chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Speech disorder, Thrombosis, Visual disturbance, Vomiting
Clinical narrative: This case was reported by a lawyer and described the occurrence of neurological complications on in a 42 yr old female pt who received Lyme disease vaccine recombinant OspA (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received  Lymerix. At an unk time after receiving Lymerix, the pt experienced neurologic complications. Time to onset, treatment, and outcome were not reported. Future expedited reports for this Lymerix case  shall be referenced to BBIND5420, which is a change from past reports referencing the voluntarily-revoked license(STN103757). In a statement of injuries, the subject's attorney alleged the subject suffers and has suffered from joint pain and swelling, flu-like symptoms, fatigue, rashes, tingling in extremities, headaches, visual problems, memory loss, cognitive problems, speech problems, blood clots in left calf, pulmonary problems, sciatic pain in left leg and buttock, sinusitis, side effects from IVIG including pain, nausea and migraines, stiffness, weakness, chills, sweating, vomiting, lightheadedness, chronic inflammatory demyelinating polyneuropathy, decreased activities of daily life. Rheumatologic, neurologic, and/or cognitive impairment of an autoimmune immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Angioneurotic oedema, Eye oedema, Rash, Rash pruritic, Swelling face
Clinical narrative: From initial information received on 01Jul05 from a health care professional regarding an adverse event occurring. It was reported that a 12 yr old male pt received a dose of Decavac, lot number U1563AA, admin IM in the left deltoid on 27Jun05. One day later, on 28Jun05, the pt developed puffy eyes, a facial rash and a rash on his neck and chest. The pt was seen by a physician and was treated with Benadryl and Prednisone per os. He was also administered Solu Medrol 125mg IM. Per the reporter, the pt did not have any respiratory distress. It was not reported if the pt has recovered from these events. From additional information received on 12Jul05 it was reported that this pt had a pruritic rash on the face and a scratch on the right cheek as a result of the rash. Slight angioedema with puffiness in the maxillary and periorbital regions was noted. He had no prior history of a similar reaction and was also treated with Atarax. He has recovered. No further information is expected, this case is considered closed.  (OMIC).
Age: 20.0
Sex: M
Vaccine: HEP, MNQ, TD
Symptoms: Abdominal pain upper, Arthralgia, Arthritis, Headache, Hypokinesia
Clinical narrative: Seriousness criteria other medically significant (OMIC). From initial information received on 7/1/2005 from a health care professional regarding an adverse event, it was reported that a 19 year old patient received a dose of Decavac, lot number U1221DA, a dose of Menactra, lot number U1575AA, and a dose of Hepatitis B, on 6/27/2005. The route and site of administrations were not provided for any products. Ten days later, the patient was diagnosed with disabling arthritis 2/26/2006 the reported term was arthralgia. The patient also complained of headache and stomach ache. Reportedly, the patients lab tests were within normal limits. At the time of this report, the patient has not recovered from these events. From additional information received later on 7/1/2005 from a health care professional, it was reported that the actual date of vaccination was on 6/17/2005 and the adverse event onset was on 6/27/2005. Reportedly, the patient becomes extremely stiff when he sits for long periods and has difficulty getting up. He also had difficulty ambulating and looks a mess and is experiencing a lot of pain. The physician prescribed Toradol for the pain. From additional information received on 9/6/2005 the onset of symptoms was 9 days post vaccination. The patient received Decavac intramuscularly in the left deltoid, Menactra intramuscularly in the right deltoid and Hepatitis B intramuscularly in the right deltoid. An EKG was negative. ASO 100, GC negative, GC negative, CPR 3.3, RSF ANA negative and chlamydia negative. Follow up information received on 2/14/2006 from a health care provider. Per the reporter, the date of the patients recovery is unknown. CBC within normal limits, chemistry within normal limits. From follow up information received on 9/6/2005 EKG negative, ASO 100, GC negative, GC negative, CPR 3.3, RSF ANA negative and chlamydia negative.
Age: 20.0
Sex: M
Vaccine: HEP, MNQ, TD
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Seriousness criteria other medically significant (OMIC). From initial information received on 7/1/2005 from a health care professional regarding an adverse event, it was reported that a 19 year old patient received a dose of Decavac, lot number U1221DA, a dose of Menactra, lot number U1575AA, and a dose of Hepatitis B, on 6/27/2005. The route and site of administrations were not provided for any products. Ten days later, the patient was diagnosed with disabling arthritis 2/26/2006 the reported term was arthralgia. The patient also complained of headache and stomach ache. Reportedly, the patients lab tests were within normal limits. At the time of this report, the patient has not recovered from these events. From additional information received later on 7/1/2005 from a health care professional, it was reported that the actual date of vaccination was on 6/17/2005 and the adverse event onset was on 6/27/2005. Reportedly, the patient becomes extremely stiff when he sits for long periods and has difficulty getting up. He also had difficulty ambulating and looks a mess and is experiencing a lot of pain. The physician prescribed Toradol for the pain. From additional information received on 9/6/2005 the onset of symptoms was 9 days post vaccination. The patient received Decavac intramuscularly in the left deltoid, Menactra intramuscularly in the right deltoid and Hepatitis B intramuscularly in the right deltoid. An EKG was negative. ASO 100, GC negative, GC negative, CPR 3.3, RSF ANA negative and chlamydia negative. Follow up information received on 2/14/2006 from a health care provider. Per the reporter, the date of the patients recovery is unknown. CBC within normal limits, chemistry within normal limits. From follow up information received on 9/6/2005 EKG negative, ASO 100, GC negative, GC negative, CPR 3.3, RSF ANA negative and chlamydia negative.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Bursitis, Drug administration error, Joint range of motion decreased, Myositis, Pain
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a health care professional on 7/22/2005. A 50 year old female patient received an intramuscular injection of Decavac, lot number U1220BA, in the left arm on 6/27/2005. One day later, she developed severe pain and decreased range of motion of her left arm. She was treated with non steroidal anti inflammatory medication and is undergoing physical therapy. An MRI of her left shoulder on 7/13/2005 suggested myositis and bursitis of sub deltoid bursa reflection injection into the deltoid and into the sub deltoid bursa. As per the reporter, it is unknown if the patient has recovered from these events. Follow up information received on 8/26/2005 from the responsible physician. It was reported that there is no additional information at this time. Due to the lack of clinically relevant information, provided with this follow up, the case version will no be submitted to the health authorities. Follow up information received on 11/2/2005 from the responsible physician. It was reported that there is no additional information at this time. Due to the lack of clinically relevant information, provided with this follow up, the case version will no be submitted to the health authorities. Follow up information received on 01/23/2006 from the responsible physician. It was reported that there is no additional information at this time. The reporter of this case is the same as for case 200501426.
Age: 11.0
Sex: M
Vaccine: IPV, TD
Symptoms: Eyelid oedema, Face oedema, Nausea, Pruritus, Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a health care professional on 8/31/2005. An 11 year old male patient with a medical history of cephalosporin allergy, had received an injection of Decavac, lot number U1211BA, in the left arm and a dose of IPOL, lot number Y0298-2 in the right arm on 8/29/2005 at 2:00pm. Twenty hours later, he developed a facial rash and pruritus. The facial rash gradually spread to include the upper arms to the elbow area bilaterally. The patient also experienced nausea and vomiting. By 8/31/2005, two days post immunization, the patient had generalized facial edema with more prominent eye lid edema. His mother also reported a fever of 100.5 degrees F. The patient was treated with steroids 40mg and Allegra was prescribed. At the time of this report the patient had not recovered from these events. Follow up information received on 9/19/2005. As per reporting physician the patient has received no previous immunizations with Decavac and IPOL. He received dose one of Decavac intramuscularly in the left arm and dose one of IPOL intramuscularly in the right arm. The patient was treated with tapering doses of Prednisone, 40mg PO QD x 5 days, 30 mg PO QD x 3 days, 20 mg PO QD x 3 days, 10 mg PO QD x 3 days and 5 mg PO QD x 2 days. there were no diagnostic test or laboratory work performed. The patient fully recovered. No further information expected.
Age: 11.0
Sex: M
Vaccine: IPV, TD
Symptoms: Rash, Vomiting
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a health care professional on 8/31/2005. An 11 year old male patient with a medical history of cephalosporin allergy, had received an injection of Decavac, lot number U1211BA, in the left arm and a dose of IPOL, lot number Y0298-2 in the right arm on 8/29/2005 at 2:00pm. Twenty hours later, he developed a facial rash and pruritus. The facial rash gradually spread to include the upper arms to the elbow area bilaterally. The patient also experienced nausea and vomiting. By 8/31/2005, two days post immunization, the patient had generalized facial edema with more prominent eye lid edema. His mother also reported a fever of 100.5 degrees F. The patient was treated with steroids 40mg and Allegra was prescribed. At the time of this report the patient had not recovered from these events. Follow up information received on 9/19/2005. As per reporting physician the patient has received no previous immunizations with Decavac and IPOL. He received dose one of Decavac intramuscularly in the left arm and dose one of IPOL intramuscularly in the right arm. The patient was treated with tapering doses of Prednisone, 40mg PO QD x 5 days, 30 mg PO QD x 3 days, 20 mg PO QD x 3 days, 10 mg PO QD x 3 days and 5 mg PO QD x 2 days. there were no diagnostic test or laboratory work performed. The patient fully recovered. No further information expected.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Convulsion, Hypersensitivity, Syncope, Syncope vasovagal
Clinical narrative: Initial report received from a health care professional on 21Sep05. An 18 yr old female pt with a medical history of an amoxicillin allergy had received an IM injection of TD ADS Adult, lot number U1341AA, in the left deltoid on 12Sep05. Ten seconds post vaccination, the pt experienced a syncopal reaction which lasted for ten seconds. The pt recovered for 30 seconds and then had a seizure which lasted for ten seconds. She was taken to an ER. She was advised that she had experienced a vagal response, but she is allergic to amoxicillin so therefore allergic to TD. Routine blood work and a brain scan were completed but no results were provided. The pt recovered from these events. Follow up information received on 09Feb06 from a physician. Attempts to follow up with the pt have been unsuccessful. Reportedly all available to the reporter information has been provided and no further information is to be expected.
Age: 1.01
Sex: M
Vaccine: HEP, IPV, VARCEL, HEP, IPV, VARCEL
Symptoms: CSF test abnormal, Cellulitis, Decreased appetite, Drug ineffective, Encephalitis
Clinical narrative: Initial report was received on 4/20/2006 from another manufacturer, report number WAES0604USA00265. An eight year old male patient with a past medical history of varicella treated with acyclovir at age four months, enterovirus infection, neonatal infection and concurrent condition of attention deficit hyperactivity disorder, had received at one year of age, a third dose of IPOL, lot number W0197, a third dose of Engerix B lot number 2725A2, and a first subcutaneous injection of Varivax, lot number 628032/1261H, on 11/23/1998. The route of administration was not reported for the Ipol and Engerix B vaccines, and the site was not reported for any of the three vaccines. Seven years post immunization, the patient was admitted to the hospital due to fever, poor oral intake, vesicular papular rash on his back, and purulent lesions on his gluteal fold. At the time, he was also found to have photophobia, phonophobia, headache, and neck stiffness. A lumbar puncture was completed,a nd the CSF showed his WBC to be at 435 and his RBC at 269. His metabolic panel showed a decreasing sodium of 128. The patient was started on antibiotic acyclovir IV and transferred to PICU due to possible SAIDH. Culture and direct antigen for vesicle were positive for varicella. The serum varicella zoster was a wild virus not a vaccine strain. The CSF IgM and IgG antibody testing for HSV and VZV were all negative. The patient was also treated with Keflex for gluteal fold cellulitis. He improved significantly, and was discharged four days later with a seven day treatment of IV Acyclovir. The final diagnosis was varicella meningitis. His discharge condition was good, and he subsequently recovered from the events.
Age: 1.01
Sex: M
Vaccine: HEP, IPV, VARCEL, HEP, IPV, VARCEL
Symptoms: Headache, Inappropriate antidiuretic hormone secretion, Meningitis, Musculoskeletal stiffness, Phobia
Clinical narrative: Initial report was received on 4/20/2006 from another manufacturer, report number WAES0604USA00265. An eight year old male patient with a past medical history of varicella treated with acyclovir at age four months, enterovirus infection, neonatal infection and concurrent condition of attention deficit hyperactivity disorder, had received at one year of age, a third dose of IPOL, lot number W0197, a third dose of Engerix B lot number 2725A2, and a first subcutaneous injection of Varivax, lot number 628032/1261H, on 11/23/1998. The route of administration was not reported for the Ipol and Engerix B vaccines, and the site was not reported for any of the three vaccines. Seven years post immunization, the patient was admitted to the hospital due to fever, poor oral intake, vesicular papular rash on his back, and purulent lesions on his gluteal fold. At the time, he was also found to have photophobia, phonophobia, headache, and neck stiffness. A lumbar puncture was completed,a nd the CSF showed his WBC to be at 435 and his RBC at 269. His metabolic panel showed a decreasing sodium of 128. The patient was started on antibiotic acyclovir IV and transferred to PICU due to possible SAIDH. Culture and direct antigen for vesicle were positive for varicella. The serum varicella zoster was a wild virus not a vaccine strain. The CSF IgM and IgG antibody testing for HSV and VZV were all negative. The patient was also treated with Keflex for gluteal fold cellulitis. He improved significantly, and was discharged four days later with a seven day treatment of IV Acyclovir. The final diagnosis was varicella meningitis. His discharge condition was good, and he subsequently recovered from the events.
Age: 1.01
Sex: M
Vaccine: HEP, IPV, VARCEL, HEP, IPV, VARCEL
Symptoms: Photophobia, Pyrexia, Rash papular, Skin ulcer, Viral infection
Clinical narrative: Initial report was received on 4/20/2006 from another manufacturer, report number WAES0604USA00265. An eight year old male patient with a past medical history of varicella treated with acyclovir at age four months, enterovirus infection, neonatal infection and concurrent condition of attention deficit hyperactivity disorder, had received at one year of age, a third dose of IPOL, lot number W0197, a third dose of Engerix B lot number 2725A2, and a first subcutaneous injection of Varivax, lot number 628032/1261H, on 11/23/1998. The route of administration was not reported for the Ipol and Engerix B vaccines, and the site was not reported for any of the three vaccines. Seven years post immunization, the patient was admitted to the hospital due to fever, poor oral intake, vesicular papular rash on his back, and purulent lesions on his gluteal fold. At the time, he was also found to have photophobia, phonophobia, headache, and neck stiffness. A lumbar puncture was completed,a nd the CSF showed his WBC to be at 435 and his RBC at 269. His metabolic panel showed a decreasing sodium of 128. The patient was started on antibiotic acyclovir IV and transferred to PICU due to possible SAIDH. Culture and direct antigen for vesicle were positive for varicella. The serum varicella zoster was a wild virus not a vaccine strain. The CSF IgM and IgG antibody testing for HSV and VZV were all negative. The patient was also treated with Keflex for gluteal fold cellulitis. He improved significantly, and was discharged four days later with a seven day treatment of IV Acyclovir. The final diagnosis was varicella meningitis. His discharge condition was good, and he subsequently recovered from the events.
Age: 1.01
Sex: M
Vaccine: HEP, IPV, VARCEL, HEP, IPV, VARCEL
Symptoms: Blister, Blood sodium decreased, Cellulitis, Decreased appetite, Drug ineffective
Clinical narrative: Initial report was received on 4/20/2006 from another manufacturer, report number WAES0604USA00265. An eight year old male patient with a past medical history of varicella treated with acyclovir at age four months, enterovirus infection, neonatal infection and concurrent condition of attention deficit hyperactivity disorder, had received at one year of age, a third dose of IPOL, lot number W0197, a third dose of Engerix B lot number 2725A2, and a first subcutaneous injection of Varivax, lot number 628032/1261H, on 11/23/1998. The route of administration was not reported for the Ipol and Engerix B vaccines, and the site was not reported for any of the three vaccines. Seven years post immunization, the patient was admitted to the hospital due to fever, poor oral intake, vesicular papular rash on his back, and purulent lesions on his gluteal fold. At the time, he was also found to have photophobia, phonophobia, headache, and neck stiffness. A lumbar puncture was completed,a nd the CSF showed his WBC to be at 435 and his RBC at 269. His metabolic panel showed a decreasing sodium of 128. The patient was started on antibiotic acyclovir IV and transferred to PICU due to possible SAIDH. Culture and direct antigen for vesicle were positive for varicella. The serum varicella zoster was a wild virus not a vaccine strain. The CSF IgM and IgG antibody testing for HSV and VZV were all negative. The patient was also treated with Keflex for gluteal fold cellulitis. He improved significantly, and was discharged four days later with a seven day treatment of IV Acyclovir. The final diagnosis was varicella meningitis. His discharge condition was good, and he subsequently recovered from the events.
Age: 1.01
Sex: M
Vaccine: HEP, IPV, VARCEL, HEP, IPV, VARCEL
Symptoms: Headache, Inappropriate antidiuretic hormone secretion, Laboratory test abnormal, Meningitis, Musculoskeletal stiffness
Clinical narrative: Initial report was received on 4/20/2006 from another manufacturer, report number WAES0604USA00265. An eight year old male patient with a past medical history of varicella treated with acyclovir at age four months, enterovirus infection, neonatal infection and concurrent condition of attention deficit hyperactivity disorder, had received at one year of age, a third dose of IPOL, lot number W0197, a third dose of Engerix B lot number 2725A2, and a first subcutaneous injection of Varivax, lot number 628032/1261H, on 11/23/1998. The route of administration was not reported for the Ipol and Engerix B vaccines, and the site was not reported for any of the three vaccines. Seven years post immunization, the patient was admitted to the hospital due to fever, poor oral intake, vesicular papular rash on his back, and purulent lesions on his gluteal fold. At the time, he was also found to have photophobia, phonophobia, headache, and neck stiffness. A lumbar puncture was completed,a nd the CSF showed his WBC to be at 435 and his RBC at 269. His metabolic panel showed a decreasing sodium of 128. The patient was started on antibiotic acyclovir IV and transferred to PICU due to possible SAIDH. Culture and direct antigen for vesicle were positive for varicella. The serum varicella zoster was a wild virus not a vaccine strain. The CSF IgM and IgG antibody testing for HSV and VZV were all negative. The patient was also treated with Keflex for gluteal fold cellulitis. He improved significantly, and was discharged four days later with a seven day treatment of IV Acyclovir. The final diagnosis was varicella meningitis. His discharge condition was good, and he subsequently recovered from the events.
Age: 1.01
Sex: M
Vaccine: HEP, IPV, VARCEL, HEP, IPV, VARCEL
Symptoms: Phobia, Photophobia, Pyrexia, Rash papular, Rash vesicular
Clinical narrative: Initial report was received on 4/20/2006 from another manufacturer, report number WAES0604USA00265. An eight year old male patient with a past medical history of varicella treated with acyclovir at age four months, enterovirus infection, neonatal infection and concurrent condition of attention deficit hyperactivity disorder, had received at one year of age, a third dose of IPOL, lot number W0197, a third dose of Engerix B lot number 2725A2, and a first subcutaneous injection of Varivax, lot number 628032/1261H, on 11/23/1998. The route of administration was not reported for the Ipol and Engerix B vaccines, and the site was not reported for any of the three vaccines. Seven years post immunization, the patient was admitted to the hospital due to fever, poor oral intake, vesicular papular rash on his back, and purulent lesions on his gluteal fold. At the time, he was also found to have photophobia, phonophobia, headache, and neck stiffness. A lumbar puncture was completed,a nd the CSF showed his WBC to be at 435 and his RBC at 269. His metabolic panel showed a decreasing sodium of 128. The patient was started on antibiotic acyclovir IV and transferred to PICU due to possible SAIDH. Culture and direct antigen for vesicle were positive for varicella. The serum varicella zoster was a wild virus not a vaccine strain. The CSF IgM and IgG antibody testing for HSV and VZV were all negative. The patient was also treated with Keflex for gluteal fold cellulitis. He improved significantly, and was discharged four days later with a seven day treatment of IV Acyclovir. The final diagnosis was varicella meningitis. His discharge condition was good, and he subsequently recovered from the events.
Age: 1.01
Sex: M
Vaccine: HEP, IPV, VARCEL, HEP, IPV, VARCEL
Symptoms: Red blood cell abnormality, Sepsis, Skin ulcer, Viral infection, White blood cell disorder
Clinical narrative: Initial report was received on 4/20/2006 from another manufacturer, report number WAES0604USA00265. An eight year old male patient with a past medical history of varicella treated with acyclovir at age four months, enterovirus infection, neonatal infection and concurrent condition of attention deficit hyperactivity disorder, had received at one year of age, a third dose of IPOL, lot number W0197, a third dose of Engerix B lot number 2725A2, and a first subcutaneous injection of Varivax, lot number 628032/1261H, on 11/23/1998. The route of administration was not reported for the Ipol and Engerix B vaccines, and the site was not reported for any of the three vaccines. Seven years post immunization, the patient was admitted to the hospital due to fever, poor oral intake, vesicular papular rash on his back, and purulent lesions on his gluteal fold. At the time, he was also found to have photophobia, phonophobia, headache, and neck stiffness. A lumbar puncture was completed,a nd the CSF showed his WBC to be at 435 and his RBC at 269. His metabolic panel showed a decreasing sodium of 128. The patient was started on antibiotic acyclovir IV and transferred to PICU due to possible SAIDH. Culture and direct antigen for vesicle were positive for varicella. The serum varicella zoster was a wild virus not a vaccine strain. The CSF IgM and IgG antibody testing for HSV and VZV were all negative. The patient was also treated with Keflex for gluteal fold cellulitis. He improved significantly, and was discharged four days later with a seven day treatment of IV Acyclovir. The final diagnosis was varicella meningitis. His discharge condition was good, and he subsequently recovered from the events.
Age: 52.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site abscess, Injection site induration
Clinical narrative: Seriousness criteria other medically significant (OMIC). A 53 year old female patient received an intramuscular injection of Decavac, lot number U1587AA, in the left deltoid on 1/11/2006. Five days later, the patient developed a hard knob at the injection site. She treated the area with ice. On 1/18/2006, the patient was seen in an ER. An incision and drainage of the site was done, and the patient was diagnosed with an abscess of the left deltoid. She was treated with IV Zosyn and Keflex for ten days. She subsequently recovered.
Age: 52.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site abscess, Injection site mass
Clinical narrative: Seriousness criteria other medically significant (OMIC). A 53 year old female patient received an intramuscular injection of Decavac, lot number U1587AA, in the left deltoid on 1/11/2006. Five days later, the patient developed a hard knob at the injection site. She treated the area with ice. On 1/18/2006, the patient was seen in an ER. An incision and drainage of the site was done, and the patient was diagnosed with an abscess of the left deltoid. She was treated with IV Zosyn and Keflex for ten days. She subsequently recovered.
Age: 58.0
Sex: F
Vaccine: TD, TD
Symptoms: Angioneurotic oedema, Face oedema, Influenza like illness, Pain, Urticaria
Clinical narrative: From initial information received on 20May05 from the pt regarding an adverse event occurring. It was reported that the 57 yr old female received her first dose of Decavac, lot number U1211DA, administered in the left deltoid on 14May05 at 12:00PM due to a cat scratch. Two days later, on 16May05, the pt developed flu-like symptoms, aching all over and welts (also reported as hives) on her back and chest, which enlarged to pancake size the following day. The pt was seen in the ER and was treated with Benadryl and Zyrtec. At the time of this report, the pt continues to have hives and has contacted a physician. She has not recovered from these events. Follow up received on 23Sep05: No additional information received. Further information requested. Case upgraded to Serious 07Feb06: Follow up information received on 07Feb06 from the pt. The Decavac vaccination was the pt's second dose of Tetanus. She received her first dose 10-12 yrs ago for a dog bite. Per the pt she has had persistent large welts and facial swelling since 15May05. She was seen by an allergist (date not reported) and was told that this was angioedema. She has been treated for this with Benadryl, Singulair and Allegra. An MRI and CAT scan have been completed (date and results not reported). The pt has an extensive history of allergies to cats, latex, shellfish, eggs, acidic foods, dust, mold and penicillin. Per the pt she had a cat bite at the time of the vaccination. The pt has not recovered from these events at the time of this report. (OMIC)
Age: 18.0
Sex: F
Vaccine: DTAP, MNQ, DTAP, MNQ
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling feet/hands; numbness of extremities; wrong vaccine administered. An 18 year old female pt had received on 2/22/06, in IM, RA, first dose injection of Menactra and an IM, LA, forth dose of injection of Daptacel (Misuse: person 7 years of age and older should not receive DTAP), lot C2341AA). Three days post/vax, the pt experienced bilateral hand and foot tingling. Distal paresthesias and numbness were worse in her lower extremities. The next day, she was examined in an emergency Room, and the day after that, she was examined by an internal medicine specialist who consulted a neurologist. Relevant diagnostic tests included a CT scan of the head which was negative and CBC, ESR, and a chemistry panel which were all within normal limits. The event was determined not to be Guillain-Barre Syndrome because the pt still had all reflexes present. Per the reporter, "the symptoms have slowly gone away". At the time of this report, the pt had recovered from the event. This case was considered non-serious.
Age: 18.0
Sex: F
Vaccine: DTAP, MNQ, DTAP, MNQ
Symptoms: Medication error, Paraesthesia
Clinical narrative: Tingling feet/hands; numbness of extremities; wrong vaccine administered. An 18 year old female pt had received on 2/22/06, in IM, RA, first dose injection of Menactra and an IM, LA, forth dose of injection of Daptacel (Misuse: person 7 years of age and older should not receive DTAP), lot C2341AA). Three days post/vax, the pt experienced bilateral hand and foot tingling. Distal paresthesias and numbness were worse in her lower extremities. The next day, she was examined in an emergency Room, and the day after that, she was examined by an internal medicine specialist who consulted a neurologist. Relevant diagnostic tests included a CT scan of the head which was negative and CBC, ESR, and a chemistry panel which were all within normal limits. The event was determined not to be Guillain-Barre Syndrome because the pt still had all reflexes present. Per the reporter, "the symptoms have slowly gone away". At the time of this report, the pt had recovered from the event. This case was considered non-serious.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Initial report received on 06Apr06. A 15 yr old male pt had received on 27Feb06, an IM, left arm, first dose injection of Menactra, lot number U1852AA, and an IM, right arm, injection of Adacel, lot number C2124AA. Ten days post vaccination, the pt experienced body achiness, fatigue, numbness and tingling in his hand and leg on the same side. The pt was examined by a neurologist. and an EMG showed sensory conduction and motor conduction to be fine but the H reflex is the problem. The pt was reportedly improving and his upper extremity reflexes were better. However, there was still an absence of reflexes in his lower extremities. He had some paresthesias, but is no longer weak. Per the neurologist, the pt may have a mild neuropathy, but not a progressive Guillain Barre syndrome. No treatment was needed and the pt was to return for a follow up at approx the end of Apr 2006. At the time of this report, the pt had not recovered. This case is considered as non serious.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Fatigue, Hypoaesthesia, Myalgia, Neuropathy, Paraesthesia
Clinical narrative: Initial report received on 06Apr06. A 15 yr old male pt had received on 27Feb06, an IM, left arm, first dose injection of Menactra, lot number U1852AA, and an IM, right arm, injection of Adacel, lot number C2124AA. Ten days post vaccination, the pt experienced body achiness, fatigue, numbness and tingling in his hand and leg on the same side. The pt was examined by a neurologist. and an EMG showed sensory conduction and motor conduction to be fine but the H reflex is the problem. The pt was reportedly improving and his upper extremity reflexes were better. However, there was still an absence of reflexes in his lower extremities. He had some paresthesias, but is no longer weak. Per the neurologist, the pt may have a mild neuropathy, but not a progressive Guillain Barre syndrome. No treatment was needed and the pt was to return for a follow up at approx the end of Apr 2006. At the time of this report, the pt had not recovered. This case is considered as non serious.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Injection site erythema, Injection site inflammation, Rash pustular
Clinical narrative: Vitals: BP128/81  HR98  T97.5 +robust take L deltoid.  Intense erythema/inflammation, 5X5cm surrounding vaccination site, no satellite lesions.  Sparse pustular lesions w/ focal surrounding erythema to chest, back and underwear region (most intensely on back of thighs).  Diagnosed with generalized vaccinia.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Diarrhoea, Hypotonia, Malaise
Clinical narrative: Information title the age of autism pox part 1 has been received, concerning a 12 month old male with a history of a stubborn and severe case of roseola who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant therapy that day included a dose of varicella virus vaccine live. Subsequently, four days after the injection, the patient became ill with a fever and lay limp in his mothers arms for the first time in his life. It was noted that he began having chronic diarrhea and by his 15 month old checkup he had regressed so drastically that his pediatrician suggested he could be autistic. The physician agreed to the parents request for an immediate neurodevelopmental evaluation, which resulted in a diagnosis if full syndrome autism. No additional information was provided. Upon internal review, autism was considered an other medical event (OMIC). No additional information was provided.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information title the age of autism pox part 1 has been received, concerning a 12 month old male with a history of a stubborn and severe case of roseola who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant therapy that day included a dose of varicella virus vaccine live. Subsequently, four days after the injection, the patient became ill with a fever and lay limp in his mothers arms for the first time in his life. It was noted that he began having chronic diarrhea and by his 15 month old checkup he had regressed so drastically that his pediatrician suggested he could be autistic. The physician agreed to the parents request for an immediate neurodevelopmental evaluation, which resulted in a diagnosis if full syndrome autism. No additional information was provided. Upon internal review, autism was considered an other medical event (OMIC). No additional information was provided.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased, Irritability, Urinary tract infection
Clinical narrative: Severe inconsolable irritability for 2 day following Dtap shot. Irritability relieved briefly with Lumbar puncture. Persisting symptoms thinks less severe for 8-9 days. Discharge summary states urinary tract infection. msv Medical records state temperature elevation. msv
Age: 0.13
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Apnoea, Crying, Erythema, Pyrexia
Clinical narrative: Continual crying after injections with apnea? 1st NOC x 2, no fever. Hives next day with small pea size red area RL (no lump) still crying with another apnea? episode. Pt taken to hospital on 4/14. Admitted and observed for 24 hrs. No apnea noted during hospital stay, vitals wnl and blood work neg according to hospital records.
Age: 0.13
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Continual crying after injections with apnea? 1st NOC x 2, no fever. Hives next day with small pea size red area RL (no lump) still crying with another apnea? episode. Pt taken to hospital on 4/14. Admitted and observed for 24 hrs. No apnea noted during hospital stay, vitals wnl and blood work neg according to hospital records.
Age: 0.13
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizures recurrent 11/17/05, 12/05, 1/06, 3/06, 4/06. Apnea, Tx: phenobarbital, Keppra. 60 day Follow-up Information 24-JUL-2006: Still on seizure prophylaxis. He is doing well. We have discussed DTAP for now dft parent request.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Apnoea
Clinical narrative: Episode of apparent apnea with color change on day of vaccination. No other episodes. No other reason for episode.  5/15/06 9 pages to include ED and DC summary-admitted for ALTE (apparent life threatening event due to apnea) admitted 5/3-5/5/06-final DX ALTE-no apnea or desats or temp elevation during hospital stay.Prior to apnea event decreased appetite reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Pt developed 9cm area of induration 40 hours after administration of Menactra only to mid outer right arm. Menactra administered on 5/2/06 at 16:00 PM. Reaction documented 5/4/06 at 08:00 AM.
Age: 1.03
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Temp to 103; prolonged grand mal seizures; transported to emergency dept; observation.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Initial report received on 4/4/06 from a health care professional. A 19 year old male pt with a history of drug allergies to Advair, penicillin and Biaxin, had received his 1st dose of Menactra, IM, in the left deltoid, on 8/16/05. Two months later, the pt experienced a rash that began bilaterally on his fingers and spread up his arms to his axillary area. The rash was also present in the groin area. The rash appeared as "thousands of tiny pink spots". Over the past eight months, the rash has occurred off and on. The pt was treated with steroids and all blood work, "ASO (Anti-Streptolysin O) test, and skin punch test were negative. The pt has not recovered from the events.
Age: 0.94
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diarrhoea, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Right leg swollen small amt, feverish, diarrhea. Dx: localized rxn to Dtap inj
Age: 5.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: Injection site oedema, Movement disorder
Clinical narrative: Severe swelling entire upper thigh involves knee. Limited ability to ambulate.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling in the site between Dtap and IPV.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site hypersensitivity, Injection site warmth, Oedema
Clinical narrative: 04/14/2006 Right arm swelling last 24 hours after receiving DTaP and IPV in this arm. No fever or other c/o. Arm with 5 cm erythematous patch minimally hot, no skin breakdown. Mild hypersensitivity.
Age: 1.01
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site hypersensitivity, Rash papular
Clinical narrative: Pt developed redness and tiny flesh colored papules in the area around the injection site. It appeared to be a histamine reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Red, sore, swollen area upper deltoid right arm.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received DTAP on 4/27/06. Woke up with red, swollen sore arm at site. Cellulitis was treated with warm compresses and Augmentin.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L arm redden and slightly swollen from under shoulder to 2"-3" above elbow.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Difficulty in walking, Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: L leg injection site is red and swollen > 2 inches. Redness is an elevated wheal. Pt c/o difficulty walking and pain at sight.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis (redness, tenderness and swelling of thigh) from groin to knee-onset about 24 hr post injection.
Age: 66.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth right deltoid area. Discomfort, tenderness at site low-grade fever. Advised cold pack, Tylenol prn. Given 1000mg Tylenol po in office.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt developed pain and redness at injection site L arm.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Received varicella vaccine 12/19/99. Diagnosed with chicken pox 4/17/06.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: With injection No 3 of Rabies vaccine area immediate up rise, red, swollen, evidence of inj No 2 size of a quarter. Up rise and inj No 1 size of a dime. Up rise and swollen. Denies pain. MD evaluated at time up rise; verbal order no more shots.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Erythema induratum, Rash pruritic
Clinical narrative: Erythema-silver dollar sized; pruritic, silver dollar sized, Persist > 2w. Still active.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile convulsion within 24 hrs after DTAP shot. Temperature 104.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: 5/2/06-Arm started hurting, red, raised limb at site of injection. 5/3/06-Body hurting everywhere, > neck, jaw, back, knees, hips and across chest. 5/4/06-Body pain disappeared. Only pain in arm. 5/5/06-Pain in arm continues.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of R thigh. R thigh cellulitis, treated with Augmentin and Rocephin 750mg.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Petechiae, Thrombocytopenia
Clinical narrative: Thrombocytopenia and Petechia. Resolved 4/4/06.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: R upper arm red, swelling, pruritus.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MER
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L upper arm swollen area, red.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Swelling
Clinical narrative: 4/22 through 4/24-joint pain in shoulders, hips and back. 4/27-swelling of knees.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Clumsiness, Dysphemia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Leg pain, fever, malaise. 4/28/06, 15:00, Pt attempted to get out of a chair and walk from the kitchen to the playroom but crumpled onto the floor, crying about how his legs hurt. He was unable to stand. I picked him up and sat down on the sofa and noticed that he was hot and flushed. His temperature was 102 degrees and his entire body was warm with red flushing. 14:00-He was about the same. I remained on the sofa with him while he was in a daze, staring and intermittently whimpering, crying and complaining of leg pain. 16:30-I called your office and spoke to the message service. 17:00-He was the same. He was given homeopathic remedy thuja IM. 17:30 Fever was gone. Pt's spirits came back although he was unable to walk and complained of pain in his legs. 18:00=He began walking unsteadily with stiff legs. 19:00-Did a little rough playing with his younger brother and even ran a few steps. 19:30-Went to bed and slept through the night. On 4/28-ate and played fairly normally although there was stiffness in his gaits, increased clumsiness and a general loss of agility. Stuttering, which had disappeared completely several months ago, reappeared. Although normally, he does not nap, at 14:30, he lay down and slept until 17:00. He woke from his nap with a 99 degree temperature. He complained about pain in his legs and had difficulty walking. He was given thuja remedy. 17:30-He began to perk up but would not walk. Participated and played from a chair. Some capsaicin cream was rubbed onto his legs. 18:00-He began walking and running a bit, but stiffly. His abilities came back, little by little. Seemed much better at bedtime, 19:30. 4/30-He was fairly recovered. For the first time, the DPT injection site in his right leg was red and swollen like a pimple. I also noticed leg stiffness, clumsiness and stuttering. Mostly, he attempts to mask his ailments and only admitted once during the day to any pain. 5/1-He got up complaining about the DPT injection site. It appeared that he had been scratching it. There was a bloody pus discharge. Bacitracin and a band aid were applied. His mental and physical well being seemed improved and he went to nursery school as usual. He received the thuja remedy. 5/2-The injection site had a scab. He received a thuja remedy and went to nursery school. In the future, due to his and my family's medical history, please do not administer more that one vaccine at a time to either he or to my other son.