chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: YF
Symptoms: Hyperhidrosis, Injection site erythema, Injection site irritation, Nausea, Pyrexia
Clinical narrative: Initial report received on 03 December 2007 from a health care professional. An adult patient, with no concurrent illness, who was traveling on a cruise ship as an entertainer, had received a subcutaneous dose of YF VAX vaccine (lot number UF197AA) on 26 November 2007. The site of administration was not reported. At an unspecified amount of time later, the patient developed big red spots and burning at the injection site, along with sweating, fever, and nausea. The patient did not seek medical attention. Treatment received was not reported. At the time of this report, the adverse events were resolving. The reported for this case is the same as for cases 2007-04169, 2007-04170, 2007-04171, 2007-04172.
Sex: U
Vaccine: YF
Symptoms: Rash macular
Clinical narrative: Initial report received on 03 December 2007 from a health care professional. An adult patient, with no concurrent illness, who was traveling on a cruise ship as an entertainer, had received a subcutaneous dose of YF VAX vaccine (lot number UF197AA) on 26 November 2007. The site of administration was not reported. At an unspecified amount of time later, the patient developed big red spots and burning at the injection site, along with sweating, fever, and nausea. The patient did not seek medical attention. Treatment received was not reported. At the time of this report, the adverse events were resolving. The reported for this case is the same as for cases 2007-04169, 2007-04170, 2007-04171, 2007-04172.
Age: 36.0
Sex: U
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initial report received from a health care professional on 10 September 2007. A 36-year-old patient (sex not reported) had received an injection of Tetanus toxoid Absorbed vaccine (route, site and lot number unknown), and within 24 hours, developed redness and swelling from their shoulder to the elbow of the vaccinated arm. No additional information was provided at the time of the report. A second case (2007-03101 - injection site redness, fever) was received from the same reporter. Follow-up information received from the reporter on 23 October 2007. The reporter did not have any further information.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: Arthralgia, Headache, Nausea, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Initial report received on 03 April 2008 from a health care professional. A 26-year-old male patient with no pre-existing medical conditions, had received an intramuscular injection of TYPHIM VI, lot number Z0664-4 and an intramuscular injection of Yellow Fever Vaccine, lot number UF175AA (sites not reported) on 21 March 2008 and 12 days later at 07:00, he complained of fever (102 degrees Fahrenheit orally), headache, sore throat, and nausea. The patient self medicated with ibuprofen to reduce fever. On 03 April 2008, he presented to his primary care physician with same complaints along with joint discomfort (achy). The physician performed a strep test (results negative) and instructed the patient to return home and continue with fever reducers and to drink plenty of fluids. The patient's recovery status was unknown at the time of the report.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: Streptococcal identification test negative
Clinical narrative: Initial report received on 03 April 2008 from a health care professional. A 26-year-old male patient with no pre-existing medical conditions, had received an intramuscular injection of TYPHIM VI, lot number Z0664-4 and an intramuscular injection of Yellow Fever Vaccine, lot number UF175AA (sites not reported) on 21 March 2008 and 12 days later at 07:00, he complained of fever (102 degrees Fahrenheit orally), headache, sore throat, and nausea. The patient self medicated with ibuprofen to reduce fever. On 03 April 2008, he presented to his primary care physician with same complaints along with joint discomfort (achy). The physician performed a strep test (results negative) and instructed the patient to return home and continue with fever reducers and to drink plenty of fluids. The patient's recovery status was unknown at the time of the report.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Initial report received on 23 April 2008 from a health care professional in the USA. A 20 year old female patient with no medical history received on 17 April 2008 a first subcutaneous left arm injection of Yellow Fever vaccine (Sanofi Pasteur, lot UF300AA). On 22 April 2008, 5 days post vaccination, the patient developed a fever and injection site redness, warmth, and itchiness measuring approximately 6 cm by 6 cm. The patient had also received the following vaccinations within the 4 weeks prior; on 26 March 2008, a first left deltoid intramuscular injection of Td (Sanofi Pasteur, lot # U2293CA), a first left deltoid intramuscular injection of Menactra (lot # U2606AA), and a first right deltoid intramuscular injection of Pneumonia vaccine (Merck, lot # 0380U) and on 02 April 2008 a first left deltoid intramuscular injection of Influenza vaccine (Sanofi Pasteur, lot # U2531AA). The patient had no medications and no illness at time of vaccination. Corrective treatment was not reported. At the time of the report, 23 April 2008, the patient had recovered.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Nausea, Ultrasound scan abnormal, Urinary tract infection, Urticaria, Vomiting
Clinical narrative: Initial report received from a physician on 19 Jun 2007. A 24 year old, female patient developed nausea, vomiting and hives after she received YF-VAX (lot number UF044AA) subcutaneously in the right deltoid on 14 June 2007. The patient did not have any illness and was not on any medications at the time of the vaccination. It was reported the patient recovered. Follow up received from a health care professional; Lot number for YF VAX WAS confirmed (UF044AA). The patient underwent, on an unspecified date, an ultrasound (U/T) that was positive for Urinary Tract Infection (UTI). The patient did not have any relevant medical history and was not ill at vaccination time. The patient did not have adverse events following prior vaccination. Follow-up information received 23 October 2007. The onset date and date of recovery for the urinary tract infection were reported to be unknown. No additional information was provided at the time of the report.
Age: 19.0
Sex: F
Vaccine: TD, TYP
Symptoms: Abdominal discomfort, Diarrhoea, Muscle spasms, Nausea, Pyrexia
Clinical narrative: The night after the vaccination: fever & abdominal discomfort. The following day: nausea and vomiting. The third day: diareah, cramps, nausea.
Age: 19.0
Sex: F
Vaccine: TD, TYP
Symptoms: Vomiting
Clinical narrative: The night after the vaccination: fever & abdominal discomfort. The following day: nausea and vomiting. The third day: diareah, cramps, nausea.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site mass, Pain, Pruritus, Swelling
Clinical narrative: Red, itchy, lumpy swelling (approximately 2" diameter), sore to the touch and to movement.  By day 9 (7/19) there is still a small lumpy area at the site of the injection.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: intussusception.  08/26/2008 MR received for DOS 7/10-11/2008 with D/C DX:  Intussusception.   Pt presented with 1 day hx of blood in stool and abdominal pain, fever, fussiness, nausea and vomiting.  PE (+) for abdominal tenderness and guarding. Sent for air enema reduction following US (+) for IS. Reduction successful. D/C next day.
Age: 1.08
Sex: F
Vaccine: HEP, HIBV, PNC, VARCEL
Symptoms: Pyrexia, Rash, Skin lesion
Clinical narrative: Fever over 100.2 degrees for two days following vaccination, treated with tylenol.  Rash on chest and back and "pox" like bumps on butt.  No treatment for rash.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Asthenia, Loss of consciousness, Pallor, Syncope
Clinical narrative: On 07/19/2008 at approximately 11:50 a.m. Client (13 years of age) fainted during the placement of vaccines. Client received a Meningococcal and Varicella Vaccine to the left arm; she also received a Tdap Vaccine to the right arm when she lost consciousness and leaned forward in her seat. She was escorted to the floor where her legs were raised above the level of the heart. Client lost consciousness for approximately 8-9 seconds before she was alert to person, place and time. Client's vital signs were as follows: pulse 52/minute; blood pressure 98/52; and, respirations 12/minute. Client stated that she doesn't recall fainting. Client was not cold or clammy; however, she did appear somewhat pale. Client complained of feeling weak. Client's mother stated that client had not eaten breakfast. There are no reported illnesses and client is not taking any medications. Upon feeling better, client was assisted to a sitting position and then to a wheelchair. Client is not currently under a doctor's care and was advised to follow-up with her doctor. Client's mother refused emergency medical attention. The vaccines were administered at School. The vaccination was part of an outreach clinic put on by the Department of Public Health. Client's mother was given instructions to take client to the emergency room if client's condition worsens.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: l deltoid red and swollen 8mm x 5 mm
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial non-serous report received from a health care professional on 20 July 2007. A 58-year-old female with a history of allergy to penicillin received a left deltoid intramuscular injection of Tetanus Toxoid Adsorbed (Lot number U1856BA) on 10 July 2007 and 48 hours later developed pain, itching and swelling at the injection site. She visited her doctor on 20 July 2007 complaining of swelling of the left deltoid to underarm, headache, achiness, fever and site being warm to touch. The event was treated with erythromycin and hydroxyzine. Recovery status was reported as "not recovered." The patient had no illness at the time of vaccination. No additional details were provided at the time of this report. The initial report also indicated that the office had three additional patients with similar reactions the previous month. At the time of this report, the patients were unidentified and their reactions were not specified. Follow-up information was received from a health care professional on 21 September 2007. Corrections were provided for the date of vaccination and the date of onset for the event. The date of vaccination had been 16 July 2007 and the event was reported to have started on 18 July 2007. The patients recovery status was changed from "not recovered" to "unknown." No additional information was provided.
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Pain, Pyrexia
Clinical narrative: Initial non-serous report received from a health care professional on 20 July 2007. A 58-year-old female with a history of allergy to penicillin received a left deltoid intramuscular injection of Tetanus Toxoid Adsorbed (Lot number U1856BA) on 10 July 2007 and 48 hours later developed pain, itching and swelling at the injection site. She visited her doctor on 20 July 2007 complaining of swelling of the left deltoid to underarm, headache, achiness, fever and site being warm to touch. The event was treated with erythromycin and hydroxyzine. Recovery status was reported as "not recovered." The patient had no illness at the time of vaccination. No additional details were provided at the time of this report. The initial report also indicated that the office had three additional patients with similar reactions the previous month. At the time of this report, the patients were unidentified and their reactions were not specified. Follow-up information was received from a health care professional on 21 September 2007. Corrections were provided for the date of vaccination and the date of onset for the event. The date of vaccination had been 16 July 2007 and the event was reported to have started on 18 July 2007. The patients recovery status was changed from "not recovered" to "unknown." No additional information was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Autonomic neuropathy, Blood pressure, Choking, Dizziness
Clinical narrative: Information has been received from a 72 year old female with high blood pressure, high cholesterol and drug reactions to BACTRIM (caused vomiting and nausea), ULTRAM (caused vomiting and nausea) and ZOLOFT (caused terrible headache) who in April 2007, was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included CLARITIN, CENTRUM SILVER, QVAR, PROAIR HFA, OS-CAL and medications for cholesterol and high blood pressure.  In April 2007, the next day after the vaccination, the patient experienced low blood pressure.  She was given a pain killer (manufacturer unspecified) as well.  A few days later, she had a blood pressure of 50/30 and she could not lift her head.  The patient passed out and could not stand.  She had memory and focusing problems.  The patient also developed an asthma-like condition.  Her valve did not close.  So she often chokes, but CLARITIN helped.  The patient was hospitalized for 2-3 months and in a wheelchair.  All kinds of tests including blood exchange were performed.  The patient was diagnosed with "autonomic neuropathy with orthostatic hypertension".  At the time of the report, the patient was recovering from the events.  She still felt lightheaded and had low blood pressure.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Hypotension, Laboratory test, Loss of consciousness, Memory impairment
Clinical narrative: Information has been received from a 72 year old female with high blood pressure, high cholesterol and drug reactions to BACTRIM (caused vomiting and nausea), ULTRAM (caused vomiting and nausea) and ZOLOFT (caused terrible headache) who in April 2007, was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included CLARITIN, CENTRUM SILVER, QVAR, PROAIR HFA, OS-CAL and medications for cholesterol and high blood pressure.  In April 2007, the next day after the vaccination, the patient experienced low blood pressure.  She was given a pain killer (manufacturer unspecified) as well.  A few days later, she had a blood pressure of 50/30 and she could not lift her head.  The patient passed out and could not stand.  She had memory and focusing problems.  The patient also developed an asthma-like condition.  Her valve did not close.  So she often chokes, but CLARITIN helped.  The patient was hospitalized for 2-3 months and in a wheelchair.  All kinds of tests including blood exchange were performed.  The patient was diagnosed with "autonomic neuropathy with orthostatic hypertension".  At the time of the report, the patient was recovering from the events.  She still felt lightheaded and had low blood pressure.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Orthostatic hypertension
Clinical narrative: Information has been received from a 72 year old female with high blood pressure, high cholesterol and drug reactions to BACTRIM (caused vomiting and nausea), ULTRAM (caused vomiting and nausea) and ZOLOFT (caused terrible headache) who in April 2007, was vaccinated with a dose of ZOSTAVAX.  Concomitant therapy included CLARITIN, CENTRUM SILVER, QVAR, PROAIR HFA, OS-CAL and medications for cholesterol and high blood pressure.  In April 2007, the next day after the vaccination, the patient experienced low blood pressure.  She was given a pain killer (manufacturer unspecified) as well.  A few days later, she had a blood pressure of 50/30 and she could not lift her head.  The patient passed out and could not stand.  She had memory and focusing problems.  The patient also developed an asthma-like condition.  Her valve did not close.  So she often chokes, but CLARITIN helped.  The patient was hospitalized for 2-3 months and in a wheelchair.  All kinds of tests including blood exchange were performed.  The patient was diagnosed with "autonomic neuropathy with orthostatic hypertension".  At the time of the report, the patient was recovering from the events.  She still felt lightheaded and had low blood pressure.  Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Headache, Nausea, Rash, Swelling, Vomiting
Clinical narrative: Developed nausea, vomiting, increased BP, severe headache, facial swelling following administration of Typhoid vaccine.
Age: 46.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Blood pressure increased, Headache, Nausea, Swelling face, Vomiting
Clinical narrative: Developed nausea, vomiting, increased BP, severe headache, facial swelling following administration of Typhoid vaccine.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female with no known medical history and no known allergies who was vaccinated with GARDASIL. Subsequently the patient experienced an unexplainable death.  The mother of the patient found her daughter unresponsive and dead in her bed.  It was noted that this death was reported to VAERS and the death was not caused by GARDASIL.  It is unknown if medical attention was sought.  The medical assistant considered the death to be disabling and life-threatening.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Death, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 14 year old female who was vaccinated with a first dose of GARDASIL and experienced syncope.  She was taken to an emergency room and released.  The patient was vaccinated with a second dose of GARDASIL (unspecified time).  Subsequently, the patient experienced her first seizure (unspecified time) and was taken to the emergency room (no further details provided).  The patient was vaccinated with a third dose of GARDASIL at 15 years old.  Approximately 27-JUN-2008, two weeks after the third dose, the patient developed a complication.  She was taken to the hospital by ambulance but passed away during the transport from an unknown cause.  The physician has asked the mother for the autopsy report.  The reporting medical assistant considered the syncope, seizure and "a complication" were considered to be immediately life-threatening and disabling.  Additional information has been requested.  2/13/09 Autopsy report received.  COD:  Seizure Disorder. Summary Diagnoses: Clinical history of seizure disorder.  Pulmonary congestion and edema.  Passive visceral congestion.  2/20/2009 ER received from CDC. Pt presented to ER via EMS following witnessed seizure activity with fall from standing. Upon EMS arrival pt had agonal respirations and was pulseless in V-fib at 650. Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and pt expired.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old white female with mild asthma, and no previous pregnancies, who on 21-MAY-2008 was vaccinated with the first dose of GARDASIL and then discovered that she was pregnant. Concomitant medications included prenatal vitamin with folic acid. The patient's last menstrual period was 02-APR-2008 and estimated date of delivery is 06-JAN-2009. On 23-MAY-2008 ultrasound results showed that the fetus was 5 weeks and there were no problems. On 04-JUN-2008 the patient had a spontaneous abortion at five weeks, four days. At the time of this report the patient's outcome was unknown. Upon internal review, the spontaneous abortion was considered to be an other important medical event. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dysarthria, Hemiplegia, Immediate post-injection reaction, Migraine
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 15-MAY-2007 was vaccinated with her first dose of GARDASIL. There was no other vaccination to the patient on that day. On 15-MAY-2007, immediately post vaccination, the patient developed slurred speech for 10 minutes, paralysis of left side for 30 to 40 minutes and a migraine. Subsequently, the patient recovered from the events. Unspecified medical attention was sought. Upon internal review, hemiplegia was determined to be an other important medical event. Additional information has been requested. 8/13/08-records received for DOS 8/15/07-neurology clinic visit for evaluation of two spells associated with headache as well as third severe headache in past 3 months. First spell occurred in June of 2007 when her speech became slurred and developed ;numbness or loss of sensation in entire left lower extremity followed by entire left upper extremity. Speech problem resolved within 10 minutes and loss of sensation persisted for 30 minutes and as this was resolving developed a severe headache over left temple migrated to right temple. Felt like bright light burning directly into left side of head, severe photophobia, vomiting and severely nauseous. Evaluated in ED with head CT which was unremarkable. The next episode occurred in July with no speech problems, only sensation loss in left leg and foot and arm. Fell asleep for 2 hours and up awakening no sensory abnormalities. Seen in ED and repeat CT scan. Two weeks prior to this office visit had significant headache and sensory symptoms. PE normal. Consistent with classic migraine with aura.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician, who was notified by a patient's mother that her 14 year old daughter, with no previous medical history of seizures reported, who on 11-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 660387/1967U) and on 11-JUN-2008 was vaccinated with the second dose of GARDASIL (Lot # 659182/1757U).  The patient experienced 2 generalized seizures.  On 30-JUN-2008, the patient experienced the first seizure at home which lasted for 5 minutes.  On 05-JUL-2008, the patient experienced the second seizure with duration for 5 minutes.  On 11-JUL-2008, the patient sought medical attention by a phone call.  The patient has recovered and is being monitored.  Upon internal review, the 2 generalized seizures were considered to be an other important medical events.  Additional information has been requested. 8/4/08-records received for DOS 7/5/08-seen in ED for C/O seizure lasting 2 minutes and postictal, hit face during seizure, nose jaw and neck pain. Genrealized seizure. First seizure 5 days ago.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Monoplegia, Nuclear magnetic resonance imaging, Pain, Physiotherapy
Clinical narrative: Information has been received from a consumer concerning her daughter, a 25 year old who in approximately March 2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  The consumer reported that her daughter developed paralysis on her right arm, has limited mobility and is in constant pain after getting the first dose of GARDASIL.  MRI and physical therapy were performed, however results were not provided.  The patient's paralysis on her right arm, limited mobility and constant pain persisted.  The patient sought medical attention.  Upon internal review, paralysis on her right arm was determined to be an other important medical event.  No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Convulsion, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 12-14 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL. Concomitant vaccinations received on the same day included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). The physician reported that a patient fainted post vaccination with GARDASIL. The patient was vaccinated with her first dose of GARDASIL, on an unknown date, and also with MENACTRA and another vaccine diphtheria (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), on the same day. Immediately post vaccination the patient fainted and had "seizure like activity". The patient sought for medical attention: in the office. At the time of the report, the patient outcome was unknown. There was no product quality complaint. Upon internal review "seizure like activity" was considered to be other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a 12-14 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL. Concomitant vaccinations received on the same day included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). The physician reported that a patient fainted post vaccination with GARDASIL. The patient was vaccinated with her first dose of GARDASIL, on an unknown date, and also with MENACTRA and another vaccine diphtheria (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), on the same day. Immediately post vaccination the patient fainted and had "seizure like activity". The patient sought for medical attention: in the office. At the time of the report, the patient outcome was unknown. There was no product quality complaint. Upon internal review "seizure like activity" was considered to be other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Pulmonary embolism, Skin papilloma, Thrombosis
Clinical narrative: Information has been received from a mother concerning her 26 year old daughter with no pertinent medical history and no drug reaction allergies who in last May or June 2007 was vaccinated with the first dose of GARDASIL (Lot # not provided), in August 2007 was vaccinated with the second dose of GARDASIL (Lot # Not provided) and in November 2007 with the third dose of GARDASIL (Lot # not provided). Concomitant therapy included hormonal contraceptives (unspecified). The mother reported that in December 2007, the patient developed warts on her foot and she started to experience difficulty in breathing and tightening of the chest this year and on 13-JUN-2008, she was hospitalized for 4 days. The mother noted that the patient was placed on warfarin sodium (manufacturer not provided) that she needs to take for 6 months. Patient still has clots on her lungs. On an unspecified date, a full coagulation panel was performed (results not provided). Additional information has been requested.  07/23/2008 MR received for DOS 6/5-7/2008 with D/C DX:  Acute Bilateral Pulmonary Emboli.  Oral Contraceptives.  Possible Family hx of thrombophilia.  Pleuritic pain 2' to acute PE. Pt presented with increasing SOB x 1 week, inability to run usual distance 2' to SOB, recent onset of R-sided back and posterior thorax pain and R axilla pain. Recent calf pain. PE (+) for mild crackles R lung base, anxiety and tearfulness r/t dx. Significant pleuritic pain. Started on Heparin then Coumadin and switched to Arixtra for outpt use. D/C BCPs. Seen in ER on 6/14/08 with DX: Hematoma in SubQ tissue (at Arixtra injection site).
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from an office manager concerning a 22 year old female who on 03-JUL-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot #660391/0063X).  The patient fainted and had a seizure after vaccination.  The patient sought unspecified medical attention.  On 03-JUL-2008, the patient had recovered.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a parent concerning her daughter who was vaccinated with GARDASIL (lot #, date not reported).  The parent reported that the daughter fainted and "started moving around as though she was going to start convulsing".  The second dose of GARDASIL (lot #, and date not reported) was given.  It was reported that the patient sought medical attention (office visit).  No further information was available.  Upon internal review, the patient's convulsion was considered to be an other important medical event.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Stillbirth
Clinical narrative: Information has been received from a consumer concerning her approximately 25 year old female friend who was vaccinated with the series of GARDASIL. Subsequently, the patient then became pregnant, and delivered a still born baby. The patient sought unspecified medical attention. The reporter indicated that the patient is now fine and the reporter does not want to provide any further information. No product quality complaint was involved. Upon internal review, still born was considered to be an other important medical event. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Convulsion, Neurological examination, Sleep study
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with an irregular heart rate, menstrual issues and migraines who was vaccinated intramuscularly with the third 0.5 mL dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  Subsequently, It was reported that the patient experienced a seizure after her third dose of GARDASIL.  The patient sought unspecified medical attention.  Diagnostic studies performed included neurological testing and a sleep study but no results were reported.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Upon internal review, seizure is considered to be an other important medical event.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Body temperature increased, Immediate post-injection reaction, Musculoskeletal pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning his 19 year old daughter with no medical history and no drug allergies, who on 06-JUL-2008 was vaccinated intramuscularly into the left deltoid muscle with the third 0.5 mL dose of GARDASIL.  There was no concomitant medication.  On 06-JUL-2008, immediately after the injection, the patient experienced severe pain of the left shoulder, tingling of the left fingers, and a feeling of weakness of the left hand.  She then developed localized hives on the left upper arm, a low grade temperature and vomited once.  On 07-JUL-2008 the hives, fever and vomiting were resolved, but the pain and tingling persisted.  At the time of this report, the outcome of the weakness of the left hand was unknown.  It was reported that the first dose of GARDASIL was given in January 2008, and that the patient did not experience any problems after receiving the first or second doses of GARDASIL.  No product quality complaint was involved.  The reporting physician considered the severe pain of the left shoulder and the tingling of the left fingers to be disabling.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Pyrexia, Urticaria, Vomiting
Clinical narrative: Information has been received from a physician concerning his 19 year old daughter with no medical history and no drug allergies, who on 06-JUL-2008 was vaccinated intramuscularly into the left deltoid muscle with the third 0.5 mL dose of GARDASIL.  There was no concomitant medication.  On 06-JUL-2008, immediately after the injection, the patient experienced severe pain of the left shoulder, tingling of the left fingers, and a feeling of weakness of the left hand.  She then developed localized hives on the left upper arm, a low grade temperature and vomited once.  On 07-JUL-2008 the hives, fever and vomiting were resolved, but the pain and tingling persisted.  At the time of this report, the outcome of the weakness of the left hand was unknown.  It was reported that the first dose of GARDASIL was given in January 2008, and that the patient did not experience any problems after receiving the first or second doses of GARDASIL.  No product quality complaint was involved.  The reporting physician considered the severe pain of the left shoulder and the tingling of the left fingers to be disabling.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Hypoaesthesia, Paralysis
Clinical narrative: Information has been received from a sales representative who was told by health professionals of media reports concerning a 13 year old female, who on 31-DEC-2007 was vaccinated with a first dose of GARDASIL.  On 31-DEC-2007 the patient experienced memory loss, numbness of body and paralysis.  A pediatrician was told by a consumer that the consumer doubted the validity of the report.  It was reported that the patient played soccer, and as a result has a history of concussions.  The patient recovered on an unknown date.  the event could not be confirmed.  No product quality complaint was involved.  The memory loss, numbness of body, and paralysis were considered to be disabling.  Additional information is not available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Information has been received from a 25 year old female healthcare worker with no medical history or known drug allergies who on 02-FEB-2007 was vaccinated with a first dose of GARDASIL. There was no concomitant medication. The patient stated that she would not complete the vaccine series because she was 4 weeks pregnant. A pregnancy test was performed. The patient's expected delivery date was 19-OCT-2007. The patient sought unspecified medical attention. On approximately 17-MAR-2008, at approximately nine weeks, the patient reported that she had terminated the pregnancy. She did not provide a reason. She reported that she had no complications and was doing well. No product quality complaint was involved. Upon internal review terminated pregnancy was considered to be an other important medical event. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with a dose of ZOSTAVAX. On an unspecified date the patient developed shingles along the sciatic region. At the time of the report the patient was debilitated with pain. The patient's shingles persisted. The reporter considered shingles to be disabling. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Asthenia, Bacteria urine identified, Blood albumin decreased, Blood creatinine increased
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old white female allergic to VICODIN which caused stomach upset, asthma, dyslipidaemia and hyperthyroidism, chronic atrial fibrillation and a history of heart problems who on 05-JUN-2008 was vaccinated intramuscularly with a 0.65 ml dose of ZOSTAVAX (LOT# 659407/0295X). Concomitant therapy included NORVASC, albuterol, FLOVENT, LIPITOR, methimazole, AVAPRO, estrogens, PREMARIN, COUMADIN. On 05-JUN-2008 the patient felt well when she had the injection. In the afternoon, the patient started to become weak and tired without fever. On 07-JUN-2008, the patient's legs ached. In the morning on 09-Jun-2008 the patient continued to feel bad and was not very interested in eating. The patient went to the physician's office and a series of laboratory tests were done. The registered nurse found that the patient's blood pressure was 54/32. The patient felt tired and was more short of breath than usual. The patient's legs did not ache this morning. On 10-JUN-2008, the patient came back for a recheck of her hypotension noted on 09-JUN-2008. Her blood pressure was 100/60. The physician felt that her breathing was fine. She didn't feel short of breath. After a review of the laboratory results and examinations, acute renal dysfunction, urinary tract infection, anemia and hyponatremia were diagnosed. Methimazole and NORVASC were stopped. The total daily dose of propylthiouracil was decreased to 50mg twice a day. Clindamycin 150mg three times a day was prescribed for 10 days. Furosomide 40 mg was increased to 1.5 tablets every morning for 3 days. Potassium chloride was taken 2 doses in the morning and 1 dose in the afternoon for 3 days. The patient was encouraged to increase fluids by drinking two 8oz glasses of V8 or tomato juice and 6 - 8oz glasses of water daily. On 13-JUN-2008, the patient came in for a recheck. The patient's hyponatremia and acute renal dysfunction were improved. Her anemia was stable. She recovered from fatigue and decreased appetite. AVAPRO was decreased to 150mg daily. The physician considered the patient's events to be other important medical events. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose abnormal, Blood pressure, Blood sodium decreased, Blood urea increased, Blood urine present
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old white female allergic to VICODIN which caused stomach upset, asthma, dyslipidaemia and hyperthyroidism, chronic atrial fibrillation and a history of heart problems who on 05-JUN-2008 was vaccinated intramuscularly with a 0.65 ml dose of ZOSTAVAX (LOT# 659407/0295X). Concomitant therapy included NORVASC, albuterol, FLOVENT, LIPITOR, methimazole, AVAPRO, estrogens, PREMARIN, COUMADIN. On 05-JUN-2008 the patient felt well when she had the injection. In the afternoon, the patient started to become weak and tired without fever. On 07-JUN-2008, the patient's legs ached. In the morning on 09-Jun-2008 the patient continued to feel bad and was not very interested in eating. The patient went to the physician's office and a series of laboratory tests were done. The registered nurse found that the patient's blood pressure was 54/32. The patient felt tired and was more short of breath than usual. The patient's legs did not ache this morning. On 10-JUN-2008, the patient came back for a recheck of her hypotension noted on 09-JUN-2008. Her blood pressure was 100/60. The physician felt that her breathing was fine. She didn't feel short of breath. After a review of the laboratory results and examinations, acute renal dysfunction, urinary tract infection, anemia and hyponatremia were diagnosed. Methimazole and NORVASC were stopped. The total daily dose of propylthiouracil was decreased to 50mg twice a day. Clindamycin 150mg three times a day was prescribed for 10 days. Furosomide 40 mg was increased to 1.5 tablets every morning for 3 days. Potassium chloride was taken 2 doses in the morning and 1 dose in the afternoon for 3 days. The patient was encouraged to increase fluids by drinking two 8oz glasses of V8 or tomato juice and 6 - 8oz glasses of water daily. On 13-JUN-2008, the patient came in for a recheck. The patient's hyponatremia and acute renal dysfunction were improved. Her anemia was stable. She recovered from fatigue and decreased appetite. AVAPRO was decreased to 150mg daily. The physician considered the patient's events to be other important medical events. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Carbon dioxide decreased, Culture urine negative, Decreased appetite, Dyspnoea, Eosinophil percentage increased
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old white female allergic to VICODIN which caused stomach upset, asthma, dyslipidaemia and hyperthyroidism, chronic atrial fibrillation and a history of heart problems who on 05-JUN-2008 was vaccinated intramuscularly with a 0.65 ml dose of ZOSTAVAX (LOT# 659407/0295X). Concomitant therapy included NORVASC, albuterol, FLOVENT, LIPITOR, methimazole, AVAPRO, estrogens, PREMARIN, COUMADIN. On 05-JUN-2008 the patient felt well when she had the injection. In the afternoon, the patient started to become weak and tired without fever. On 07-JUN-2008, the patient's legs ached. In the morning on 09-Jun-2008 the patient continued to feel bad and was not very interested in eating. The patient went to the physician's office and a series of laboratory tests were done. The registered nurse found that the patient's blood pressure was 54/32. The patient felt tired and was more short of breath than usual. The patient's legs did not ache this morning. On 10-JUN-2008, the patient came back for a recheck of her hypotension noted on 09-JUN-2008. Her blood pressure was 100/60. The physician felt that her breathing was fine. She didn't feel short of breath. After a review of the laboratory results and examinations, acute renal dysfunction, urinary tract infection, anemia and hyponatremia were diagnosed. Methimazole and NORVASC were stopped. The total daily dose of propylthiouracil was decreased to 50mg twice a day. Clindamycin 150mg three times a day was prescribed for 10 days. Furosomide 40 mg was increased to 1.5 tablets every morning for 3 days. Potassium chloride was taken 2 doses in the morning and 1 dose in the afternoon for 3 days. The patient was encouraged to increase fluids by drinking two 8oz glasses of V8 or tomato juice and 6 - 8oz glasses of water daily. On 13-JUN-2008, the patient came in for a recheck. The patient's hyponatremia and acute renal dysfunction were improved. Her anemia was stable. She recovered from fatigue and decreased appetite. AVAPRO was decreased to 150mg daily. The physician considered the patient's events to be other important medical events. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Glomerular filtration rate decreased, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old white female allergic to VICODIN which caused stomach upset, asthma, dyslipidaemia and hyperthyroidism, chronic atrial fibrillation and a history of heart problems who on 05-JUN-2008 was vaccinated intramuscularly with a 0.65 ml dose of ZOSTAVAX (LOT# 659407/0295X). Concomitant therapy included NORVASC, albuterol, FLOVENT, LIPITOR, methimazole, AVAPRO, estrogens, PREMARIN, COUMADIN. On 05-JUN-2008 the patient felt well when she had the injection. In the afternoon, the patient started to become weak and tired without fever. On 07-JUN-2008, the patient's legs ached. In the morning on 09-Jun-2008 the patient continued to feel bad and was not very interested in eating. The patient went to the physician's office and a series of laboratory tests were done. The registered nurse found that the patient's blood pressure was 54/32. The patient felt tired and was more short of breath than usual. The patient's legs did not ache this morning. On 10-JUN-2008, the patient came back for a recheck of her hypotension noted on 09-JUN-2008. Her blood pressure was 100/60. The physician felt that her breathing was fine. She didn't feel short of breath. After a review of the laboratory results and examinations, acute renal dysfunction, urinary tract infection, anemia and hyponatremia were diagnosed. Methimazole and NORVASC were stopped. The total daily dose of propylthiouracil was decreased to 50mg twice a day. Clindamycin 150mg three times a day was prescribed for 10 days. Furosomide 40 mg was increased to 1.5 tablets every morning for 3 days. Potassium chloride was taken 2 doses in the morning and 1 dose in the afternoon for 3 days. The patient was encouraged to increase fluids by drinking two 8oz glasses of V8 or tomato juice and 6 - 8oz glasses of water daily. On 13-JUN-2008, the patient came in for a recheck. The patient's hyponatremia and acute renal dysfunction were improved. Her anemia was stable. She recovered from fatigue and decreased appetite. AVAPRO was decreased to 150mg daily. The physician considered the patient's events to be other important medical events. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyponatraemia, Hypotension, International normalised ratio, Lymphocyte percentage decreased, Neutrophil count increased
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old white female allergic to VICODIN which caused stomach upset, asthma, dyslipidaemia and hyperthyroidism, chronic atrial fibrillation and a history of heart problems who on 05-JUN-2008 was vaccinated intramuscularly with a 0.65 ml dose of ZOSTAVAX (LOT# 659407/0295X). Concomitant therapy included NORVASC, albuterol, FLOVENT, LIPITOR, methimazole, AVAPRO, estrogens, PREMARIN, COUMADIN. On 05-JUN-2008 the patient felt well when she had the injection. In the afternoon, the patient started to become weak and tired without fever. On 07-JUN-2008, the patient's legs ached. In the morning on 09-Jun-2008 the patient continued to feel bad and was not very interested in eating. The patient went to the physician's office and a series of laboratory tests were done. The registered nurse found that the patient's blood pressure was 54/32. The patient felt tired and was more short of breath than usual. The patient's legs did not ache this morning. On 10-JUN-2008, the patient came back for a recheck of her hypotension noted on 09-JUN-2008. Her blood pressure was 100/60. The physician felt that her breathing was fine. She didn't feel short of breath. After a review of the laboratory results and examinations, acute renal dysfunction, urinary tract infection, anemia and hyponatremia were diagnosed. Methimazole and NORVASC were stopped. The total daily dose of propylthiouracil was decreased to 50mg twice a day. Clindamycin 150mg three times a day was prescribed for 10 days. Furosomide 40 mg was increased to 1.5 tablets every morning for 3 days. Potassium chloride was taken 2 doses in the morning and 1 dose in the afternoon for 3 days. The patient was encouraged to increase fluids by drinking two 8oz glasses of V8 or tomato juice and 6 - 8oz glasses of water daily. On 13-JUN-2008, the patient came in for a recheck. The patient's hyponatremia and acute renal dysfunction were improved. Her anemia was stable. She recovered from fatigue and decreased appetite. AVAPRO was decreased to 150mg daily. The physician considered the patient's events to be other important medical events. Additional information has been requested.