chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Arthralgia, Blood immunoglobulin M decreased, Full blood count normal, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with second dose of GARDASIL. Subsequently on an unspecified date the patient experienced joint pain after receiving the second dose of GARDASIL. Unspecified medical attention was sought. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a physician concerning a 16 year old female who on 11-APR-2008 was vaccinated with GARDASIL (lot# 657737/0522U) in the left arm. On 15-APR-2008 the patient experienced patient experienced arthralgia and myalgia. Follow-up information was also received from medical records. The patient was seen in the office on 29-APR-2008. On 15-APR-2008 "two weeks ago" the patient developed soreness in both shoulders along the anterior head of the biceps tendon and over the lechial tuberosities bilaterally and in the right knee. The patient had been playing tennis intensely, but stopped that for about a week but the pain seemed to get worse. The patient had taken ALEVE in the morning and acetaminophen (+) diphenhydramine hydrochloride. A tick was removed from the left side of her abdomen about two weeks ago. They believe it was only attached for less than a day and was not apparently engorged. There was mild tenderness over the short head of the biceps bilaterally. There was no other joint inflammation apparent. There was no tenderness or swelling. The tick bite appeared to be healing well. The assessment was that myalgia and arthralgia was probably from heavy tennis playing. The physician could not exclude a reaction to the GARDASIL or an affect of the tick bite. Diclofenac sodium was given to the patient for the next two weeks. The patient was to return if symptoms are unresolved in the next several weeks and sooner if a rash, fever or other joint pain developed. A complete blood cell count with differential/platelet, lyme AB, rheumatoid arthritis factor and sedimentation rate were performed and the results were normal. On 12-MAY-2008 the symptoms were much better. The patient was not playing tennis, mother felt heavy tennis practice was most likely cause the symptoms. The third dose was scheduled for 11-AUG-2008. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with second dose of GARDASIL. Subsequently on an unspecified date the patient experienced joint pain after receiving the second dose of GARDASIL. Unspecified medical attention was sought. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a physician concerning a 16 year old female who on 11-APR-2008 was vaccinated with GARDASIL (lot# 657737/0522U) in the left arm. On 15-APR-2008 the patient experienced patient experienced arthralgia and myalgia. Follow-up information was also received from medical records. The patient was seen in the office on 29-APR-2008. On 15-APR-2008 "two weeks ago" the patient developed soreness in both shoulders along the anterior head of the biceps tendon and over the lechial tuberosities bilaterally and in the right knee. The patient had been playing tennis intensely, but stopped that for about a week but the pain seemed to get worse. The patient had taken ALEVE in the morning and acetaminophen (+) diphenhydramine hydrochloride. A tick was removed from the left side of her abdomen about two weeks ago. They believe it was only attached for less than a day and was not apparently engorged. There was mild tenderness over the short head of the biceps bilaterally. There was no other joint inflammation apparent. There was no tenderness or swelling. The tick bite appeared to be healing well. The assessment was that myalgia and arthralgia was probably from heavy tennis playing. The physician could not exclude a reaction to the GARDASIL or an affect of the tick bite. Diclofenac sodium was given to the patient for the next two weeks. The patient was to return if symptoms are unresolved in the next several weeks and sooner if a rash, fever or other joint pain developed. A complete blood cell count with differential/platelet, lyme AB, rheumatoid arthritis factor and sedimentation rate were performed and the results were normal. On 12-MAY-2008 the symptoms were much better. The patient was not playing tennis, mother felt heavy tennis practice was most likely cause the symptoms. The third dose was scheduled for 11-AUG-2008. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: Information has been received from a nurse concerning a 13 year old female with no medical history or known drug allergies who on 24-APR-2008 was vaccinated IM with a 0.5 mL first dose of GARDASIL (lot # 659653/1448U).  There was no concomitant medication.  On 24-APR-2008, 20 minutes after receiving the dose, the patient developed a red rash on her left face, chin, and neck.  The rash consisted of an area of redness, without lesions.  There was no itching or respiratory problems.  The nurse practitioner treated the patient with an unspecified steroid injection and prescribed a MEDROL dose pack.  The patient was seen in the office on 28-APR-2008, for an unrelated illness, and the rash had resolved.  No product quality complaint was involved.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health care worker concerning a female (age not reported) who on an unspecified date was vaccinated with a second dose of GARDASIL. Subsequently the patient fainted after receiving the second dose of GARDASIL. Unspecified medical attention was sought. At the time of reporting it was unknown if the patient had recovered. No further information is available. This report is one of two reports from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a female with a history of obesity who on 19-FEB-2008 was vaccinated with a first dose of GARDASIL (lot # not reported) and has not menstruated. Concomitant therapy included MENACTRA (lot # not reported). The parent placed a call to the physician's office on 28-APR-2008 the notify and inquire about the situation. Pregnancy has not been determined. Patient outcome was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a 21 year old female who in approximately June 2007, "9 or 10 months ago", was vaccinated "by injection" with a first dose of GARDASIL (lot # not reported). The physician reported that the patient developed a sore throat after receiving the first dose of GARDASIL. The patient sought unspecified medical attention. The patient outcome was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Polymenorrhoea
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 23-OCT-2007 was vaccinated with GARDASIL (lot number not specified).  In October 2007, the patient experienced an increase in the number of menstrual cycles.  The doctor is trying an unspecified birth control to help regulate her cycles.  On approximately 14-Feb-2008 the patient received her second dose of GARDASIL (lot number not specified).  The patient sought unspecified medical attention in the office.  Additional information has been requested. Initial and follow-up information has been received from a physician concenring a 17 year old female with no medical history and no allergies who on 23-Oct-2007 was vaccinated intramuscularly in right deltoid with first dose of GARDASIL (lot # 657006/0188U). It was reported that "sometime" in October 2007, the patient experienced an increase in the number of menstrual cycles, previously always regular. Frequency described as every 2 weeks instead of monthly. On an unspecified date, the patient started an oral contraceptives to regulate her menstrual cycles. On approximately 14-Feb-2008 the patient received her second dose of GARDASIL (lot number not specified). The patient sought unspecified medical attention in the office . At the time of this report the outcome was unknown. No additional information is available.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Hypoaesthesia, Inappropriate schedule of drug administration, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning  a 29 year old female who on 14-APR-2008 was IM vaccinated in her left arm with her first dose of GARDASIL (lot number 659964/1978U). Concomitant therapy included hormonal contraceptives (unspecified). On 21-APR-2008 the patient experienced a very painful ear ache. On 22-APR-2008 the patient experienced numbness in the lower left arm and tingling in the lower left arm. This numbness and tingling was not at time of injection site. Subsequently, the patient recovered from the very painful ear ache. The patient's numbness and tingling in the lower left arm persisted. The patient sought unspecified medical care with an office visit. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Influenza like illness, Injection site pain, Pain, Sleep disorder
Clinical narrative: Information has been received from a physician concerning a 24 year old female with a history of sulfonamide allergy who on 13-NOV-2007 was IM vaccinated with her first dose of GARDASIL (lot number 659435/1265U). On 14-JAN-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot number 659435/1265U). On 29-APR-2008 the patient received her third dose of GARDASIL (lot number 660389/1968U) intramuscularly. Concomitant therapy included APRI. On 13-NOV-2007 the patient experienced injection site pain. On 14-JAN-2008 the patient experienced injection site pain. On 29-APR-2008 the patient experienced body aches, felt like she had the flu and barely slept overnight. The patient's body aches, flu-like symptoms and difficulty sleeping persisted. The patient sought medical attention by calling the office. The patient was told to drink fluids and take TYLENOL. The patient missed work due to her symptoms. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a female who on approximately 02-APR-2008 was vaccinated with GARDASIL (lot number unspecified).  "Approximately four weeks ago", on 02-APR-2008, the patient experienced persistent pain in her arm localized to the injection site.  There was no nerve pain or pain any where else in her arm.  The patient's persistent pain in her arm localized to the injection site persisted. The patient sought unspecified medical treatment.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hirsutism
Clinical narrative: Information has been received from a physician concerning a 12 year old female who was vaccinated with all three 0.5 mL doses of GARDASIL (lot # not reported). After the third dose was administered a small growth of facial hair was noted under her chin within a month. The patient's status was not reported. No laboratory diagnostic test was performed. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Malaise, Syncope
Clinical narrative: Information has been received from a physician concerning a female )age not reported) who was vaccinated with the first and second dose of GARDASIL (lot # not reported). The physician reported that the patient fainted after her first dose of GARDASIL (lot # not reported). After the second dose of GARDASIL (lot # not reported), she was lightheaded and complained of being unwell. The patients complaints of not feeling well since the first vaccination. The patient's status was reported as not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MMR
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with the first 0.5 mL dose of GARDASIL (lot # not reported). On approximately 23-APR-2008 "last week" the patient fainted after getting the first dose of GARDASIL (lot # not reported). The patient recovered. Additional information has been requested.  10/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Follow up information was received on 19-JUN-2008. The registered nurse reported that the patient was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot # 657617/0384U) on 10-JUL-2007. On the same day the patient was vaccinated SQ in the left arm with a dose of MMR II (lot # 654685/0987F), IM in the right deltoid with the first dose of VAQTA (lot # 657306/0360U) and IM in the left deltoid with a dose of DTAP (lot # C2455AA). It was reported that the patient fainted after given the first dose of GARDASIL. It was reported that it was the last shot given out of 4 shots. The registered nurse had the patient lie on her back on the exam bed. She fainted while sitting up and she came to right after. The patient recovered on 10-JUL-2007. The patient is allergic to amoxicillin. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Feeling abnormal, Mood swings, Panic attack
Clinical narrative: Information has been received from the mother of a 19 year old female consumer who in early January 2008, was vaccinated with the first dose of GARDASIL (lot not reported), In later February 2008 the patient was vaccinated with the second dose of GARDASIL (lot not reported). There was no concomitant medication. In January 2008, the patient began to experience depression and a feeling of "just not being herself with no known reason". Two weeks after her second dose of GARDASIL (lot not reported), she experienced a panic attack. Her current condition was described as resembling a "hormonal mood swing reaction." There does not seem to be an explanation for these feelings. She experienced these feeling away at college as well as at home. She is being seen by a physician and has an upcoming appointment in early May 2008 for these symptoms. The patient's status was reported as not recovered. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure normal, Heart rate normal, Hyperhidrosis, Laboratory test normal, Pallor
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 11-Mar-2008 was vaccinated with the first dose of GARDASIL (lot # 659182/1757U). There was no concomitant medication. On 11-MAR-2008 within 15 minutes of sitting after the vaccination, she became pale and started to sweat for 2 to 3 minutes. It was reported that the patient is an athlete and had practice prior to vaccination. The patient's blood pressure and heart rate were taken yielding normal results. The patient recovered on 11-MAR-2008. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Heart rate normal, Hyperhidrosis, Pallor
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 11-Mar-2008 was vaccinated with the first dose of GARDASIL (lot # 659182/1757U). There was no concomitant medication. On 11-MAR-2008 within 15 minutes of sitting after the vaccination, she became pale and started to sweat for 2 to 3 minutes. It was reported that the patient is an athlete and had practice prior to vaccination. The patient's blood pressure and heart rate were taken yielding normal results. The patient recovered on 11-MAR-2008. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health care worker concerning a female (age not reported) who on an unspecified date was vaccinated with a third dose of GARDASIL. Subsequently the patient developed a rash on her chest after receiving the third dose of GARDASIL. Unspecified medical attention was sought. At the time of reporting it was unknown if the patient had recovered. No further information is available. This is one of two reports from the same source.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Hypoaesthesia, Inappropriate schedule of drug administration, Pain of skin, Paraesthesia
Clinical narrative: Information has been received from a physician's assistant concerning a 29 year old female who on 14-APR-2008 was vaccinated in the left arm with her first dose of GARDASIL (Lot # not provided). Concomitant therapy included ORTHO TRI-CYCLEN LO. The patient experienced a left ear ache and pain at the left scalp. On or around 20-APR-2008, the patient developed numbness and/or tingling of the left arm. The pain on the ear and scalp did resolve, but the arm sensation still persisted. The patient was treated with VALTREX (time unspecified by reporter) by the primary physician because he suspected that it was shingles, but later ruled that out. The patient sought unspecified medical attention by seeing her primary physician. No other details were provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who, on an unspecified date was vaccinated intramuscularly with her first GARDASIL (Lot # and site not reported). "About 2 weeks post vaccination", the patient developed a rash on her torso and the backs of her legs. The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with three doses of GARDASIL. It was reported that patient was positive for HPV r11 6 11 16 18 vlp after getting all three doses of vaccination. The patient did not get the vaccination in the reporting physician's office. No other information to report. The patient was positive for hpv r11 6 11 16 18 vlp at the time of this report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with the first 0.5 mL dose of GARDASIL (lot # not reported). On approximately 23-APR-2008 "last week" the patient fainted after getting the first dose of GARDASIL (lot # not reported). It was also reported that the patient received on an unspecified date the second dose of GARDASIL (lot # not reported). The patient fainted after the second dose of GARDASIL (lot # not reported) also. The patient recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a health care professional concerning a 26 year old female who on 03-JUN-2007 was vaccinated with a first dose of GARDASIL (lot# 653736/0014U) in the left deltoid. The consumer reported that she went to the emergency room after her whole left side of her body was numb 2 days after receiving her vaccine. At the time of reporting it was unknown if the patient had recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who, on an unspecified date was vaccinated intramuscularly with her first dose of GARDASIL (Lot # and site not reported). "About 72 hours post vaccination", the patient developed a rash on her arms and chest. The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a "few" patients (ages and genders unknown), who, on an unspecified dates, were vaccinated with doses of GARDASIL. Subsequently, when the patients were returning to receive another dose of GARDASIL the patients had redness in the :shape of a band aid" at the injection site. At the time of the report, the outcomes of the patients were unknown.  This is one of two reports from the same source. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Irritability, Nasal congestion, Surgery, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-week-old male with no pre-existing allergies or birth defects who on 02-JAN-2008 was vaccinated at 1210 with an oral first dose of ROTATEQ (lot# 697979/1194U).  Concomitant vaccination at 1210 included a first dose in the left lower leg of ACTHIB (lot# UF222AA), a first dose in the left upper leg of PEDIARIX (lot# AC21B130AA) and a first dose in the right upper leg of PREVNAR (lot# B54015L).  It was reported that the patient may have had gastroenteritis at the time of vaccination.  On 07-JAN-2008 the patient developed congestion, vomiting, loose bowel movement, positive gas, was voiding and was afebrile.  On 08-Jan-2008 the patient took a small amount of fluid (4 oz) and vomited immediately.  He was fussy all night, had a weak cry and was sent to the emergency room for evaluation.  It was reported that he had "forty-eight hours or so of vomiting mostly non-bilious, but occasionally yellow.  He had no pain pattern that was definitive, and had some loose stools, but no gross blood".  He was diagnosed with intussusception on air contrast enema and it was irreducible.  Diagnostic tests revealed a negative urinalysis, WBC 10,000, ultrasound negative.  On 09-Jan-2008 he went to the operating room and the intussusception was reduced.  The surgery was uneventful and the patient did extremely well.  Pathology tissue revealed fibroadipose tissue with chronic inflammation, adipose tissue and two hyperplastic lymph nodes.  The patient was hospitalized for 2-3 days.  Follow-up on 21-Jan-2008 indicated that the patient was healthy and happy, the belly was soft and his wound was healing nicely.  The abdominal wall was intact.  The physician reported that intussusception, weak cry, congestion and fussy required hospitalization and were considered to be life threatening.  A lot check has been initiated.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Diarrhoea, Enema administration, Flatulence, Intussusception
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-week-old male with no pre-existing allergies or birth defects who on 02-JAN-2008 was vaccinated at 1210 with an oral first dose of ROTATEQ (lot# 697979/1194U).  Concomitant vaccination at 1210 included a first dose in the left lower leg of ACTHIB (lot# UF222AA), a first dose in the left upper leg of PEDIARIX (lot# AC21B130AA) and a first dose in the right upper leg of PREVNAR (lot# B54015L).  It was reported that the patient may have had gastroenteritis at the time of vaccination.  On 07-JAN-2008 the patient developed congestion, vomiting, loose bowel movement, positive gas, was voiding and was afebrile.  On 08-Jan-2008 the patient took a small amount of fluid (4 oz) and vomited immediately.  He was fussy all night, had a weak cry and was sent to the emergency room for evaluation.  It was reported that he had "forty-eight hours or so of vomiting mostly non-bilious, but occasionally yellow.  He had no pain pattern that was definitive, and had some loose stools, but no gross blood".  He was diagnosed with intussusception on air contrast enema and it was irreducible.  Diagnostic tests revealed a negative urinalysis, WBC 10,000, ultrasound negative.  On 09-Jan-2008 he went to the operating room and the intussusception was reduced.  The surgery was uneventful and the patient did extremely well.  Pathology tissue revealed fibroadipose tissue with chronic inflammation, adipose tissue and two hyperplastic lymph nodes.  The patient was hospitalized for 2-3 days.  Follow-up on 21-Jan-2008 indicated that the patient was healthy and happy, the belly was soft and his wound was healing nicely.  The abdominal wall was intact.  The physician reported that intussusception, weak cry, congestion and fussy required hospitalization and were considered to be life threatening.  A lot check has been initiated.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Respiratory tract congestion, Ultrasound scan normal, Urine analysis normal, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-week-old male with no pre-existing allergies or birth defects who on 02-JAN-2008 was vaccinated at 1210 with an oral first dose of ROTATEQ (lot# 697979/1194U).  Concomitant vaccination at 1210 included a first dose in the left lower leg of ACTHIB (lot# UF222AA), a first dose in the left upper leg of PEDIARIX (lot# AC21B130AA) and a first dose in the right upper leg of PREVNAR (lot# B54015L).  It was reported that the patient may have had gastroenteritis at the time of vaccination.  On 07-JAN-2008 the patient developed congestion, vomiting, loose bowel movement, positive gas, was voiding and was afebrile.  On 08-Jan-2008 the patient took a small amount of fluid (4 oz) and vomited immediately.  He was fussy all night, had a weak cry and was sent to the emergency room for evaluation.  It was reported that he had "forty-eight hours or so of vomiting mostly non-bilious, but occasionally yellow.  He had no pain pattern that was definitive, and had some loose stools, but no gross blood".  He was diagnosed with intussusception on air contrast enema and it was irreducible.  Diagnostic tests revealed a negative urinalysis, WBC 10,000, ultrasound negative.  On 09-Jan-2008 he went to the operating room and the intussusception was reduced.  The surgery was uneventful and the patient did extremely well.  Pathology tissue revealed fibroadipose tissue with chronic inflammation, adipose tissue and two hyperplastic lymph nodes.  The patient was hospitalized for 2-3 days.  Follow-up on 21-Jan-2008 indicated that the patient was healthy and happy, the belly was soft and his wound was healing nicely.  The abdominal wall was intact.  The physician reported that intussusception, weak cry, congestion and fussy required hospitalization and were considered to be life threatening.  A lot check has been initiated.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-week-old male with no pre-existing allergies or birth defects who on 02-JAN-2008 was vaccinated at 1210 with an oral first dose of ROTATEQ (lot# 697979/1194U).  Concomitant vaccination at 1210 included a first dose in the left lower leg of ACTHIB (lot# UF222AA), a first dose in the left upper leg of PEDIARIX (lot# AC21B130AA) and a first dose in the right upper leg of PREVNAR (lot# B54015L).  It was reported that the patient may have had gastroenteritis at the time of vaccination.  On 07-JAN-2008 the patient developed congestion, vomiting, loose bowel movement, positive gas, was voiding and was afebrile.  On 08-Jan-2008 the patient took a small amount of fluid (4 oz) and vomited immediately.  He was fussy all night, had a weak cry and was sent to the emergency room for evaluation.  It was reported that he had "forty-eight hours or so of vomiting mostly non-bilious, but occasionally yellow.  He had no pain pattern that was definitive, and had some loose stools, but no gross blood".  He was diagnosed with intussusception on air contrast enema and it was irreducible.  Diagnostic tests revealed a negative urinalysis, WBC 10,000, ultrasound negative.  On 09-Jan-2008 he went to the operating room and the intussusception was reduced.  The surgery was uneventful and the patient did extremely well.  Pathology tissue revealed fibroadipose tissue with chronic inflammation, adipose tissue and two hyperplastic lymph nodes.  The patient was hospitalized for 2-3 days.  Follow-up on 21-Jan-2008 indicated that the patient was healthy and happy, the belly was soft and his wound was healing nicely.  The abdominal wall was intact.  The physician reported that intussusception, weak cry, congestion and fussy required hospitalization and were considered to be life threatening.  A lot check has been initiated.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema abnormal, Crying, Diarrhoea, Enema administration, Flatulence
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-week-old male with no pre-existing allergies or birth defects who on 02-JAN-2008 was vaccinated at 1210 with an oral first dose of ROTATEQ (lot# 697979/1194U).  Concomitant vaccination at 1210 included a first dose in the left lower leg of ACTHIB (lot# UF222AA), a first dose in the left upper leg of PEDIARIX (lot# AC21B130AA) and a first dose in the right upper leg of PREVNAR (lot# B54015L).  It was reported that the patient may have had gastroenteritis at the time of vaccination.  On 07-JAN-2008 the patient developed congestion, vomiting, loose bowel movement, positive gas, was voiding and was afebrile.  On 08-Jan-2008 the patient took a small amount of fluid (4 oz) and vomited immediately.  He was fussy all night, had a weak cry and was sent to the emergency room for evaluation.  It was reported that he had "forty-eight hours or so of vomiting mostly non-bilious, but occasionally yellow.  He had no pain pattern that was definitive, and had some loose stools, but no gross blood".  He was diagnosed with intussusception on air contrast enema and it was irreducible.  Diagnostic tests revealed a negative urinalysis, WBC 10,000, ultrasound negative.  On 09-Jan-2008 he went to the operating room and the intussusception was reduced.  The surgery was uneventful and the patient did extremely well.  Pathology tissue revealed fibroadipose tissue with chronic inflammation, adipose tissue and two hyperplastic lymph nodes.  The patient was hospitalized for 2-3 days.  Follow-up on 21-Jan-2008 indicated that the patient was healthy and happy, the belly was soft and his wound was healing nicely.  The abdominal wall was intact.  The physician reported that intussusception, weak cry, congestion and fussy required hospitalization and were considered to be life threatening.  A lot check has been initiated.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inflammation, Intussusception, Irritability, Lymphadenopathy, Respiratory tract congestion
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-week-old male with no pre-existing allergies or birth defects who on 02-JAN-2008 was vaccinated at 1210 with an oral first dose of ROTATEQ (lot# 697979/1194U).  Concomitant vaccination at 1210 included a first dose in the left lower leg of ACTHIB (lot# UF222AA), a first dose in the left upper leg of PEDIARIX (lot# AC21B130AA) and a first dose in the right upper leg of PREVNAR (lot# B54015L).  It was reported that the patient may have had gastroenteritis at the time of vaccination.  On 07-JAN-2008 the patient developed congestion, vomiting, loose bowel movement, positive gas, was voiding and was afebrile.  On 08-Jan-2008 the patient took a small amount of fluid (4 oz) and vomited immediately.  He was fussy all night, had a weak cry and was sent to the emergency room for evaluation.  It was reported that he had "forty-eight hours or so of vomiting mostly non-bilious, but occasionally yellow.  He had no pain pattern that was definitive, and had some loose stools, but no gross blood".  He was diagnosed with intussusception on air contrast enema and it was irreducible.  Diagnostic tests revealed a negative urinalysis, WBC 10,000, ultrasound negative.  On 09-Jan-2008 he went to the operating room and the intussusception was reduced.  The surgery was uneventful and the patient did extremely well.  Pathology tissue revealed fibroadipose tissue with chronic inflammation, adipose tissue and two hyperplastic lymph nodes.  The patient was hospitalized for 2-3 days.  Follow-up on 21-Jan-2008 indicated that the patient was healthy and happy, the belly was soft and his wound was healing nicely.  The abdominal wall was intact.  The physician reported that intussusception, weak cry, congestion and fussy required hospitalization and were considered to be life threatening.  A lot check has been initiated.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Surgery, Ultrasound scan normal, Urine analysis normal, Vomiting, White blood cell count normal
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-week-old male with no pre-existing allergies or birth defects who on 02-JAN-2008 was vaccinated at 1210 with an oral first dose of ROTATEQ (lot# 697979/1194U).  Concomitant vaccination at 1210 included a first dose in the left lower leg of ACTHIB (lot# UF222AA), a first dose in the left upper leg of PEDIARIX (lot# AC21B130AA) and a first dose in the right upper leg of PREVNAR (lot# B54015L).  It was reported that the patient may have had gastroenteritis at the time of vaccination.  On 07-JAN-2008 the patient developed congestion, vomiting, loose bowel movement, positive gas, was voiding and was afebrile.  On 08-Jan-2008 the patient took a small amount of fluid (4 oz) and vomited immediately.  He was fussy all night, had a weak cry and was sent to the emergency room for evaluation.  It was reported that he had "forty-eight hours or so of vomiting mostly non-bilious, but occasionally yellow.  He had no pain pattern that was definitive, and had some loose stools, but no gross blood".  He was diagnosed with intussusception on air contrast enema and it was irreducible.  Diagnostic tests revealed a negative urinalysis, WBC 10,000, ultrasound negative.  On 09-Jan-2008 he went to the operating room and the intussusception was reduced.  The surgery was uneventful and the patient did extremely well.  Pathology tissue revealed fibroadipose tissue with chronic inflammation, adipose tissue and two hyperplastic lymph nodes.  The patient was hospitalized for 2-3 days.  Follow-up on 21-Jan-2008 indicated that the patient was healthy and happy, the belly was soft and his wound was healing nicely.  The abdominal wall was intact.  The physician reported that intussusception, weak cry, congestion and fussy required hospitalization and were considered to be life threatening.  A lot check has been initiated.  Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP, TDAP, TYP, YF
Symptoms: Fatigue, Headache, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: YELLOW FEVER - RED CIRCLE WITH BRUISING IN CENTER (WITH LOSS OF RED COLOR) ONLY IN CENTER OF INJECTION SITE - OCCURED AT 6 DAY AFTER INJ.  TDAP - EXTREME SWELLING (EGG SIZE), ICHING, REDNESS DIAMETER SIZE OF GRAPEFRUIT WITH FINGER LOOKING RED GOING DOWN ARM - NEXT AND SHOULDER SORENESS ON INJECTION ARM SIDE ONLY - LOW GRADE FEVER, ACHES, PAIN IN ARM AND SHOULD, HEADACHE, AND EXTREME FATIGUE EXPERIENCE DAY AFTER SHOT - SWELLING CONTINUES EACH DAY.  NOW AT DAY 4.
Age: 35.0
Sex: F
Vaccine: HEP, TDAP, TYP, YF
Symptoms: Injection site pruritus, Injection site swelling, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: YELLOW FEVER - RED CIRCLE WITH BRUISING IN CENTER (WITH LOSS OF RED COLOR) ONLY IN CENTER OF INJECTION SITE - OCCURED AT 6 DAY AFTER INJ.  TDAP - EXTREME SWELLING (EGG SIZE), ICHING, REDNESS DIAMETER SIZE OF GRAPEFRUIT WITH FINGER LOOKING RED GOING DOWN ARM - NEXT AND SHOULDER SORENESS ON INJECTION ARM SIDE ONLY - LOW GRADE FEVER, ACHES, PAIN IN ARM AND SHOULD, HEADACHE, AND EXTREME FATIGUE EXPERIENCE DAY AFTER SHOT - SWELLING CONTINUES EACH DAY.  NOW AT DAY 4.
Age: 35.0
Sex: F
Vaccine: HEP, TDAP, TYP, YF
Symptoms: Pyrexia
Clinical narrative: YELLOW FEVER - RED CIRCLE WITH BRUISING IN CENTER (WITH LOSS OF RED COLOR) ONLY IN CENTER OF INJECTION SITE - OCCURED AT 6 DAY AFTER INJ.  TDAP - EXTREME SWELLING (EGG SIZE), ICHING, REDNESS DIAMETER SIZE OF GRAPEFRUIT WITH FINGER LOOKING RED GOING DOWN ARM - NEXT AND SHOULDER SORENESS ON INJECTION ARM SIDE ONLY - LOW GRADE FEVER, ACHES, PAIN IN ARM AND SHOULD, HEADACHE, AND EXTREME FATIGUE EXPERIENCE DAY AFTER SHOT - SWELLING CONTINUES EACH DAY.  NOW AT DAY 4.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Asthenia, Blood test, Confusional state, Electroencephalogram normal
Clinical narrative: Anxiety - panic attack soon after first GARDASIL according to mom - but mom did not report - till 9.7.07- when she was seen in office said that - she has been having for past 1 yr - 11.17.07 - syncope 11.18.07 numbness LT forearm and hand. Hospitalized - Dx migraine. Rx TOPAMAX. 11/07 - possible seizures. 12/07 - Neuro consult. EEG normal. Rx KEPPRA - now under control but continues to have confusion.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Migraine, Panic attack, Syncope
Clinical narrative: Anxiety - panic attack soon after first GARDASIL according to mom - but mom did not report - till 9.7.07- when she was seen in office said that - she has been having for past 1 yr - 11.17.07 - syncope 11.18.07 numbness LT forearm and hand. Hospitalized - Dx migraine. Rx TOPAMAX. 11/07 - possible seizures. 12/07 - Neuro consult. EEG normal. Rx KEPPRA - now under control but continues to have confusion.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Abdominal pain lower, Arthralgia, Asthenia, Back pain
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Bronchitis, Chest discomfort, Chills, Condition aggravated
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Culture urine negative, Dizziness, Dyspnoea, Dysuria
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram normal, Fatigue, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Lumbar radiculopathy, Malaise, Micturition urgency, Middle ear effusion
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle strain, Muscular weakness, Myalgia, Myopia, Nerve conduction studies normal
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Otitis media acute, Otorrhoea
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia, Protein urine present, Pyrexia
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Sinus headache, Sleep disorder, Tympanic membrane disorder, Tympanic membrane perforation
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Urine leukocyte esterase positive, Viral infection, Vision blurred
Clinical narrative: 11/19/07 Influenza vaccine was administered at a regular doctor's visit and a couple of days later started feeling weakness, numbness and pain in lower back and legs and again on 3/15/08 after being sick with severe flu symptoms ended up in the emergency room and was administered another influenza and pneumonia vaccine that made my entire body from neck back became numb and weak.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Abasia, Asthma, Body temperature increased, Bronchitis, Convulsion
Clinical narrative: Immunization given at 2 pm 5/1/08.  "Fever" that night, lethargic, next day wouldn't walk.  On 5/4 at 1 am "fever" was worse and had seizure.  Taken to ER where temperature was 102 and O2 sats were 82.  Developed cough and asthma, bronchitis for 10 days.  Finally improving this week. 5/27/08-records received for DOS 5/4-5/5/08, DC DX: Child with recent pneumonia with some persistent infiltrates on x-ray which could be resolving from prior infection versus new from current febrile respiratory illness. First time febrile seizure.  Four days prior to admission had decreased eating, decreased activity and not acting his usual self, 2-3 days ago fever and somewhat sluggish. Three days prior received vaccines. Coughing day prior and vomiting. Began shaky or jerking movements, stiff.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Cough, Full blood count, Lethargy, Oxygen saturation decreased, Pyrexia
Clinical narrative: Immunization given at 2 pm 5/1/08.  "Fever" that night, lethargic, next day wouldn't walk.  On 5/4 at 1 am "fever" was worse and had seizure.  Taken to ER where temperature was 102 and O2 sats were 82.  Developed cough and asthma, bronchitis for 10 days.  Finally improving this week. 5/27/08-records received for DOS 5/4-5/5/08, DC DX: Child with recent pneumonia with some persistent infiltrates on x-ray which could be resolving from prior infection versus new from current febrile respiratory illness. First time febrile seizure.  Four days prior to admission had decreased eating, decreased activity and not acting his usual self, 2-3 days ago fever and somewhat sluggish. Three days prior received vaccines. Coughing day prior and vomiting. Began shaky or jerking movements, stiff.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Immunization given at 2 pm 5/1/08.  "Fever" that night, lethargic, next day wouldn't walk.  On 5/4 at 1 am "fever" was worse and had seizure.  Taken to ER where temperature was 102 and O2 sats were 82.  Developed cough and asthma, bronchitis for 10 days.  Finally improving this week. 5/27/08-records received for DOS 5/4-5/5/08, DC DX: Child with recent pneumonia with some persistent infiltrates on x-ray which could be resolving from prior infection versus new from current febrile respiratory illness. First time febrile seizure.  Four days prior to admission had decreased eating, decreased activity and not acting his usual self, 2-3 days ago fever and somewhat sluggish. Three days prior received vaccines. Coughing day prior and vomiting. Began shaky or jerking movements, stiff.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Atonic seizures, Body temperature increased, Chest X-ray, Computerised tomogram, Convulsion
Clinical narrative: Patient had 103.5 temperature and continued with 101.7 temperature for 3 days.  Respiratory illness started after temperature with decreased appetite and cough with congestion for approximately 2 weeks.  Had atonic/drop seizure x 2 and was hospitalized 01/22/08 - 01/30/08 had convulsive seizure x 2 in hospital.  All tests came back and was diagnosed with viral encephalitis and seizures.  Hospitalized in February due to poor seizure control. 6/3/08-records received for DOS 1/22-1/30/08-DC DX: Seizures. Mild viral encephalitis. Presented with two atonic episodes. Cough. Sleepier, high pitched cry. Abnormal movements with facial twitching. Post-ictal. Altered mental status with high pitched cry, failure to focus, fussiness and loss of truncal stability. Developed diarrhea.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: Cough, Culture urine, Decreased appetite, Electroencephalogram, Encephalitis viral
Clinical narrative: Patient had 103.5 temperature and continued with 101.7 temperature for 3 days.  Respiratory illness started after temperature with decreased appetite and cough with congestion for approximately 2 weeks.  Had atonic/drop seizure x 2 and was hospitalized 01/22/08 - 01/30/08 had convulsive seizure x 2 in hospital.  All tests came back and was diagnosed with viral encephalitis and seizures.  Hospitalized in February due to poor seizure control. 6/3/08-records received for DOS 1/22-1/30/08-DC DX: Seizures. Mild viral encephalitis. Presented with two atonic episodes. Cough. Sleepier, high pitched cry. Abnormal movements with facial twitching. Post-ictal. Altered mental status with high pitched cry, failure to focus, fussiness and loss of truncal stability. Developed diarrhea.