chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter who on 31-OCT-2007 was vaccinated with the first dose and on 28-Dec-2007 with the second dose of GARDASIL (lot# not provided). The patient was scheduled to receive the third dose on 28-Mar-2008. On 29-Mar-2008, the patient experienced nose bleeds. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Insomnia
Clinical narrative: Information has been received from a consumer concerning her 20 year old niece with obesity who was vaccinated with a third dose of GARDASIL (lot# unspecified). On approximately 24-MAR-2008 the patient experienced insomnia and she had been very upset. The patient received the vaccinations at an other (unspecified) physician's office. On 31-Mar-2008, the patient went to see a therapist and she was diagnosed with "clinical depression". The patient was being treated with PAXIL. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal, Smear cervix normal
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who was vaccinated with all three doses of GARDASIL (lot# dose 1, 654389/0961F, dose 2, 657617/0384U, dose 3, 658094/0524U). The nurse stated that prior to receiving GARDASIL the patient's PAP test results were normal. However, following the completion of the series the patient received another PAP test which showed "High-Risk HPV positive". The nurse also stated that the patient tolerated all of three doses well. It was unknown whether medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dizziness
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 27-MAR-2008 was vaccinated with GARDASIL (65994/1978U). Concomitant therapy included HAVRIX (lot# not reported). On 27-MAR-2008 the patient experienced wooziness and began crying. Subsequently, the patient recovered from the wooziness and crying. The patient's sister had the same AE after receiving GARDASIL. See SR# 1-2774239123. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Migraine, Muscle spasms, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with a history of sexual abuse who was vaccinated with the first three doses of GARDASIL (lot#'s not reported) on 23-OCT-2006, 20-DEC-2006 and 31-MAY-2007 at another location. On 21-NOV-2007 and 31-JAN-2008 the patient was vaccinated with a fourth dose and fifth dose of GARDASIL (0469U) at the reporting physician's office. Subsequently, the patient experienced inappropriate schedule of vaccine administered. Per the reporter, the patient has experienced headaches described as migraines and bilateral leg pain/spasm for the last month (start date unspecified). The patient is not recovered from the headaches and leg pain and there is no other information to report. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/14/2008. Information has been received from an LPN concerning a 14 year old female with a history of sexual abuse and attention deficit disorder who at her mother's request was vaccinated at another pediatrician's office with the first three doses of GARDASIL vaccine (lot#'s not reported) on 23-OCT-2006, 20-DEC-2006 and 31-MAY-2007 at another location. At the patient's fathers request, on 21-NOV-2007 and 11-JAN-2008 the patient was vaccinated with a fourth dose IM in the right deltoid and a fifth dose IM in the left deltoid of GARDASIL vaccine (0469U) at the reporting physician's office. Subsequently, the patient experienced inappropriate schedule of vaccine administered. On 31-MAR-2008 the nurse reported that in an unspecified date the patient reported that she experienced headaches described as migraines and bilateral leg pains/spasm for the last month (start date unspecififed). She reported that the headaches and leg pains are not continual, but "fluctuate" and are intermittent. The mother was informed to keep a log of the events. At this time it is unknown whether or not the patient has recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with a second dose of Gardasil (no lot # provided).  Subsequently the patient fainted after receiving the injection.  Subsequently, the patient recovered from fainting.  The patient sought unspecified medical attention.  No product quality complaint was involved.  This is one of the multiple reports from the same source (WAES# 0803USA04759).  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Feeling abnormal, Urinary incontinence
Clinical narrative: Information has been received from a physician concerning a 13 year old female with a history of asthma who on 28-MAR-2008 was vaccinated with the first dose of Gardasil (lot# not reported).  Concomitant suspect therapy included Varivax (Oka/Merck) (MSD) (lot# not reported).  Other concomitant therapy included Tdap (lot # not reported) and Hep A (unspecified) (lot# not reported).  On 28-MAR-2008 the patient urinated on herself and was dazed for about 10 minutes after receiving the first dose of Gardasil.  Subsequently, the patient recovered from having urinated on herself and being dazed.  The patient sought unspecified medical attention in the physician's office.  No other information is available at this time.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 04/14/2008. Information has been received from a physician concerning a 13 year old female with a history of asthma who on 28-MAR-2008 was vaccinated IM in the left arm with the first dose of GARDASIL (658182/1757U). Concomitant suspect therapy included SC vaccination in the left arm with VARIVAX (lot# 659940/1798U). Other concomitant therapy included IM vaccination in the left arm with ADACEL (Sanofi Pasteur) (C2904AA), IM vaccination in the right arm with HAVRIX (GSK)(AHAVB223AA) and IM vaccination in the right arm with MENACTRA (Sanofi Pasteur) (U2546AA). On 28-MAR-2008 the patient urinated on herself and was dazed for about 10 minutes after receiving the first dose of GARDASIL. Subsequently, the patient recovered from having urinated on herself and being dazed. The patient sought unspecified medical attention in the physician's office. No other information is available at this time. Additional information received from B-form (18-APR-2008). The patient became light-headed and was incontinent of a large volume of urine. The patient remained listless for 3-4 minutes and responded within another 2 minutes. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Urticaria, Wheezing
Clinical narrative: Information has been received from a physician concerning a 24 year old female with a history of hay fever and allergy to MACRODANTIN who on 08-MAR-2008 was vaccinated with the first dose of GARDASIL (655604/0052X). On 09-MAR-2008 the patient experienced an "allergic reaction" characterized by "hives and wheezing". Subsequently, the patient recovered from hives and wheezing. The patient sought unspecified medical attention. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with the first dose of GARDASIL (lot# not reported).  2 days post vaccination the patient experienced a localized rash at the injection site.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HEP, HPV4
Symptoms: Anaphylactic reaction, Throat tightness
Clinical narrative: Information has been received from a registered nurse concerning an 11-12 year old female who on an unspecified date was vaccinated with her first dose of Gardasil (lot number, route and site not reported).  Concomitant suspect therapy on the same day included an unspecified Hep B vaccine (manufacturer, lot number, route and site not reported).  The patient received the Gardasil 20-25 minutes after the hepatitis vaccine and subsequently the patient developed an anaphylactic reaction.  The patient was administered epinephrine at the office because her throat closed up.  The patient will not finish the Gardasil series.  The patient recovered on an unspecified date.  The event was reported as requiring intervention (other important medical event).  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms
Clinical narrative: Information has been received from a health professional concerning a female who on 27-MAR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 27-MAR-2008 the patient experienced back spasms within 6 hours of receiving the first dose. The patient sought unspecified medical attention. Subsequently, the patient recovered from her back spasms. Per the reporter, the patient may like to be contacted. No further information is available. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 12-MAR-2008 was vaccinated with the second dose of GARDASIL (lot# not reported).  On approximately 19-MAR-2008 the patient experienced very dark, almost black blood for the first three days of her period.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from very dark, almost black bleeding.  No further information was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on 11-SEP-2007 was vaccinated with the first dose of Gardasil (657622/0388U).  On 13-NOV-2007 the patient was vaccinated with the second dose of Gardasil (657622/0388U).  On 18-MAR-2008 the patient was vaccinated IM with the third dose of Gardasil (658490/0802U).  Subsequently, the patient developed pain at the injection site that has persisted.  The patient sought unspecified medical attention.  The patient did not experience a fever, swelling, redness, numbness, or weakness in the arm.  All three injections were given in left arm.  The patient did not have a reaction with the first two doses.  Per the reporter, the patient is recovering.  No additional information is available.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Dizziness, Eye rolling, Increased bronchial secretion, Pallor
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 31-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 659964/1978U).  Concomitant therapy included HAVRIX.  Shortly after receiving the vaccine, the patient experienced dizziness. The patient drank water and a few minutes later she lost her colro, eyes rolled back and made a grugling noise. Subsequently, the patient recovered on 31-MAR-2008 from feeling dizzy.  She remained in the office until the symptoms subsided.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/14/2008.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient "in her early twenties" who was vaccinated with "one dose" of GARDASIL (lot # not reported). Subsequently the patient went to a gynecologist and had an abnormal PAP test. It is unknown if the patient had abnormal PAP tests prior to receiving GARDASIL. This is one of several reports from the same source. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Blood test, Myelitis transverse
Clinical narrative: Information has been received from a 24 year old female with no known drug allergies and no past medical history who sometime in January 2008, was vaccinated in the deltoid at her OBGYN's office with her first dose of Gardasil (lot# unspecified). The consumer reported that she received her second dose of Gardasil (lot# unspecified). Subsequently, two days later on 20-MAR-2008 the patient had a tingling/numbing feeling in her arm that felt like she slept on her arm and it "fell asleep". The consumer also stated that the tingling/numbing feeling gradually got worse to the point where her touch sensation is different from left arm; it feels heavy and like her hand is swollen. The consumer also stated that the feeling she has goes from her shoulder on her right arm to her fingertips. She indicated that she received the second dose of Gardasil in her left arm around the triceps area of the arm. The consumer reported that her arm still does not feel better, she spoke to her primary care physician even though she did not receive the vaccination there, who has done blood work and is requesting her to do a EMG. The patient had sought medical attention at her doctors office. The patient's outcome is reported as not recovered. No further AE information is available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia, Sensation of heaviness
Clinical narrative: Information has been received from a 24 year old female with no known drug allergies and no past medical history who sometime in January 2008, was vaccinated in the deltoid at her OBGYN's office with her first dose of Gardasil (lot# unspecified). The consumer reported that she received her second dose of Gardasil (lot# unspecified). Subsequently, two days later on 20-MAR-2008 the patient had a tingling/numbing feeling in her arm that felt like she slept on her arm and it "fell asleep". The consumer also stated that the tingling/numbing feeling gradually got worse to the point where her touch sensation is different from left arm; it feels heavy and like her hand is swollen. The consumer also stated that the feeling she has goes from her shoulder on her right arm to her fingertips. She indicated that she received the second dose of Gardasil in her left arm around the triceps area of the arm. The consumer reported that her arm still does not feel better, she spoke to her primary care physician even though she did not receive the vaccination there, who has done blood work and is requesting her to do a EMG. The patient had sought medical attention at her doctors office. The patient's outcome is reported as not recovered. No further AE information is available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Electromyogram, Hypoaesthesia, Laboratory test, Oedema peripheral, Paraesthesia
Clinical narrative: Information has been received from a 24 year old female with no known drug allergies and no past medical history who sometime in January 2008, was vaccinated in the deltoid at her OBGYN's office with her first dose of Gardasil (lot# unspecified). The consumer reported that she received her second dose of Gardasil (lot# unspecified). Subsequently, two days later on 20-MAR-2008 the patient had a tingling/numbing feeling in her arm that felt like she slept on her arm and it "fell asleep". The consumer also stated that the tingling/numbing feeling gradually got worse to the point where her touch sensation is different from left arm; it feels heavy and like her hand is swollen. The consumer also stated that the feeling she has goes from her shoulder on her right arm to her fingertips. She indicated that she received the second dose of Gardasil in her left arm around the triceps area of the arm. The consumer reported that her arm still does not feel better, she spoke to her primary care physician even though she did not receive the vaccination there, who has done blood work and is requesting her to do a EMG. The patient had sought medical attention at her doctors office. The patient's outcome is reported as not recovered. No further AE information is available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Sensation of heaviness
Clinical narrative: Information has been received from a 24 year old female with no known drug allergies and no past medical history who sometime in January 2008, was vaccinated in the deltoid at her OBGYN's office with her first dose of Gardasil (lot# unspecified). The consumer reported that she received her second dose of Gardasil (lot# unspecified). Subsequently, two days later on 20-MAR-2008 the patient had a tingling/numbing feeling in her arm that felt like she slept on her arm and it "fell asleep". The consumer also stated that the tingling/numbing feeling gradually got worse to the point where her touch sensation is different from left arm; it feels heavy and like her hand is swollen. The consumer also stated that the feeling she has goes from her shoulder on her right arm to her fingertips. She indicated that she received the second dose of Gardasil in her left arm around the triceps area of the arm. The consumer reported that her arm still does not feel better, she spoke to her primary care physician even though she did not receive the vaccination there, who has done blood work and is requesting her to do a EMG. The patient had sought medical attention at her doctors office. The patient's outcome is reported as not recovered. No further AE information is available. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Blood culture, Culture urine, Decreased appetite, Full blood count, Irritability
Clinical narrative: Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week.  After a few days fever appeared, as well as lack of appetite, irritability and discontinue of normal activities.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week.  After a few days fever appeared, as well as lack of appetite, irritability and discontinue of normal activities.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Activities of daily living impaired, Anorexia, Blood culture, Culture urine, Full blood count
Clinical narrative: Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week.  After a few days fever appeared, as well as lack of appetite, irritability and discontinue of normal activities.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Urine analysis
Clinical narrative: Within one hour of receiving vaccinations, severe irritability and fever began.  Fever continued for two days and irritability for one week.  After a few days fever appeared, as well as lack of appetite, irritability and discontinue of normal activities.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, MMRV
Symptoms: Abnormal behaviour, Anger, Cognitive disorder, Crying, Mood swings
Clinical narrative: Crying and sore arm for long time on and off into the next day. Sensitive and tearful for 6 hours since then acting "more retarded"/"slow to understand"/"not listening", not focus, started on next day and continues to now. Screaming on and off, easily distracted, unlike before. Takes a lot of focus to dress and brush teeth. Strange behavior like licking hands, mood swings either mean spirited/easily angered or sweet. Trouble processing info, inattentive (bumping into walls), dropping things more.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, MMRV
Symptoms: Pain in extremity, Screaming
Clinical narrative: Crying and sore arm for long time on and off into the next day. Sensitive and tearful for 6 hours since then acting "more retarded"/"slow to understand"/"not listening", not focus, started on next day and continues to now. Screaming on and off, easily distracted, unlike before. Takes a lot of focus to dress and brush teeth. Strange behavior like licking hands, mood swings either mean spirited/easily angered or sweet. Trouble processing info, inattentive (bumping into walls), dropping things more.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Induration, Rash erythematous
Clinical narrative: 9 x 3 cm indurated, erythematous area on right arm.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Arthralgia, Blood glucose normal, Blood thyroid stimulating hormone normal, Cough, Full blood count normal
Clinical narrative: Information has been received from a registered nurse (RN) concerning her 19 year old daughter who on 30-JUL-2007 was vaccinated with her first dose of GARDASIL (lot, route and site not reported).  On 05-OCT-2007 she was vaccinated with her second dose of GARDASIL (lot, route and site not reported) and on 08-FEB-2008 was vaccinated with her third dose of GARDASIL (lot, route and site not reported).  Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 30-JUL-2007 and a booster of hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 08-FEB-2008, meningococcal vaccine (unspecified) on 30-JUL-2007, influenza virus vaccine (unspecified) on 05-OCT-2007, and fexofenadine hydrochloride (ALLEGRA), pseudoephedrine HC1 (SUDAFED) and hormonal contraceptives (unspecified).  The nurse stated that after completing the series, on 23-FEB-2008 her daughter developed a sore throat, arthralgia, coughing, runny nose, hand numbness and tingling.  The patient contacted the physician on an unspecified date.  A test for strep throat (date not reported) was negative.  The patient's liver and spleen were within normal limits.  Also, the patient's complete blood count, thyroid stimulating hormone, glucose, and erythrocyte sedimentation rate were within normal limits.  At the time of reporting the patient had not recovered.  No other information was available.  Sore throat, arthralgia, coughing, runny nose, hand numbness and tingling were considered to be disabling by the reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Hypoaesthesia, Liver function test normal, Paraesthesia, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Information has been received from a registered nurse (RN) concerning her 19 year old daughter who on 30-JUL-2007 was vaccinated with her first dose of GARDASIL (lot, route and site not reported).  On 05-OCT-2007 she was vaccinated with her second dose of GARDASIL (lot, route and site not reported) and on 08-FEB-2008 was vaccinated with her third dose of GARDASIL (lot, route and site not reported).  Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 30-JUL-2007 and a booster of hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 08-FEB-2008, meningococcal vaccine (unspecified) on 30-JUL-2007, influenza virus vaccine (unspecified) on 05-OCT-2007, and fexofenadine hydrochloride (ALLEGRA), pseudoephedrine HC1 (SUDAFED) and hormonal contraceptives (unspecified).  The nurse stated that after completing the series, on 23-FEB-2008 her daughter developed a sore throat, arthralgia, coughing, runny nose, hand numbness and tingling.  The patient contacted the physician on an unspecified date.  A test for strep throat (date not reported) was negative.  The patient's liver and spleen were within normal limits.  Also, the patient's complete blood count, thyroid stimulating hormone, glucose, and erythrocyte sedimentation rate were within normal limits.  At the time of reporting the patient had not recovered.  No other information was available.  Sore throat, arthralgia, coughing, runny nose, hand numbness and tingling were considered to be disabling by the reporter.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Streptococcal identification test negative
Clinical narrative: Information has been received from a registered nurse (RN) concerning her 19 year old daughter who on 30-JUL-2007 was vaccinated with her first dose of GARDASIL (lot, route and site not reported).  On 05-OCT-2007 she was vaccinated with her second dose of GARDASIL (lot, route and site not reported) and on 08-FEB-2008 was vaccinated with her third dose of GARDASIL (lot, route and site not reported).  Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 30-JUL-2007 and a booster of hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 08-FEB-2008, meningococcal vaccine (unspecified) on 30-JUL-2007, influenza virus vaccine (unspecified) on 05-OCT-2007, and fexofenadine hydrochloride (ALLEGRA), pseudoephedrine HC1 (SUDAFED) and hormonal contraceptives (unspecified).  The nurse stated that after completing the series, on 23-FEB-2008 her daughter developed a sore throat, arthralgia, coughing, runny nose, hand numbness and tingling.  The patient contacted the physician on an unspecified date.  A test for strep throat (date not reported) was negative.  The patient's liver and spleen were within normal limits.  Also, the patient's complete blood count, thyroid stimulating hormone, glucose, and erythrocyte sedimentation rate were within normal limits.  At the time of reporting the patient had not recovered.  No other information was available.  Sore throat, arthralgia, coughing, runny nose, hand numbness and tingling were considered to be disabling by the reporter.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 year old female who was vaccinated with her first dose of GARDASIL (lot number, route, and site not reported) on an unspecified date.  On an unspecified date the patient was vaccinated with her second dose of GARDASIL (lot number, route, and site not reported).  The patient had no reaction after her first dose.  Several days after the second dose the patient began experiencing 10-12 seizures a day.  The patient saw a neurologist on an unspecified date.  After being put on an unspecified medication by the neurologist, the seizures subsided but have since returned.  No further information was available.  Upon internal review seizures were considered to be an other important medical event.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo, Vertigo positional
Clinical narrative: Information has been received from a physician concerning his 71 year old wife who "about 5 weeks ago" approximately 28-JAN-2008 was vaccinated SQ with ZOSTAVAX (Oka/Merck).  There was no concomitant medication.  On the day after receiving ZOSTAVAX (Oka/Merck) the patient developed vertigo.  Unspecified medical attention was sought.  There were no lab studies performed.  At the time of the report the patient was recovering.  Her husband stated his wife's vertigo seemed to improve slightly with exercise.  There was no product quality complaint involved.  Follow-up information from the 71 year old white female patient with multiple airborne allergies indicated that on 05-FEB-2008 she was vaccinated "mid-day" in the upper right arm with ZOSTAVAX (Oka/Merck).  There was no illness at the time of vaccination.  Subsequently, on 06-Feb-2008 she had a whirling sensation when she laid down, rolled over or sat up.  On an unspecified date she had a chiropractic evaluation to see if her neck was out of place, which it was not.  The chiropractor adjusted her lower back primarily.  After the chiropractic adjustment (that did not include her neck) she nearly fell over, but her doctor caught her.  On 06-MAR-2008 the patient recovered.  It was noted that the patient had made an ENT appointment by phone before the vertigo subsided.  The patient stated she saw the doctor after 06-MAR-2008 so he only explained things to her.  The doctor's explanation of the condition was Benign Positional Vertigo.  The patient considered her vertigo to be disabling.  Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Body temperature increased, Culture stool positive, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a licensed visiting nurse concerning an approximately 12 week old male with gastrooesophageal reflux disease and no allergies who on 04-APR-2008 was vaccinated with a first dose of ROTATEQ (lot # 659915/0015X).  Concomitant therapy included metoclopramide hydrochloride (REGLAN) and ranitidine HC1 (ZANTAC).  On approximately 04-APR-2008, the patient developed intractable vomiting and diarrhea.  The patient was hospitalized for two days.  The patient received oral and intravenous rehydration.  The stool work-up was negative with the exception of being positive for Rotavirus.  The patient had a recorded temperature in the hospital of 102F.  The patient was seen in the office on 07-APR-2008.  The patient recovered on an unspecified date.  A product quality complaint was not involved.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed visiting nurse concerning an approximately 12 week old male with gastrooesophageal reflux disease and no allergies who on 04-APR-2008 was vaccinated with a first dose of ROTATEQ (lot # 659915/0015X).  Concomitant therapy included metoclopramide hydrochloride (REGLAN) and ranitidine HC1 (ZANTAC).  On approximately 04-APR-2008, the patient developed intractable vomiting and diarrhea.  The patient was hospitalized for two days.  The patient received oral and intravenous rehydration.  The stool work-up was negative with the exception of being positive for Rotavirus.  The patient had a recorded temperature in the hospital of 102F.  The patient was seen in the office on 07-APR-2008.  The patient recovered on an unspecified date.  A product quality complaint was not involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Chest pain, Electrocardiogram normal, Skin discolouration
Clinical narrative: Initial report received on 10 April 2008 from a pharmacist.  A 19-year-old female patient, with no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a first, intramuscular, left arm dose of ADACEL (Lot # C2842AA), and a second, subcutaneous, left arm dose of "MMRII" (manufacturer Merck, Lot # 0748U) on 19 November 2007.  Thirty-five days after receiving the vaccinations, the patient developed chest pain and her hands turned blue.  She was taken to the emergency room where cardiac and neurology consults were completed.  An Echocardiogram and diagnostic laboratory data were within normal limits.  The patient was discharged from the emergency room with a heart monitor that she wore for one month.  The results of the heart monitor readings were not provided.  One-hundred-five days later, the patient again developed chest pain, and her hands turned blue.  It was not reported whether the patient was medically evaluated that time, or if treatments were received, or diagnostic tests performed.  The recovery status of the patient was not reported.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Patient was DOA at local hospital 3 days after immunes were given.  2/27/09 Autopsy report states COD as sudden unexplained death of infant & manner of death as undetermined.  Autopsy report also states patient's caregiver was smoker; patient co-sleeping w/2 adults who had used alcohol & marijuana.    04/29/08 Reviewed ER medical records of 4/06/08. FINAL DX: full cardiopulmonary arrest & prehospital death of uncertain cause. Records reveal patient arrived in ER asystolic w/pupils fixed & dilated, rigor mortis already present, cyanotic, mottled, early livido w/CPR in progress.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Haematochezia, Intussusception, Surgery, Vomiting
Clinical narrative: 8 days after receiving 1st set of immunizations (including Rotateq) Pt developed bilious vomiting and blood in stool. Sent to ED and found to have ileocecal intussusception. Pt had an ileocecetomy.  5/9/08 Reviewed hospital medical records of 1/11-1/15/2008. FINAL DX: Ileocecal intussusception, surgically reduced & appendectomy Records reveal patient experienced abdominal distention, hypoactive BS & bilious vomiting.  Air contrast enema reduction initially thought to be successful but did not improve & developed significant abdominal distention.  Repeat abdominal x-ray c/w IS.  Repeat air contrast enema unsuccessful.  Taken to OR for ileocecectomy w/primary anastamosis.  Progressed well postoperatively & d/c to home.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Antiphospholipid syndrome, Arthralgia, Fatigue, Headache, Thrombosis
Clinical narrative: Given Anthrax vaccine #4 (lot# FAV069) on 9-6-03 noticed subtle physical change - joint pain, fatigue, head-aches & a large varicose vein on my lower left leg.  In June 2007 I had 3 blood clots in same leg & was diagnosed w/ autoimmune disease - antiphospholipid syndrome - non-curable.  Taking Coumadin daily for rest of my life.  06/23/2008 MR received dated 9/04/2007-1/09/2008 with DX: Antiphospholipid antibody syndrome manifested with DVT of the LLE in conjuntion with a prolonged APTT and dilute Russell viper venom time of significant inhibition on a 1:1 mix; presence of lupus anticoagulant, presence of phospholipid IgG antibody, and presence of beta 2 GPI antibody IgGs.  In addition, the beta 2 GPI antibody IgA was borderline. DVT. Migraine Headaches.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Varicose vein
Clinical narrative: Given Anthrax vaccine #4 (lot# FAV069) on 9-6-03 noticed subtle physical change - joint pain, fatigue, head-aches & a large varicose vein on my lower left leg.  In June 2007 I had 3 blood clots in same leg & was diagnosed w/ autoimmune disease - antiphospholipid syndrome - non-curable.  Taking Coumadin daily for rest of my life.  06/23/2008 MR received dated 9/04/2007-1/09/2008 with DX: Antiphospholipid antibody syndrome manifested with DVT of the LLE in conjuntion with a prolonged APTT and dilute Russell viper venom time of significant inhibition on a 1:1 mix; presence of lupus anticoagulant, presence of phospholipid IgG antibody, and presence of beta 2 GPI antibody IgGs.  In addition, the beta 2 GPI antibody IgA was borderline. DVT. Migraine Headaches.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Dyskinesia, Heart rate increased, Hyperaesthesia, Physical examination normal
Clinical narrative: Patient has immunization on 3/25 - was fed 30min later well about 1 hour later, patient seemed  jerky to parents and patient would jerk with slightest of touch. Patient had Temperature of 101 24 hours later. Patient given Tylenol; Temperature our office 2hr later 99.6/ Patient seen with nl exam on 3/26 except HR 160
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Temperature 103.6 - irritability for 48 hours.  Onset for 24 hours 3/25/08 8 hours post immunization.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Dysphagia, Throat irritation
Clinical narrative: After inj. while driving had sensation "fog in throat" and difficulty swallowing. Called 911 and pulled to side of road. Paramedics arrived and pt OK.  No epi given. Sensation gone. Pt never lost ability to swallow. Called office to notify. Rx for Benadryl and Prednisone if needed. Spoke w/pt next day and everything fine.
Age: 44.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Eye pruritus, Injection site rash, Ocular hyperaemia, Tachycardia
Clinical narrative: Rash on Rt arm near injection site; episodes of tachycardia; eyes itchy & red; started day after injections; continued - and gradually resolved by 4-14-08.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Patient c/o slight dizziness while in mother's vehicle.  Patient c/o headache pain scale 7/10.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: rash at site within 6 hrs -extreme redness and swelling picture available on request
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abscess, Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Localized redness, tenderness to touch, arm swelling, hot to touch; Treatment Septra DS 1 tab PO BID x 10d
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: NONE. No adverse event occured. We were instructed to file thi by our local DPH immunization manager because Boostrix not Adacel.
Age: 16.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Abdominal pain upper, Heart rate increased, Nausea, Pallor
Clinical narrative: Nausea, stomach pains, very pale, heart beating very fast.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Had Menactra on 4/2/08. Broke out in hives AM of 4-4-08. At one point had some shortness of Breath - has resolved.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Nausea, Vomiting
Clinical narrative: Severe nausea and vomiting 4 hours after shot, lasted "a few hours"; felt weak the next day.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction, Oedema peripheral, Pyrexia, Rash pustular
Clinical narrative: Had Varivax on 4-1 Now with fever and swelling; left arm swollen trice  P 1cm pink approximately central red pustule - Local immunization reaction
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Developmental delay, Pyrexia, Speech disorder
Clinical narrative: Mother reports pt started running fever and after he awoke from a nap he had lost milestones. He could not talk any longer. He ran fever of 100-102.5 for 3 days. She took him to doctor for follow up. Doctor referred him to neurologist.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: On 3/21/08, child developed a fever of 102.2 which lasted for 3 days.  On 3/24/08, fever broke and child broke out with a red rash over entire body.  Rash was slightly raised.  Rash was gone by 3/27/08.  Was seen by provider on 3/24/08 and doctor thought it might be related to getting vaccines.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient c/o redness and swelling at injection site for 2 days with blister.  Keflex prescribed.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC
Symptoms: Lethargy, Rash, Vomiting
Clinical narrative: 5 days after, vomiting, 1/2 a day- then non raised rash began at midsection traveling to extremities. Took apx. one  month to clear up. Child was lethargic during this time. Rash did not itch. Under skin surface
Age: 9.0
Sex: M
Vaccine: DT, MMR
Symptoms: Unevaluable event
Clinical narrative: "None"
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: DTaP given 4/8/08 in Lt thigh.  Afternoon/eve of 4/9/08 - L thigh red & swollen.  Swollen & red from diaper line to knee.  Warm, fever 102 degrees 4/10/08.  4/12/08 - swelling subsided.  Still on 4/14/08 looks bruised & greyish, still tender.  Used dry heat to area & Tylenol.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: DTaP given 4/8/08 in Lt thigh.  Afternoon/eve of 4/9/08 - L thigh red & swollen.  Swollen & red from diaper line to knee.  Warm, fever 102 degrees 4/10/08.  4/12/08 - swelling subsided.  Still on 4/14/08 looks bruised & greyish, still tender.  Used dry heat to area & Tylenol.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dysphagia, Musculoskeletal stiffness, Oedema peripheral, Pain
Clinical narrative: Complained of left arm swelling, ache, joints pain, sore throat and swelling, fever 101-102 F, difficulty swallowing, itchiness.  Generalized rash, and stiffness on neck on 3/18.  Still complaining joints pain, stiffening of neck.  Rash noted on chest.  Takes OTC Benadryl, Tylenol, Ecotrin aspirin, and Valium for sleep 3-27-08.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngeal oedema, Pharyngolaryngeal pain, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Complained of left arm swelling, ache, joints pain, sore throat and swelling, fever 101-102 F, difficulty swallowing, itchiness.  Generalized rash, and stiffness on neck on 3/18.  Still complaining joints pain, stiffening of neck.  Rash noted on chest.  Takes OTC Benadryl, Tylenol, Ecotrin aspirin, and Valium for sleep 3-27-08.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: 6:00 pm the evening of the vaccine admin. started running a fever around 102 deg-off and on thru the night- then 4/15/08 in the aft. around 1:00 pm-temp- 103- and then 104.3 around 4:00 pm-also more fussy-irritable- and decreased appetite
Age: 39.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Pruritus, Rash
Clinical narrative: Patient was administered two vaccines, Typhim VI and Menactra on 04/16/2008 at 5:30PM.  At 1:00AM on 4/17/2008 the patient awoke with pruritis and and a ill defined rash on his trunk, arms, and upper thighs.  There were no respiratory or other symptoms noted.  The patient presented to the Occupational Health Clinic at approximately 9:00AM on 4/17/2008 with the same complaint of itching.  He reported that he had taken no medications for his symptoms, although at approximately 7:00PM on 4/16/2008 he had taken Mobic 7.5MG for an ankle injury.  He reports that he just started taking this medication a "couple of days before" as prescribed by his orthopaedic physician.  There were no signs of respiratory distress.  After assessment the patient was given 50 MG of PO Benadryl.  On follow up with the patient at 10:30AM on 4/17/2008 he was asymptomatic.  The patient was told to follow up with his physician and to contact this provider if there were any further issues.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site vesicles, Rash vesicular
Clinical narrative: Eight days after vaccine patient developed 2-3 pruritic varicella blister lesions at site of injection.
Age: 10.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site induration, Rash pruritic
Clinical narrative: Patient came into the clinic with a large induration around the right deltoid and a itchy rash the extended to the elbow after the 2nd Anthrax shot.  The patient was directed by the doctor to take Tylenol or Motrin prior to next Anthrax immunizations and to take Benadryl after the vaccination.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Computerised tomogram normal, Gastritis, Malaise, Pyrexia, X-ray normal
Clinical narrative: Gastritis, Zantac IV Fever, malaise, Tylenol
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Joint swelling, Lymphadenopathy, Oedema peripheral, Urticaria
Clinical narrative: PT WAS GIVEN THE TYPHIM VACCINE ON 4-10-08.  ON THE AFTERNOON OF 4-11-08 PT STARTED TO HAVE SWOLLEN GLANDS IN THE BACK OF HER HEAD AND NECK.  THIS CONTINUED ON AND SHE STILL HAS THEM TODAY.  ON THE MORNING OF THE 14TH THE PATIENT WOKE UP AND BROKE OUT IN HIVES.  THESE RESOLVED WITHIN 2 DAYS.  ON THE AFTERNOON OF THE 16TH PT STARTED TO HAVE JOINT PAIN AND SWELLING IN HER WRISTS, ELBOWS, HANDS, AND ANKLES.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HBHEPB, PNC, RV5
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: Patient received an extra dose of Hepatitis B vaccine on this same day.
Age: 37.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Local reaction, Pyrexia, Rash, Skin warm, Tenderness
Clinical narrative: Patient reports extreme local reaction beginning 2 hours post-vaccination.  Reaction stemming from subcutaneous vaccine site of the left extremity continuing up through deltoid region.  Reports welts, raised skin area that is gradually resolving.  Area noted today to be approximately softball size at posterior arm, very heated and tender to touch.  Also, patient reports fever up to 101 starting yesterday.
Age: 37.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient reports extreme local reaction beginning 2 hours post-vaccination.  Reaction stemming from subcutaneous vaccine site of the left extremity continuing up through deltoid region.  Reports welts, raised skin area that is gradually resolving.  Area noted today to be approximately softball size at posterior arm, very heated and tender to touch.  Also, patient reports fever up to 101 starting yesterday.
Age: 73.0
Sex: M
Vaccine: DTOX, PPV
Symptoms: Hypokinesia, Injection site pain, Metabolic function test, Muscle spasms
Clinical narrative: About 2 hrs after receiving both dT and Pneumovax in the Right deltoid (on 4/14), he experienced local soreness and inability to lift the right arm.  He also experienced muscular cramps in arms, legs and abdomen.  The cramps have persisted, but he could raise the right arm on 4/16.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Swelling
Clinical narrative: Erythema, swelling, cellulitis like reaction with induration.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: About 6 hours after PPV shot was administered, rt (injection) arm became very painful. 10 on a 10 scale. Patient was up all night because pain was so intense. Sometimes shooting to other body parts. Feet, shins, knees, head and neck were affected. Some pain 48 hrs later, but worst was from 6 to 32 hours after injection.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Muscle contractions involuntary, Pallor
Clinical narrative: After first dose of Gardasil given and completed, client briefly lost consciousness.  Client leaned to right of chair, caught by RN, Left arm contracted, returned to consciousness within one minute or less.  Alert and oriented immediately after episode.  Mildly pale, not dizzy.  Stayed 15 minutes, drank juice and then left accompanied by mother without further incident.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: A day after receiving Td booster, felt sore and achy to left upper arm and noticed tenderness in left axilla.
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. was given Dtap vs. Tdap or TD booster after an updated vaccine was needed.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: One day after vaccine, injection site became red, swollen, hot to the touch. There was also a hard lump. Patient seen in this office today. Arm better, but still swollen, red, & hot to the touch. Patient put on Benadryl, 1 1/2 tsp. q 6 hours. Patient to return tomorrow for follow-up.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema peripheral
Clinical narrative: SWELLING LIMB TO LIMB. HOT TO TOUCH. SWELLING IS WRAPPING AROUND THE APPENDAGE. PRESCRIBED FEXOFENADINE AND MOTRIN TO CONTROL SWELLING AND POSSIBILITY OF STEROIDS IF SWELLING CONTINUES OVER NIGHT.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Reaction of difficult breathing, chest and throat pains, fever, fast heart beats.  Patient complained of symptoms on 4/16/08 @ approx 10:00 p.m., one day after shot was administered.