chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Local reaction at left deltoid, 9cm X 9.5cm erythema, induration and pruritus.
Age: 17.0
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Convulsion, Meningitis, Viral infection
Clinical narrative: 12/00; mononucleosis. 1/01; viral meningitis with non-epileptic seizures (lost 1 month of school). Seizures tapering to 1 occasionally and very mild. 6/1; After immunizations, seizures are back as in 1/01. Not recovered as of 6/14/01.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Irritability, Pyrexia
Clinical narrative: Irritability; increased temperature (37.4C-37.5C Ax); desats. Tylenol given, post vax, and X 2 in the AM to treat. Fever 102F decreased back to 50%.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Joint range of motion decreased, Pyrexia
Clinical narrative: Febrile with temperature of 101.1F, localized erythema, edema at injection site, pain and decreased ROM on left arm.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Chills, Injection site pain, Injection site swelling
Clinical narrative: Site of administration very sore, had chills and arm swollen.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Ear discomfort, Nasal congestion, Pyrexia, Sinus headache
Clinical narrative: Developed fever the night the shot was received. Pt reports temperature of 102F-103F. Took ASA to reduce fever (2 tablets) X 1. When pt awoke the next AM, he had head congestion, stuffy nose, sinus pressure and right ear "completely plugged". Pt complained of continued head congestion to this day.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Chickenpox marks on belly, shoulders, arms and itchy. Afebrile.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Back pain, Headache, Injection site pain, Lymphadenopathy, Neck pain
Clinical narrative: 6/12/01 complained of injection site being sore immediately, post vax. The following AM, 6/13/01, temperature was 101F and complained of a headache, neck and back pain and swollen glands. Arm site ok, no redness or soreness. 6/14/01, all symptoms gone.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Pyrexia
Clinical narrative: 6/12/01 complained of injection site being sore immediately, post vax. The following AM, 6/13/01, temperature was 101F and complained of a headache, neck and back pain and swollen glands. Arm site ok, no redness or soreness. 6/14/01, all symptoms gone.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cyanosis, Loss of consciousness, Pallor
Clinical narrative: The pt received 2 injections. Immediately after receiving the 2nd injection (IPV), the pt passed out for about 30 seconds and then regained consciousness. He was pale and slightly blue around the mouth. He was examined at that point, by a physician, who dx'd a vasovagal response. The pt left the clinic much improved and in good spirits.
Age: 3.0
Sex: M
Vaccine: OPV, VARCEL
Symptoms: Rash
Clinical narrative: Came to office on 6/10/01, with having "spots" on chest X 5 days. Spread to foot and back. No fever.
Age: 1.08
Sex: F
Vaccine: IPV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever X 1 day, few red dots, blanch with pressure.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Fatigue, Headache, Tongue oedema
Clinical narrative: Chest pain, general body fatigue, fever, swelling of tongue (airway remained open) and severe headache. Awaiting follow-up in 3-5 days. ASA-steroid burst.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Irritability, Urticaria, Vomiting
Clinical narrative: Developed urticarial rash, generalized, within several hours, post vax. Other symptoms were irritability and 1 episode of emesis. Treatment: Benadryl syrup.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Pyrexia, Rash erythematous, Sleep disorder
Clinical narrative: Child was awake during night of shots and had temperature (according to mother, but did not take temperature to see how high and may also be teething). Mom gave child Tylenol during the night. Now has a red raised rash on all of body except legs. Exposed to 5th disease, 2 weeks ago. Told mom to call doctor now. No respiratory problems. On 6/6/01, mom called next day and said she called the doctor and he said to give baby Benadryl and mom did this and rash cleared up a lot by the next day. No temperature and was to take baby to doctor if it didn't clear up.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Abscess, Injection site haemorrhage, Injection site mass, Skin discolouration
Clinical narrative: The pt experienced bruising on the right thigh where shots were and then progressed to multiple abscesses. No tenderness or redness. On 4/6/01, the pt was seen by a physician for multiple abscesses at the site of injection. On his anterior right thigh he has four lesions all of which are fluctuant with brawny type edema over the skin. They are variable in size from just over one cm to about three cm in size. Diagnosis was sterile abscesses and they were incised and drained. The follow-up states that,"drainage of multiple abscesses wounds are all healing well without any evidence of infection. He does have swelling in his left thigh consistent with formation of another abscess. This was aspirated in the office today and I suspect this will be resolution of it and he will be back on a PRN basis."
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Abscess, Contusion, Injection site abscess, Injection site oedema
Clinical narrative: The pt experienced bruising on the right thigh where shots were and then progressed to multiple abscesses. No tenderness or redness. On 4/6/01, the pt was seen by a physician for multiple abscesses at the site of injection. On his anterior right thigh he has four lesions all of which are fluctuant with brawny type edema over the skin. They are variable in size from just over one cm to about three cm in size. Diagnosis was sterile abscesses and they were incised and drained. The follow-up states that,"drainage of multiple abscesses wounds are all healing well without any evidence of infection. He does have swelling in his left thigh consistent with formation of another abscess. This was aspirated in the office today and I suspect this will be resolution of it and he will be back on a PRN basis."
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Convulsion
Clinical narrative: Patient experienced a generalized seizure lasting 10 minutes.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning an approximately 30 year old who was possibly exposed to her 15 year old vaccinated niece who developed chickenpox and was scabbed all over on 5/4/98. It was reported that the 15 year old was vaccinated on 4/15/98. Subsequently in 1998 possible secondary transmission was reported ant the pt died presumably from chickenpox. The physician was not aware if the pt had been in contact with her niece or had any exposure to chickenpox. Additional information has been requested. Follow-up from the physician reported that the pt was taking steroids for an unknown cause. It was reported that her child developed natural chickenpox, that the pt was exposed to her child and subsequently died. The physician did not know the cause of death but she "felt that it was from natural chickenpox and she did not think that this was a complication from the vaccine." The physician did not have any further details because they were not her pts. It was reproted that the pt's niece had no history of chickenpox and was vaccinated with the first dose of varicella vaccine live after exposure to her cousin, the pt's child, who had natural chickenpox. No further info is expected.
Age: 50.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Abdominal discomfort, Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia
Clinical narrative: The pt experienced dizziness, and hard time focusing. This will last for 2-5 minutes 2-3 times a day and 2 days a week. Blacked out yesterday while driving and 2 weeks ago noticed a lump on left side. Had upset stomach X 2 weeks. Something gave him a rash. He states he felt well yesterday morning. At about 08:00, he took his daughter to school and while driving back, his vision went away and lasted about 30 seconds; couldn't see anything. His body felt fine and slowly over 15-20 minutes, his vision came back. He went to work but felt a little dazed the rest of the day. Today, he has epigastric pain. Dx'd as symptoms most likely due to migraine, new onset and epigastric pain due to PUD or gastritis. Also, planar fasciitis discussed and info given and arch supports. Follow-up visit on 11/9/99, has some nasal congestion. I think his episode last week was vertigo and his episode last month was a migraine. On 12/22/99, here for 5 days of congestion, body aches all over and weakness. Also, has a non-productive cough with wheezing and SOB. He has a feverish feeling, sinus congestion and some diarrhea. On exam, he has right basilar crackles. Dx'd with bronchitis and URI and rx'd Erythromycin 250mg qid; Azmacort 4 puffs 1id 1X2. Seen on 6/19/00 and dx'd with HTN; fatigue; lack of sleep; cough; sore throat X 10 days and treated with Atenolol 50mg po. Continue with Thera-flu and fluids. Seen on 5/31/01 with dizziness and headaches; brief blurred vision X 2 years and neck pain. Discussed with pt headache due to tension and stress. On 7/24/01, has slight tender lump on left thorax X months, nodes on left upper extremity and back that he wants excised. Unclear if he wants left thorax lump off. He is concerned if it may be cancer. Dx'd with limpoma and moles. Dermatology referral for mole excision. Seem 8/27/01 with feeling tense, headache and anxiety attach 2 X and went to ER on 8/3/01. Treated with cyclobenzaprine; diazepam 5mg. Added Hytrin 2mg 1 po qhs 60, Serax 10mg 1 po bid.  Follow up 07/02/2001: "Dizziness and visual disturbances persist.  New onset headaches "behind head" over past 6-7 months...therefore patient has not recovered from adverse event.  Patient however, is on full duty status."
Age: 50.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Bronchitis, Cough, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: The pt experienced dizziness, and hard time focusing. This will last for 2-5 minutes 2-3 times a day and 2 days a week. Blacked out yesterday while driving and 2 weeks ago noticed a lump on left side. Had upset stomach X 2 weeks. Something gave him a rash. He states he felt well yesterday morning. At about 08:00, he took his daughter to school and while driving back, his vision went away and lasted about 30 seconds; couldn't see anything. His body felt fine and slowly over 15-20 minutes, his vision came back. He went to work but felt a little dazed the rest of the day. Today, he has epigastric pain. Dx'd as symptoms most likely due to migraine, new onset and epigastric pain due to PUD or gastritis. Also, planar fasciitis discussed and info given and arch supports. Follow-up visit on 11/9/99, has some nasal congestion. I think his episode last week was vertigo and his episode last month was a migraine. On 12/22/99, here for 5 days of congestion, body aches all over and weakness. Also, has a non-productive cough with wheezing and SOB. He has a feverish feeling, sinus congestion and some diarrhea. On exam, he has right basilar crackles. Dx'd with bronchitis and URI and rx'd Erythromycin 250mg qid; Azmacort 4 puffs 1id 1X2. Seen on 6/19/00 and dx'd with HTN; fatigue; lack of sleep; cough; sore throat X 10 days and treated with Atenolol 50mg po. Continue with Thera-flu and fluids. Seen on 5/31/01 with dizziness and headaches; brief blurred vision X 2 years and neck pain. Discussed with pt headache due to tension and stress. On 7/24/01, has slight tender lump on left thorax X months, nodes on left upper extremity and back that he wants excised. Unclear if he wants left thorax lump off. He is concerned if it may be cancer. Dx'd with limpoma and moles. Dermatology referral for mole excision. Seem 8/27/01 with feeling tense, headache and anxiety attach 2 X and went to ER on 8/3/01. Treated with cyclobenzaprine; diazepam 5mg. Added Hytrin 2mg 1 po qhs 60, Serax 10mg 1 po bid.  Follow up 07/02/2001: "Dizziness and visual disturbances persist.  New onset headaches "behind head" over past 6-7 months...therefore patient has not recovered from adverse event.  Patient however, is on full duty status."
Age: 50.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Fasciitis, Flushing, Gastrointestinal disorder, Hypercholesterolaemia, Hypertension
Clinical narrative: The pt experienced dizziness, and hard time focusing. This will last for 2-5 minutes 2-3 times a day and 2 days a week. Blacked out yesterday while driving and 2 weeks ago noticed a lump on left side. Had upset stomach X 2 weeks. Something gave him a rash. He states he felt well yesterday morning. At about 08:00, he took his daughter to school and while driving back, his vision went away and lasted about 30 seconds; couldn't see anything. His body felt fine and slowly over 15-20 minutes, his vision came back. He went to work but felt a little dazed the rest of the day. Today, he has epigastric pain. Dx'd as symptoms most likely due to migraine, new onset and epigastric pain due to PUD or gastritis. Also, planar fasciitis discussed and info given and arch supports. Follow-up visit on 11/9/99, has some nasal congestion. I think his episode last week was vertigo and his episode last month was a migraine. On 12/22/99, here for 5 days of congestion, body aches all over and weakness. Also, has a non-productive cough with wheezing and SOB. He has a feverish feeling, sinus congestion and some diarrhea. On exam, he has right basilar crackles. Dx'd with bronchitis and URI and rx'd Erythromycin 250mg qid; Azmacort 4 puffs 1id 1X2. Seen on 6/19/00 and dx'd with HTN; fatigue; lack of sleep; cough; sore throat X 10 days and treated with Atenolol 50mg po. Continue with Thera-flu and fluids. Seen on 5/31/01 with dizziness and headaches; brief blurred vision X 2 years and neck pain. Discussed with pt headache due to tension and stress. On 7/24/01, has slight tender lump on left thorax X months, nodes on left upper extremity and back that he wants excised. Unclear if he wants left thorax lump off. He is concerned if it may be cancer. Dx'd with limpoma and moles. Dermatology referral for mole excision. Seem 8/27/01 with feeling tense, headache and anxiety attach 2 X and went to ER on 8/3/01. Treated with cyclobenzaprine; diazepam 5mg. Added Hytrin 2mg 1 po qhs 60, Serax 10mg 1 po bid.  Follow up 07/02/2001: "Dizziness and visual disturbances persist.  New onset headaches "behind head" over past 6-7 months...therefore patient has not recovered from adverse event.  Patient however, is on full duty status."
Age: 50.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Loss of consciousness, Migraine, Nasal congestion, Neurofibromatosis, Pain
Clinical narrative: The pt experienced dizziness, and hard time focusing. This will last for 2-5 minutes 2-3 times a day and 2 days a week. Blacked out yesterday while driving and 2 weeks ago noticed a lump on left side. Had upset stomach X 2 weeks. Something gave him a rash. He states he felt well yesterday morning. At about 08:00, he took his daughter to school and while driving back, his vision went away and lasted about 30 seconds; couldn't see anything. His body felt fine and slowly over 15-20 minutes, his vision came back. He went to work but felt a little dazed the rest of the day. Today, he has epigastric pain. Dx'd as symptoms most likely due to migraine, new onset and epigastric pain due to PUD or gastritis. Also, planar fasciitis discussed and info given and arch supports. Follow-up visit on 11/9/99, has some nasal congestion. I think his episode last week was vertigo and his episode last month was a migraine. On 12/22/99, here for 5 days of congestion, body aches all over and weakness. Also, has a non-productive cough with wheezing and SOB. He has a feverish feeling, sinus congestion and some diarrhea. On exam, he has right basilar crackles. Dx'd with bronchitis and URI and rx'd Erythromycin 250mg qid; Azmacort 4 puffs 1id 1X2. Seen on 6/19/00 and dx'd with HTN; fatigue; lack of sleep; cough; sore throat X 10 days and treated with Atenolol 50mg po. Continue with Thera-flu and fluids. Seen on 5/31/01 with dizziness and headaches; brief blurred vision X 2 years and neck pain. Discussed with pt headache due to tension and stress. On 7/24/01, has slight tender lump on left thorax X months, nodes on left upper extremity and back that he wants excised. Unclear if he wants left thorax lump off. He is concerned if it may be cancer. Dx'd with limpoma and moles. Dermatology referral for mole excision. Seem 8/27/01 with feeling tense, headache and anxiety attach 2 X and went to ER on 8/3/01. Treated with cyclobenzaprine; diazepam 5mg. Added Hytrin 2mg 1 po qhs 60, Serax 10mg 1 po bid.  Follow up 07/02/2001: "Dizziness and visual disturbances persist.  New onset headaches "behind head" over past 6-7 months...therefore patient has not recovered from adverse event.  Patient however, is on full duty status."
Age: 50.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Rales, Upper respiratory tract infection, Vertigo, Visual disturbance, Wheezing
Clinical narrative: The pt experienced dizziness, and hard time focusing. This will last for 2-5 minutes 2-3 times a day and 2 days a week. Blacked out yesterday while driving and 2 weeks ago noticed a lump on left side. Had upset stomach X 2 weeks. Something gave him a rash. He states he felt well yesterday morning. At about 08:00, he took his daughter to school and while driving back, his vision went away and lasted about 30 seconds; couldn't see anything. His body felt fine and slowly over 15-20 minutes, his vision came back. He went to work but felt a little dazed the rest of the day. Today, he has epigastric pain. Dx'd as symptoms most likely due to migraine, new onset and epigastric pain due to PUD or gastritis. Also, planar fasciitis discussed and info given and arch supports. Follow-up visit on 11/9/99, has some nasal congestion. I think his episode last week was vertigo and his episode last month was a migraine. On 12/22/99, here for 5 days of congestion, body aches all over and weakness. Also, has a non-productive cough with wheezing and SOB. He has a feverish feeling, sinus congestion and some diarrhea. On exam, he has right basilar crackles. Dx'd with bronchitis and URI and rx'd Erythromycin 250mg qid; Azmacort 4 puffs 1id 1X2. Seen on 6/19/00 and dx'd with HTN; fatigue; lack of sleep; cough; sore throat X 10 days and treated with Atenolol 50mg po. Continue with Thera-flu and fluids. Seen on 5/31/01 with dizziness and headaches; brief blurred vision X 2 years and neck pain. Discussed with pt headache due to tension and stress. On 7/24/01, has slight tender lump on left thorax X months, nodes on left upper extremity and back that he wants excised. Unclear if he wants left thorax lump off. He is concerned if it may be cancer. Dx'd with limpoma and moles. Dermatology referral for mole excision. Seem 8/27/01 with feeling tense, headache and anxiety attach 2 X and went to ER on 8/3/01. Treated with cyclobenzaprine; diazepam 5mg. Added Hytrin 2mg 1 po qhs 60, Serax 10mg 1 po bid.  Follow up 07/02/2001: "Dizziness and visual disturbances persist.  New onset headaches "behind head" over past 6-7 months...therefore patient has not recovered from adverse event.  Patient however, is on full duty status."
Age: 0.3
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Abdominal pain, Agitation, Crying, Intussusception, Lethargy
Clinical narrative: Approximately 1-2 hours post vax, the pt cried in great pain for about 1 hour. Then the pt slept through the next morning. He was very lethargic that increased during the day. The pt vomited once, experienced abdominal cramping and pain. The pt was diagnosed with intussusception.
Age: 0.3
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Somnolence, Vomiting
Clinical narrative: Approximately 1-2 hours post vax, the pt cried in great pain for about 1 hour. Then the pt slept through the next morning. He was very lethargic that increased during the day. The pt vomited once, experienced abdominal cramping and pain. The pt was diagnosed with intussusception.
Age: 41.0
Sex: F
Vaccine: HEPA, MEN, TTOX, TYP, YF
Symptoms: Hypertension, Lymphadenopathy, Pyrexia
Clinical narrative: On 6/1/01 the pt experienced severely swollen lymph nodes and a temp of 104 for 5 days. On 6/13/01 blood pressure was 190/100 and remains very high. Blood pressure was normal on the day of vaccines.
Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Contusion, Injection site abscess, Injection site haemorrhage, Injection site mass, Injection site pain
Clinical narrative: Patient developed a local reaction on 4/16. On 4/23 the patient had a hard lump and bruising at injection site. On 4/26 patient was noted to have a pea-size left inguinal node and a 1 cm slightly tender mass on left thigh which was a hematoma or possible early abscess.
Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Injection site reaction, Lymphadenopathy
Clinical narrative: Patient developed a local reaction on 4/16. On 4/23 the patient had a hard lump and bruising at injection site. On 4/26 patient was noted to have a pea-size left inguinal node and a 1 cm slightly tender mass on left thigh which was a hematoma or possible early abscess.
Age: 5.5
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling 3 1/4" X 4" anterio-lateral left thigh.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: 23 days, post vax, pt had macro-papular rash, a few vesicles and < 30 lesions. No fever. Mild itching. No signs or symptoms of secondary infection.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Blister, Infection, Rash erythematous, Skin disorder
Clinical narrative: Patient developed rash 2-3 days after receiving vaccines. Rash was initially 2-3 raised, red spots which appeared on the legs but had spread to chest, extremities and neck by 6/8/01. Father reported on 6/12/01 that rash was beginning to look like blisters and some were rupturing and scabbing over. On examination of 6/13/01, patient was diagnosed with rule out varicella and impetigo. The left lower leg, chest and arms showed red papules. The patient received varicella vaccine on 2/15/01 and had no known exposure to chicken pox.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Blister, Rash erythematous, Skin ulcer
Clinical narrative: Patient developed rash 2-3 days after receiving vaccines. Rash was initially 2-3 raised, red spots which appeared on the legs but had spread to chest, extremities and neck by 6/8/01. Father reported on 6/12/01 that rash was beginning to look like blisters and some were rupturing and scabbing over. On examination of 6/13/01, patient was diagnosed with rule out varicella and impetigo. The left lower leg, chest and arms showed red papules. The patient received varicella vaccine on 2/15/01 and had no known exposure to chicken pox.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Cough, Infection, Pyrexia, Rash morbilliform, Rhinitis
Clinical narrative: Patient developed mild case of measles with distinct morbilliform rash, cough, coryza and high fever
Sex: U
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Six months after receiving vaccines, the patient reported arthralgia. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient developed a 3.5" x 4" red, warm, firm and tender area over lower left deltoid. The patient was prescribed antibiotics for 7 days.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient developed a 5 x 3 cm area of redness, warmth and tenderness.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient developed a 30 x 35 cm area of redness and warmth on left upper arm at site of injection.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Patient developed chicken pox more than two years post vaccination.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed a 3-4" red, swollen rash on right thigh that was warm to the touch.
Age: 83.0
Sex: M
Vaccine: TD
Symptoms: Ecchymosis
Clinical narrative: Patient developed broken blood vessels and ecchymosis in right arm.
Age: 1.7
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed a 3 x 7 cm area of erythema and swelling on left deltoid.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Irritability
Clinical narrative: Patient developed a 6 x 6 cm area of redness and warmth to the touch. The patient became fussy but not inconsolable.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: Two days post vaccine, the patient developed approximately 10-12 raised, papular, erythematous lesions on back and thighs.
Age: 2.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed a 6 x 6 cm localized area of redness and swelling.
Age: 30.0
Sex: M
Vaccine: MMR, TD
Symptoms: Erythema, Hypoaesthesia, Pain
Clinical narrative: Patient developed redness and soreness that occurred 1 day after vaccination. This resolved in 2 days. Patient developed numbness in fingers. Three and a half weeks post vaccine, the patient awoke with excruciating pain in right shoulder that did not respond to muscle relaxants or ibuprofen.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Patient developed chicken pox.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Pyrexia, Tremor
Clinical narrative: Sixteen hours after vaccine, patient developed shakiness, backache and fever. Before Tylenol she was burning up, and after Tylenol her temperature was 100. She was asymptomatic after 30-35 hours.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed a 4 x 2" localized reaction on right leg characterized by redness and swelling.
Age: 4.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed an 11.5 x 12 cm baseball sized red raised area.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Patient developed a 7.5 cm diameter round rash that was warm to the touch.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient developed a 3 x 6 cm area of redness and warmth.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Oedema peripheral, Skin nodule
Clinical narrative: Patient's right leg became swollen with a lump and a 3 x 6 cm area of erythema.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: On 4/7/02 the pt developed erythema, swelling, and urticarial purplish ecchymotic rash. The pt had two ER visits, was treated with Benadryl and then diagnosed with an allergic reaction. On 4/10/01 the pt was hospitalized to rule out autoimmune thrombocytopenia or Henoch Schonlein purpura on admission he had a fever and diarrhea as well as rash, urticaria and purpura. The pt was treated with Benadryl and Solu-Medrol. The pt was dx with a rash with unknown etiology. The pt was discharged from the hospital and was considered recovered on 4/14/01. It was also noted that the pt did not have any adverse events following prior vaccinations. It has been determined this is a duplicate report. Therefore the duplicate is being deleted from our files and the reports consolidated.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Autoimmune disorder, Diarrhoea, Ecchymosis, Erythema, Henoch-Schonlein purpura
Clinical narrative: On 4/7/02 the pt developed erythema, swelling, and urticarial purplish ecchymotic rash. The pt had two ER visits, was treated with Benadryl and then diagnosed with an allergic reaction. On 4/10/01 the pt was hospitalized to rule out autoimmune thrombocytopenia or Henoch Schonlein purpura on admission he had a fever and diarrhea as well as rash, urticaria and purpura. The pt was treated with Benadryl and Solu-Medrol. The pt was dx with a rash with unknown etiology. The pt was discharged from the hospital and was considered recovered on 4/14/01. It was also noted that the pt did not have any adverse events following prior vaccinations. It has been determined this is a duplicate report. Therefore the duplicate is being deleted from our files and the reports consolidated.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Oedema, Pyrexia, Rash, Thrombocytopenia, Urticaria
Clinical narrative: On 4/7/02 the pt developed erythema, swelling, and urticarial purplish ecchymotic rash. The pt had two ER visits, was treated with Benadryl and then diagnosed with an allergic reaction. On 4/10/01 the pt was hospitalized to rule out autoimmune thrombocytopenia or Henoch Schonlein purpura on admission he had a fever and diarrhea as well as rash, urticaria and purpura. The pt was treated with Benadryl and Solu-Medrol. The pt was dx with a rash with unknown etiology. The pt was discharged from the hospital and was considered recovered on 4/14/01. It was also noted that the pt did not have any adverse events following prior vaccinations. It has been determined this is a duplicate report. Therefore the duplicate is being deleted from our files and the reports consolidated.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Diarrhoea, Ecchymosis, Face oedema, Hypersensitivity, Pyrexia
Clinical narrative: On 4/7/02 the pt developed erythema, swelling, and urticarial purplish ecchymotic rash. The pt had two ER visits, was treated with Benadryl and then diagnosed with an allergic reaction. On 4/10/01 the pt was hospitalized to rule out autoimmune thrombocytopenia or Henoch Schonlein purpura on admission he had a fever and diarrhea as well as rash, urticaria and purpura. The pt was treated with Benadryl and Solu-Medrol. The pt was dx with a rash with unknown etiology. The pt was discharged from the hospital and was considered recovered on 4/14/01. It was also noted that the pt did not have any adverse events following prior vaccinations. It has been determined this is a duplicate report. Therefore the duplicate is being deleted from our files and the reports consolidated.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC, VARCEL, DTAP, PNC, VARCEL, DTAP, PNC, VARCEL
Symptoms: Rash maculo-papular, Urticaria, Viral infection
Clinical narrative: On 4/7/02 the pt developed erythema, swelling, and urticarial purplish ecchymotic rash. The pt had two ER visits, was treated with Benadryl and then diagnosed with an allergic reaction. On 4/10/01 the pt was hospitalized to rule out autoimmune thrombocytopenia or Henoch Schonlein purpura on admission he had a fever and diarrhea as well as rash, urticaria and purpura. The pt was treated with Benadryl and Solu-Medrol. The pt was dx with a rash with unknown etiology. The pt was discharged from the hospital and was considered recovered on 4/14/01. It was also noted that the pt did not have any adverse events following prior vaccinations. It has been determined this is a duplicate report. Therefore the duplicate is being deleted from our files and the reports consolidated.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth, Petechiae
Clinical narrative: Information has been received from a health professional concerning a 4 month old male who on 4/18/01 was vaccinated in the left thigh with haemophilus b conjugate vaccine Hep-B vaccine recombinant (yeast). Concomitant vaccine therapy included a second dose IM in the right thigh of streptococcus pneumoniae vaccine (Prevnar) (lot 474738), a dose in the left thigh of aluminum, potassium + pertussis vaccine + tetanus toxoid (Tripedia) and a dose in the right thigh of diphtheria toxoid (Infanrix-IPV-HIB). On 4/19/01, the pt developed a generalized petechial rash and an injection site reaction described as tenderness, redness, warmth and swelling at the streptococcus pneumoniae vaccine (Prevnar) injection site. It was noted that 2 other injection sites were also red and inflammed. On 4/19/01, the pt was completely covered with purpura and petechia. He was hospitalized on 4/20/01, for 3 days, with thrombocytopenia. The platelet count was not provided. The pt was treated with immune globulin and is "now doing fine". A follow up report received 11/21/2001 adds: Subsequently the pt recovered.  This was originally reported by a nurse practitioner. Additional info has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Platelet count decreased, Purpura, Thrombocytopenia
Clinical narrative: Information has been received from a health professional concerning a 4 month old male who on 4/18/01 was vaccinated in the left thigh with haemophilus b conjugate vaccine Hep-B vaccine recombinant (yeast). Concomitant vaccine therapy included a second dose IM in the right thigh of streptococcus pneumoniae vaccine (Prevnar) (lot 474738), a dose in the left thigh of aluminum, potassium + pertussis vaccine + tetanus toxoid (Tripedia) and a dose in the right thigh of diphtheria toxoid (Infanrix-IPV-HIB). On 4/19/01, the pt developed a generalized petechial rash and an injection site reaction described as tenderness, redness, warmth and swelling at the streptococcus pneumoniae vaccine (Prevnar) injection site. It was noted that 2 other injection sites were also red and inflammed. On 4/19/01, the pt was completely covered with purpura and petechia. He was hospitalized on 4/20/01, for 3 days, with thrombocytopenia. The platelet count was not provided. The pt was treated with immune globulin and is "now doing fine". A follow up report received 11/21/2001 adds: Subsequently the pt recovered.  This was originally reported by a nurse practitioner. Additional info has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 4 month old male who on 4/18/01 was vaccinated in the left thigh with haemophilus b conjugate vaccine Hep-B vaccine recombinant (yeast). Concomitant vaccine therapy included a second dose IM in the right thigh of streptococcus pneumoniae vaccine (Prevnar) (lot 474738), a dose in the left thigh of aluminum, potassium + pertussis vaccine + tetanus toxoid (Tripedia) and a dose in the right thigh of diphtheria toxoid (Infanrix-IPV-HIB). On 4/19/01, the pt developed a generalized petechial rash and an injection site reaction described as tenderness, redness, warmth and swelling at the streptococcus pneumoniae vaccine (Prevnar) injection site. It was noted that 2 other injection sites were also red and inflammed. On 4/19/01, the pt was completely covered with purpura and petechia. He was hospitalized on 4/20/01, for 3 days, with thrombocytopenia. The platelet count was not provided. The pt was treated with immune globulin and is "now doing fine". A follow up report received 11/21/2001 adds: Subsequently the pt recovered.  This was originally reported by a nurse practitioner. Additional info has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Petechiae, Purpura, Thrombocytopenia
Clinical narrative: Information has been received from a health professional concerning a 4 month old male who on 4/18/01 was vaccinated in the left thigh with haemophilus b conjugate vaccine Hep-B vaccine recombinant (yeast). Concomitant vaccine therapy included a second dose IM in the right thigh of streptococcus pneumoniae vaccine (Prevnar) (lot 474738), a dose in the left thigh of aluminum, potassium + pertussis vaccine + tetanus toxoid (Tripedia) and a dose in the right thigh of diphtheria toxoid (Infanrix-IPV-HIB). On 4/19/01, the pt developed a generalized petechial rash and an injection site reaction described as tenderness, redness, warmth and swelling at the streptococcus pneumoniae vaccine (Prevnar) injection site. It was noted that 2 other injection sites were also red and inflammed. On 4/19/01, the pt was completely covered with purpura and petechia. He was hospitalized on 4/20/01, for 3 days, with thrombocytopenia. The platelet count was not provided. The pt was treated with immune globulin and is "now doing fine". A follow up report received 11/21/2001 adds: Subsequently the pt recovered.  This was originally reported by a nurse practitioner. Additional info has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Autism, Constipation, Convulsion, Drooling, Irritability
Clinical narrative: Information has been received from a foreign legal firm concerning an approx. 15 month old male with a history of croup at 12 months, who on 1/27/93 was vaccinated with his 1st dose of MMRII. Concomitant therapy included Hib conjugate vaccine in the right leg on 1/17/93. In approx. 1/93, the pt experienced autism, with initial symptoms of fever and irritability. At the mother's request, the child had been seen by an ENT surgeon because he had always drooled and was a mouth breather. His hearing was tested in 8/94 and was determined to be normal. The pt was referred to a speech therapist in July, 1994 and had been recently assessed by the therapist. The pt was evaluated by a physician with his mother and 4.5 year old brother, on 10/5/94, for behavior problems and speech delay. It was reported that the pt is the 2nd of 2 children. His father is a photographer and his mother is an ENT nurse. His mother had a normal pregnancy and the pt was born full term, with a birth weight of 8lbs. His motor milestones were normal, although he did not walk until approx. 14 or 15 months of age. During the evaluation, the pt's mother stated she was happy with the pt's development and that her main concern was with the pt's speech. The pt had a good vocabulary but did not put words together and missed the ending of the words. His gross motor function were normal and fine coordination was good. He was described as having poor listening skills, being overactive and agile and having no fear. He was able to concentrate when watching video and television. He attended playgroup 3 days a week and mixed well, but his teacher had to keep him under control because he tended to be quite active. It was reported that during the evaluation, the pt only cooperated in building a tower. He did not sit on the chair, climbed on the table, threw toys everywhere and did not concentrate. The assessment had to be abandoned due to his unacceptable behavior, attended playgroup 3 mornings a week. On 2/19/97, the pt received a booster shot of MMRII in the left leg (lot HC39880). Upon internal review, the pt's autism, fever, and irritability were considered "Other Medical Events". Additional information has been requested. Follow up information states that 2 weeks after injection, he developed a serious thirst.Within 6 months after the injection, approximately 7/93, it was reported that the pt's behaviour deterorated, he started to get constipated.He started vomiting, was not speaking a great deal. Within 9 months the pt's sleeping pattern was poor. He displayed obsessional behavior and started having temper tantrums. It was reported that in 1997, the pt had developed absence seizures. On 02/19/97 the pt received a booster of MMRII. The pt was diagnosed with autism in December 2000. Upon internal review, the pt's autism ans seizure were considered OMIC.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Psychomotor hyperactivity, Pyrexia, Sleep disorder, Speech disorder, Thirst
Clinical narrative: Information has been received from a foreign legal firm concerning an approx. 15 month old male with a history of croup at 12 months, who on 1/27/93 was vaccinated with his 1st dose of MMRII. Concomitant therapy included Hib conjugate vaccine in the right leg on 1/17/93. In approx. 1/93, the pt experienced autism, with initial symptoms of fever and irritability. At the mother's request, the child had been seen by an ENT surgeon because he had always drooled and was a mouth breather. His hearing was tested in 8/94 and was determined to be normal. The pt was referred to a speech therapist in July, 1994 and had been recently assessed by the therapist. The pt was evaluated by a physician with his mother and 4.5 year old brother, on 10/5/94, for behavior problems and speech delay. It was reported that the pt is the 2nd of 2 children. His father is a photographer and his mother is an ENT nurse. His mother had a normal pregnancy and the pt was born full term, with a birth weight of 8lbs. His motor milestones were normal, although he did not walk until approx. 14 or 15 months of age. During the evaluation, the pt's mother stated she was happy with the pt's development and that her main concern was with the pt's speech. The pt had a good vocabulary but did not put words together and missed the ending of the words. His gross motor function were normal and fine coordination was good. He was described as having poor listening skills, being overactive and agile and having no fear. He was able to concentrate when watching video and television. He attended playgroup 3 days a week and mixed well, but his teacher had to keep him under control because he tended to be quite active. It was reported that during the evaluation, the pt only cooperated in building a tower. He did not sit on the chair, climbed on the table, threw toys everywhere and did not concentrate. The assessment had to be abandoned due to his unacceptable behavior, attended playgroup 3 mornings a week. On 2/19/97, the pt received a booster shot of MMRII in the left leg (lot HC39880). Upon internal review, the pt's autism, fever, and irritability were considered "Other Medical Events". Additional information has been requested. Follow up information states that 2 weeks after injection, he developed a serious thirst.Within 6 months after the injection, approximately 7/93, it was reported that the pt's behaviour deterorated, he started to get constipated.He started vomiting, was not speaking a great deal. Within 9 months the pt's sleeping pattern was poor. He displayed obsessional behavior and started having temper tantrums. It was reported that in 1997, the pt had developed absence seizures. On 02/19/97 the pt received a booster of MMRII. The pt was diagnosed with autism in December 2000. Upon internal review, the pt's autism ans seizure were considered OMIC.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Information has been received from a foreign legal firm concerning an approx. 15 month old male with a history of croup at 12 months, who on 1/27/93 was vaccinated with his 1st dose of MMRII. Concomitant therapy included Hib conjugate vaccine in the right leg on 1/17/93. In approx. 1/93, the pt experienced autism, with initial symptoms of fever and irritability. At the mother's request, the child had been seen by an ENT surgeon because he had always drooled and was a mouth breather. His hearing was tested in 8/94 and was determined to be normal. The pt was referred to a speech therapist in July, 1994 and had been recently assessed by the therapist. The pt was evaluated by a physician with his mother and 4.5 year old brother, on 10/5/94, for behavior problems and speech delay. It was reported that the pt is the 2nd of 2 children. His father is a photographer and his mother is an ENT nurse. His mother had a normal pregnancy and the pt was born full term, with a birth weight of 8lbs. His motor milestones were normal, although he did not walk until approx. 14 or 15 months of age. During the evaluation, the pt's mother stated she was happy with the pt's development and that her main concern was with the pt's speech. The pt had a good vocabulary but did not put words together and missed the ending of the words. His gross motor function were normal and fine coordination was good. He was described as having poor listening skills, being overactive and agile and having no fear. He was able to concentrate when watching video and television. He attended playgroup 3 days a week and mixed well, but his teacher had to keep him under control because he tended to be quite active. It was reported that during the evaluation, the pt only cooperated in building a tower. He did not sit on the chair, climbed on the table, threw toys everywhere and did not concentrate. The assessment had to be abandoned due to his unacceptable behavior, attended playgroup 3 mornings a week. On 2/19/97, the pt received a booster shot of MMRII in the left leg (lot HC39880). Upon internal review, the pt's autism, fever, and irritability were considered "Other Medical Events". Additional information has been requested. Follow up information states that 2 weeks after injection, he developed a serious thirst.Within 6 months after the injection, approximately 7/93, it was reported that the pt's behaviour deterorated, he started to get constipated.He started vomiting, was not speaking a great deal. Within 9 months the pt's sleeping pattern was poor. He displayed obsessional behavior and started having temper tantrums. It was reported that in 1997, the pt had developed absence seizures. On 02/19/97 the pt received a booster of MMRII. The pt was diagnosed with autism in December 2000. Upon internal review, the pt's autism ans seizure were considered OMIC.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: A nurse reported that a 34 year old male now 36 years of age, received an injection of Flu Shield '99-'00 formula, in 10/99. Approx. 1 week later, he was dx'd with Guillain-Barre Syndrome. The pt was hospitalized and recovered. No further information was available at the date of this report. This report of a serious, labeled event is being submitted in a 15 day time frame.