chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female who on 11-JUL-2008 was vaccinated with her dose of GARDASIL vaccine (yeast) (LOT# 660387/1967U). Concomitant therapy included GYNAZOLE and FEMCON. Approximately the following day on 12-JUL-2008, the patient experienced a generalized rash. The medical assistant also states that the patient began treatment with GYNAZOLE on 11-JUL-2008 for yeast infection. Subsequently, the patient recovered from generalized rash. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome
Clinical narrative: Information has been received from a registered nurse, who was told by one of her patients that a female patient who an unknown date was vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently, the patient developed chronic fatigue syndrome. At the time of reporting, the patient's chronic fatigue syndrome persisted. There was no product quality complaint. This is one of several reports provided by the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fibromyalgia, Migraine
Clinical narrative: Information has been received from a pharmacist concerning to her 21 year old daughter with allergic reaction to cefaclor (CECLOR) and ovarian cyst, in the last year (in 2007) was vaccinated with three doses of HPV 4L1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included duloxetine hydrochloride (CYMBALTA) and lamotrigine )LAMICTAL). The patient developed fibromyalgia and more severe migraine headaches after received three HPV 4L1 6 11 16 18 VLP vaccine (yeast) injections "last year" (date unspecificed). The fibromyalgia was diagnosed in February 2008. Blood studies performed (results not provided). The patient was prescribed cyclobenzaprine HCL (FLEXERIL), gabapentin (NEURONTIN) and eletrptan hydrobromide (REPLAX). At the time of the reporting the patient was not recovered. The patient sought medical attention in office visit. There was no product quality complaint. Additional information is expected. 11/11/08-records received for DOS 10/9/07-C/O migraines times 1 week, body aches. Stress at school. Received 1st Gardasil vaccine 10/9/07-second dose 12/17/07 and 3rd dose 4/22/08-
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a female patient between 18-26 years of age, who was vaccinated with her second dose of GARDASIL vaccine (yeast). The physician reported that the patient received her 2nd dose of HPV vaccine and developed migraine headaches. The patient had been taking TOPAMAX and the headache persisted. The physician reported that the patient was due for her third dose of HPV vaccine "soon" and was considering not receiving it due to her concern over the headaches. At the time of the report, the patient had not recovered. The patient sought medical attention at the physician's office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who six months ago, in approximately March 2008, was vaccinated with the first dose of GARDASIL (lot # 659657/1487U). Later that same day of administration, the patient's lips began to swell and her mother gave her child oral BENADRYL and the patient recovered. Approximately 4 months ago, in approximately May 2008, was vaccinated with the second dose of GARDASIL (LOT #660391/0063X). After the second vaccination, the patient's lips began to swell, oral BENADRYL was given and the patient recovered. No other medical follow-up was necessary. When the physician heard about the incident, he decided not to vaccinate the patient with the third dose of HPV vaccine. At the time of the report the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Influenza like illness, Injection site pain
Clinical narrative: Information has been received from a 49 year old female with seasonal allergy who on 01-JUL-2008 was vaccinated with an unspecified dose of GARDASIL. Concomitant therapy included SYNTHROID and unspecified allergy medications. On 02-JUl-2008, the patient experienced pain and soreness at the injection site and flu like symptoms. The patient did not seek medical attention. About 3 weeks after receiving shots, on approximately 22-JUL-2008, the patient recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a 26 year old female who on 27-AUG-2008 was vaccinated with the first dose of GARDASIL. The patient had a menstrual period on 06-AUG-2008 and next period on 30-AUG-2008. Her periods are normally regular. The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who "within the last week" on approximately 18-SEP-2008 was vaccinated with the first dose of GARDASIL. It was reported that "right after vaccination," the patient fainted after getting GARDASIL. It was unknown if the patient sought medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/14/2008. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # not provided), intramuscular, 0.5mL. On 12-SEP-2008 the patient developed flu like symptoms. The patient sought for medical attention. Subsequently, the patient recovered from flu like symptoms. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Mass, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 23-JUL-2008 was vaccinated with the first dose of GARDASIL (lot # 659964/1978U) via IM. Concomitant therapy included unspecified birth control pill. Later the same day, she experienced pain in her whole arm lasting for 2 weeks and swelling, a big throbbing lump, at site for a few days. She sought medical attention in office. No treatment required. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure orthostatic decreased, Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a nurse concerning a female patient between 9-26 years old who on an unknown date was vaccinated with the second dose of GARDASIL. Soon after the administration, the patient experienced dizziness, headache, nausea, and suspected drop in orthostatic pressure. Unspecified medical attention was given in the office. On the same date as the administration, the patient recovered. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Anxiety
Clinical narrative: Information has been received from a nurse concerning an approximately 18 year old female who in approximately February 2008, "last spring" was vaccinated with a dose of GARDASIL (it is not known which dose it was in the series, lot number was not available). Concomitant therapy included "other unspecified vaccinations." It was reported that the patient experienced general anxiety after the shot was given. The patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pain, Nuclear magnetic resonance imaging normal, Vision blurred
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 18-JUN-2007, 30-AUG-2007 and on 24-JUN-2008 was vaccinated IM with a 0.5 mL dose of GARDASIL. In approximately June 2008, a short time after the third dose, the patient experienced pain and blurry vision in her left eye. The symptoms have continued to the present. The patient had sought unspecified medical attention. A magnetic resonance imaging was done but the result was normal. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nasopharyngitis, Pregnancy test positive, Pyrexia, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 13 year old female who received her second dose of GARDASIL (lot no. 660620/0571X) "a few weeks ago." The patient come in the office on 26-SEP2008 with a fever, cold and was diagnosed with an upper respiratory infection. The patient also took pregnancy test on 26-SEP-2008 and it was confirmed she is 4 months pregnant. Physician referred patient to an obstetrician/Gynecologist and the third dose of GARDASIL will not be given. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Neck pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female with no pertinent medical history and no drug reactions/allergies who on 16-FEB-2008 was vaccinated with the first dose of GARDASIL, on 14-APR-2008 was vaccinated with the second dose of GARDASIL, and on 23-SEP-2008, the patient was vaccinated with the third dose of GARDASIL into her left deltoid (Lot# 659968/0847X). There was not concomitant medication. On 24-SEP-2008, the patient developed severe pain radiating from the injection site (left deltoid) up into her neck. The patient's severe pain radiating from the injection site (left deltoid) up into neck persisted. It was reported that the patient sought medical attention: phone call. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning a 15 year old female with asthma and an allergy to BACTRIM who on 01-JUN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included montelukast sodium (MSD) and ZYRTEC. The patient developed hives after getting the vaccine. Medical attention was sought. On an unspecified date, she recovered. She was yet to receive her second shot. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Skin papilloma
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with allergic reaction to minocycline, and warts, who on 02-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5 milliliter, intramuscular. The patient had one or two warts at the time of vaccination. Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Since the first vaccination with GARDASIL, the patient developed 40 leg warts and she sought medical attention to a dermatologist for the wart removal. No exact time frame for the development of the warts was available. The mother of the patient did not want her daughter to receive the second dose of GARDASIL and the patient had not received the second dose at the time of the report. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Rash macular
Clinical narrative: Information has been received from a physician concerning a 22 year old female with anxiety who on 24-SEP-2008 was administered the second dose of GARDASIL, 0.5 mL, IM (Lot# 659184/0843X). On 25-SEP-2008, the patient developed redness at the injection site, blotchiness and red streaks down her entire arm. Subsequently, the patient recovered from the symptoms on 25-SEP-2008. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Dizziness, Visual impairment
Clinical narrative: Information has been received from a physician concerning a 23 year old health female who on 26-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 660555/0279X). Concomitant therapy included DEPO-PROVERA (not administered with GARDASIL). Later that day, on 26-AUG-2008, the patient had dizzy spells and vision changes lasting for 2 weeks. She had no headache. The patient's blood sugar was normal. She reported these symptoms to the physician after they had already resolved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who on 08-SEP-2008 was vaccinated with her first dose of GARDASIL (LOT#: 0573X) 0.5mL intramuscularly. Subsequently the patient experienced a severe pain and discomfort in the whole arm that the injection was given in. No treatment requirement. The patient's injection site severe pain and discomfort in the whole arm persisted. The patient sought medical attention in the office on 26-SEP-2008 with continued pain. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on an unknown date, was vaccinated with the first dose of GARDASIL. On an unknown date, after receiving the vaccine, the patient fainted. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from an unspecified source concerning a patient who was vaccinated with a dose GARDASIL. Subsequently, the patient indicated that "the shot really does hurt! It hurts a lot going in, and then it fades quickly." No details on date of administration. No further information is available.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration, Migraine
Clinical narrative: Information has been received from a health professional concerning a 33 year old white day care female with no known drug allergies/reactions and no pertinent medical history reported who on 01-JUL-2008 was vaccinated the first dose of with GARADSIL (lot # 660553/0070X) intramuscularly. There was no concomitant medication. On 02-JUL-2008, 4 hours after vaccination, the patient experienced migraine and headache. The patient did not seek medical attention. Subsequently, on 04-JUL-2008, the patient recovered from migraine and headache. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Rash
Clinical narrative: Information has been received from a health professional concerning a 14 year old white female who on 24-JUL-2008, at 10:30, was vaccinated with the first dose of GARDASIL Lot # 659182/1757U, into the left arm, DAPTACEL, Lot # C2688AA, into the left arm and MENACTRA, Lot # U2421AA, into the right arm. It was reported that on 24-JUL-2008 at 4:00 PM, the patient experienced rash down arm that had vaccine injected it lasted for several days. It was also pain at site of injection at the time of administration. On 26-JUL-2008, the patient recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physical therapist concerning a friend's daughter, a 19 year old female who was vaccinated with 3 doses of GARDASIL. It was reported that the patient had alopecia. The patient lost her eyebrows, eyelashes and was completely bald. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. No further information is available.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Immediate post-injection reaction, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 36 year old female who on 23-JUL-2008 was vaccinated with her second dose of GARDASIL 0.5mL intramuscularly. "Immediately after dose" (on 23-JUL-2008) the patient reported hair loss. The patient's hair loss persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 10-SEP-2008 was vaccinated with her first dose of GARDASIL 0.5ml, intramuscularly. On 11-Sep-2008, the patient's mother reported that the patient developed flu symptoms after vaccination. The outcome of the patient was not reported. The patient sought medical attention by phone. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Madarosis
Clinical narrative: Information has been received from a medical assistant concerning her neighbor's 19 year old daughter who received 3 doses of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  In the spring of 2008, in approximately April 2008, her hair started to fall out.  By August 2008, she was completely bald and had no eyelashes or eyebrows.  He mother stated that the physician said that it may have been caused by GARDASIL.  The daughter is not a patient at the practice where the medical assistant works.  The patient sought medical attention.  At the time of the reporting, the outcome of the patient was unknown.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 23-APR-2008 was vaccinated with the third dose of GARDASIL. The physician reported that after the patient's last dose of GARDASIL the patient experienced skin warts that were all over her body cleared up. Biopsy of skin warts were performed. The patient sought unspecified medical attention. Additional information has been requested. 6/24/09 CDC spoke with Provider who stated that all warts started PRIOR TO HPV4 vaccine. Pt was treated with interferon, freezing and drugs and none of these cured the warts that were all over the body. Then given HPV4 vaccine on the following dates: Oct. 2007, Jan 2008 and 4/23/08. All warts had cleared up after receipt of # 3 dose of HPV4. 7/20/09 Consultant records received DOS 7/26/06 to 1/31/07. Assessment: Warts. Warts on legs, feet, arms, hands, face; treated by laser, intralesional injection, topical ointments. Dry peeling skin on face. History of tonsillectomy, myringotomy. Endometriosis. Multiple nevi. \ksk 9/29/09 PCP records received.  Warts cleared up by 9/2008.
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram normal, Head discomfort, Headache
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with the second dose of GARDASIL 0.5ml, and experienced some chest pain and some symptoms.  In June 2008, the patient was vaccinated with the third dose of GARDASIL 0.5ml . After receiving the third dose, in approximately June 2008 the patient developed chest pain, headache, sharp pain behind her right ear and numbness and tingling on her head. A chest X-ray and CAT scan were performed but the results came back normal. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with the second dose of GARDASIL 0.5ml, and experienced some chest pain and some symptoms.  In June 2008, the patient was vaccinated with the third dose of GARDASIL 0.5ml . After receiving the third dose, in approximately June 2008 the patient developed chest pain, headache, sharp pain behind her right ear and numbness and tingling on her head. A chest X-ray and CAT scan were performed but the results came back normal. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no known drug or food allergies who in August 2008, was vaccinated with the first dose of GARDASIL, and two days later experienced a generalized rash. The rash had not yet resolved. The patient was being treated with BENADRYL. The patient sought medical attention and called the physician. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 23 year old female who about 5 weeks ago, in approximately August 2008, was vaccinated with an unspecified dose of GARDASIL (lot#0250X), intramuscularly. Subsequently on an unspecified date, the patient experienced severe arm pain at the site of her last GARDASIL vaccination. The patient sought medical attention in the office. At the time of reporting her symptoms had continued. This is one of two reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Constipation, Cytomegalovirus test positive, Epstein-Barr virus antibody positive, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 14-APR-2008 was vaccinated with the first dose of GARDASIL. On 16-JUN-2008, the patient was vaccinated with a second dose of GARDASIL. Patient then went to the emergency room on 19JUN-2008. It was unspecified if the patient was hospitalized that day. The next day, on 20-JUN-2008, the patient came in the physician's office with petechial rash, hot flashes and muscle pain. The office did a complete blood count, high mono, and esosithil count, and a high alcoholine phosphate count. The next visit was on 21-JUN-2008; the patient had no bleeding but had a low white count and petechial rash on legs. On 23-JUN-2008, the patient's spleen tip was enlarged. The patient physician gave the patient a possible diagnosis of Ehrlichiosis. The patient was ordered a complete blood count(CBC), serum antinuclear antibodies test (ANA) and anti- DNA testing. The patient was tested for cytomegalovirus, rheumatoid factor, and Rocky Mountain spotted fever. A complete blood count showed low white count, negative serum antinuclear antibodies test (ANA) and normal rheumatoid factor (RF). Cytomegalovirus test (CMV) came back low white count; negative serum antinuclear antibodies test (ANA), and normal rheumatoid factor. Cytomegalovirus test (CMV) came back high, erichias, West Nile and Rocky Mountain spotted fever came back negative. Epstein-Barr came back high at 5.31. On 09-JUL-2008, the patient's rash was still present. On 14-JUL-2008, the patient had hives on her arms, constipation, and positive cytomegalovirus test. At this point the patient was referred to the infectious disease specialist. On 23-JUL-2008, the infectious disease physician ordered the patient not to receive the third dose of GARDASIL. The patient's history of persistent malaise, fatigue, and low platelet count had resolved by 09-JUL-2008. Additional information has been requested.  11/4/08 Reviewed PCP medical records of 6/16-7/29/2008. FINAL DX: none provided Records reveal patient received 2nd dose of vaccine 6/16/08.  RTC 6/20 after experienced petechial rash, hot flashes, myalgias.  Exam revealed enlarged lymph nodes.  Dx w/possible viral syndrome.  Labs ordered.  Seen in Er 6/19/08 for rash & dx w/'low count'.  Dx w/viral syndrome w/improving plt & wbc counts.  RTC 6/23 w/hives all over, myalgias, fever.  Dx w/possible erlichiocia & additional labs ordered.  RTC 7/14 w/recurrent hives, malaise, constipation.  Dx w/CMV & possible HPV reaction. Referred to ID on 7/23/08 for persistent fatigue, malaise, leukopenia.  No dx provided & advised not to receive final vaccine.  RTC 10/13 w/reactive airways disease, croupy cough.  Tx w/nebs & antibiotics.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hot flush, Laboratory test normal, Myalgia, Petechiae, Rheumatoid factor negative
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 14-APR-2008 was vaccinated with the first dose of GARDASIL. On 16-JUN-2008, the patient was vaccinated with a second dose of GARDASIL. Patient then went to the emergency room on 19JUN-2008. It was unspecified if the patient was hospitalized that day. The next day, on 20-JUN-2008, the patient came in the physician's office with petechial rash, hot flashes and muscle pain. The office did a complete blood count, high mono, and esosithil count, and a high alcoholine phosphate count. The next visit was on 21-JUN-2008; the patient had no bleeding but had a low white count and petechial rash on legs. On 23-JUN-2008, the patient's spleen tip was enlarged. The patient physician gave the patient a possible diagnosis of Ehrlichiosis. The patient was ordered a complete blood count(CBC), serum antinuclear antibodies test (ANA) and anti- DNA testing. The patient was tested for cytomegalovirus, rheumatoid factor, and Rocky Mountain spotted fever. A complete blood count showed low white count, negative serum antinuclear antibodies test (ANA) and normal rheumatoid factor (RF). Cytomegalovirus test (CMV) came back low white count; negative serum antinuclear antibodies test (ANA), and normal rheumatoid factor. Cytomegalovirus test (CMV) came back high, erichias, West Nile and Rocky Mountain spotted fever came back negative. Epstein-Barr came back high at 5.31. On 09-JUL-2008, the patient's rash was still present. On 14-JUL-2008, the patient had hives on her arms, constipation, and positive cytomegalovirus test. At this point the patient was referred to the infectious disease specialist. On 23-JUL-2008, the infectious disease physician ordered the patient not to receive the third dose of GARDASIL. The patient's history of persistent malaise, fatigue, and low platelet count had resolved by 09-JUL-2008. Additional information has been requested.  11/4/08 Reviewed PCP medical records of 6/16-7/29/2008. FINAL DX: none provided Records reveal patient received 2nd dose of vaccine 6/16/08.  RTC 6/20 after experienced petechial rash, hot flashes, myalgias.  Exam revealed enlarged lymph nodes.  Dx w/possible viral syndrome.  Labs ordered.  Seen in Er 6/19/08 for rash & dx w/'low count'.  Dx w/viral syndrome w/improving plt & wbc counts.  RTC 6/23 w/hives all over, myalgias, fever.  Dx w/possible erlichiocia & additional labs ordered.  RTC 7/14 w/recurrent hives, malaise, constipation.  Dx w/CMV & possible HPV reaction. Referred to ID on 7/23/08 for persistent fatigue, malaise, leukopenia.  No dx provided & advised not to receive final vaccine.  RTC 10/13 w/reactive airways disease, croupy cough.  Tx w/nebs & antibiotics.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Splenomegaly, Urticaria, White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 14-APR-2008 was vaccinated with the first dose of GARDASIL. On 16-JUN-2008, the patient was vaccinated with a second dose of GARDASIL. Patient then went to the emergency room on 19JUN-2008. It was unspecified if the patient was hospitalized that day. The next day, on 20-JUN-2008, the patient came in the physician's office with petechial rash, hot flashes and muscle pain. The office did a complete blood count, high mono, and esosithil count, and a high alcoholine phosphate count. The next visit was on 21-JUN-2008; the patient had no bleeding but had a low white count and petechial rash on legs. On 23-JUN-2008, the patient's spleen tip was enlarged. The patient physician gave the patient a possible diagnosis of Ehrlichiosis. The patient was ordered a complete blood count(CBC), serum antinuclear antibodies test (ANA) and anti- DNA testing. The patient was tested for cytomegalovirus, rheumatoid factor, and Rocky Mountain spotted fever. A complete blood count showed low white count, negative serum antinuclear antibodies test (ANA) and normal rheumatoid factor (RF). Cytomegalovirus test (CMV) came back low white count; negative serum antinuclear antibodies test (ANA), and normal rheumatoid factor. Cytomegalovirus test (CMV) came back high, erichias, West Nile and Rocky Mountain spotted fever came back negative. Epstein-Barr came back high at 5.31. On 09-JUL-2008, the patient's rash was still present. On 14-JUL-2008, the patient had hives on her arms, constipation, and positive cytomegalovirus test. At this point the patient was referred to the infectious disease specialist. On 23-JUL-2008, the infectious disease physician ordered the patient not to receive the third dose of GARDASIL. The patient's history of persistent malaise, fatigue, and low platelet count had resolved by 09-JUL-2008. Additional information has been requested.  11/4/08 Reviewed PCP medical records of 6/16-7/29/2008. FINAL DX: none provided Records reveal patient received 2nd dose of vaccine 6/16/08.  RTC 6/20 after experienced petechial rash, hot flashes, myalgias.  Exam revealed enlarged lymph nodes.  Dx w/possible viral syndrome.  Labs ordered.  Seen in Er 6/19/08 for rash & dx w/'low count'.  Dx w/viral syndrome w/improving plt & wbc counts.  RTC 6/23 w/hives all over, myalgias, fever.  Dx w/possible erlichiocia & additional labs ordered.  RTC 7/14 w/recurrent hives, malaise, constipation.  Dx w/CMV & possible HPV reaction. Referred to ID on 7/23/08 for persistent fatigue, malaise, leukopenia.  No dx provided & advised not to receive final vaccine.  RTC 10/13 w/reactive airways disease, croupy cough.  Tx w/nebs & antibiotics.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Nasal congestion, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: Information has been received from a 22 year old female patient with allergy reaction from to antibiotic, who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL. On approximately 24-SEP-2008, the patient received her second dose of GARDASIL. There was no concomitant medications. On 28-SEP-2008, the patient woke up with stuffy nose, cough, fever, and general body aches. The patient did mention that her family recently had suffered from cold symptoms as well and she may have picked it from them. She did not had a similar reaction after the first dose of GARDASIL. The patient also stated that her arm was still a little sore. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 22 year old female patient with allergy reaction from to antibiotic, who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL. On approximately 24-SEP-2008, the patient received her second dose of GARDASIL. There was no concomitant medications. On 28-SEP-2008, the patient woke up with stuffy nose, cough, fever, and general body aches. The patient did mention that her family recently had suffered from cold symptoms as well and she may have picked it from them. She did not had a similar reaction after the first dose of GARDASIL. The patient also stated that her arm was still a little sore. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who in August 2008, was vaccinated with the first dose of GARDASIL. In August 2008, the patient experienced pain for one month in the arm she received the injection. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Underdose
Clinical narrative: Information has received from a general practitioner concerning a 16 year female in good health with a history of blood pressure increased 2 years ago who in January 2008, was vaccinated with the first dose of GARDASIL. No adverse effect. In March 2008, the patient was vaccinated with a second dose of GARDASIL. 24 hours after the second dose of GARDASIL in March 2008, the patient experienced severe fever 40 deg C during two days. There was no associated symptoms. She had some Paracetamol. In March 2008, she also had blood pressure at 15/8. In September 2008, the patient received only half of the third dose of GARDASIL. There was an under dose. In September 2008, the patient had blood pressure at 15/9. she had no concomitant treatment. She had recovered on an unspecified date. Other business partner numbers included: EZ008-08727 and E2008-0B737. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, IPV, TDAP
Symptoms: Asthenia, Cold sweat, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with asthma, peanut allergy, shellfish allergy, Ipratropium (Atrovent) allergy, and ibuprofen (Motrin) allergy who on 09-Jul-2008 was vaccinated with the first dose of GARDASIL (lot# 660393/ 0067X). 0.5ml, intramuscularly. Concomitant therapy included unspecified asthma drug. The physician stated that on 09-Jul-2009, the patient developed muscle ache, weakness, clammy hands and was feverish for five hours after receiving GARDASIL. The physician reported that the patient received VERO, DTAP at the same office visit. No other symptoms reported. On 10-Jul-2008 the patient had recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/14/2008.  Initial and follow up information has been receivede from a physician concerning a 13 year old female patient with bronchial asthma, peanut allergy, shellfish allergy, honey allergy, strawberry allergy, ATROVENT allergy, and MOTRIN allergy who on 09-JUL-2008 at private doctor's office /hospital was vaccinated with the first dose of GARDASIL (Lot # 660393/0067X), 0.5 ml, intramuscularly.  Concomitant vaccine include ADACEL.  Concomitant drug included unspecified asthma drug.  The physician stated that on 09-JUL-2008, the patient developed muscle aches, weakness, clammy hands and was feverish for 5 hours after receiving GARDASIL, and then recoved spontaneously the same day.  No further information is available.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Diagnostic procedure, Joint effusion, Muscular weakness
Clinical narrative: Information has been received from a mother of a 14 year old female patient with no known medical history and no known drug allergies, who on 16-Sep-2008 was vaccinated with the first dose of GARDASIL . Concomitant therapy included HEP A vaccine and Lisdexamfetamine Dimesylate. The mother reported that on the night of 28-Sep-2008, her daughter's knees felt very weak. The mother also reported that on 29-Sep-2008, her daughter went to school, then around 12:30 pm she had came home from school because the weakness moved from knees to her thighs and she felt like she didn't have knees and she was going to fall over. The mother reported that on 29-Sep-2008 her daughter went to her pediatrician who did strength test on her legs but her strength was fine, and she did say she had some fluid in her right knee but her knee was not hot. The mother reported that the physician was not sure what was causing the symptoms since the patients activities did not change, but stated to give it 72 hours and if nothing had changed the patient had come back and get blood work done. The mother also reported that on 29-Sep-2008 her daughter did stay home from school. The patient sought medical attention. At the time of the report the patient had not recovered. Additional information has been requested.  11/4/2008 PCP records received. Healthy with no problems noted at WCC 9/16/08. Vax given. Returned 9/29/08 with c/o joint/muscle pain and weakness. Tx ibuprofen and rest. Pt has recovered.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female who on an unknown dates was vaccinated with the three doses of GARDASIL. It was reported by the nurse that the patient developed reaction after each of the doses. On an unknown date, after the first dose the patient developed small rash at the injection site. On an unknown date, after the second dose, the patient developed a "bigger" reaction at the injection site. On an unknown date, after the third dose, the patient developed hives all over her body. The patient was given medication for the reaction. The patient was see by an allergist who determined that the reaction was due to the vaccine. On an unknown date, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 26 year old daughter who in 2007 was vaccinated with the three doses of GARDASIL third dose was in August 2007. There was no concomitant medication. On approximately 09-Sep-2008, the patient had a Papanicolaou test positive and revealed mild dysplasia. As of 30-Sep-2008, the patient had not recovered. The patient sought unspecified medical attention. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain, Injection site induration, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient who on 24-SEP-2008 was vaccinated with the first dose of GARDASIL 0.5ml. There was no concomitant medication. On 25-Sep-2008, the patient experienced pain in the arm, also in her shoulder and axillary area. She was seen in the office, date not provided, with a hard lump and swelling at the site. No treatment required. The patient not had any labs test done. There was no product quality complaint. Additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Feeling hot, Oedema peripheral, Rash, Urticaria
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter with allergy to Amoxicillin no pertinent medical history and no concomitant therapy reported, who on 04-Mar-2008 was vaccinated with the first dose of GARDASIL 0.5ml and experienced swelling, redness and feeling hot from her shoulder to elbow in the injection arm. On 09-May-2008 received her second dose of GARDASIL 0.5ml and experienced rash and hives which have not gone away. On 05-Sep-2008, received the third dose of GARDASIL 0.5ml and experienced her arm swelling again. The patient sought medical attention, physician. At the time of the reporting the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 20 year old female who is July 2008, was vaccinated with the first dose of GARDASIL (lot# 660555/ 0279X) and on 27-SEP-2008 was vaccinated with the second dose of GARDASIL (lot# 661044/0548X). On 29-Sep-2008 the patient began to feel unwell with fever of 101.3 F. She later developed nausea, passed out and vomited once or twice. The patient sought medical attention, in office. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 27 year old female who about 1 week ago, on approximately 22-Sep-2008, was vaccinated with an unspecified dose of GARDASIL (lot#0373X), intramuscularly. Subsequently on an unspecified date the patient experienced sever arm pain at the site of her last GARDASIL vaccination. The patient sought medical attention in the office. At the time of reporting her symptoms had continued. This is one of two reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 11 year old female who in August 2008, was vaccinated with the first dose of GARDASIL. In August 2008, the patient experienced hives. Subsequently, the patient recovered from the hives. The physician reported that the patient had recovered. The patient sought medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Myalgia, Pyrexia, Rash
Clinical narrative: Fever 103 axillary, frontal headache, muscle ache arms, rash on torso.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: No reaction on previous exposure to drug, Pruritus, Urticaria
Clinical narrative: Pt reprots she had Hives on her neck, stomach and leg area 5 hours after receiving the flu inactivae injection on 10/17/08. Pt felt itchy all over her body. Report no other sx and no new changes in her daily routine besides the flu shot. Pt states her hives have gone a way this am and after here reading her VIS sheet, she was insturted to call in to the clinic. Pt has had flu shots in previous years with no side effects.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Feeling hot, Increased upper airway secretion, Vomiting
Clinical narrative: Had flu shot at 11:00a.m. 10-17-08.  At 1pm I was feeling very warm.  At 6pm starting chocking at dinner, couldn't catch my breath. Thought it was the perfume from person next to me. Then began Wheezing at vomited. At 7:30pm went to sleep for night. Woke up once noticed wheezing still. Got up at 8:30a.m. 10-18-08 wheezing, couldn't take deep breath, coughed a lot.  Coughed up some plem a few times. Drank a glass of water.  Started to calm down. By 10:18a.m. all wheezing seemed to disappear.  Never when to doctor. Husband got flu shot this morning brought paper with this email address, thought I should complete this form.
Sex: U
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Had flu shot at 11:00a.m. 10-17-08.  At 1pm I was feeling very warm.  At 6pm starting chocking at dinner, couldn't catch my breath. Thought it was the perfume from person next to me. Then began Wheezing at vomited. At 7:30pm went to sleep for night. Woke up once noticed wheezing still. Got up at 8:30a.m. 10-18-08 wheezing, couldn't take deep breath, coughed a lot.  Coughed up some plem a few times. Drank a glass of water.  Started to calm down. By 10:18a.m. all wheezing seemed to disappear.  Never when to doctor. Husband got flu shot this morning brought paper with this email address, thought I should complete this form.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dysgeusia, Eye irritation, Feeling abnormal, Flushing
Clinical narrative: I woke up this morning feeling just fine, and I have not been sick, nor did I feel like I was getting sick.  I went to get a  flu vaccine this morning around 11:30 am. at my local store.   Following the vaccine, I felt normal tenderness in the location of the vaccine. I finished my errands and went home around 1:30 pm, at which time I noticed a few very obvious adverse reactions.   My face is flushed and hot to the touch and temp is 99.7.  My eyes feel watery, red and irritated.  My brain somehow feels like it has expanded, making my upper jaw feel very strange and enlarged.  My nose feels strange as well...and my head overall feels like there is a vise grip on it.  It is a strange tightening feeling, and it extends down the back of my neck.   I have a metallic taste in my mouth.  I called my family doctor's answering service and spoke to the doctor on call around 2:45.  She told me to take ibuprofen, and drink fluids, and said it is probably not due to the vaccine...but that if other symptoms should develop, I could call her back or go to the ER for evaluation. I do not feel that the symptoms I am having are a normal reaction to the vaccine, and I am concerned.  On my receipt,it says that the manufacturer of this vaccine is "fluzine"--which was not a choice in your list below, which is why I didn't choose a manufacturer.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Lacrimation increased, Muscle tightness, Ocular hyperaemia, Pyrexia
Clinical narrative: I woke up this morning feeling just fine, and I have not been sick, nor did I feel like I was getting sick.  I went to get a  flu vaccine this morning around 11:30 am. at my local store.   Following the vaccine, I felt normal tenderness in the location of the vaccine. I finished my errands and went home around 1:30 pm, at which time I noticed a few very obvious adverse reactions.   My face is flushed and hot to the touch and temp is 99.7.  My eyes feel watery, red and irritated.  My brain somehow feels like it has expanded, making my upper jaw feel very strange and enlarged.  My nose feels strange as well...and my head overall feels like there is a vise grip on it.  It is a strange tightening feeling, and it extends down the back of my neck.   I have a metallic taste in my mouth.  I called my family doctor's answering service and spoke to the doctor on call around 2:45.  She told me to take ibuprofen, and drink fluids, and said it is probably not due to the vaccine...but that if other symptoms should develop, I could call her back or go to the ER for evaluation. I do not feel that the symptoms I am having are a normal reaction to the vaccine, and I am concerned.  On my receipt,it says that the manufacturer of this vaccine is "fluzine"--which was not a choice in your list below, which is why I didn't choose a manufacturer.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: I woke up this morning feeling just fine, and I have not been sick, nor did I feel like I was getting sick.  I went to get a  flu vaccine this morning around 11:30 am. at my local store.   Following the vaccine, I felt normal tenderness in the location of the vaccine. I finished my errands and went home around 1:30 pm, at which time I noticed a few very obvious adverse reactions.   My face is flushed and hot to the touch and temp is 99.7.  My eyes feel watery, red and irritated.  My brain somehow feels like it has expanded, making my upper jaw feel very strange and enlarged.  My nose feels strange as well...and my head overall feels like there is a vise grip on it.  It is a strange tightening feeling, and it extends down the back of my neck.   I have a metallic taste in my mouth.  I called my family doctor's answering service and spoke to the doctor on call around 2:45.  She told me to take ibuprofen, and drink fluids, and said it is probably not due to the vaccine...but that if other symptoms should develop, I could call her back or go to the ER for evaluation. I do not feel that the symptoms I am having are a normal reaction to the vaccine, and I am concerned.  On my receipt,it says that the manufacturer of this vaccine is "fluzine"--which was not a choice in your list below, which is why I didn't choose a manufacturer.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Eye swelling, Lacrimation increased, Lethargy, Sneezing
Clinical narrative: sneezing, cough, puffy eyes, watery eyes, wheezing, skin turned red from head to toe, hives, lathargy
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria, Wheezing
Clinical narrative: sneezing, cough, puffy eyes, watery eyes, wheezing, skin turned red from head to toe, hives, lathargy
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Awakened morning after injection with swelling, induration, redness, pain, tenderness, and increased warmth in 6cm x 7cm area right deltoid. Wa seen in office 9/23/08 and diagnosed with an Arthus reaction t otetanus toxoid.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Awakened morning after injection with swelling, induration, redness, pain, tenderness, and increased warmth in 6cm x 7cm area right deltoid. Wa seen in office 9/23/08 and diagnosed with an Arthus reaction t otetanus toxoid.