chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: HIBV, HIBV, HIBV
Symptoms: Vasodilatation
Clinical narrative: August 31, 1999 within a few hours post vax, pt developed an injection site reaction characterized by redness, warmth, lump and fever of 101 to 102 degrees. Treatment was Tylenol for fever and instructed mom to apply warm compresses to the injection site. September 1, 1999 the injection site reaction worsened and the pt continued to have a fever of 101 to 102 degrees F. Pt developed stiffness in her leg. Mother was instructed to massage and move the infant's leg. On September 2, 1999 the injection site swelling and redness had extended almost to infant's knee. A fever of 101 degrees F and leg stiffness persisted. Follow-up information received 03/27/2000 indicated the child saw MD and recovered.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Same day post vax, the pt developed an injection site reaction characterized by redness and swelling. The infant was hospitalized and treated with Benadryl and Motrin. The infant was discharged from the hospital within 24 hours.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Same day post vax, the pt developed an injection site reaction characterized by redness and swelling. The infant was hospitalized and treated with Benadryl and Motrin. The infant was discharged from the hospital within 24 hours.
Age: 2.08
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Four hours, post vax, the child developed an injection site reaction characterized by an 11cm X 11cm area of swelling and redness at the site of Acel-Imune injection. She recovered. This is 1 of 3 pts from this facility who developed an injection site reaction, post vax, Acel-Imune lot 467012.
Age: 2.08
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Four hours, post vax, the child developed an injection site reaction characterized by an 11cm X 11cm area of swelling and redness at the site of Acel-Imune injection. She recovered. This is 1 of 3 pts from this facility who developed an injection site reaction, post vax, Acel-Imune lot 467012.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The same day, post vax, the child developed an injection site reaction characterized by a 7cm X 2.5cm area of swelling, redness and warmth at the site of Acel-Imune injection. She recovered. This is 1 of 3 pts from this facility who developed an injection site reaction following Acel-Imune lot 467012.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The same day, post vax, the child developed an injection site reaction characterized by a 7cm X 2.5cm area of swelling, redness and warmth at the site of Acel-Imune injection. She recovered. This is 1 of 3 pts from this facility who developed an injection site reaction following Acel-Imune lot 467012.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The next day, post vax, the child developed an injection site reaction characterized by a 13cm X 9cm area of redness and swelling.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The next day, post vax, the child developed an injection site reaction characterized by a 13cm X 9cm area of redness and swelling.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, RV, DTAP, HIBV, IPV, RV
Symptoms: Diarrhoea, Gastroenteritis, Vomiting
Clinical narrative: On August 22, 1999 the pt vomited once and developed watery diarrhea. Stool culture was positive for rotavirus. Additional information received 02/09/2000 indicated that the infant received ActHib instead of hib-titer
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, RV, DTAP, HIBV, IPV, RV
Symptoms: Diarrhoea, Infection, Vomiting
Clinical narrative: On August 22, 1999 the pt vomited once and developed watery diarrhea. Stool culture was positive for rotavirus. Additional information received 02/09/2000 indicated that the infant received ActHib instead of hib-titer
Sex: M
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Injection site abscess, Pyrexia
Clinical narrative: Several days post vax, the pt developed a "superficial abscess at the varicella virus vaccine site". He received treatment with therapy of antibiotics for the abscess and recovered from the experience. Approximately one week post vax, the child developed a fever and on approximately 8/22/00, the child had a seizure. The reporter stated that at first, it was suspected to be a febrile seizure, however this has not been confirmed. The child was admitted to the hospital and a lumbar puncture was done on 8/22/00.   In a follow up phone call on 9/20/00, the mother reported that the child's fever has resolved and he has not had any more seizures since the initial one. However, she did report the child had several "staring spells" in early September, which have since resolved and not reoccurred. It was noted that the pt had a one-time only seizure for which to date no cause has been identified, however, she did stated that encephalitis was ruled out. The seizure was felt to be immediately life-threatening and upon medical review was considered to be an "other medical event". No further information is available.
Sex: M
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Injection site abscess, Pyrexia, Staring
Clinical narrative: Several days post vax, the pt developed a "superficial abscess at the varicella virus vaccine site". He received treatment with therapy of antibiotics for the abscess and recovered from the experience. Approximately one week post vax, the child developed a fever and on approximately 8/22/00, the child had a seizure. The reporter stated that at first, it was suspected to be a febrile seizure, however this has not been confirmed. The child was admitted to the hospital and a lumbar puncture was done on 8/22/00.   In a follow up phone call on 9/20/00, the mother reported that the child's fever has resolved and he has not had any more seizures since the initial one. However, she did report the child had several "staring spells" in early September, which have since resolved and not reoccurred. It was noted that the pt had a one-time only seizure for which to date no cause has been identified, however, she did stated that encephalitis was ruled out. The seizure was felt to be immediately life-threatening and upon medical review was considered to be an "other medical event". No further information is available.
Age: 13.0
Sex: F
Vaccine: RAB
Symptoms: Angioneurotic oedema, Dysphagia, Urticaria
Clinical narrative: 24 hours post vax, following the rabies vaccine, the pt developed dysphagia, angioedema and urticaria. No other details were reported. This is considered "other medically significant."
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Infection, Pruritus, Pyrexia, Rash
Clinical narrative: On 8/30/00, the pt experienced aches in joints and a fever. On 8/31/00, the pt developed chickenpox and itching which worsened on 9/1/00 at which time the lesions were all over the pt's body. The lesions lasted until 9/8/00 before they crusted and dried up. The pt was off work for 9 days and recovered on 9/9/00. The pt sought unspecified medical attention. Follow-up received on 9/27/00, from an RN stated that the pt was incapacitated for 9 days in that she was covered with vesicular lesions. The RN did not actually see the pt but it was reported to her by the pt. The pt was 6 weeks post-partum when she received the varicella vaccine and it was noted that she also had a 2 year old at home.  It was noted that since varicella virus vaccine is an attenuated virus, the children could experience a rash up to 42 days from the mother's rash. The reporter will provide the information if the children develop chickenpox.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Angioneurotic oedema, Blood creatine phosphokinase increased, Cardio-respiratory arrest, Cardiomegaly, Coma
Clinical narrative: Pt presented to ER in cardiopulmonary arrest, unresponsive, and cyanotic. Pt was briefly intubated and given epinephrine IV and ACLS protocol. He became responsive, breathing spontaneously and was extubated. Pt had notable angioedema and was given Solu-Medrol IV and neb treatment which helped. Pt became symptomatic again with tongue swelling and stridor was given epinephrine SQ and taken to ICU. Diganosed in hospital with angioedema.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Cyanosis, Emphysema, Hyperglycaemia, Hypoxia, Stridor
Clinical narrative: Pt presented to ER in cardiopulmonary arrest, unresponsive, and cyanotic. Pt was briefly intubated and given epinephrine IV and ACLS protocol. He became responsive, breathing spontaneously and was extubated. Pt had notable angioedema and was given Solu-Medrol IV and neb treatment which helped. Pt became symptomatic again with tongue swelling and stridor was given epinephrine SQ and taken to ICU. Diganosed in hospital with angioedema.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Tongue oedema
Clinical narrative: Pt presented to ER in cardiopulmonary arrest, unresponsive, and cyanotic. Pt was briefly intubated and given epinephrine IV and ACLS protocol. He became responsive, breathing spontaneously and was extubated. Pt had notable angioedema and was given Solu-Medrol IV and neb treatment which helped. Pt became symptomatic again with tongue swelling and stridor was given epinephrine SQ and taken to ICU. Diganosed in hospital with angioedema.
Age: 1.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Aphasia, Constipation, Hypotonia, Malaise, Pyrexia
Clinical narrative: Post vax, the child had decreased communications/speech language, decrease of muscle tone, problems with constipation. Immediate symptoms included fever and general malaise.
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Dizziness, Insomnia, Joint stiffness, Pain
Clinical narrative: The pt experienced a fever, stiff joints, insomnia, severe back and leg pain, dizziness and blurred vision. No treatment was required.  A follow up report received 1/8/2001 adds: Update per phone call from pt: states he is getting worse in that he has trouble walking and has a good deal of pain in feet, legs, knees, and now hips. He is concerned because the symptoms are "moving upwards" and he plays piano. These symptoms are "unlike Lyme Disease". The antibiotic tx did help decrease the fatigue and dizziness about 50%. He has no fever or sweats, but still has blurred vision. He remains on Voltarin and also takes glucosamine and milk thistle (homeopathic treatment from nutritionist). He has consulted with a specialist in Lyme Disease who believes he did have Lyme Disease for about 9 months with minor symptoms of slightly stiff neck and occasional fever. The tests for Lyme came back negative then positive s/p first dose of vaccine. He then had two positive testings s/p dose two of vaccine.  Follow up 10/30/2000: "Patient does not know lot #."
Age: 58.0
Sex: M
Vaccine: LYME
Symptoms: Pyrexia, Vision blurred
Clinical narrative: The pt experienced a fever, stiff joints, insomnia, severe back and leg pain, dizziness and blurred vision. No treatment was required.  A follow up report received 1/8/2001 adds: Update per phone call from pt: states he is getting worse in that he has trouble walking and has a good deal of pain in feet, legs, knees, and now hips. He is concerned because the symptoms are "moving upwards" and he plays piano. These symptoms are "unlike Lyme Disease". The antibiotic tx did help decrease the fatigue and dizziness about 50%. He has no fever or sweats, but still has blurred vision. He remains on Voltarin and also takes glucosamine and milk thistle (homeopathic treatment from nutritionist). He has consulted with a specialist in Lyme Disease who believes he did have Lyme Disease for about 9 months with minor symptoms of slightly stiff neck and occasional fever. The tests for Lyme came back negative then positive s/p first dose of vaccine. He then had two positive testings s/p dose two of vaccine.  Follow up 10/30/2000: "Patient does not know lot #."
Age: 1.25
Sex: F
Vaccine: HIBV, PNC
Symptoms: Febrile convulsion, Lethargy, Pyrexia, Staring, Vomiting
Clinical narrative: Next day post vax, the pt spiked a temperature and had an episode of lethargy, vomiting, and eyes glazing over. No loss of consciousness. Responded to Motrin. Seen in physician's office on 10/3-believed to  have had a mild febrile seizure.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Severe irritability for 5 days. Fever for 1-2 days.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Post vax, the pt developed erythema at injection site and hives on left lateral thigh and left and right inner thighs.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain, Vasodilation procedure
Clinical narrative: Post vax, the pt was seen in ER with large, red, warm area around injection site. He also complained of mild pain originally thought of as cellulitis. Pt started on Keflex and Motrin. Symptoms worsened-redness and subcutaneous nodules.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Post vax, the pt had erythema in mid right deltoid extending to just below the elbow. Sight fluctuance mid lesion. No fever.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Flatulence, Gastroenteritis, Screaming, Viral infection
Clinical narrative: Post vax, the pt complains of screaming since vaccines. Increased gas; this could be cause or effect reaction to shots vs coincidental viral gastroenteritis. Treated with Pedialyte for 2 feeds then advance to formula. Call if she seems ill.
Age: 60.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: 3 days post vax, the pt developed itching. 6 days post vax, the pt developed hives. Followed up by PMD and allergist.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Rash
Clinical narrative: The pt complained of rash over abdomen, back, face, neck and arms. Also some joint pain relieved with Tylenol. No fever. Rash is ongoing.
Age: 46.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Hypertension, Nausea
Clinical narrative: Within 15 minutes post vax, the pt complained of lightheadedness. BP was 140/100, Pulse 80, Blood pressure increased to 160/100. Coloring was pink with a wave of nausea. The pt was taken to her primary care physician.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Agitation, Injection site reaction, Pyrexia
Clinical narrative: The pt experienced a localized reaction with crying and fever.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Pain
Clinical narrative: The pt experienced a 2cm erythema at site of injection. The left arm was tender at the axilla.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Chest pain, Ear disorder, Erythema, Nasal congestion, Oedema
Clinical narrative: On 9/28/00, the pt complained of chest heaviness and swelling. Mom noted that ears were reddened but did not think they were swollen. Pt slept most of the day and was a little congested that evening. Mom noted she had not felt well on 9/27. She does not was her son to stop the Hep B series. Concern was that the pt had a similar reaction to bee stings.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Somnolence
Clinical narrative: On 9/28/00, the pt complained of chest heaviness and swelling. Mom noted that ears were reddened but did not think they were swollen. Pt slept most of the day and was a little congested that evening. Mom noted she had not felt well on 9/27. She does not was her son to stop the Hep B series. Concern was that the pt had a similar reaction to bee stings.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Injection site swelling, Rash, Skin exfoliation
Clinical narrative: Mother states one week post vax, the pt developed a raised rash on upper body with itching. Mother used calamine lotion. Some peeling around rash was noted. No physician was available at that time of morning. Mother stated she would take child to PMD.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: The pt experienced a rash on the back, chest, diaper area that started on 9/26. The pt was taken back to the MD and the MD feels it is a reaction to the vax. Was advised to keep the child out of daycare for one week.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injection site pain, Injection site rash, Lymphadenopathy, Nasal congestion
Clinical narrative: The pt experienced enlarged armpit glands and the injection site was tender and painful. The next day, the pt experienced lung congestion and cough. Redness at injection site was also experienced and a fever 48 hours later. Treated with Tylenol.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: The pt experienced enlarged armpit glands and the injection site was tender and painful. The next day, the pt experienced lung congestion and cough. Redness at injection site was also experienced and a fever 48 hours later. Treated with Tylenol.
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: 3 hours post vax, the pt experienced a fever of 104.7, then she vomited and was taken to the ER and treated with IV fluids and IV Rocephin. No rash was noted.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Adrenal disorder, Pulmonary congestion, Pulmonary oedema, Renal disorder, Sudden infant death syndrome
Clinical narrative: The reported states "Don't know", understands the infant was DOA at the hospital but was not verified. Autopsy also states pulmonary edema, lung congestion, kidney congestion, congestion of adrenals. Cause of death given as sudden infant death syndrome.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Unevaluable event
Clinical narrative: The reported states "Don't know", understands the infant was DOA at the hospital but was not verified. Autopsy also states pulmonary edema, lung congestion, kidney congestion, congestion of adrenals. Cause of death given as sudden infant death syndrome.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Infection, Lymphadenopathy, Pharyngitis, Pyrexia, Viral infection
Clinical narrative: The pt experienced a fever up to 103.8 for two days then it dropped to 100 - 101 for 2 days. The fever began the same day as vax. Throat was red, glands were swollen. No rash was noted. MD states he cannot rule out that the MMR vax as cause however it could also be viral.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Infection, Pyrexia, Sepsis
Clinical narrative: A territory representative reported that a male received doses of Hib-Titer at the ages of 2, 4, 7 and 15 months. The child subsequently, developed Hib sepsis. Hospitalization is presumed, although not documented. This report was submitted by the Montgomery Co (Ohio) Health Dept to the Ohio Dept of Health. Follow-up information indicated that the child was taken to the ER on 3/25/00. His temperature was 104.4F, and a blood culture was positive for H. influenza type B. The child was treated with amoxicillin/clavulanic acid and recovered.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Laboratory test abnormal, Urticaria
Clinical narrative: Within 2 nhours post vax, the pt developed hives. Her mother administered diphenhydramine and took the infant to the pediatrician's office, epinephrine was administered. The hives resolved by that evening. The generalized hives treated with epinephrine are considered medically important.
Age: 1.4
Sex: F
Vaccine: DTAP, DTP, HIBV
Symptoms: Injection site erythema
Clinical narrative: On 4/25/2000, pt developed and injection site reaction characterized by redness and small red bumps at the site. This is 1 of 2 pts from this facility who developed and reaction.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Lethargy
Clinical narrative: Same day as vax became lethargic.
Age: 1.08
Sex: M
Vaccine: DTP, HIBV
Symptoms: Injection site swelling, Rash
Clinical narrative: The next day after vax, pt developed a rash on his upper torso and upper thighs. He also developed swelling at the injection site. Additional information received on 4/24/2000 indicated that the pt was seen by MD.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: Post vax pt developed hives.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Rash
Clinical narrative: On 04/26/2000, pt developed an injection site reaction characterized by redness and small red bumps at site.  This is 1 of 2 pts from this facility who experienced this event.
Sex: M
Vaccine: HIBV
Symptoms: Eye disorder
Clinical narrative: During administration, the syringe came apart and the vax splashed onto the skin and into the eye of pts father. Water was used to cleanse the skin and irrigate the eye. Child's father stated his eye's felt weird.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: A sales representative reported that a 4 month old male received Acel-Imune, Hib-Titer and IPV (Aventis Pasteur SA) vaccines on 02/22/00. Immediately, post vax, Acel-Imune, he developed swelling at the injection site. He was treated with Benadryl and the swelling resolved after 5 to 7 minutes. This is 1 of 2 pts from this facility who experienced this event following receipt of Acel-Imune, lot 466023.
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: A physician reported that a 17 month old male received Acel-Imune and IPV (PMC France) vaccines on 3/1/00. He subsequently, developed a fever of 104F. He also developed redness, swelling and warmth at the site of Acel-Imune; the injection site reaction looked "like a cellulitis". The child was treated symptomatically and was reportedly recovering as of 3/6/00. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Acel-Imune, lot 467011.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A physician reported that a 33 month old male received Acel-Imune, Recombivax-HB (Merck) and IPV (Aventis Pasteur SA) vaccines on 3/3/00. Two days later, the child developed redness, swelling and tenderness at the site of Acel-Imune site. He recovered.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported that a 28 month old male received an injection of Acel-Imune and subsequently, developed an injection site reaction characterized by an area of redness, swelling and warmth "the size of a half-dollar". On 3/18/00, the pt was seen by the physician, who advised treatment with cool compresses. The pt recovered. This is 1 of 2 reports from this facility of injection site reactions following receipt of 2 different lots of Acel-Imune.
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Tremor
Clinical narrative: A mother reported that her son received Acel-Imune and subsequently, developed a fever and trembling. He recovered. Follow-up information received on 4/13/00, identified the pt. He remained recovered.
Sex: U
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: An MA reported that a child received an injection of Acel-Imune and subsequently, developed an unspecified reaction. This is 1 of 5 pts from this facility who experienced an adverse event following receipt of Acel-Imune, lot 467009. The reporter indicated that 5 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A physician reported that an 18 month old female received Acel-Imune and IPV (PMC France) vaccines on 3/1/00. She subsequently, developed redness, swelling, warmth and pain at the site of Acel-Imune administration. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Acel-Imune, lot 457011.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: A sales representative reported that a 6 month old female received Acel-Imune, Hib-Titer and IPV (Aventis Pasteur SA) vaccines on 2/22/00. Immediately, post vax of Acel-Imune, she developed swelling at the injection site. She recovered after 5 to 7 minutes. This is 1 of 2 pts from this facility who experienced this event following receipt of Acel-Imune, lot 466023.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: A nurse reported that a 4 year old male received his 5th dose of Acel-Imune, as well as, MMR (Merck) and IPV (Aventis Pasteur SA) vaccines on 4/11/00. On 4/13/00, he developed an injection site reaction characterized by blotching, swelling and redness measuring an area greater than 5cm. He recovered.
Age: 5.0
Sex: U
Vaccine: DTAP, OPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: A physician reported that a 5 year old child received Acel-Imune and Orimune and subsequently, developed an injection site reaction characterized by a large, red and raised area. The pt recovered. The reporter indicated that 2, 5 year old pts, from this facility experienced this event following receipt of Acel-Imune; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A nurse reported that an 18 month old female received her 5th injection of Acel-Imune and subsequently, developed an injection site reaction characterized by "severe" swelling, redness and pain. No further information was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction, following receipt of 2 different lots of Acel-Imune.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: A nurse reported that an 18 month old female received an injection of Acel-Imune on 4/21/00. The next day, she developed an injection site reaction characterized by a 5" area of redness, edema and warmth. The child also developed a fever of 99.8F. She was treated with topical and oral Benadryl. As of 4/24/00, the injection site reaction was "smaller", but the swelling and warmth persisted. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of 2 different lots of Acel-Imune.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A nurse reported that a 4 year old female received a 6th injection of Acel-Imune and subsequently, developed an injection site reaction characterized by "severe" swelling, redness and pain. No further information was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of 2 different lots of Acel-Imune.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Rash macular
Clinical narrative: Post vax pt developed an injection site reaction characterized by swelling and blotchy redness. The patient recovered. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Acel-Immune lot 469-396.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The same day she developed an injection site reaction characterized by a golf ball sized area of redness, swelling and warmth. This is 1 of 3 patients from this who developed an injection site reaction.
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Subsequently pt developed an injection site reaction characterized by redness extending from the shoulder to elbow, swelling and warmth. The patient recovered. This is 6 patients from this facility who developed and reaction.
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt subsequently developed and injection site reaction characterized by redness extending from the shoulder to the elbow, swelling and warmth. The patient recovered. This is 6 patients at the facility who developed an injection site reaction.
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt subsequently developed an injection site reaction characterized by redness extending from the shoulder to the elbow, swelling and warmth. The patient recovered. This is 6 patients from this facility who developed and injection site reaction.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Subsequently pt developed injection site reaction characterized by redness extending from the shoulder to the elbow, swelling and warmth. The patient recovered. There are 6 patients from facility who developed an reaction.
Age: 1.25
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Subsequently pt developed an injection site reaction characterized by redness extending from the shoulder to the elbow, swelling and warmth. The patient recovered. This is 6 patients from facility who developed an injection site reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: On May 02, 2000 within 5 to 7 hours, pt developed an injection site reaction with redness and swelling which extended from his elbow to shoulder. He was treated with cool compresses and Tylenol. This is 1 of 2 reports from this facility of adverse events.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Subsequently, pt developed a large swollen gland under his arm and an extensive rash approximately 2 inches round.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: On April 21, 2000, she developed an injection site reaction characterized by redness and swelling. The swelling extended to involve her entire thigh. This is 1 of 3 patients from this facility who developed an injection site reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: April 24, 2000 the child developed an injection site reaction characterized by a 3 inch area of redness, swelling, and pain at the site. The patient recovered. This is 1 of 3 patients from this facility who developed reaction.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt developed injection site reaction characterized by an area of swelling and redness measuring 2.5 in by 2 in. This is 1 of 3 patients from this facility who developed an injection site reaction following injection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Injection site erythema, Injection site oedema, Pyrexia, Restlessness
Clinical narrative: With in 5 to 7  hours, pt developed fever, headache, restlessness that night and injection site reaction characterized by redness and swelling. This is 1 of 2 reports from this facility.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: On May 10, 2000 the child developed an injection site reaction characterized by a 6 cm area of redness, tenderness, and swelling at the site of Acel-Imune administration. On May 11, 2000 she was seen by the physician and treated with Benadryl and augmentin.
Sex: U
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: A few pts received an injection and developed reactions which the reporter did not describe. No further information was available at the date of this report.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Irritability, Screaming
Clinical narrative: Pt subsequently experienced uncontrolled screaming and irritability for approximately 4 to 5 hours. Copies of this report have been forwarded to Aventis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: The nurse reported that a 4 year old male received an injection of Acel-Immune on 04/11/00.  The next day the patient developed an injection site reaction characterized by an area of redness, itching, and swelling, measuring 2 inches in diameter. The patient recovered. This is 1 out of 3 patients from this facility that developed an injection site reaction following receipt of Acel-Immune lot 469-396.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported a 20 month old male received an injection of Acel-Immune on 4/12/00. The next day, the patient developed an injection site reaction characterized by a "silver dollar" sized area of redness and swelling. The patient recovered. This is 1 out of 3 patients from this facility who developed an injection site reaction following the receipt of Acel-Immune lot 469-396.
Age: 0.4
Sex: U
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported that a 5 month old infant received Acel-Immune, IPV, and Comvax vaccines on 05/31/2000.  That evening, the infant developed an injection site reaction characterized by redness and swelling at site of Acel-Immune administration. The infant was treated with Acetaminophen and recovered. This is 1 out of 4 patients from this facility who had an adverse experience following receipt of Acel-Immune lot 469-396 or the concomitantly administered vaccines.
Age: 1.5
Sex: U
Vaccine: DTAP
Symptoms: Conjunctivitis, Injection site erythema, Injection site oedema
Clinical narrative: A territory representative reported that an 18 month old child received an injection of Acel-Immune vaccine. The child was receiving Tobrex for treatment of conjunctivitis at the time of immunization. On 5/25/00, the child developed an injection site reaction characterized by a 13cm by 9cm area of swelling and redness.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A physician reported that an 18 month old child received an injection of Acel-Immune on 5/15/00. The next day (24 hrs), the child developed an injection site reaction characterized by an area of redness, swelling, and warmth measuring approximately 7cm in diameter. The child recovered.
Age: 1.6
Sex: U
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Irritability
Clinical narrative: A nurse reported that a19 month old child received Acel-Immune and IPV vaccines on 5/24/2000. The next day, 5/26/00, the child developed an injection site reaction characterized by redness and swelling that extended from the Acel-Immune injection site at the left deltoid to the elbow. The child was also fussy at night. The child recovered. This is 1 out of 4 patients from this facility who had an adverse experience following receipt of Acel-Immune lot 469-396 or the concomitantly administered vaccines. A copy of the report has been forwarded to Aventis Pasteur, manufacturer of IPV.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Bronchitis, Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported that a 24 month old child received an injection of Acel-Immune on 5/22/00. The child was receiving Amoxicillin for the treatment of bronchitis at the time of immunization. On 5/24/2000, the child developed an injection site reaction characterized by redness and swelling at the site of Acel-Immune administration. The reaction was treated with Diphenhydramine and the child recovered. This is 1 out of 4 patients from this facility who had an adverse experience following receipt of Acel-Immune lot 469-396 or the concomitantly administered vaccines.
Age: 0.4
Sex: U
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported that a 5 month old infant received Acel-Immune and IPV vaccines in May 2000. The infant developed an injection site reaction characterized by redness and swelling at the site of Acel-Immune administration. The infant recovered. This is 1 out of 4 patients from this facility who had an adverse experience following receipt of Acel-Immune lot 469-396 or the concomitantly administered vaccines.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Sinusitis
Clinical narrative: A nurse reported that a 19 month old male received an injection of Acel-Immune on 02/29/00. On 03/02/00, the patient developed an injection site reaction characterized by an area  of redness and warmth which was "a silver dollar in size". The patient was seen by the physician, who advised treatment with cool compresses. The patient recovered. This is 1 of 2 reports from this facility of injection site reactions following receipt of 2 different lots of Acel-Immune.
Age: 2.08
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Urticaria
Clinical narrative: A nurse reported that a 26 month old male received Acel-Immune. Hib-Titer and Varivax vaccines on 03/27/00. On 04/04/00, the patient developed generalized hives. A copy of this report has been forwarded to Merck, manufacturer of Varivax.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A medical assistant reported that a 5 year old child received an injection of Acel-Immune on 04/06.00. Two days later, the child developed an injection site reaction described a "cellulitis". This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Age: 1.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A medical assistant reported that a 12 month old child received an injection of Acel-Immune and developed an injection site reaction described as "cellulitis". This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Age: 6.0
Sex: U
Vaccine: DTAP, MMR, OPV
Symptoms: Injection site rash
Clinical narrative: A nurse reported that a 6 year old received the first dose of Acel-Immune, as well as Orimune and MMR vaccines on 04/26/00 and subsequently, developed a rash on the upper right arm, site of Acel-Immune administration. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Acel-Immune lot 467-674.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A medical assistant reported that a 4 year old child received an injection of Acel-Immune on 04/04/00. On 04/08/00, the child developed an injection site reaction described as "cellulitis". The child was treated with Tylenol and compresses. This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Age: 0.5
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A medical assistant reported that a 6 month old infant received an injection of Acel-Immune on 03/03/00 and developed an injection site reaction described as "cellulitis". This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A medical assistant reported that a 4 year old child received an injection of Acel-Immune on 01/12/2000 and developed an injection site reaction described as "cellulitis". This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Injection site reaction
Clinical narrative: A medical assistant reported that a 4 year old child received an injection of Acel-Immune on 09/07/00. On 09/10/00, the child developed an injection site reaction and was treated with Augmentin. This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: A medical assistant reported that a 24 month old child received an injection of Acel-Immune and developed an injection site reaction. This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Age: 1.6
Sex: U
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: A medical assistant reported that an 18 month old child received an injection of Acel-Immune on 11/01/99 and developed an injection site reaction. This is 1 of 8 patients from this facility who developed an injection site reaction following receipt 0 3 different lots of Acel-Immune.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Abscess, Vaccine positive rechallenge
Clinical narrative: On Feb 2, 2000 the pt developed a sterile abscess measuring 1 inch by 1 inch at the injection site. Eventually, the abscess developed fluctuant areas and drained spontaneously. On March 29, 2000, a superficial lesion remained. The patient recovered.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, OPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Pt subsequently developed and injection site reaction. MD described the reaction as a "5 inch ring of cellulitis".
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: Post vax two to three minutes pt developed small hives on his legs and lower trunk. The pt was treated with diphenhydramine elixir and recovered.
Age: 1.5
Sex: U
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: The child has a history of an ear infection and was treated with Augmentin, gentamicin and Rocephin on May 5, 2000. On May 17, 2000 the pt developed a large injection site reaction at the site characterized by induration, redness and inflammation. As of May 22, 2000 the patient was recovering.
Age: 0.6
Sex: F
Vaccine: DTAP
Symptoms: Abscess, Injection site mass, Vaccine positive rechallenge
Clinical narrative: On April 14, 2000 the patient developed a lump at the injection site. The patient was seen by the physician on April 22, 2000 a diagnosis of sterile abscess was made. The patient recovered.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Rash
Clinical narrative: A nurse reported that several patients developed red rashes at the injection site within 24 to 48 hours of receiving the injection. No further information is available at the date of this report. Additional reports will be generated when identifying information is available.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The next day after vax the child developed an injection site reaction characterized by redness and warmth. The patient was treated with warm compresses. She recovered. This is 1 of 3 patients from this facility who developed and injection site reaction following receipt of Acel-Imune, lot 467011.
Age: 0.08
Sex: F
Vaccine: DTAP
Symptoms: Agitation
Clinical narrative: Subsequently pt developed a prolonged period of inconsolable irritability. The infant recovered.
Age: 4.0
Sex: U
Vaccine: DTAP, MMR
Symptoms: Injection site rash
Clinical narrative: Subsequently the pt developed a rash on her left deltoid, site of administration. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Acel-Imune lot 467474.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The next day post vax child developed an injection site reaction characterized by redness and warmth. The patient was treated with warm compresses. She recovered. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Acel-Imune lot 467011.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Apnoea, Cardiac arrest
Clinical narrative: Post vax, the pt was playing badminton in high school physical education class when he collapsed. CPR started by PE teacher and school nurse until paramedics arrived. Expired at hospital. Autopsy performed. Pathology tissues of heart sent for conduction studies.
Age: 1.92
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Convulsion, Laboratory test abnormal, Paralysis flaccid, Pyrexia
Clinical narrative: 10 days post vax, the pt experienced a sudden generalized seizure and fever. Then she experienced a period of flaccid paralysis from her neck down. Sensory was intact. She improved over the next 4 hours. Possible post vax encephalomyelopathy.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Cough, Erythema, Haemorrhage, Headache, Lethargy
Clinical narrative: Within 24 hours post vax, the pt's nose became swollen and red. Within 48 hours post vax, the sores broke open on his nose with yellowish pus that seeped out for approximately 48 hours. There were open, bleeding sores on my nose for 7 days, then the sores started to heal. By 10 days post vax, the sores were gone. Sores were accompanied by headache, cough, and lethargy.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Oedema, Skin ulcer
Clinical narrative: Within 24 hours post vax, the pt's nose became swollen and red. Within 48 hours post vax, the sores broke open on his nose with yellowish pus that seeped out for approximately 48 hours. There were open, bleeding sores on my nose for 7 days, then the sores started to heal. By 10 days post vax, the sores were gone. Sores were accompanied by headache, cough, and lethargy.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Headache, Muscular weakness, Pyrexia, Syncope
Clinical narrative: On 8/6/99, the pt became dizzy while eating lunch. The pt also experienced lightheadedness and almost passed out. The pt also experienced weakness and spent the remainder of the day in bed. A headache, fever and weakness occurred. The symptoms resolved the following day.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Coma, Hypotonia, Staring
Clinical narrative: The pt woke from his nap and was unresponsive, staring out into space, would not respond to day care providers or Mom. The pt was limp "like a rag doll". This event lasted for 2 1/2 hours and then gradually the pt returned to normal.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying, Injection site pain
Clinical narrative: The pt experienced high pitched crying for 1 hour post vax. The pt calmed down with Tylenol. The pt experienced slight tenderness of both thighs.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Irritability, Pyrexia, Urticaria
Clinical narrative: Within 24 hours of vax, the pt developed a fever of 104 (rectally) and fussiness. The child was seen the following day with a fever of 101.3 (axillary). Child was fussy, had urticaria on lower extremities. The child recovered.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Agitation, Pyrexia
Clinical narrative: The pt experienced extreme, inconsolable, irritability for 3-4 hours. Very irritable for 3 days. Febrile for 24 hours.