chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.63
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis
Clinical narrative: Information has been received from a receptionist at a physician's office concerning an 8 month old male who on 27 Apr 2006, 20 Jun 2006 and 29 Aug 2006 was vaccinated PO with the first, second, and third 2.0mL doses, respectively, of Rotateq (human bovine) (Lot #65366/0138F). The receptionist reported that on 27 Sep 2006, the patient was diagnosed with rotavirus. Unspecified medical attention was sought.  No laboratory/dianostic tests were performed. At the time of this report, the patient was recovering. Additional information has been requested. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a physician concerning a male with a preexisting history of gastroesophaegeal reflux, who was vaccinated with a first 2ml oral dose of Rotateq (human bovine). Concomitant therapy included ranitidine HCl (Zantac) and metoclopramide hydrochloride (Reglan). "Within the last four months" in 2006, the patient developed gastroesophageal reflux disease. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient with gastrooesophageal reflux disease (GERD) who was vaccinated PO with a dose of Rotateq. Concomitant therapy included medication to control GERD. The physician reported that the patient subsequently vomited the dose up after the vaccine was administered. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested. 04/04/2010 Information has been received from a physician and registered nurse concerning a 9-week-old female with gastrooesophageal reflux disease (GERD) who on 05-OCT-2006, at 1130, was vaccinated PO with the first dose of ROTATEQ (Lot #654248/0577F). Concomitant vacciantions administered on that same day and time included the first dose in the right leg of PEDIARIX (Lot #AC21B069AA), the first dose in the left leg of PEDVAXHIB (lot #651986/0527R) and the first dose in the left leg of PREVENAR (Lot #A25969C). Other concomitant drug therapy included medication (not further specified) to control GERD and Tylenol (given 1 hour prior to vaccination). It was reported that on 05-OCT-2006, at 1130, the patient vomited the dose back up after the vaccine was administered. Unspecified medical attention was sought and no laboratory/diagnostic tests were performed. On that same day, the patient recovered. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse concerning possibly 10 patients who were vaccinated PO with the first 2.0 mL dose of Rotavirus reassortant vaccine live after 12 weeks of age. It was unknown if medical attention was sought. At the time of this report, no adverse experiences were 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: 0.33
Sex: M
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a woman in a physician's office concerning a 17-week-old Hispanic male with no medical history who on 15-SEP-2006, at 14:30, was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortment vaccine live (human-bovine). There was no illness at the time of vaccination. No laboratory/diagnostic tests were performed as medical attention was not sought. No adverse events were reported as the patient did well. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a consumer concerning her 6 month old son who on 26-OCT-2006 was vaccinated with an oral first dose of rotavirus reassortant vaccine live (human bovine). It was reported that no adverse experiences was observed. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a 4 month old Hispanic male with no medical history or allergies who on 18-SEP-2006 at 5:50 PM was vaccinated with a 2 mL PO first dose of rotavirus reassortant vaccine live (human-bovine) (lot # 654970/0777F). There was no illness at the time of vaccination. There was no adverse event and the patient did well. Medical attention was not sought. No laboratory tests were performed. There was no product quality complaint involved. No further information is available.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated PO with the first dose of rotavirus reassortant vaccine live (human-bovine). The physician reported that, 48 hours after being vaccinated, the patient developed prolonged diarrhea. It was noted that 10-12 diapers per day were needed due to the diarrhea. Unspecified medical attention was sought. Subsequently, the patient recovered from the prolonged diarrhea. The physician also noted that the patient would receive the second dose of rotavirus reassortant vaccine live (human-bovine) at four months of age. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 29 month old male who on 23-OCT-2006 was vaccinated PO with the first dose of rotavirus reassortant vaccine live (human-bovine) (lot # 653980/0285F). It was unknown if medical attention was sought and no symptoms were noted. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4-month- old male who was vaccinated PO with a 2.0 mL dose ROTATEQ vaccine. The physician reported that the patient subsequently developed excessive diarrhea. Unspecified medical attention was sought. The day after onset, the patient's diarrhea resolved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2006. Follow-up information from a physician's assistant indicated that she could only remember that either a 2 or 4 month old male was vaccinated with a dose of ROTATEQ vaccine, and then less than 24 hours after the dose the patient developed diarrhea. It was reported that the patient's mother did not want the infant to receive the next dose because of the diarrhea. Additional information is not expected.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on 28-SEP-2006 was vaccinated with an oral first dose of rotavirus reassortant vaccine live (human-bovine). The physician reported no side effect or problems after the first dose. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a first oral dose of rotavirus reassortant vaccine live (human-bovine) a month later than indicated. It was reported that no adverse effect was involved. It was noted that a second dose would be administered as indicated. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.24
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Medication error, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old female who on approximately 27-JUN-2006 was vaccinated with PO the first 2.0 mL dose of rotavirus reassortant vaccine live (human-bovine). The physician reported that on approximately 27-JUN-2006, the patient experienced vomiting and diarrhea. Unspecified medical attention was sought. On approximately 27-JUN-2006, the patient's vomiting and diarrhea resolved. Additional information has been requested. 4/06/10 Follow up information has been received from a registered nurse concerning a 9-week-old female with no medical history who on 01-JUN-2006, at 1306, was vaccinated PO with the first dose of ROTATEQ (Lot # 653754/0139F). Concomitant vacciantions administered on that same day and time included the first IM dose of HIB conj vaccine (Lot #652704/1159R). There was no illness at the time of vaccination. The RN reported that on 02-JUN-2006, the patient developed vomiting and diarrhea. The vomiting was once daily for three days and the diarrhea was 3-4 times daily for three days. No other symptoms were noted. Unspecified medical attention was sought and no laboratory/diagnostic tests were performed. No treatment was required. Subsequently, the patient recovered from the vomiting and diarrhea. Additional information is not expected.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Irritability, Pyrexia, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received from a physician concerning a 4 month old male with gastrooesophageal reflux disease who on 12-SEP-2006 in the morning was vaccinated with a first dose 0.2 mL oral dose of ROTATEQ (lot # 654392/0578F). Concomitant vaccination administered that morning included a 3rd IM dose of PEDIARIX (AC21B034AA), a 3rd IM dose of PREVNAR (lot # B18634A) anda 3rd dose of ACTHIB (lot# UE852AA). There was no illness at the time of vaccination. Subsequently, on 12-SEP-2006 at 10:50 pm the patient developed severe vomiting for one week. On 13-SEP-2006 the patient developed a fever of 102.3 and was fussy. Unspecified medical attention was sought. The patient recovered "by 19-SEP-2006". There was no product quality complaint involved. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 2 month old patient with no medical history or allergies who on 16-OCT-2006 was vaccinated PO with the first dose of rotavirus reassortant vaccine live (human-bovine). There was no concomitant therapy. The LPN reported that on 16-OCT-2006, the patient vomited in the office after rotavirus reassortant vaccine live (human-bovine) was administered. The LPN indicated that the vaccine was vomited as well as the contents of the patient's stomach. It was unknown if medical attention was sought. No laboratory/diagnostic tests were performed. On that same day, the patient recovered. The LPN noted that there have been on residual effects since the vomiting. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 2 month old patient with no medical history or allergies who on 16-OCT-2006 was vaccinated PO with the first dose of rotavirus reassortant vaccine live (human-bovine). There was no concomitant therapy. The LPN reported that on 16-OCT-2006, the patient vomited in the office after rotavirus reassortant vaccine live (human-bovine) was administered. The LPN indicated that the vaccine was vomited as well as the contents of the patient's stomach. It was unknown if medical attention was sought. No laboratory/diagnostic tests were performed. On that same day, the patient recovered. The LPN noted that there have been no residual effects since the vomiting. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who on 21-SEP-2006 was vaccinated with an oral first dose of rotavirus reassortant vaccine live (human-bovine). The physician reported no side effect or problems. No product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Crying
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old male who on approximately 20-OCT-2006 was vaccinated PO with a 2.0 mL dose of rotavirus reassortant vaccine live (human-bovine). Concomitant vaccinations administered on that same day included "standard two month old shots". The physician reported that on approximately 20-OCT-2006, the patient was crying and appeared to be in abdominal pain. Unspecified medical attention was sought and the patient's mother was advised to take her son to the Emergency Room (ER) (it was unknown if patient was hospitalized). At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Viral infection, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 10/23/2006 was vaccinated with a first oral dose of rotavirus vaccine. On 10/28/06 the pt experienced vomiting and was hospitalized. The length of the hospitalization was not specified. It was reported that a test was performed to demonstrate a positive rotavirus test. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Anorexia, Salivary hypersecretion, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient with a mild milk soy protein intolerance (MSPI) who was vaccinated PO with a 2.0 mL dose of Rotateq. The physician reported that for a 10 day period after being vaccinated, the patient developed anorexia characterized by a 6 oz. weight loss as they were not eating. The physician also reported that the patient was also kind of "spitty." Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Breath holding, Cyanosis
Clinical narrative: Information has been received from a physician concerning a 2-month-old female who was vaccinated PO with the first 2.0 mL dose of ROTATEQ. It was noted that the patient was being fed formula (nor further specified). The physician reported that the patient subsequently held her breath and turned blue. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Body temperature increased, Inappropriate schedule of drug administration, Irritability, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 4 month old female who was vaccinated with a first dose in her fourth month and second dose in her fifth month of ROTATEQ. Two weeks after each dose the patient developed a colicky fussing for one week. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a physician concerning a 4 month old female with no medical history or allergies who was vaccinated PO on 07-AUG-2006 with a first dose in her fourth month and on 05-SEP-2006 with a second dose in her fifth month of ROTATEQ (lot # 654504/0695F).  Concomitant vaccination administered on 07-AUG-2006 included an IM second dose in the right thigh of PEDIARIX (lot # AC12B066AA), an IM second dose in the right thigh of ACTHIB (lot # UE914AA) and an IM second dose in the right thigh of PREVNAR (lot # B00655K).  At the time of vaccination on 07-AUG-2006 the patient had a temperature of 100.5.  Two weeks after each dose the patient developed a colicky fussing for one weekMedical attention was not sought.  Subsequently the patient recovered.  There was no product quality complaint involved.  Additional information is not expected.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a 4 month old patient who was vaccinated once with a 2 mL oral dose of rotavirus reassortant vaccine live (human-bovine). The patient had no adverse reaction. It was reported that the patient came back and received their second dose of rotavirus reassortant vaccine live (human-bovine). No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health professional concerning a 4 month old pt who was vaccinated once with a 2ml oral dose of Rotavirus vaccine. The pt had no adverse reaction. It was reported that the pt came back at 6 months of age and was vaccainted with a second dose of Rotavirus vaccine. 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 health professional concerning a pt who was vaccinated with a 2 ml dose of Rotavirus vaccine. Subsequently the pt vomited. It was noted that the dose was not repeated. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided.
Sex: U
Vaccine: RV5
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of Rotavirus vaccine. It was reported that the pt experienced a stomach ache. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has beer requested. This is in follow-up to report(s) previously submitted on 11/14/2006.  Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ.  It was reported that the patient experienced a stomach ache.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning a 25 year old female customer service representative. On 9/18/06, the pt was vaccinated in the right deltoid with the first dose of 0.5ml of HPV vaccine (lot 653937/0637F). There were no other illnesses noted at the time of vaccination. The nurse practitioner reported that the pt was severely obese and when she received the HPV vaccine, the medication dribbled down her arm. It was report that upon removal of the needle, blood tinged fluid flowed from the injection site. The nurse practitioner was unable to estimate the amount but assumed the pt received less than the full dose. The plan was to re inject the pt with a full dose. At the time of this report, the outcome of the events were unk. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Malaise, Mood swings
Clinical narrative: Information has been received from a nurse concerning a 21 year old female with asthma, unspecified drug reaction to Penicillin and Amoxicillin and might have been exposed to papilloma viral infection. On 7/19/06, the pt was vaccinated IM with the first dose of HPV vaccine (lot 653650/0697F). Concomitant therapy included unspecified hormonal contraceptives. Subsequently, the pt experienced fatigue, was sick and had mood swings for two months. It was reported that the pt felt rotten after receiving HPV vaccine. (date unk). The pt sought unspecified medical attention. The pt underwent a test for mononucleosis that came back neg (date unk). It was reported that the pt felt better two weeks before the second dose of HPV was due to be administered (date unk). It was reported that the pt does not want to receive the second and third dose of HPV vaccine. At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 17 year old female pt with on past medical history who on 10/2/06 was vaccainted with a dose of HPV vaccine, lot 653735/0688F. Concomitant therapy included an unspecified flu shot. It was reported that after receiving HPV vaccine, the pt passed out. Medical attention was sought. the pt recovered the same day. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from physician concerning a 17 year old female with no other pertinent medical history reported and no known allergies or adverse drug reactions reported. On 9/26/06 the pt was vaccainted with HPV vaccine (lot 653735/0688F). There were no concomitant medications reported. Subsequently, the pt passed out after receiving the vaccine. The pt sought unspecified medical attention. On 9/26/06, the pt had recovered from the event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning an adult pt who was vaccinated with a dose of HPV vaccine. The pt complained of pain while being injected using the pre filled syringe. The nurse reported that another pt did not complain of pain when a normal syringe was used. The nurse suggested the pre filled needles may be dull causing pain during injection. The pts outcome was not reported. A product quality complaint was involved. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a healthcare professional concerning a 15 year old female student who on 9/14/06 at 3:00 pm was vaccinated in the right hip with her first dose of HPV vaccine, lot 654540/0800F. On 9/18/06 the pt developed low grade fever and swollen glands. Her outcome was unk. The reporter indicated the pt would be evaluated at her next vaccination. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a registered nurse and a medical assistant concerning a 27 year old female with seasonal allergies, a possible penicillin allergy and had a history of an abnormal Papanicolaou smear and loop electrosurgical excision procedure. On 8/2/06, the pt was vaccinated IM in the arm with the first 0.5ml pre filled syringe dose of HPV Vaccine (lot 653650/0640F). Concomitant therapy included unspecified hormonal contraceptive (reported as birth control pills). Following the first vaccination, the pt did not experience any adverse reactions. On 10/2/06, the pt was vaccinated with the second dose of HPV vaccine. On 10/2/06, 12 hours after the vaccination, the pt woke up in the middle of the night with right red, itchy hands and feet (also reported as soaked them in ice). It was reported that the symptoms were better the afternoon of the vaccination. On 10/3/06, the pt took Benadryl. The pt sought unspecified medical attention. On 10/4/06, the registered nurse spoke with the pt in the afternoon and all symptoms had resolved. The medical assistant note that the pt had no immediate severe symptoms. The medical assistant reported that there was no mention of seriousness of events in the pts chart and reported that the events did not look like they were serious. The registered nurse further reported that she would not classify the events as serious. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician concerning her 18 year old daughter who on 10/01/2006 was vaccinated with HPV vaccine IM in right deltoid. On 10/2/06, within 24 hours, the pt experienced itchy rash on her elbows, feet, buttocks and back. She was given Benadryl and topical steroid cream to treat the symptoms. The pts itchy rash on her elbows, feet, buttocks and back persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA04386). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site anaesthesia, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experience (WAES #'s 0610USA04385, 0610USA04386 and 0610USA03730). Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2006.  Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F).  Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site.  The patient sought unspecified medical attention.  It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm.  The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away.  It was also reported that the patient recovered from numbness at the injection site.  It was reported that 3 other female patient's had the same experience (WAES # WAES0610USA04385, WAES0610USA04386, and 0610USA03730).  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5ml dose of HPV (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patient's had the same experiences (WAES #'s 0610USA04384, 0610USA04386 and 0610USA03730). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patientt who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES #'s 0610USA04384, 0610USA04356 and 0610USA03730). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 mL dose of GARDADIL (lot #653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES0620USA04384, WAES0610USA04385 and WAES0610USA03730). Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a health professional concerning a female patient who was not pregnant and who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # 653735/0688F). Initially the patient experienced numbness at the injection site immediately after administration of the vaccine which was followed by "tingling or prickly feeling" on arm of the injection site. The patient sought unspecified medical attention. It was reported that the patient felt "right away" a numb feeling and then a tingling sensation down the arm. The tingling or prickly feeling lasted for a period of 2 to 5 minutes and then totally went away. It was also reported that the patient recovered from numbness at the injection site. It was reported that 3 other female patients had the same experience (WAES #'s 0610USA04384, 0610USA04385 and 0610USA03730). Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Injection site pain, Pain, Pyrexia
Clinical narrative: Information has been received from a 26 year old female medical assistant (not CMA) with migraines, sulfonamide allergy and drug hypersensitivity to over the counter cold medications, who on 27-SEP-2006, was vaccinated IM with a 0.5ml dose of HPV (lot # 653735/0688F). Concomitant therapy included ethinyl estradiol/norethindrone (OVCON 35), netaxalone (SKELAXIN) and acetaminophen/hydrocodone bitartrate (VICODIN TABLETS). On 27-SEP-2006, the patient experienced severe pain at the injection site while the medication was being injected. The medical assistant also reported the pain as a sore bruised feeling that lasted for 4 to 5 days. On approximately 27-SEP-2006, the patient also experienced slight fever for 4 to 5 days. On 04-OCT-2006, she had physical therapy and the sore bruised feeling came back. Subsequently, the medical assistant recovered, however it was unknown if she recovered from the sore bruised feeling that came back on 04-OCT-2006. There was no product quality complaint involved. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 06-OCT-2006 was vaccinated in the right arm with the first dose of HPV (lot # not provided). On 06-OCT-2006, the patient experienced lightheadedness and numbness in her left arm. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from lightheadedness and numbness in her left arm and was able to leave the office. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Muscle spasms, Pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 05-OCT-2006 was vaccinated IM with a dose of HPV. Concomitant therapy included hepatitis A virus vaccine (unspecified), administered at the same time and in the same arm. The physician reported that the patient was experiencing "severe spasmatic pain in her arm", and that the muscle would tense up for a 5 to 10 minute time frame. An hour later the pain would subside. Medical attention was sought. The patient recovered the next day, 06-OCT-2006. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 25 year old female with anxiety, depression and a lump in her vagina who on 02-OCT-2006 was vaccinated with IM  in the upper arm with a 0.5 mL first dose of HPV (lot 653978/0955F). Concomitant therapy included bupropion HCl (WELLBUTRIN XL), diclofenac potassium (CATAFLAM) and paroxetine HCl (PAXIL). On 02-OCT-2006, ten minutes post vaccination, the patient passed out for a few seconds. The patient received unspecified medical attention. Subsequently, on 02-OCT-2006, the patient recovered. Additional information has been requested. 01/05/2007 Information has been received from a physician concerning a 25 year old female with anxiety, depression and a lump in her vagina who at 8:30 AM on 02-OCT-2006 was vaccinated intramuscularly in the upper right arm with a 0.5 ml first dose of GARDASIL (lot 653978/0955F). Concomitant therapy included WELLBUTRIN XL, CATAFLAM and PAXIL. The patient stated that she faints when given shots. On 02-OCT-2006, ten minutes post vaccination, the patient passed out for a few seconds. The patient felt fine after vaccination. The patient was advised to sit in the waiting room for at least 10 minutes before driving. Someone went to check on the patient, and the patient stated she thought she went out. The patient walked to a room to lie down. The patient felt fine later, left office, and was considered recovered. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a physician concerning her 15 year old daughter who was vaccinated with HPV. Subsequently, the patient experienced red dots/rashes on her ankles, elbows, and buttocks. Subsequently, the patient recovered from red dots/rashes on ankles, elbows, and buttocks. Therapy with HPV was not re-introduced. Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a physician concerning her approximately 18 year old student daughter (previously reported as her 15 year old daughter) who was vaccinated with a first dose of GARDASIL. Subsequently, 48-72 hours after the first dose, the patient experienced red dots/rashes on her ankles, elbows, and buttocks, also reported as an itchy rash on ankles and abdomen. The patient was treated successfully with BENADRYL and recovered from red dots/rashes on ankles, elbows, and buttocks, also reported as an itchy rash on ankles and abdomen within 24 hours. Before the second dose of GARDASIL, the patient was pre-medicated with CLARITIN. No rash or other adverse experience was noted. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning an 11 year old female who was the daughter of a nurse that works in his office. On 30-SEP-2006 the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot #654540/0800F). At that same time, the patient received a second dose of FLUMIST. On 01-OCT-2006 the patient had a "funny feeling in her face." By 03-OCT-2006 "her face was crooked on one side and becoming paralyzed." The patient was treated with an unspecified steroid medication and was reported to be "feeling better," but the symptoms were not totally gone. The patient was seen by a neurologist and was diagnosed with Bell's Palsy. The physician reported that one year ago, the patient was given FLUMIST and had no adverse reactions. At the time of this report, the patient was recovering from the events. The physician reported that it was his opinion that "Bells Palsy was caused by FLUMIST and not GARDASIL." Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a 21 year old female with a history of an allergic reaction to penicillin and sulfonamide who on 21-SEP-2006 was vaccinated with HPV. On 21-SEP-2006, following vaccination, the patient broke out in hives all over her upper body particularly in the face, chest, and arms. Unspecified medical attention was sought. Subsequently, the patient recovered on 26- SEP-2006. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Information has been received from a physician and a 22 year old white female certified medical assistant with latex allergy, drug hypersensitivity to pertussis and iodine allergy and a history of unspecified adverse reaction after first dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (at less than 1 year of  age. On 05-OCT-2006, at 4:00 PM,. the patient was vaccinated, into the right arm, with a first dose of HPV (lot # 653978/0955F). On 05-OCT-2006, at 4:00 PM, the patient experienced burning "as if the arm was cut with razor blade and alcohol was poured on cut," and it "hurt really bad." The patient also developed dizziness, numbness in her lower arm, fever, fatigue, and malaise. She reported that her arm swelled up 2 times the normal size and was red. She developed a dime size lump and redness at the injection site that was itchy when touched or pressed on. Unspecified medical attention was sought. At the time of the report, the dime size lump, redness and itching at the injection site persisted. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Malaise, Pruritus, Pyrexia, Thermal burn
Clinical narrative: Information has been received from a physician and a 22 year old white female certified medical assistant with latex allergy, drug hypersensitivity to pertussis and iodine allergy and a history of unspecified adverse reaction after first dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (at less than 1 year of  age. On 05-OCT-2006, at 4:00 PM,. the patient was vaccinated, into the right arm, with a first dose of HPV (lot # 653978/0955F). On 05-OCT-2006, at 4:00 PM, the patient experienced burning "as if the arm was cut with razor blade and alcohol was poured on cut," and it "hurt really bad." The patient also developed dizziness, numbness in her lower arm, fever, fatigue, and malaise. She reported that her arm swelled up 2 times the normal size and was red. She developed a dime size lump and redness at the injection site that was itchy when touched or pressed on. Unspecified medical attention was sought. At the time of the report, the dime size lump, redness and itching at the injection site persisted. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dysuria, Vaginal pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female who on 05-OCT-2006 was vaccinated with a first dose of HPV (lot # 653735/0688F). There was no concomitant medication. on 06-OCT-2006 the patient experienced sharp pain around the abdomen area and vaginal area and intense pain during urination. It was reported that the pain was on and off. It was reported that the patient was going to go to the physician's office to be evaluated. At the time of the report, the patient's outcome was unknown. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a certified medical assistant concerning a 16 year old female who on 05-OCT-2006 was vaccinated with a first dose of GARASIL (lot #653735/0688F). There was no concomitant medication. On 06-OCT-2006 the patient experienced sharp pain around the abdomen area and vaginal area and intense pain during urination. It was reported that the pain was on and off. It was reported that the patient was going to go to the physician's office to be evaluated. At the time of the report, the patient's outcome was unknown. Additional information is not available.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no past medical history who on approximately 10/4/06 was vaccinated, into the arm, with a 0.5ml dose of HPV vaccine. Concomitant therapy included a dose of Hep A vaccine. It was reported that the nurse rubbed the childs arm after the vaccination and the child passed out. The physician thought that it was a vasovagal reaction and revived her with ammonia. On approximately 10/04/06, the pt recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4, VARCEL
Symptoms: Hypoaesthesia, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 12 year old female with asthma and Advair allergy who on 10/11/06 was vaccinated with HVP vaccine. Concomitant therapy that day included varicella virus vaccine and influenza vaccine. On 10/11/06 the pt experienced numbing at injection site and around arm. The pt recovered. Unspecified medical attention was sought. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing
Clinical narrative: Information has been received from a nurse concerning her 15 year old niece who was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast) (0.5 ml). Subsequently, "soon after having injections", the patient experienced dizziness and flushing "about ten minutes after her injections".  It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) with "other shots" and blood work.  The patient recovered ;about 15 minutes after injections". Unspecified medical attention was sought. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Influenza like illness
Clinical narrative: Information has been received from a 22 year old female nurse consumer who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced stomach ache and flu-like symptoms "for about a week'. The patient recovered. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 11-Oct-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653978/0955F) (0.5ml), intramuscularly. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). On 12-Oct-2006 the patient experienced "rash on her face and neck". Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Information has been received from a physician concerning a 14 year old female student who on 05-Oct-2006 was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653735/0688F). Concomitant therapy given at the same time in the same arm included a dose of hepatitis A virus vaccine (unspecified). On 06-Oct-2006, the patient experienced extremely severe cramping pain in arm at the vaccine site intermittently over about 16 hours following vaccination.  The episodes lasted about 30 minutes each and were incapacitating.  During the time between episodes the patient was completely pain free.  The episodes continued through the night with the same intensity. The episodes stopped abruptly the next morning and there was no reoccurrence. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced numbness at the injection site and numbness around the arm. Additional information has been requested.