chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse reactions noted.  Patient denies change in health status.  Pt had shingles vac 2 yrs ago at different physician & did not remember until she asked nurse to put it on her shot record & first one was there so pt. actually received a second shingles vac.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Oedema peripheral, Pain in extremity, Skin tightness
Clinical narrative: 12/14/2007 Mother contacted clinic stating her daughter had swelling from shoulder to elbow, skin tight and warm to touch over swollen area. Patient c/o arm hurting. Mother stated she had received immunizations on 12/12/2007. Parent advised to bring pt in for assessment.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Patient developed swelling/mass on right thigh - seen in clinic 10/24/07, no treatment given.  Swelling resolved.
Age: 10.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Erythema, Urticaria
Clinical narrative: Local erythema/wheal approx 4" diameter.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RV5
Symptoms: Abscess, Erythema, Rash
Clinical narrative: 12/11-received vaccine    12/12-developed abcess behind right ear, was first noticed at 3 pm then cleaned and kept clear of babys hair  12/13 noon abcess looked very wet still and small red dots appeared on face and chest  12/13 8pm previous red dots have grown in size and abcess has spread to chest   12/14 taken to Dr's office at 9 am given perscriptions for oral and topical antibiotic, cefdinir 125, mupirocin 2% and sent to hospital for blood work. Results to be available Monday 12/17.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Throat tightness
Clinical narrative: Approximately 20 - 30 minutes (12:40) after receiving injection, she returned to clinic with complaints of "throat tightening up". Face sl. flushed.  No signs of respiratory distress.  Could talk.  Forwarded to emergency room.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Gait disturbance, Hyperhidrosis
Clinical narrative: 19 hours after the shot, I got dizzy, light-headed and felt weak. I had to sit down as my walking was unsteady and I was afraid of passing out. I had a friend sit with me for a half-hour and I drank water. The dizziness lasted about one hour. Within three hours the lightheadedness was gone. My temperature remained normal throughout. I had slight perspiration for one hour.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Facial palsy, Guillain-Barre syndrome, Headache, Intensive care
Clinical narrative: Headache, muscle weakness in legs, tingling in fingers and legs, facial paralysis. Physical, occupational, and speech therapy required.  Diagnosed as Guillain-Barre Syndrome.  7 sessions of plasma exchange required.  Intensive care req., catheter, and iv required.  First and only flu shot ever received.  12/26/2007 Vax record received.  Info updated in database:  GSK AFLUA321CA./pc 01/07/2008 MR received for DOS 11/28-12/06/2007 with Discharge/Transfer DX:  Guillain-Barre Syndrome.  Depression.  Bi-polar disorder. Pt presented to ER with c/o progressive generalized weakness.  Sx began 5-6 [[name]]s prior to admission with lower extremity tingling which progressed up to the tongue.  Generalized weakness also progressing from lower extremities upward, resulting in falls. Upon PE DTRs were absent in the LEs with unsteady gait and decreased vibratory sensation. Respiratory status remained stable.  Developed 7th cranial nerve involvement with facial droop, difficulty smiling and raising eyebrows.  Some urinary retention resulting in [[name]] cath placement. Txd with plasmapheresis with slow improvement. Pt initially had some anxiety due to psych meds being held, but this improved on resumption. Pt transferred for further rehab. Per 60 [[name]] follow up: Some residual speech and facial symptoms related to GULLIAN [[name]] felt like due to influenza vaccine approx 2 wk prior to onset of symptoms. Patient continues to have improved resolving symptoms and findings from her GUILLAIN [[name]].
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Plasmapheresis
Clinical narrative: Headache, muscle weakness in legs, tingling in fingers and legs, facial paralysis. Physical, occupational, and speech therapy required.  Diagnosed as Guillain-Barre Syndrome.  7 sessions of plasma exchange required.  Intensive care req., catheter, and iv required.  First and only flu shot ever received.  12/26/2007 Vax record received.  Info updated in database:  GSK AFLUA321CA./pc 01/07/2008 MR received for DOS 11/28-12/06/2007 with Discharge/Transfer DX:  Guillain-Barre Syndrome.  Depression.  Bi-polar disorder. Pt presented to ER with c/o progressive generalized weakness.  Sx began 5-6 [[name]]s prior to admission with lower extremity tingling which progressed up to the tongue.  Generalized weakness also progressing from lower extremities upward, resulting in falls. Upon PE DTRs were absent in the LEs with unsteady gait and decreased vibratory sensation. Respiratory status remained stable.  Developed 7th cranial nerve involvement with facial droop, difficulty smiling and raising eyebrows.  Some urinary retention resulting in [[name]] cath placement. Txd with plasmapheresis with slow improvement. Pt initially had some anxiety due to psych meds being held, but this improved on resumption. Pt transferred for further rehab. Per 60 [[name]] follow up: Some residual speech and facial symptoms related to GULLIAN [[name]] felt like due to influenza vaccine approx 2 wk prior to onset of symptoms. Patient continues to have improved resolving symptoms and findings from her GUILLAIN [[name]].
Age: 29.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Local reaction, Pain, Swelling
Clinical narrative: I received a tetanus shot in my right arm on Friday. By Saturday I'd experienced localized swelling around the area where the shot was administered and extreme pain when trying to raise that arm up to shoulder height.  Today is Sunday and the pain is excruciating, whether I move my arm or keep it still by my side. I can only sleep on my back so my arm can rest still by my side.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site warmth
Clinical narrative: cellulitis at injection site; began 2 days post vaccination. observed for 24 hours (? delayed type hypersens) but erythema progressed (4x2 cm), developed petechiae in center, increased calor/tenderness; treated with minocycline 100 bid x 10 days. spoke with patient today (2 days post initiation of abx and lesion is now 1 cm in size and no longer swollen/tender).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Hyperaesthesia, Nausea
Clinical narrative: Approximately 5 hours after injection, I developed a high fever, intense chills, bad headache, queasiness followed by projectile vomiting, extreme skin/nerve sensitivity (could barely tolerate anything touching my skin), which lasted approximately 6 hours.  I was very weak for about 24 hours, then healthy again.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Approximately 5 hours after injection, I developed a high fever, intense chills, bad headache, queasiness followed by projectile vomiting, extreme skin/nerve sensitivity (could barely tolerate anything touching my skin), which lasted approximately 6 hours.  I was very weak for about 24 hours, then healthy again.
Age: 2.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Anorexia, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: CHILD WAS FIT BEFORE ADMINISTERING THE VACCINATION ....INJECTION ADMINISTRED:  FLU SHOT + HEPATATIS A VACCINE                                    ADVERSE EVENTS: VOMITTING, DIARHEA , LOSS OF APPETITE, FEVER FOR PAST 2 DAYS.
Age: 15.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Blood test normal, Full blood count normal, Gait disturbance, Headache, Laboratory test normal
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention (CDC), VAERS# 271552. The initial reporter to the CDC had been a health care professional. A 14-year-old male patient, who had costochondritis at the time of vaccination, had received a first dose, left arm, intramuscular injection of Menactra, lot number U1808AA; and a first dose, right arm, intramuscular injection of Decavac, lot number U1703AA; on 12 January 2007. Eight days post-vaccination (onset date of events also reported as 21 January 2007), the patient developed weakness in his legs and arms, headaches, and lethargy. He "then" developed a sore throat without fever and ascending paresis with difficulty walking. Strep and mono testing were negative. Relevant diagnostic testing performed on an unspecified date included: CBC normal, mono heterophile negative, EBC titers low-negative, blood chemistries normal, no CSF testing done. Treatment included frequent small feedings, bedrest, and analgesics. He was examined in the office three times over six days and showed signs no reduced weakness by early February 2007. Exam showed 3+, symmetric reflexes and mild foot paresthesias. Medical records had noted Guillain Barre Syndrome although "not 100% sure" as the patient did not have decreased reflexes. It was also noted that the lack of decreased reflexes could have been attributed to reflex testing not being performed until nine days after initial symptoms. The patient was not referred to a neurologist "at this point" and was to be re-examined in the office on 06 February 2007. Additional reported events included complaints of being "tired, weakness in legs, tingling in feet, headache (no stiff neck), possibly GBS." As per CDC this case has been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome. The event was considered to be life threatening. The subject recovered from the event on an unspecified date.
Age: 15.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Lethargy, Mononucleosis heterophile test negative, Muscular weakness, Paraesthesia, Paresis
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention (CDC), VAERS# 271552. The initial reporter to the CDC had been a health care professional. A 14-year-old male patient, who had costochondritis at the time of vaccination, had received a first dose, left arm, intramuscular injection of Menactra, lot number U1808AA; and a first dose, right arm, intramuscular injection of Decavac, lot number U1703AA; on 12 January 2007. Eight days post-vaccination (onset date of events also reported as 21 January 2007), the patient developed weakness in his legs and arms, headaches, and lethargy. He "then" developed a sore throat without fever and ascending paresis with difficulty walking. Strep and mono testing were negative. Relevant diagnostic testing performed on an unspecified date included: CBC normal, mono heterophile negative, EBC titers low-negative, blood chemistries normal, no CSF testing done. Treatment included frequent small feedings, bedrest, and analgesics. He was examined in the office three times over six days and showed signs no reduced weakness by early February 2007. Exam showed 3+, symmetric reflexes and mild foot paresthesias. Medical records had noted Guillain Barre Syndrome although "not 100% sure" as the patient did not have decreased reflexes. It was also noted that the lack of decreased reflexes could have been attributed to reflex testing not being performed until nine days after initial symptoms. The patient was not referred to a neurologist "at this point" and was to be re-examined in the office on 06 February 2007. Additional reported events included complaints of being "tired, weakness in legs, tingling in feet, headache (no stiff neck), possibly GBS." As per CDC this case has been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome. The event was considered to be life threatening. The subject recovered from the event on an unspecified date.
Age: 15.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Pharyngolaryngeal pain, Streptococcal serology negative
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention (CDC), VAERS# 271552. The initial reporter to the CDC had been a health care professional. A 14-year-old male patient, who had costochondritis at the time of vaccination, had received a first dose, left arm, intramuscular injection of Menactra, lot number U1808AA; and a first dose, right arm, intramuscular injection of Decavac, lot number U1703AA; on 12 January 2007. Eight days post-vaccination (onset date of events also reported as 21 January 2007), the patient developed weakness in his legs and arms, headaches, and lethargy. He "then" developed a sore throat without fever and ascending paresis with difficulty walking. Strep and mono testing were negative. Relevant diagnostic testing performed on an unspecified date included: CBC normal, mono heterophile negative, EBC titers low-negative, blood chemistries normal, no CSF testing done. Treatment included frequent small feedings, bedrest, and analgesics. He was examined in the office three times over six days and showed signs no reduced weakness by early February 2007. Exam showed 3+, symmetric reflexes and mild foot paresthesias. Medical records had noted Guillain Barre Syndrome although "not 100% sure" as the patient did not have decreased reflexes. It was also noted that the lack of decreased reflexes could have been attributed to reflex testing not being performed until nine days after initial symptoms. The patient was not referred to a neurologist "at this point" and was to be re-examined in the office on 06 February 2007. Additional reported events included complaints of being "tired, weakness in legs, tingling in feet, headache (no stiff neck), possibly GBS." As per CDC this case has been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome. The event was considered to be life threatening. The subject recovered from the event on an unspecified date.
Age: 15.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Fatigue, Gait disturbance, Guillain-Barre syndrome, Headache, Lethargy
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention (CDC), VAERS# 271552. The initial reporter to the CDC had been a health care professional. A 14-year-old male patient, who had costochondritis at the time of vaccination, had received a first dose, left arm, intramuscular injection of Menactra, lot number U1808AA; and a first dose, right arm, intramuscular injection of Decavac, lot number U1703AA; on 12 January 2007. Eight days post-vaccination (onset date of events also reported as 21 January 2007), the patient developed weakness in his legs and arms, headaches, and lethargy. He "then" developed a sore throat without fever and ascending paresis with difficulty walking. Strep and mono testing were negative. Relevant diagnostic testing performed on an unspecified date included: CBC normal, mono heterophile negative, EBC titers low-negative, blood chemistries normal, no CSF testing done. Treatment included frequent small feedings, bedrest, and analgesics. He was examined in the office three times over six days and showed signs no reduced weakness by early February 2007. Exam showed 3+, symmetric reflexes and mild foot paresthesias. Medical records had noted Guillain Barre Syndrome although "not 100% sure" as the patient did not have decreased reflexes. It was also noted that the lack of decreased reflexes could have been attributed to reflex testing not being performed until nine days after initial symptoms. The patient was not referred to a neurologist "at this point" and was to be re-examined in the office on 06 February 2007. Additional reported events included complaints of being "tired, weakness in legs, tingling in feet, headache (no stiff neck), possibly GBS." As per CDC this case has been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome. The event was considered to be life threatening. The subject recovered from the event on an unspecified date.
Age: 15.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Muscular weakness, Paraesthesia, Paresis, Pharyngolaryngeal pain
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention (CDC), VAERS# 271552. The initial reporter to the CDC had been a health care professional. A 14-year-old male patient, who had costochondritis at the time of vaccination, had received a first dose, left arm, intramuscular injection of Menactra, lot number U1808AA; and a first dose, right arm, intramuscular injection of Decavac, lot number U1703AA; on 12 January 2007. Eight days post-vaccination (onset date of events also reported as 21 January 2007), the patient developed weakness in his legs and arms, headaches, and lethargy. He "then" developed a sore throat without fever and ascending paresis with difficulty walking. Strep and mono testing were negative. Relevant diagnostic testing performed on an unspecified date included: CBC normal, mono heterophile negative, EBC titers low-negative, blood chemistries normal, no CSF testing done. Treatment included frequent small feedings, bedrest, and analgesics. He was examined in the office three times over six days and showed signs no reduced weakness by early February 2007. Exam showed 3+, symmetric reflexes and mild foot paresthesias. Medical records had noted Guillain Barre Syndrome although "not 100% sure" as the patient did not have decreased reflexes. It was also noted that the lack of decreased reflexes could have been attributed to reflex testing not being performed until nine days after initial symptoms. The patient was not referred to a neurologist "at this point" and was to be re-examined in the office on 06 February 2007. Additional reported events included complaints of being "tired, weakness in legs, tingling in feet, headache (no stiff neck), possibly GBS." As per CDC this case has been confirmed by CISA (Clinical Immunization Safety Assessment network) as being Guillain Barre syndrome. The event was considered to be life threatening. The subject recovered from the event on an unspecified date.
Age: 0.8
Sex: M
Vaccine: HEP, HEP
Symptoms: Biopsy skin, Pyrexia, Rash, Vasculitis
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 month old male with penicillin allergy and asthma who on 13-MAR-2007 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast).  Concomitant therapy included albuterol.  The nurse practitioner reported that the patient developed lymphocytic vasculitis on 18-MAR-2007 five days after receiving the third dose of hepatitis B virus vaccine rHBsAg (yeast) on 13-MAR-2007 (LOT #654437/1246F).  The patient received the first dose of hepatitis B virus vaccine rHBsAg (yeast) on 10-JUN-2006, the second dose on 10-AUG-2006 and the third dose on 13-MAR-2007.  The patient was evaluated in a local emergency room on 18-MAR-2007 and was referred to an unspecified dermatologist.  The dermatologist evaluated the patient on 20-MAR-2007 and performed a skin biopsy which revealed lymphocytic vasculitis.  The patient was hospitalized on 20-MAR-2007 but details of the hospitalization are unavailable.  The patient was discharged on 21-MAR-2007.  The patient was examined in the office in follow up on 04-APR-2007 and had completely recovered.  Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HEP, HEP
Symptoms: Biopsy skin, Vasculitis
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 month old male with penicillin allergy and asthma who on 13-MAR-2007 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast).  Concomitant therapy included albuterol.  The nurse practitioner reported that the patient developed lymphocytic vasculitis on 18-MAR-2007 five days after receiving the third dose of hepatitis B virus vaccine rHBsAg (yeast) on 13-MAR-2007 (LOT #654437/1246F).  The patient received the first dose of hepatitis B virus vaccine rHBsAg (yeast) on 10-JUN-2006, the second dose on 10-AUG-2006 and the third dose on 13-MAR-2007.  The patient was evaluated in a local emergency room on 18-MAR-2007 and was referred to an unspecified dermatologist.  The dermatologist evaluated the patient on 20-MAR-2007 and performed a skin biopsy which revealed lymphocytic vasculitis.  The patient was hospitalized on 20-MAR-2007 but details of the hospitalization are unavailable.  The patient was discharged on 21-MAR-2007.  The patient was examined in the office in follow up on 04-APR-2007 and had completely recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Electromyogram, Full blood count, Guillain-Barre syndrome, Lumbar puncture, Mycoplasma serology positive
Clinical narrative: Initial report received on 19 July 2007 via a line listing from the Centers for Disease Control and Prevention, VAERS# 278503. A 15-year-old female patient had received an injection of Menactra, lot number U2172AA; and an injection of Human Papillomavirus Vaccine, lot number not reported; on 12 April 2007. Eleven days post-immunization, the patient experienced unspecified symptoms associated with Guillain Barre Syndrome. Pre-existing illness and other drugs were "none reported." The case was being reviewed by the Clinical Immunization Safety Assessment Network, but confirmation of Guillain Barre Syndrome was not provided. Additional medically relevant information was not provided, and recovery status was not reported. Follow-up information was received from the CDC on 30 August 2007 which noted that Guillain Barre Syndrome had been confirmed by the Clinical Immunization Safety Assessment (CISA). No additional information was provided. Follow-up information received on 01 October 2007 from the Centers for Disease Control and Prevention. It was reported that the patient recovered. The date of recovery was not provided.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received on 19 July 2007 via a line listing from the Centers for Disease Control and Prevention, VAERS# 278503. A 15-year-old female patient had received an injection of Menactra, lot number U2172AA; and an injection of Human Papillomavirus Vaccine, lot number not reported; on 12 April 2007. Eleven days post-immunization, the patient experienced unspecified symptoms associated with Guillain Barre Syndrome. Pre-existing illness and other drugs were "none reported." The case was being reviewed by the Clinical Immunization Safety Assessment Network, but confirmation of Guillain Barre Syndrome was not provided. Additional medically relevant information was not provided, and recovery status was not reported. Follow-up information was received from the CDC on 30 August 2007 which noted that Guillain Barre Syndrome had been confirmed by the Clinical Immunization Safety Assessment (CISA). No additional information was provided. Follow-up information received on 01 October 2007 from the Centers for Disease Control and Prevention. It was reported that the patient recovered. The date of recovery was not provided.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cough, Ear pain, Facial paresis, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Initial report received on 19 July 2007 via a line listing from the Centers for Disease Control and Prevention, VAERS #284761.  A 12-year-old female patient, with a history of juvenile rheumatoid arthritis, had received an injection of Menactra, lot number U2366AA, on 25 June 2007.  Other vaccines administered were "none reported".  Fifteen days post-immunization, the patient experienced unspecified symptoms associated with Guillain Barre syndrome.  The case was being reviewed by an agency, but confirmation of Guillain Barre syndrome was not provided.  Additional medically relevant information was not provided, and recovery status was not reported.  A corrective version was created on 07 August 2007 with the Latest Received Date of the previous version, (19 July 2007), in order to add the Menactra lot number to a structured field in the database.  Follow-up information received on 30 August 2007 from the Centers for Disease Control and Prevention.  This case was confirmed by an agency as Guillain Barre syndrome.  No additional information was provided.  Follow-up information received on 01 October 2007 from the Centers for Disease Control and Prevention.  It was reported that the patient recovered.  The date of recovery was not provided.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Musculoskeletal stiffness, Pain, Protein total increased, Rhinorrhoea
Clinical narrative: Initial report received on 19 July 2007 via a line listing from the Centers for Disease Control and Prevention, VAERS #284761.  A 12-year-old female patient, with a history of juvenile rheumatoid arthritis, had received an injection of Menactra, lot number U2366AA, on 25 June 2007.  Other vaccines administered were "none reported".  Fifteen days post-immunization, the patient experienced unspecified symptoms associated with Guillain Barre syndrome.  The case was being reviewed by an agency, but confirmation of Guillain Barre syndrome was not provided.  Additional medically relevant information was not provided, and recovery status was not reported.  A corrective version was created on 07 August 2007 with the Latest Received Date of the previous version, (19 July 2007), in order to add the Menactra lot number to a structured field in the database.  Follow-up information received on 30 August 2007 from the Centers for Disease Control and Prevention.  This case was confirmed by an agency as Guillain Barre syndrome.  No additional information was provided.  Follow-up information received on 01 October 2007 from the Centers for Disease Control and Prevention.  It was reported that the patient recovered.  The date of recovery was not provided.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received on 19 July 2007 via a line listing from the Centers for Disease Control and Prevention, VAERS #284761.  A 12-year-old female patient, with a history of juvenile rheumatoid arthritis, had received an injection of Menactra, lot number U2366AA, on 25 June 2007.  Other vaccines administered were "none reported".  Fifteen days post-immunization, the patient experienced unspecified symptoms associated with Guillain Barre syndrome.  The case was being reviewed by an agency, but confirmation of Guillain Barre syndrome was not provided.  Additional medically relevant information was not provided, and recovery status was not reported.  A corrective version was created on 07 August 2007 with the Latest Received Date of the previous version, (19 July 2007), in order to add the Menactra lot number to a structured field in the database.  Follow-up information received on 30 August 2007 from the Centers for Disease Control and Prevention.  This case was confirmed by an agency as Guillain Barre syndrome.  No additional information was provided.  Follow-up information received on 01 October 2007 from the Centers for Disease Control and Prevention.  It was reported that the patient recovered.  The date of recovery was not provided.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Guillain-Barre syndrome, Headache, Hypoaesthesia, Lumbar puncture
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 288351.  The original reporter to the CDC was a nurse.  A 13 year-old male patient, with no reported concurrent illnesses, or pre-existing medical conditions, and who had unknown use of other medications, had received a first intramuscular dose of Menactra, lot number U2231AA, in the left arm (also reported as left deltoid) on 27 July 2007.  On 13 August 2007 at 09:45 a.m., the mother reported to the primary care physician that her son had been treated for pneumonia with Zithromax about 10 days after his vaccination with Menactra.  Reportedly, the Zithromax therapy was completed on 10 August 2007.  At an unspecified amount of time after receiving the Menactra immunization, the mother reported the patient had experienced numbness of his tongue and right arm.  The numbness progressed to include both arms and legs and he was "really sick".  The mother took the patient to the emergency room (date not provided) where he was treated with a "new antibiotic".  At that time, the mother did not think the doctor was aware the patient had previously received a vaccine (doctor was subsequently notified of the patient's vaccination).  It was later found out, the patient had been transported to the hospital and hospitalized (dates not provided).  The mother was later contacted by the CDC and reportedly, the patient had experienced elevated protein in his spinal fluid, and additional symptom of increased muscle weakness in his legs.  It was the mother's understanding that the neurologist suspected a mild case of Guillain-Barre syndrome.  Relevant diagnostic tests for West Nile virus and encephalitis were pending at the time of this report.  The mother reported a meningitis test was negative.  At the time of this report, the recovery status of the patient was "unknown".
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Malaise, Metabolic function test, Muscular weakness, Pneumonia primary atypical, Urine analysis
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 288351.  The original reporter to the CDC was a nurse.  A 13 year-old male patient, with no reported concurrent illnesses, or pre-existing medical conditions, and who had unknown use of other medications, had received a first intramuscular dose of Menactra, lot number U2231AA, in the left arm (also reported as left deltoid) on 27 July 2007.  On 13 August 2007 at 09:45 a.m., the mother reported to the primary care physician that her son had been treated for pneumonia with Zithromax about 10 days after his vaccination with Menactra.  Reportedly, the Zithromax therapy was completed on 10 August 2007.  At an unspecified amount of time after receiving the Menactra immunization, the mother reported the patient had experienced numbness of his tongue and right arm.  The numbness progressed to include both arms and legs and he was "really sick".  The mother took the patient to the emergency room (date not provided) where he was treated with a "new antibiotic".  At that time, the mother did not think the doctor was aware the patient had previously received a vaccine (doctor was subsequently notified of the patient's vaccination).  It was later found out, the patient had been transported to the hospital and hospitalized (dates not provided).  The mother was later contacted by the CDC and reportedly, the patient had experienced elevated protein in his spinal fluid, and additional symptom of increased muscle weakness in his legs.  It was the mother's understanding that the neurologist suspected a mild case of Guillain-Barre syndrome.  Relevant diagnostic tests for West Nile virus and encephalitis were pending at the time of this report.  The mother reported a meningitis test was negative.  At the time of this report, the recovery status of the patient was "unknown".
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Malaise
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 288351.  The original reporter to the CDC was a nurse.  A 13 year-old male patient, with no reported concurrent illnesses, or pre-existing medical conditions, and who had unknown use of other medications, had received a first intramuscular dose of Menactra, lot number U2231AA, in the left arm (also reported as left deltoid) on 27 July 2007.  On 13 August 2007 at 09:45 a.m., the mother reported to the primary care physician that her son had been treated for pneumonia with Zithromax about 10 days after his vaccination with Menactra.  Reportedly, the Zithromax therapy was completed on 10 August 2007.  At an unspecified amount of time after receiving the Menactra immunization, the mother reported the patient had experienced numbness of his tongue and right arm.  The numbness progressed to include both arms and legs and he was "really sick".  The mother took the patient to the emergency room (date not provided) where he was treated with a "new antibiotic".  At that time, the mother did not think the doctor was aware the patient had previously received a vaccine (doctor was subsequently notified of the patient's vaccination).  It was later found out, the patient had been transported to the hospital and hospitalized (dates not provided).  The mother was later contacted by the CDC and reportedly, the patient had experienced elevated protein in his spinal fluid, and additional symptom of increased muscle weakness in his legs.  It was the mother's understanding that the neurologist suspected a mild case of Guillain-Barre syndrome.  Relevant diagnostic tests for West Nile virus and encephalitis were pending at the time of this report.  The mother reported a meningitis test was negative.  At the time of this report, the recovery status of the patient was "unknown".
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Muscular weakness, Pneumonia, Protein total increased
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 288351.  The original reporter to the CDC was a nurse.  A 13 year-old male patient, with no reported concurrent illnesses, or pre-existing medical conditions, and who had unknown use of other medications, had received a first intramuscular dose of Menactra, lot number U2231AA, in the left arm (also reported as left deltoid) on 27 July 2007.  On 13 August 2007 at 09:45 a.m., the mother reported to the primary care physician that her son had been treated for pneumonia with Zithromax about 10 days after his vaccination with Menactra.  Reportedly, the Zithromax therapy was completed on 10 August 2007.  At an unspecified amount of time after receiving the Menactra immunization, the mother reported the patient had experienced numbness of his tongue and right arm.  The numbness progressed to include both arms and legs and he was "really sick".  The mother took the patient to the emergency room (date not provided) where he was treated with a "new antibiotic".  At that time, the mother did not think the doctor was aware the patient had previously received a vaccine (doctor was subsequently notified of the patient's vaccination).  It was later found out, the patient had been transported to the hospital and hospitalized (dates not provided).  The mother was later contacted by the CDC and reportedly, the patient had experienced elevated protein in his spinal fluid, and additional symptom of increased muscle weakness in his legs.  It was the mother's understanding that the neurologist suspected a mild case of Guillain-Barre syndrome.  Relevant diagnostic tests for West Nile virus and encephalitis were pending at the time of this report.  The mother reported a meningitis test was negative.  At the time of this report, the recovery status of the patient was "unknown".
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Injection site pain
Clinical narrative: Initial report received from a health care professional on 17 August 2007. A 13-year-old male patient, with no past medical history, had received an intramuscular injection of Menactra, lot number U2393BA, on 14 August 2007 and on the evening of vaccination, had developed "weakness, significant site pain, difficulty walking, taking deep breaths". The symptoms had been resolved at the time of this report and the reporter stated the patient had recovered from the event. The event did not require a doctor's visit or emergency room visit and the patient had not received any treatment for the reported event. No additional information had been provided at the time of this report. The reporter of this case also reported two other cases of adverse events following Menactra injections. Those events are captured in case numbers 2007-02830 and 2007-02832.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Gait disturbance, Hyperventilation, Injection site pain
Clinical narrative: Initial report received from a health care professional on 17 August 2007. A 13-year-old male patient, with no past medical history, had received an intramuscular injection of Menactra, lot number U2393BA, on 14 August 2007 and on the evening of vaccination, had developed "weakness, significant site pain, difficulty walking, taking deep breaths". The symptoms had been resolved at the time of this report and the reporter stated the patient had recovered from the event. The event did not require a doctor's visit or emergency room visit and the patient had not received any treatment for the reported event. No additional information had been provided at the time of this report. The reporter of this case also reported two other cases of adverse events following Menactra injections. Those events are captured in case numbers 2007-02830 and 2007-02832.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Back pain, Burning sensation, C-reactive protein normal, CSF glucose normal
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290243.  The original reporter to the CDC was a health care professional.  A 17 year-old female patient, with no reported concurrent illnesses, or pre-existing medical conditions, had received a first intramuscular dose of Menactra, lot number U2338AA, in the right arm on 16 August 2007.  On 18 August 2007, which was two days post-immunization, the patient had complaints of weakness, burning sensation in the upper extremities, back, and lower extremities.  She also had severe back pain, urinary retention, and difficulty walking.  The patient was admitted to the hospital 14 days later on 01 September 2007.  Relevant diagnostic tests and laboratory data revealed cerebral spinal fluid with a white cell count of 56, lymphocytes 69%, protein 39, and glucose 57.  Urinalysis was negative, and C-reactive protein was 0.8.  An MRI of the brain was normal.  Blood work showed white blood cell count 12.4, hemoglobin 12.9, and platelets 317,000.  The patient was discharged on 07 September 2007.  This event was considered by the reporter as life threatening.  The patient was diagnosed with possible "Guillain-Barre like syndrome".  The patient recovered (date of recovery not provided).
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: CSF protein normal, CSF white blood cell count increased, Gait disturbance, Haematocrit normal, Haemoglobin normal
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290243.  The original reporter to the CDC was a health care professional.  A 17 year-old female patient, with no reported concurrent illnesses, or pre-existing medical conditions, had received a first intramuscular dose of Menactra, lot number U2338AA, in the right arm on 16 August 2007.  On 18 August 2007, which was two days post-immunization, the patient had complaints of weakness, burning sensation in the upper extremities, back, and lower extremities.  She also had severe back pain, urinary retention, and difficulty walking.  The patient was admitted to the hospital 14 days later on 01 September 2007.  Relevant diagnostic tests and laboratory data revealed cerebral spinal fluid with a white cell count of 56, lymphocytes 69%, protein 39, and glucose 57.  Urinalysis was negative, and C-reactive protein was 0.8.  An MRI of the brain was normal.  Blood work showed white blood cell count 12.4, hemoglobin 12.9, and platelets 317,000.  The patient was discharged on 07 September 2007.  This event was considered by the reporter as life threatening.  The patient was diagnosed with possible "Guillain-Barre like syndrome".  The patient recovered (date of recovery not provided).
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Platelet count normal, Urinary retention, Urine analysis normal, White blood cell count increased
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290243.  The original reporter to the CDC was a health care professional.  A 17 year-old female patient, with no reported concurrent illnesses, or pre-existing medical conditions, had received a first intramuscular dose of Menactra, lot number U2338AA, in the right arm on 16 August 2007.  On 18 August 2007, which was two days post-immunization, the patient had complaints of weakness, burning sensation in the upper extremities, back, and lower extremities.  She also had severe back pain, urinary retention, and difficulty walking.  The patient was admitted to the hospital 14 days later on 01 September 2007.  Relevant diagnostic tests and laboratory data revealed cerebral spinal fluid with a white cell count of 56, lymphocytes 69%, protein 39, and glucose 57.  Urinalysis was negative, and C-reactive protein was 0.8.  An MRI of the brain was normal.  Blood work showed white blood cell count 12.4, hemoglobin 12.9, and platelets 317,000.  The patient was discharged on 07 September 2007.  This event was considered by the reporter as life threatening.  The patient was diagnosed with possible "Guillain-Barre like syndrome".  The patient recovered (date of recovery not provided).
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: CSF lymphocyte count normal, CSF protein normal, CSF white blood cell count increased, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290243.  The original reporter to the CDC was a health care professional.  A 17 year-old female patient, with no reported concurrent illnesses, or pre-existing medical conditions, had received a first intramuscular dose of Menactra, lot number U2338AA, in the right arm on 16 August 2007.  On 18 August 2007, which was two days post-immunization, the patient had complaints of weakness, burning sensation in the upper extremities, back, and lower extremities.  She also had severe back pain, urinary retention, and difficulty walking.  The patient was admitted to the hospital 14 days later on 01 September 2007.  Relevant diagnostic tests and laboratory data revealed cerebral spinal fluid with a white cell count of 56, lymphocytes 69%, protein 39, and glucose 57.  Urinalysis was negative, and C-reactive protein was 0.8.  An MRI of the brain was normal.  Blood work showed white blood cell count 12.4, hemoglobin 12.9, and platelets 317,000.  The patient was discharged on 07 September 2007.  This event was considered by the reporter as life threatening.  The patient was diagnosed with possible "Guillain-Barre like syndrome".  The patient recovered (date of recovery not provided).
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count abnormal, Nuclear magnetic resonance imaging brain normal, Platelet count normal
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290243.  The original reporter to the CDC was a health care professional.  A 17 year-old female patient, with no reported concurrent illnesses, or pre-existing medical conditions, had received a first intramuscular dose of Menactra, lot number U2338AA, in the right arm on 16 August 2007.  On 18 August 2007, which was two days post-immunization, the patient had complaints of weakness, burning sensation in the upper extremities, back, and lower extremities.  She also had severe back pain, urinary retention, and difficulty walking.  The patient was admitted to the hospital 14 days later on 01 September 2007.  Relevant diagnostic tests and laboratory data revealed cerebral spinal fluid with a white cell count of 56, lymphocytes 69%, protein 39, and glucose 57.  Urinalysis was negative, and C-reactive protein was 0.8.  An MRI of the brain was normal.  Blood work showed white blood cell count 12.4, hemoglobin 12.9, and platelets 317,000.  The patient was discharged on 07 September 2007.  This event was considered by the reporter as life threatening.  The patient was diagnosed with possible "Guillain-Barre like syndrome".  The patient recovered (date of recovery not provided).
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Protein total increased, Urinary retention, Urine analysis normal, White blood cell count increased
Clinical narrative: Initial report received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS number 290243.  The original reporter to the CDC was a health care professional.  A 17 year-old female patient, with no reported concurrent illnesses, or pre-existing medical conditions, had received a first intramuscular dose of Menactra, lot number U2338AA, in the right arm on 16 August 2007.  On 18 August 2007, which was two days post-immunization, the patient had complaints of weakness, burning sensation in the upper extremities, back, and lower extremities.  She also had severe back pain, urinary retention, and difficulty walking.  The patient was admitted to the hospital 14 days later on 01 September 2007.  Relevant diagnostic tests and laboratory data revealed cerebral spinal fluid with a white cell count of 56, lymphocytes 69%, protein 39, and glucose 57.  Urinalysis was negative, and C-reactive protein was 0.8.  An MRI of the brain was normal.  Blood work showed white blood cell count 12.4, hemoglobin 12.9, and platelets 317,000.  The patient was discharged on 07 September 2007.  This event was considered by the reporter as life threatening.  The patient was diagnosed with possible "Guillain-Barre like syndrome".  The patient recovered (date of recovery not provided).
Age: 18.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Asthenia, Dysphagia, Dyspnoea, Hypoaesthesia, Intestinal functional disorder
Clinical narrative: Initial information received on 18 September 2007 from the Centers for Disease Control and Prevention, VAERS #290355.  The initial reporter to the CDC had been a health care professional.  A 17-year-old male received an intramuscular injection of Menactra (Lot number U2394BA, site of vaccination unknown), an intramuscular injection of Adacel (Lot number C2769AA, site of vaccination unknown) and an intramuscular injection of Twinrix (manufactured by GlaxoSmithKline; Lot number AHABB100AA, site of administration unknown) on 22 August 2007.  On 11 September 2007, 20 days after receiving the vaccines, the patient was diagnosed with possible Guillain-Barre syndrome.  The patient complained of numbness to extremities, difficulty speaking, shortness of breath, trouble swallowing, blurred vision, difficulty walking, weakness throughout the body, bowel problems, regurgitation and difficulty taking deep breaths.  The event required hospitalization.  Recovery status was not reported.  No additional information was provided at the time of this report.