chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest discomfort, Choking, Inappropriate schedule of drug administration, Injection site discomfort
Clinical narrative: Information has been received from a nurse practitioner concerning a "31 year old" female who on 14-DEC-2009 was vaccinated with a first dose of PNEUMOVAX 23 (therapy route and lot # not provided). On 18-JAN-2011 the patient received a second 0.5 ml dose of PNEUMOVAX 23 (therapy route not provided, lot # 665401/1320Y, expired date unspecified). On 18-JAN-2011 the patient experienced "tightness in the chest that radiated down through the arm of the injection site of PNEUMOVAX vaccine". Patient also experienced constant neck and back pain and woke up choking. Patient did not inform the office she had been vaccinated with PNEUMOVAX 23 on 14-DEC-2009 until after receiving the product again on 18-JAN-2011. The office asked if she had received it before administrating the product and the patient said she had not. Then after receiving the injection and experiencing symptoms she reported having the shot before. Treatment given for this adverse event included 600 mg MOTRIN. "Tightness in the chest that radiated down through the arm of the injection site", constant neck and back pain and woke up choking were considered to be immediately life-threatening, disabling and overdose. At the time of reporting, the patient is recovering. A lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Neck pain
Clinical narrative: Information has been received from a nurse practitioner concerning a "31 year old" female who on 14-DEC-2009 was vaccinated with a first dose of PNEUMOVAX 23 (therapy route and lot # not provided). On 18-JAN-2011 the patient received a second 0.5 ml dose of PNEUMOVAX 23 (therapy route not provided, lot # 665401/1320Y, expired date unspecified). On 18-JAN-2011 the patient experienced "tightness in the chest that radiated down through the arm of the injection site of PNEUMOVAX vaccine". Patient also experienced constant neck and back pain and woke up choking. Patient did not inform the office she had been vaccinated with PNEUMOVAX 23 on 14-DEC-2009 until after receiving the product again on 18-JAN-2011. The office asked if she had received it before administrating the product and the patient said she had not. Then after receiving the injection and experiencing symptoms she reported having the shot before. Treatment given for this adverse event included 600 mg MOTRIN. "Tightness in the chest that radiated down through the arm of the injection site", constant neck and back pain and woke up choking were considered to be immediately life-threatening, disabling and overdose. At the time of reporting, the patient is recovering. A lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy abnormal, Human papilloma virus test positive, Neoplasm, Papilloma viral infection, Precancerous cells present
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female patient with asthma in 2007 and no allergies, who on 02-MAR-2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# 654510/0962F), IM. On 24-MAY-2007 was vaccinated with a second 0.5 ml dose of GARDASIL (lot# 654510/0962F), IM, and on 17-OCT-2007 was vaccinated with a third 0.5ml dose of GARDASIL (Lot# 658488/0930U), IM. Concomitant therapy included DEPO-PROVERA which was reported that she re-started on 04-JAN-2011 and it was not taken in 2010. On 17-OCT-2007 and in 2009 Papanicolaou test were performed and both were negative. The nurse reported that on 16-NOV-2010 a human papilloma virus test was performed that was positive and the patient was sent to a gynecologist. The patient on unspecified date had a colposcopy that was positive for HPV neoplasia. The nurse also stated that this was not present prior to receiving GARDASIL. The nurse reported that these events were related to "pre cancer". The nurse reported that the patient would have a loop electrosurgical excision procedure (LEEP) at the gynecologist's (date not reported). At the time of the report the patient had not recovered from these events. Upon internal review "pre-cancer" was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female patient with asthma in 2007 and no allergies, who on 02-MAR-2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# 654510/0962F), IM. On 24-MAY-2007 was vaccinated with a second 0.5 ml dose of GARDASIL (lot# 654510/0962F), IM, and on 17-OCT-2007 was vaccinated with a third 0.5ml dose of GARDASIL (Lot# 658488/0930U), IM. Concomitant therapy included DEPO-PROVERA which was reported that she re-started on 04-JAN-2011 and it was not taken in 2010. On 17-OCT-2007 and in 2009 Papanicolaou test were performed and both were negative. The nurse reported that on 16-NOV-2010 a human papilloma virus test was performed that was positive and the patient was sent to a gynecologist. The patient on unspecified date had a colposcopy that was positive for HPV neoplasia. The nurse also stated that this was not present prior to receiving GARDASIL. The nurse reported that these events were related to "pre cancer". The nurse reported that the patient would have a loop electrosurgical excision procedure (LEEP) at the gynecologist's (date not reported). At the time of the report the patient had not recovered from these events. Upon internal review "pre-cancer" was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness unilateral
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who was vaccinated with GARDASIL (dose and route unknown) on an unspecified date. Subsequently the patient experienced blindness in her one eye. The patient went to the optomologist and was given unspecified treatment for blindness. The optomologist was blaming GARDASIL for blindness in her one eye. At the time of the report, the patient's outcome was unknown. Upon internal review, blindness in one eye was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning an unspecified number of patients who on unspecified date were vaccinated with a dose of ROTATEQ (dose, route and Lot# not reported). On an unspecified date an unspecified number of patients developed intussusception. At the time of the report the patients' outcome was unknown. The physician stated that she was starting to use ROTATEQ again since "the cases of intussusception have not been showing up like she claims she once used to see with the medication". She did not mention any specific number of patients. Upon internal review intussusception was considered to be other important medical event. All telephone attempts to obtain follow up information have been unsuccessful. Attempts to verify the existence of an identifiable patient have been unsuccessful. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT LEG SWOLLEN, WARM TO TOUCH AND RED
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Erythema, Injection site swelling, Joint swelling, Pruritus, Rash
Clinical narrative: SWELLING ON ADMINISTRATION SITE STARTED, IN THE NIGHT RASHES AND SMALL ELEVATED SPOTS NOTED ON NECK, GROIN, FACE, AXILLA, UPPER EXTREMITIES THE AREAS OF RASHES GETTING BIG AND ITCHING STARTED, SUBSIDED WITH BENADRYL ONE DOSE IN ER, NEXT MORNING FOUND BIG AREAS OF ELEVATION ON FACE, SCALP, NECK, GROIN, SWOLLEN RED KNEES, WRIST
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Oedema, Pruritus, Rash papular, Urticaria
Clinical narrative: SWELLING ON ADMINISTRATION SITE STARTED, IN THE NIGHT RASHES AND SMALL ELEVATED SPOTS NOTED ON NECK, GROIN, FACE, AXILLA, UPPER EXTREMITIES THE AREAS OF RASHES GETTING BIG AND ITCHING STARTED, SUBSIDED WITH BENADRYL ONE DOSE IN ER, NEXT MORNING FOUND BIG AREAS OF ELEVATION ON FACE, SCALP, NECK, GROIN, SWOLLEN RED KNEES, WRIST
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Erythema, Fall, Oedema peripheral
Clinical narrative: 1/28/11: 1800 had whole body shaking with chills..very painful arm with heat & swelling. 2400 was febrile 1/29/11: 0400 awoke with bedding and gown wet with no fever. 0700 was weak..incurred 3 falls with no injury (am a distance runner and this was atypical). 2200 arm less sore shows well demarcated erythmic circle about 6.35cm in diam 1/30/11: 2200 arm only mildly sore, less heat & erythemic area reduced to 5cm diam & no longer well demarcated 1/31/11:  Arm to mildly sore, erythemic, still have obscure circle @5cm diam.  Have a call into precsriber's nurse to assess of sensitivity.  Never had problems with breathing.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: 1/28/11: 1800 had whole body shaking with chills..very painful arm with heat & swelling. 2400 was febrile 1/29/11: 0400 awoke with bedding and gown wet with no fever. 0700 was weak..incurred 3 falls with no injury (am a distance runner and this was atypical). 2200 arm less sore shows well demarcated erythmic circle about 6.35cm in diam 1/30/11: 2200 arm only mildly sore, less heat & erythemic area reduced to 5cm diam & no longer well demarcated 1/31/11:  Arm to mildly sore, erythemic, still have obscure circle @5cm diam.  Have a call into precsriber's nurse to assess of sensitivity.  Never had problems with breathing.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Myalgia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of muscle pain in a 70-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included multiple sclerosis. Concurrent medications included zolpidem, MIRAPEX, PAXIL, HCTZ, COZAAR and septradia (unknown medication). On 19 January 2011 the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 21 January 2011, 2 days after vaccination with FLULAVAL, the subject experienced muscle pain and feeling of discomfort. The pharmacist reported that the subject's muscle aches were uncomfortable feeling, TYLENOL was helping, but when the subject stopped taking TYLENOL her muscle aches continued. The pharmacist considered the events were clinically significant (or requiring intervention). The subject was treated with TYLENOL. At the time of reporting the muscle aches and uncomfortable feeling were unresolved. The pharmacist considered the events were probably related to vaccination with FLULAVAL.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: No treatment. Symptoms include arm pain, pain the radiates from shoulder down causing decrease usage, numbness.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Patient report 2-3 days of fever to 102 degrees at highest, headache, muscle aches, chills & redness & tenderness at injection site.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient report 2-3 days of fever to 102 degrees at highest, headache, muscle aches, chills & redness & tenderness at injection site.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal pain, Angioedema, Mechanical urticaria, Swelling face
Clinical narrative: urticaria dermatographism (1/27/2011); facial swelling, angioedema, urticaria dermatographism, abdominal pain (1/28/2011); required epinephrine on multiple occasions
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal distension, Abdominal pain upper, Blood test, Chest pain, Computerised tomogram abdomen abnormal
Clinical narrative: urticaria dermatographism (1/27/2011); facial swelling, angioedema, urticaria dermatographism, abdominal pain (1/28/2011); required epinephrine on multiple occasions
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Computerised tomogram abnormal, Dyspepsia, Dyspnoea, Intensive care, Pruritus generalised
Clinical narrative: urticaria dermatographism (1/27/2011); facial swelling, angioedema, urticaria dermatographism, abdominal pain (1/28/2011); required epinephrine on multiple occasions
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Throat tightness, Urticaria, Vomiting
Clinical narrative: urticaria dermatographism (1/27/2011); facial swelling, angioedema, urticaria dermatographism, abdominal pain (1/28/2011); required epinephrine on multiple occasions
Age: 20.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Asthenia, Dyspnoea, Fatigue, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Right after vaccine experienced pain and itching at injection site with a raised bump, severe numbness in hands and feet, difficulty breathing, shortness of breath, fatigue, loss of energy, etc.
Age: 20.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Right after vaccine experienced pain and itching at injection site with a raised bump, severe numbness in hands and feet, difficulty breathing, shortness of breath, fatigue, loss of energy, etc.
Age: 0.18
Sex: F
Vaccine: DTAP, DTPIPV, HIBV
Symptoms: Decreased appetite, Depressed level of consciousness, Irritability, Pyrexia, Somnolence
Clinical narrative: Fussy, sleepy (not wanting to wake up), loss of appetite (missed feeding), fever (lasted 2 hrs. but had given infant Tylenol), glassy eyed (not focusing on anything, not alert). All systems, excluding fussiness and loss of appetite lasted until 1/28/11 at 5:30 PM.
Age: 0.18
Sex: F
Vaccine: DTAP, DTPIPV, HIBV
Symptoms: Staring
Clinical narrative: Fussy, sleepy (not wanting to wake up), loss of appetite (missed feeding), fever (lasted 2 hrs. but had given infant Tylenol), glassy eyed (not focusing on anything, not alert). All systems, excluding fussiness and loss of appetite lasted until 1/28/11 at 5:30 PM.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, HIBV
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: Influenza vaccine (inactivated 0.25ml) IM 1-13-2011 in the morning (9 am) at 3pm foster mother reports temp 102 & child c/o leg sore. Improved w/TYLENOL resolved < 48hrs after injection.
Age: 1.27
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Mild increase in temperature between the evening of 01/24/2011 and 01/26/2011. Increased fever on 01/27/2011 @ 101F (identified on 7:00PM). Continuous fever of 101F-101.5 on 01/27/2011 - 01/28/2011. Fever increased 101.8 on 01/29/2011 at 7:00 AM. Fever further increased up to 103.8 F on 01/29/2011 while Tylenol was given every 5 hrs, and in the afternoon (and further) 6:00 PM Motrin was given (every 7 hrs) as per physician's recommendation. Fever remained at 103.3 up to 01/30/2011 (7:00 AM). Throughout the day Tylenol/Motrin were given as per recommendation of the physician and fever stayed at 102.2. By midnight 01/31/2011 temperature returned to normal.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pityriasis rosea, Rash
Clinical narrative: RASH DIAGNOSED AS PITYARIASIS ROSEA BY DOCTOR
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Tremor
Clinical narrative: Female developed tremors in legs about 1/2 hour after receiving influenza vaccine. Mother recommended school personnel to administer Benadryl 50mg capsule as this adverse event occurred after starting on an antibiotic series.  Benadryl was given by school personnel.  Instructed child to lay down.  Tremors lasted about 20 minutes.  Child was assisted to a private room to lay down and rest.  Checked her every 1/2 hour.  Complained of being tired but tremors did not occur again.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Chills, Headache, Myalgia
Clinical narrative: States at 4:30 PM had chills, fever 104, cough with production of brownish sputum, headache, weakness, vomiting, chest tightness, muscle soreness, sores in mouth
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Productive cough, Pyrexia, Sputum discoloured, Stomatitis, Vomiting
Clinical narrative: States at 4:30 PM had chills, fever 104, cough with production of brownish sputum, headache, weakness, vomiting, chest tightness, muscle soreness, sores in mouth
Age: 24.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The Yellow Fever Vaccine was administered subcut in pt's right arm on 1/20/2010. After 48 hours, pt. stated that injection site was erythematous and hot to the touch, with a red ring around the swollen injection site. The swelling was approximately 5 inches by 3 inches. Pt. saw her Dr. on 1/25/11, who diagnosed cellulitis and prescribed Keflex 500 mg. qid. Pt. said that swelling and discomfort have subsided but that right hand is swollen. She was to have a follow up appt. with her Dr. this afternoon.
Age: 24.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Oedema peripheral
Clinical narrative: The Yellow Fever Vaccine was administered subcut in pt's right arm on 1/20/2010. After 48 hours, pt. stated that injection site was erythematous and hot to the touch, with a red ring around the swollen injection site. The swelling was approximately 5 inches by 3 inches. Pt. saw her Dr. on 1/25/11, who diagnosed cellulitis and prescribed Keflex 500 mg. qid. Pt. said that swelling and discomfort have subsided but that right hand is swollen. She was to have a follow up appt. with her Dr. this afternoon.
Age: 66.0
Sex: M
Vaccine: TD, YF
Symptoms: Abasia, Asthenia, CSF protein increased, CSF white blood cell count negative, Electromyogram abnormal
Clinical narrative: Pt a 67 year old male received flu vaccine along with yellow fever and tetanus vaccines on 11/4/2010.  He developed a sore throat initially and URTI with productive cough that lasted 10 days and started 2 days following the vaccines.  Pt was admitted 11/30/2010 with shoulder pain (initial symptom), increased weakness, unsteady gait, bilateral leg and arm numbness.  LP showed CSF had elevated protein levels at 125 mg/dL without increased WBC and Guillain Barre Syndrome was suspected.  Pt received IVIG 0.4 g/kg x 5 days starting 12/2/2010.  EMG results 12/3/2010 showed prolonged F waves which are also indicative of GBS.  Pt's symptoms progressed while inpatient to facial paralysis and respiratory symptoms along with increasing weakness and inability to ambulate.  Symptoms began improving 12/6/2010 and transferred 12/9/2010 for rehab where he was discharged 12/29/2010.  At time of d/c was able to perform ADLs with little to no assistance.
Age: 66.0
Sex: M
Vaccine: TD, YF
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Pt a 67 year old male received flu vaccine along with yellow fever and tetanus vaccines on 11/4/2010.  He developed a sore throat initially and URTI with productive cough that lasted 10 days and started 2 days following the vaccines.  Pt was admitted 11/30/2010 with shoulder pain (initial symptom), increased weakness, unsteady gait, bilateral leg and arm numbness.  LP showed CSF had elevated protein levels at 125 mg/dL without increased WBC and Guillain Barre Syndrome was suspected.  Pt received IVIG 0.4 g/kg x 5 days starting 12/2/2010.  EMG results 12/3/2010 showed prolonged F waves which are also indicative of GBS.  Pt's symptoms progressed while inpatient to facial paralysis and respiratory symptoms along with increasing weakness and inability to ambulate.  Symptoms began improving 12/6/2010 and transferred 12/9/2010 for rehab where he was discharged 12/29/2010.  At time of d/c was able to perform ADLs with little to no assistance.
Age: 66.0
Sex: M
Vaccine: TD, YF
Symptoms: Musculoskeletal pain, Oropharyngeal pain, Productive cough, Respiratory disorder, Upper respiratory tract infection
Clinical narrative: Pt a 67 year old male received flu vaccine along with yellow fever and tetanus vaccines on 11/4/2010.  He developed a sore throat initially and URTI with productive cough that lasted 10 days and started 2 days following the vaccines.  Pt was admitted 11/30/2010 with shoulder pain (initial symptom), increased weakness, unsteady gait, bilateral leg and arm numbness.  LP showed CSF had elevated protein levels at 125 mg/dL without increased WBC and Guillain Barre Syndrome was suspected.  Pt received IVIG 0.4 g/kg x 5 days starting 12/2/2010.  EMG results 12/3/2010 showed prolonged F waves which are also indicative of GBS.  Pt's symptoms progressed while inpatient to facial paralysis and respiratory symptoms along with increasing weakness and inability to ambulate.  Symptoms began improving 12/6/2010 and transferred 12/9/2010 for rehab where he was discharged 12/29/2010.  At time of d/c was able to perform ADLs with little to no assistance.
Age: 66.0
Sex: M
Vaccine: TD, YF
Symptoms: VIIth nerve paralysis
Clinical narrative: Pt a 67 year old male received flu vaccine along with yellow fever and tetanus vaccines on 11/4/2010.  He developed a sore throat initially and URTI with productive cough that lasted 10 days and started 2 days following the vaccines.  Pt was admitted 11/30/2010 with shoulder pain (initial symptom), increased weakness, unsteady gait, bilateral leg and arm numbness.  LP showed CSF had elevated protein levels at 125 mg/dL without increased WBC and Guillain Barre Syndrome was suspected.  Pt received IVIG 0.4 g/kg x 5 days starting 12/2/2010.  EMG results 12/3/2010 showed prolonged F waves which are also indicative of GBS.  Pt's symptoms progressed while inpatient to facial paralysis and respiratory symptoms along with increasing weakness and inability to ambulate.  Symptoms began improving 12/6/2010 and transferred 12/9/2010 for rehab where he was discharged 12/29/2010.  At time of d/c was able to perform ADLs with little to no assistance.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Thinking abnormal
Clinical narrative: wild thoughts, nausea
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Bursitis, Joint range of motion decreased, Myalgia
Clinical narrative: Sore muscles with increased pain intensity and rom limitations over next 2 weeks
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic stimulation tests normal, Ear discomfort, Electromyogram abnormal, Electroneurography, Eyelid function disorder
Clinical narrative: On vacation, experienced inner ear discomfort and moderate right-side numbness of tongue for several days. Onset of severe symptoms several days later, as described below. (In retrospect, these are known early indications of Bell's Palsy.)  Awoke on 11/26/10 with substantial right facial weakness, which degenerated further over the course of the next several days until I had complete/nearly complete right facial paralysis. Specifically: I could not close my eye (needed to be taped shut at night), move the right side of my mouth, nose, cheek, forehead, etc. The initial diagnosis (I was traveling with physicians) was Bell's Palsy, and upon return to the U.S. I saw a neurologist who confirmed the Bell's Palsy diagnosis. I was graded at level 5 or 6 on the House-Brackmann Scale. Per doctor's advice, I treated immediately upon onset with high-dose prednisone and upon return to the U.S. one day after onset, Valcyclovir 4x/day for 10 days. I also began a fish oil supplement and a high dose of Methylcobalamin (Vitamin B12).   I recovered beginning the middle of the third week post-onset, reached full recovery at four weeks.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paresis, Hypoaesthesia oral, Movement disorder, Nuclear magnetic resonance imaging brain normal, VIIth nerve paralysis
Clinical narrative: On vacation, experienced inner ear discomfort and moderate right-side numbness of tongue for several days. Onset of severe symptoms several days later, as described below. (In retrospect, these are known early indications of Bell's Palsy.)  Awoke on 11/26/10 with substantial right facial weakness, which degenerated further over the course of the next several days until I had complete/nearly complete right facial paralysis. Specifically: I could not close my eye (needed to be taped shut at night), move the right side of my mouth, nose, cheek, forehead, etc. The initial diagnosis (I was traveling with physicians) was Bell's Palsy, and upon return to the U.S. I saw a neurologist who confirmed the Bell's Palsy diagnosis. I was graded at level 5 or 6 on the House-Brackmann Scale. Per doctor's advice, I treated immediately upon onset with high-dose prednisone and upon return to the U.S. one day after onset, Valcyclovir 4x/day for 10 days. I also began a fish oil supplement and a high dose of Methylcobalamin (Vitamin B12).   I recovered beginning the middle of the third week post-onset, reached full recovery at four weeks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mom reports child received vaccine 1/27/11 child did fine; till 1/29/11 developed high temperature and slan rash appeared at neck upper chest came to clinic today 1/31/11 no shortness breath 1) Rxd BENADRYL 12.5mg/5ml prn HS 2) Rxd Loratadine 5mg/5ml QD.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscle spasms, Muscle tightness, Muscle twitching, Pain
Clinical narrative: States noticed pain in L deltoid (works out with weights as is police officer) day after shot. Resumed weight workouts. On approx 12/24/10 noticed muscle spasms & twitching. Denies swelling of extremities. C/o burning pain in arm & now tightening of arm shoulder muscle that she feels maybe related to shot.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Patient states approximately 3 hours after receiving TDAP vaccine on 12/21/10, had rash & itching over chest & arms.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Local reaction, Nausea, Pain, Pyrexia
Clinical narrative: Local rxn swelling pain approximately 6cm, nausea, H/A, fever.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Local rxn swelling pain approximately 6cm, nausea, H/A, fever.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Impetigo, Injection site erythema, Rash vesicular, Vaccination site induration
Clinical narrative: Vaccinated 1/13/11. Developed hard red area above vaccine site about 01/20/11. Broke out with vesicular, impetiginous rash 1/28/11. Started BACTROBAN 1/21/11 & BACTRIM po 1/28/11.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: No fever 2 days after vaccinations were given - pt developed erythema & swelling on (L) upper extremity (around where vaccination was given). Erythema began spreading down arm & was accompanied by pruritus. Pt presented to ER - was given Clindamycin x 14 days due to ? cellulitis? vs. allergic rxn? Recommended BENADRYL & TYLENOL prn for other sx. Sx have improved after 2 days.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Extended local reaction with erythema, induration & pain 10 x 4 cm on (L) upper arm down from inj site of DTAP.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Patient stated developed an area 3 inches below injection site. Measuring 5 inches x 4 inches at widest point. Patient given antibiotic and instructions to return 2/1/11. Patient was seen 1/31/11.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient fainted following physical - had received #3 HPV vaccine - (Pt fell to floor  - hit her head and required treatment in ER).
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Tues. 1-25-11- Itching at site. Wed. 1-26-11 redness & pain at 4 p.m. (just finished skiing). Thurs. 1-27-11 Redness and swelling extending from rt. elbow to rt. shoulder hot to touch painful. No fever. Fri. swelling lessened. Mon- 1-31 Back in school. Sm. knot at site.
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Tues. 1-25-11- Itching at site. Wed. 1-26-11 redness & pain at 4 p.m. (just finished skiing). Thurs. 1-27-11 Redness and swelling extending from rt. elbow to rt. shoulder hot to touch painful. No fever. Fri. swelling lessened. Mon- 1-31 Back in school. Sm. knot at site.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fall, Loss of consciousness
Clinical narrative: Approximately 5 mins after receiving vaccines patient passed out and fell from standing position. First aid treatment was given.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Malaise, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Fever up to 102 degrees 5 days post TDAP imm. Muscle aches and weakness moderate fatigue mild to moderate malaise symptom onset 5 days after imm.
Age: 1.02
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Back pain, Blood immunoglobulin M increased, Blood test normal, Chest X-ray abnormal, Dysphagia
Clinical narrative: GUILLAIN-BARRE Syndrome - lost ability to crawl, dysphagia, back pain. Also had URI, patchy airspace opacities on CXR, mycoplasma IgM positive. Discharged on Zithromax.
Age: 1.02
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Electromyogram normal, Guillain-Barre syndrome, Inability to crawl, Lumbar puncture normal, Mycoplasma test positive
Clinical narrative: GUILLAIN-BARRE Syndrome - lost ability to crawl, dysphagia, back pain. Also had URI, patchy airspace opacities on CXR, mycoplasma IgM positive. Discharged on Zithromax.
Age: 1.02
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Tensilon test normal, Upper respiratory tract infection
Clinical narrative: GUILLAIN-BARRE Syndrome - lost ability to crawl, dysphagia, back pain. Also had URI, patchy airspace opacities on CXR, mycoplasma IgM positive. Discharged on Zithromax.
Age: 0.55
Sex: M
Vaccine: FLU3, DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Convulsion, Laboratory test, Pyrexia, Tongue disorder, Unresponsive to stimuli
Clinical narrative: Initial report was received on 22 January and 26 January 2011 from a consumer, who is also the patient's parent. A six-month-old male patient had received an injection of FLUZONE (Unspecified) (lot number, route and site of administration not reported) on 09 November 2010 at 4:30 pm and "within 10 hours" of administration (also reported as 3 am), he experienced a febrile seizure. At the time of the event, the patient's father had heard a strange noise coming from the patient's room. When he went in, he found his son with his tongue hanging out of his mouth, his lips were bluish in color, his eye were rolled up and back, he was motionless and did not respond. The father picked up his son and put cool water on his lips and patted him on the back. After one to two minutes, his son moved his tongue back in his mouth but was still not responding. The father called 911 and the emergency medical team arrived about five minutes later. The patient's temperature was 103.0 degrees Fahrenheit and he was still not responding. The emergency medical team placed a cold cloth on the patient's head and transported him to the emergency room. According to the reporter, corrective treatment consisted of MOTRIN and after four to five hours, the patient was back to normal and released. Later that same day, the patient was evaluated by his pediatrician but no further treatment or tests had been ordered or performed. The patient had no siblings and no prior history of seizures. Outcome was recovered. This patient experienced another adverse event which has been captured in case number 2011-00363. Documents held by sender: none.
Age: 0.55
Sex: M
Vaccine: FLU3, DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Body temperature increased, Cyanosis, Febrile convulsion, Gaze palsy, Tongue paralysis
Clinical narrative: Initial report was received on 22 January and 26 January 2011 from a consumer, who is also the patient's parent. A six-month-old male patient had received an injection of FLUZONE (Unspecified) (lot number, route and site of administration not reported) on 09 November 2010 at 4:30 pm and "within 10 hours" of administration (also reported as 3 am), he experienced a febrile seizure. At the time of the event, the patient's father had heard a strange noise coming from the patient's room. When he went in, he found his son with his tongue hanging out of his mouth, his lips were bluish in color, his eye were rolled up and back, he was motionless and did not respond. The father picked up his son and put cool water on his lips and patted him on the back. After one to two minutes, his son moved his tongue back in his mouth but was still not responding. The father called 911 and the emergency medical team arrived about five minutes later. The patient's temperature was 103.0 degrees Fahrenheit and he was still not responding. The emergency medical team placed a cold cloth on the patient's head and transported him to the emergency room. According to the reporter, corrective treatment consisted of MOTRIN and after four to five hours, the patient was back to normal and released. Later that same day, the patient was evaluated by his pediatrician but no further treatment or tests had been ordered or performed. The patient had no siblings and no prior history of seizures. Outcome was recovered. This patient experienced another adverse event which has been captured in case number 2011-00363. Documents held by sender: none.
Age: 0.55
Sex: M
Vaccine: FLU3, DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial report was received on 22 January and 26 January 2011 from a consumer, who is also the patient's parent. A six-month-old male patient had received an injection of FLUZONE (Unspecified) (lot number, route and site of administration not reported) on 09 November 2010 at 4:30 pm and "within 10 hours" of administration (also reported as 3 am), he experienced a febrile seizure. At the time of the event, the patient's father had heard a strange noise coming from the patient's room. When he went in, he found his son with his tongue hanging out of his mouth, his lips were bluish in color, his eye were rolled up and back, he was motionless and did not respond. The father picked up his son and put cool water on his lips and patted him on the back. After one to two minutes, his son moved his tongue back in his mouth but was still not responding. The father called 911 and the emergency medical team arrived about five minutes later. The patient's temperature was 103.0 degrees Fahrenheit and he was still not responding. The emergency medical team placed a cold cloth on the patient's head and transported him to the emergency room. According to the reporter, corrective treatment consisted of MOTRIN and after four to five hours, the patient was back to normal and released. Later that same day, the patient was evaluated by his pediatrician but no further treatment or tests had been ordered or performed. The patient had no siblings and no prior history of seizures. Outcome was recovered. This patient experienced another adverse event which has been captured in case number 2011-00363. Documents held by sender: none.
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test, Convulsion, Febrile convulsion, Pyrexia, Urine analysis
Clinical narrative: Initial report was received 25 January and 26 January 2011 from a consumer, who is the patient's parent. An 11-month-old female patient had received a second dose intramuscular left thigh injection of FLUZONE (unspecified, lot number unknown) on 02 December 2010 and two days later, she developed a fever of 101 degrees Fahrenheit. She was administered TYLENOL every four hours and the following day, on 05 December 2010, her fever increased to 102.8 degrees and she was taken to the emergency room. While at the emergency room, she experienced a febrile seizure that "she brought herself out of approximately 45 minutes after onset"  and was back to normal. The patient received intravenous (IV) fluids as corrective treatment and was released. The patient was evaluated by her pediatrician the following day and no further treatments or tests were ordered. Outcome was recovered. She had not been exposed to any sick contacts and she had no concurrent illnesses at the time of vaccination. She had no known allergies, no medical conditions and she had not been taking any concomitant medications. The patient previously received an intramuscular first dose of FLUZONE one month prior to 02 December 2010 and her "9 month vaccines" with no adverse events experienced. Documents held by sender: None.
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: Initial report was received 25 January and 26 January 2011 from a consumer, who is the patient's parent. An 11-month-old female patient had received a second dose intramuscular left thigh injection of FLUZONE (unspecified, lot number unknown) on 02 December 2010 and two days later, she developed a fever of 101 degrees Fahrenheit. She was administered TYLENOL every four hours and the following day, on 05 December 2010, her fever increased to 102.8 degrees and she was taken to the emergency room. While at the emergency room, she experienced a febrile seizure that "she brought herself out of approximately 45 minutes after onset"  and was back to normal. The patient received intravenous (IV) fluids as corrective treatment and was released. The patient was evaluated by her pediatrician the following day and no further treatments or tests were ordered. Outcome was recovered. She had not been exposed to any sick contacts and she had no concurrent illnesses at the time of vaccination. She had no known allergies, no medical conditions and she had not been taking any concomitant medications. The patient previously received an intramuscular first dose of FLUZONE one month prior to 02 December 2010 and her "9 month vaccines" with no adverse events experienced. Documents held by sender: None.
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Initial report was received 25 January and 26 January 2011 from a consumer, who is the patient's parent. An 11-month-old female patient had received a second dose intramuscular left thigh injection of FLUZONE (unspecified, lot number unknown) on 02 December 2010 and two days later, she developed a fever of 101 degrees Fahrenheit. She was administered TYLENOL every four hours and the following day, on 05 December 2010, her fever increased to 102.8 degrees and she was taken to the emergency room. While at the emergency room, she experienced a febrile seizure that "she brought herself out of approximately 45 minutes after onset"  and was back to normal. The patient received intravenous (IV) fluids as corrective treatment and was released. The patient was evaluated by her pediatrician the following day and no further treatments or tests were ordered. Outcome was recovered. She had not been exposed to any sick contacts and she had no concurrent illnesses at the time of vaccination. She had no known allergies, no medical conditions and she had not been taking any concomitant medications. The patient previously received an intramuscular first dose of FLUZONE one month prior to 02 December 2010 and her "9 month vaccines" with no adverse events experienced. Documents held by sender: None.
Age: 1.9
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Febrile convulsion, Laboratory test
Clinical narrative: Had a one minute seizure observed by her PGM on 9/29/10. Sudden fever, not lasting long. Seen at hospital.
Age: 1.9
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood culture negative, Chest X-ray normal, Convulsion, Culture throat negative, Pyrexia
Clinical narrative: Had a one minute seizure observed by her PGM on 9/29/10. Sudden fever, not lasting long. Seen at hospital.
Age: 62.0
Sex: F
Vaccine: FLUX, UNK, FLU3, PPV
Symptoms: Abasia, Chills, Cough, Disorientation, Dysphonia
Clinical narrative: Client describes being "in agony" for 2 days. Feeling "horrible" for 3 days. Headache, body aches, chills, feeling hot and cold; sore/red arm (vaccine site), "slight fever", cannot lay on arm; could not get out of bed for 2 days. Runny nose, leaking urine, irritable, confused; labored breathing when going upstairs; cough.
Age: 62.0
Sex: F
Vaccine: FLUX, UNK, FLU3, PPV
Symptoms: Erythema, Fatigue, Feeling hot, Feeling of body temperature change, Headache
Clinical narrative: Client describes being "in agony" for 2 days. Feeling "horrible" for 3 days. Headache, body aches, chills, feeling hot and cold; sore/red arm (vaccine site), "slight fever", cannot lay on arm; could not get out of bed for 2 days. Runny nose, leaking urine, irritable, confused; labored breathing when going upstairs; cough.
Age: 62.0
Sex: F
Vaccine: FLUX, UNK, FLU3, PPV
Symptoms: Irritability, Pain in extremity, Pollakiuria, Rhinorrhoea, Sluggishness
Clinical narrative: Client describes being "in agony" for 2 days. Feeling "horrible" for 3 days. Headache, body aches, chills, feeling hot and cold; sore/red arm (vaccine site), "slight fever", cannot lay on arm; could not get out of bed for 2 days. Runny nose, leaking urine, irritable, confused; labored breathing when going upstairs; cough.
Age: 62.0
Sex: F
Vaccine: FLUX, UNK, FLU3, PPV
Symptoms: Activities of daily living impaired, Chills, Confusional state, Cough, Dyspnoea
Clinical narrative: Client describes being "in agony" for 2 days. Feeling "horrible" for 3 days. Headache, body aches, chills, feeling hot and cold; sore/red arm (vaccine site), "slight fever", cannot lay on arm; could not get out of bed for 2 days. Runny nose, leaking urine, irritable, confused; labored breathing when going upstairs; cough.
Age: 62.0
Sex: F
Vaccine: FLUX, UNK, FLU3, PPV
Symptoms: Feeling abnormal, Feeling of body temperature change, Headache, Injection site erythema, Irritability
Clinical narrative: Client describes being "in agony" for 2 days. Feeling "horrible" for 3 days. Headache, body aches, chills, feeling hot and cold; sore/red arm (vaccine site), "slight fever", cannot lay on arm; could not get out of bed for 2 days. Runny nose, leaking urine, irritable, confused; labored breathing when going upstairs; cough.
Age: 62.0
Sex: F
Vaccine: FLUX, UNK, FLU3, PPV
Symptoms: Pain, Pyrexia, Rhinorrhoea, Urinary incontinence, Vaccination site pain
Clinical narrative: Client describes being "in agony" for 2 days. Feeling "horrible" for 3 days. Headache, body aches, chills, feeling hot and cold; sore/red arm (vaccine site), "slight fever", cannot lay on arm; could not get out of bed for 2 days. Runny nose, leaking urine, irritable, confused; labored breathing when going upstairs; cough.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal pain, Angioedema, Mechanical urticaria, Swelling face
Clinical narrative: Woke up with extremely itchy skin all over body, breaking out in hives.  Taken to ER and treated with IV and Benadryl.  On 01/28/2011 developed burning sensation in stomach and chest.  Went to sleep and woke up at 2:30AM on 1/29/2011 in excrutiating pain in stomach, vomiting, and again breaking into hives.  Brought to ER at 7AM and symptoms are still there.  Trouble breathing. Throat closing up. In ICU.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal distension, Abdominal pain upper, Blood test, Chest pain, Computerised tomogram abdomen abnormal
Clinical narrative: Woke up with extremely itchy skin all over body, breaking out in hives.  Taken to ER and treated with IV and Benadryl.  On 01/28/2011 developed burning sensation in stomach and chest.  Went to sleep and woke up at 2:30AM on 1/29/2011 in excrutiating pain in stomach, vomiting, and again breaking into hives.  Brought to ER at 7AM and symptoms are still there.  Trouble breathing. Throat closing up. In ICU.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Computerised tomogram abnormal, Dyspepsia, Dyspnoea, Intensive care, Pruritus generalised
Clinical narrative: Woke up with extremely itchy skin all over body, breaking out in hives.  Taken to ER and treated with IV and Benadryl.  On 01/28/2011 developed burning sensation in stomach and chest.  Went to sleep and woke up at 2:30AM on 1/29/2011 in excrutiating pain in stomach, vomiting, and again breaking into hives.  Brought to ER at 7AM and symptoms are still there.  Trouble breathing. Throat closing up. In ICU.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Throat tightness, Urticaria, Vomiting
Clinical narrative: Woke up with extremely itchy skin all over body, breaking out in hives.  Taken to ER and treated with IV and Benadryl.  On 01/28/2011 developed burning sensation in stomach and chest.  Went to sleep and woke up at 2:30AM on 1/29/2011 in excrutiating pain in stomach, vomiting, and again breaking into hives.  Brought to ER at 7AM and symptoms are still there.  Trouble breathing. Throat closing up. In ICU.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Head began to itch before bed.  Next day whole body seem itchy especially my back.  Took 50 mg Benadryl at 8:00 pm.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, OPV, RVX
Symptoms: Apnoea, Blood test, Chest X-ray, Convulsion, Electroencephalogram
Clinical narrative: SEIZURE THAT LASTED APPROXIMATELY 15 MINUTES ON 1/29/2011 WITH PERIODS OF APNEA AFTER SEIZURE. SEIZURE THE FOLLOWING DAY 1/30/2011 THAT LASTED APPROXIMATELY 45 MINUTES.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye pruritus, Hypersensitivity, Lip oedema, Ocular hyperaemia
Clinical narrative: PATIENT REFERS REDNESS AND ITCH IN EYES, DRY COUGH, LARYNX PRESSURE AND MOUTH EDEMA (LIPS).
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema mouth, Oropharyngeal discomfort
Clinical narrative: PATIENT REFERS REDNESS AND ITCH IN EYES, DRY COUGH, LARYNX PRESSURE AND MOUTH EDEMA (LIPS).
Age: 0.17
Sex: F
Vaccine: DTAP, RVX
Symptoms: Crying, Diarrhoea, Injection site swelling, Irritability, Pyrexia
Clinical narrative: EXTREME IRRITABILITY, INCONSOLABLE CRYING, SWELLING AT INJECTION SITE, MILD FEVER, DIARRHEA; TREATED WITH CHILDREN'S TYLENOL; LASTED UNTIL THE NEXT DAY
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: (L) arm hurting, red & swollen tender. Reassure by physician.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 1/25/11 Mother called to report onset 2 days ago of redness & swelling (L) thigh in area of vaccine administration 4 days prior (1-19-11). Child rec'd 3 vaccine injections in (L) thigh that day as noted below. Mother states increase in swelling & redness today - has golf ball size lump & itching - states looks like bee sting. No fever, no limp just tender to touch. Advised to have physician exam. Seen by Dr on 1-25-11. Rx ORAPRED & BENADRYL. Stated prob reaction to MMRV. Was able to note injection site of DTAP above - no reaction. As of 1/31/11 reaction resolved.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Lymphadenopathy
Clinical narrative: Swollen lymph nodes - 2.5cm x 3.5cm posterior auricular/1x2cm preauricular/also with diffuse swelling of axilla & 8x10cm area of edema/erythema around injection site. Treated with MOTRIN only.