chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 15 year old female with sulfonamide allergy who on 14-Dec-2006 was vaccinated with a first dose of Gardasil vaccine (yeast) (lot#653650/0697F) pre-filled syringe IM into the left deltoid. Concomitant vaccination on 14-Dec-2006 included a dose of influenza virus vaccine (unspecified) (manufacturer unknown). On 14-Dec-2006 the patient experienced broke out in rash all over her body. There was no fever associated with the rash. It was unclear if there was any local rash or reaction at the injection site. At the same visit the patient was given amoxicillin for an unknown reason. As of 15-Dec-2006 the rash persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Full blood count normal, Injection site pain, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 20 year old female with an allergy to antibiotics who on 16-Nov-2006 was vaccinated with a first dose of Gardasil vaccine (yeast). On 17-Nov-2006 the patient developed pain at the injection site. The patient began to have joint pain throughout her body. The location of the joint rotated and was in her right knee at the time of this report. Laboratory evaluations revealed that erythrocyte sedimentation rate and complete blood count were normal. The patient was to be seen by a neurologist. The physician reported that she would most likely hold off on the second dose of Gardasil vaccine (yeast). At the time of this report, the patient's joint pain persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a physician concerning a 20 year old female with an allergy to antibiotics who on 16-NOV-2006 was vaccinated with a first dose of GARDASIL.  On 17-NOV-2006 the patient developed pain at the injection site.  The patient then began to have joint pain throughout her body.  The location of the joint rotated and was in her right knee at the time of this report.  Laboratory evaluations revealed that erythrocyte sedimentation rate and complete blood count were normal.  The physician reported that the patient was seen by a rheumatologist, but she did not have the details of the visit.  The physician reported that the patient cancelled her appointment to received her second dose of GARDASIL.  At the time of this report, the patient's joint pain persisted.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Upper respiratory tract infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with gastric reflux who on 17-Oct-2006 was vaccinated IM with a first dose of Gardasil vaccine (yeast) (lot#653735/0688F). Concomitant therapy included Nuvaring and Aciphex. That evening the patient experienced quite a bit of nausea and a headache. It was noted that the patient couldn't study. On 18-Oct-2006, the nausea was gone. The patient thought that her headache was due to new contacts. On 19-Oct-2006, the patient's headache went away after she took her contacts out. One month later the patient experienced a upper respiratory infection but the nurse practitioner did not think it was related to the vaccine. Unspecified medical attention was sought. No diagnostic laboratory studies were involved. At the time of this report the outcome of upper respiratory infection was unknown. No product quality complaint was involved. Additional information has been requested. The patient stated that the nausea was a small price to pay for protection. On 18-Dec-2006, the patient was vaccinated into the left deltoid with a second dose of GARDASIL (lot# 654885/1424F). No product quality complaint was involved. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: HPV4
Symptoms: Drug hypersensitivity, Face oedema, Lip swelling, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female with an allergy to benzoyl peroxide who on 11-Dec-2006 was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast). Concomitant therapy included Yasmin. On 14-Dec-2006 the patient began to experience muscle aches, and on 17-Dec-2006 the patient began experiencing swelling of her face and lips, but no rash. The patient treated herself with Benadryl and was scheduled to see her physician on 18-Dec-2006. At the time of this report, the muscle aches and swelling of her face and lips persisted. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 19 year old female with no persistent medical history or drug reactions/allergies, who on 15-Dec-2006 was vaccinated with Gardasil vaccine (yeast) (0.5 ml). There was no concomitant medication. On 15-Dec-2006, following vaccination, the patient developed a red itchy rash "all over". Unspecified medication attention was sought. At the time of this report the patient had not recovered. No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a female patient (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Subsequently the patient experienced a missed menstrual period. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the missed menstrual period. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: Information has been received from a nurse concerning a 24 year old female with a history of panic attacks who on 07-Nov-2006 was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast) (lot#653938/0954F). Concomitant therapy included Asacol. On 07-Nov-2006 later that night, the patient experienced tachycardia and difficulty breathing. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a nurse concerning a 24 year old female data assistant with Crohn's disease and allergies to CLINDAMYCIN and CODEINE a history of panic attacks who on 07-NOV-2006 at 14:30 was vaccinated into the right deltoid with first a 0.5 ml dose of GARDASIL (lot # 653938/0954F).  Concomitant therapy included ASACOL.  On 07-NOV-2006 later that night, the patient experienced tachycardia and difficulty breathing.  No other symtoms were noted.  Unspecified medical attention was sought.  On 08-NOV-2006, the patient recovered.  No product quality complaint was involved.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Pain, Sciatic nerve injury, Sciatica
Clinical narrative: SCIATICA; DRUG ADMINISTERED AT INAPPROPRIATE SITE. Information has been received from a nurse practitioner concerning a female patient who on 19-DEC-2006 was vaccinated IM into the dorsogluteal muscle with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medications. On 19-DEC-2006, the patient experienced sciatic nerve pain (noted that when the patient was vaccinated the sciatic nerve was hit).  The pain went up her back and then it crossed over to the middle onto the left back. The pain occurred right after the injection.  It was noted that there was no bruising or inflammation. Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  At the time of this report, the patient had not recovered. No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a clinical coordinator at a doctor's office concerning a female who was vaccinated with a first and second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml).  Subsequently, the patient fainted after receiving both doses. The patient recovered. There were no relevant diagnostic test or laboratory data.  Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Information has been received from a consumer concerning her 53 year old father with liver problems and no drug allergies who on 22-NOV-2006 inadvertently received HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml), orally. There was no concomitant medication.  Subsequently, "in late November" the patient experienced nausea, dizziness and weakness.  At the time of the report, the patient had not recovered.  There were no relevant diagnostic tests or laboratory data.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning her 20 year old daughter with no medical history or allergies, who on 18-DEC-2006 was vaccinated IM with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication. On 18-DEC-2006, the patient experienced throbbing pain in her arm.  Unspecified medical attention was sought. No diagnostic studies were performed.  At the time of this report, the patient's pain was subsiding. No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning a 17 year old female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL, injection. concomitant medication was not reported.  Subsequently on an unspecified date, the patient fainted after she received the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sough unspecified medical attention.  The office manager stated that the patient did not have anything to eat prior to receiving the injection.  Subsequently on an unspecified date, the patient recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL, injection.  Concomitant medication was not reported.  Subsequently on an unspecified date, the patient developed a rash while being administered HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sough unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a nurse concerning a 19 year old female patient with asthma, depression and allergies to valproate sodium, diazepam, gabapentin and acetaminophen (+) butalbital (+) caffeine who on 18-DEC-2006 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLF vaccine (yeast), 1pt #654540/1161F.  Concomitant therapy included montelukast sodium (MSD), escitalopram oxalate, lansoprazole, and metoprolol succinate.  On 20-DEC-2006 the patient called the office and stated that the injection site was itchy. Medical attention was sought.  The physician's office to follow up with patient, her outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pain
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 14 year old female who in "early" December 2006, was vaccinated with Gardasil. There was no concomitant medication. Subsequently in "early" December 2006, the patient experienced flu-like symptoms and pain for about 4 days after injection. The sought unspecified medical attention. No diagnostics were performed.  Subsequently, in "mid-December" the patient recovered from flu-like symptoms and pain for about 4 days after injection.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a clinical manager concerning a female who on "13-DEC-2006 or 14-DEC-2006" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). On 13-DEC-2006, or 14-DEC-2006, the patient fainted almost immediately after receiving the vaccination.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who in approximately December 2006, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast).  In approximately December 2006, when administering the vaccine with the prefilled syringe, the nurse release the spring before removing the syringe, therefore causing the patient pain at the injection site. No additional information was available at the time of reporting. No further information is available. This is in follow-up to report(s) previously submitted on 1/16/2007. Additional information was received from the registered nurse via telephone who reported that the patient received the full dose of the GARDASIL. No additional information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female with pertinent medical history and drug reaction/allergies not reported who on an unspecified date was vaccinated with the initial dose of Gardasil injection. Concomitant medication was not reported. In December 2006 ( a few weeks ago), the patient fainted after Gardasil was administered. The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female who had hypersensitivity reported as "Motrin for allergies". On 19 Dec 2006, the patient was vaccinated intramuscularly with the firs "single dose vial" of Gardasil (Lot # 653938/0954F). Concomitant therapy included Motrin, Desogen, Allegra and Zantac. On 19 Dec 2006, "almost immediately after vaccination", the patient became a little flushed in the face and had to take a minute to sit and gather herself together. The patient was noted to have a blood pressure of 101/65 mmHg (date unknown). The patient sought unspecified medical attention. It was reported that the patient" improved within seconds". On 19 Dec 2006, the patient had recovered from the event. The licensed practical nurse reported that they were planning to vaccinate for the second and third dose as indicated in the "PI". Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a licensed practical nurse concerning a 20 year old female who had hypersensitivity reported as MOTRIN for allergies" and no illness at the time of vaccination.  On 19-Dec-2006, the patient was vaccinated intramuscularly with the first "single dose vial" of GARDASIL (Lot # 653938/0954F).  Concomitant therapy included MOTRIN, DESOGEN, ALLEGRA and ZANTAC.  On 19-DEC-2006, "almost immediately after vaccination", the patient became a little flushed in the face, experienced dizziness, and had to take a minute to sit and gather herself together.  The patient was noted to have a blood pressure of 101/65 mmHg (date unknown).  Vital signs taken were very similar to those taken during the exam.  It was reported that the patient "improved within seconds".  On 19-DEC-2006, the patient had recovered from the event and left the office without further incident.  The licensed practical nurse reported that they were planning to vaccinate for the second and third dose as indicated in the "PI".  No additional information is expected.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness postural, Headache
Clinical narrative: Information has been received from a physician concerning an 18 year old white female who on 27 Nov 2006 was vaccinated with Gardasil (lot number 653650/0641F). Concomitant therapy on 27 Nov 2006 included Fluvirin. On 01 Dec 2006 the patient experienced dizziness with walking or standing. On 02 Dec 2006 the patient experienced headache on top of her head. Subsequently, the patient recovered from dizziness with walking or standing and headache on top of her head. A prescription treatment was given for the experiences (not specified). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Pain
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently, following vaccination, the patient experienced pain and a burning sensation in the arm. Unspecified medical attention was sought. At the time of this report, the patient's pain and burning sensation in the arm persisted. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Pain
Clinical narrative: Information has been received from a pharmacist and a 25 year old female patient with sulfonamide allergy reporting that on 18 Dec 2006 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Lexapro. Four days later, on approximately 22 Dec 2006, the patient developed painful genital warts. The patient's painful genital warts persisted and she sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Herpes virus infection
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on 25 Aug 2006 was vaccinated with a first dose of Gardasil, intramuscularly. Subsequently the patient developed a herpes virus infection. The patient's pediatrician had concluded that the infection was not due to Gardasil. It was also reported that the patient's second dose was delayed because some time after the first dose, because she developed the herpes virus infection. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a female patient (age not reported) who on an unspecified date was vaccinated with the initial dose of Gardasil. Concomitant medication was not reported. In December 2006, the patient experienced really bad diarrhea after receiving the first dose of Gardasil. The outcome of the event was not reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, the patient almost fainted immediately after receiving Gardasil. The nurse at the physician's office stated that the girl seemed "afraid of needles." The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Lymphadenopathy, Nausea, Pharyngolaryngeal pain, Vomiting
Clinical narrative: Information has been received from a physician via a company representative concerning a female (age not reported) who, on an unspecified date, was vaccinated with a first dose o Gardasil (Lot # not reported). The physician reporeted that after the first dose, the patient experienced nausea, diarrhea and vomiting. The physician also reported that after the second dose of Gardasil, the patient experienced a sore throat and swollen glands. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 20 Dec 2006 was vaccinated with a first dose of Gardasil. On 24 Dec 2006, the patient developed a full body rash. The patient did not seek medical attention for her experience. At the time of this report, the patient had not recovered. Additional information has been requested. 5/14/2010 Follow up: The patient was seen in the emergency room. A physician in the emergency room indicated that it did not look like a vaccine reaction. The physician prescribed prednisone for the rash. The rash resolved overnight. The patient subsequently recovered on 25-DEC-2006 or 26-DEC-2006. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a female pharmacist who was vaccinated IM with a second dose of Gardasil. The pharmacist reported that she did not feel the second injection. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient who on 22 Nov 2006 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 22 Nov 2006, the physician reported that the patient experienced reaction a "tendonitiis like" pain near the injection site. It was noted that there were no signs of cellulitis and the pain has not been responsive to OTC non-steroidal medication. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Rash
Clinical narrative: Information has been received from a 26 year old female pharmacist who on 27 Dec 2006 was vaccinated with a 0.5 mL dose of Gardasil. On 30 Dec 2006, the patient developed bumps on skin, located mainly on the back, sporadic on the chest, 5-6 noted, and also on belly: none on legs. The pharmacist reported that they were painful and "felt like bruises," The patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from the mother of an 11 year old female with an allergy to Rondec and migraines who on 25 Oct 2006 was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included an unspecified migraine therapy. The mother reported that her daughter received the second dose of Gardasil approximately 35 days after receiving the first dose. The mother was informed by her physician that it was "okay" and that the patient did not have to restart the series. The mother also reported that following the second vaccination, on 30 Nov 2006, her daughter experienced pain in the arm in which she was vaccinated. Unspecified medical attention was sought. The patient subsequently recovered from the pain on an unspecified date. Additional information has been requested. Conflicting information received from the patient's physician reported that there was no adverse reaction experienced. No addtional information is expected.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who on 27 Dec 2006 was vaccinated with a first dose of Gardasil concomitantly with a dose of influenza virus vaccine (unspecified) using a different injection site. On 27 Dec 2006, approximately  2 hours after the vaccination, the patient experienced swelling and numbness in her lower lip. On approximately 29 Dec 2006, the patient recovered without treatment. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a female who on approximately 27 Dec 2006 was vaccinated with a second dose of Gardasil. On approximately 27 Dec 2006 the patient developed swelling in the arm. The patient was treated with Benadryl. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from an office manager concerning a 16 year old female who on 04 Dec 2006 was vaccinated IM, into the left deltoid, with 0.5 ml second dose of Gardasil (lot #653736/0868F). On 05 Dec 2006 the patient developed an itchy rash on her arm. The patient was treated with Benadryl and the rash was gone the on the night of 05 Dec 2006. On 06 Dec 2006, the patient recovered. The office manger reported that there was no adverse reaction after the patient's first dose of Gardasil. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a teenage female who on 04 Dec 2006 was vaccinated with the second dose of Gardasil (lot#653736/0868F), IM injection. Concomitant medication was not reported. On 05 Dec 2006, the patient developed a rash on her forearms. The physician reported that the patient was seen by another physician in the office, who prescirbed Benadryl to treat the rash. The outcome of the event was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from an RN concerning a 21 year old female patient who on 23 Oct 2006 was vaccinated IM with her first dose of Gardasil, lot #654540/1162F. On approximately 27 Dec 2006 the patient was vaccinated with her 2nd dose of Gardasil. On 27 Dec 2006 the patient developed a painful injection site after vaccination and also developed a red rash going up and then down her arm and around the injection site. She was given Benadryl and advised to keep an ice pack on it for the rest of the day. As of the report date the patient was recovering. Additional information has been requested. Follow up information has been received concerning the female patient who on 05-DEC-2006 at 1:30 p.m. was vaccinated IM in Left arm with her second dose of GARDASIL, lot # 654540/1162F. On the same day (not 27-DEC-2006 as previously reported), after the vaccination, the patient's arm became red at the site of injection. Within 5 minutes the redness traveled up her arm and down to her elbow. A rash appeared. The area was warm to touch and painful. BENADRYL 25 mg PO was given. The patient's arm remained sor for seven days. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on 20-Oct-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included Ortho Evra. On 19-Dec-2006 the patient was diagnosed with mononucleosis by her primary care physician. The patient sought unspecified medical attention. At the time of this report the patient's mononucleosis persisted. The reporter felt that the mononucleosis was not related to therapy with Gardasil vaccine (yeast). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 01-Dec-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided).On unspecified date in December, 2006, the patient separate two periods (dates not provided). The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 19 year old female with a hypersensitivity to "sepna" who on an unspecified date was vaccinated (at another unspecified physicians office) with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included naproxen sodium (Aleve) and ibuprofen. Subsequently, the patient reported that she experienced itching and swelling at the injection site which spread to her body. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatitis acute, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast) (lot# not provided). Concomitant therapy included Strattera and Concerta. Subsequently, the patient presented to the reporting physicians office for her second dose of Gardasil vaccine (yeast) and the patient's mother reported that the patient had been diagnosed with "acute immune hepatitis". The physician reported that the patient was asymptomatic, looked fine and was not sick. The physician did not give the second dose of the vaccine at that time based on the report from the mother. The physician reported that she is watching the patient's liver function tests which have progressively risen to 70. The reporting physician felt that the auto immune hepatitis was not related to therapy with Gardasil vaccine (yeast). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Rash pruritic
Clinical narrative: Information has been received from an RN concerning a patient who has an allergic reaction after being vaccinated with a dose of Gardasil vaccine (yeast). The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Initial and follow up information has been received from an RN concerning a 16 year old female student who on 14-DEC-2006 at 5:00 P.M. was vaccinated IM in left deltoid with her second dose of GARDASIL, lot #653736/0868F.  The patient developed an allergic reaction after being vaccinated (onset reported as the morning of "05-DEC-2006"), an itchy rash on the inside of her arms.  She was treated with BENADRYL and recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a female who in approximately December 2006, was vaccinated with Gardasil vaccine (yeast). In approximately December 2006, when administering the vaccine with the pre-filled syringe, the nurse released the spring before removing the syringe, therefore causing the patient pain at the injection site. No additional information was available at the time of reporting. No further information is available. 5/14/2010 Follow up: Additional information has been received rom the registered nurse via telephone. The nurse reported that the patient received the full dose of GARDASIL. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil vaccine (yeast), 0.5 ml, injection. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash while being administered Gardasil vaccine (yeast). The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Subsequently the patient experienced a missed menstrual period. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the missed menstrual period. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: IPV, PNC, RV5
Symptoms: Body temperature increased, Pyrexia, Thirst decreased
Clinical narrative: Information has been received from a physician concerning an 18 week old male, with no medical history and no allergies, who on 30-Oct-2006, at 6:15 pm, was vaccinated with a second oral dose of Rotateq vaccine (human-bovine) (lot#654664/0726F). Concomitant vaccines administered at the same time included a first intramuscular dose of IPOL (Lot# 20306-2) and second intramuscular dose of Prevnar (lot#B08646C). There was no illness at the time of vaccination. On 31-Oct-2006, at about noon, the patient did not want to drink and had a fever of 102 F. The patient was seen in the office, and it was reported that the exam was normal. The patient's fever lasted 24 hours. It was reported that the patient recovered on 01-Nov-2006. Additional information has been requested.
Age: 0.07
Sex: M
Vaccine: RV5
Symptoms: Crying
Clinical narrative: Information has been received from a physician concerning a male child who on approximately 04-Oct-2006 was vaccinated with a dose of Rotateq vaccine (human-bovine). The physician reported that on approximately 04-Oct-2006, after receiving the vaccine, the patient would not stop crying. The child was sent to the hospital due to the non-stop crying. After three hours in the hospital waiting room, the child stopped crying. The child was subsequently seen by a physician and sent home. It was noted that the child "didn't have any medication and was not incapacitated. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, MMRV, PNC
Symptoms: Blood test, Body temperature increased, Laboratory test, Lumbar puncture, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 6 week old female who, "about one month ago", on approximately 01 Nov 2006, was vaccinated with a 2 ml oral first dose of Rotateq. Concomitant vaccines administered on the same day included a dose of Prevnar and a dose of Pediarix. "Later in the day", on approximately 01 Nov 2006, the patient experienced fever of over 103 degrees. The patient went to the emergency room and was hospitalized overnight. It was noted that the patient had a spinal tap and blood work done. The patient improved the next day and was sent home. The patient was considered to be recovered a couple of days after receiving Rotateq by the reporter. No product quality complaint was involved. The patient's experience was considered to be immediately life threatening and disabling. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Body temperature increased, Diarrhoea, Nasopharyngitis, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 10 week old male, with no allergies, who on 10-OCT-2006 was vaccinated with a first 2 ml oral dose of rotavirus GI G2 G3 G4 P1 reassortment vaccine live (human-bovine) (Lot# 654794/0776F). Concomitant therapy included ranitidine HCl for reflux and amoxicillin for an ear infection. It was reported that the patient was experiencing cold symptoms at the time of vaccination. On 11-OCT-2006 the patient experienced vomiting and diarrhea. It was reported that the physician was unsure if vomiting and diarrhea were definitely related to the vaccination with rotavirus reassortment vaccine live and indicated that it could have also been viral. It was reported that the patient's diarrhea stopped "6 days later", on 17-OCT-2006 the patient was vaccinated with a second dose of rotavirus reassortment vaccine live. Concomitant vaccinations administered on 04-DEC-2006 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, HIB conj-hepatitis B vaccine (MSD), a dose of poliovirus vaccine inactivated, and a dose of pneumococcal A vaccine. On 04-DEC-2006 the patient had cold symptoms and a fever of 100.4 during the evening. It was noted that there was no vomiting or diarrhea following the second dose of rotavirus reassortment vaccine live. At the time of the report the patient was still experiencing fever. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: HIBV, RV5
Symptoms: Condition aggravated, Diarrhoea, Irritability, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a registered nurse concerning a 2 month old female who was born at 40 weeks gestation, with a normal delivery and no perinatal complications, who had a history of vomiting since she was two weeks old and a family history of a mother with a strong history of colic, severe reflux as a baby, and was always admitted to the hospital, who on 21 September 2006, was vaccinated with a first oral dose of Rotateq vaccine (human-bovine) (Lot# 653754/0139F). Concomitant vaccination administered on the same day included a dose of PEDVAXHIB. Concomitant therapy included PREVACID, 2.25 ml daily for gastroesophageal reflux, DONNATAL, 0.5 ml every six hours for colic and grape water for colic. There was no illness at the time of vaccination. About one week later, on 21 September 2006, it was reported that the patient developed rotavirus symptoms of diarrhea and vomiting and was admitted to the hospital on 28-SEP-2006. The patient was hospitalized for one day. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a registered nurse via medical records indicated that the patient was seen on 21-SEP-2006 for a two month well child care visit. It was noted that the patient looked good, was not vomiting for a few days, and was doing well. Following the vaccinations with ROTATEQ and PEDVAXHIB the physician told her mother to give the patient TYLENOL. The patient's mother reported that the patient had been throwing up curdled formula every time she ate, though she had been moving her bowels and urinating okay. The physician changed the formula but she started vomiting more so the patient's mother changed it back, but the patient was still throwing up curdled formula. The patient was admitted to the hospital for observation on 28-SEP-2006 with vomiting, fussiness, and diarrhea. It was noted that the mother was young and overwhelmed with the vomiting of the baby for the past week and although there had been no weight loss for the patient, the mother was nervous because she herself had a history of similar symptoms when she was a baby. The physician planned to observe to see how many times the patient throws up, what she tolerates and her daily weight. The patient was discharged on 29-SEP-2006. It was reported that the patient recovered. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who was vaccinated with an oral first dose of Rotateq vaccine (human-bovine). Subsequently the patient vomited. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 5-month-old female who on 04-DEC-2006 was vaccinated with the first dose of rotavirus reassortant vaccine live. Unspecified medical attention was sought and no symptoms were reported.  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 6-month-old patient who was vaccinated PO with the second dose of Rotateq vaccine (human-bovine) 16 weeks after the first dose. It was unknown if medical attention was sought and no problems were reported. Additional information has been requested.
Age: 0.27
Sex: M
Vaccine: HEP, IPV, RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 14-week-old male who on 17-Nov-2006 was vaccinated PO with the first 2.0 ml dose of Rotateq vaccine (human-bovine). Concomitant vaccinations administered on that same day included a dose of poliovirus vaccine inactivated (unspecified) and a dose of hepatitis B virus vaccine rHBsAg (yeast). Unspecified medical attention was sought and no adverse reaction was noted. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5, UNK
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated with a dose of Rotateq. Concomitant vaccinations included "other childhood vaccines". It was reported that the patient experienced a mild seizure. No other information was provided. Upon internal review the patient's experience was considered to be an other important medical event. Additional information is not expected.
Age: 0.36
Sex: M
Vaccine: MMRV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old male who on approximately 11 Nov 2006 was vaccinated with the second dose of Rotateq. The physician reported that in November 2006, within two weeks of receiving the second dose, the patient developed vomiting and diarrhea and was hospitalized for 24 hours. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning several patients between the ages of 16 weeks and 6 months who were vaccinated with an initial dose of rotavirus reassortant vaccine live. No symptoms were known.  Unspecified medical attention was sought.  There was no product quality complaint involved. 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. This is in follow-up to report (s) previously submitted on 1/16/2007.  Follow-up information from the registered nurse indicated that "so far" none of the children had reported any adverse experiences.  Additional information is not available.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old male, with an unremarkable medical history and no allergies, who was vaccinated with a first 2ml oral dose of Rotateq vaccine (human-bovine). Subsequently the patient experienced diarrhea. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated with a dose of Rotateq vaccine (human-bovine). Concomitant therapy included Tylenol. The physician reported that the patient vomited shortly after being vaccinated. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. The physician indicated that the patient was given acetaminophen shortly before Rotateq vaccine (human-bovine) and felt that was the reason for the vomiting. Additional information has been requested. No further information is available.
Age: 1.08
Sex: M
Vaccine: FLUX, RV5
Symptoms: Diarrhoea, Vomiting, Wrong drug administered
Clinical narrative: Information has been received from an office manager in a physician's office concerning a 13 month old male who on 12 Dec 2006 was vaccinated inadvertently with a dose of Rotateq vaccine live (human-bovine) when Rocephin was ordered. After the inadvertent administration the patient was given Rocephin, 250 mg as well as a dose of influenza virus vaccine (unspecified). At the time of the report the patient had diarrhea and was throwing up. No other information was provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLUX, RV5
Symptoms: Ear infection, Inappropriate schedule of drug administration, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male, with no allergies, who on 12-Dec-2006 was vaccinated with a dose of ROTATEQ (human-bovine) (Lot # 654247/0600F). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 12-Dec-2006 the patient experienced vomiting after returning home from the physician's office. The patient was brought back to the office and found to have an ear infection. The patient was prescribed ROCEPHIN. It was reported that the patient was not hospitalized. No product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: RV5
Symptoms: Drug administered at inappropriate site, Ocular hyperaemia
Clinical narrative: Information has been received from a 40 year old female registered nurse with a codeine allergy but no other medical history who when she administered Rotateq (human-bovine) to a baby, the baby sneezed (WAES#0701USA00705) and some of the vaccine went into her eyes and mouth. Unspecified medical attention was sought and the RN flushed her eyes with water. No laboratory/diagnostic tests were performed. The RN reported that she developed a little bit of redness in her eyes which she thought might be from the flushing. The RN indicated that at the time of the event she was not on any medication. At the time of this report, the RN was noted to be recovering. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a licensed visiting nurse (LVN) concerning a 4-week-old patient who on approximately 21-Sep-2006 was vaccinated PO with the first dose of Rotateq vaccine live (human-bovine). It was unknown if medical attention was sought. No reaction had been reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Incorrect dose administered, Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 4-month-old female with no medical history or allergies who on 10-Oct-2006 was vaccinated PO with the second dose of Rotateq vaccine (human-bovine) (lot#655174/0848F). Concomitant therapy included ranitidine HCl (ZANTAC). The RN reported that on 10-Oct-2006, while receiving the second dose of Rotateq vaccine (human-bovine), the patient threw up and only received half (1.0 ml) of the recommended dose. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. On 10-Oct-2006, the patient recovered.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 mL dose of Rotateq (human bovine). The physician reported that the patient developed diarrhea symptoms while being administered Rotateq (human bovine). Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional informatio has been requested.