chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Diarrhoea, Gastroenteritis viral, Headache, Lumbar puncture normal
Clinical narrative: Initial report received on 13 November 2007 from a health care professional. A 35-year-old female patient, with no concurrent illnesses or pre-existing medical conditions, had received a right deltoid dose of DECAVAC, lot number U1961EA, on 06 November 2007. The route of administration was not provided. The following day, the patient presented to the emergency room with complaint of headache, neck pain, temperature of 101.5 degrees Fahrenheit, nausea, and diarrhea. She was treated with intravenous fluids, ROCEPHIN, and TORADOL, and was diagnosed with viral gastroenteritis. A lumbar puncture was completed and was negative for meningitis. The patient was discharged to home the same day with VICODIN for her headache. At the time of this report, it was "unknown" if the patient had fully recovered. Follow-up information received on 14 December 2007 from a health care professional. There was no illness at the time of vaccination, and the patient was taking no other medication. The patient had not received any other vaccinations within four weeks of the 06 November 2007 vaccination. The reporter for this case is the same as for case 2007-03867.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Neck pain
Clinical narrative: Initial report received on 13 November 2007 from a health care professional. A 35-year-old female patient, with no concurrent illnesses or pre-existing medical conditions, had received a right deltoid dose of DECAVAC, lot number U1961EA, on 06 November 2007. The route of administration was not provided. The following day, the patient presented to the emergency room with complaint of headache, neck pain, temperature of 101.5 degrees Fahrenheit, nausea, and diarrhea. She was treated with intravenous fluids, ROCEPHIN, and TORADOL, and was diagnosed with viral gastroenteritis. A lumbar puncture was completed and was negative for meningitis. The patient was discharged to home the same day with VICODIN for her headache. At the time of this report, it was "unknown" if the patient had fully recovered. Follow-up information received on 14 December 2007 from a health care professional. There was no illness at the time of vaccination, and the patient was taking no other medication. The patient had not received any other vaccinations within four weeks of the 06 November 2007 vaccination. The reporter for this case is the same as for case 2007-03867.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Hypoaesthesia, Pain in extremity, Radiculitis brachial
Clinical narrative: Initial report received on 15 November 2007 from a nurse. A 34-year-old male with concurrent illness of cough and sore throat, and who had a past medical history of "(?) leaky valve", had received a left deltoid intramuscular dose of DECAVAC (lot number U1954AB) on 05 November 2007. Twenty-four hours post-vaccination, the patient developed brachial neuritis and had pain from the shoulder to the fingers. His third and fourth fingers were numb. Three days after vaccination (approximately 08 November 2007) the numbness in the fingers were gone; and the patient had developed numbness from the left elbow to the left shoulder and left ribs. At the time of this report, the patient had not sought medical attention and no treatment was reported. At the time of this report, the patient had not recovered. Follow-up information was received from the reporter on 28 December 2007 which noted that the patient was being referred to an Infection Control Nurse. No other medically significant information was provided. Follow-up information received on 19 February 2008 from a health care professional. Copies of medical records were provided to the patient. Per the reporter, there was no additional information.
Sex: F
Vaccine: FLUX, HEPA, IPV, MNQ, TD, TYP
Symptoms: Alopecia, Dark circles under eyes, Skin wrinkling
Clinical narrative: This case was reported by a health professional on 04 September 2007.  A female patient with no reported medical history received injections of DECAVAC, FLUZONE, IPOL, MENOMUNE, TYPHIM VI, and HAVRIX (manufacturers and lot numbers not reported) on 20 December 2006.  "Almost immediately", the patient reported that she experienced "dark circles under my eyes, bags under my eyes, a permanent tired line in my face, and hair loss".  Per the reporter, the events were ongoing.  Follow-up information received on 26 November 2007 from a health care professional.  The reporter provided the following information concerning the vaccines administered.  DECAVAC, lot number U1880DA was administered in the left deltoid; MENACTRA, lot number U2135AA, was administered in the left deltoid; IPOL, lot number Z0306, was administered in the right arm; FLUZONE, lot number ASLUA203BA, (not a valid sanofi pasteur lot number), was administered in the right deltoid; TYPHIM VI, lot number Z0572, was administered in the right deltoid; and HAVRIX, manufacturer GSK, lot number AHAVB109, was administered in the right deltoid.  Contact information was provided for the physician who was following the patient.  The reporter indicated that she does not know if the patient had recovered and that she does not have additional information to provide regarding this case.  The patient's husband also reported experiencing dark circles under eyes, bags under eyes, and a permanent tired line in the face after receiving the above vaccines; this information is captured in case number 2007-02806.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Autoimmune disorder, Chest discomfort, Dyspnoea, Muscle spasms, Pruritus
Clinical narrative: This case was reported by the patient, who is a physician, on 03 January 2008. A 65-year-old female patient received a right deltoid intramuscular injection of DECAVAC on 12 December 2007 (lot number reported as ZV1958BA; not a valid sanofi-pasteur lot number). The patient had a history of post-infectious migratory arthritis secondary to a Shigella gastrointestinal infection (1991-1992). She had suffered severe arthritis for two years following the infection, but other than a flare in 1996 following a knee injury, the condition had settled down. Relevant medical history also included positive anti-nuclear antibodies and positive human leukocyte antigen B27. Concomitant medications included daily aspirin and RESTASIS eye drops. On 15 December 2007, three days after vaccination, the patient was awoken at midnight with bilateral thigh cramps which she described as 'the worse pain she had ever experienced in her life". The cramps persisted for approximately five hours, and then resolved. On 24 or 25 December 2007, she began to notice a maculopapular, erythematous, pruritic rash which began on her upper chest and spread to her entire chest, neck, upper arms, and axillary area. At the time of the report, the rash was fading on the chest, but persisted on the arms. She also developed pruritus of both lower legs, with no associated rash. She had seen a physician who informed her that the rashes were "due to the Td vaccination" and they were "related to her underlying autoimmune disease". In addition, approximately five to six days post-vaccination, the patient reported chest tightness and mild shortness of breath after swimming; this resolved within a couple of days. She was scheduled to see her rheumatologist for follow-up.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: This case was reported by the patient, who is a physician, on 03 January 2008. A 65-year-old female patient received a right deltoid intramuscular injection of DECAVAC on 12 December 2007 (lot number reported as ZV1958BA; not a valid sanofi-pasteur lot number). The patient had a history of post-infectious migratory arthritis secondary to a Shigella gastrointestinal infection (1991-1992). She had suffered severe arthritis for two years following the infection, but other than a flare in 1996 following a knee injury, the condition had settled down. Relevant medical history also included positive anti-nuclear antibodies and positive human leukocyte antigen B27. Concomitant medications included daily aspirin and RESTASIS eye drops. On 15 December 2007, three days after vaccination, the patient was awoken at midnight with bilateral thigh cramps which she described as 'the worse pain she had ever experienced in her life". The cramps persisted for approximately five hours, and then resolved. On 24 or 25 December 2007, she began to notice a maculopapular, erythematous, pruritic rash which began on her upper chest and spread to her entire chest, neck, upper arms, and axillary area. At the time of the report, the rash was fading on the chest, but persisted on the arms. She also developed pruritus of both lower legs, with no associated rash. She had seen a physician who informed her that the rashes were "due to the Td vaccination" and they were "related to her underlying autoimmune disease". In addition, approximately five to six days post-vaccination, the patient reported chest tightness and mild shortness of breath after swimming; this resolved within a couple of days. She was scheduled to see her rheumatologist for follow-up.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Chest discomfort, Condition aggravated, Dyspnoea, Muscle spasms, Pruritus
Clinical narrative: This case was reported by the patient, who is a physician, on 03 January 2008. A 65-year-old female patient received a right deltoid intramuscular injection of DECAVAC on 12 December 2007 (lot number reported as ZV1958BA; not a valid sanofi-pasteur lot number). The patient had a history of post-infectious migratory arthritis secondary to a Shigella gastrointestinal infection (1991-1992). She had suffered severe arthritis for two years following the infection, but other than a flare in 1996 following a knee injury, the condition had settled down. Relevant medical history also included positive anti-nuclear antibodies and positive human leukocyte antigen B27. Concomitant medications included daily aspirin and RESTASIS eye drops. On 15 December 2007, three days after vaccination, the patient was awoken at midnight with bilateral thigh cramps which she described as 'the worse pain she had ever experienced in her life". The cramps persisted for approximately five hours, and then resolved. On 24 or 25 December 2007, she began to notice a maculopapular, erythematous, pruritic rash which began on her upper chest and spread to her entire chest, neck, upper arms, and axillary area. At the time of the report, the rash was fading on the chest, but persisted on the arms. She also developed pruritus of both lower legs, with no associated rash. She had seen a physician who informed her that the rashes were "due to the Td vaccination" and they were "related to her underlying autoimmune disease". In addition, approximately five to six days post-vaccination, the patient reported chest tightness and mild shortness of breath after swimming; this resolved within a couple of days. She was scheduled to see her rheumatologist for follow-up.
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Initial report received from a health care professional on 21 December 2007. A 60-year-old female received an intramuscular injection of DECAVAC, lot number 01958CA (invalid Sanofi Pasteur lot number), on 04 October 2007 after stepping on glass. Four days later, on 08 October 2007, the patient experienced swelling and redness at the site of injection. The reaction was approximately 6 cm in size. The patient was evaluated by a physician that day and was treated with DECADRON 1 mg and DEPOMEDROL 20 mg. On 10 October 2007 she was treated with KEFLEX. By 12 October 2007, there was less redness and swelling noted. It is unknown whether the patient recovered from the event.
Age: 59.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 21 December 2007. A 60-year-old female received an intramuscular injection of DECAVAC, lot number 01958CA (invalid Sanofi Pasteur lot number), on 04 October 2007 after stepping on glass. Four days later, on 08 October 2007, the patient experienced swelling and redness at the site of injection. The reaction was approximately 6 cm in size. The patient was evaluated by a physician that day and was treated with DECADRON 1 mg and DEPOMEDROL 20 mg. On 10 October 2007 she was treated with KEFLEX. By 12 October 2007, there was less redness and swelling noted. It is unknown whether the patient recovered from the event.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Arthritis, Injection site discomfort, Injection site induration, Injection site pain, Musculoskeletal pain
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT (assessed 17 January 2008). A 34 year old male patient received on 06 August 2007 a dose of DECAVAC (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, a day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "PREDNISONE shots". Relevant diagnostics test was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, see needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into a shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. Based upon this new information, it was determined that the event meets the seriousness criteria for "Other-medically significant". In light of this new information, the case has been upgraded to serious. The patient received because in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of "a 50-cent piece". An MRI revealed an edematous rotator cuff. Since then, he had been treated with several courses of PREDNISONE, local injections of KENALOG into the bursa and muscle tendon, and oral DECADRON. He also underwent physical therapy. Per the reporter, the patient had experienced range of motion and decreased pain after initiating therapy with DECADRON.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT (assessed 17 January 2008). A 34 year old male patient received on 06 August 2007 a dose of DECAVAC (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, a day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "PREDNISONE shots". Relevant diagnostics test was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, see needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into a shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. Based upon this new information, it was determined that the event meets the seriousness criteria for "Other-medically significant". In light of this new information, the case has been upgraded to serious. The patient received because in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of "a 50-cent piece". An MRI revealed an edematous rotator cuff. Since then, he had been treated with several courses of PREDNISONE, local injections of KENALOG into the bursa and muscle tendon, and oral DECADRON. He also underwent physical therapy. Per the reporter, the patient had experienced range of motion and decreased pain after initiating therapy with DECADRON.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Arthritis, Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site induration
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT (assessed 17 January 2008). A 34 year old male patient received on 06 August 2007 a dose of DECAVAC (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, a day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "PREDNISONE shots". Relevant diagnostics test was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, see needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into a shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. Based upon this new information, it was determined that the event meets the seriousness criteria for "Other-medically significant". In light of this new information, the case has been upgraded to serious. The patient received because in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of "a 50-cent piece". An MRI revealed an edematous rotator cuff. Since then, he had been treated with several courses of PREDNISONE, local injections of KENALOG into the bursa and muscle tendon, and oral DECADRON. He also underwent physical therapy. Per the reporter, the patient had experienced range of motion and decreased pain after initiating therapy with DECADRON.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Oedema, Pain
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT (assessed 17 January 2008). A 34 year old male patient received on 06 August 2007 a dose of DECAVAC (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, a day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "PREDNISONE shots". Relevant diagnostics test was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, see needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into a shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. Based upon this new information, it was determined that the event meets the seriousness criteria for "Other-medically significant". In light of this new information, the case has been upgraded to serious. The patient received because in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of "a 50-cent piece". An MRI revealed an edematous rotator cuff. Since then, he had been treated with several courses of PREDNISONE, local injections of KENALOG into the bursa and muscle tendon, and oral DECADRON. He also underwent physical therapy. Per the reporter, the patient had experienced range of motion and decreased pain after initiating therapy with DECADRON.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Rotator cuff syndrome
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. SERIOUSNESS CRITERIA: OTHER-MEDICALLY SIGNIFICANT (assessed 17 January 2008). A 34 year old male patient received on 06 August 2007 a dose of DECAVAC (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, a day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "PREDNISONE shots". Relevant diagnostics test was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, see needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into a shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. Based upon this new information, it was determined that the event meets the seriousness criteria for "Other-medically significant". In light of this new information, the case has been upgraded to serious. The patient received because in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of "a 50-cent piece". An MRI revealed an edematous rotator cuff. Since then, he had been treated with several courses of PREDNISONE, local injections of KENALOG into the bursa and muscle tendon, and oral DECADRON. He also underwent physical therapy. Per the reporter, the patient had experienced range of motion and decreased pain after initiating therapy with DECADRON.
Age: 1.1
Sex: M
Vaccine: MMR, PNC
Symptoms: Abnormal behaviour, Aphasia, Cough, Developmental delay, Diagnostic procedure
Clinical narrative: After 2 weeks: Fever, cough, red throat, wheezing, ear infection, loss of language, self-injurious behavior, loss of eye contact, stopped responding to name, repetitive behaviors (running in circles, lining up toys), and general developmental delays. Treatment: Amoxicillin for 10 days starting on 3/6/2007.  Other treatments: Speech, physical and occupational therapy, child development sessions, floortime therapy, and special diet for multiple food allergies. Currently receiving multiple services for developmental delays.  5/16/08 Reviewed PCP office records of 3/9/2007-4/25/2008. On 3/9/07 was on antibiotic for wheezing, cough & fever.  Was improved.  Dx: probable pneumonitis.  Returned to office w/varicella 5/22/2007.  Returned 10/6/2007 for cough & fever x 3 days. Dx w/otitis.  Visit of 1/21/2008 states patient had been doing well until 5/2007 when began to lose speech & eye contact, repetitive play.  Was receiving speech therapy & was in early intervention program for autism.  Multiple food allergies were noted.  6/3/08 Reviewed consultant records from early intervention services for 8/2007-4/2008.   FINAL DX: developmental & speech delays Records reveal patient experienced language delays, tantrums, poor eye contact, head banging, perseveration w/toys & objects.  Receives PT/OT/ST, child development specialist, floor time, center based program & respite care.
Age: 1.1
Sex: M
Vaccine: MMR, PNC
Symptoms: Disturbance in attention, Ear infection, Food allergy, Occupational therapy, Pharyngeal erythema
Clinical narrative: After 2 weeks: Fever, cough, red throat, wheezing, ear infection, loss of language, self-injurious behavior, loss of eye contact, stopped responding to name, repetitive behaviors (running in circles, lining up toys), and general developmental delays. Treatment: Amoxicillin for 10 days starting on 3/6/2007.  Other treatments: Speech, physical and occupational therapy, child development sessions, floortime therapy, and special diet for multiple food allergies. Currently receiving multiple services for developmental delays.  5/16/08 Reviewed PCP office records of 3/9/2007-4/25/2008. On 3/9/07 was on antibiotic for wheezing, cough & fever.  Was improved.  Dx: probable pneumonitis.  Returned to office w/varicella 5/22/2007.  Returned 10/6/2007 for cough & fever x 3 days. Dx w/otitis.  Visit of 1/21/2008 states patient had been doing well until 5/2007 when began to lose speech & eye contact, repetitive play.  Was receiving speech therapy & was in early intervention program for autism.  Multiple food allergies were noted.  6/3/08 Reviewed consultant records from early intervention services for 8/2007-4/2008.   FINAL DX: developmental & speech delays Records reveal patient experienced language delays, tantrums, poor eye contact, head banging, perseveration w/toys & objects.  Receives PT/OT/ST, child development specialist, floor time, center based program & respite care.
Age: 1.1
Sex: M
Vaccine: MMR, PNC
Symptoms: Physiotherapy, Pyrexia, Self injurious behaviour, Speech rehabilitation, Stereotypy
Clinical narrative: After 2 weeks: Fever, cough, red throat, wheezing, ear infection, loss of language, self-injurious behavior, loss of eye contact, stopped responding to name, repetitive behaviors (running in circles, lining up toys), and general developmental delays. Treatment: Amoxicillin for 10 days starting on 3/6/2007.  Other treatments: Speech, physical and occupational therapy, child development sessions, floortime therapy, and special diet for multiple food allergies. Currently receiving multiple services for developmental delays.  5/16/08 Reviewed PCP office records of 3/9/2007-4/25/2008. On 3/9/07 was on antibiotic for wheezing, cough & fever.  Was improved.  Dx: probable pneumonitis.  Returned to office w/varicella 5/22/2007.  Returned 10/6/2007 for cough & fever x 3 days. Dx w/otitis.  Visit of 1/21/2008 states patient had been doing well until 5/2007 when began to lose speech & eye contact, repetitive play.  Was receiving speech therapy & was in early intervention program for autism.  Multiple food allergies were noted.  6/3/08 Reviewed consultant records from early intervention services for 8/2007-4/2008.   FINAL DX: developmental & speech delays Records reveal patient experienced language delays, tantrums, poor eye contact, head banging, perseveration w/toys & objects.  Receives PT/OT/ST, child development specialist, floor time, center based program & respite care.
Age: 1.1
Sex: M
Vaccine: MMR, PNC
Symptoms: Unresponsive to stimuli, Wheezing
Clinical narrative: After 2 weeks: Fever, cough, red throat, wheezing, ear infection, loss of language, self-injurious behavior, loss of eye contact, stopped responding to name, repetitive behaviors (running in circles, lining up toys), and general developmental delays. Treatment: Amoxicillin for 10 days starting on 3/6/2007.  Other treatments: Speech, physical and occupational therapy, child development sessions, floortime therapy, and special diet for multiple food allergies. Currently receiving multiple services for developmental delays.  5/16/08 Reviewed PCP office records of 3/9/2007-4/25/2008. On 3/9/07 was on antibiotic for wheezing, cough & fever.  Was improved.  Dx: probable pneumonitis.  Returned to office w/varicella 5/22/2007.  Returned 10/6/2007 for cough & fever x 3 days. Dx w/otitis.  Visit of 1/21/2008 states patient had been doing well until 5/2007 when began to lose speech & eye contact, repetitive play.  Was receiving speech therapy & was in early intervention program for autism.  Multiple food allergies were noted.  6/3/08 Reviewed consultant records from early intervention services for 8/2007-4/2008.   FINAL DX: developmental & speech delays Records reveal patient experienced language delays, tantrums, poor eye contact, head banging, perseveration w/toys & objects.  Receives PT/OT/ST, child development specialist, floor time, center based program & respite care.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Apgar score normal, Congenital genital malformation, Dacryostenosis congenital, Delivery
Clinical narrative: Initial and follow-up information has been received for a pregnancy registry for Gardasil.  A nurse reported concerning a 23 year old female with a penicillin allergy, sulfonamide allergy, drug hypersensitivity to REGLAN and allergy to flu vaccine with a history of 1 full term delivery (no birth defects and no complications), family history of maternal diabetes who on 02-FEB-2007 was vaccinated with Gardasil, 0.5 mL in her left arm (route unspecified) (LOT# 655617/1447F).  Concomitant therapy included NUVARING, MYLANTA, ZOFRAN, and prenatal vitamins.  As of 26-APR-2007, the patient was pregnant.  Her last menstrual period was 08-FEB-2007.  It was confirmed by an office pregnancy test and unspecified "prenatal labs with blood tests" (results not reported).  On 16-APR-2007, the patient had an ultrasound with results within normal limits (WNL) and reason for testing was "dating".  No problems were reported.  As of 26-APR-2007, the patient was pregnant and was taking prenatal vitamins.  The patient's estimated date of delivery was 11-NOV-2007.  Follow-up information was received from the registered nurse via a questionnaire and medical records.  All screening ultrasounds were normal.  On 07-NOV-2007, the patient delivered a full term normal female infant 6 pounds, 12 ounces, Apgar score 8 and 9.  There were no infections or illnesses during the pregnancy.  There was no complications during the pregnancy or labor/delivery.  It was indicated on the questionnaire that the baby had congenital anomalies.  A phone call was made to the registered nurse who reported that the baby did not have any congenital anomalies and that it was an error on the questionnaire.  The mother had group B streptococci (GBS) positive and was treated with vancomycin.  On 07-NOV-2007, at birth, the baby was given vitamin K IM.  On 09-NOV-2007, the baby had mild jaundice.  On 15-NOV-2007 newborn check up, the baby had mild gynecomastia and a touch of jaundice, sclera was yellow.  Breast feeding continued.  On 17-NOV-2007, evaluation revealed the baby had green discharge on the left conjunctiva.  Diagnosis as left nasolacrimal duct stenosis.  The baby was treated with OCUFLOX.  On 07-DEC-2007, the baby had a check up.  It was reported that the baby was fussy and gassy.  The baby had colic behavior, sudden screaming and acts as if in pain.  Dx was gastroesophageal reflux.  Treatment included: continue with ofloxacin, continue breast feeding, reflux precautions and ZANTAC 1 ml twice daily.  To return in 1 month for evaluation.  The outcome of abdominal colic, left nasolacrimal duct stenosis, GERD, gynaecomastia, jaundice, and screaming was not reported.  At an office visit on 15-MAR-2008 at 4 months of age, it was noted that the baby had complete agglutination of the labia minora which was "removed".  No additional information is expected.  Medical records available upon request.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Flatulence, Gastrooesophageal reflux disease, Gynaecomastia, Irritability
Clinical narrative: Initial and follow-up information has been received for a pregnancy registry for Gardasil.  A nurse reported concerning a 23 year old female with a penicillin allergy, sulfonamide allergy, drug hypersensitivity to REGLAN and allergy to flu vaccine with a history of 1 full term delivery (no birth defects and no complications), family history of maternal diabetes who on 02-FEB-2007 was vaccinated with Gardasil, 0.5 mL in her left arm (route unspecified) (LOT# 655617/1447F).  Concomitant therapy included NUVARING, MYLANTA, ZOFRAN, and prenatal vitamins.  As of 26-APR-2007, the patient was pregnant.  Her last menstrual period was 08-FEB-2007.  It was confirmed by an office pregnancy test and unspecified "prenatal labs with blood tests" (results not reported).  On 16-APR-2007, the patient had an ultrasound with results within normal limits (WNL) and reason for testing was "dating".  No problems were reported.  As of 26-APR-2007, the patient was pregnant and was taking prenatal vitamins.  The patient's estimated date of delivery was 11-NOV-2007.  Follow-up information was received from the registered nurse via a questionnaire and medical records.  All screening ultrasounds were normal.  On 07-NOV-2007, the patient delivered a full term normal female infant 6 pounds, 12 ounces, Apgar score 8 and 9.  There were no infections or illnesses during the pregnancy.  There was no complications during the pregnancy or labor/delivery.  It was indicated on the questionnaire that the baby had congenital anomalies.  A phone call was made to the registered nurse who reported that the baby did not have any congenital anomalies and that it was an error on the questionnaire.  The mother had group B streptococci (GBS) positive and was treated with vancomycin.  On 07-NOV-2007, at birth, the baby was given vitamin K IM.  On 09-NOV-2007, the baby had mild jaundice.  On 15-NOV-2007 newborn check up, the baby had mild gynecomastia and a touch of jaundice, sclera was yellow.  Breast feeding continued.  On 17-NOV-2007, evaluation revealed the baby had green discharge on the left conjunctiva.  Diagnosis as left nasolacrimal duct stenosis.  The baby was treated with OCUFLOX.  On 07-DEC-2007, the baby had a check up.  It was reported that the baby was fussy and gassy.  The baby had colic behavior, sudden screaming and acts as if in pain.  Dx was gastroesophageal reflux.  Treatment included: continue with ofloxacin, continue breast feeding, reflux precautions and ZANTAC 1 ml twice daily.  To return in 1 month for evaluation.  The outcome of abdominal colic, left nasolacrimal duct stenosis, GERD, gynaecomastia, jaundice, and screaming was not reported.  At an office visit on 15-MAR-2008 at 4 months of age, it was noted that the baby had complete agglutination of the labia minora which was "removed".  No additional information is expected.  Medical records available upon request.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Jaundice neonatal, Pregnancy test positive, Screaming, Streptococcal identification test positive, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received for a pregnancy registry for Gardasil.  A nurse reported concerning a 23 year old female with a penicillin allergy, sulfonamide allergy, drug hypersensitivity to REGLAN and allergy to flu vaccine with a history of 1 full term delivery (no birth defects and no complications), family history of maternal diabetes who on 02-FEB-2007 was vaccinated with Gardasil, 0.5 mL in her left arm (route unspecified) (LOT# 655617/1447F).  Concomitant therapy included NUVARING, MYLANTA, ZOFRAN, and prenatal vitamins.  As of 26-APR-2007, the patient was pregnant.  Her last menstrual period was 08-FEB-2007.  It was confirmed by an office pregnancy test and unspecified "prenatal labs with blood tests" (results not reported).  On 16-APR-2007, the patient had an ultrasound with results within normal limits (WNL) and reason for testing was "dating".  No problems were reported.  As of 26-APR-2007, the patient was pregnant and was taking prenatal vitamins.  The patient's estimated date of delivery was 11-NOV-2007.  Follow-up information was received from the registered nurse via a questionnaire and medical records.  All screening ultrasounds were normal.  On 07-NOV-2007, the patient delivered a full term normal female infant 6 pounds, 12 ounces, Apgar score 8 and 9.  There were no infections or illnesses during the pregnancy.  There was no complications during the pregnancy or labor/delivery.  It was indicated on the questionnaire that the baby had congenital anomalies.  A phone call was made to the registered nurse who reported that the baby did not have any congenital anomalies and that it was an error on the questionnaire.  The mother had group B streptococci (GBS) positive and was treated with vancomycin.  On 07-NOV-2007, at birth, the baby was given vitamin K IM.  On 09-NOV-2007, the baby had mild jaundice.  On 15-NOV-2007 newborn check up, the baby had mild gynecomastia and a touch of jaundice, sclera was yellow.  Breast feeding continued.  On 17-NOV-2007, evaluation revealed the baby had green discharge on the left conjunctiva.  Diagnosis as left nasolacrimal duct stenosis.  The baby was treated with OCUFLOX.  On 07-DEC-2007, the baby had a check up.  It was reported that the baby was fussy and gassy.  The baby had colic behavior, sudden screaming and acts as if in pain.  Dx was gastroesophageal reflux.  Treatment included: continue with ofloxacin, continue breast feeding, reflux precautions and ZANTAC 1 ml twice daily.  To return in 1 month for evaluation.  The outcome of abdominal colic, left nasolacrimal duct stenosis, GERD, gynaecomastia, jaundice, and screaming was not reported.  At an office visit on 15-MAR-2008 at 4 months of age, it was noted that the baby had complete agglutination of the labia minora which was "removed".  No additional information is expected.  Medical records available upon request.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Drug screen positive, Intra-uterine death
Clinical narrative: Initial and follow-up information has been received from a registered nurse through the Merck pregnancy registry concerning an 18 year old female smoker with one previous pregnancy and one elective termination and bipolar disorder (stopped medications April 2007), an Low grade squamous intraepithelial lesion (LG SIL) PAP on 25-JUL-2007, anemia, a sister who is a carrier of cystic fibrosis, and with a history of an overdose on TYLOX in February 2007, who on 25-JUL-2007 was vaccinated intramuscularly in the left deltoid with a 0.5mL first dose of GARDASIL (Lot# 658222/0927U). Other concomitant therapy included ferrous sulfate. Subsequently, the patient was pregnant. At the time of the vaccination with GARDASIL the patient had a negative pregnancy test. The patient's last menstrual period was 13-JUL-2007 and her estimated date of delivery was 18-APR-2008. The patient called the physician. A pregnancy test was performed (no results provided). On 08-OCT-2007 the patient was vaccinated with a 0.5cc dose of influenza virus vaccine (unspecified). On 08-OCT-2007 an ultrasound was performed for viability and dating the results were "IUP - FH x 2" twins and a urine test for THC was positive. On 06-NOV-2007 a serum alpha-fetoprotein test was performed for genetic screening and was within normal limits. On 16-NOV-2007 a level II ultrasound was performed and was within normal limits, however showed an echogenic foci for twin B. On 18-NOV-2007 the patient went to the emergency room with the complaint of stomach pain and was treated with IV famotidine (MSD), and REGLAN. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Follow-up information indicated that on 30-JAN-2008 it was determined that there was a demise of Twin A with an estimated gestational age of 28 weeks. However, the demise of Twin A took place at 22 weeks. On 06-FEB-2008 and 07-FEB-2008 the patient received a dose of CELESTONE SOLUSPAN to enhance fetal lung maturity. On 26-FEB-2008, Twin A was stillborn. An autopsy was performed and showed no anomalies for Twin A. On 26-FEB-2008 the patient gave birth to twin B at 32.4 weeks from her last menstrual period. Twin B was a male that weighed 3 pounds 4 ounces, was 15 1/2 inches long, had a head circumference of 27, and an apgar score of 7/9. The infant was born premature and it was reported that there were no complications during the delivery. Twin B was normal with no congenital anomalies. Twin B was transferred to the neonatal intensive care unit (NICU) secondary to prematurity. It was reported that there were several ultrasounds performed during the pregnancy and PIH tests post demise of Twin A. Upon internal review intra-uterine death was considered to be an other important medical event. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal, Laboratory test normal, Pregnancy test, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a registered nurse through the Merck pregnancy registry concerning an 18 year old female smoker with one previous pregnancy and one elective termination and bipolar disorder (stopped medications April 2007), an Low grade squamous intraepithelial lesion (LG SIL) PAP on 25-JUL-2007, anemia, a sister who is a carrier of cystic fibrosis, and with a history of an overdose on TYLOX in February 2007, who on 25-JUL-2007 was vaccinated intramuscularly in the left deltoid with a 0.5mL first dose of GARDASIL (Lot# 658222/0927U). Other concomitant therapy included ferrous sulfate. Subsequently, the patient was pregnant. At the time of the vaccination with GARDASIL the patient had a negative pregnancy test. The patient's last menstrual period was 13-JUL-2007 and her estimated date of delivery was 18-APR-2008. The patient called the physician. A pregnancy test was performed (no results provided). On 08-OCT-2007 the patient was vaccinated with a 0.5cc dose of influenza virus vaccine (unspecified). On 08-OCT-2007 an ultrasound was performed for viability and dating the results were "IUP - FH x 2" twins and a urine test for THC was positive. On 06-NOV-2007 a serum alpha-fetoprotein test was performed for genetic screening and was within normal limits. On 16-NOV-2007 a level II ultrasound was performed and was within normal limits, however showed an echogenic foci for twin B. On 18-NOV-2007 the patient went to the emergency room with the complaint of stomach pain and was treated with IV famotidine (MSD), and REGLAN. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Follow-up information indicated that on 30-JAN-2008 it was determined that there was a demise of Twin A with an estimated gestational age of 28 weeks. However, the demise of Twin A took place at 22 weeks. On 06-FEB-2008 and 07-FEB-2008 the patient received a dose of CELESTONE SOLUSPAN to enhance fetal lung maturity. On 26-FEB-2008, Twin A was stillborn. An autopsy was performed and showed no anomalies for Twin A. On 26-FEB-2008 the patient gave birth to twin B at 32.4 weeks from her last menstrual period. Twin B was a male that weighed 3 pounds 4 ounces, was 15 1/2 inches long, had a head circumference of 27, and an apgar score of 7/9. The infant was born premature and it was reported that there were no complications during the delivery. Twin B was normal with no congenital anomalies. Twin B was transferred to the neonatal intensive care unit (NICU) secondary to prematurity. It was reported that there were several ultrasounds performed during the pregnancy and PIH tests post demise of Twin A. Upon internal review intra-uterine death was considered to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the first, second and third dose of Gardasil. Subsequently, the patient experienced amenorrhea for various durations, (up to several months, after receiving all three doses of Gardasil. The patient had "no pain, just no periods." The patient sought unspecified medical attention. The patient received DEPO PROVERA to induce a period several weeks after the first missing period. Subsequently, the patient recovered. No product quality complaint was involved. Amenorrhea was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning an 18-20 year old female who on an unspecified date was vaccinated with her first dose of Gardasil (lot number, route and site not reported). On an unspecified date the patient was vaccinated with her second dose of Gardasil (lot number, route and site not reported). The nurse practitioner reported that the patient experienced seizures the day after receiving the second dose of Gardasil. The patient's outcome was not reported. No further information was provided. Upon internal review seizures were considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion, Hypotension, Syncope
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown) with a history of fainting while seeing blood, who, on an unspecified date, was vaccinated with a second dose of Gardasil.  Subsequently, the patient experienced very low blood pressure, fainted, and had a seizure.  At the time of the report, the outcome of the patient was unknown.  Upon internal review seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with depression and no known drug allergies, who on 19-FEB-2008 was vaccinated with the first dose of Gardasil.  Concomitant therapy included EFFEXOR and TOPAMAX.  On 21-FEB-2008 the patient developed urticaria after administration of her first dose of Gardasil.  The patient was examined in the Emergency Room and was treated with epinephrine and prednisone.  She was not admitted and was released the same day (date unknown).  No diagnostic laboratory testing was performed.  It was reported that she was currently taking prednisone and an antihistamine.  At the time of this report, the outcome had not recovered.  No product quality complaint was involved.  The reporting physician considered the urticaria to be disabling, due to the patient's mental stress.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pancreatitis
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old male with allergic reaction to CIPRO and hypertension who on 07-APR-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included LIPITOR, lisinopril and aspirin. Subsequently the patient developed pancreatitis and was hospitalized. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.