chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Rash, Swelling
Clinical narrative: Swelling rash on arms, knees, feet lasted 5 day with no treatment.
Age: 7.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Urticaria
Clinical narrative: Hives on face, arms, legs, trunk 2 days after immunizations
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC
Symptoms: Urticaria
Clinical narrative: Mother reported child broke out in hives after receiving vaccines.  Stated she gave benadryl and they went away.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site reaction, Pyrexia
Clinical narrative: 7x5 cm large local reaction at site of vaccination and fever of 101.5, given prescription Keflex given on 2/1/07-reaction much improved on 2/2/07-redness resolved induration 2x2cm
Sex: M
Vaccine: HEPAB
Symptoms: Rash pruritic
Clinical narrative: Prolonged pruritic rash x 1 month, treated with Prednisone im, po and Antihistamines
Age: 58.0
Sex: F
Vaccine: TYP
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Called complained of soreness and golf ball size area in region of Typhim Vi injection site.
Age: 52.0
Sex: M
Vaccine: TD
Symptoms: Atrophy, Blood creatine phosphokinase, Electromyogram, Injection site pain, Injection site swelling
Clinical narrative: Pt received Td vaccine on 11/2/05 in left deltoid-Developed pain and swelling in left upper extrem. The pain worsened. Had a cardiac work up that was negative in March 2006. RTC 7/19/06 to see me.  Exam showed atrophy of left deltoid and muscle, same residual pain and swelling, CK was elevated at 492. Patient ultimately saw a neurologist who diagnosed post vaccination bronchial pleuritis.
Age: 64.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site pain, Tenderness
Clinical narrative: 9/28/2006-client called Health Department to report Right arm pain and inability to use arm for approximately 8 hours. Pain on scale of 8-9. Arm between shoulder and elbow feels bruised but no visable swelling or bruising noted. Advised calling medical doctor. 10/3/06 states better. Pain 1-2 of 10. On 10/1/06 with Naprosyn but 10/2/06 pain again 3-4. Advised calling medical doctor for anti-inflammatory and evaluation.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: morning after injection given, area around sight and 2 inch in diameter red, irritated s/ swollen, itches
Age: 60.0
Sex: F
Vaccine: MEA
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a health professional concerning a 50 year old white female with no allergies or medical history who on 17-Nov-2005 was vaccinated SC in the left arm with a 0.5 ml first dose of measles virus vaccine live (lot#647584/0662R). There was no illness at the time of vaccination. On 01-Dec-2005, at 8:20 am, the patient called complaining that she had experiences a fever during the night and had a rash on her face, upper chest and abdomen. No treatment was ordered and the patient was sent home. At the time of this report the patient was recovering. Unspecified medical attention was sought. No product quality was involved. Follow up indicated that the patient's temperature was up to 98.8 and she had a red blotchy rash on face, upper chest and abdomen. There were no lab tests done and the patient recovered on 05-Dec-2005. Additional information is not expected.  Information has been received from a health professional concerning a 50 year old female with no allergies and no medical history who on 17-NOV-2005 was vaccinated SC in the left arm with a 0.5mL first dose of  measles virus vaccine live (Enders-Edmonston) (lot #647584/the0662R). There was no illness at the time of vaccination. On 01-DEC-2005, at 8:20 am, the patient called complaining that she had experienced a fever during the night and had a rash on her face, upper chest and abdomen. No treatment was ordered and the patient was sent home. At the time of this report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the patient's temperature was 98.8 and she had a red blotchy rash on face, upper chest and abdomen. There were no lab tests done and the patient recovered on 05-DEC-2005. Addtional information is not expected.
Age: 2.0
Sex: F
Vaccine: MEA
Symptoms: Pallor, Skin discolouration, Skin lesion
Clinical narrative: Information has been received from a consumer her 24-month-old daughter with no allergies or medical history who on 12-Dec-2005 was vaccinated SC in the left thigh with a first dose of measles virus vaccine live (lot#647584/1146P). There was no concomitant medication. Illness at the time of vaccination with 12 to 10 lesions on her torso. The lesions were pink and were turning pale. The patient's mother called her daughter's physician. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow-up information was received from a physician's office which indicated that on 12-Dec-2005, the patient had a rash on her torso and groin. She subsequently recovered. The patient had no adverse events following prior vaccination. No further information is expected.
Sex: F
Vaccine: MEA
Symptoms: Rash
Clinical narrative: Information has been received from a physician who cares for the patient's grandmother, concerning a female patient who was vaccinated with a dose of measles virus vaccine live. The physician reported that the female patient broke out in a rash while playing with her grandmother and the patient was seen by her pediatrician. It was noted that the patient's grandmother is post kidney transplant and therefore she sought medical attention as she was concerned with the possibility that she could contact a vaccine virus. There was no product quality complaint reported. Follow-up information received on 18-Jan-2006 from a physician reported that the patient did not have a "reaction". The physician only questioned whether the patient who developed a rash, could shed virus to an immunocompromised family member. Additional information indicated that the immunocompromised grandmother did not develop an adverse event. It was noted that her grandmother was vaccinated with a dose of measles virus vaccine live and developed a rash. No additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MEA
Symptoms: Erythema, Injection site rash, Rash macular
Clinical narrative: Information has been received from a physician concerning a 21-year-old female with asthma, and allergies to pollen, cats, mold, and dogs, and with a history of heat rash who on 25-May-2006 was vaccinated SC in the left arm with an 0.5 ml dose of measles virus vaccine live (lot#652338/085R). There was no illness at the time of vaccination. Concomitant therapy included vitamins (unspecified) and Zyrtec. On 27-May-2006, the day after vaccination, the patient experienced a transient rash below the injection site of the left arm and patch of redness on other arm and leg. Subsequently, the patient recovered. No treatment was noted. No lab diagnostic studies were performed. There was no product quality complaint. Follow up information received from a physician indicated that a macular rash developed on the left arm below the injection site. The patient recovered on 28-May-2006. Unspecified medical attention was sought. There were no relevant diagnostic tests of laboratory data. No additional information is expected.
Age: 1.0
Sex: M
Vaccine: MEA
Symptoms: Agitation, Diarrhoea, Nasal congestion, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male with  no known allergies or past medical history who on 01-Jun-2006 was vaccinated SC in the arm with a 0.5 ml first dose of measles virus vaccine live (lot#652338/0974R). There was no concomitant medication or illness at the time of vaccination. On 05-Jun-2006 (also reported as 15-Jun-2006) the patient developed congestion, a fever of 102 which lasted 8 days had "seemed fussy". On 12-Jun-2006 (also reported as 15-Jun-2006), the patient developed a rubella like rash on his truck which lasted 10 days. On approximately 15-Jun-2006 the patient also developed diarrhea which lasted 10 days. Unspecified medical attention was sought. No lab tests were performed. Subsequently, the patient has fully recovered. It was reported that the patient and his sibling had not had adverse events following prior vaccination. There was no product quality complaint involved. Additional information is not expected.
Sex: M
Vaccine: MEA
Symptoms: Blood immunoglobulin G decreased, Measles antibody negative
Clinical narrative: Information has been received from a healthcare professional concerning an adult male with no allergies who was vaccinated with a dose of Measles virus vaccine live. The healthcare professional reported that the patient's blood work subsequently came up low  for titers for measles at 54 or 56. Unspecified medical attention was sought. The healthcare professional indicated that the patient was probably vaccinated against measles as a child. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Site of injection on right arm raised, red, and painful.  Redness, edema, and pain have intensified over past 2 days.  Cephalexin prescribed to cover for infection.  Tylenol #3 given prn pain.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urticaria
Clinical narrative: AFTER RECIEVING IMMUNIZATIONS PT. DEVELOPED URTICARIA ON FACE, ARMS, AND LEGS. LUNGS CLEAR, NO WHEEZING OR BREATHING DIFFICULTIES.  ADVISED TO GIVE BENADRYL ALLERGY 1/2 TSP EVERY 6 HOURS AS NEEDED. ADVISED TO BE SEEN IMMEDIATELY IF COUGH, WHEEZE, OR BREATHING DIFFICULTIES.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: 5 days after being administered the 2nd in a series of Gardasil developed hives requiring Benadryl and a visit to local ER. No facial edema, difficulty breathing or SOB occurred
Age: 0.6
Sex: F
Vaccine: DT
Symptoms: Anorexia, Pyrexia, Vomiting
Clinical narrative: She received her DTaP at about 10:00 AM. That afternoon she was not interested in eating any food, and she vomited at midnight, and three more times in the next five hours, and once more the next day. She also was running a 101 temperature. She nursed fine during/after her reaction, but didn't eat solid food again for 10 days.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Rash
Clinical narrative: RASH ONSET 2-1-07 (10 DAYS AFTER MMR/VZV)
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Generalized macular/papular rash on face, trunk, arms, and legs. Onset was 1-20-2007. Has just moved to Springfield from Indiana. Came to the local Health Department with symptoms.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Abdominal pain upper, Aphthous stomatitis, Malaise, Oral pain
Clinical narrative: Canker type sores in mouth still present. Complained of sore throat,achy,abdominal pain, general malaise the past couple of days but feeling better yesterday.  Important to note is that she has a boyfriend who may have been infected with HG (herpes gladitorium)-his wrestling team had "ringworm" and "staph" and now area wrestlers are showing up with HG which is said to be confused often times with staph skin infections.  Cold sores are common with HG and are contagious of course, so it might be possible that she contracted the sores by kissing her boyfriend who may have been infected with HG?? Not sure and can't prove that he was infected.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain, Pharyngolaryngeal pain
Clinical narrative: Canker type sores in mouth still present. Complained of sore throat,achy,abdominal pain, general malaise the past couple of days but feeling better yesterday.  Important to note is that she has a boyfriend who may have been infected with HG (herpes gladitorium)-his wrestling team had "ringworm" and "staph" and now area wrestlers are showing up with HG which is said to be confused often times with staph skin infections.  Cold sores are common with HG and are contagious of course, so it might be possible that she contracted the sores by kissing her boyfriend who may have been infected with HG?? Not sure and can't prove that he was infected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: 1 day following vaccine had swelling and pain; on day 2 reported to clinic for evaluation where he has 1 cm round patch of dark erythema surrounded by 15cm mild erythema with swelling and warmth and pain; no vesicles or other skin changes
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pyrexia, Sleep disorder, Tremor
Clinical narrative: The day after the immunization, late afternoon, I developed violent chills and could not stop shaking for about 20 minutes.  At that time I developed a fever of 101.5 F.  Fever went away during the night and did not return.  However, the next day I developed a headache which worsened during the evening hours.  This headache lasted through the night (I could not sleep as a result of it); it then faded away during the next day.  FYI:mfr is Sanofi
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Lacrimation increased, Pain in extremity
Clinical narrative: Pt received Pneumovax at 0945 2/2/2007, left office  without any problems or complaints of pain. Patient in office @ 1630 with complaint of pain in right arm from fingers to shoulder, he was unable to drive his truck, patient in tears with the pain, ice applied, site is free from any redness, swelling at this time, 800mg of Ibuprofen given p.o.  @ 1642.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Injection site pain, Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Pt received Pneumovax at 0945 2/2/2007, left office  without any problems or complaints of pain. Patient in office @ 1630 with complaint of pain in right arm from fingers to shoulder, he was unable to drive his truck, patient in tears with the pain, ice applied, site is free from any redness, swelling at this time, 800mg of Ibuprofen given p.o.  @ 1642.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Tenderness
Clinical narrative: Pt received Pneumovax at 0945 2/2/2007, left office  without any problems or complaints of pain. Patient in office @ 1630 with complaint of pain in right arm from fingers to shoulder, he was unable to drive his truck, patient in tears with the pain, ice applied, site is free from any redness, swelling at this time, 800mg of Ibuprofen given p.o.  @ 1642.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received Pneumovax at 0945 2/2/2007, left office  without any problems or complaints of pain. Patient in office @ 1630 with complaint of pain in right arm from fingers to shoulder, he was unable to drive his truck, patient in tears with the pain, ice applied, site is free from any redness, swelling at this time, 800mg of Ibuprofen given p.o.  @ 1642.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Patient received Hepatitis A vaccine #1 in the left arm,  nocomplaints voiced at time of vaccination. 3 days later 2/2/2007 pt mother brought to clinic with localized redness, tenderness, warmth at the site with swelling to 5 - 6 cm.  ice applied, patient parent informed to give benadryl 12.5 mg po q 4 hours PRN and cool compresses to the site may also use motrin PRN.  return to clinic if any further problems and no further Hepatitis A vaccines are to be given.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Feeling hot, Oedema, Pruritus
Clinical narrative: swelling, redness, warmth and pruritis beginning 24 hours after vaccine.  No fever.  Examined 3 days after vaccine with warmth, redness of approx 2.5 by 3 inches
Age: 7.0
Sex: F
Vaccine: FLUX, PNC
Symptoms: Feeling hot, Headache, Hypersensitivity, Injection site cellulitis, Injection site erythema
Clinical narrative: By early evening, Jade c/o'd of localized pain in LD, general malaise nnd headache.  She was warm to the touch and 325 mg APAP was given.  She slept on and off w/increasing c/o pain in her LD.  On Oct. 27th, she c/o'd of severe localized pain (as bad as when she broke her arm) and had a temp of 103.2 in the axilla per mercury thermometer.  She continued to c/o headache and vomited X2.  The reddened area had become slighltly raised, red, hot, extremely tender, and spread out from the immunization site to several areas in the LUE above the elbow.  She was seen by her pediatrician around noon, who dx'd cellulitis and possible allergic rx. She was tx'd w/APAP, Benedryl, & Keflex 1.5 t. qid from 10/27-10/29/2007 then switched to cefadroxil 500 mg 1 tab bid x 7d.  Note:  The medication was changed for convenience not ineffectiveness.  By 10/28 temp was down to 101.8 axilla and by 10/30/2006 she was pretty much back to normal.
Age: 7.0
Sex: F
Vaccine: FLUX, PNC
Symptoms: Injection site pain, Injection site warmth, Malaise, Pyrexia, Sleep disorder
Clinical narrative: By early evening, Jade c/o'd of localized pain in LD, general malaise nnd headache.  She was warm to the touch and 325 mg APAP was given.  She slept on and off w/increasing c/o pain in her LD.  On Oct. 27th, she c/o'd of severe localized pain (as bad as when she broke her arm) and had a temp of 103.2 in the axilla per mercury thermometer.  She continued to c/o headache and vomited X2.  The reddened area had become slighltly raised, red, hot, extremely tender, and spread out from the immunization site to several areas in the LUE above the elbow.  She was seen by her pediatrician around noon, who dx'd cellulitis and possible allergic rx. She was tx'd w/APAP, Benedryl, & Keflex 1.5 t. qid from 10/27-10/29/2007 then switched to cefadroxil 500 mg 1 tab bid x 7d.  Note:  The medication was changed for convenience not ineffectiveness.  By 10/28 temp was down to 101.8 axilla and by 10/30/2006 she was pretty much back to normal.
Age: 7.0
Sex: F
Vaccine: FLUX, PNC
Symptoms: Vomiting
Clinical narrative: By early evening, Jade c/o'd of localized pain in LD, general malaise nnd headache.  She was warm to the touch and 325 mg APAP was given.  She slept on and off w/increasing c/o pain in her LD.  On Oct. 27th, she c/o'd of severe localized pain (as bad as when she broke her arm) and had a temp of 103.2 in the axilla per mercury thermometer.  She continued to c/o headache and vomited X2.  The reddened area had become slighltly raised, red, hot, extremely tender, and spread out from the immunization site to several areas in the LUE above the elbow.  She was seen by her pediatrician around noon, who dx'd cellulitis and possible allergic rx. She was tx'd w/APAP, Benedryl, & Keflex 1.5 t. qid from 10/27-10/29/2007 then switched to cefadroxil 500 mg 1 tab bid x 7d.  Note:  The medication was changed for convenience not ineffectiveness.  By 10/28 temp was down to 101.8 axilla and by 10/30/2006 she was pretty much back to normal.
Age: 13.0
Sex: F
Vaccine: FLU3, HPVX, TDAP, VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Laboratory test normal, Syncope
Clinical narrative: FAINTING VS SEIZURES. CT AND LABS WNL
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest pain, Pain, Pyrexia
Clinical narrative: achey, feverish, chest  hurting
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Antinuclear antibody, Bacterial test negative, Demyelination, Hypoaesthesia, Muscular weakness
Clinical narrative: Seriousness criteria other medically significant. Initial information received on 01 December 2006 from a health care professional. A 44 year old female patient, with no pre existing medical conditions and no illness at the time of vaccination, had received a left arm, intramuscular injection of Fluzone SV 2006/2007 lot number U2164AA, on 09 November 2006. Two days post vaccination, the patient experienced weakness in her left arm and hand. She reportedly now has numbness of the left arm and hand. She was examined in the office on 30 November 2006 and referred to neurologist. Diagnostic testing included a Lyme titer and ANA (results not provided). Follow up information received on 10 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received from 26 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received on 26 January 2007 from a health care professional. This case had been considered listed non serious for the information received on 01 December 2006 and 10 January 2007. Based upon new information received from this reporter, this case was upgraded to serious. EMG nerve conduction studies performed on 12 December 2006 were normal. A cervical and thoracic MRI performed on 08 January 2007 showed signal abnormality suggesting demyelination. Diagnosis from a neurology consultation was transverse myelitis. The patient is followed by neurology at this time. Additional information was not provided.  1/12/09 Received PCP medical records of 11/28/06-3/17/08. FINAL DX: transverse myelitis Records reveal patient experienced left arm/shoulder, breast & back symptoms of pain, numbness, burning, heaviness, low grade fever, fatigue, impaired touch sensation x 3 wks.  Received flu shot in RA.  Developed hyperesthesia/paresthesia of bilateral extremities, slurred speech & impaired mentation when fatigued.  Referred to neuro x 2.  Tx w/steroids & had some improvement.  2/16/09 Received Neuro consult medical records of 1/12/2007-3/2008. FINAL DX: transverse myelitis Records reveal patient experienced paresthesia of left arm & right leg, painful dyesthesia of left chest wall & feet, spasticity of left leg, fatigue, 18# wt loss.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myelitis transverse
Clinical narrative: Seriousness criteria other medically significant. Initial information received on 01 December 2006 from a health care professional. A 44 year old female patient, with no pre existing medical conditions and no illness at the time of vaccination, had received a left arm, intramuscular injection of Fluzone SV 2006/2007 lot number U2164AA, on 09 November 2006. Two days post vaccination, the patient experienced weakness in her left arm and hand. She reportedly now has numbness of the left arm and hand. She was examined in the office on 30 November 2006 and referred to neurologist. Diagnostic testing included a Lyme titer and ANA (results not provided). Follow up information received on 10 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received from 26 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received on 26 January 2007 from a health care professional. This case had been considered listed non serious for the information received on 01 December 2006 and 10 January 2007. Based upon new information received from this reporter, this case was upgraded to serious. EMG nerve conduction studies performed on 12 December 2006 were normal. A cervical and thoracic MRI performed on 08 January 2007 showed signal abnormality suggesting demyelination. Diagnosis from a neurology consultation was transverse myelitis. The patient is followed by neurology at this time. Additional information was not provided.  1/12/09 Received PCP medical records of 11/28/06-3/17/08. FINAL DX: transverse myelitis Records reveal patient experienced left arm/shoulder, breast & back symptoms of pain, numbness, burning, heaviness, low grade fever, fatigue, impaired touch sensation x 3 wks.  Received flu shot in RA.  Developed hyperesthesia/paresthesia of bilateral extremities, slurred speech & impaired mentation when fatigued.  Referred to neuro x 2.  Tx w/steroids & had some improvement.  2/16/09 Received Neuro consult medical records of 1/12/2007-3/2008. FINAL DX: transverse myelitis Records reveal patient experienced paresthesia of left arm & right leg, painful dyesthesia of left chest wall & feet, spasticity of left leg, fatigue, 18# wt loss.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Chest discomfort, Discomfort, Hypoaesthesia, Injection site discolouration
Clinical narrative: Seriousness criteria other medically significant. Initial information received on 01 December 2006 from a health care professional. A 44 year old female patient, with no pre existing medical conditions and no illness at the time of vaccination, had received a left arm, intramuscular injection of Fluzone SV 2006/2007 lot number U2164AA, on 09 November 2006. Two days post vaccination, the patient experienced weakness in her left arm and hand. She reportedly now has numbness of the left arm and hand. She was examined in the office on 30 November 2006 and referred to neurologist. Diagnostic testing included a Lyme titer and ANA (results not provided). Follow up information received on 10 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received from 26 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received on 26 January 2007 from a health care professional. This case had been considered listed non serious for the information received on 01 December 2006 and 10 January 2007. Based upon new information received from this reporter, this case was upgraded to serious. EMG nerve conduction studies performed on 12 December 2006 were normal. A cervical and thoracic MRI performed on 08 January 2007 showed signal abnormality suggesting demyelination. Diagnosis from a neurology consultation was transverse myelitis. The patient is followed by neurology at this time. Additional information was not provided.  1/12/09 Received PCP medical records of 11/28/06-3/17/08. FINAL DX: transverse myelitis Records reveal patient experienced left arm/shoulder, breast & back symptoms of pain, numbness, burning, heaviness, low grade fever, fatigue, impaired touch sensation x 3 wks.  Received flu shot in RA.  Developed hyperesthesia/paresthesia of bilateral extremities, slurred speech & impaired mentation when fatigued.  Referred to neuro x 2.  Tx w/steroids & had some improvement.  2/16/09 Received Neuro consult medical records of 1/12/2007-3/2008. FINAL DX: transverse myelitis Records reveal patient experienced paresthesia of left arm & right leg, painful dyesthesia of left chest wall & feet, spasticity of left leg, fatigue, 18# wt loss.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging, Pain in extremity, Spinal X-ray
Clinical narrative: Seriousness criteria other medically significant. Initial information received on 01 December 2006 from a health care professional. A 44 year old female patient, with no pre existing medical conditions and no illness at the time of vaccination, had received a left arm, intramuscular injection of Fluzone SV 2006/2007 lot number U2164AA, on 09 November 2006. Two days post vaccination, the patient experienced weakness in her left arm and hand. She reportedly now has numbness of the left arm and hand. She was examined in the office on 30 November 2006 and referred to neurologist. Diagnostic testing included a Lyme titer and ANA (results not provided). Follow up information received on 10 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received from 26 January 2007 from a health care professional. The patient was taking no other medications at the time of vaccination. Additional medically relevant information was not provided. Follow up information received on 26 January 2007 from a health care professional. This case had been considered listed non serious for the information received on 01 December 2006 and 10 January 2007. Based upon new information received from this reporter, this case was upgraded to serious. EMG nerve conduction studies performed on 12 December 2006 were normal. A cervical and thoracic MRI performed on 08 January 2007 showed signal abnormality suggesting demyelination. Diagnosis from a neurology consultation was transverse myelitis. The patient is followed by neurology at this time. Additional information was not provided.  1/12/09 Received PCP medical records of 11/28/06-3/17/08. FINAL DX: transverse myelitis Records reveal patient experienced left arm/shoulder, breast & back symptoms of pain, numbness, burning, heaviness, low grade fever, fatigue, impaired touch sensation x 3 wks.  Received flu shot in RA.  Developed hyperesthesia/paresthesia of bilateral extremities, slurred speech & impaired mentation when fatigued.  Referred to neuro x 2.  Tx w/steroids & had some improvement.  2/16/09 Received Neuro consult medical records of 1/12/2007-3/2008. FINAL DX: transverse myelitis Records reveal patient experienced paresthesia of left arm & right leg, painful dyesthesia of left chest wall & feet, spasticity of left leg, fatigue, 18# wt loss.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Swelling, Vomiting
Clinical narrative: Swelling, redness, vomiting
Age: 49.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Body temperature increased, Chills, Muscle spasms, Nausea, Sleep disorder
Clinical narrative: On 1/19/07 approx about 9pm started to feel chills and muscle cramps. On 1/18/07 1am-woke up due to muscle cramps, chills. Temp was 103, treated with tylenol every 4 hours, which ended 1/19/07. Also did hae nausea
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Diarrhoea, Injection site bruising, Injection site erythema, Injection site warmth, Vomiting
Clinical narrative: Right arm site of injection red, warm to touch, mild bruised.  Vomiting and diarrhea
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Extreme itching covering entire body following Tdap vaccination. Treated self with oral Benadryl. Onset occurred 1 day after injection with increase of itching the following day. No otherside effects.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Tic
Clinical narrative: tics since vaccine give not down to approx 5/minute
Age: 5.0
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Pt developed pain then redness and blisters at site of varicella vaccine consistent with shingles.
Age: 12.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Acne, Decreased appetite, Injection site induration
Clinical narrative: Mother stated she started seeing pimples at injection site 1/28/07, pt noted to have induration around injection site, mom states pt appetite has not been as it usually is. No distress to pt.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Bone disorder, Injection site reaction, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging abnormal, Osteomyelitis
Clinical narrative: pain in arm approx 6 weeks, contacted MD, xray showed infection of bone or covering over bone? at skin injection site. MD: mri shows scar tisswue on bone/periosteo change/osteomyelitis? therapy recommended: physical therapy.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray, X-ray abnormal
Clinical narrative: pain in arm approx 6 weeks, contacted MD, xray showed infection of bone or covering over bone? at skin injection site. MD: mri shows scar tisswue on bone/periosteo change/osteomyelitis? therapy recommended: physical therapy.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea, vomiting, stomach ache, fever.  the vaccine date listed is the first date taken: subsequently taken 1/27, 1/29, 1/31 as per instructions.  I was given a tetnus shot in my left arm on 1/24 in PM (the system won't let me out even though I tried to delete so I'm picking a manufacturer & type that may not be correct).
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Patient received vaccine on 12/07/05, and next day contacted doctors office complaining of having a large band of welts approximately 4 inches up and down vertically and 6 inches horizontally at the injection site, arm swollen above the elbow, purple bruising around the injection site, pain in the upper arm, inability to raise the arm. Patient was seen on 12/13/05 fro a scheduled doctors visit. At the doctors visit patients arm was itchy, but there was no redness or swelling, there was a red bruise, 4cm in diameter, at the injection site with 2cm in diameter yellowing on outer edges. Patient recovered.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Patient received vaccine on 12/07/05, and next day contacted doctors office complaining of having a large band of welts approximately 4 inches up and down vertically and 6 inches horizontally at the injection site, arm swollen above the elbow, purple bruising around the injection site, pain in the upper arm, inability to raise the arm. Patient was seen on 12/13/05 fro a scheduled doctors visit. At the doctors visit patients arm was itchy, but there was no redness or swelling, there was a red bruise, 4cm in diameter, at the injection site with 2cm in diameter yellowing on outer edges. Patient recovered.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Dizziness, Headache, Neck pain
Clinical narrative: patient received Td injection due to laceration on 02/12/06 and that same day back of patient's head, neck, back in general and legs began to ache and patient felt dizzy. Ache continued for couple of days.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Nausea, Paraesthesia
Clinical narrative: Patient developed headache, chills at night, nausea and tingling at the head day after receiving TD vaccination. Symptoms were still ongoing when the patient saw her doctor on 06/23/06. Follow up received on 07/24/06 patient recovered.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient reported nausea, vomiting and diarrhea that started approximately five hours after immunization was administered. Follow up 10/24/06 patient recovered.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Chest discomfort, Muscle spasms
Clinical narrative: Patient experienced generalized weakness and muscle spasms, that started shortly after the booster Td shot was administered. Patient also had a feeling of a chest pressure, that lasted 2 days. There was no rash. On the day of vaccination patient had stitches removed from a previous lesion. On 09/26/06 patient visited her doctor and was feeling much better. RN noted that patient recovered.
Age: 1.83
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Body temperature increased, Convulsion, Laboratory test
Clinical narrative: 11/23/06 pt had been playing with cousins in the afternoon, had diaper change, started seizing. EMT's came, transported to ER. Temp in ambulance 103.7 rectal.  ER exam, C&R labwork negative.  11/26/06-temp 102 in evening. 11/27/06 recovered. Never acted ill during this time
Age: 0.2
Sex: F
Vaccine: HIBV, RVX, HIBV, RV5
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 10 week old female, with a history of being a fussy baby who spits up, who on 18-Jan-2007 was vaccinated with a first dose of Rotateq vaccine (human-bovine) (lot#655867/1111F). Concomitant vaccine administered on the same day included a dose of Hib conj vaccine (manufacturer unknown). On 20-Jan-2007 the patient developed very bad diarrhea and severe diaper rash. It was noted that the patient's skin was denuded in some areas to the rash. The patient had no fever or vomiting. The patient was treated with antibiotic ointment, triple paste and by switching the patient's soy formula. At the time of the report the diaper rash had shown improvement but the diarrhea continued. It was noted that there was no blood in the patient's stool. Very bad diarrhea and severe diaper rash were considered to be disabling by the reporter. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HIBV, RVX, HIBV, RV5
Symptoms: Dermatitis diaper, Diarrhoea, Skin atrophy, Stool analysis
Clinical narrative: Information has been received from a physician concerning a 10 week old female, with a history of being a fussy baby who spits up, who on 18-Jan-2007 was vaccinated with a first dose of Rotateq vaccine (human-bovine) (lot#655867/1111F). Concomitant vaccine administered on the same day included a dose of Hib conj vaccine (manufacturer unknown). On 20-Jan-2007 the patient developed very bad diarrhea and severe diaper rash. It was noted that the patient's skin was denuded in some areas to the rash. The patient had no fever or vomiting. The patient was treated with antibiotic ointment, triple paste and by switching the patient's soy formula. At the time of the report the diaper rash had shown improvement but the diarrhea continued. It was noted that there was no blood in the patient's stool. Very bad diarrhea and severe diaper rash were considered to be disabling by the reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Diabetes mellitus, Dizziness, Electromyogram, Guillain-Barre syndrome
Clinical narrative: Extreme pain lower legs, arms, Flu, staph infection onset of diabetes following. EMG given. Shot, antibiotics, pain killers, walking cane.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Lethargy, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme pain lower legs, arms, Flu, staph infection onset of diabetes following. EMG given. Shot, antibiotics, pain killers, walking cane.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Staphylococcal infection, Vomiting
Clinical narrative: Extreme pain lower legs, arms, Flu, staph infection onset of diabetes following. EMG given. Shot, antibiotics, pain killers, walking cane.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diabetes mellitus, Electromyogram, Guillain-Barre syndrome, Influenza, Pain in extremity
Clinical narrative: Extreme pain lower legs, arms, Flu, staph infection onset of diabetes following. EMG given. Shot, antibiotics, pain killers, walking cane.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Staphylococcal infection, Walking aid user
Clinical narrative: Extreme pain lower legs, arms, Flu, staph infection onset of diabetes following. EMG given. Shot, antibiotics, pain killers, walking cane.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Dyspnoea, Swelling face
Clinical narrative: information has been received from a registered nurse concerning a 4 year old male with no pertinent medical history of allergies, who on 23 Jan 2007 was vaccinated subcutaneously with a 0.5ml dose of ProQuad (lot# 655752/1122F). Concomitant vaccination s included a fifth dose of Tripedia (lot# U1813AB) given intramuscularly and a fourth dose of Ipol given intramuscularly. There was no illness at the time of vaccination. On 23 Jan 2007, the patient remained in the department for 30-45 minutes following vaccination then went home. On the way home (also reported as fifteen minutes after the vaccination), the patient complained of a slight cough, difficulty breathing and throat pain, his mother reported that she noted facial swelling. He was returned to the clinic and was given Solu Medrol. He was taken to the emergency room and was discharged on 9am on 24 Jan 2007 when he was free of symptoms. He went home on Benadryl and with Epipen. He was scheduled to be seen in the clinic on 26 Jan 2007. he was recovered at the time of this report. It was reported that prior vaccinations with MMR II, Varivax, Dtap and Polio vaccine have been well tolerated with no adverse symptoms. The reporter considered the patient's experiences to be life threatening and other important medical events. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Cough, Dyspnoea, Pharyngolaryngeal pain, Swelling face
Clinical narrative: information has been received from a registered nurse concerning a 4 year old male with no pertinent medical history of allergies, who on 23 Jan 2007 was vaccinated subcutaneously with a 0.5ml dose of ProQuad (lot# 655752/1122F). Concomitant vaccination s included a fifth dose of Tripedia (lot# U1813AB) given intramuscularly and a fourth dose of Ipol given intramuscularly. There was no illness at the time of vaccination. On 23 Jan 2007, the patient remained in the department for 30-45 minutes following vaccination then went home. On the way home (also reported as fifteen minutes after the vaccination), the patient complained of a slight cough, difficulty breathing and throat pain, his mother reported that she noted facial swelling. He was returned to the clinic and was given Solu Medrol. He was taken to the emergency room and was discharged on 9am on 24 Jan 2007 when he was free of symptoms. He went home on Benadryl and with Epipen. He was scheduled to be seen in the clinic on 26 Jan 2007. he was recovered at the time of this report. It was reported that prior vaccinations with MMR II, Varivax, Dtap and Polio vaccine have been well tolerated with no adverse symptoms. The reporter considered the patient's experiences to be life threatening and other important medical events. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TTOX
Symptoms: Lymphadenopathy
Clinical narrative: Rc'd shot 1/31/07, on morning of 2/2/07 pt noticed swollen lymph nodes in neck. No treatment received.
Age: 1.21
Sex: M
Vaccine: FLU3, MMRV, PNC
Clinical narrative: Seen on 1/26/07 and received ProQuad, Prevnar, and Flu vaccine. According to grandmother died on Sunday.  4/17/2007 Received Autopsy Report which reveals COD as sepsis with bronchopneumonia & tracheobronchitis.  Anatomic findings include: small abrasions on central forehead; marked congestion & edema of bilat lungs; enlarged heart; small contusion on right forhead; skin lesions around mouth & nares & dried mucous around nares.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who in 2006 was vaccinated PO with the first 2.0 ml dose of Rotateq. In Late 2006 2 months after receiving the first dose, the patient threw up and had bloody diapers. Unspecified medical attention was sought. It was noted that the patient was not given the subsequent dosed of Rotateq. At the time of this report, the outcome was unknown. Upon internal review, blood diapers was determined to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Haematochezia, Occult blood
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old patient who on approximately 25 Dec 2006 was vaccinated PO with a 2.0 ml dose of Rotateq. The physician reported that on approximately 25 Dec 2006, the patient developed blood in the stool. Unspecified medical attention was sought. A fecal blood occult test was performed (results not provided). Within a few couple days after onset, the patient's blood in stool resolved. Upon internal review, blood in the stool with determined to be an other important medical event. Additional information has been requested.
Age: 0.26
Sex: F
Vaccine: RV5
Symptoms: Abdominal distension, Cyanosis, Laboratory test, Respiratory arrest
Clinical narrative: Information has been received from a physician concerning a 2 month old female with no medical history or allergies who at the end of December 2006, was vaccinated PO with a dose of Rotateq. There was no concomitant therapy. The physician reported that at the end of December 2006, the patient developed abdominal distention. The patient was taken to the Emergency room and was admitted overnight. While hospitalized, the patient stopped breathing and turned blue. Unspecified laboratory tests were performed. The patient subsequently recovered. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Culture, Gastroenteritis rotavirus, Influenza serology, Nasal aspiration, Rotavirus test
Clinical narrative: Information has been received from a pharmacist concerning a 12 week old hospitalized male with renal insufficiency, no drug reaction or allergies and who was born prematurely who on 17 Jan 2006 was vaccinated with a 2 ml oral dose of Rotateq. Concomitant therapy included israpidine, amoxicillin, Prevacid and vitamins (unspecified). On 29 Jan 2007 the patient developed rotavirus. Lab test that were preformed included, rotavirus stool test, various system cultures, RSV and influenza. The results of these tests were not reported. The patients hospitalization continued. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test positive, Virus serology test
Clinical narrative: Information has been received from a pharmacist concerning a 12 week old hospitalized male with renal insufficiency, no drug reaction or allergies and who was born prematurely who on 17 Jan 2006 was vaccinated with a 2 ml oral dose of Rotateq. Concomitant therapy included israpidine, amoxicillin, Prevacid and vitamins (unspecified). On 29 Jan 2007 the patient developed rotavirus. Lab test that were preformed included, rotavirus stool test, various system cultures, RSV and influenza. The results of these tests were not reported. The patients hospitalization continued. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.