chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with Gardasil.  There was no illness reported at the time of vaccination.  The patient had not eaten breakfast.  Subsequently, the patient fainted after receiving the vaccine.  The patient did not seek medical attention.  Subsequently, the patient recovered from fainting.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Initial and follow up information has been received from a registered nurse concerning a 19 year old white female with drug hypersensitivity to codeine and environmental allergies who on 11-JAN-2008 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #655154/1220U) intramuscularly in the left deltoid at 10:00 am. There was no illness reported at the time of vaccination. Two to three minutes after the injection the patient felt dizzy and passed out. Her vital signs remained stable. The patient stated that she had not eaten yet an d felt better after eating and drinking something. The patient recovered on 11-JAN-2008. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Information has been received from a nurse concerning a 23 year old female who on 09-JAN-2008 was vaccinated with Gardasil. There was no concomitant medication. There was no illness reported at the time of vaccination. On 10-JAN-2008, the patient developed raised, red and itchy rash all over her abdomen, thighs and arms and called the physician. No physician visit was indicated. No laboratory/diagnostic tests were performed. The nurse reported that they advised the patient to take Benadryl. The patient outcome was unknown. Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received from a nurse concerning a 23 year old female with penicillin allergy who on 09-JAN-2008 was vaccinated with her second dose of GARDASIL (Lot #659653/1448U) intramuscularly in the left deltoid at approximately 9-9:30 am. There was no concomitant medication and no illness reported at the time of vaccination. On 10-JAN-2008, the patient developed a raised, red, itchy rash all over her abdomen, legs, thighs and arms and called the physician. No physician visit was indicated. The patient was told to take BENADRYL 50 mg orally. The patient phoned the physician's office 11-JAN-2008 and reported that she never took the BENADRYL and the rash went away on its own. The patient has recovered from the itchy rash as of 11-JAN-2008. No further information is expected.
Sex: U
Vaccine: RV5
Symptoms: Bronchospasm
Clinical narrative: Information has been received from a physician concerning a patient, with a history of asthma, who was vaccinated with a third dose of ROTATEQ. Subsequently the patient experienced bronchospasms. No other information was provided. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician assistant concerning a female (age not reported) who was vaccinated (date, route and site not reported) with the 2nd dose of GARDASIL (lot# not reported). The patient experienced a "severe reaction at the site of injection" after receiving the 2nd dose of GARDASIL. The patient developed swelling, discomfort and redness at injection site which lasted for 2 weeks. The patient received medical attention via the telephone and recovered on an unspecified date. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Scar
Clinical narrative: Information has been received from a nurse concerning a 26 year old female who was vaccinated with her "second dose of series" of Gardasil, injection.  Concomitant therapy included "orthotricycline".  About a week after the second dose of Gardasil the patient developed a rash on her forearms and the rash left scars on her forearms as well.  As of 11-JAN-2008, the patient was recovering.  Medical attention was sought from a dermatologist.  The product quality complaint unit was not involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of Gardasil, injection.  The patient had considerable swelling and redness at the injection site.  When the patient had the second dose of Gardasil, injection the redness and swelling traveled up to her neck.  The physician elected to not let her get the third dose.  As of 11-JAN-2008 the patient was recovered.  Medical attention was sought.  The product quality complaint unit was not involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL. Within 12 to 16 hours post vaccination the patient developed a diffuse rash that was not located at the injection site. The patient's outcome was not reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 59 day old male who on 05-NOV-2007 was vaccinated with a dose of Rotateq.  There was no concomitant medication.  On 08-NOV-2007 the patient  developed diarrhea 7 to 8 times a day, and a severe diaper rash.  The patient came into the office on 12-NOV-2007 because the diarrhea still did not stop.  At the time of the report the patient was recovering.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Diarrhoea, Dry skin, Hyperkeratosis, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 31 year old female with an allergy to flaxseed oil pills and no pertinent medical history who on 18-DEC-2007 was vaccinated with Gardasil, 0.5 ml, intramuscularly in the left deltoid. There was no concomitant medication. On 20-DEC-2007 the patient developed flu-like symptoms of diarrhea, achiness and fever that lasted a "few days (unspecified)." The patient then developed dryness of the lips and skin. The patient went to her brother, a dermatologist, that performed a biopsy of the skin condition on 24-DEC-2007. The biopsy determined the skin condition was orthokeratosis. The patient was given prednisone and BENADRYL for the orthokeratosis and was recovered by 29-DEC-2007. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Lip dry, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 31 year old female with an allergy to flaxseed oil pills and no pertinent medical history who on 18-DEC-2007 was vaccinated with Gardasil, 0.5 ml, intramuscularly in the left deltoid. There was no concomitant medication. On 20-DEC-2007 the patient developed flu-like symptoms of diarrhea, achiness and fever that lasted a "few days (unspecified)." The patient then developed dryness of the lips and skin. The patient went to her brother, a dermatologist, that performed a biopsy of the skin condition on 24-DEC-2007. The biopsy determined the skin condition was orthokeratosis. The patient was given prednisone and BENADRYL for the orthokeratosis and was recovered by 29-DEC-2007. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 2007 was vaccinated with her first dose of GARDASIL, 0.5 ml via injection. The patient did not experience any adverse event with her first dose. On approximately 04-JAN-2008 the patient received her second dose of GARDASIL, 0.5 ml via injection and fainted. On that same date, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning 20 - 27 year old females who were vaccinated with Gardasil. Subsequently 99% of her patients were saying that Gardasil vaccination is the most painful than any other vaccine. Patients were tearing up because the vaccination was so painful. The patient's outcomes were not reported. 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.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Nodule
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 27-DEC-2007 was vaccinated with GARDASIL. Subsequently the patient developed a sub curvecular node on the left hand where the shot was given. As of 11-JAN-2008 the patient had not recovered. Additional information has been requested. This is in follow up to reorts previously submitted on 2/14/2008 Initial and follow up information has been received from a nurse practioner concerning a 14 year old female who on 27-DEC-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL in the left arm. As of 11-Jan-2008 the patient had not recovered. On 11-JAN-2008 the patient developed subclavicular lymphadenopathy. The patient was seen and treated with AUGMENTIN and the  subclavicular lymphadenopathy "cleared". The patient recovered 18-AUG-2008. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Burning sensation, Dyspnoea, Swollen tongue
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no known allergies who on 09-JAN-2008 was vaccinated with Gardasil. There was no concomitant medication. On 09-JAN-2008, 10 minutes after receiving her first dose of the vaccine, the patient experienced anaphylactic reaction. She had a burning feeling in her stomach and head, her tongue started to swell, and she had difficulty breathing. The patient sought unspecified medical attention. The outcome of the patient was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information ahs been received from a nurse practitioner concerning a female who on 08-JAN-2008 was vaccinated in the left arm with the third dose of Gardasil. There was no illness reported that the time of vaccination. It was reported on 11-JAN-2008, that on an unspecified date, the patient developed a rash on her left arm after receiving her third dose of Gardasil. The rash extended from the injection site downward to the elbow and upward to the shoulder. The patient was examined in the office and prescribed Benadryl. No laboratory/diagnostic tests were performed. It was reported that on 11-JAN-2008, that the symptoms resolved after the patient started Benadryl but returned when the Benadryl was discontinued. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old male, with no medical history and no allergies, who on 27-DEC-2007 was vaccinated with a third dose of Rotateq. Concomitant vaccines included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of PREVNAR. On 27-DEC-2007 the patient experienced vomiting. On 31-DEC-2007 the patient recovered. No product quality complaint was involved. No other information was provided. This is one of two reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with no known allergies who was vaccinated with Gardasil.  There was no concomitant medication.  Subsequently the patient experienced arm swelling at injection site.  The patient sought unspecified medical attention.  The outcome of the patient was not reported.  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) with a history of fainting when receiving vaccines and having blood drawn who was vaccinated (date, route and site not reported) with the 1st dose of Gardasil (lot# not reported).  The patient fainted after receiving the 1st dose of Gardasil.  The patient received unspecified medical attention and recovered.  No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 23 year old female with no pertinent medical history or drug reactions/allergies who on 11-JAN-2008 was vaccinated with her first dose of Gardasil (659439/1267U), 0.5mL intramuscularly.  There was no concomitant medication.  The patient experienced dizziness after the injection and stated that she felt "hot inside".  The patient was observed in the office for 20 minutes after the injection and then was released.  The patient then continued on to work.  She had called the office back an hour later stating that she was still "having that feeling".  Medical attention was sought, in the office and by telephone.  No lab diagnostics were performed.  The patient's outcome was not provided.  The product quality complaint unit was not involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with her first dos of Gardasil early in the day and around 9 p.m. she developed a rash all over her body. When she was seen by the doctor he sent her to a hospital. The patient's outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an infant patient who was vaccinated with unknown doses of Rotateq. It was reported that the patient did not complete the series of vaccination. The physician also reported that after receiving the vaccine the patient had developed rotavirus. A diagnostic laboratory test was undertaken which came back positive for rotavirus. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 21-week-old female with no medical history or allergies who on 12-JUL-2007, 28-SEP-2007 and 20-NOV-2007 was vaccinated orally with her first, second and third dose of Rotateq (lot# 656393/0240U, 657520/0670U, and 657669/1393U), respectively. There was no concomitant medication. After the second dose of Rotateq the patient developed loose, liquid stools 3-4 times a day on 28-SEP-2007. The patient's parents called the physician's office and reported that no blood was noted. It was reported that the patient recovered and received the third vaccination. No problems were noted with the first or third vaccinations. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008. Additional information has been received indicating that the "child is fine. Had no blood in stool." Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from an 18 year old female consumer, who on an unspecified date was vaccinated with the second dose of Gardasil (lot # not reported). The consumer reported "I got very sick just after I received my second Gardasil shot." The outcome and duration of the event were not specified. The consumer did not seek medical attention. No further information is available.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 19-week-old male with no medical history or allergies who on 03-DEC-2007 was vaccinated PO with the second 2.0 mL dose of ROTATEQ. There was no concomitant therapy. The CMA reported that on 05-DEC-2007, the patient developed diarrhea. No laboratory/diagnostic tests were performed as medical attention was not sought. The patient's diarrhea subsequently resolved without treatment. No other symptoms were reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Haematology test, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 22 year old female who on 21-JUN-2007 was vaccinated with her first dose of Gardasil.  Concomitant therapy included ORTHO-CYCLEN.  On 27-DEC-2007 the patient was vaccinated with her third dose of Gardasil (lot# 659055/1522U).  On 08-JAN-2008 the patient experienced severe joint pain in lower extremities, pain in her ankle and in her foot.  The patient's severe joint pain in lower extremities, pain in her ankle and in her foot persisted.  She saw her family physician who told her to take ibuprofen (ADVIL).  She also had blood work done.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Headache, Laboratory test, Pyrexia, Vaccine positive rechallenge, Vaginal discharge
Clinical narrative: Information has been received from consumer concerning her daughter who on 18-JUN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included varicella vaccine live, for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included hepatitis A virus vaccine (unspecified) and "NEASCTRA" as reported. On approximately 18-JUN-2007 the patient experienced a fever, headaches, vaginal sores and vaginal infection that was kind of like a yeast infection with heavy discharge and vaginal itchiness. The patient was checked fro STD's, including herpes, but it was all negative. In September the patient was vaccinated with her second dose of GARDASIL only and she had the same reaction as the first vaccination. Both times she was treated with antibiotics. The patient's fever, headaches, vaginal sores and vaginal infection persisted. The patient was scheduled to receive the third dose on 03-JAN-2008, but she has mononucleosis. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Vaginal infection, Vaginal lesion, Vulvovaginal pruritus
Clinical narrative: Information has been received from consumer concerning her daughter who on 18-JUN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included varicella vaccine live, for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included hepatitis A virus vaccine (unspecified) and "NEASCTRA" as reported. On approximately 18-JUN-2007 the patient experienced a fever, headaches, vaginal sores and vaginal infection that was kind of like a yeast infection with heavy discharge and vaginal itchiness. The patient was checked fro STD's, including herpes, but it was all negative. In September the patient was vaccinated with her second dose of GARDASIL only and she had the same reaction as the first vaccination. Both times she was treated with antibiotics. The patient's fever, headaches, vaginal sores and vaginal infection persisted. The patient was scheduled to receive the third dose on 03-JAN-2008, but she has mononucleosis. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Vomiting, Weight decreased
Clinical narrative: Information has been received from a physician concerning an 18 week old male with no pertinent medical history or drug allergies who on 16-NOV-2007 and 21-JAN-2008 was vaccinated with his first and second doses of ROTATEQ (lot# not provided).  There was no concomitant medication.  On 24-JAN-2008 the patient experienced vomiting and diarrhea.  On approximately 25-JAN-2008 the patient also experienced mild dehydration and lost one pound.  The physician stated that the patient appeared to be becoming worse.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a physician concerning an 18 week old male with no pertinent medical history or drug allergies who on 16-NOV-2007 and 21-JAN-2008 was vaccinated with his first and second dose of ROTATEQ (lot not provided). There was no concomitant medication. On 24-JAN-2008 the patient experienced vomiting and diarrhea. On approximately 25-JAN-2008 the patient also experienced mild dehydration and lost one pound. The physician stated that the patient appeared to be becoming worse. There was no product quality complaint. Follow-up information from the reporting physician indicated that the 18 week old male has a typical acute viral gastroenteritis that started on 24-JAN-2008 with symptoms of vomiting, diarrhea, mild dehydration and loss of one pound. There was no illness at the time of vaccination. There was no testing for rotavirus done or any other laboratory or diagnostic studies. The patient recovered well after 2 weeks. It was also noted that the event "may have been coincidental by chance." Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with two doses of Gardasil and vomited after both doses.  The third dose has not been given yet, but it will be given.  The patient sought medical attention by staying at the physician's office.  Her outcome was not reported.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Induration, Local reaction, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 10 year old female who in January 2008 was vaccinated with her first dose of 0.5 ml Gardasil.  The patient developed a localized arm reaction.  The affected area was 8" on her upper deltoid and involved swelling and induration.  The patient was treated with diphenhydramine hydrochloride (BENADRYL) and unspecified anti-inflammatories.  The patient did not experience any systemic reactions.  No other details were available.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 92 day old patient who has vaccinated with the first dose of ROTATEQ. The patient sought medical attention in the physician's office. There was no product quality complaint. No other information noted. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Accidental exposure, Diarrhoea
Clinical narrative: Information has been received from a male physician who reported after he administered ROTATEQ physician will get 3 loose stools afterwards.  Unspecified medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Feeling hot, Nausea, Swollen tongue, Syncope
Clinical narrative: Information has been received from a consumer, via a company representative, regarding the consumer's 19 year old daughter (also the niece of the representative), with no pertinent medical history, who on 10-JAN-2008 was vaccinated with the first dose of Gardasil (lot # not reported).  There was no concomitant medication.  Approximately 10 or 15 minutes after the vaccination, the consumer's daughter experienced nausea, swelling of the tongue, and her ears "felt steaming in heat."  She also fainted.  The mother reported that her daughter's blood pressure also dropped (value not provided).  Her daughter was given "a large dose" of diphenhydramine (BENADRYL), and the swelling of the tongue "subsided."  At the time of this report, the outcome of the events was unknown.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Initial and follow up information has been received from a healthcare professional, concerning a 22 year old caucasian female patient, with allergies to penicillin, amoxicillin and cefaclor (CECLOR) and a recent unspecified infection with azithromycin (Z-PAK) completed just prior to vaccination, who on 11-JAN-2008 was vaccinated IM, with the first dose, 0.5 ml, of GARDASIL (lot #659055/1522U). Concomitant therapy included YASMIN. After the vaccination, the patient experienced dizziness and lightheadedness. She was placed in a reclined position and observed for 30 minutes, and was then able to leave. However, later in the day, she called to report that she was still dizzy, lightheaded, nausea, and she had a low grade fever (temperature not taken with thermometer). On 14-JAN-2008, the patient felt better and had recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Neck pain
Clinical narrative: Information has been received from a office manager concerning a 23 year old female who on 19-DEC-2007 was vaccinated (route and site not reported) with the 1st dose of GARDASIL (lot# not reported). The patient was not on any concomitant medications. On 19-DEC-2007, a couple of hours post vaccination, the patient developed pain in injection site arm, the pain went all the way up to her neck. The patient was given ibuprofen (manufacturer not specified) but it did not work. The patient contacted her family practitioner and was given VICODIN (manufacturer not specified) and that worked for the pain. No lab diagnostic test were performed. The patient received medical attention via a call to the clinic. The patient recovered on unknown date. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2008.  Information has been received from an office manager concerning a 23 year old female who on 19-DEC-2007 was vaccinated (IM in deltoid) with the 1st dose of GARDASIL (lot# 558563/1063U).  The patient was not on any concomitant medications.  On 19-DEC-2007, a couple of hours post vaccination, the patient developed pain in injection site arm, the pain went all the wasy up to her neck.  The patient was given IBUPROFEN (manufacturer not specified) but it did not work.  The patient contacted her family practitioner and was given VICODIN (manufacturer not specified) and that worked for the pain.  No lab diagnostic test were performed.  The patient received medical attention via a call to the clinic.  The patient recovered on 21-DEC-2007.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, PER
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning an 11 year old female who in January 2008 was vaccinated with GARDASIL. Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. The physician reported that almost immediately after the vaccination the patient experienced "dizziness and felt like she was going to faint". No lot number was provided and no further information was provided. The physician reported that the patient was fine after waiting a little while. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old female with gastrooesophageal reflux who on 25-JAN-2008 was vaccinated PO with her first 2.0 ml dose of ROTATEQ (lot# 657673/0904U) and vomited immediately after. Medical attention was sought via physician's office. The outcome was unknown. There was no product quality complaint. Additional information has been requested. 02/11/2010 Follow-up information from the reporting physician concerning a 9 week old female who on 23-JAN-2008 was vaccinated PO with her first dose of GARDASIL (lot# 657673/0904U). There was to illness at the time vaccination. Concomitant vaccinations administered on that same day included the first IM dose of PEVENAR (lot#041339), the first IM dose of RECOMBIVAX HB and (DAPTACEL) (lot# C2933AB) and first IM dose of (IPOL) (lot# A047U). Immediately after the dose of GARDASIL (lot # 657673/0904U) the patient vomited and subsequently removed immediately after immediately after dose. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 23-JAN-2008 was vaccinated PO with her first 2.0 ml dose of ROTATEQ (lot# not available).  On 25-JAN-2008 the patient experienced severe vomiting and diarrhea that led to dehydration.  Per physician, the patient was brought to the Emergency Room to seek rehydration therapy on that same day, but was not admitted to the hospital.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old (gender unknown) patient who was vaccinated with the first dose of ROTATEQ.  Subsequently the patient experienced 10 days of persistent diarrhea.  Subsequently, the patient recovered on the 11th day after vaccination.  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Dermatitis diaper
Clinical narrative: Information has been received from a physician concerning an approximately 4 month old male who was vaccinated PO with his first and second dose of ROTATEQ (lot# 657661/0973U). Subsequently the patient experienced "wicked diaper rash." The patient did not seek medical attention. The outcome was unknown. The physician reported that the patient's mother decided to finish the series with the third oral dose of ROTATEQ (lot# unavailable), but was not sure if the patient experienced the diaper rash again. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Culture stool, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 2 month old female who was vaccinated PO with her first 2.0 ml dose of ROTATEQ.  Subsequently "24 hours after vaccination, the patient became febrile, fussy and developed severe diarrhea."  The patient sought unspecified medical attention and was subsequently "admitted to the hospital for 2 days."  A stool specimen was performed.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 month old patient and twin sibling (WAES# 0802USA00512) who on 14-JAN-2008 was vaccinated PO with the third dose of ROTATEQ (lot# 657516/1128U).  The patient did not seek medical attention.  No symptoms were noted.  There was no product quality complaint.  This is one of several reports from the same source.  Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 month old patient and twin sibling (WAES# 0802USA00297) who on 14-JAN-2008 was vaccinated with the third dose of ROTATEQ (lot# 657516/00512). The patient did not seek medical attention. No symptoms were noted. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: RV5, UNK
Symptoms: Crying, Irritability
Clinical narrative: Information has been received from a health professional concerning a 6 to 12 week old female with gastrooesophageal reflux disease who was vaccinated with a first 2 ml oral dose of ROTATEQ.  Concomitant therapy included "other recommended vaccines at two months of age".  Subsequently the patient experienced fussiness and crying for about 24 hours after receiving ROTATEQ.  Subsequently, the patient recovered.  Medical attention was not sought.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anticipatory anxiety
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Per the reporter, "the patient who already received the first dose of GARDASIL came in to the office with anticipatory anxiety about receiving the rest of the series of GARDASIL. The patient did not mention any side effects after receiving the first dose of GARDASIL, but for some reason she is having anxiety about receiving the rest of the series." The patient sought unspecified medical attention. No further AE information is available. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who in November 2007, was vaccinated with Gardasil.  Per the reporter, the patient was inadvertently vaccinated in the arm, unknown which arm, with Gardasil.  Subsequently, the patient experienced incorrect vaccine administered and inappropriate age.  The patient sought unspecified medical attention in the physician's office.  No other information was available.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 20 year old female who in 2007 was vaccinated with the second dose of GARDASIL. On 31-DEC-2007 the patient experienced pain at the injection site, swelling at the injection site and redness at the injection site. The patient sought unspecified medical attention. No further information was available an no lot number was provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 25-JUL-2007 was vaccinated IM in the left deltoid with the first dose of Gardasil (lot# not reported).  On 25-SEP-2007 the patient was vaccinated IM in the right deltoid with the second dose of Gardasil (658560/1062U).  Subsequently the patient experienced localized redness at the injection site.  The patient did not have any shortness of breath, pain or other symptoms.  On 07-JAN-2008 the patient came to the clinic for her son's visit and had a small, white circle around the injection site.  It is not itchy or painful and there are no other problems.  There were no problems reported following the first vaccination with Gardasil.  No other information is available.  Additional information has been requested. Additional information received from B-form (17-MAR-2008): the patient stated that she had a "ring" on her arm - no raising, no itching. Pain was present post-injection for the initial day and then there was no more pain. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy muscle, Myofascitis
Clinical narrative: Information has been received from a physician concerning a 22 year old female with a history of sulfonamide allergy, penicillin allergy and Levaquin allergy on 22-JUN-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 657868/0523U). Concomitant therapy included hormonal contraceptives (unspecified). The patient received a second dose of GARDASIL (lot# 654539/0742U). Subsequently the patient experienced macrophagic myofascitis about two weeks after being vaccinated. The physician states that the patient has been treated with corticosteroids and has improved. The patient had a muscle biopsy and sought medical attention in the office. Therapy was discontinued. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cardiac monitoring, Haematology test, Night sweats, Syncope, Syncope vasovagal
Clinical narrative: Information has been received from a consumer concerning her daughter who in approximately April 2007, was vaccinated with her first dose of GARDASIL. A couple weeks after the first vaccination the daughter began to experience vasovagal syndrome, vomiting, and fainting. Her daughter received all three doses of GARDASIL and the AE worsened after each vaccination. She has also had night sweats. The daughter is home bound and cannot attend school. The third vaccination was given in November 2007. The patient has not recovered. She has had blood work, other unknown tests and a heart monitor. She has sought medical attention in the doctors office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a consumer concerning her daughter who in approximately April 2007, was vaccinated with her first dose of GARDASIL. A couple weeks after the first vaccination the daughter began to experience vasovagal syndrome, vomiting, and fainting. Her daughter received all three doses of GARDASIL and the AE worsened after each vaccination. She has also had night sweats. The daughter is home bound and cannot attend school. The third vaccination was given in November 2007. The patient has not recovered. She has had blood work, other unknown tests and a heart monitor. She has sought medical attention in the doctors office. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Erythema, Nausea, Rash macular
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 14-JAN-2008 was vaccinated intramuscularly with the first dose of Gardasil (655327/1287U).  On 15-JAN-2008 the patient experienced dizziness, nausea, diarrhea and a red, blotchy, itchy rash to her upper torso.  The patient's dizziness, nausea, diarrhea and red, blotchy, itchy rash to her upper torso persisted.  The patient sought unspecified medical attention.  No other information is available at this time.  Follow up AE info (17-JAN-2008):  The representative called to make sure that this AE was reported.  No further information was provided.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 14-JAN-2008 was vaccinated intramuscularly with the first dose of Gardasil (655327/1287U).  On 15-JAN-2008 the patient experienced dizziness, nausea, diarrhea and a red, blotchy, itchy rash to her upper torso.  The patient's dizziness, nausea, diarrhea and red, blotchy, itchy rash to her upper torso persisted.  The patient sought unspecified medical attention.  No other information is available at this time.  Follow up AE info (17-JAN-2008):  The representative called to make sure that this AE was reported.  No further information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Convulsion, Electrocardiogram, Gaze palsy, Immediate post-injection reaction
Clinical narrative: Information has been received from a nurse at an OB/GYN office concerning a 15 year old female who in January 2008, was vaccinated with a first dose of Gardasil at her pediatrician's office.  Post vaccination, the patient fainted almost immediately.  The patient also experienced the "seizure like symptoms" of uncontrollable shaking and eyes rolling back in her head for approximately 20 seconds.  Subsequently, the patient recovered and was sent home approximately 3 hours later.  It was reported that an electrocardiogram and blood work were performed (no results provided).  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Information has been received from a nurse at an OB/GYN office concerning a 15 year old female who in January 2008, was vaccinated with a first dose of Gardasil at her pediatrician's office.  Post vaccination, the patient fainted almost immediately.  The patient also experienced the "seizure like symptoms" of uncontrollable shaking and eyes rolling back in her head for approximately 20 seconds.  Subsequently, the patient recovered and was sent home approximately 3 hours later.  It was reported that an electrocardiogram and blood work were performed (no results provided).  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Malaise
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of GARDASIL. Per the reporter, the patient experienced a bad rash at the injection site that lasted a few days and felt ill. Subsequently, the patient recovered from the bad rash at the injection site and feeling ill. The patient sought unspecified medical attention. The patient's mother decided that the patient would not go on to receive the second and third doses. No further information was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dry skin, Eczema, Pruritus, Rash, Skin burning sensation
Clinical narrative: Information has been received from a health professional concerning a 20 year old white female with sinusitis and no known drug allergies, who on 04-JAN-2008 was vaccinated IM in the left deltoid (previously mentioned as in the right arm) with GARDASIL (lot#658219/0755U). Concomitant therapy included MOTRIN, DURAPHEN FORTE and ZITHROMAX. In January 2008, the patient experienced red itchy hands. Two days after the vaccination the patient developed red itchy hands. She stated that when the patient applies lotion to her hands they burn and "feel like they are on fire". Follow up information indicated that the patient experienced dry red hands on 05-JAN-2008 (left worse than right) looked like eczema. A steroid cream was given for hands. The patient's outcome was unknown. No product quality complaint was involved.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a third dose of Gardasil.  It was reported that the patient received all three doses in her bottom.  It was reported that the patient experienced sore gluteus muscle after the vaccination in the gluteus muscle.  Physician did not specify which vaccination caused the soreness.  It was unknown whether medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. 07/08/08 Follow up information indicated that the patient received all 3 doses in the gluteus muscle. The physician did not know whether the patient received adequate dose IM. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Dizziness, Dizziness, Feeling hot, Nausea, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with Gardasil.  It was not known if this was the first, second or third dose.  Subsequently the patient felt dizzy and had to be kept in the examination room for 25 minutes until she recovered.  The patient sought unspecified medical attention.  Per the reporter, the patient has had the same reaction to other vaccines, but the identity of those vaccines was unknown.  Additional information has been requested. 02/10/2010 Follow up information received on B-form (26-FEB-2008): Per the reporter, within a few minutes after receiving the vaccines, the patient complained of feeling faint, hot, nauseous. The patien's color was gray and blood pressure was 110/70. The patient continued to feel weak and dizzy. The physician came to see the patient. The exam was normal and the patient was diagnosed with a syncopal episode post -injection. The patient's blood pressure was 109/72 and pulse was 67. The patient was allowed to rest until the symptoms subsided.  This is in follow-up to report(s) previously submitted on 2/14/2008; 4/7/2008. Information has been received from a physician concerning a 19 year old female with a history of AMOXIL allergy who on 11-JAN-2008 was vaccinated IM with the first dose of GARDASIL (659439/1267U) (duration and dose not reported)(Lot# reported as 1462U). Other concomitant therapy included HAVRIX (GSK) (AHAVB225AA). On 11-JAN-2008 the patient experienced syncopal episode. Subsequently, the patient recovered from syncopal episode.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with Gardasil.  It was not known if this was the first, second or third dose.  Subsequently the patient felt dizzy and had to be kept in the examination room for 25 minutes until she recovered.  The patient sought unspecified medical attention.  Per the reporter, the patient has had the same reaction to other vaccines, but the identity of those vaccines was unknown.  Additional information has been requested. 02/10/2010 Follow up information received on B-form (26-FEB-2008): Per the reporter, within a few minutes after receiving the vaccines, the patient complained of feeling faint, hot, nauseous. The patien's color was gray and blood pressure was 110/70. The patient continued to feel weak and dizzy. The physician came to see the patient. The exam was normal and the patient was diagnosed with a syncopal episode post -injection. The patient's blood pressure was 109/72 and pulse was 67. The patient was allowed to rest until the symptoms subsided.  This is in follow-up to report(s) previously submitted on 2/14/2008; 4/7/2008. Information has been received from a physician concerning a 19 year old female with a history of AMOXIL allergy who on 11-JAN-2008 was vaccinated IM with the first dose of GARDASIL (659439/1267U) (duration and dose not reported)(Lot# reported as 1462U). Other concomitant therapy included HAVRIX (GSK) (AHAVB225AA). On 11-JAN-2008 the patient experienced syncopal episode. Subsequently, the patient recovered from syncopal episode.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning multiple patients who were vaccinated with GARDASIL. Some of the patients experienced injection-site pain especially after the 2nd dose. Unspecified medical attention was sought. Subsequently, the patients recovered from injection-site pain. No other information was provided. This is one of several reports received from the same source. Additional information has been requested.