chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Dizziness, Feeling hot, Hypotension, Loss of consciousness
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 21 year old female who was vaccinated on 14-JUN-2007 in the pm, was vaccinated IM in the left deltoid with Gardasil (lot # 658100/0529U). On 14-JUN-2007 the patient experienced dizziness. Unspecified medical attention was sought. Subsequently, the patient recovered  from dizziness and warm for 20 seconds the same day. She had loss of consciousness for 20 seconds. The patients blood pressure measurement was hypotensive and was reported as 94/50 with a total heartbeat count of 56. The patient was layed down for approximately a half hour and reported that she felt fine. Her blood pressure measurement was reported as normal. On 14-Jun-2007, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physicians assistant concerning a 9 year old female who was vaccinated with Gardasil. Subsequently 6 hours after the vaccination the patient experienced vomiting. Unspecified medical attention was sought. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who on 04-JUN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil. Five minutes later the patient experienced dizziness and fainted while sitting in a chair. Unspecified medical attention was sought. Subsequently, the patient recovered from dizziness and fainting. This is one of several reports received from the same source. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Rash erythematous, Rash pruritic, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient with a penicillin allergy and no medical history who on 06-JUN-2007 was vaccinated IM with a dose of Gardasil. There was no concomitant medication. On the morning of 07-JUN-2007, the patient developed a rash that was red, erythematous, and itchy. It was on her trunk, neck and arms. She also felt faint or dizzy as the rash began. The treatment was Benadryl. No diagnostic laboratory studies were performed. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no medical history or drug allergies, who on 12-APR-2007 was vaccinated with a first dose of Gardasil. There was no concomitant medication. Three days after vaccination, the patient developed a severe generalized rash all over her body. The patient was referred to a dermatologist who treated the rash with hydrocortisone (Cotizone). No laboratory diagnostic studies were performed. Subsequently, the patient recovered after a couple days. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Nausea
Clinical narrative: Information has been received from a physician concerning a female between the age of 12 and 16, who, a "couple months ago" was vaccinated with a 0.5mL dose of Gardasil. Concomitant therapy included Menactra. Twenty-four hours after being vaccinated with Gardasil the patient experienced nausea and weakness. The patient sought unspecified medical attention. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. After the patient received one dose of Gardasil she experienced numbness in her arm. Patient received vaccination from her primary care physician and not the reporting physician. The patient did seek unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (Lot Number unknown) injection. The physician reported that the patient fainted after receiving Gardasil. Medical attention was sought. At the time of reporting the outcome was unknown. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot number unknown) injection. The physician reported that the patient fainted after receiving Gardasil. Medical attention was sought. No further information was provided. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Nausea, Off label use
Clinical narrative: Information has been received from a 41 year old with no pertinent medical history or drug reactions/allergies who on 01-JUN-2007 was vaccinated with her first dose of Gardasil (lot number unknown) 0.5 mL. There was no concomitant medication used. On 01-JUN-2007 the consumer reported that she experienced nausea following the first dose of Gardasil. The consumer recovered from the nausea on 02-JUN-2007. She did not seek medical attention. No additional information is available.
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a certified medical assistant concerning multiple patients' (unknown number) who were vaccinated with a dose of Gardasil. Subsequently the patients' complained of pain while and after receiving vaccinations of Gardasil. It was reported that all of their patients' complain of the pain. It was also reported that vaccinations are given via intramuscular route using two inch needles. The needles do not completely penetrate nor do the staff want to "force it." It was also reported that for all patients' the symptoms resolved. No product quality complaint was involved. Attempts are being made to obtain additional identifying to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Fall, Head injury, Heart rate irregular
Clinical narrative: Information has been received from a physician's office manager concerning a 21 year old female who on 20-FEB-2007 received her first dose of GARDASIL. After receiving the vaccination, on 20-FEB-2007, the patient fell backwards and hit the back of her head in the physician's office. She was taken to the emergency room for treatment. The patient was not admitted to the hospital. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Aura, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 22-MAY-2007 was vaccinated IM with a first dose of Gardasil (Lot# "0170U"). Concomitant therapy included a dose of Menactra. Within fifteen minutes, the patient "passed out cold." Unspecified medical attention was sought. Subsequently, the patient recovered and was fine. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a medical assistant concerning a 17 year old female patient with no known allergies who on 22-MAY-2007, was vaccinated IM into the right deltoid with a first dose of GARDASIL (Lot# 655620/0171U). Concomitant therapy included a dose of MENACTRA. Ten minutes after administering the vaccination the patient fainted and "passed out cold." It was reported that the patient was in aura for about 20 minutes after fainting. Unspecified medical attention was sought. The patient recovered and was fine from "passed out cold." On 22-MAY-2007, the patient recovered from fainted and aura. No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 04-JUN-2007 was vaccinated IM with a 0.5 ml first dose Gardasil. On 04-JUN-2007 the patient fainted and hit her head. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old patient who was hysterical prior to receiving the vaccine and on 05-JUN-2007 was vaccinated IM with a 0.5 ml dose of Gardasil. On 05-JUN-2007 after the vaccination, the patient felt light headed. Unspecified medical attention was sought. Subsequently, the patient recovered from light headedness. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient who on 06-JUN-2007 was vaccinated IM with a 0.5 ml second dose of Gardasil. On 06-JUN-2007 the patient felt dizzy. Unspecified medical attention was sought. Subsequently, the patient recovered from dizziness. This is one of several reports from the same source.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Menstruation irregular
Clinical narrative: Information has been received from a licensed practical nurse, concerning herself, a female in her 20's, who was vaccinated on an unspecified date, with the first dose of Gardasil. The day following the vaccination, the nurse reported that her period came early, and she felt sick. The nurse recovered after an unknown duration of time. The nurse sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil (Lot Number unknown). The nurse reported that on 23-APR-2007 the female was vaccinated with her second dose of Gardasil (Lot Number 655324/0089U) 0.5mL. On an unspecified date, the patient experienced violent headaches. There was no concomitant medication. Medical attention was sought. Additional information was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 16 year old female patient, who "in the last couple of months," was vaccinated with the first dose, 0.5 ml, of Gardasil. The physician reported the patient fainted after receiving the injection, and urinated on herself when she fainted. The patient recovered from the events after an unknown duration of time. The patient was later vaccinated (unspecified date) with the second dose of Gardasil, with no problems reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain, Pregnancy test positive
Clinical narrative: Information has been received from the Merck Pregnancy Registry via a consumer concerning her 17 year old daughter with a food allergy to pineapples who on 05-APR-2007 received her first dose of Gardasil. Concomitant therapy included Phenergan. On 05-APR-2007, the patient experienced pain at the injection site for several hours. The patient sought unspecified medical attention. The patient recovered on 06-APR-2007. Subsequently, the patient was informed that she was pregnant by a physician at the hospital ER. Pregnancy was confirmed via pregnancy test. The date of her last menstrual period was approximately 15-MAR-2007 and her estimated delivery date is 20-DEC-2007. The patient was not admitted. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes, Stomatitis
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who on 26-FEB-2006 was vaccinated with a dose of Gardasil. Concomitant therapy included Abreva. On 27-FEB-2007, 24 hours after vaccination the patient experienced redness around mouth. On 28-FEB-2007, 48 hours after vaccination the patient cold sore around mouth. According to the nurse, the lesions resolved but returned again 3 weeks after the vaccination. Medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Pain in extremity
Clinical narrative: Information has been received from a immunization Coordinator at the physician's office concerning a 12 year old female who sometime in March 2007, was vaccinated with Gardasil. About two months post vaccination sometime in May 2007, the patient could not walk and was complaining of leg pain. The patient sought medical attention. Patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hypoaesthesia, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who in approximately May 2007, was vaccinated with the third dose of Gardasil and had a reaction at the injection site and pain on her arm right after receiving the injection. As of 08-JUN- 2007, the patient's experiences had improved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a physician concerning a 19 year old female who on 02-MAY-2007 was vaccinated with the third dose of GARDASIL, IM in the right arm. Concomitant medication was not reported. It was reported that there was no reaction with the first and second doses of GARDASIL. No illness was reported at the time of vaccination. In approximately May 2007, the patient experienced pain on her right arm. On 04-MAY-2007 the second day after she received the vaccine, the patient developed a 30 mm local reaction erythema, numbness and warm to touch. Subsequently 36 hours later, the patient recovered from the 30 mm local reaction erythema, numbness and warm to touch. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Skin warm
Clinical narrative: Information has been received from a physician concerning a female who in approximately May 2007, was vaccinated with the third dose of Gardasil and had a reaction at the injection site and pain on her arm right after receiving the injection. As of 08-JUN- 2007, the patient's experiences had improved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from a physician concerning a 19 year old female who on 02-MAY-2007 was vaccinated with the third dose of GARDASIL, IM in the right arm. Concomitant medication was not reported. It was reported that there was no reaction with the first and second doses of GARDASIL. No illness was reported at the time of vaccination. In approximately May 2007, the patient experienced pain on her right arm. On 04-MAY-2007 the second day after she received the vaccine, the patient developed a 30 mm local reaction erythema, numbness and warm to touch. Subsequently 36 hours later, the patient recovered from the 30 mm local reaction erythema, numbness and warm to touch. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has received from a nurse practitioner concerning a 21 year old female with an allergy to nonsteroidal anti-inflammatory drugs who on 26-MAR-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included Yaz and Zyrtec. On 26-MAR-2007 the patient experienced worst headache ever. The vaccination was given in the morning and the patient had a headache until she went to bed. The patient was better the next morning. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a Registered Nurse concerning a female who was vaccinated with Gardasil (date and dose unknown). Subsequently the patient "passed out"after receiving Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered from passing out. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a Registered Nurse concerning a female with a history of migraines who on 07-JUN-2007 was vaccinated with the first dose of Gardasil. On 07-JUN-2007 the patient experienced nausea, vomiting and a bad headache perhaps a migraine after receiving the vaccination. Subsequently, the patient recovered from nausea, vomiting and bad headache/migraine. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with an allergic reaction to septra (hives) and a history of passing out with injections who on 08-JUN-2007 was vaccinated with Gardasil (lot# 657736/0389U). On 08-JUN-2007 the patient passed out. Medical attention was sought. The patient stayed in the office for about half hour and during that time the patient was laying down. The patient's vitals were  rechecked and patient was okay and sent home. No product quality complaint was involved. Additional information has been requested. In follow up the physician reported that "there have been no problems with any of our patients". No further information was available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from other source concerning a female (age not reported) who was vaccinated on unspecified date with Gardasil (lot number unknown). On the same date, the patient also was vaccinated with 2 other vaccines. On an unspecified date when administered Gardasil, the patient passed out. The patient recovered from the adverse event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with no pertinent medical history, drug reactions or allergies who on 07-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (653735/0688F) 0.5 mL IM. There was no concomitant medication used. The patient experienced a dull ache in her wrist, neck and back on 08-JUN-2007 the day after the first dose of GARDASIL vaccine (yeast) (653735/0688F) was administered. Medical attention was sought. No further information is available. At the time of reporting, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 26-MAR-2007 was vaccinated with a dose of Gardasil. On 26-MAR-2007 the patient experienced generalized body aches, which made her go to bed to sleep it off. Medical attention was sought. The felt better the next day. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who in May 2007, received her third dose of Gardasil. In approximately May 2007, the patient had an abnormal pap smear. The physician reported that the result of the pap smear came out positive for high risk HPV. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: DTPIPV, HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from the physician office manager concerning a healthy 17 year old female who on an unspecified date was vaccinated with Gardasil (lot number unknown). Concomitant therapy included DTAP-IPV (Sanofi Pasteur). On an unspecified date the patient was sitting and fell to the floor after receiving a dose of DTAP-IPV (Sanofi Pasteur) followed by a dose of Gardasil. The patient came to approximately a minute after she fainted. Medical attention was sought in the physician's office and "left the office smiling". Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Abdominal pain lower, Computerised tomogram
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 18-MAY-2007 was vaccinated IM in her left arm with Vaqta. Concomitant therapy included Gardasil and Boostrix. On 19-MAY-2007 the patient experienced severe lower right abdominal pain. he patient sought medical attention at the hospital and had a CT Scan performed. It was reported the CT Scan was normal and the patient was not admitted to the hospital. Subsequently, the patient recovered from severe lower right abdominal pain. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is in follow-up to report (s) previously submitted to 7/6/2007. Initial and follow-up information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL. It was reported that the patient had received one dose of GARDASIL and fainted. It was not reported, if she was one of the patient's that had not eaten that day prior to her vaccination or if she was one of the patients that had received another vaccine at the same time. The patient was observed at the office for an unspecified period and then was allowed to leave. It was reported that the patient recovered. This is one of two patients. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. In follow-up it was reported by the registered nurse that she did not know which patient was described and was unable to look up the lot number or give any more information. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient (the exact age of the patient is unknown) who was vaccinated with a dose of Gardasil and fainted after being given the injection. Unspecified medical attention was sought by the patient. The outcome was unknown. The reporter reported that they had two other patients (ranged from 9 to 11 years) who fainted after being given Gardasil. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. It was reported that the patient had fainted after vaccination. The patient sought unspecified medical attention. The patient's outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: PRURITIS, ERYTHEMA AND EDEMA 145MM X 115MM, TREATED WITH BENADRYL
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Blood test, Cellulitis, Induration, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with no medical history and no allergies who on 21-MAR-2007 was vaccinated with a dose of ProQuad (Lot # 654835/0823F) that was the color of milky yellow instead of clear yellow. There was no concomitant medication. On 22-MAR-2007, the patient developed cellulitis and was hospitalized for 3 days on heavy antibiotics. At the time of this report, the patient had not recovered. There were no laboratory or diagnostic tests performed. No additional information was provided. No product quality complaint was involved. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Skin warm, White blood cell count normal
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with no medical history and no allergies who on 21-MAR-2007 was vaccinated with a dose of ProQuad (Lot # 654835/0823F) that was the color of milky yellow instead of clear yellow. There was no concomitant medication. On 22-MAR-2007, the patient developed cellulitis and was hospitalized for 3 days on heavy antibiotics. At the time of this report, the patient had not recovered. There were no laboratory or diagnostic tests performed. No additional information was provided. No product quality complaint was involved. A lot check has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Cellulitis, Poor quality drug administered
Clinical narrative: Information has been received from a consumer concerning her 4 year old son with no medical history and no allergies who on 21-MAR-2007 was vaccinated with a dose of ProQuad (Lot # 654835/0823F) that was the color of milky yellow instead of clear yellow. There was no concomitant medication. On 22-MAR-2007, the patient developed cellulitis and was hospitalized for 3 days on heavy antibiotics. At the time of this report, the patient had not recovered. There were no laboratory or diagnostic tests performed. No additional information was provided. No product quality complaint was involved. A lot check has been requested. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HIBV, DTAP, HIBV
Symptoms: Body temperature increased, Chills, Pyrexia, Tremor
Clinical narrative: Initial report received from a health care professional on 30 May 2007. An 18 month old, male patient (with a history of no known allergies and resolved eye duct obstruction) developed a 104F temperature, unconsolable crying overnight and "shaking", on the same day after receiving Daptacel (lot number 02490AA intramuscularly in the thigh and Hib (Merck, lot number 1125F) intramuscularly in the thigh on 29 May 2007. He was given Tylenol and cool packs. At the time of the vaccinations, the child did not have any illness and was not on any medications. At the time of the report, the patient had not recovered. Follow-up information was received on 03 July 2007 from a health professional. The patient had received three previous doses of Daptacel and Hib. He was admitted to the hospital overnight on 29 May 2007 and had a CBC and strep throat culture (results not reported). The event had recovered. The case was upgraded to serious in this version due to new information which noted that the patient had been hospitalized.
Age: 1.5
Sex: M
Vaccine: HIBV, DTAP, HIBV
Symptoms: Body temperature increased, Crying, Culture throat, Dacryostenosis acquired, Full blood count
Clinical narrative: Initial report received from a health care professional on 30 May 2007. An 18 month old, male patient (with a history of no known allergies and resolved eye duct obstruction) developed a 104F temperature, unconsolable crying overnight and "shaking", on the same day after receiving Daptacel (lot number 02490AA intramuscularly in the thigh and Hib (Merck, lot number 1125F) intramuscularly in the thigh on 29 May 2007. He was given Tylenol and cool packs. At the time of the vaccinations, the child did not have any illness and was not on any medications. At the time of the report, the patient had not recovered. Follow-up information was received on 03 July 2007 from a health professional. The patient had received three previous doses of Daptacel and Hib. He was admitted to the hospital overnight on 29 May 2007 and had a CBC and strep throat culture (results not reported). The event had recovered. The case was upgraded to serious in this version due to new information which noted that the patient had been hospitalized.
Age: 1.5
Sex: M
Vaccine: HIBV, DTAP, HIBV
Symptoms: Tremor
Clinical narrative: Initial report received from a health care professional on 30 May 2007. An 18 month old, male patient (with a history of no known allergies and resolved eye duct obstruction) developed a 104F temperature, unconsolable crying overnight and "shaking", on the same day after receiving Daptacel (lot number 02490AA intramuscularly in the thigh and Hib (Merck, lot number 1125F) intramuscularly in the thigh on 29 May 2007. He was given Tylenol and cool packs. At the time of the vaccinations, the child did not have any illness and was not on any medications. At the time of the report, the patient had not recovered. Follow-up information was received on 03 July 2007 from a health professional. The patient had received three previous doses of Daptacel and Hib. He was admitted to the hospital overnight on 29 May 2007 and had a CBC and strep throat culture (results not reported). The event had recovered. The case was upgraded to serious in this version due to new information which noted that the patient had been hospitalized.
Age: 13.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out on our way out of the DR office.  She did come to pretty quickly without assistance.  She has not had this happen before after shots.  She also had the Varinox #2 (Merck/0368U) shot that day - I couldn't find it on the drop-down box below.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Diabetes mellitus insulin-dependent, Pollakiuria
Clinical narrative: Mother states that within a week after getting the vaccines, patient started complaining of frequency in urinating. Hence, parents took him to MD; blood drawn an was hospitalized.  07/23/2007 MR received for DOS 7/10-12/2006.  Pt presented with several day hx of polyuria, nocturia, and polydipsia.   Consult with DX of Type I Diabetes, newly diagnosed. Txd with sliding scale insulin with good response. D/C DX: Acute new onset diabetes, currently nonketotic.
Age: 40.0
Sex: M
Vaccine: ANTH, HEP, PPV, SMALL
Symptoms: Amnesia, Headache, Rash
Clinical narrative: -Headache -Memory Loss -Rash (Red Areas)
Age: 62.0
Sex: F
Vaccine: HEP, YF
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Nausea, Pyrexia
Clinical narrative: Received yellow fever and Hep B #2 on 5/30/07. 8 days later (6/7/07) she felt flu-like symptoms primarily fatigue (sleeping 12 + hours a day), mild nausea, low grade fever, redness at yellow fever injection site.
Age: 84.0
Sex: F
Vaccine: YF
Symptoms: Rash
Clinical narrative: Patient reported to clinic on 5/14/07 the onset on 5/8-or5/9 of a rash on arms bilaterally without pruitus, fever or respiratory distress. Patient coincidentally had a primary care appointment and reported the rash to her PCP, No treatment was instituted. Rash resolved in 1 week without sequelae.
Age: 49.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Ear haemorrhage, Ear pain, Pain, Pyrexia, Tympanic membrane perforation
Clinical narrative: Within 24 hr of YF vaccine developed achiness. 48 hr after vaccine had pain and bleeding from both ears, low grade fever. Next day saw internist, referred to ENT doctor had bilaterally perforated eardrums, Rx with antibiotics and steroids.
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received from a licensed practical nurse through the Merck pregnancy concerning a female patient with latex allergy and a history of bipolar disorder who on 29-MAY-2007, was vaccinated IM with a first 0.5 ml dose of Gardasil (Lot# 655324/0089U). Concomitant therapy included lamotrigine (LAMICTAL), valacyclovir HCl (VALTREX), aripiprazole (ABILIFY), vitamins (unspecified), garlic extract (+) omega-3 marine triglycerides (+) vitamin E (OPTIMUM OMEGA), calcium (unspecified), ascorbic acid and pyridoxine. Subsequently, the nurse reported that the patient had a positive pregnancy test and will be terminating her pregnancy. Follow up information stated that the patient terminated her pregnancy on 29-JUN-2007. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, terminated her pregnancy was considered to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature baby
Clinical narrative: Information has been received from a nurse practitioner as part of the pregnancy registry for Gardasil concerning a 17 year old female with no history of drug reactions/allergy who on 16-FEB-2007 was vaccinated with a first dose of Gardasil (lot # 656049/0187U) 0.5 ml IM. On 06-JUN-2007, was vaccinated with a second dose of Gardasil (lot # 657736/0389U). There was no concomitant medication. Medical attention was sought. It was reported that the patient did not know she was pregnant until a baby was delivered on the patient's bathroom floor on 21-JUN-2007 at an approximated gestation of 30 weeks. Estimated date of delivery September 2007. The baby died eight days later on 29-JUN-2007 of schizencephaly. The patient claimed to be unaware of her pregnancy because she had her menstrual periods throughout her pregnancy and did not gain weight. The patient had no prenatal care. No other information was available at the time of reporting. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B, Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse concerning a male about 6 years old who "years ago" was vaccinated with a complete series of Recombivax HB. The patient did not seroconvert and subsequently developed hepatitis B. The patient required a liver transplant and the patient was hospitalized. At the time of this report, the outcome was unknown. No product quality complaint was involved. The patient's experiences were determined to be other important medical events by the reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Incorrect dose administered, Pneumatosis intestinalis
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 27-APR-2007 was vaccinated with a 1 ml oral dose of Rotateq (Lot# unavailable). Concomitant vaccines included a dose of Ipol, a dose of Recombivax HB (manufacturer unknown), a dose of diptheria toxoid (+) pertussis acellular vaccine (unspecified (+) tetanus toxoid, a dose of Pedvaxhib (manufacturer unknown) and a dose of Prevenar. On 01-MAY-2007 the patient was hospitalized for severe diarrhea and pneumatosis intestinalis. It was reported that the patient was discharged from the hospital and was recovered. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Kawasaki's disease, Ocular hyperaemia, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 4 month old male who, at "two months old," was vaccinated with an oral dose of Rotateq. It was reported that the patient experienced a very high fever, a rash on the body, and red eyes, Kawasaki's disease. Subsequently the patient was hospitalized. No product quality complaint was involved. No other information was provided. Additional information has been requested.  9/4/07 Reviewed hospital medical records which reveal patient experienced fever, diffuse erythematous maculopapular rash, red eyes, nonpurulent conjunctivitis bilaterally, nonproductive cough, watery diarrhea, decreased oral intake, palmar erythema, red lips w/fissures, red tongue & irritability x 5 days.  Seen in ER x 3 & d/c to home.  Admitted 6/27-6/29/07.  Tx w/IVIG & high dose ASA.  Improved & d/c to home on low dose ASA. FINAL DX: Kawasaki syndrome.  10/19/07 Records faxed to CDC.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Barium enema, Culture stool, Diarrhoea, Diarrhoea haemorrhagic, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on 28-JUN-2007 was vaccinated with Rotateq PO. The physician reported that on 28-JUN-2007 the patient received Rotateq PO and later that evening experienced a brief bout of severe vomiting, which was followed by bloody mucous diarrhea. The physician reported that the patient was brought to the emergency room and was given IV fluids. The patient was admitted to the hospital for evaluation. The patient was found to be clinically fine and was discharged from the hospital. After a few days of symptoms, on 02-JUL-2007 the patient had a repeat experience with the same symptoms. The physician reported that the patient was being evaluated for intussusception. The patient had a stool culture and barium enema on an unspecified date. The physician reported that the patient had not yet recovered. The lot number was not available because the reporting physician did not administer the vaccination. Additional information has been requested.   08/13/2007 MR requested for ER visit 6/29/2007 for c/o 15 episodes of vomiting over a 2 hour period 1 day s/p Rotavirus vax.    PE revealed listlessness, sunken eyes, otherwise WNL. No further vomiting after admission but did have 2 episodes of bloody, mucusy stool.  Final Dx:  Gastroenteritis.  Hematochezia.  Recent Rotavirus vaccine.  Probable Campylobacter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Post herpetic neuralgia, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 76 year old female with no known drug allergies, osteoarthritis, osteoporosis and back pain who on 15-MAR-2007 was vaccinated with a single dose of Zostavax (Lot # 656608/0032U). On 19-MAY-2007 patient experienced chest pains and developed lesions on her left thigh and physician considered it as shingles. The patient also had post herpetic neuralgia. The patient was treated with Valtrex 1 g TID/7 days, Kenalog 40 mg IM, Darvocet-N 100 one 8-4-6 hr PRN, Neurontin up to 900 mg/d, Vicodin and Ambien PRN. At the time of report the patient was recovering. A product quality complaint was not involved. The patient's experiences were considered to be disabling. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP
Symptoms: Arthralgia, Asthenia, Asthenia, Back pain, Hypoaesthesia
Clinical narrative: blood - high cholesterol, numbness and tingling: in arms, depression - deep problems, energy: loss, pain (muscle and joints), pain (lower back), blood pressure: varies, fibromyalgia, etc  5/27/08 Reviewed VA medical records of 10/2004-05/2008. Records reveal patient experienced: hyperlipidemia, right arm & neck pain w/radiculopathy, low back pain (since 2003)w/radiculopathy, left shoulder dislocation while on active duty overseas 11/2003-7/2004. insomnia, obesity, recurrent tonsillitis & URI, GERD, depression, DJD, bilateral CTS, DDD, adjustment disorder w/mixed anxiety & depressed mood, hand fracture from fall, recurrent left shoulder subluxation, capsulloraphy w/adhesive capsulitis of left shoulder, HTN, HA, eye floaters, bilateral sacroilitis w/steroid injections, sciatica, trochanteric bursitis, right dequervain tenosynovitis, right epicondylitis.  1/11/2010 Arthritis, major depression, high blood pressure, high blood cholesterol, energy low levels, Myalagia mood; anxious, irritable, libido: loss, flu-like symptoms, sleep problems, weight gain, neck, rigid pain, legs, lower back, muscles and joint, back, right thumb radiating up through forearm, tens needed for pain, numbness and tingling fingers, leg, memory: trouble remembering recent information.
Age: 29.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP
Symptoms: Myalgia, Paraesthesia
Clinical narrative: blood - high cholesterol, numbness and tingling: in arms, depression - deep problems, energy: loss, pain (muscle and joints), pain (lower back), blood pressure: varies, fibromyalgia, etc  5/27/08 Reviewed VA medical records of 10/2004-05/2008. Records reveal patient experienced: hyperlipidemia, right arm & neck pain w/radiculopathy, low back pain (since 2003)w/radiculopathy, left shoulder dislocation while on active duty overseas 11/2003-7/2004. insomnia, obesity, recurrent tonsillitis & URI, GERD, depression, DJD, bilateral CTS, DDD, adjustment disorder w/mixed anxiety & depressed mood, hand fracture from fall, recurrent left shoulder subluxation, capsulloraphy w/adhesive capsulitis of left shoulder, HTN, HA, eye floaters, bilateral sacroilitis w/steroid injections, sciatica, trochanteric bursitis, right dequervain tenosynovitis, right epicondylitis.  1/11/2010 Arthritis, major depression, high blood pressure, high blood cholesterol, energy low levels, Myalagia mood; anxious, irritable, libido: loss, flu-like symptoms, sleep problems, weight gain, neck, rigid pain, legs, lower back, muscles and joint, back, right thumb radiating up through forearm, tens needed for pain, numbness and tingling fingers, leg, memory: trouble remembering recent information.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Fatigue, Injection site pain, Lethargy, Muscular weakness, Pyrexia
Clinical narrative: A case was received from a health professional in the United States on 20 June 2007. An 11-year-old male patient experienced weakness, pain at the injection site, lethargy, tiredness, and fever following left arm intramuscular injection of Adacel (lot number C2689AA), right arm intramuscular injection of Menactra (lot number U2233CA), left arm intramuscular injection of Hepatitis A (lot number 0018U), and subcutaneous right arm injection of Varivax (lot number 0456U). All vaccinations were given on 06 June 2007, and within 12 hours the patient experienced weakness in both legs, pain at the injection site in both arms, lethargy, tiredness, and fever (101 degrees Fahrenheit). he was seen in the physician's office and then sent to the emergency room, where he was given Motrin. The patient has no known medical history, no concomitant medications, and was not ill at the time of vaccination. The events resolved.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Lip swelling, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: A case was reported by a health professional in the United States on 18 June 2007. An 18-year-old female patient experienced hives, swelling of the lip, hands, and feet, and fever after receiving an intramuscular deltoid injection of Menactra (lot number U2339AA) and Gardasil (lot number 0523U). The vaccines were administered on 12 June 2007, and within 24 hours the patient developed hives, swelling of the lip, hands, and feet, and fever (no documented temperature). Treatment included Benadryl and Tylenol, and the patient was seen by her physician on 13 June 2007 and 18 June 2007. The patient had a history of scoliosis with spinal fusion (07 July 2005). No concomitant medications were reported, and it was unknown if the patient had any illness at the time of vaccination. Outcome was unknown.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Body temperature increased, Lip swelling, Oedema peripheral, Pyrexia, Syncope
Clinical narrative: A case was reported by a health professional in the United States on 18 June 2007. An 18-year-old female patient experienced hives, swelling of the lip, hands, and feet, and fever after receiving an intramuscular deltoid injection of Menactra (lot number U2339AA) and Gardasil (lot number 0523U). The vaccines were administered on 12 June 2007, and within 24 hours the patient developed hives, swelling of the lip, hands, and feet, and fever (no documented temperature). Treatment included Benadryl and Tylenol, and the patient was seen by her physician on 13 June 2007 and 18 June 2007. The patient had a history of scoliosis with spinal fusion (07 July 2005). No concomitant medications were reported, and it was unknown if the patient had any illness at the time of vaccination. Outcome was unknown.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: A case was reported by a health professional in the United States on 18 June 2007. An 18-year-old female patient experienced hives, swelling of the lip, hands, and feet, and fever after receiving an intramuscular deltoid injection of Menactra (lot number U2339AA) and Gardasil (lot number 0523U). The vaccines were administered on 12 June 2007, and within 24 hours the patient developed hives, swelling of the lip, hands, and feet, and fever (no documented temperature). Treatment included Benadryl and Tylenol, and the patient was seen by her physician on 13 June 2007 and 18 June 2007. The patient had a history of scoliosis with spinal fusion (07 July 2005). No concomitant medications were reported, and it was unknown if the patient had any illness at the time of vaccination. Outcome was unknown.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Small hive developed below area of injection of Proquad in about 5 min after injection. Benadryl given no respir sx in voice or swallowing lungs clear
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Pt developed a warm tender erythematous rash on (L) upper arm pattern extends 10.3cm elbow x 10.6 cm, circum of arm is 20.2 cm (R) arm with smaller pattern of eryth 3.5 cm x 2.5 cm with central clearing, pinpoint puncture central
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: (L) thigh red spots slightly raised approx 2.5 x 2 cm probably blisters
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Blood culture, Dizziness, Full blood count, Headache
Clinical narrative: high fever 104 deg body stiffness dizziness weakness headache
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Pyrexia, Urine analysis
Clinical narrative: high fever 104 deg body stiffness dizziness weakness headache
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Rash generalised
Clinical narrative: generalized rash
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Throat irritation, Urticaria
Clinical narrative: pt had a few hives on 7/10/07-later in day after the Gardasil. Hives were worse on 7/11/07 with itch throat. Went to ER-given Benadryl and Prednisone x 7 days. pt also given an Epi Pen for future use.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram normal, Grand mal convulsion, Laboratory test normal, Urinary incontinence
Clinical narrative: Grand Mal seizures w/urinary incontinence observed on 7-7-07 while at dinner table
Age: 42.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Burning sensation, Culture, Erythema, Full blood count, Induration
Clinical narrative: Next day following Anthrax injection, son noticed his upper arm was swollen, red, burning and felt "hard" to touch