chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MMR, MNQ, TD
Symptoms: CSF culture positive, Meningitis meningococcal, Serology positive
Clinical narrative: Patient vaccinated on 3/8/06 with Menactra (lot U1769AA).  Culture confirmed meningococcal disease on 5/18/07.  CSF culture was positive for Neisseria meningitidis serogroup Y. 1/29/09 Reviewed partial hospital medical records for 5/20/2007. FINAL DX: bacterial meningitis. Records reveal patient experienced HA, stiff neck, SOB, tachycardia. ICU.  S/S resolved w/n 24 hours of treatment.  Transferred to reg floor on continued IV antibiotics.  2/10/09 Received hospital records of 5/18-5/23/2007. FINAL DX: meningococcal meningitis; leukocytosia w/left shift secondary to meningitis, resolved; hyperglycemia, probably secondary to steroids but his A1C is 6.5; dehydration, resolved w/IVF; hypokalemia, resolved w/replacement; question herpes simplex virus infection of lower lip Records reveal patient experienced flu-like s/s, generalized aching, confusion, low grade fever, stiff neck, tinnitus & progressively worsening HA.  LP & ID consult done.  Admitted to ICU & tx w/IVF, IV antibiotics, steroids.  Improved & d/c to home on continued IV antibiotics.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood culture positive, Meningitis meningococcal, Serology abnormal
Clinical narrative: Patient vaccinated on 8/16/05 with Menactra (lot U1766AA).  Culture confirmed meningococcal disease on 7/6/06.  Blood culture was positive for Neisseria meningitidis serogroup C.  2/5/09 Received hospital medical records of 7/7-7/13/2006. FINAL DX: septic shock due to gram neg type C meningococcemia w/known type 1 DM.  Also hypogammaglobulinemia. Records reveal patient experienced neck pain, low back pain, bilateral shooting leg pain, low blood pressure, fever & elevated blood sugar x 1 day.  Admitted to PICU.  ID consult done.  Tx w/IV antibiotics, IVF.  Improved & d/c to home w/immunology & encocrine f/u. 2/24/09 Received vax records from PCP for 8/16/2005 which confirms as reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Blood culture positive, Meningitis meningococcal
Clinical narrative: Patient vaccinated on 5/31/06 with Menactra (lot U1822AA).  Culture confirmed meningococcal disease on 4/28/08.  Blood culture was positive for Neisseria meningitidis serogroup C.1/5/09-records received for DOS 4/30-5/2/08-DC DX: Meningococcemia. Presented with C/O feeling bad and neck and back pain, body aches, fevers up to 102 and chills. C/O headache at time of discharge and underwent a blood patch.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blood culture positive, Death, Meningitis meningococcal, Serology test
Clinical narrative: Patient vaccinated on 5/1/06 with Menactra (lot U2004AA).  Culture confirmed meningococcal disease on 6/5/08.  Blood culture was positive for Neisseria meningitidis serogroup C. 3/4/09-death certificate received-COD Sepsis. Acute Meningococcemia. 3/8/09-office note received for DOS 5/1/06-well visit-mild scoliosis. 3/19/09-records received for DOS 6/3/08-life flight tranferred in hypotensive state intubated. Lifting weights day before, developed diffuse abdominal painlast evening worsened overnight, this morning developed fever and sweats with vomiting. Mottled, hypotensive and tachycardic. PE: cold, tachycardic febrile and mottled. Bleeding from both eyes. Unresponsive. Purpura, petechiae in eyes. At receiving facility in cardiac arrest resuscitation efforts failed. Pronounced dead.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: CSF culture positive, Meningitis meningococcal, Serology positive
Clinical narrative: Patient vaccinated on 7/6/05 with Menactra (lot U1572AC).  Culture confirmed meningococcal disease on 4/22/08.  CSF culture positive for Neisseria meningitidis serogroup C.  12/29/08 Reviewed hospital medical records of 04/22-5/06/2008 FINAL DX: meningococcemia w/sepsis syndrome; neisseria meningitidis meningitis; DIC; rhabdomyolysis; elevated LFTs secondary to sepsis syndrome; acute renal failure; candida vulvovaginitis; normochromic normocytic anemia; transient orthostatic hypotension; myalgias; neuropathic pain; physical deconditioning; hypomagnesemia; hypokalemia; purpura fulminans secondary to meningococcemia. Records reveal patient experienced fever, chills, myalgias, nausea, vomiting, tachycardia, hypotension & lethargy.  ID, neuro, intensivist & GYN consults done.  Tx w/IV antibiotics, steroids & vasopressors in ICU.  Improved gradually & transferred to inpatient rehab.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MNQ, TD
Symptoms: Blood culture positive, Death, Meningitis meningococcal, Serology abnormal
Clinical narrative: Patient vaccinated with Menactra on 6/25/07 (lot U2236AA).  Culture confirmed meningococcal disease on 9/26/07.  Blood culture was positive for Neisseria meningitidis serogroup C. 1/6/09-records received-on 9/26/08-Three day history of fatigue, fever, tachycardia, altered mental status, blurry vision and headache. Developed diffuse rash, renal failure, coagulopathy and repiratory failure. 1/6/09-autopsy report received-Neisseria Sepsis. Antemortem blood culture positive for neisseria meningitidis, serogroup C. Bilateral hemorrhagic adrenal necrosis (Waterhouse-Friderichsen syndrome). Diffuse confluent petechial purpuric rash. petechial hemorrhages of left conjunctivia, gingivae, scalp and subgaleal tissue. Small vessel fibrin thromboemboli identified clinically disseminated intravascular coagulopathy (DIC). Neutrophilic pulmonary airspace infiltration consistent with terminal ventilator dependence. Bilateral pleural effusions.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient received flu shot at 7:58PM. Asked patient to stay in the store for 20 minutes after the shot. Patient returned to the clinic at 8:20PM complaining of mild itching over her extremities and back. No rash/hives/redness is visible on the extremities or trunk on examination. Patient denies dizziness or SOB. Patient stated that "it's an weird sensation". Patient given Children's Liquid Benadryl, 12.5mg/5mL, 10mL given by mouth in the clinic and monitored for nearly 40 minutes. Patient tolerated medication fine and symptoms not worsened. Instructed patient to continue to take Children's Liquid Benadryl, 12.5mg/5mL, 10mL by mouth every 4-6 hours for the next 24 hours. Patient instructed to call 911 immediately if symptoms of urticaria, angioedema, respiratory symptoms, dizziness or changes in level of consciousness occurs. Patient verbalized understanding of instructions.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster
Clinical narrative: local shingles; cellulitis
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site abscess, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm (deltoid area) swollen, red, and painful at injection site.  Recieved vaccine on 12/11/08, symptoms started 12/12/08. Diagnosed with cellulitis/abscess (probably sterile) of left arm. Course of treatment - cool compress BID for 3 days for 20 minutes each, Prednisone 20 mg 1 by mouth BID for 3 days, if abscess not better in three days then to begin Cephalelin 500mg, 1 by mouth TID for 7 days.
Age: 24.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Apnoea, Dizziness, Gaze palsy, Loss of consciousness, Mydriasis
Clinical narrative: Patient c/o feeling dizzy and passed out after receiving vaccines. Was unresponsive with eyes rolled back in head, pallor, dilated pupils and short period of apnea.  It almost appeared that he had a seizure.  Became responsive after about 10-15 seconds.  Vitals were stable with color returning after about 10 minutes.  Pt. no longer felt dizzy before leaving area.  Was coherent and responding appropriately to questions.  States that he had never had this type of response to vaccines prior to this.
Age: 24.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: No reaction on previous exposure to drug, Pallor, Unresponsive to stimuli
Clinical narrative: Patient c/o feeling dizzy and passed out after receiving vaccines. Was unresponsive with eyes rolled back in head, pallor, dilated pupils and short period of apnea.  It almost appeared that he had a seizure.  Became responsive after about 10-15 seconds.  Vitals were stable with color returning after about 10 minutes.  Pt. no longer felt dizzy before leaving area.  Was coherent and responding appropriately to questions.  States that he had never had this type of response to vaccines prior to this.
Age: 41.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Nausea
Clinical narrative: Asthma, Nausea.  1/20/09 Reviewed GYN medical records of 12/15/08. FINAL DX:none provided.  Normal GYN exam. Records reveal patient experienced asthma like symptoms reported by phone.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Lancinating pain above right ear and foreheadbeginning 11/13/08.
Age: 45.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Dizziness, Electromyogram, Fatigue, Injection site pain
Clinical narrative: Shot was given at about 12:40 pm on 12/8/2008. During the evening at about 5:00 pm I felt fatigue, dizziness, weak knees and a very sore arm at the injection area. When I woke up on the morning of 12/10/2008 I experienced tingling in my left hand. Over the weekend the tingling turned to pain in the left hand and arm. I saw Dr. on Monday, December 15th for diagnosis. He referred me to the clinic where I was tested at 9:45 AM on 12/19/2008. I believe when the shot was given my Ulnar nerve was nicked and that is what is causing the tingling and pain in my hand.
Age: 45.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Nerve conduction studies, Pain in extremity, Paraesthesia
Clinical narrative: Shot was given at about 12:40 pm on 12/8/2008. During the evening at about 5:00 pm I felt fatigue, dizziness, weak knees and a very sore arm at the injection area. When I woke up on the morning of 12/10/2008 I experienced tingling in my left hand. Over the weekend the tingling turned to pain in the left hand and arm. I saw Dr. on Monday, December 15th for diagnosis. He referred me to the clinic where I was tested at 9:45 AM on 12/19/2008. I believe when the shot was given my Ulnar nerve was nicked and that is what is causing the tingling and pain in my hand.
Age: 45.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Electromyogram, Nerve conduction studies, Unevaluable event
Clinical narrative: Shot was given at about 12:40 pm on 12/8/2008. During the evening at about 5:00 pm I felt fatigue, dizziness, weak knees and a very sore arm at the injection area. When I woke up on the morning of 12/10/2008 I experienced tingling in my left hand. Over the weekend the tingling turned to pain in the left hand and arm. I saw Dr. on Monday, December 15th for diagnosis. He referred me to the clinic where I was tested at 9:45 AM on 12/19/2008. I believe when the shot was given my Ulnar nerve was nicked and that is what is causing the tingling and pain in my hand.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Abnormal behaviour, Obsessive-compulsive disorder, Sleep disorder
Clinical narrative: Patient developed increased obsessive symptoms , trouble wearing clothes, sleeping issues, potty issues. Resolving now. Began right after recieving vaccine. No treatment.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Erythema around the injection site, not warm
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Nausea, Paraesthesia
Clinical narrative: CHILLS,NAUSEA, TINGLING IN LEFT ARM, FATIGUE
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Abortion spontaneous, Cervicitis, Chlamydial infection, Drug exposure during pregnancy, Muscle spasms
Clinical narrative: Subject 1-07-03285 is a nearly 19 year old G2P1 female who was initially seen in the emergency room on 05Feb2008 for 1 day history of sporadic vaginal bleeding with no other symptoms. Her last menstrual period was 20Dec2007. Her human chorionic gonadotropin (HCG) level was 18,638 units/ml, which is consistent with 4 to 5 weeks gestation. An ultrasound revealed an intrauterine pregnancy. Urine analysis was negative for trichomonas by wet mount but positive by PCR. Her urine analysis was also negative for yeast and positive for clue cells and moderate amount of WBC. She was diagnoses with a threatened miscarriage and was sent home for follow-up in one week. Her specimen from the cervix was reported positive on 07Feb2008 for Chlamydia trachomatis by PCR and was negative for Neisseria gonorrhoeae. Subject was again seen in the ER on 11Feb2008 for daily vaginal bleeding of approximately 1 pad/day. She complained of mild suprapubic cramping. Repeat ultrasound showed an irregular yolk sac contour and a fetal pole that was not visualized. Mean gestational sac measurement corresponded to a 7 week gestation. Her HCG increased to 20,000 units/ml. These observations were consistent with nonviable pregnancy and impending miscarriage. She was sent home and instructed to take prenatal vitamins and avoid cigarette smoke. Repeat cervical test for GC and Chlamydia was again positive for Chlamydia trachomatis by PCR. The subject was seen in the ER on 03Mar2008 for vaginal discharge irritation and for treatment of her positive Chlamydia trachomatis test. Her HCG level was 8 consisted with a nonpregnant state. An ultrasound did not reveal an intrauterine pregnancy. Subject was treated with rocephin 250 mg IM and one gram oral dose of zithromax.   Final diagnosis: Complete Miscarriage Secondary: Chlamydia trachomatis cervicitis  Past Medical History: none Medication: none.  Date of Last Menstrual Period: 20 Dec 2007   Influenza vaccine: FluMist Date of Vaccination: 21 Nov 2007 Date of Birth: 13 Feb 1989 Date of SAE:  March 3, 2008 SAE: Serious and unexpected. SAE not related to FluMist.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Polymerase chain reaction, Pregnancy test, Ultrasound scan vagina, Urine analysis abnormal, Vaginal discharge
Clinical narrative: Subject 1-07-03285 is a nearly 19 year old G2P1 female who was initially seen in the emergency room on 05Feb2008 for 1 day history of sporadic vaginal bleeding with no other symptoms. Her last menstrual period was 20Dec2007. Her human chorionic gonadotropin (HCG) level was 18,638 units/ml, which is consistent with 4 to 5 weeks gestation. An ultrasound revealed an intrauterine pregnancy. Urine analysis was negative for trichomonas by wet mount but positive by PCR. Her urine analysis was also negative for yeast and positive for clue cells and moderate amount of WBC. She was diagnoses with a threatened miscarriage and was sent home for follow-up in one week. Her specimen from the cervix was reported positive on 07Feb2008 for Chlamydia trachomatis by PCR and was negative for Neisseria gonorrhoeae. Subject was again seen in the ER on 11Feb2008 for daily vaginal bleeding of approximately 1 pad/day. She complained of mild suprapubic cramping. Repeat ultrasound showed an irregular yolk sac contour and a fetal pole that was not visualized. Mean gestational sac measurement corresponded to a 7 week gestation. Her HCG increased to 20,000 units/ml. These observations were consistent with nonviable pregnancy and impending miscarriage. She was sent home and instructed to take prenatal vitamins and avoid cigarette smoke. Repeat cervical test for GC and Chlamydia was again positive for Chlamydia trachomatis by PCR. The subject was seen in the ER on 03Mar2008 for vaginal discharge irritation and for treatment of her positive Chlamydia trachomatis test. Her HCG level was 8 consisted with a nonpregnant state. An ultrasound did not reveal an intrauterine pregnancy. Subject was treated with rocephin 250 mg IM and one gram oral dose of zithromax.   Final diagnosis: Complete Miscarriage Secondary: Chlamydia trachomatis cervicitis  Past Medical History: none Medication: none.  Date of Last Menstrual Period: 20 Dec 2007   Influenza vaccine: FluMist Date of Vaccination: 21 Nov 2007 Date of Birth: 13 Feb 1989 Date of SAE:  March 3, 2008 SAE: Serious and unexpected. SAE not related to FluMist.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Vaginal haemorrhage
Clinical narrative: Subject 1-07-03285 is a nearly 19 year old G2P1 female who was initially seen in the emergency room on 05Feb2008 for 1 day history of sporadic vaginal bleeding with no other symptoms. Her last menstrual period was 20Dec2007. Her human chorionic gonadotropin (HCG) level was 18,638 units/ml, which is consistent with 4 to 5 weeks gestation. An ultrasound revealed an intrauterine pregnancy. Urine analysis was negative for trichomonas by wet mount but positive by PCR. Her urine analysis was also negative for yeast and positive for clue cells and moderate amount of WBC. She was diagnoses with a threatened miscarriage and was sent home for follow-up in one week. Her specimen from the cervix was reported positive on 07Feb2008 for Chlamydia trachomatis by PCR and was negative for Neisseria gonorrhoeae. Subject was again seen in the ER on 11Feb2008 for daily vaginal bleeding of approximately 1 pad/day. She complained of mild suprapubic cramping. Repeat ultrasound showed an irregular yolk sac contour and a fetal pole that was not visualized. Mean gestational sac measurement corresponded to a 7 week gestation. Her HCG increased to 20,000 units/ml. These observations were consistent with nonviable pregnancy and impending miscarriage. She was sent home and instructed to take prenatal vitamins and avoid cigarette smoke. Repeat cervical test for GC and Chlamydia was again positive for Chlamydia trachomatis by PCR. The subject was seen in the ER on 03Mar2008 for vaginal discharge irritation and for treatment of her positive Chlamydia trachomatis test. Her HCG level was 8 consisted with a nonpregnant state. An ultrasound did not reveal an intrauterine pregnancy. Subject was treated with rocephin 250 mg IM and one gram oral dose of zithromax.   Final diagnosis: Complete Miscarriage Secondary: Chlamydia trachomatis cervicitis  Past Medical History: none Medication: none.  Date of Last Menstrual Period: 20 Dec 2007   Influenza vaccine: FluMist Date of Vaccination: 21 Nov 2007 Date of Birth: 13 Feb 1989 Date of SAE:  March 3, 2008 SAE: Serious and unexpected. SAE not related to FluMist.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, IPV, YF
Symptoms: Dyspnoea, Oxygen saturation decreased, Rash, Rhinorrhoea, Wheezing
Clinical narrative: DYSPNEA, RHINORRHEA, WHEEZES APPROX 30-40 MINS AFTER MULTIPLE INJECTIONS.  TREATED SUCCESSFULLY WITH ALBUTERAL/IPRATROPIUM, PREDNISONE, O2 AND BENADRYL.   SHE THEN DEVELOPED A RASH BUT NEVER HAD ANY RASH OR ERYTHEMA AT INJECTION SITES.  SHE WAS DISCHARGED WITH FLOVENT, RANITIDINE,ZYRTEC,ALBUTERAL MDI RXS.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Injection site erythema, Injection site pruritus
Clinical narrative: Gardasil administered to left deltoid IM. Client complained of feeling dizzy approx. 15 - 25 seconds later. Slight paleness to skin and hands clammy. 2nd nurse called to assist.  Feet were propped up, cold compresses applied, client stated approx 5 - 7 minutes later that she was feeling better. Client left office on own accord, with mother, after approx. 10 minutes of observation. When client presented to another clinic in health department she refused 2nd Gardasil shot with complaints of feeling weak for 2 days post vaccine. Further stated that injection site was itching and red.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pallor
Clinical narrative: Gardasil administered to left deltoid IM. Client complained of feeling dizzy approx. 15 - 25 seconds later. Slight paleness to skin and hands clammy. 2nd nurse called to assist.  Feet were propped up, cold compresses applied, client stated approx 5 - 7 minutes later that she was feeling better. Client left office on own accord, with mother, after approx. 10 minutes of observation. When client presented to another clinic in health department she refused 2nd Gardasil shot with complaints of feeling weak for 2 days post vaccine. Further stated that injection site was itching and red.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA THE INTRANASAL ROUTE
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Blood product transfusion, Electromyogram abnormal, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging normal
Clinical narrative: Guillain Barre Syndrome Resolved s/p IVIG x 5 day; symtoms occured after recent Flu Vaccination at work place.  1/08/09 Reviewed hospital medical records of 12/08-12/17/2008. FINAL DX: Guillain-barre syndrome Records reveal patient experienced bilateral LE weakness, numbness & ascending paralysis; blurry vision; & difficulty swallowing x 2 days.  ICU Neuro & ENT consults done.  Tx w/IVIG & improved dramatically.  D/C to home w/continued outpatient PT/OT.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Dermatitis
Clinical narrative: Severe Dermatitis Condition. Spread all over my body and the legs are heavily affected. I applied Hydrocortizone ointment but no reduction. Also applied moisturizing cream (REMEDY). (Received Twinrix Inj - from pharmacy). **Note I do not have health insurance as i come from a foreign country on 29th August 2008.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: RECEIVED INFLUENZA IM VACCINE VIA INTRANASAL ROUTE
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Arthralgia, Chest pain, Conversion disorder, Facial paresis, Gait disturbance
Clinical narrative: A serious, spontaneous report of conversion disorder reaction, facial muscles have not moved and numbness in toes and fingers was received from a consumer concerning a 12 year old female subsequent to FLUMIST. The patient has a history of psychosocial issues. The patient received GARDASIL the same day as FLUMIST. The patient received FLUMIST intranasal for Flu vaccination on 11-Nov-2008. On 11-Nov-2008 the patient was seen in the pediatricians office for chest pains and during the visit received FLUMIST and GARDASIL. Since 24 hours after administration the patients facial muscles have not moved and she has numbness in her toes and fingers. The patient subsequently was seen by a neurologist, cardiologist and the pediatrician for the events and an MRI was taken. Results are not available. The events are on going and the patient is scheduled to begin physical therapy. The responsible physician assessed the events as not related to vaccine administration and instead considered the event a conversion disorder reaction. The event is considered a serious important medical event.  1/2/09 Received PCP, ER & Neuro medical records of 11/24-12/3/08 FINAL DX: none provided; possible conversion reaction Records reveal patient experienced HA, weakness, difficulty walking, pain in all extremities x approx 3 wks.  Missed several days of school.  Had been seen in Urgent care 11/24 & 11/27 for sore throat, HA & body aches.  W/u WNL.  Dx w/viral illness & pharyngitis.  Flat affect, weight loss.  Required follow-up attempts have been performed, requested information unable to be obtained.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Hypoaesthesia, Physiotherapy
Clinical narrative: A serious, spontaneous report of conversion disorder reaction, facial muscles have not moved and numbness in toes and fingers was received from a consumer concerning a 12 year old female subsequent to FLUMIST. The patient has a history of psychosocial issues. The patient received GARDASIL the same day as FLUMIST. The patient received FLUMIST intranasal for Flu vaccination on 11-Nov-2008. On 11-Nov-2008 the patient was seen in the pediatricians office for chest pains and during the visit received FLUMIST and GARDASIL. Since 24 hours after administration the patients facial muscles have not moved and she has numbness in her toes and fingers. The patient subsequently was seen by a neurologist, cardiologist and the pediatrician for the events and an MRI was taken. Results are not available. The events are on going and the patient is scheduled to begin physical therapy. The responsible physician assessed the events as not related to vaccine administration and instead considered the event a conversion disorder reaction. The event is considered a serious important medical event.  1/2/09 Received PCP, ER & Neuro medical records of 11/24-12/3/08 FINAL DX: none provided; possible conversion reaction Records reveal patient experienced HA, weakness, difficulty walking, pain in all extremities x approx 3 wks.  Missed several days of school.  Had been seen in Urgent care 11/24 & 11/27 for sore throat, HA & body aches.  W/u WNL.  Dx w/viral illness & pharyngitis.  Flat affect, weight loss.  Required follow-up attempts have been performed, requested information unable to be obtained.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L side thigh swelling, redness, and warm to touch
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, MMR, PNC, VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Cough, Full blood count, Haemorrhage
Clinical narrative: Fever started 2 days after receiving vaccination, bleeding a lot. Rash 3 days after receiving the vaccine's , started on her face now spreading to her body. Cough, runny nose for 1 day. pink macular papular rash on face, rash also at trunk. Slight nasal discharge.
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, MMR, PNC, VARCEL
Symptoms: Measles antibody, Pyrexia, Rash, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Fever started 2 days after receiving vaccination, bleeding a lot. Rash 3 days after receiving the vaccine's , started on her face now spreading to her body. Cough, runny nose for 1 day. pink macular papular rash on face, rash also at trunk. Slight nasal discharge.
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, MMR, PNC, VARCEL
Symptoms: Rubella antibody negative
Clinical narrative: Fever started 2 days after receiving vaccination, bleeding a lot. Rash 3 days after receiving the vaccine's , started on her face now spreading to her body. Cough, runny nose for 1 day. pink macular papular rash on face, rash also at trunk. Slight nasal discharge.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: (L) arm muscle soreness for 1 week duration.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Blood culture, Body temperature increased, Enzyme abnormality, Headache
Clinical narrative: Headache about 24hrs later, no pain killers helped. Temperature about 48hrs later. Both got worse. Went to Dr 6 days later. Said viral must fight off. Continued a full 2 wks after vaccination. Then a wk of severe stomach bloating.  3/9/09 Received PCP medical recods of 07/17/08-1/26/2009. FINAL DX: Low grade squamous intraepithelial lesion, HPV infection Records reveal patient experienced good health on 7/17/08.  RTC 11/10/08 & 11/26/08  w/vaginal discharge.  Colposcopy done 1/12/09.  RTC 1/26/09 & tx w/meds.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Viral infection
Clinical narrative: Headache about 24hrs later, no pain killers helped. Temperature about 48hrs later. Both got worse. Went to Dr 6 days later. Said viral must fight off. Continued a full 2 wks after vaccination. Then a wk of severe stomach bloating.  3/9/09 Received PCP medical recods of 07/17/08-1/26/2009. FINAL DX: Low grade squamous intraepithelial lesion, HPV infection Records reveal patient experienced good health on 7/17/08.  RTC 11/10/08 & 11/26/08  w/vaginal discharge.  Colposcopy done 1/12/09.  RTC 1/26/09 & tx w/meds.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling started on 12/2.  Patient brought in on 12/3/08, 2.5X5cm area of erythema on left thigh, without tenderness or warmth.  Continued to spread overnight and was started on KEFLEX on 12/4/08 for ollulitis.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Excoriation, Fall, Syncope
Clinical narrative: 2nd dose of GARDASIL administered on 12/19/08. Pt experienced syncope, fell to the floor, experienced abrasion on (L) side of face. After 30 mins. pt "felt better",given water for hydration. Driven home by mother
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: 3cm induration, erythematous. Mildly  tender, afebrile. 3 days after administration of vaccine. went to ER 12/12/2008 given PREDNISONE and AATARAX.
Age: 0.24
Sex: F
Vaccine: HEP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Infrequent bowel movements, Lethargy, Screaming
Clinical narrative: Mom stated child "screamed" for 8 hrs day of vaccine & off & on the next day. Child did not have BM for 4 days after vaccines & only then with infant suppository. C/O lethargy for several days after vaccines. Mom states she is a "medic" and did not take child to ER or PCP, child has temp of 101 degrees.  Advised mom to take child to PCP for further evaluation of condition and recommendation of further vaccines.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal discomfort
Clinical narrative: Shoulder discomfort, tension. Red raised area in middle of injection 1 1/2-3cm. Pink area 4x6inches, elm leaf shape.
Age: 16.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Nasal congestion, Pruritus
Clinical narrative: About ten minutes after receiving a VARIVAX and MENACTRA injection patient complained of his nose becoming congesed. He also complained of itchiness, PH of allergies to hamsters. His BP was 140/70, pulse 80. The nose was patent and were no wheezes. He received EPINEPHRINE, 1000, 0.3IM, BENADRYL 50 + oxygen increased 4. He was observed for an hour then was fine.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: Patient received PEDIARIX, PREVNAR, HIB and ROTATEQ the morning of 12/17/2008. That night per mother's report, she cried inconsolably from 10pm - 4 am. Not even feeding  Calmed her(she's usually very happy). No fevers. No other symptoms developed.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Neurological examination normal, Pain in extremity
Clinical narrative: Her whole arm hurts. Hurts most on her deltoid and travels down her arm. Has seen MD to get labs done and neurology exam.
Age: 1.08
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Patient was given MMR injection in the (R) thigh & varicella in the left thigh. After about 2 minutes, he developed a dime size urticaria near or around the injection site on both. Pt kept x30 minutes after & given BENADRYL. He did okay.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Had VARIVAX 4-14-07 in another country & now developing varicella.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Red, inflamed & itchy at injection site, lasted for a couple days, has gone down now.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Received vaccine at 6:30 pm on 12-17-08. Severe vomiting began at 2:30am with fever. Vomiting continued til 9am.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, pain, redness shoulder to wrist advised cold compresses.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Facial pain, Headache, Myalgia, Photophobia, Pyrexia
Clinical narrative: Pt started with myalglas and fever on 12/09/08 along with facial pain. Seen by doctor on 12/10/08 and Rx'd Amoxicillin. Re-evaluated by another doctor 12/15/08 for worsening myalglas, headache with photophobia. Sent to ER for eval the same day. Re-eval by Doctor 12-16-08 and scheduled for RUQ abd US and brain CT. MRI brain ordered  for 12/19/08.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Report received from a Pharmacy Buyer on 31-Oct-2008.  A patient (age/sex/initials not reported) received AFLURIA (CSL Influenza vaccine) on an unknown date.  On an unknown date, patient experienced vertigo.  Per the Pharmacy Buyer, she does not know any more details.  Pharmacy Buyer to have the Pharmacist call CSL Biotherapies and provide additional information.  Pharmacy Buyer would not provide name nor phone number of pharmacist.  No serious criteria mentioned.  Causality: unassessable/unclassifiable.  Follow-up information received on 03-Nov-2008 from a pharmacist.  A 49 year-old female received AFLURIA (CSL Influenza vaccine; lot 02349111A, exp date 30-Jun-2009) on 24-Oct-2008.  On 28-Oct-2008, she was experiencing vertigo.  Patient's physician does not believe the vertigo was caused by the AFLURIA, physician believes the patient's viral syndrome which she had two weeks prior to the flu shot was the cause.  Patient had not yet recovered.  Assessment:  The company considered this event unlikely to be related to the suspect drug.  Informaiton derived from this AE report does not change the current safety profile of AFLURIA (CSL Influenza vaccine).
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Report received from ZLB Plasma Center 0n 27-Oct-2008.   A 26 year-old female (S.L. / DOB 08-AUG-1982) received AFLURIA (CSL influenza vaccine, lot 03549111A) on 22-Oct-2008 at 13:27.  On 20-Oct-2008, patient was given two doses IM of HEPATITIS vaccine, lot 0398x.   At the time of her AFLURIA vaccination, patient had no illness.  Patient had no pre-existing allergies, concomitant medications or medical conditions.  On 23-Oct-2008 at 9:30am, approximately 20 hours after receiving AFLURIA, patient complained of nausea, malaise, and muscle pain.  Per the reporter, the patient recovered.  Additional information had been requested.  Assessment:  No serious criteria mentioned.  Causality: Possible.  Follow-up information was received on 28-Oct-2008 from ZLB Plasma Center on 28-Oct-2008.  The patient's symptoms resolved in about 48 hours.  She did not contact her primary care physician (PCP) and was not treated for her symptoms.  Patient is not pregnant.  No additional information is expected.  No change is assessment.  Information derived from this AE report does not change the current safety profile of the product.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Varicella
Clinical narrative: Report received from a PharmD on 27-Oct-2008.  PharmD reported that a patient (initials, DOB and gender unspecified), over 18 years-old, experienced shingles/chicken pox after receiving AFLURIA (CSL Influenza vaccine, date of administration unknown).  It is not yet known how long after receiving AFLURIA that the patient experienced shingles/chicken pox.  The reporter is not sure if the patient had any other disease states of medications.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality: unclassifiable/ unassessable.  Follow-up information received on 18-Nov-2008 from PharmD.  A 19 year-old female received AFLURIA by IM injection to the upper deltoid on the evening of 17-Oct-2008 (lot 02349111A).  At the time of vaccination, patient had no illness nor was patient receiving any other medications.  On 24-Oct-2008, the patient 'came down' with the chicken pox which was medically confirmed on 25-Oct-2008 by her physician.  Patient recovered (date not provided).  Follow-up information received on 19-Nov-2008 from PharmD.  Patient is not pregnant.  No additional information is expected.  The company considered this event as unlikely to be related to the administration of AFLURIA.  Information derived from this AE report does not change the current safety profile of AFLURIA (FLUVAX).
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Pain, Pruritus, Varicella
Clinical narrative: Report received from a PharmD on 27-Oct-2008.  PharmD reported that a patient (initials, DOB and gender unspecified), over 18-years-old, experienced shingles/chicken pox after receiving AFLURIA (CSL influenza vaccine, data of administration unknown).  It is not yet known how long after receiving AFLURIA that the patient experienced shingles/chicken pox.  The reporter is not sure if the patient had any other disease states or medications.  Additional information has been requested.  ASSESSMENT:  No serious criteria mentioned.  Causality:  unclassifiable/unassessable;  Follow-up information received on 07-Nov-2008 from PharmD.  A 26 year-old male patient (G.S.L./DOB 16-Jul-1982), received AFLURIA (CSL Influenza vaccine) on the upper deltoid IM on 01-Oct-2008 at 7:30 pm.  Lot 02349111A was administered.  At the time of vaccine, patient had no illness.  No pre-existing conditions or allergies nor concomitant medications were noted.  On 15-Oct-2008, patient started to get itchy around lower extremities and had severe pain in trunk.  Patient saw his physician who diagnosed symptoms as shingles (no mention of chicken pox as noted earlier).  Physician stated treatment would be in vain after shingles breakout.  Patient is recovering.  No further information is expected.  The company considered events as unlikely to be related to the administration of AFLURIA.  Information derived from this AE report dies not change the current safety profile of AFLURIA (FLUVAX).
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Report received from a PharmD on 27-Oct-2008.  An employee received AFLURIA (CSL influenza vaccine, data of administration unknown).  At unknown time after administration, the patient developed localized reactions at the injection site 2-4 inches in diameter.  The site was red and circular, warm, and puffy.  The employee received a prefilled syringe.  (The report concerned two patients.  For other patient, see case 200814226).  Additional information has been requested.  ASSESSMENT:  No serious criteria mentioned.  Causality: unassessable/unclassifiable.  Follow-up information was received on 11-Nov-2008 from the PharmD.  Per the PharmD, he will not be providing any additional details as he discussed the case with the hospital nurse and they decided the events were within the expected and listed ADRs.  No change in assessment.  Information derived from this AE report dies not change the current safety profile of AFLURIA (FLUVAX).
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Report received from a PharmD on 27-Oct-2008.  An employee received AFLUIA (CSL influenza vaccine, date of administration unknown).  At unknown time after administration, the patient developed localized reaction at the injection site 2-4 inches in diameter.  The site was red and circular, warm, and puffy.  The employee received a prefilled syringe.  (The report concerned two patients.  For other patient, see case 200814227).  Additional information has been requested.  No serious criteria mentioned.  Causality: unassessable/ unclassifiable.  Follow-up information was received on 11-Nov-2008 from the PharmD.  Per the PharmD, he will not be providing any additional details as he discussed the case with the hospital nurse and they decided the events were within the expected and listed ADRs.   No change in assessment.  Information derived from this AE report does not change the current safety profile of AFLURIA (FLUVAX).
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Report received from a Plasma Center employee on 23-Oct-2008.  A 21 year-old female received AFLURIA (CSL Influenza vaccine) via IM injection to the right deltoid (lot 03549111A) on 20-Oct-2008 at 20:30 hours.  The patient had no pre-existing diagnosed allergies or medical conditions.  She was not ill at the time of vaccination. On 20-Oct-2008 at 21:00 hours, patient had general/localized pain in the area of right deltoid.  The pain spread from shoulder to elbow.  Patient stated that her fingers started tingling at approximately 1:00am on 21-Oct-2008.  When she awoke at 6:00am on 21-Oct-2008, her arm was numb.  There was no redness, swelling, or bruising noted to the area.  Temperature was 98.4 F.  Patient had not been running a fever, but the patient felt like she did have a fever the morning post the injection (21-Oct-2008).  Additional information has been requested.  No serious criteria mentioned.  The company considered these events as possibly related to the administration of AFLURIA.  Follow-up information received from a nurse on 06-Nov-2008 from Plasma Center.  Per the reporter, patient has recovered and did receive treatment at the regional occupation care center where she was given (?) PREDNISONE.  No further information is expected.  Information derived from this AE report does not change the current safety profile of the AFLURIA (CSL Influenza vaccine).  Results of CSL Quality Assurance batch review for 03549111A received 18-NOV-2008.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysphonia, Ear discomfort, Electrocardiogram normal, Pharyngeal oedema
Clinical narrative: Report received from RN who is also the patient on 23-Oct-2008.  An adult female (BLH) received AFLURIA on 22-Oct-2008 (the patient was unsure if dose was from pre-filled syringe or vial).  The patient experienced chest tightness, swelling or throat, and ears clogging 2 hours post-vaccination.  She took 25 mg BENADRYL and felt better 30 minutes later.  She went to the ER and received a SOLU-MEDROL shot and received prescription for PREDNISONE 20 mg twice daily for 5 days.  The patient reported she feels much better today (23-Oct-2008) and her symptoms are basically gone.  Patient reports history of allergy to penicillin and THIMERISOL.  Awaiting further information.  No serious criteria mentioned.  Causality: Possible.  Follow-up information received on 24-Oct-2008 from an RN (not the patient who is also a RN).  RN confirmed that this 54 year-old female received a single dose syringe of AFLURIA IM to the left arm on 22-Oct-2008 at 8:00am.  Lot administered: 01149111A.  At 11:00am on 22-Oct-2008, patient experienced chest discomfort and her voice became hoarse.  She has no prior allergic reactions to flu shots or allergies to the preservatives for the vaccine.  She was evaluated and treated in the emergency department.  Her EKG was normal (date/time not provided).  Patient took 25 mg PO BENADRYL for 5 days, SOLUMEDROL IM, and PREDNISONE PO.  Per the RN, patient has fully recovered.  It is not known if patient received any other vaccinations within 4 weeks prior to receiving AFLURIA.  No further information is expected.  No change in assessment.  Information derived from this AE report does not change the current safety profile of the product.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Nausea, Vomiting
Clinical narrative: Report received from Plasma Center employee on 23-Oct-2008:  A 58 year-old female received AFLURIA (CSL Influenza vaccine) IM at left deltoid on 20-Oct-2008 at 9:53 AM (0953).  AFLURIA lot # administered 03549111A, exp date 30-JUN-2009.  The patient had no illnesses at the time of vaccination.  Concomitant medications reported as hydrocodone prn and OTC allergy medication prn.  Reporter indicates the patient has experienced adverse events following prior vaccinations: at age 20 (??-???-1970) with cholera vaccination and at age 31 (??-???-1981) with swine flu vaccination.  On 21-Oct-2008, at 10:00 AM, approximately 24 hours post-vaccination, the patient complained of nausea, muscle pain, malaise and vomited once.  The reporter indicates the patient was recovered at the time of the report (23-Oct-2008).  The reporter considered the event as non-serious.  No further information is expected.  No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 28-Oct-2008 from Plasma Center Employee.  The patient did not contact her primary care physician, she is not pregnant, and she recovered fully.  No further information is expected.  Information derived from this report does not change the current safety profile of the product.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Report received from an Emergency Medical Technician (EMT) at Plasma center on 22-Oct-2008:  A female employee received AFLURIA (CSL influenza vaccine) on 21-Oct-2008 at 10:00 AM.  AFLURIA lot # 03549111A, exp date 30-Jun-2009.  The patient developed headache, nausea, chills, muscle aches, and fever 100.2F starting 2 hours after receiving the shot (12:45 PM).  Awaiting further information.  No serious criteria mentioned.  Causality: Possible.  Information derived from the AE report does not change the current safety profile of the product.  Results of CSL Quality Assurance batch review for 03549111A received 18-NOV-2008.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event report.