chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Convulsion, Dyspnoea, Scan brain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 6-month-old male subject who was vaccinated with Pediarix for prophylaxis. Previous and/or concurrent vaccination included Haemophilus influenzae type b vaccine given on 19 December 2006; influenza vaccine given on 19 December 2006; influenza virus vaccine given on 19 December 2006; pneumococcal vaccine given on 19 December 2006. On 19 December 2006 at 10:30 the subject received 3rd dose of Pediarix (.5 ml, unknown). On 19 December 2006, 3 hours after vaccination with Pediarix, the subject experienced "continual" seizure and problem breathing. The subject was hospitalised for 3 days and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The reporter stated that even though the subject received additional vaccines that day, it was thought that Pediarix was the cause of the adverse events. Follow up information received on 19 January 2007 indicated that the reporter felt that the events were not related to treatment with Pediarix. The events remained resolved and were not considered at the time of follow-up to be severely or permanently disabling.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Petechiae
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of petechiae in a 4-month-old female subject who was vaccinated with Pediarix for prophylaxis.  Concurrent vaccination included Prevnar given on 27 March 2007.  On 27 March 2007 the subject received 2nd dose of Pediarix at 0.5 ml in the left thigh.  In 2007, at an unspecified time after vaccination with Pediarix, the subject experienced petechiae on the bilateral lower extremities.  The event resolved within one week without treatment.  The healthcare professional considered the event was probably related to vaccination with Pediarix.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Crying, Hypersomnia, Pyrexia, Screaming
Clinical narrative: This case was reported by a consumer and described the occurrence of fussy in a 4-month-old female subject who was vaccinated with Pediarix for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent vaccination included Haemophilius influenzae type b vaccine; Aventis given on 3 May 2007 and 24 July 2007; pneumococcal vaccine, unspecified; given on 3 May 2007 and 24 July 2007.  On 3 May 2007 and 24 July 2007 the subject received 1st dose and 2nd dose of Pediarix (.5 ml, unknown).  Less than one day after vaccination with Pediarix, the subject experienced fussy and not being oneself.  The events resolved at an unspecified time.  Following vaccination with Pediarix on 24 Aug 2007, the six-month old subject also experienced not being oneself, screaming without control, excessive sleep and fever.  At the time of reporting the events were improved.
Age: 18.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Headache, Inappropriate schedule of drug administration, Injection site pain, Local reaction, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a 18-year-old female subject who was vaccinated with Pediarix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included Birth control. On 13 August 2007, the subject presented for vaccination with Gardasil. Instead, on 13 August 2007 at 11:15 the subject was mistakenly vaccinated with Pediarix (unknown, right arm) instead of Gardasil. The consumer reported that she was notified that she received "the third dose of Pediarix". On 13 August 2007, less than one day after vaccination with Pediarix, the subject experienced headache and arm pain at injection site. At the time of reporting the outcome of the events were was unspecified. On 16 October 2007, follow-up was received from the healthcare professional. The reporter indicated that on 13 August 2007, the subject experienced a headache and arm pain at the injection site. she was diagnosed with a local reaction. The headache and arm pain lasted less that twenty four hours. The events resolved on 14 August 2007. The reporter considered that the events were not serious and related to the use of Pediarix. She noted that the events could have been associated with the erroneous administration of Pediarix.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old female subject who was vaccinated with Pediarix for prophylaxis.  Concurrent vaccination included HIB given on 9 August 2007.  On 9 August 2007 the subject received 1st dose of Pediarix at 0.5 ml in the left thigh.  An unspecified amount of time after vaccination with Pediarix, the subject developed a fever.  The fever lasted for two days and then resolved.  On the third day following vaccination with Pediarix, the subject developed a rash starting on the face and chest then spreading to the torso and legs.  The rash was described as spotty, flat and red.  The nurse felt that the events could possibly be related to heat.  The child had no problem with feedings and was not having any respiratory problems.  At the time of reporting the rash was worse.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Fatigue, Screaming, Sleep disorder
Clinical narrative: This case was reported by a sales representative via a physician and described the occurrence of screaming in a 2-month-old male subject who was vaccinated with Pediarix for prophylaxis. On 17 August 2007 the subject received 1st dose of Pediarix (.5 ml, unknown). On 17 August 2007, less than one day after vaccination with Pediarix, the subject experienced screaming to the point of exhaustion, crying and sleep interruption. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with Pediarix.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 4 and one-half month-old male subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  On 30 August 2007 the subject received 3rd dose of Pediarix (.5 ml, unknown).  On 30 August 2007, at an unspecified time after vaccination with Pediarix, the subject experienced fever and inappropriate schedule of drug administration as the subject had received a vaccination at 2 and 4 months of age.  The third dose was inadvertently given at 4 and one-half months of age.  At the time of reporting the outcome of the events was unspecified.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Irritability, Pyrexia, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of inappropriate schedule of drug administration in a 6-month-old male subject who was vaccinated with Pediarix for prophylaxis.  Concurrent vaccination included HIB (manufacturer unspecified), Rotateq, Prevnar (manufacturer unspecified) all given on 30 August 2007.  On 30 August 2007 at 10:00 the subject received 3rd dose of Pediarix at 0.5 ml.  First Pediarix was given to the child in June 2007, when the subject was 4 months old.  The 2nd dose of Pediarix was given to the subject in August 2007 and the 3rd dose was given only three weeks after the 2nd dose.  This was considered to be an inappropriate schedule of drug administration.  One day after the 3rd dose of Pediarix, on 31 August 2007, the subject developed fever, was cranky and had a lump on his right thigh.  The fever and crankiness improved.  The outcome of the thigh lump was not known.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Haematochezia
Clinical narrative: This case was reported by a physician and described the occurrence of bloody stools in a 4-month-old male subject who was vaccinated with Pediarix for prophylaxis. Concurrent medical conditions included enteropathy. Previous and/or concurrent vaccination included unspecified vaccine given on an unspecified date. On an unspecified date the subject received 1st dose of Pediarix (.5 ml, unknown). On an unspecified date, the subject received the second dose of Pediarix at 9 months of age. Less than one day after each vaccination with Pediarix, the subject experienced bloody stools. At the time of reporting the outcome of the event was unspecified. It was noted that it took several days for the event to resolve. The physician considered the event was possibly related to vaccination with Pediarix.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Condition aggravated, Hypersomnia, Medication error, Rhinorrhoea, Somnolence
Clinical narrative: This case was reported by a consumer and described the occurrence of increased runny nose in a 9-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject received no concurrent medications.  On 19 September 2007, no concurrent vaccines were administered.  On unspecified dates, the subject received the first two doses of Pediarix (unknown), and on 20 June 2007 she received the third dose of Pediarix (unknown).  At unspecified time(s) following one or more of the initial three Pediarix vaccinations, the subject experienced increased sleepiness and slept more.  On 19 September 2007 the subject was inadvertently administered a fourth dose of Pediarix (unknown).  On 19 September 2007, less than one day after vaccination with Pediarix, the subject experienced an "increased runny nose of clear discharge".  The subject also experienced increased "sleep habits" described as sleeping more, which the reporter noted "normally occurs".  At the time of reporting the outcome of the events was unspecified.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Skin test, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 3-month-old female subject who was vaccinated with Pediarix for prophylaxis. Concurrent vaccination included Hib vaccine, RotaTeq and Prevnar all given on 25 June 2007. On 25 June 2007 the subject received 1st dose of Pediarix (unknown). On 25 June 2007, approximately 5 to 6 hours after vaccination with Pediarix, the subject developed hives. The infant was sent to an allergist for skin testing. At the time of reporting the event was resolved. The healthcare professional considered the event was possibly related to vaccination with Pediarix.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a physician and described the occurrence of nodule injection site in a 2-month-old male subject who was vaccinated with Pediarix (GlaxoSmithKline), Prevnar (Wyeth) for prophylaxis.  Concurrent vaccination included ActHib (Aventis) and RotaTeq (Merck) both given on 27 September 2007.  On 27 September 2007 the subject received 1st dose of Pediarix at 0.5 ml in the left thigh.  On 27 September 2007 the subject received 1st dose of Prevnar at a different site in the left thigh.  Approximately 2 to 3 days (28 September 2007), after vaccination with Pediarix and Prevnar, the subject developed a nodule at the injection site (3cm x 3xcm wide and 1cm in elevation).  At the time of reporting the event was unresolved.  The physician considered the event was probably related to vaccination with Pediarix.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Injection site reaction, Oedema peripheral
Clinical narrative: This case was reported by a consumer, the patient's mother, and described the occurrence of fever in a 2-month-old female subject who was vaccinated with Pediarix for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent medical conditions included healthy infant.  Previous and/or concurrent vaccination included HIB given on 19 December 2006; Prevnar, given on 19 December 2006.  There were no concurrent medications.  On 19 December 2006 the subject received 1st dose of Pediarix (.5 unknown, unknown).  On 19 December 2006, less than one day after vaccination with Pediarix, the subject experienced fever of 100.4 for 24 hours after the vaccination and injection site reaction.  An unspecified time after vaccination with Pediarix the subject experienced bilateral leg swelling with a "hard knot" that lasted for approximately four weeks.  The reporter did not know in which leg the subject received the vaccination.  She was treated with acetaminophen (Tylenol) for the fever.  At the time of reporting, the events were resolved.  According to the reporter, the physician had delayed the subject's next dose of Pediarix until the six month visit.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV
Symptoms: Inappropriate schedule of drug administration, Injection site cellulitis, Injection site erythema, Injection site oedema, Medication error
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 1-year-old male subject who was vaccinated with Pediarix for prophylaxis. The subject had no adverse events following receipt of prior immunizations. The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported. There were no concurrent medications. On 12 December 2006 at 10:00 a.m. the subject received 4th dose of Pediarix in the right arm. Pediarix is not recommended as a booster (or 4th dose) in the diphtheria and tetanus toxoids and acellular pertussis vaccine or inactivated poliovirus vaccine immunization series. On 12 December 2006, the subject also received Hib vaccine and influenza virus vaccine at unspecified sites of administration. On 13 December 2006, 1 day after vaccination with Pediarix, the subject experienced redness and edema at the injection site of Pediarix. On 14 December 2006, the subject was seen at a physician's office and was diagnosed with injection site cellulitis. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Rocephin and Augmentin. At the time of initial reporting, 14 March 2007, the events were resolved.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 6-month-old subject of unspecified gender who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  On 26 March 2007 the subject received an unspecified dose of Pediarix.  On 26 March 2007, less than one day after vaccination with Pediarix, the subject experienced a rash (specified of rash not described).  The subject was seen in an urgent care center and treated with Benadryl.  At the time of reporting the outcome of the event was unspecified.  The healthcare professional considered the event was probably related to vaccination with Pediarix.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ocular hyperaemia, Wheezing
Clinical narrative: This case was reported by a pharmacist and described the occurrence of wheezing in an infant male subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  The subject's date of birth was thought to be around 12 September 2006.  Previous and/or concurrent vaccination included ActHIB (Aventis Pasteur); unknown given on 15 November 2006, 26 January 2007 and 27 March 2007; hepatitis B vaccine (manufacturer unspecified); unknown given on 12 September 2006; Rotateq (Merck); unknown given on 15 November 2006, 26 January 2007 and 27 March 2007; Prevnar (Wyeth Labs); unknown given on 15 November 2006, 26 January 2007 and 27 March 2007.  On 15 November 2006, 26 January 2007 and 27 March 2007 the subject received 1st dose, 2nd dose and 3rd dose of Pediarix (unknown).  On 17 November 2006, 2 days after vaccination with 1st dose of Pediarix, the subject experienced wheezing and eye erythema.  According to the reporting pharmacist, these events recurred 1 to 2 days following vaccination with 2nd and 3rd doses of Pediarix administered on 26 January 2007 and 27 March 2007, respectively.  The wheezing and eye erythema resolved on an unspecified date after the 1st dose of Pediarix.  The outcomes of the events after the 2nd and 3rd doses of Pediarix were unspecified.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Urticaria, Wrong technique in drug usage process
Clinical narrative: This case was reported by a pharmacist and described the occurrence of welt injection site in a subject of unspecified age and gender who was vaccinated with Pediarix for prophylaxis.  The pharmacist reported that "children" experienced welts at the injection site, however a specific number of subjects was not reported.  On an unspecified date on or before 26 April 2007, the subject received unspecified dose of Pediarix in an unspecified thigh.  At an unspecified time after vaccination with Pediarix, the subject experienced welt injection site.  The pharmacist reported that, "A new nurse's injection technique was evaluated and there was a possibility that the nurse is injecting the subjects subcutaneously instead of intramuscularly."  At the time of initial reporting the outcome of the events was unspecified.  Follow-up information received on 11 May 2007 indicated that Pediarix was inadvertently administered to the subject subcutaneously.  The events did resolve and according to the reporter, they were related to administration of Pediarix.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional via a sales representative, and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with Pediarix for prophylaxis. The subject had reportedly received "Deptacel" on unspecified date(s). On an unspecified date the subject received the third dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced decreased therapeutic response. The reporter indicated that "about 50 percent of patient ['s] ... levels of tetanus are below 0.1". It was noted that the subject required revaccination for tetanus, although medical attention was not required. At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a consumer and described the occurrence of leg knot in a male subject of unspecified age who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  The reporter is the parent of the subject.  A physician or other health care professional has not verified this report.  On an unspecified date before 17 May 2007, the subject received 1st dose of Pediarix at an unspecified date of injection.  At an unspecified time after vaccination with Pediarix, the subject experienced "a knot in his leg."  At the time of reporting the event was resolved.  The consumer reported that the leg knot "lasted over a month."  The consumer also reported that the subject, "only got Pediarix so far."
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hepatitis B core antigen positive, Hepatitis B surface antigen negative
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B core antigen positive in a 3-year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included Haemophilius influenzae type b vaccine (Merck) and PREVNAR (Wyeth) given on 31 August 2004. On 31 August 2004 the subject received 3rd dose of Pediarix at 0.5 ml in the right thigh. On 18 May 2007, 3 years after vaccination with Pediarix, the subject experienced hepatitis B core antigen positive and hepatitis B surface antigen negative. At the time of reporting the outcome of the events was unspecified.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, PNC
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a 4-month-old subject of unspecified gender who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  On an unspecified date on or after 01 November 2006 and before 08 November 2006, the subject received 2nd dose of Pediarix.  On the same day, the subject received Prevnar (Lederle Labs).  Approximately 2 hours after vaccination with Pediarix, on an unspecified date on or after 01 November 2006 and before 08 November 2006, the subject experienced "a rash on the abdomen which faded and then goes to other areas."  The subject was seen by a physician.  The outcome of the event was not reported.  The physician considered the event was probably related to vaccination with Pediarix.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date before 08 November 2006, the subject received unspecified dose of Pediarix. Approximately 2 hours after vaccination with Pediarix, on an unspecified date before 08 November 2006, the subject experienced "a rash on the abdomen which faded and then goes to other areas." The subject was seen by a physician. The outcome of the event was not reported. The physician considered the event was probably related to vaccination with Pediarix.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old female subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  The subject had no pre-existing medical conditions.  There were no concurrent medications.  On 28 November 2006 the subject received 1st dose of Pediarix.  On 28 November 2006 the subject also received PedvaxHIB (Merck) and Prevnar (Lederle Labs).  On 29 November 2006, 1 day after vaccination with Pediarix, the subject experienced a "high" fever, pain and "uncontrolled" crying.  The subject was seen at a physician's office.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The fever resolved on 30 November 2006.  At the time of initial reporting, 18 December 2006, the crying and pain were ongoing.  The healthcare professional considered the events were probably related to vaccination with Pediarix.  Follow-up information was received on 13 April 2007.  The subject received PedvaxHIB and Prevnar intramuscularly.  The reporting healthcare professional indicated the events improved on 16 January 2007.  At the time of reporting, the Pediarix had not been re-introduced to the subject and the immunization series with Pediarix had been delayed.  In addition, the subject had not received vaccination with subsequent DTaP doses.  The healthcare professional considered the events were possibly related to vaccination with Pediarix and believed that the DTaP components of Pediarix caused the events.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Crying, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 6-month-old subject of unspecified gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date on or before 18 December 2006, the subject received the 3rd dose of Pediarix. At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 18 December 2006, the subject experienced fever, pain and crying. The subject was seen at a physician's office. The healthcare professional considered the events were clinically significant (or requiring intervention). The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Pediarix. Follow-up information was received on 13 April 2007. Concurrent conditions included otitis media with onset of 12 December 2006. Previous and/or concurrent vaccinations included pneumococcal vaccine, unspecified, intramuscular given on 11 December 2006. The subject experienced pain, fever, and crying on 11 December 2006. The events resolved on an unknown date. The reporting healthcare professional indicated that she did not consider the events as serious, but thought they jeopardized the subject or required intervention. The immunization series with Pediarix was not re-introduced, discontinued, or delayed. The subject did not experience any adverse events following previous vaccinations. The healthcare professional considered the events were possibly related to vaccination with Pediarix and believed that the DTaP components of Pediarix caused the events.
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Crying, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a child of unspecified gender who was vaccinated with Pediarix for prophylaxis.  On an unspecified date on or before 18 December 2006, the subject received unspecified dose of Pediarix.  At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 18 December 2006, the subject experienced fever, pain and crying.  The subject was seen at a physician's office.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The outcome of the events was not reported.  The healthcare professional considered the events were probably related to vaccination with Pediarix.  Follow-up information was received on 13 April 2007 via a registered nurse, who reported that the subject was 4 months old (gender unspecified).  The subject received Prevnar and PedvaxHIB intramuscularly on 14 December 2006.  On 15 December 2006, the subject experienced fever, pain and crying.  As of 18 December 2006, the events were resolved.  The subject experienced no adverse events following previous vaccinations.  At the time of reporting, Pediarix had been reintroduced to the subject and the symptoms did not recur.  The reporting nurse initially indicated the events to be clinically significant (or requiring intervention); upon follow-up, the nurse also considered the events to be not serious.  The reporting nurse considered the events were possibly related to vaccination with Pediarix.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Activated partial thromboplastin time, Back pain, CSF cell count normal, Chest X-ray normal
Clinical narrative: 11/22/2007 sudden complaint of tingling of hands and upper back ache around 8:30 pm. Went to lay down. Couldn't get comfortable. Felt like heart was racing. Checked BP and pulse, both high for me at 150/96, pulse 98. Felt chills and body felt cold. I just did not feel good. Went to urgent care. Walked in from the parking lot holding onto husband's arm. Feeling generalized weakness. Diagnosed with dehydration. Unable to walk back to the car because legs felt weak, my husband wheeled me in the wheelchair to the car.  I held onto his arm walking into the house. I was told to drink Pedialite or Gatorade. Went straight to bed at around 10:00 pm. Drank Pedialite at bedside. Woke up at around 1 am on 11/23/2007, thinking Pedialite is too sweet, I need water. Husband was sleeping with our 10 month old son in his room. I sat at the edge of the bed thinking I need to get to the kitchen for water for my dehydration. I put my left foot on the floor and I ended up on my knees. I could not stand. I crawled to my son's room to wake up my husband to call 911. I was at ER around 1:30 am with both legs paralyzed and hands were very weak. I was admitted to ICU diagnosed by the Neurologist with Guillain-Barre Syndrome, suspected due to the Influenza Vaccine that I received 6 weeks prior. I had a CT scan, lumbar puncture, MRI and blood work done. The next day I was treated with Plasma Phoresis. I had 5 treatments over a course of 7 days. After each treatment I started to have little improvement in my right leg then left foot. I was then transferred to Rehabilitation Center on 12/4/2007. I was discharged home on 12/28/2007. I am wheelchair bound, but able to get around short distances with a front wheel walker. Left leg and left hand still weaker than right side. Weak grips. Nipple line to toes have impaired sensation. Currently disabled. I am receiving home health P.T. and will receive home health O.T. 1/22/08-records received for DOS 11/23-12/04/07 DC DX: Guillain Barre syndrome, status post plasmapheresis. Secondary diagnosis:urinary tract infection. Presented to ER with C/O weakness of both upper and lower extremities starting 1 day before admission. Feels sharp pain involving upper back and chest. Numbness and tingling to both upper and lower extremities. Inability to walk.  Per 60 day follow up: Still have weakness in left hand, weakness in left leg greater than right, impaired sensation from below breast line to toes, occasional leg spasms, loss of bladder control.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Computerised tomogram normal, Culture positive, Dehydration, Diplegia
Clinical narrative: 11/22/2007 sudden complaint of tingling of hands and upper back ache around 8:30 pm. Went to lay down. Couldn't get comfortable. Felt like heart was racing. Checked BP and pulse, both high for me at 150/96, pulse 98. Felt chills and body felt cold. I just did not feel good. Went to urgent care. Walked in from the parking lot holding onto husband's arm. Feeling generalized weakness. Diagnosed with dehydration. Unable to walk back to the car because legs felt weak, my husband wheeled me in the wheelchair to the car.  I held onto his arm walking into the house. I was told to drink Pedialite or Gatorade. Went straight to bed at around 10:00 pm. Drank Pedialite at bedside. Woke up at around 1 am on 11/23/2007, thinking Pedialite is too sweet, I need water. Husband was sleeping with our 10 month old son in his room. I sat at the edge of the bed thinking I need to get to the kitchen for water for my dehydration. I put my left foot on the floor and I ended up on my knees. I could not stand. I crawled to my son's room to wake up my husband to call 911. I was at ER around 1:30 am with both legs paralyzed and hands were very weak. I was admitted to ICU diagnosed by the Neurologist with Guillain-Barre Syndrome, suspected due to the Influenza Vaccine that I received 6 weeks prior. I had a CT scan, lumbar puncture, MRI and blood work done. The next day I was treated with Plasma Phoresis. I had 5 treatments over a course of 7 days. After each treatment I started to have little improvement in my right leg then left foot. I was then transferred to Rehabilitation Center on 12/4/2007. I was discharged home on 12/28/2007. I am wheelchair bound, but able to get around short distances with a front wheel walker. Left leg and left hand still weaker than right side. Weak grips. Nipple line to toes have impaired sensation. Currently disabled. I am receiving home health P.T. and will receive home health O.T. 1/22/08-records received for DOS 11/23-12/04/07 DC DX: Guillain Barre syndrome, status post plasmapheresis. Secondary diagnosis:urinary tract infection. Presented to ER with C/O weakness of both upper and lower extremities starting 1 day before admission. Feels sharp pain involving upper back and chest. Numbness and tingling to both upper and lower extremities. Inability to walk.  Per 60 day follow up: Still have weakness in left hand, weakness in left leg greater than right, impaired sensation from below breast line to toes, occasional leg spasms, loss of bladder control.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Eosinophil percentage increased, Feeling cold, Grip strength decreased, Guillain-Barre syndrome, Intensive care
Clinical narrative: 11/22/2007 sudden complaint of tingling of hands and upper back ache around 8:30 pm. Went to lay down. Couldn't get comfortable. Felt like heart was racing. Checked BP and pulse, both high for me at 150/96, pulse 98. Felt chills and body felt cold. I just did not feel good. Went to urgent care. Walked in from the parking lot holding onto husband's arm. Feeling generalized weakness. Diagnosed with dehydration. Unable to walk back to the car because legs felt weak, my husband wheeled me in the wheelchair to the car.  I held onto his arm walking into the house. I was told to drink Pedialite or Gatorade. Went straight to bed at around 10:00 pm. Drank Pedialite at bedside. Woke up at around 1 am on 11/23/2007, thinking Pedialite is too sweet, I need water. Husband was sleeping with our 10 month old son in his room. I sat at the edge of the bed thinking I need to get to the kitchen for water for my dehydration. I put my left foot on the floor and I ended up on my knees. I could not stand. I crawled to my son's room to wake up my husband to call 911. I was at ER around 1:30 am with both legs paralyzed and hands were very weak. I was admitted to ICU diagnosed by the Neurologist with Guillain-Barre Syndrome, suspected due to the Influenza Vaccine that I received 6 weeks prior. I had a CT scan, lumbar puncture, MRI and blood work done. The next day I was treated with Plasma Phoresis. I had 5 treatments over a course of 7 days. After each treatment I started to have little improvement in my right leg then left foot. I was then transferred to Rehabilitation Center on 12/4/2007. I was discharged home on 12/28/2007. I am wheelchair bound, but able to get around short distances with a front wheel walker. Left leg and left hand still weaker than right side. Weak grips. Nipple line to toes have impaired sensation. Currently disabled. I am receiving home health P.T. and will receive home health O.T. 1/22/08-records received for DOS 11/23-12/04/07 DC DX: Guillain Barre syndrome, status post plasmapheresis. Secondary diagnosis:urinary tract infection. Presented to ER with C/O weakness of both upper and lower extremities starting 1 day before admission. Feels sharp pain involving upper back and chest. Numbness and tingling to both upper and lower extremities. Inability to walk.  Per 60 day follow up: Still have weakness in left hand, weakness in left leg greater than right, impaired sensation from below breast line to toes, occasional leg spasms, loss of bladder control.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscular weakness, Nitrite urine present, Nuclear magnetic resonance imaging normal, Palpitations
Clinical narrative: 11/22/2007 sudden complaint of tingling of hands and upper back ache around 8:30 pm. Went to lay down. Couldn't get comfortable. Felt like heart was racing. Checked BP and pulse, both high for me at 150/96, pulse 98. Felt chills and body felt cold. I just did not feel good. Went to urgent care. Walked in from the parking lot holding onto husband's arm. Feeling generalized weakness. Diagnosed with dehydration. Unable to walk back to the car because legs felt weak, my husband wheeled me in the wheelchair to the car.  I held onto his arm walking into the house. I was told to drink Pedialite or Gatorade. Went straight to bed at around 10:00 pm. Drank Pedialite at bedside. Woke up at around 1 am on 11/23/2007, thinking Pedialite is too sweet, I need water. Husband was sleeping with our 10 month old son in his room. I sat at the edge of the bed thinking I need to get to the kitchen for water for my dehydration. I put my left foot on the floor and I ended up on my knees. I could not stand. I crawled to my son's room to wake up my husband to call 911. I was at ER around 1:30 am with both legs paralyzed and hands were very weak. I was admitted to ICU diagnosed by the Neurologist with Guillain-Barre Syndrome, suspected due to the Influenza Vaccine that I received 6 weeks prior. I had a CT scan, lumbar puncture, MRI and blood work done. The next day I was treated with Plasma Phoresis. I had 5 treatments over a course of 7 days. After each treatment I started to have little improvement in my right leg then left foot. I was then transferred to Rehabilitation Center on 12/4/2007. I was discharged home on 12/28/2007. I am wheelchair bound, but able to get around short distances with a front wheel walker. Left leg and left hand still weaker than right side. Weak grips. Nipple line to toes have impaired sensation. Currently disabled. I am receiving home health P.T. and will receive home health O.T. 1/22/08-records received for DOS 11/23-12/04/07 DC DX: Guillain Barre syndrome, status post plasmapheresis. Secondary diagnosis:urinary tract infection. Presented to ER with C/O weakness of both upper and lower extremities starting 1 day before admission. Feels sharp pain involving upper back and chest. Numbness and tingling to both upper and lower extremities. Inability to walk.  Per 60 day follow up: Still have weakness in left hand, weakness in left leg greater than right, impaired sensation from below breast line to toes, occasional leg spasms, loss of bladder control.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Plasmapheresis, Prothrombin time prolonged, Scan brain, Sensory loss
Clinical narrative: 11/22/2007 sudden complaint of tingling of hands and upper back ache around 8:30 pm. Went to lay down. Couldn't get comfortable. Felt like heart was racing. Checked BP and pulse, both high for me at 150/96, pulse 98. Felt chills and body felt cold. I just did not feel good. Went to urgent care. Walked in from the parking lot holding onto husband's arm. Feeling generalized weakness. Diagnosed with dehydration. Unable to walk back to the car because legs felt weak, my husband wheeled me in the wheelchair to the car.  I held onto his arm walking into the house. I was told to drink Pedialite or Gatorade. Went straight to bed at around 10:00 pm. Drank Pedialite at bedside. Woke up at around 1 am on 11/23/2007, thinking Pedialite is too sweet, I need water. Husband was sleeping with our 10 month old son in his room. I sat at the edge of the bed thinking I need to get to the kitchen for water for my dehydration. I put my left foot on the floor and I ended up on my knees. I could not stand. I crawled to my son's room to wake up my husband to call 911. I was at ER around 1:30 am with both legs paralyzed and hands were very weak. I was admitted to ICU diagnosed by the Neurologist with Guillain-Barre Syndrome, suspected due to the Influenza Vaccine that I received 6 weeks prior. I had a CT scan, lumbar puncture, MRI and blood work done. The next day I was treated with Plasma Phoresis. I had 5 treatments over a course of 7 days. After each treatment I started to have little improvement in my right leg then left foot. I was then transferred to Rehabilitation Center on 12/4/2007. I was discharged home on 12/28/2007. I am wheelchair bound, but able to get around short distances with a front wheel walker. Left leg and left hand still weaker than right side. Weak grips. Nipple line to toes have impaired sensation. Currently disabled. I am receiving home health P.T. and will receive home health O.T. 1/22/08-records received for DOS 11/23-12/04/07 DC DX: Guillain Barre syndrome, status post plasmapheresis. Secondary diagnosis:urinary tract infection. Presented to ER with C/O weakness of both upper and lower extremities starting 1 day before admission. Feels sharp pain involving upper back and chest. Numbness and tingling to both upper and lower extremities. Inability to walk.  Per 60 day follow up: Still have weakness in left hand, weakness in left leg greater than right, impaired sensation from below breast line to toes, occasional leg spasms, loss of bladder control.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis, White blood cell count decreased
Clinical narrative: 11/22/2007 sudden complaint of tingling of hands and upper back ache around 8:30 pm. Went to lay down. Couldn't get comfortable. Felt like heart was racing. Checked BP and pulse, both high for me at 150/96, pulse 98. Felt chills and body felt cold. I just did not feel good. Went to urgent care. Walked in from the parking lot holding onto husband's arm. Feeling generalized weakness. Diagnosed with dehydration. Unable to walk back to the car because legs felt weak, my husband wheeled me in the wheelchair to the car.  I held onto his arm walking into the house. I was told to drink Pedialite or Gatorade. Went straight to bed at around 10:00 pm. Drank Pedialite at bedside. Woke up at around 1 am on 11/23/2007, thinking Pedialite is too sweet, I need water. Husband was sleeping with our 10 month old son in his room. I sat at the edge of the bed thinking I need to get to the kitchen for water for my dehydration. I put my left foot on the floor and I ended up on my knees. I could not stand. I crawled to my son's room to wake up my husband to call 911. I was at ER around 1:30 am with both legs paralyzed and hands were very weak. I was admitted to ICU diagnosed by the Neurologist with Guillain-Barre Syndrome, suspected due to the Influenza Vaccine that I received 6 weeks prior. I had a CT scan, lumbar puncture, MRI and blood work done. The next day I was treated with Plasma Phoresis. I had 5 treatments over a course of 7 days. After each treatment I started to have little improvement in my right leg then left foot. I was then transferred to Rehabilitation Center on 12/4/2007. I was discharged home on 12/28/2007. I am wheelchair bound, but able to get around short distances with a front wheel walker. Left leg and left hand still weaker than right side. Weak grips. Nipple line to toes have impaired sensation. Currently disabled. I am receiving home health P.T. and will receive home health O.T. 1/22/08-records received for DOS 11/23-12/04/07 DC DX: Guillain Barre syndrome, status post plasmapheresis. Secondary diagnosis:urinary tract infection. Presented to ER with C/O weakness of both upper and lower extremities starting 1 day before admission. Feels sharp pain involving upper back and chest. Numbness and tingling to both upper and lower extremities. Inability to walk.  Per 60 day follow up: Still have weakness in left hand, weakness in left leg greater than right, impaired sensation from below breast line to toes, occasional leg spasms, loss of bladder control.
Sex: M
Vaccine: FLUN3
Symptoms: Pericarditis
Clinical narrative: A serious report was received from a consumer concerning a male adult.  No medical or drug history was reported for this patient.  The patient received FluMist on an unreported date.  A wife's email states "We have questions about whether or not my husband's FluMist vaccine caused his current pericarditis diagnosis".  The patient remained hospitalized at the time of the report.  Additional FluMist dosing is not indicated for this season.  The reporter did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: PATIENT RECEIVED Tdap VACCINE ON 01/07/2008 IN RIGHT UPPER ARM. ON 01/09/2008 PATIENT CALLED CLINIC REPORTING SHE HAD REDNESS AND SWELLING AT THE INJECTION SITE "THE SIZE OF A BASEBALL"AND FEVER.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Rash macular, Vomiting
Clinical narrative: Diarrhea 2 days after vaccine, vomiting times 1 and abdominal pain day of vaccine, macular rash on her back about 3 days after the vaccine that is resolving.  Patient still has lingering fatigue.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hearing impaired, Pain, Rash pruritic
Clinical narrative: Patient reports developing itchy rash two weeks post vaccination administration, rash developed into "pimple like blisters" which also became painful.  Over the next 2 weeks pain continued to spread, patient reports pain started underneath her breast, down her abdomen, and down her legs.  The pain she described as sharp burning pain when she touched her skin.  Pain symptoms improved, although patient still has dull pain.  January 5th, patient attended church at which time she noticied she was unable to hear music or speakers, which time she thought was "bad speakers or sound system"  However symptoms continues as her hearing seams to be coming in and out and sound is like it is being produced by a speaker which is cutting in and out.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain limited range of motion to R deltoid area of site of immunization.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Full blood count, Hypoglycaemia, Syncope, Syncope vasovagal
Clinical narrative: VASAL SYNCOPE, DEHYDRATION, HYPOGLYCEMIA - SHE HAS BEEN FAINTING REGULARLY AFTER THE SHOT WAS ADMINISTERED, AND IT FIRST HAPPENED BEFORE SHE EVEN LEFT THE DOCTOR'S OFFICE. WE HAVE BEEN SPENDING A LOT OF TIME AT THE DOCTOR'S OFFICE, AND EMERGENCY ROOM.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Headache
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 27-DEC-2007 was vaccinated with a first dose 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # unknown).  The physician reported that patient, on 29-DEC-2007, two days after being vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) experienced a seizure and was subsequently hospitalized.  It was reported that at the time of this report patient just had headaches.  No further information was provided.  Additional information has been requested.  3/26/09 ER record received for DOS 12/29/07 with  DX:  Seizure-new onset. Pt presented to ER after an episode of loss of consciousness, falling and shaking of extremities, eyes rolling up and foaming at the mouth.  Post ictal during EMS ride to ER with confusion.   WNL upon arrival at ED. D/C for outpt f/u. No further records available from PCP due to fire in office.  Unknown if pt has had further sx or if under a neurologist's care. 5/19/09 neuro consult received dated 2/5/08 with f/u 3/27/08 with dx: Episode of seizure etiology unclear.  Pt had just received HPV vax and there is a suspicion that it may be the triggering cause.  PE WNL. No further episodes per parent TC on 5/18/09
Age: 44.0
Sex: F
Vaccine: FLU3, HEPAB, PPV, TDAP, TYP
Symptoms: Back pain, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Client's R arm sore after immunizations on 12-7-07.  On 12-8-07 p.m. client's back started hurting.  R arm getting very sore and flu-like symptoms.  Client had to take 2 extra strength Tylenol then and later as needed.  On 12-9-07 Sunday night, client noticed that her R arm had a 3" x 5" to 6" long raised, warm and rough to touch, red hives which was following her bicep & it was itching at and around injection site.
Age: 44.0
Sex: F
Vaccine: FLU3, HEPAB, PPV, TDAP, TYP
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Client's R arm sore after immunizations on 12-7-07.  On 12-8-07 p.m. client's back started hurting.  R arm getting very sore and flu-like symptoms.  Client had to take 2 extra strength Tylenol then and later as needed.  On 12-9-07 Sunday night, client noticed that her R arm had a 3" x 5" to 6" long raised, warm and rough to touch, red hives which was following her bicep & it was itching at and around injection site.
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Several hours after receiving vaccinations pt. developed hives.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client has reddened arm, swollen and warm to touch.  Injections given 2 days ago 11/26/07.  She phoned physician and was told to continue ibuprofen and ice packs to arm.  Left arm.