chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Blindness, Dizziness, Fatigue
Clinical narrative: This report described the occurrence of an "Optic nerve problem" (NOS) and vision loss in a 47 year old female patient who received Lyme disease vaccine recombinant OsPa (LymeRix) for prophylaxis. This report was received as part of litigation proceddings, and has not been verified by a physician or other healthcare professional. The patient submitted a reports (dated Dec 16, 2002) directly to VAERS. The patient's medical history included "herinated disc in lower back". There were reportedly no concurrent conditions or medication. On the VAERS form completed by the patient, she reported that she received injection of Lymerix on March 9, 2000 (lot LY12A2) and May 11, 2001 (lot LY128A2). This is not the recommended schedule for immunization with Lymerix. On the VAERS form completed by the patient, she indicated that her adverse experience began on May 20, 2001, nine days after receiving the second dose of Lymerix. For the description of the event, she wrote, "Urinary tract infection- antibiotics-19 days. Elbow swollen, napracin (NIC)- 7 days. Severe aches, ongoing since 04/02. Dizziness- moderate to severe global heterogeneous hyproperfusion/lesion on brain also (MRI (magnectic resonance imaging)) (Doxycycline). Tingling and numbness has gone away. Tachycardia- Toprol (metoprolol) if needed. Optic nerve problem>" She indicated that she had been seen by a physician. She also indicated that the events were unresolved. She also indicated that diagnostic evaluations revealed abnormalities: please see Laboratory Data section. On September 3, 2003, the patient's attorney alleged, (The patient) suffered joint pain. fatigue, tingling, vision loss, hearing loss, ringing in her ears, head pressure, memory loss, and concentration problems. The onset of her symptoms is not clear at this time. The "optic nerve problems" and vision loss in this report are considered to be medically serious (OMIC). On 15Sept04 the pt's attorney alleged that the pt now 51 years old experienced joint pain, fatigue, tingling, vision and hearing loss, memory loss, concentration problems, and an abnormal MRI demonstrating global hypoperfusion, time to onset, treatement, and outcome were not reported.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Headache, Hypoaesthesia, Impaired healing, Laboratory test abnormal, Nerve injury
Clinical narrative: This report described the occurrence of an "Optic nerve problem" (NOS) and vision loss in a 47 year old female patient who received Lyme disease vaccine recombinant OsPa (LymeRix) for prophylaxis. This report was received as part of litigation proceddings, and has not been verified by a physician or other healthcare professional. The patient submitted a reports (dated Dec 16, 2002) directly to VAERS. The patient's medical history included "herinated disc in lower back". There were reportedly no concurrent conditions or medication. On the VAERS form completed by the patient, she reported that she received injection of Lymerix on March 9, 2000 (lot LY12A2) and May 11, 2001 (lot LY128A2). This is not the recommended schedule for immunization with Lymerix. On the VAERS form completed by the patient, she indicated that her adverse experience began on May 20, 2001, nine days after receiving the second dose of Lymerix. For the description of the event, she wrote, "Urinary tract infection- antibiotics-19 days. Elbow swollen, napracin (NIC)- 7 days. Severe aches, ongoing since 04/02. Dizziness- moderate to severe global heterogeneous hyproperfusion/lesion on brain also (MRI (magnectic resonance imaging)) (Doxycycline). Tingling and numbness has gone away. Tachycardia- Toprol (metoprolol) if needed. Optic nerve problem>" She indicated that she had been seen by a physician. She also indicated that the events were unresolved. She also indicated that diagnostic evaluations revealed abnormalities: please see Laboratory Data section. On September 3, 2003, the patient's attorney alleged, (The patient) suffered joint pain. fatigue, tingling, vision loss, hearing loss, ringing in her ears, head pressure, memory loss, and concentration problems. The onset of her symptoms is not clear at this time. The "optic nerve problems" and vision loss in this report are considered to be medically serious (OMIC). On 15Sept04 the pt's attorney alleged that the pt now 51 years old experienced joint pain, fatigue, tingling, vision and hearing loss, memory loss, concentration problems, and an abnormal MRI demonstrating global hypoperfusion, time to onset, treatement, and outcome were not reported.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pain, Paraesthesia, Tachycardia, Tinnitus
Clinical narrative: This report described the occurrence of an "Optic nerve problem" (NOS) and vision loss in a 47 year old female patient who received Lyme disease vaccine recombinant OsPa (LymeRix) for prophylaxis. This report was received as part of litigation proceddings, and has not been verified by a physician or other healthcare professional. The patient submitted a reports (dated Dec 16, 2002) directly to VAERS. The patient's medical history included "herinated disc in lower back". There were reportedly no concurrent conditions or medication. On the VAERS form completed by the patient, she reported that she received injection of Lymerix on March 9, 2000 (lot LY12A2) and May 11, 2001 (lot LY128A2). This is not the recommended schedule for immunization with Lymerix. On the VAERS form completed by the patient, she indicated that her adverse experience began on May 20, 2001, nine days after receiving the second dose of Lymerix. For the description of the event, she wrote, "Urinary tract infection- antibiotics-19 days. Elbow swollen, napracin (NIC)- 7 days. Severe aches, ongoing since 04/02. Dizziness- moderate to severe global heterogeneous hyproperfusion/lesion on brain also (MRI (magnectic resonance imaging)) (Doxycycline). Tingling and numbness has gone away. Tachycardia- Toprol (metoprolol) if needed. Optic nerve problem>" She indicated that she had been seen by a physician. She also indicated that the events were unresolved. She also indicated that diagnostic evaluations revealed abnormalities: please see Laboratory Data section. On September 3, 2003, the patient's attorney alleged, (The patient) suffered joint pain. fatigue, tingling, vision loss, hearing loss, ringing in her ears, head pressure, memory loss, and concentration problems. The onset of her symptoms is not clear at this time. The "optic nerve problems" and vision loss in this report are considered to be medically serious (OMIC). On 15Sept04 the pt's attorney alleged that the pt now 51 years old experienced joint pain, fatigue, tingling, vision and hearing loss, memory loss, concentration problems, and an abnormal MRI demonstrating global hypoperfusion, time to onset, treatement, and outcome were not reported.
Age: 16.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Eye oedema, Lymphadenopathy
Clinical narrative: This case described the occurrence of an allergic reaction in a 16-year-old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's mother and has been verified by a physician. The mother submitted a report directly to VAERS. On 07/22/2003 at 15:30, the pt reportedly received the 1st dose of Engerix-B (lot ENG5386A2). On 07/24/2003 at 08:00, two days post-immunization, the pt experienced swollen eyes and a sore throat. On 07/25/2003, the pt was seen by the vaccine provider, who reportedly made a diagnosis of viral infection because "the white blood cell count was low." Laboratory analyses also revealed an increased concentration of aspartate aminotransferase. The pt reportedly then went on a vacation. According to the mother, when the pt returned on 08/02/2003, her condition was "much worse" and her eyes were still "very" swollen. On 08/03/2003, the pt was seen in an urgent care clinic, where a different physician made a diagnosis of allergic reaction and prescribed cetirizine hydrochloride (Zyrtec) and prednisone. The mother reported that, as of 08/08/2003, the events had improved, but there was "still some swelling and swollen lymph nodes". Additional info was received from the treating physician on 09/11/2003. He indicated that the allergic reaction/viral infection resolved on 08/04/2003. He considered these events to be life-threatening, to have jeopardized the pt, and to have been related to vaccination with Engerix-B. No info was provided regarding the increased aspartate aminotransferase concentration. The Engerix-B immunization series was discontinued. As a result of the info received on 09/11/2003, this report has been reclassified as serious. Follow-up of this case was received by the vaccine provider on 9/23/03. Approximately two days post-immunization, the pt develped a sore left arm, orbital eyelid edema, a sore on her left upper gum, sore throat, and edematous eyelids. Hematological ovaluations were normal with the exception of decreased white blood count of 3900 cells/mcL and elevated aspartate aminotransferase 54 U/L. Urinalysis was negative. Serology results were negative for Epstein Barr virus and antinuclear antibodies. The pt was diagnosed with a possible viral syndrome. The physician considered the events to be non-serious and unrelated to the vaccination with Engerix B, but possibly related to a concurrent viral syndrome.
Age: 16.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Aspartate aminotransferase increased, Eye swelling, Hypersensitivity, Laboratory test abnormal, Leukopenia
Clinical narrative: This case described the occurrence of an allergic reaction in a 16-year-old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's mother and has been verified by a physician. The mother submitted a report directly to VAERS. On 07/22/2003 at 15:30, the pt reportedly received the 1st dose of Engerix-B (lot ENG5386A2). On 07/24/2003 at 08:00, two days post-immunization, the pt experienced swollen eyes and a sore throat. On 07/25/2003, the pt was seen by the vaccine provider, who reportedly made a diagnosis of viral infection because "the white blood cell count was low." Laboratory analyses also revealed an increased concentration of aspartate aminotransferase. The pt reportedly then went on a vacation. According to the mother, when the pt returned on 08/02/2003, her condition was "much worse" and her eyes were still "very" swollen. On 08/03/2003, the pt was seen in an urgent care clinic, where a different physician made a diagnosis of allergic reaction and prescribed cetirizine hydrochloride (Zyrtec) and prednisone. The mother reported that, as of 08/08/2003, the events had improved, but there was "still some swelling and swollen lymph nodes". Additional info was received from the treating physician on 09/11/2003. He indicated that the allergic reaction/viral infection resolved on 08/04/2003. He considered these events to be life-threatening, to have jeopardized the pt, and to have been related to vaccination with Engerix-B. No info was provided regarding the increased aspartate aminotransferase concentration. The Engerix-B immunization series was discontinued. As a result of the info received on 09/11/2003, this report has been reclassified as serious. Follow-up of this case was received by the vaccine provider on 9/23/03. Approximately two days post-immunization, the pt develped a sore left arm, orbital eyelid edema, a sore on her left upper gum, sore throat, and edematous eyelids. Hematological ovaluations were normal with the exception of decreased white blood count of 3900 cells/mcL and elevated aspartate aminotransferase 54 U/L. Urinalysis was negative. Serology results were negative for Epstein Barr virus and antinuclear antibodies. The pt was diagnosed with a possible viral syndrome. The physician considered the events to be non-serious and unrelated to the vaccination with Engerix B, but possibly related to a concurrent viral syndrome.
Age: 16.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Lymphadenopathy, Pharyngolaryngeal pain, Viral infection
Clinical narrative: This case described the occurrence of an allergic reaction in a 16-year-old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's mother and has been verified by a physician. The mother submitted a report directly to VAERS. On 07/22/2003 at 15:30, the pt reportedly received the 1st dose of Engerix-B (lot ENG5386A2). On 07/24/2003 at 08:00, two days post-immunization, the pt experienced swollen eyes and a sore throat. On 07/25/2003, the pt was seen by the vaccine provider, who reportedly made a diagnosis of viral infection because "the white blood cell count was low." Laboratory analyses also revealed an increased concentration of aspartate aminotransferase. The pt reportedly then went on a vacation. According to the mother, when the pt returned on 08/02/2003, her condition was "much worse" and her eyes were still "very" swollen. On 08/03/2003, the pt was seen in an urgent care clinic, where a different physician made a diagnosis of allergic reaction and prescribed cetirizine hydrochloride (Zyrtec) and prednisone. The mother reported that, as of 08/08/2003, the events had improved, but there was "still some swelling and swollen lymph nodes". Additional info was received from the treating physician on 09/11/2003. He indicated that the allergic reaction/viral infection resolved on 08/04/2003. He considered these events to be life-threatening, to have jeopardized the pt, and to have been related to vaccination with Engerix-B. No info was provided regarding the increased aspartate aminotransferase concentration. The Engerix-B immunization series was discontinued. As a result of the info received on 09/11/2003, this report has been reclassified as serious. Follow-up of this case was received by the vaccine provider on 9/23/03. Approximately two days post-immunization, the pt develped a sore left arm, orbital eyelid edema, a sore on her left upper gum, sore throat, and edematous eyelids. Hematological ovaluations were normal with the exception of decreased white blood count of 3900 cells/mcL and elevated aspartate aminotransferase 54 U/L. Urinalysis was negative. Serology results were negative for Epstein Barr virus and antinuclear antibodies. The pt was diagnosed with a possible viral syndrome. The physician considered the events to be non-serious and unrelated to the vaccination with Engerix B, but possibly related to a concurrent viral syndrome.
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Hepatitis, Influenza like illness, Jaundice, Skin discolouration
Clinical narrative: This case was reported by a pharmacist and describes the occurrence of autoimmune hepatitis in an adult female patient who received hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The patient received injections of Engerix B on March 10, 2003 and May 02, 2003. At an unspecified time after the second dose, the patient travelled to visit family for three to four days. On the last day of the visit, the patient developed vomiting and diarrhea and "thought she had the flu". "A few days later", the patient became yellow. She was seen by a physician, who made a diagnosis of autoimmune hepatitis. The outcome of the event was unknown. Autoimmune hepatitis is considered to me medically serious. (OMIC)
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist and describes the occurrence of autoimmune hepatitis in an adult female patient who received hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The patient received injections of Engerix B on March 10, 2003 and May 02, 2003. At an unspecified time after the second dose, the patient travelled to visit family for three to four days. On the last day of the visit, the patient developed vomiting and diarrhea and "thought she had the flu". "A few days later", the patient became yellow. She was seen by a physician, who made a diagnosis of autoimmune hepatitis. The outcome of the event was unknown. Autoimmune hepatitis is considered to me medically serious. (OMIC)
Sex: M
Vaccine: LYME
Symptoms: Joint range of motion decreased, Pain, Shoulder pain
Clinical narrative: This report described the occurrence of shoulder pain in a male patient who received Lyme disease vaccine recombinant OsPa (Lymerix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other healthcare professional. On September 3, 2003, the patient's attorney alleged that the patient received injections of Lymerix on July 12, 2000. August 19, 2000 and August 15, 2001 according to the client." The attorney further alleged, The patient suffered pain and disability of his shoulder, decreasing range of motion and increasing pain. The onset of his symptoms is not clear at this time."
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Convulsion, Demyelination, Electroencephalogram abnormal, Encephalitis, Laboratory test abnormal
Clinical narrative: Seizures, abnormal MRI finding consistant with acute demyelinating Encephalmyelitis (ADEA). Hospital discharge states pneumonia and fever.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Seizures, abnormal MRI finding consistant with acute demyelinating Encephalmyelitis (ADEA). Hospital discharge states pneumonia and fever.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Brain oedema, Convulsion, Cough, Encephalitis, Pyrexia
Clinical narrative: Seizures, abnormal MRI finding consistant with acute demyelinating Encephalmyelitis (ADEA). Hospital discharge states pneumonia and fever.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Seizures, abnormal MRI finding consistant with acute demyelinating Encephalmyelitis (ADEA). Hospital discharge states pneumonia and fever.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site inflammation
Clinical narrative: Local erythema and inflammation approx 5 x 6 inches surrounding injection site at left thigh. Warm to touch. Dr. prescribed Duricef and follow up on Saturday 9/20/2003.
Age: 9.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Feeling hot
Clinical narrative: Red area 2 inches long and 5 inches wide on left arm. Area also warm to touch. Pt came to office area, was measured and was instructed to give Benadryl and apply cold wash cloth to red area.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Rash, cervical lymphadenopathy, fevers, cough.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Insomnia, Pain
Clinical narrative: 9/2: Same day as administered, within 30 minutes started to have throbbing pain in left arm. Felt achy for 8 days. Couldn't sleep for 5 days, is taking Celebrex 2x day. Helps to be comfortable to sleep at night.
Age: 0.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Decreased appetite, Irritability, Sleep disorder, Vomiting
Clinical narrative: Fussy, decreased appetite, some vomiting, poor sleep in the week following immunization. As of 9/15/03, parents do not believe the child has returned to previous status or temperament. Exam and development normal on 9/15/03.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Body temperature decreased, Listless, Urticaria, Vomiting
Clinical narrative: Vomiting soon after vaccine. Low temp 96, right listless. Arm developed generalized urticaria about 1 hour after vaccine. Rx with epi 0.12 ml IM. Decaredron 4mg. Benadryl PO 12.5mg.
Age: 15.0
Sex: M
Vaccine: TTOX
Symptoms: Epistaxis, Rash pruritic
Clinical narrative: Itching, rash, nose bleeding during the night.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, OPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: 4 X 6 CM AREA RED, WARM, SWOLLEN AREA-RIGHT DELTOID, 24 HOURS AFTER DTAP INJECTION
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Joint stiffness, Pharyngolaryngeal pain
Clinical narrative: Developed flu like symptoms, sore throat, joint stiffness, local swelling with redness at injection site at R upper arm and some generalized pruritis.  Symptoms lasted 5 days, possibly 2-3 more days.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: Developed flu like symptoms, sore throat, joint stiffness, local swelling with redness at injection site at R upper arm and some generalized pruritis.  Symptoms lasted 5 days, possibly 2-3 more days.
Age: 39.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Fatigue, Myocarditis
Clinical narrative: Pt c/o chest pain, SOB with mild exertion and fatigue.  Saw PMP (7/20/03) who ordered stress-ECHO, chem panel, thyroid panel, sed rate and CBC.  Stress ECHO, abnormal.  Cardiac cath (8/29/03) finding: "focal myocarditis," pt on beta blocker and ACE inhibitor.
Age: 39.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Dizziness, Dyspnoea, Hypokinesia, Laboratory test abnormal, Myocarditis
Clinical narrative: Pt c/o chest pain, SOB with mild exertion and fatigue.  Saw PMP (7/20/03) who ordered stress-ECHO, chem panel, thyroid panel, sed rate and CBC.  Stress ECHO, abnormal.  Cardiac cath (8/29/03) finding: "focal myocarditis," pt on beta blocker and ACE inhibitor.
Age: 39.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Palpitations
Clinical narrative: Pt c/o chest pain, SOB with mild exertion and fatigue.  Saw PMP (7/20/03) who ordered stress-ECHO, chem panel, thyroid panel, sed rate and CBC.  Stress ECHO, abnormal.  Cardiac cath (8/29/03) finding: "focal myocarditis," pt on beta blocker and ACE inhibitor.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Rash erythematous, Rash papular
Clinical narrative: low-grade fever started about 24 hours after vaccinne Erythematous, papular rash just below injection site on left thigh where DTaP was injected
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Complained of pain in the right deltoid area at site of injection.  Significant swelling, warm and red.  Improved within 2 days.  This is 2nd resident with reaction from same lot and we have saved vial.  There may have been one other resident as well.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 12x13cm red area at site.  Left arm very swollen and painful.  Afebrile.  Reported another today from same vial.  Saved vial.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Approximately four hours after immunizations were given, the infant developed welts and edema of face, hands and feet. Child was sent to nearest ER. Dx: Urticaria  Benadry was given
Age: 2.0
Sex: F
Vaccine: DT, HEP, HEPA
Symptoms: Gait disturbance, Injection site warmth, Swelling
Clinical narrative: Mother states "Left leg from diaper edge to one inch below knee was swollen double the size.  Warm to touch but not red.  Walked with weight on tip of toes.  Lasted 5 days." Contacted Dr., was not seen, instructed to bring in if progressed.  Child was never examined by MD.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Received anthrax #6 yesterday (9/20/03) L arm.  Mild irritation noted.  Patiend used "heat/vibrator" on injection site last pm, noted "blister" and "redness" this am.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV
Symptoms: Facial palsy, Nasal congestion, Pyrexia
Clinical narrative: Left side facial paralysis next morning lasting at least 1 1/2-2 hours. Was noticed about 9:00 AM on 6/19/03 when she awoke. Don't know if it started earlier in the night. Was not happening when she went to bed around 10 PM. By 10:30 AM 6/19/03 symptoms mostly disappeared. No treatment given. She was very fussy and had fever of 100.9. Left thigh injection site very swollen.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV
Symptoms: Facial palsy, Injection site oedema, Irritability, Pyrexia
Clinical narrative: Left side facial paralysis next morning lasting at least 1 1/2-2 hours. Was noticed about 9:00 AM on 6/19/03 when she awoke. Don't know if it started earlier in the night. Was not happening when she went to bed around 10 PM. By 10:30 AM 6/19/03 symptoms mostly disappeared. No treatment given. She was very fussy and had fever of 100.9. Left thigh injection site very swollen.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Oliguria, Oral candidiasis, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 7 week old male patient who on 8/28/03 at around 11am was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 644699/1215M). Concomitant vaccination the same day included Streptococcus pneumoniae vaccine, diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (INFANRIX) and poliovirus vaccine inactivated (IPOL). It was reported that the patient was vaccinated with hepatitis B virus vaccine at birth while in the hospital. Post vaccination on 8/28/03, the patient was given a dose of acetaminophen prior to leaving the health department. Subsequently on 8/28/03, the patient was taken to the emergency room and his symptoms included a rash which was described by the mother as raised, red bumps and generalized; fever of 102.5; edema of the fingers and face; non-stop crying and vomiting. He was being treated with acetaminophen every four hours for the fever. The patient was taken to the emergency room again on 8/29/03 and 8/30/03. On each of the three visits to the ER, the patient was seen by the same physician and was not admitted. On Sunday 8/31/03 the mother of the child woke up at 6am to check on the child and she thought he was doing better. He was asleep in his crib, so the mother reported that she went back to bed. The mother woke up again around 8am and found the child dead in his crib. The cause of death is unknown. A autopsy was done and as of 9/9/03 the results were still pending. The patient events were considered to be immediately life-threatening and disabling by the reporter. There was no product quality complaint involved. Additional information has been requested. Follow-up information from the physician indicated that the pt was vaccinated with the first set of vaccines and died soon after. The physician reported that she was not able to provide any further medical information. Additional information is being sought. Follow Up: The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and REsearch was released. No further information is available.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Oedema peripheral, Pyrexia, Rash, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 7 week old male patient who on 8/28/03 at around 11am was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 644699/1215M). Concomitant vaccination the same day included Streptococcus pneumoniae vaccine, diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (INFANRIX) and poliovirus vaccine inactivated (IPOL). It was reported that the patient was vaccinated with hepatitis B virus vaccine at birth while in the hospital. Post vaccination on 8/28/03, the patient was given a dose of acetaminophen prior to leaving the health department. Subsequently on 8/28/03, the patient was taken to the emergency room and his symptoms included a rash which was described by the mother as raised, red bumps and generalized; fever of 102.5; edema of the fingers and face; non-stop crying and vomiting. He was being treated with acetaminophen every four hours for the fever. The patient was taken to the emergency room again on 8/29/03 and 8/30/03. On each of the three visits to the ER, the patient was seen by the same physician and was not admitted. On Sunday 8/31/03 the mother of the child woke up at 6am to check on the child and she thought he was doing better. He was asleep in his crib, so the mother reported that she went back to bed. The mother woke up again around 8am and found the child dead in his crib. The cause of death is unknown. A autopsy was done and as of 9/9/03 the results were still pending. The patient events were considered to be immediately life-threatening and disabling by the reporter. There was no product quality complaint involved. Additional information has been requested. Follow-up information from the physician indicated that the pt was vaccinated with the first set of vaccines and died soon after. The physician reported that she was not able to provide any further medical information. Additional information is being sought. Follow Up: The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and REsearch was released. No further information is available.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 7 week old male patient who on 8/28/03 at around 11am was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 644699/1215M). Concomitant vaccination the same day included Streptococcus pneumoniae vaccine, diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (INFANRIX) and poliovirus vaccine inactivated (IPOL). It was reported that the patient was vaccinated with hepatitis B virus vaccine at birth while in the hospital. Post vaccination on 8/28/03, the patient was given a dose of acetaminophen prior to leaving the health department. Subsequently on 8/28/03, the patient was taken to the emergency room and his symptoms included a rash which was described by the mother as raised, red bumps and generalized; fever of 102.5; edema of the fingers and face; non-stop crying and vomiting. He was being treated with acetaminophen every four hours for the fever. The patient was taken to the emergency room again on 8/29/03 and 8/30/03. On each of the three visits to the ER, the patient was seen by the same physician and was not admitted. On Sunday 8/31/03 the mother of the child woke up at 6am to check on the child and she thought he was doing better. He was asleep in his crib, so the mother reported that she went back to bed. The mother woke up again around 8am and found the child dead in his crib. The cause of death is unknown. A autopsy was done and as of 9/9/03 the results were still pending. The patient events were considered to be immediately life-threatening and disabling by the reporter. There was no product quality complaint involved. Additional information has been requested. Follow-up information from the physician indicated that the pt was vaccinated with the first set of vaccines and died soon after. The physician reported that she was not able to provide any further medical information. Additional information is being sought. Follow Up: The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and REsearch was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Td given 8/18/03 IM left deltoid. Next day pt developed redness and soreness. Came back to office on 9/10/03 with 2cm x 2cm area of tenderness, erythema over left upper arm. Treated with Celebrex and Omnicef BID for 7 days. Recheck 9/17. Reported area had drained. Less redness and soreness. Much improved.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Arthralgia, Erythema, Pruritus, Pyrexia, Tenderness
Clinical narrative: Pruritis and erythema without pain on the right thigh (9/17/03). Cephaloxin and benadryl started. Follow up 9/19/03 increased area of tenderness and arid margin of erythema with fever 102.8 and pain of the right knee. Pt sent to medical center ER.
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Rash erythematous
Clinical narrative: 6 days after receiving DTaP, IVP and MMR, pt had an erythematous raised rash on left thigh. No pain.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: 9/16/03 Parents here for a triage, for a viral infection. Parents mention that 9/7/03 child received shots here and later same day child began to seizure, went to hospital ER via ambulance. No fever related to seizure. Denies trauma of any type, only new immunizations given earlier 9/8/03.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Large red circle at injection site 9mm x 6mm.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Localized erythema, induration with mild tenderness. C/w commonly prescribed.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Irritability, Rash
Clinical narrative: Red rash (on trunk only) noticed 9/16/03 6:00 PM. Fussy; afebrile. Parent phoned family physician, who told parent rash was probably a mild reaction to an immunization. Rash gone by 9/18/03 at 5:00 PM.
Sex: U
Vaccine: MMR
Symptoms: Purpura
Clinical narrative: Information has been received on 9/9/03 from a physician concerning an employee's child who was vaccinated about two weeks ago on approximately 8/26/03, with a dose of MMR (second generation) (lot not available). Subsequently the patient developed Henoch-Schonlein purpura. Medical attention was sought. The physician may not be contacted and did not have any additional information to provide. Upon internal review, Henoch-Schonlein purpura was determined to be an other important medical event (OMIC). No further information is available.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal, Rash pustular, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a pathologist concerning a 13 month old Hispanic male with interstitial lung disease (diagnosed 11/02) who on 7/31/03 was vaccinated in the left lower extremity with a 0.5 ml dose of varicella virus vaccine live (lot # 644799/0191N). At the end of August 2003, the patient developed a vesicular rash and was hospitalized. The admission diagnosis and present diagnosis were unknown. The pathologist obtained fluid from a vesicular lesion which was direct fluorescent-antibody positive. The reporter noted that he would like to send the vesicular fluid swabs and a small scab for varicella zoster virus identification. The pathologist indicated that he was not sure why the patient was hospitalized but suspected it was due to his medical history. The reporter was attempting to obtain clinical information from an infectious disease doctor. Additional information was received from the pathologist which indicated that on 8/23/03 a two to three millimeter scab was obtained from the right lateral thigh and submitted for varicella zoster virus identification. The patient's rash was described as having pustules, vesicles, and scabs. The distribution of lesions included five on the upper back, two on the left arm, one on the left hand, one on the right hand, and one on the right thigh for a total of 10 lesions. It was noted that the patient did not have a recent exposure to chickenpox or shingles. At the time of the report, the patient remained hospitalized and stable. Additional information has been requested. Follow up on 11/25/2003: "Additional information was obtained from the University which indicated that an adequate lesion specimen consisting of a vesicle swab and a scab was received for a polymerase chain reaction analysis.  The results revealed that varicella zoster virus DNA was amplified and contained the OKA/MERCK vaccine strain virus.  B-globin DNA was also amplified.  It was noted that the patient had developed varicella zoster.  Additional information has been requested.  This report no longer meets the criteria for expedited submission because the adverse experience has been changed to an expected event."
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Back pain, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Onset day 1, cough, fever, rhinorrhea, cervical adenopathy, headache, fatigue, no rash. Gradual progression Day 16 hospitalized for low back pain, diarrhea, vomiting. Prescribed IV's. Gradual improvement - symptom free 30 days post shot.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Lymphadenopathy, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Onset day 1, cough, fever, rhinorrhea, cervical adenopathy, headache, fatigue, no rash. Gradual progression Day 16 hospitalized for low back pain, diarrhea, vomiting. Prescribed IV's. Gradual improvement - symptom free 30 days post shot.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Heat, redness, swelling at left arm for 3 days.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Antisocial behaviour, Growth retardation, Laboratory test abnormal
Clinical narrative: Had achieved appropriate milestones at 6 month check. Within the next few weeks, his social interactions changed; he failed to advance with motor milestones. He continues to have significant global developmental delays.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug toxicity, Dyspnoea, Urticaria
Clinical narrative: Hives covering entire body; heavy and labored breathing. Treated in ER with Benadryl and continued with Benadryl for 2 days. The 60 day follow up received on 12/3/03 stated autism caused by mercury poisoning-undergoing testing for mercury poisoning at this time. "Leaky gut" syndrome causing pt to be on a special diet and supplements.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abscess, Eczema, Nephrotic syndrome, Skin ulcer, Vomiting
Clinical narrative: 2/26/03 Skin lesions times 2, vomiting; Cutirate and diagnosed with eczema or fine corporis; given Phenergan. 3/2/03 Skin abscess left thigh; Keflex; Cutirate vs. eczema. 3/11/03 Nephrotic syndrome; hospitalized out of town and then to local hospital. The 60 day follow up received on 12/31/03 states pt has been exposed to active varicella and did not develop any response. We are assuming that all live vaccines are contraindicated in this child. If this is incorrect, please update our office. The discharge summary received on 1/28/04 states nephrotic syndrome. 7/7/04: came down with sore throat and stuffy head, virus. 7/11/04: urine was 2000+ w/protein started on 45mg. Prednisone/calcum carbonate, 2 ml of 500mg/5ml
Age: 51.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site reaction, Injection site vesicles
Clinical narrative: About 8/26/2003 developed blister at site of smallpox vaccine (received vaccine 3/6/03). Blister was fluid filled, drained and now scab at site.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: At an unknown time following vaccine injections pt reportedly experienced hives on abdomen and chest, with some symptoms of throat swelling. Urticaria was diagnosed. Medrol Dose pack, Zyrtec 10 mg daily, OTC Pepcid, BID, was prescribed. Advised to return if dyspnea occurred.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pustule, Injection site warmth
Clinical narrative: Received smallpox 9/4/03; checked arm 9/11/03 with primary response, on 9/13/03 developed redness, swelling, heat approx 6" surrounding smallpox vaccine site, excessive drainage from smallpox pustule lymphad left axilla. Rx with Levaquin 500 mg for 5 days. Return to clinic 9/16, cellulitis resolved, no redness, no swelling, scab formed.
Age: 56.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction
Clinical narrative: Smallpox scab lasted 9 weeks (longer than the usual 8 weeks).
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Cow pox, Skin ulcer
Clinical narrative: Generalized vaccinia starting Day #10 following vaccination (major 1 hour reaction). 3 lesions noted. F/U visit 9/12/03 (Day #18) showed resolution of lesions.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Myalgia
Clinical narrative: Lower extremity arthalgias and myalgias mild-moderate. Given Ibuprofen 800 mg Tx's PRN.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Loss of consciousness, Medication error
Clinical narrative: My daughter was taken through innuendo and collusion by county social services and given to her father who she has never known. She was in foster care when she was reimmunized and did not need this because she was up to date on all her immunizations! Passed out shortly after immunization.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left upper arm (deltoid) noted to be reddened and swollen with heat after DTaP given.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Dyspnoea, Headache, Hyperhidrosis, Hypotension
Clinical narrative: Pt experienced hypotension, headache, dizziness, difficulty breathing, pallor, diaphoresis shorthly after vaccination.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Pallor
Clinical narrative: Pt experienced hypotension, headache, dizziness, difficulty breathing, pallor, diaphoresis shorthly after vaccination.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Pt seen at clinic 2 days after vaccine was given. Site of circular redness to upper left arm approx 3-4 inches above elbow. Site approx 1 inch in diameter and warm to touch. Site very tender to touch. Treatment recommended: ice pack if needed for pain and Advil or Tylenol as needed for pain. Call clinic if sx not improving in 1-2 days or with increased redness or striates up or down arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Redness and swelling to injection site. Injection site anterior right thigh. 10 x 12cm indurated. Pt Rx Orapred.
Age: 45.0
Sex: F
Vaccine: MMR, TD
Symptoms: Erythema, Joint range of motion decreased, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Pt said, next day after vaccine given, her left arm began to throb, and hurt. It became very red and hot, the swelling was enormous and very firm. She could not raise it but a few inches from her side. Today, 9/2/03, the redness is approx 6 x 6 in size. Some firmness still present. It's warm to touch and she can bring it up halfway her shoulder. She is afebrile today (her temperature at the time was 102).
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: Large area on right thigh swollen and warm, red but not tender, it is itching.
Age: 1.7
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Oral mucosal blistering, Pain, Pyrexia, Skin ulcer
Clinical narrative: Fever blisters in oral cavity at the tongue and gums. Temperature up to 101.4 degrees. Lesions were in the mouth for several days. Painful.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Pt seen in primary care clinic, was given Pneumovax vaccine (lot #0256W Exp 1/8/05) on 6/19/03. Next day pt called clinic and complained of swelling, redness and area hot to touch. Was informed to come to ER for evaluation. Pt arrived at ER at 16:37. Pt left ER at 18:45 stating that he could not wait any longer to be seen.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Received #5 DTaP and #4 IPV and #2 MMR on 08/19/03 after going home received call that child had hives. Mother gave Benadryl for age, did subside but returned. Week later with hives and meds received.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Rash
Clinical narrative: Pt came to office 9/15/03 for a physical. Mother stated pt started with rash yesterday, worse today. MD diagnosed rash as chickenpox, over 50 lesions, had Varivax 8/14/2000.
Age: 53.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Confusional state, Fatigue, Photosensitivity reaction, Skin ulcer
Clinical narrative: 8/29: Lesions developed. Fatigue, confusion, photosensitivity.
Age: 53.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Headache, Infection, Photophobia
Clinical narrative: 8/29: Lesions developed. Fatigue, confusion, photosensitivity.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Eye swelling, Urticaria
Clinical narrative: Child received vaccines approximately 3:30 PM 9/16/03. Did fine that day. Awoke approximately 8:40 AM 9/17/03 with diffuse urticaria. Minimal eye swelling. Improved with Benadryl. Never had trouble breathing.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Rash on left arm and extending to chest.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: DTaP injection site red, swollen. 2 days. States not painful. Cold packs to site. Benadryl 3/4 to 1 tsp QID.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain, Arthralgia, Difficulty in walking, Epistaxis, Henoch-Schonlein purpura
Clinical narrative: Nosebleed on 8/29/03. On 8/30/03, pt complained of joint pain, abdominal pain and nausea. 2 nosebleeds on 8/30/03. On 8/31/03, pt was lethargic and experienced malaise all day. 9/1/03 complained of joint pain. 9/2/03 had swollen joints (knees) and difficulty walking. Visited Dr on 9/2/03. 1st blood tests performed. Visited Dr again on 9/4/03. Dr diagnosed Henoch-Schoenlein Purpura. Did hemoccult and UA. Put on steroid, Predaped. Out of school 9/5, 9/6 and 9/7. Returned to school on 9/8. Broke out with rash again on 9/8/03. Dr advised to keep pt at home. Back to Dr on 9/13 complaining of abdominal pain. Did another hemoccult and UA. Mother has not heard from results of those tests. Pt returned to school on 9/15/03. Rash still comes and goes. Joint pain is better.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Joint swelling, Lethargy, Malaise, Nausea, Rash
Clinical narrative: Nosebleed on 8/29/03. On 8/30/03, pt complained of joint pain, abdominal pain and nausea. 2 nosebleeds on 8/30/03. On 8/31/03, pt was lethargic and experienced malaise all day. 9/1/03 complained of joint pain. 9/2/03 had swollen joints (knees) and difficulty walking. Visited Dr on 9/2/03. 1st blood tests performed. Visited Dr again on 9/4/03. Dr diagnosed Henoch-Schoenlein Purpura. Did hemoccult and UA. Put on steroid, Predaped. Out of school 9/5, 9/6 and 9/7. Returned to school on 9/8. Broke out with rash again on 9/8/03. Dr advised to keep pt at home. Back to Dr on 9/13 complaining of abdominal pain. Did another hemoccult and UA. Mother has not heard from results of those tests. Pt returned to school on 9/15/03. Rash still comes and goes. Joint pain is better.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Thrombocytopenic purpura
Clinical narrative: I.T.P. developed on 9/2/03. Received steroids and (?).
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Pt has documentation of receiving varicella vaccine 12/10/1997. Pt diagnosed with varicella disease 9/12/2003.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: 2-3 minutes after MMR vaccine administered, pt developed red blotchy rash on face only, no difficulty breathing. No other signs of reaction noted. 6.25mg benadryl given. Rash disappeared within 10 minutes after benadryl given.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Convulsion
Clinical narrative: Generalized tonic/clonic seizure at home at 6 AM, seen at ER. Recovered without incident. Seen in office at about 10 AM. 2nd tonic/clonic seizure lasting 90-120 seconds. Recovered without incident. Sent to ER.