chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Faeces discoloured, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 25 year old female who on 15-FEB-2007 was vaccinated iM in the left deltoid with a first dose of Gardasil lot # 653938/0954F and on 05-APR-2007 was vaccinated with a second dose of Gardasil lot # 653736/0014U. Concomitant therapy included Nexium. On 05-APR-2007 the patient developed loose green stool, injection site redness and injection site swelling. The loose green stools lasted for 24 hours and then resolved. On 27-APR-2007 patient had an office visit and it was noted that the injection site redness and swelling resolved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 25 year old female patient who on 15-FEB-2007 was vaccinated IM in left deltoid with a first dose of GARDASIL lot # 653938/0954F and on 05-APR-2007, at 1:30 PM was vaccinated with a second dose of GARDASIL lot #653736/0014U. Concomitant therapy included NEXIUM. On 05-APR-2007 the patient developed loose green stool, injection site redness and injection site swelling. The loose green stools lasted for 24 hours and then resolved. On 27-APR-2007 patient had an office visit and it was noted that the injection site redness and swelling resolved. In follow up it was indicated that on 06-APR-2007 patient recovered. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a 20 year old female who in March 2007 was vaccinated with Gardasil. Subsequently the patient experienced hair loss. The patient's hair loss persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Throat irritation
Clinical narrative: Information has been received from a nurse practitioner and a licensed practical nurse concerning a 15 year old, female, student with no illness at time of vaccination with Bactrim allergy, rash who on 09-APR-2007 at 2:00 p.m. was vaccinated intramuscularly with the first dose of Gardasil, (Lot #656049/0187U). It was reported that at 8:00 a.m. on 10-APR-2007, the patient had 'a tickly feeling in her throat - which caused her to clear her throat, constantly. It was reported that the patient's "tickly feeling in her throat" which caused to clear her throat, constantly, went away after twenty four hours. It was reported that there was no soreness to the injection site noted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a office nurse in a physician's office concerning a female in her late teens who was vaccinated with Gardasil. Concomitant therapy included Dtap. Subsequently the patient felt dizzy immediately after receiving the vaccine. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated with Gardasil. There was no concomitant medication. Subsequently the patient experienced burning sensation after receiving the vaccination and sought medical attention. Subsequently, the patient recovered from the burning sensation. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a licensed practical nurse (LPN) concerning a 10 year old female, who on 26-MAR-2007, was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL, (Lot # 657868/0523U), expiration date 09-FEB-2010). There were no concomitant medication. Subsequently the patient experienced burning sensation after receiving the vaccination and sought unspecified medical attention. The symptom lasted for a few minutes. Subsequently, the patient recovered from the burning sensation. No product quality complaint was involved. In follow-up it was reported by the LPN that the patient complained of burning and soreness at the injection site after the medication was administered. It was reported that the burning lasted for approximately one hour. At the time of the report, it was unknown if the patient recovered from soreness at injection site. No medication treatment was needed. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pain
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history who on 23-FEB-2007 was vaccinated IM in her right arm with 0.5 ml, first dose of GARDASIL vaccine (lot # 656049/0187U). There was no concomitant medications. On 23-FEB-2007 the patient experienced initial stinging that turned into muscle soreness. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. As of 30-APR-2007, the patient's initial stinging and muscle soreness persisted. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007. Additional information not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Vaginal discharge
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician via a company representative concerning a female patient who was vaccinated IM in the left arm with a 0.5ml first (lot #6550503/0012U) and On 30-MAR-2007 with a second dose (lot #657006/0188U) of GARDASIL vaccine. There was no concomitant medication. Subsequently the patient experienced a yeast infection after each dose of the vaccination. It was noted that the patient recovered on therapy from both yeast infections. Follow-up information was received from a certified medical assitant which indicated that the patietn experienced vaginal discharge on 11-JAN-2007. Unspecified medical attention was sought. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning an 18 year old female who sometime in April 2007 was vaccinated with her first dose of Gardasil. There was no concomitant medication. Subsequently, the patient claims that ever since she received the vaccination, she gets her "period every 13 days" as opposed to every 28 days which is considered normal for her. Unspecified medical attention was sought. The patient's outcome was reported as unknown. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Fatigue
Clinical narrative: Information has been received from a nurse concerning a 26 year old female patient who on 27-APR-2007 was vaccinated IM with a 0.5 ml first dose Gardasil. There was no concomitant medication. Since 28-APR-2007 the patient felt depressed and fatigued. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a physician via a company representative concerning a female patient who on 21-APR-2007 was vaccinated IM in the deltoid with a first dose of Gardasil. Concomitant therapy included Zyrtec. On 22-APR-2007 the patient went out in the  sun and experienced rash on her legs and on the arm she was given the injection. It was noted the that the rash was not itchy and lasted a couple of days before resolving completely. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pain
Clinical narrative: Information has been received from a consumer concerning her daughter who on 02-NOV-2006 was vaccinated with her first dose of Gardasil. There was no concomitant medication. The patient's mother indicated that the shot her daughter received was extremely painful. She did not say if her daughter experienced the same pain when she got the second shot on 22-APR-2007 which was more than two months later. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a physician via a company representative concerning a 19 year old female patient who was vaccinated with 0.5 ml second dose of Gardasil. Subsequently the patient experienced urinary tract infection. Unspecified medical attention was sought. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Epistaxis, Pain, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a company representative and a nurse concerning a 17 year old female patient who on 26-APR-2007 was vaccinated with Gardasil (lot # 657621/0387U). On 26-APR-2007 the patient experienced body ache, cough, sore throat and a nose bleed. The nurse reported the following: The patient did not go to dance class that night which is unlike her. On 27-APR-2007, the patient went to 'Six Flags:" and only went on one ride which is unlike her. The patient did nothing over the weekend. The patient had 3 nose bleeds that started on 29-APR-2007 and the 3rd nose bleed lasted from 1:15 am on 30-APR-2007. The patient did not go to school on 30-APR-2007. The patient will see her primary care physician for follow-up. The patient was not recovered at the time of the report. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site mass, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a 24 year old female with papilloma viral infection who on 23-FEB-2007 was vaccinated with Gardasil (lot #654702/0011U). Concomitant therapy Nuvaring. Subsequently the patient experienced arm pain, swelling, itchiness, redness, and lump at injection site on left deltoid. Unspecified medical attention was sought. The patient status was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a company representative and a nurse concerning a 11 year old female who was vaccinated with a 0.5 ml dose of Gardasil. The patient developed a fever and missed at least one day aft school. The interval between administration of the vaccine and the onset of the fever is unknown. The nurse mentioned that the patient also received four additional injections at the same office visit. Subsequently, the patient recovered from the fever. Unspecified medical attention was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a nurse and a physician concerning a 12 year old female who had no illness at the time of being vaccinated. On 10-APR-2007, the patient was vaccinated with a first dose of GARDASIL (lot # 656049/0187U) 0.5 ml, IM in the right upper arm. Also on 10-APR-2007, the patient was vaccinated with a first dose of ADACEL (lot # C2688AA) IM in the left upper arm; a first dose of VAQTA (MSD) (lot # 656993/0001U) IM in the right upper arm; and a first dose of MENACTRA (lot # U1922AB) IM in the left upper arm. On 11-APR-2007, at HS, the patient developed a fever for 24 hours. The patient sought medical attention. She also experienced a headache which was not resolved with MOTRIN and missed school on 12-APR-2007. On 13-APR-2007, the patient recovered. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced dizziness immediately following vaccination. The nurse practitioner reported that the patient was fine and recovered shortly thereafter. Unspecified medical attention was sought. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who was vaccinated with her first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced weakness and nausea after receiving the vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered from the symptoms. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a female who reported that she received the first two doses of Gardasil and "developed a lump at the injection site. At the time of the report, it was unknown if the patient recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness, Injection site pain, Loss of consciousness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 15 year old female. The patient received her first dose of Gardasil and had no adverse reaction. On the week of 23-APR-2007 the patient was vaccinated with Gardasil second dose. Immediately after receiving her second dose, the patient's arm which received the injection began to hurt, the patient became dizzy and passed out. Her lips turned blue. Unspecified medical attention was sought. The patient was not given any other vaccines on the day she was given her second dose of Gardasil. Subsequently, the patient recovered from the arm pain, dizziness, passing out and lips turning blue. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Swelling
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 26 year old female with no known medical history and allergies to penicillin, amoxicillin and Biaxin who on 27-DEC-2006 was vaccinated intramuscularly with a second 0.5 mL dose of Gardasil (Lot #653937/0637F). There was no concomitant medication. Subsequently, on an unspecified date, the patient developed a quarter size area of redness at the injection site. No laboratory diagnostic tests were performed. Approximately one month after the injection was given, the patient recovered. It was also noted that on 30-Apr-2007, the patient was vaccinated with a dose of GARDASIL (Lot # 657622/0386U). On an unspecified date, the patient developed redness, swelling. On an unknown date, the patient recovered.No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female child (age not reported) who was the daughter of one of the reporting physician's patients. On unspecified dates, the patient was vaccinated with a first, second and third 0.5 mL dose of Gardasil at her pediatrician's office. Subsequently the patient experienced pain after each of her three doses of Gardasil, progressively getting worse each time. After the third dose, the patient also experienced nausea and had to stay home from school. Subsequently, the patient recovered from pain and nausea. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil, (No lot # was provided). Subsequently the patient experienced immediately after being vaccinated, numbness, and tingling in the arm on both her first and second dose. The patient sought unspecified medical attention. Subsequently, it was reported that the "patient was fine when she got home". It was reported that the patient was fine now. Additional information has been requested. It has been determined that WAES # 0705USA00161 is a duplicate of WAES # 0705USA01053. Therefore, WAES #0705USA00161 is being deleted from our files and the reports consolidated into WAES # 0705USA01053.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: Information has been received from a registered nurse, concerning a 20 year old female who on approximately 16-APR-2007 was vaccinated with the first dose, IM in the right deltoid, 0.5ml, of Gardasil. Concomitant therapy included Valtrex and hormonal contraceptives (unspecified). Immediately after the injection (approximately 16-APR-2007), the patient's arm was sore. On 30-APR-2007, two weeks later, the nurse confirmed the soreness continued and the patient complained her arm with any pressure applied; in addition, a small lump was present under the skin at the injection site. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 female who on 11-APR-2007 was vaccinated with a 0.5 mL dose of Gardasil (Lot # "03874"). Subsequently, the patient fainted 5 minutes after receiving the Gardasil. At the time of this report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Glossitis, Glossodynia, Paraesthesia oral, Physical examination abnormal, Rash papular
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 24-APR-2007 was vaccinated IM with a second dose of Gardasil (lot #656051/0244U). On 26-APR-2007, the patient was seen by her physician with complaints of a sore and "tingling" tongue. The physician reported that the patient stated she "may have had the tingling " before vaccination with Gardasil, although, "she wasn't sure." Upon physical examination, the patient's tongue was noted to be reddened with some raised papules, and subsequently, the patient was diagnosed with glossitis. The patient was administered viscous lidocaine and liquid Benadryl topically to the tongue, in order to decreased the irritation, and was instructed to contact the physician if the condition did not improve. The physician did not feel that the patient's glossitis was an allergic reaction, and reported that the patient will continue with the vaccination series. At the time of this report, the patient had not contacted the physician regarding the outcome of the glossitis and tingling was unknown. No additional information is expected. This is a consolidation of two reports concerning the same patient.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tongue disorder
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 24-APR-2007 was vaccinated IM with a second dose of Gardasil (lot #656051/0244U). On 26-APR-2007, the patient was seen by her physician with complaints of a sore and "tingling" tongue. The physician reported that the patient stated she "may have had the tingling " before vaccination with Gardasil, although, "she wasn't sure." Upon physical examination, the patient's tongue was noted to be reddened with some raised papules, and subsequently, the patient was diagnosed with glossitis. The patient was administered viscous lidocaine and liquid Benadryl topically to the tongue, in order to decreased the irritation, and was instructed to contact the physician if the condition did not improve. The physician did not feel that the patient's glossitis was an allergic reaction, and reported that the patient will continue with the vaccination series. At the time of this report, the patient had not contacted the physician regarding the outcome of the glossitis and tingling was unknown. No additional information is expected. This is a consolidation of two reports concerning the same patient.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who in 2007 was vaccinated with Gardasil. It was reported that the patient had injection site pain after receiving the vaccination. The second dose was not given because of the continued pain. The patient sought unspecified medical attention. This is one of two reports received from the same source. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient who was vaccinated IM (date unspecified), with the first dose of Gardasil. The physician reported that the patient "fainted in the office waiting room shortly after being vaccinated." The physician stated the patient was presumed to be doing fine, though she had not heard from the patient. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received froma physician, concerning a 17 year old female patient, with no known drug allergies, who on 04-JAN-2007, was vaccinated IM in the lteft arm, with the first dose of GARDASIL (Lot #655165/1425F). Follow up information added that the patient had developed an area of induration at the site of injection (date of onset not specified). The physician indicated that the patient did not require an office visit or other treatment. At the time of this report, the outcome of both events was unknown. Additional information has neem requested.
Sex: F
Vaccine: HPV4
Symptoms: Petechiae
Clinical narrative: Information has been received from a health professional concerning a female consumer who in March 2007, was vaccinated with Gardasil. In March 2007, the patient experienced petechiae rash all over her body within 24 hours after receiving the first dose of Gardasil. No medical attention was required. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a physician concerning her daughter who on an unspecified date was vaccinated with a dose of Gardasil (lot 654510/0926F). Immediately after receiving Gardasil, her daughter experienced severe pain in area of injection site. There was no visible reaction at the injection site such as a rash or swelling. At the time of this report, the outcome was unknown. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to reports previously submitted on 5/14/2007. Information has been received from a physician concerning her daughter who on an unspecified date was vaccinated with a dose of Gardasil (lot 654510/0926F). Immediately after receiving Gardasil, her daughter experienced severe pain in area of injection site. She complained of a burning sensation after the injection. The physician stated that Hepatitis and B12 shots did not hurt as bad as GARDASIL. The physician reported that the pain lasted 24-28 hours and described it to the feeling of receiving an IV of potassium. There was no visible reaction at the injection site such as a rash or swelling. At the time of this report, the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 19 year old female patient who on 30-APR-2007 was vaccinated with the first dose of Gardasil. The physician reported that the patient "passed out immediately after receiving first dose of Gardasil; "she added that that patient had not eaten all day prior to receiving the vaccination. The patient recovered on 30-APR-2007, the same day of vaccination. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician and a healthcare worker, concerning a 20 year old (previously reported as 19 year old) female patient, with no known drug allergies, who on 30-APR-2007, at 11:45am, was vaccinated with the first dose of GARDASIL (Lot #656049/0187U). There was no illness at the time of vaccination. The physician originally reported that the patient "passed out immediately after receiving first dose of GARDASIL" but the healthcare worker (who administered the vaccination), clarified that at 11:55am, the patient "felt dizzy and complained of nausea, she dropped to the floor, but was conscious". The patient's blood pressure was reported as normal, and she was helped to a chair, given water, and was then okay. The physician added that the patient had not eaten all day prior to receiving the vaccination. The patient recovered on 30-APR-2007, the same day of vaccination. No further information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 19 year old female who was vaccinated with a dose of Gardasil. Subsequently the patient developed amenorrhea. Unspecified medical attention was sought. It was reported the patient planned to discontinued the series of injections. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient, who was vaccinated (date unspecified) with a dose, 0.5ml, of Gardasil. The physician reported that the patient "experienced a full body rash," after the vaccination (date unspecified). At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 22 year old female who was vaccinated with her first dose of Gardasil. After the vaccination, the patient became nauseous, sweaty, threw up and had diarrhea. Follow up information reported that the physician thought the symptoms were not related to the Gardasil vaccine because the patient had developed them a week after having exposure with a friend with the same symptoms.  Additional information not expected.
Sex: U
Vaccine: HPV4
Symptoms: Sensory disturbance
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients who were vaccinated with Gardasil. Subsequently, the patients "felt vaccine going down their arm." This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on 10-APR-2007 was vaccinated with Gardasil. On 11-APR-2007 the patient experienced a sore arm and nausea. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Information has been received from a health professional concerning a "young" female who was vaccinated with Gardasil (date of vaccination unknown). Subsequently, following the vaccination the patient lost her color, slumped over and almost fainted. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a physician concerning an approximately 11 year old female who on an unspecified date was vaccinated with a dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, two days after receiving the Gardasil, the patient became ill. The reporting physician felt the event was not related to therapy with Gardasil. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Loss of consciousness, Pain, Pain
Clinical narrative: Information has been received from a health professional a female who was vaccinated with Gardasil. Subsequently the patient experienced pain, throbbing, stinging, burning sensation and passed out after receiving vaccination. Medical attention was sought.  Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a female patient (age not reported) who  on an unspecified date was vaccinated with a dose of Gardasil. Concomitant medication was not reported. No illness was reported at the time of vaccination. On an unspecified date within 12-15 hours after receiving GARDASIL, the patient experienced nausea and vomiting. The patient recovered on an unspecified date. This is one of two reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced fainting. Unspecified medical attention was sought. At the time of report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report (s) perviously submitted on 5/14/2007.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been requested from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced fainting. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced fainting. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Throat irritation
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who on 09-APR-2007 the patient experienced a tickly feeling in her throat for 24 hours after receiving the vaccine. She needed to clear her throat constantly. There was no soreness noted to the injection site. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered tickly feeling in her throat. This is one of two reports that was received from the same source for a sibling. No further details were provided. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on 03-OCT-2006 was vaccinated with Gardasil (lot # 653736/0689F). The patient received her second dose of Gardasil (lot # 653736/0689F) on 08-DEC-2006 and her third dose (lot # 653736/0014U) on 02-APR-2007. The patient experienced soreness and pain for 2 to 3 days after each dose of Gardasil. The patient's outcome was not recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Bacterial infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with a dose of Gardasil. Subsequently, the patient experienced a bacterial infection. The outcome was not reported. The patient's sister's experience with Gardasil was reported in WAES#0704USA02596. Additional information was been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dizziness, Pain in extremity, Visual disturbance
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated on 25-APR-2007 at 12:00 pm with a first dose of GARDASIL vaccine (lot # "03840") in the left arm. Subsequently, the patient reported feeling lightheaded and saw spots.  This is one of two reports received  from the same source. 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.  This is in follow-up to report (s) previously submitted on 5/14/2007. On 25-APR-2007, at 12:00 pm, the patient reported feeling lightheaded, dizzy, and saw a few spost for about 2 minutes. The patient also experienced arm soreness for 24 hours. Subsequently, the patient recovered from feeling lightheaded, dizzy, saw a few spots, and arm soreness. This is one of two reports received from the same source. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematochezia, Laboratory test, Stool analysis
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer report # WAES0703USA00587. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 9 week old white female wit cows-milk protein enteropathy who on 12-FEB-2007 at 10:51 am was vaccinated with a 2mL oral first dose of Rotateq (lot# 655407/1115F). Concomitant vaccination administered that day at 10:51 am included at first IM dose of HIB, a first IM dose of PREVNAR, a first IM dose of DAPTACEL and a first IM dose of IPOL. On 13-FEB-2007 (previously reported as 12-FEB-2007) the patient had flecks of blood in her stool. The patient "may have had" blood in stool at the time of vaccination, but the parents was not sure. It was reported that there were visible flecks of blood and mucous in stool. The patient's stool culture were negative. The patient stool guiac/hemoccult was positive. The physician suspected cow's mils protein enteropathy. Subsequently, the patient recovered. There was no recurrence after the patient was exclusively fed elemental formula. It was reported that the patient had not experienced an adverse event following prior vaccination. The patient's hematochezia was considered to be an other important medical event. Additional information is not expected."
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Culture stool negative, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer report # WAES0703USA00587. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 9 week old white female wit cows-milk protein enteropathy who on 12-FEB-2007 at 10:51 am was vaccinated with a 2mL oral first dose of Rotateq (lot# 655407/1115F). Concomitant vaccination administered that day at 10:51 am included at first IM dose of HIB, a first IM dose of PREVNAR, a first IM dose of DAPTACEL and a first IM dose of IPOL. On 13-FEB-2007 (previously reported as 12-FEB-2007) the patient had flecks of blood in her stool. The patient "may have had" blood in stool at the time of vaccination, but the parents was not sure. It was reported that there were visible flecks of blood and mucous in stool. The patient's stool culture were negative. The patient stool guiac/hemoccult was positive. The physician suspected cow's mils protein enteropathy. Subsequently, the patient recovered. There was no recurrence after the patient was exclusively fed elemental formula. It was reported that the patient had not experienced an adverse event following prior vaccination. The patient's hematochezia was considered to be an other important medical event. Additional information is not expected."
Age: 0.33
Sex: F
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Allergy test, Culture stool, Haematochezia, Rotavirus test
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report # WAES0703USA00703. The initial reporter to this manufacturer had been a health care professional. "Information has been received from a physician assistant concerning a white female with no pertinent medical history who on 19-DEC-2006 was vaccinated with her first dose of Rotateq (Lot # 655863/1034F) and on 21-FEB-2007 she was vaccinated with the second oral dose of Rotateq Lot# 656103/1166F). Concomitant therapy included Comvax (Lot# 654992/0984F), IPOL (Lot # Z0420), DTaP-IPV (Lot # C2553AA) and PREVNAR (Lot # B47300A) (previously reported as no concomitant medication). On 24-FEB-2007, the patient experienced blood in her stool after receiving the second dose. The patient visited the doctor. Sought unspecified medical treatment. There was no product quality complaint involved. On an unspecified date, the patient recovered from blood in stool. Upon internal review, blood in her stool was considered to be an other important medical event. Additional information has been requested." Lot #C2553AA corresponds to the product Daptacel.
Age: 0.33
Sex: F
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Allergy test, Culture stool, Haematochezia
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report # WAES0703USA00703. The initial reporter to this manufacturer had been a health care professional. "Information has been received from a physician assistant concerning a white female with no pertinent medical history who on 19-DEC-2006 was vaccinated with her first dose of Rotateq (Lot # 655863/1034F) and on 21-FEB-2007 she was vaccinated with the second oral dose of Rotateq Lot# 656103/1166F). Concomitant therapy included Comvax (Lot# 654992/0984F), IPOL (Lot # Z0420), DTaP-IPV (Lot # C2553AA) and PREVNAR (Lot # B47300A) (previously reported as no concomitant medication). On 24-FEB-2007, the patient experienced blood in her stool after receiving the second dose. The patient visited the doctor. Sought unspecified medical treatment. There was no product quality complaint involved. On an unspecified date, the patient recovered from blood in stool. Upon internal review, blood in her stool was considered to be an other important medical event. Additional information has been requested." Lot #C2553AA corresponds to the product Daptacel.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Bruxism, Electroencephalogram, Musculoskeletal stiffness, Pallor, Staring
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0703USA03671. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a licensed practical nurse concerning an 18 month old male who on 14-MAR-2007 at 10:15am was vaccinated with a 0.5 mL first dose of Varivax (lot# 656070/1492F). Suspect vaccination administered that day included a fourth IM dose in the left arm of Daptacel (lot# C2553AA) and third SC dose in the left arm of IPOL (lot# Z0324). There was no illness at the time of vaccination. On 18-MAR-2007 at 12:30 PM the patient experienced a seizure-like episode. The mother described the event as follows: the patient made a "noise", the mother looked at him and noted staring with his head slightly tilted to the right, he was slightly pale, his body was stiff, his teeth were clamped down and his eyes were glassy, the patient was unresponsive for 2-5 minutes. He was rushed to the ER. The patient was scheduled for an EEG and neurological testing. The EEG was normal. The patient recovered on 18-MAR-2007. It was noted that the patient left the office with a prescription for Zyrtec. There was no product quality complaint involved. The patient's seizure like episode was considered to be an other important medical event as he was sent to the emergency room. Additional information is not expected."
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0703USA03671. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a licensed practical nurse concerning an 18 month old male who on 14-MAR-2007 at 10:15am was vaccinated with a 0.5 mL first dose of Varivax (lot# 656070/1492F). Suspect vaccination administered that day included a fourth IM dose in the left arm of Daptacel (lot# C2553AA) and third SC dose in the left arm of IPOL (lot# Z0324). There was no illness at the time of vaccination. On 18-MAR-2007 at 12:30 PM the patient experienced a seizure-like episode. The mother described the event as follows: the patient made a "noise", the mother looked at him and noted staring with his head slightly tilted to the right, he was slightly pale, his body was stiff, his teeth were clamped down and his eyes were glassy, the patient was unresponsive for 2-5 minutes. He was rushed to the ER. The patient was scheduled for an EEG and neurological testing. The EEG was normal. The patient recovered on 18-MAR-2007. It was noted that the patient left the office with a prescription for Zyrtec. There was no product quality complaint involved. The patient's seizure like episode was considered to be an other important medical event as he was sent to the emergency room. Additional information is not expected."
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Bruxism, Convulsion, Electroencephalogram normal, Musculoskeletal stiffness, Pallor
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0703USA03671. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a licensed practical nurse concerning an 18 month old male who on 14-MAR-2007 at 10:15am was vaccinated with a 0.5 mL first dose of Varivax (lot# 656070/1492F). Suspect vaccination administered that day included a fourth IM dose in the left arm of Daptacel (lot# C2553AA) and third SC dose in the left arm of IPOL (lot# Z0324). There was no illness at the time of vaccination. On 18-MAR-2007 at 12:30 PM the patient experienced a seizure-like episode. The mother described the event as follows: the patient made a "noise", the mother looked at him and noted staring with his head slightly tilted to the right, he was slightly pale, his body was stiff, his teeth were clamped down and his eyes were glassy, the patient was unresponsive for 2-5 minutes. He was rushed to the ER. The patient was scheduled for an EEG and neurological testing. The EEG was normal. The patient recovered on 18-MAR-2007. It was noted that the patient left the office with a prescription for Zyrtec. There was no product quality complaint involved. The patient's seizure like episode was considered to be an other important medical event as he was sent to the emergency room. Additional information is not expected."
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Posture abnormal, Staring, Unresponsive to stimuli
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0703USA03671. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a licensed practical nurse concerning an 18 month old male who on 14-MAR-2007 at 10:15am was vaccinated with a 0.5 mL first dose of Varivax (lot# 656070/1492F). Suspect vaccination administered that day included a fourth IM dose in the left arm of Daptacel (lot# C2553AA) and third SC dose in the left arm of IPOL (lot# Z0324). There was no illness at the time of vaccination. On 18-MAR-2007 at 12:30 PM the patient experienced a seizure-like episode. The mother described the event as follows: the patient made a "noise", the mother looked at him and noted staring with his head slightly tilted to the right, he was slightly pale, his body was stiff, his teeth were clamped down and his eyes were glassy, the patient was unresponsive for 2-5 minutes. He was rushed to the ER. The patient was scheduled for an EEG and neurological testing. The EEG was normal. The patient recovered on 18-MAR-2007. It was noted that the patient left the office with a prescription for Zyrtec. There was no product quality complaint involved. The patient's seizure like episode was considered to be an other important medical event as he was sent to the emergency room. Additional information is not expected."
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, RV5, DTAP, PNC, RV5, DTAP, PNC, RV5
Symptoms: Intussusception, Ultrasound scan abnormal
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA04162. The initial reporter to this manufacturer had been an agency.  Verbatim from the report: "Information has been received concerning a 10 month old female who on 14-NOV-2006 was vaccinated, orally with her first dose of Rotateq (LOT# 654794/0776F). Other vaccines given at the time included the third dose of PREVNAR (Lot# B08658B) and the third dose of DAPTACEL (Lot# C2489AA). On 16-MAR-2007 the patient developed intussusception and was hospitalized for 2 days. An ultrasound was performed which showed intussusception. Subsequently, the patient recovered from intussusception. The records of testing prior to release of the lot in question (Lot# 654794/0776F) has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released. No further information is available."
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, RV5, DTAP, PNC, RV5, DTAP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception, Ultrasound scan abnormal
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA04162. The initial reporter to this manufacturer had been an agency.  Verbatim from the report: "Information has been received concerning a 10 month old female who on 14-NOV-2006 was vaccinated, orally with her first dose of Rotateq (LOT# 654794/0776F). Other vaccines given at the time included the third dose of PREVNAR (Lot# B08658B) and the third dose of DAPTACEL (Lot# C2489AA). On 16-MAR-2007 the patient developed intussusception and was hospitalized for 2 days. An ultrasound was performed which showed intussusception. Subsequently, the patient recovered from intussusception. The records of testing prior to release of the lot in question (Lot# 654794/0776F) has been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released. No further information is available."