymph nodes. Unspecified lab tests were reportedly abnormal, which led the physician to consider a dx of leukemia. The reporter stated that as of 10/18/00, leukemia may have been ruled out. Additional information received from the physician on 11/14/00, indicated that a 12 month old female received Prevnar, MMR II and Varivax vaccines, as well as, PPD on 8/28/00. The child recovered.
Age: 1.25
Sex: F
Vaccine: IPV, PNC, IPV, PNC
Symptoms: Convulsion, Tremor
Clinical narrative: On 10/30/00, the child experienced a "seizure type episode". Approximately four hours later she had "unexplained tremors" while in the ER. Convulsion is considered "medically important".
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Coma, Convulsion, Drug ineffective, Dysarthria, Electroencephalogram abnormal
Clinical narrative: In 4/90, 11 days post vax, the pt experienced recurrent focal seizures. At the time his HIV infection was diagnosed in 10/85, blood analysis consistently revealed leukopenia, mild thrombocytopenia and hemoglobin concentrations of 11.2 to 13.6, lymphocyte counts were around 200-300, CD4 to CD8 ratios of 0.2-0.47. In 10/89, therapy with zidovudine was initiated. The pt had no symptoms related to HIV infection or zidovudine therapy. Although he had received the measles vaccine in 1973 at the age of 3 and a dose of MMR in 1976 at the age of 7, the pt was admitted to the hospital for three days in 2/90 with uncomplicated measles. Tachypnea and respiratory distress responded promptly to therapy with oxygen and aerosolized ribavirin. The pt responded well until two months later, when he presented after two days of recurrent right arm twitches without fever. Physical exam revealed only continuous fine twitches of th right arm. CSF analysis and computed tomography of the head gave normal results, electroencephalography, however, showed right frontal slowing with spike discharges centrally, persisted despite therapeutic anticonvulsant concentrations in serum. the pt was admitted 11 days after the onset of seizures for further diagnostic evaluation. At the time of admission, he was conscious and afebrile. He had right-arm and right-leg twitching but was able to walk. His mental status and the results of motor and sensory examination were normal. Although the latter condition responded to the fluid restriction, the pt developed slurred speech and gradually became unresponsive requiring endotracheal intubation. A 10 day course of IV therapy was given. The pt remained comatose, experiencing continuous focal seizures that could not be controlled with anticonvulsant agents. Neurological and electroencepahlographic exam on day 24 of hospitalization indicated brain death. Mechanical ventilation was discontinued on day 30. The cause of death was subacute measles encephalitis.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Encephalitis, HIV infection, Haemoglobin decreased, Leukopenia, Lymphopenia
Clinical narrative: In 4/90, 11 days post vax, the pt experienced recurrent focal seizures. At the time his HIV infection was diagnosed in 10/85, blood analysis consistently revealed leukopenia, mild thrombocytopenia and hemoglobin concentrations of 11.2 to 13.6, lymphocyte counts were around 200-300, CD4 to CD8 ratios of 0.2-0.47. In 10/89, therapy with zidovudine was initiated. The pt had no symptoms related to HIV infection or zidovudine therapy. Although he had received the measles vaccine in 1973 at the age of 3 and a dose of MMR in 1976 at the age of 7, the pt was admitted to the hospital for three days in 2/90 with uncomplicated measles. Tachypnea and respiratory distress responded promptly to therapy with oxygen and aerosolized ribavirin. The pt responded well until two months later, when he presented after two days of recurrent right arm twitches without fever. Physical exam revealed only continuous fine twitches of th right arm. CSF analysis and computed tomography of the head gave normal results, electroencephalography, however, showed right frontal slowing with spike discharges centrally, persisted despite therapeutic anticonvulsant concentrations in serum. the pt was admitted 11 days after the onset of seizures for further diagnostic evaluation. At the time of admission, he was conscious and afebrile. He had right-arm and right-leg twitching but was able to walk. His mental status and the results of motor and sensory examination were normal. Although the latter condition responded to the fluid restriction, the pt developed slurred speech and gradually became unresponsive requiring endotracheal intubation. A 10 day course of IV therapy was given. The pt remained comatose, experiencing continuous focal seizures that could not be controlled with anticonvulsant agents. Neurological and electroencepahlographic exam on day 24 of hospitalization indicated brain death. Mechanical ventilation was discontinued on day 30. The cause of death was subacute measles encephalitis.