chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician's assistant concerning an 88 year old male patient with hypertension, hyperlipidemia, arthritis, aortic valve disease and strawberries allergy who on 14-Febuary-2008, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml subcutaneously. Concomitant therapy included Coumadin, Simvastatin (MSD), Celebrex, Lasix and Hydrocodone. The physician's assistant reported that in the morning of 20-May-2009, the patient developed on his right thigh what looked like shingles. The patient was seen on the physician's office and was placed on VALTREX. At the time of the report, the patient had not recovered. The patient was enrolled in the Varicella Zoster Identification program to identify if VZV is present and if it is present to identify if it is associated with wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 20-May-2009. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Gait disturbance, Herpes zoster, Inflammation, Pain
Clinical narrative: Information has been received from a pharmacist concerning a female with blood pressure high and "some kind of eye disease" who "1 or 2 years ago" in approximately 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck), (lot number, site and route of vaccination not reported). It was reported that the patient was experiencing blisters in the back and pain. This was a light case of shingles but the patient said it was painful and she could barely walk. The pharmacist mentioned that at time the patient had received ZOSTAVAX vaccine (Merck), she experience soreness and inflammation at an unspecified arm. The patient was given VALTRAX. No date were available for the onset of the blisters and pain or the soreness and inflammation. The pharmacist mentioned the physician may have reported this AE but could not find the case. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a female with blood pressure high and "some kind of eye disease" who "1 or 2 years ago" in approximately 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck), (lot number, site and route of vaccination not reported). It was reported that the patient was experiencing blisters in the back and pain. This was a light case of shingles but the patient said it was painful and she could barely walk. The pharmacist mentioned that at time the patient had received ZOSTAVAX vaccine (Merck), she experience soreness and inflammation at an unspecified arm. The patient was given VALTRAX. No date were available for the onset of the blisters and pain or the soreness and inflammation. The pharmacist mentioned the physician may have reported this AE but could not find the case. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a medical assistant concerning an 84 year old male with ischaemic cardiomyopathy and diabetes and a history of defibrillator insertion who on 20-APR-2009 was vaccinated with ZOSTAVAX (lot number 663637/1705X). Concomitant therapy included METFORMIN, GLIMEPIRIDE, HUMULIN, DIOVAN, TOPROL XL TABLETS and VIAGRA. There were no drug reactions and allergies. On 16-MAY-2009 the patient had shingles which was a "rash located around the patient's defibrillator on the left side on the bottom". On 18-MAY-2009, the patient had sought medical attention in the office. Lab diagnostics studies were not performed. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Varicella
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with unknown drug allergies and unknown medical history who "last week" on approximately 13-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck). The patient developed chickenpox and diarrhea 36 hours after ZOSTAVAX (Merck) was given. The patient sought medical attention by speaking with the pharmacist. It was unspecified it lab studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an over 60-year old female who on an unspecified date was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (LOT# not reported).  It was reported that 5 days after vaccination.  The patient developed a case of shingles on her neck.  The patient sought an unspecified medical attention.  The outcome was not recovered.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Pain
Clinical narrative: Information has been received from a consumer concerning her husband a 62 year old male with neuralgia from phantom limb pain who on 19-MAY-2009 was vaccinated with ZOSTAVAX vaccine (Merck) (Lot# not reported). Concomitant therapy included PPD. On 19-MAY-2009, since vaccination, the patient developed headache, achy, injection site red reaction with a 2.5 inch red area and may have a fever. It was reported that the patient was not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a consumer concerning her sister, a 63 year old female who in May 2007, was vaccinated with ZOSTAVAX (Merck) (route and site not reported).  In March 2008, the patient acquired a bad case of shingles and developed post herpetic neuralgia.  The patient had required multiple doctor visits and taken NEURONTIN for her pain.  At the time of reporting, the symptoms of "post herpetic neuralgia" was still ongoing but was getting better, but the outcome of shingles was unknown.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient in her early 60s with unspecified drug allergies and no pertinent medical history who a "couple of months ago" was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, the patient came down with shingles during the "middle of last week". The patient sought unspecified medical attention. It was unspecified if lab studies were performed. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a 58 year old female consumer with no known drug allergies and a history of genital herpes who in February 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) "for the prevention of shingles".  The patient called to report her positive experience with ZOSTAVAX (Merck).  The patient reported, prior to receiving ZOSTAVAX (Merck), she was diagnosed with genital herpes and would experience weekly outbreaks.  Subsequently, immediately after receiving ZOSTAVAX (Merck), she noticed that she no longer had the genital herpes outbreaks.  The Patient sought medical attention.  She was seen by the physician.  There were no laboratory studies performed.  At the time of report, the patient's status was unknown.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: Information has been received from a pharmacist concerning a patient with unknown drug allergies and unknown medical history who "about 3 weeks ago" on approximately 30-APR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, the patient developed hemolytic anemia on an unspecified date. Medical attention was sought. The patient had an office visit. The patient's hemoglobin level was 7. At the time of report, the patient's status was unknown. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 61 year old female patient with hypothyroidism and no drug reactions or allergies who on 20-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) 0.65ml. Concomitant therapy included LEVOTHYROXINE NA. On 21-MAY-2009 after got the vaccine she developed red hot and hard to touch bump at the injection site. At the time on the report on 22-MAY-2009 the patient had not recovered. There were no laboratories diagnostics studies performed. The patient did not seek medical attention. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning herself with no pertinent medical history and with penicillin allergy who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously.  There was no concomitant medication reported.  It was reported that on an unspecified date she developed an injection site reaction after receiving ZOSTAVAX (Merck).  She developed a 6 inch diameter of redness at the site.  It was also reported that she experienced pain and soreness at the site.  The patient did not seek medical attention.  There were no laboratory diagnostic tests performed.  It was reported that the patient had recovered "2-3 weeks after the vaccination".  No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pain
Clinical narrative: Information has been received from a physician concerning a 60 year old female patient who on 22-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) 0.65ml, intramuscularly. On 22-MAY-2009 she experienced soreness and was treated with ice packs. At the time on the report on 22-MAY-2009 the patient had not recovered. The patient sought unspecified medical attention. There were no laboratories diagnostics studies performed. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Skin exfoliation, Skin lesion
Clinical narrative: Information has been received from a 68 year old female with early heart beat; arthritis and thrush from an antibiotic who on 06-MAR-2009 was vaccinated with a 0.65 mL first dose of ZOSTAVAX vaccine (Merck), subcutaneously. There was no concomitant medication. Within 3 weeks after getting the ZOSTAVAX vaccine (Merck) dose the patient stated that she developed a "sore on my ring finger on my left hand between the last knuckle and the cuticle that looked like a burn". The reporter also stated that "the redness is gone but there are little bubbles where the sore was, and the skin has been peeling off". No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient was recovering. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Abnormal behaviour, Crying, Grand mal convulsion, Hypotonia, Speech disorder
Clinical narrative: Information has been received regarding a case in litigation. A 13 month old male with well-child visit who on 24-JAN-2001 was vaccinated with VARIVAX (Merck). Concomitant therapy included PREVNAR. The next morning the patient "cried out, became limp and trembled". After a similar episode about 15 minutes later, his parents brought him to a hospital emergency room. A hospital physician diagnosed an "acute seizure disorder", and the boy was discharged in "good" condition. On 27-JAN-2001 the patient was again in the emergency room with a "grand mal seizure" lasting one minute and 20 seconds. He was eventually given DILANTIN, an anti-seizure medication. Although initial observations were that the patient was developing normally. On 02-OCT-2001, a neurologist noted that his speech was poor and that he demonstrated "behavior disturbances". Upon internal review, acute seizure disorder and grand mal seizure were determined to be other important medical events. No further information is available.
Age: 1.1
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Tremor
Clinical narrative: Information has been received regarding a case in litigation. A 13 month old male with well-child visit who on 24-JAN-2001 was vaccinated with VARIVAX (Merck). Concomitant therapy included PREVNAR. The next morning the patient "cried out, became limp and trembled". After a similar episode about 15 minutes later, his parents brought him to a hospital emergency room. A hospital physician diagnosed an "acute seizure disorder", and the boy was discharged in "good" condition. On 27-JAN-2001 the patient was again in the emergency room with a "grand mal seizure" lasting one minute and 20 seconds. He was eventually given DILANTIN, an anti-seizure medication. Although initial observations were that the patient was developing normally. On 02-OCT-2001, a neurologist noted that his speech was poor and that he demonstrated "behavior disturbances". Upon internal review, acute seizure disorder and grand mal seizure were determined to be other important medical events. No further information is available.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Botulism, Cervical spinal stenosis, Gait disturbance, Gastrooesophageal reflux disease, Hypotonia
Clinical narrative: Information has been received via a literature article regarding a case in litigation concerning a 6 month old female who on "04-OCT-2006" (date reported in article) and 22-SEP-2003 was vaccinated with the first and second PEDVAXHIB (OMPC) respectively. Concomitant therapy included DTAP. The six months "well-child" evaluation, at which all aspects of her development were found to be normal. On 07-OCT-2002, her father reported she had a cold, which worsened over the next several weeks. By 12-NOV-2002 the child had become lethargic and limp. Physicians suspected a virus or septicemia or infant botulism. Magnetic resonance imaging (MRI) revealed abnormalities of the cervical spine. On 22-SEP-2003, the patient received the second dose of PEDVAXHIB vaccinations without any adverse effect. The Vaccine Court special master reported that it was felt that transverse myelitis was more likely that the child's injury stemmed from a viral infection. The patient's failure to react to a second administration of the vaccine and the presence of "96 percent polymorphonuclear cells" suggested a direct viral invasion and not a vaccine reaction. The only evidence in favor of a vaccine reaction was the timing of the injury, which was not enough to satisfy the "logical sequence of cause and effect" tying the vaccine with the injury. Upon internal review, transverse myelitis was determined to be an other important medical event. Additional information has been requested. 12/31/09 No, she is still a quadraplegic with reievogenic bladder, bowel issues, esophogal relex and other issues.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Intestinal functional disorder, Lethargy, Myelitis transverse, Nasopharyngitis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received via a literature article regarding a case in litigation concerning a 6 month old female who on "04-OCT-2006" (date reported in article) and 22-SEP-2003 was vaccinated with the first and second PEDVAXHIB (OMPC) respectively. Concomitant therapy included DTAP. The six months "well-child" evaluation, at which all aspects of her development were found to be normal. On 07-OCT-2002, her father reported she had a cold, which worsened over the next several weeks. By 12-NOV-2002 the child had become lethargic and limp. Physicians suspected a virus or septicemia or infant botulism. Magnetic resonance imaging (MRI) revealed abnormalities of the cervical spine. On 22-SEP-2003, the patient received the second dose of PEDVAXHIB vaccinations without any adverse effect. The Vaccine Court special master reported that it was felt that transverse myelitis was more likely that the child's injury stemmed from a viral infection. The patient's failure to react to a second administration of the vaccine and the presence of "96 percent polymorphonuclear cells" suggested a direct viral invasion and not a vaccine reaction. The only evidence in favor of a vaccine reaction was the timing of the injury, which was not enough to satisfy the "logical sequence of cause and effect" tying the vaccine with the injury. Upon internal review, transverse myelitis was determined to be an other important medical event. Additional information has been requested. 12/31/09 No, she is still a quadraplegic with reievogenic bladder, bowel issues, esophogal relex and other issues.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Quadriplegia, Viral infection, White blood cell count increased
Clinical narrative: Information has been received via a literature article regarding a case in litigation concerning a 6 month old female who on "04-OCT-2006" (date reported in article) and 22-SEP-2003 was vaccinated with the first and second PEDVAXHIB (OMPC) respectively. Concomitant therapy included DTAP. The six months "well-child" evaluation, at which all aspects of her development were found to be normal. On 07-OCT-2002, her father reported she had a cold, which worsened over the next several weeks. By 12-NOV-2002 the child had become lethargic and limp. Physicians suspected a virus or septicemia or infant botulism. Magnetic resonance imaging (MRI) revealed abnormalities of the cervical spine. On 22-SEP-2003, the patient received the second dose of PEDVAXHIB vaccinations without any adverse effect. The Vaccine Court special master reported that it was felt that transverse myelitis was more likely that the child's injury stemmed from a viral infection. The patient's failure to react to a second administration of the vaccine and the presence of "96 percent polymorphonuclear cells" suggested a direct viral invasion and not a vaccine reaction. The only evidence in favor of a vaccine reaction was the timing of the injury, which was not enough to satisfy the "logical sequence of cause and effect" tying the vaccine with the injury. Upon internal review, transverse myelitis was determined to be an other important medical event. Additional information has been requested. 12/31/09 No, she is still a quadraplegic with reievogenic bladder, bowel issues, esophogal relex and other issues.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abnormal behaviour, Acute disseminated encephalomyelitis, Agitation, Biopsy brain abnormal, Blood creatinine normal
Clinical narrative: This case was initially received from the FDA on 10 April 2009.  Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770).  A 12-year-old male patient received the following vaccines on 19 April 2008:  an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck).  Lot numbers and site of administration not reported.  It was noted that the patient had received five prior doses of TDAP.  On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache.  He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head".  He also experienced vomiting and a fever.  He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis.  Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2.  Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos.  CSF protein was also increased.  A biopsy of the brain was abnormal.  Blood cultures were negative.  He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted.  He was subsequently intubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax.  He developed  seizure-like spell, and required a nasogastric tube for nutrition.  Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language.  He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections.  In July 2008 he began to show improvement, and was able to ambulate with assistance.  He was discharged to a rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy.  Outcome was not reported.  Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blood culture negative, Blood glucose normal, Blood potassium decreased, Blood sodium decreased, Blood urea normal
Clinical narrative: This case was initially received from the FDA on 10 April 2009.  Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770).  A 12-year-old male patient received the following vaccines on 19 April 2008:  an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck).  Lot numbers and site of administration not reported.  It was noted that the patient had received five prior doses of TDAP.  On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache.  He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head".  He also experienced vomiting and a fever.  He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis.  Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2.  Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos.  CSF protein was also increased.  A biopsy of the brain was abnormal.  Blood cultures were negative.  He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted.  He was subsequently intubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax.  He developed  seizure-like spell, and required a nasogastric tube for nutrition.  Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language.  He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections.  In July 2008 he began to show improvement, and was able to ambulate with assistance.  He was discharged to a rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy.  Outcome was not reported.  Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: CSF cell count normal, CSF lymphocyte count increased, CSF monocyte count decreased, CSF neutrophil count, CSF protein increased
Clinical narrative: This case was initially received from the FDA on 10 April 2009.  Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770).  A 12-year-old male patient received the following vaccines on 19 April 2008:  an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck).  Lot numbers and site of administration not reported.  It was noted that the patient had received five prior doses of TDAP.  On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache.  He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head".  He also experienced vomiting and a fever.  He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis.  Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2.  Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos.  CSF protein was also increased.  A biopsy of the brain was abnormal.  Blood cultures were negative.  He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted.  He was subsequently intubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax.  He developed  seizure-like spell, and required a nasogastric tube for nutrition.  Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language.  He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections.  In July 2008 he began to show improvement, and was able to ambulate with assistance.  He was discharged to a rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy.  Outcome was not reported.  Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Candidiasis, Clumsiness, Confusional state, Convulsion, Cough
Clinical narrative: This case was initially received from the FDA on 10 April 2009.  Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770).  A 12-year-old male patient received the following vaccines on 19 April 2008:  an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck).  Lot numbers and site of administration not reported.  It was noted that the patient had received five prior doses of TDAP.  On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache.  He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head".  He also experienced vomiting and a fever.  He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis.  Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2.  Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos.  CSF protein was also increased.  A biopsy of the brain was abnormal.  Blood cultures were negative.  He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted.  He was subsequently intubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax.  He developed  seizure-like spell, and required a nasogastric tube for nutrition.  Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language.  He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections.  In July 2008 he began to show improvement, and was able to ambulate with assistance.  He was discharged to a rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy.  Outcome was not reported.  Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Endotracheal intubation, Gastrointestinal tube insertion, Haematocrit normal, Haemoglobin normal
Clinical narrative: This case was initially received from the FDA on 10 April 2009.  Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770).  A 12-year-old male patient received the following vaccines on 19 April 2008:  an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck).  Lot numbers and site of administration not reported.  It was noted that the patient had received five prior doses of TDAP.  On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache.  He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head".  He also experienced vomiting and a fever.  He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis.  Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2.  Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos.  CSF protein was also increased.  A biopsy of the brain was abnormal.  Blood cultures were negative.  He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted.  He was subsequently intubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax.  He developed  seizure-like spell, and required a nasogastric tube for nutrition.  Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language.  He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections.  In July 2008 he began to show improvement, and was able to ambulate with assistance.  He was discharged to a rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy.  Outcome was not reported.  Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Influenza like illness, Intensive care, Mean cell volume normal, Panic reaction
Clinical narrative: This case was initially received from the FDA on 10 April 2009.  Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770).  A 12-year-old male patient received the following vaccines on 19 April 2008:  an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck).  Lot numbers and site of administration not reported.  It was noted that the patient had received five prior doses of TDAP.  On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache.  He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head".  He also experienced vomiting and a fever.  He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis.  Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2.  Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos.  CSF protein was also increased.  A biopsy of the brain was abnormal.  Blood cultures were negative.  He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted.  He was subsequently intubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax.  He developed  seizure-like spell, and required a nasogastric tube for nutrition.  Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language.  He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections.  In July 2008 he began to show improvement, and was able to ambulate with assistance.  He was discharged to a rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy.  Outcome was not reported.  Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Platelet count normal, Posturing, Pyrexia, Speech disorder, Staphylococcal infection
Clinical narrative: This case was initially received from the FDA on 10 April 2009.  Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770).  A 12-year-old male patient received the following vaccines on 19 April 2008:  an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck).  Lot numbers and site of administration not reported.  It was noted that the patient had received five prior doses of TDAP.  On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache.  He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head".  He also experienced vomiting and a fever.  He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis.  Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2.  Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos.  CSF protein was also increased.  A biopsy of the brain was abnormal.  Blood cultures were negative.  He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted.  He was subsequently intubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax.  He developed  seizure-like spell, and required a nasogastric tube for nutrition.  Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language.  He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections.  In July 2008 he began to show improvement, and was able to ambulate with assistance.  He was discharged to a rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy.  Outcome was not reported.  Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Unresponsive to stimuli, Urinary tract infection, Vomiting, White blood cell count normal
Clinical narrative: This case was initially received from the FDA on 10 April 2009.  Additional information was extracted from the VAERS database on 13 April 2009 (reference number 314770).  A 12-year-old male patient received the following vaccines on 19 April 2008:  an intramuscular injection of ADACEL, intramuscular first injection of MENACTRA, and subcutaneous second injection of VARIVAX (Merck).  Lot numbers and site of administration not reported.  It was noted that the patient had received five prior doses of TDAP.  On 13 May 2008, 24 days post-vaccination, the patient developed flu-like symptoms including cough, slight fever, and headache.  He appeared to recover after a few days, but then on 20 May 2008 had a worsening headache, dizziness, clumsiness, confusion, and experienced episodes of panicking and "talking out of his head".  He also experienced vomiting and a fever.  He was taken to the local emergency department on 21 May 2008 and on 22 May 2008 was admitted to the pediatric intensive care unit of another hospital, where he was diagnosed with acute disseminating encephalomyelitis.  Initial laboratory values included WBC 5.1, hemoglobin 14.3, hematocrit 41.7, MCV 85.6, platelets 281,000, glucose 88, BUN 15, creatinine 0.8, sodium 133, potassium 3.2.  Cerebrospinal fluid was clear and colorless with 1% segs, 89% lymphs, and 10% monos.  CSF protein was also increased.  A biopsy of the brain was abnormal.  Blood cultures were negative.  He was treated with high-dose steroids, plasmapheresis, and intravenous immunoglobulin, with no improvement noted.  He was subsequently intubated after an internal jugular line insertion attempt resulted in a lung puncture and pneumothorax.  He developed  seizure-like spell, and required a nasogastric tube for nutrition.  Posturing was noted on exam on 03 June 2008, and the patient was unable to follow commands and spoke in nonsensical language.  He developed agitation which was treated with medication (unspecified), and also developed Candida and Saprophyticus urinary tract infections.  In July 2008 he began to show improvement, and was able to ambulate with assistance.  He was discharged to a rehabilitation facility on 25 July 2008 with ongoing speech, occupational, and physical therapy.  Outcome was not reported.  Per the FDA, this case meets the Brighton Collaboration probable or confirmed ADEM case definition of diagnostic certainty for Level 1 or 2.
Age: 53.0
Sex: F
Vaccine: HEPA, TDAP, YF
Symptoms: Erythema, Swelling
Clinical narrative: A 53 year old female patient received on 23 June 2008 a right arm subcutaneous injection of YF-VAX (lot # UF305AA), a right deltoid intramuscular injection of ADACEL (lot # C2774AA), and a left arm intramuscular injection of HAVRIX (GSK, lot # AHAVB224AA).  The patient's only reported medical history was a penicillin allergy and she had no illness at the time of vaccination.  On 26 June 2008, 3 days post vaccination, the patient had a nickel size  2008.  On 28 June 2008, the red spot continued so she took CLARITIN instead of BENADRYL, because BENADRYL made her sleepy.  Also, on 28 June 2008, the patient's right shoulder began to swell with fluid and on the following day the swelling had increased to the size of a baseball.  There was no heat or redness.  On 30 June 2008, the swelling remained the same.  The patient had no respiratory difficulties or any other symptoms.  At the time of the report, the patient had not recovered.  Follow up information was received on 14 August 2008 from a health care professional.  The patient received a first time injection of YF VAX and HAVRIX and also received an injection of ADACEL (previous number of doses unknown) on 23 June 2008.  The patient fully recovered from the events on 05 July 2008, 10 days after the start of the events.  No further information was provided.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Initial report received on 11 July 2008 from a health care professional. A female patient (demographics not reported) had received a dose of ADACEL (Lot # not reported) on 08 July 2008. The route and site of administration was not reported. The following day, the patient was unable to open her fingers on both hands. The patient did not experience any pain. The recovery status was not reported. Follow-up information received from a health care professional on 15 September 2008. The 22-year-old female patient had received ADACEL (lot number C2758AA) to the left shoulder on 08 July 2008 at 16:00 hours. Adverse event onset occurred the next day at 15:30 hours. The patient also developed a mild fever and TYLENOL was prescribed. A few days later, the patient recovered.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Nausea, Pyrexia
Clinical narrative: This case was received from a health professional on 04 June 2008. A 35-year-old male patient, with no medical history, received a left deltoid injection of ADACEL (lot number C2557AA) following an unspecified injury to his left calf. The vaccine was administered on 02 June 2008, and within 24 hours the patient began experiencing nausea, chills, fever, and dyspnea. He called his physician on 04 June 2008 and reported that he was feeling better, but was leaving work to "go home to rest". According to the reporter, the patient was still recovering. No diagnostic testing or treatment was reported. Of note, the patient's brother had experienced vomiting after receiving a Tetanus vaccine at the age of 11 (no other details provided). Follow up information was received on 06 August 2008 from a health care professional. The patient received an injection of ADACEL after an injury to the left leg from a rusty pipe. The patient's symptoms lasted for 48 hours. The patient subsequently recovered from the events. No further information was reported.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial non-serious case received from a health care professional on 19 August 2008.  A 14-year-old male patient developed a large (20cm) raised, reddened,painful area over the left deltoid that was hot to the touch, after he had received an intramuscular injection of ADACEL (lot number C2863AA).  Date of vaccination and onset date of the adverse event were not reported.  It was reported that the patient had no pre-existing medical conditions;  however, it was also reported that "cellulitis" (site not specified) was present at time of vaccination.  Recovery status for the adverse event was not reported.  No additional medically relevant details were provided.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Pain, Tremor, Vomiting
Clinical narrative: Initial information received from a health care professional on 31 July 2008. An 18-year-old male patient with a history of seasonal allergies received initial doses of ADACEL, lot number C2766AA, administered intramuscularly in the right deltoid, and MENACTRA, lot number U2614AA, administered intramuscularly in the left deltoid on the afternoon of 30 July 2008. The vaccines were administered with 1 inch needles and 3cc syringes. The patient also received a tuberculin skin test with APLISOL (manufacturer Parke Davis), lot number 62418, on the same date. The patient complained of feeling tired at the time the injections were administered. Hours later, at 2:00 am on 31 July 2008, the patient developed shaking, was weak and vomited twice. He also felt that his "skin was hurting everywhere". He was seen by a physician at 11:15 am on 31 July 2008. His temperature was recorded as 96.7 Fahrenheit and no other vital signs were available. No laboratory work was completed. The patient called the physician's office at 1:00 pm that same day and reported that he was "feeling better". His recovery status was reported as unknown. Follow-up information received on 06 October 2008 from the original reporter who is a health care professional. Per the reporter, the adverse event of weakness was generalized. The recovery status of the patient was reported as "recovered"; however, the date of recovery was not provided. No further information is expected. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: CSF glucose increased, CSF protein increased, CSF white blood cell count increased, Computerised tomogram normal, Encephalitis
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 327552). A 12 year old male patient received ADACEL and MENACTRA (lot number not reported) intramuscularly on 26 September 2008. On 08 October 2008, the patient developed meningoencephalitis, altered mental status requiring intubation, fever, first time tonic clonic seizure, and was incontinent of urine. The patient required mechanical ventilation. Records stated that the patient had a fight at school, became more sleepy, fell off the couch with shaking movements observed, and foaming at the mouth. The patient was unresponsive to painful stimuli. CSF WBC 158, RBC 4, Protein 97, Glucose 83, Varicella PCR was pending. CT scan was negative. Lumbar puncture showed leukocytosis with lymphocytic predominance all consistent with viral meningoencephalitis. The patient was hospitalized from 05 October 2008 to 11 October 2008. The discharge diagnosis was viral encephalitis. Outcome was reported as life threatening.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Encephalitis viral, Endotracheal intubation, Fall, Fight in school, Foaming at mouth
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 327552). A 12 year old male patient received ADACEL and MENACTRA (lot number not reported) intramuscularly on 26 September 2008. On 08 October 2008, the patient developed meningoencephalitis, altered mental status requiring intubation, fever, first time tonic clonic seizure, and was incontinent of urine. The patient required mechanical ventilation. Records stated that the patient had a fight at school, became more sleepy, fell off the couch with shaking movements observed, and foaming at the mouth. The patient was unresponsive to painful stimuli. CSF WBC 158, RBC 4, Protein 97, Glucose 83, Varicella PCR was pending. CT scan was negative. Lumbar puncture showed leukocytosis with lymphocytic predominance all consistent with viral meningoencephalitis. The patient was hospitalized from 05 October 2008 to 11 October 2008. The discharge diagnosis was viral encephalitis. Outcome was reported as life threatening.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Grand mal convulsion, Leukocytosis, Lumbar puncture abnormal, Mechanical ventilation, Mental status changes
Clinical narrative: This serious case was extracted from the VAERS database on 28 March 2009 (reference number 327552). A 12 year old male patient received ADACEL and MENACTRA (lot number not reported) intramuscularly on 26 September 2008. On 08 October 2008, the patient developed meningoencephalitis, altered mental status requiring intubation, fever, first time tonic clonic seizure, and was incontinent of urine. The patient required mechanical ventilation. Records stated that the patient had a fight at school, became more sleepy, fell off the couch with shaking movements observed, and foaming at the mouth. The patient was unresponsive to painful stimuli. CSF WBC 158, RBC 4, Protein 97, Glucose 83, Varicella PCR was pending. CT scan was negative. Lumbar puncture showed leukocytosis with lymphocytic predominance all consistent with viral meningoencephalitis. The patient was hospitalized from 05 October 2008 to 11 October 2008. The discharge diagnosis was viral encephalitis. Outcome was reported as life threatening.