chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium enema, Enema administration, Haematochezia, Intussusception
Clinical narrative: Information has been received from the FDA (VAER# 289041) through the CDC via medical records regarding a 24-week-old male who on 14-JUN-2007 was vaccinated with his second dose of Rotateq (lot# 656390/0236U). The patient was noted to be healthy the day of vaccination. Concomitant vaccination administered that same day included the second dose of PedvaxHIB (lot# 654679/1126F), the second dose of Pediarix (lot# AC21B114CA) and the second dose of Prevnar (lot# B08692H). On 04-AUG-2007 the patient experienced intussusception characterized by 1 day intermittent symptoms with colicky abdominal pain, blood tinged mucous stool. On 04-AUG-2007 the patient was hospitalized for 2 days for observation status post intussusception reduction. Overnight, the intussusception recurred as evidenced through a positive abdominal ultrasound then spontaneously resolved. Lab reports from the hospital included barium enema confirmation of intussusception in the transverse colon, abdominal ultrasound (+) for intussusception recurrence, ileocolic intussusception and mesenteric adenitis and blood work within normal limits. The final diagnosis was intussusception, enema reduced. The discharge summary indicated that the patient experienced mucousy emesis, decreased appetite, abdominal pain, fussiness, listlessness and refusal to lie prone for 1 day, & bloody mucousy stool on the day of admission. The patient was discharged to home on 05-AUG-2007. A follow up note in August 2007 indicated that the patient was doing well post-operation. The patient recovered. Intussusception was considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologicals Evaluation and Research (CBER) and was released by the regulatory agency. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools
Clinical narrative: Information has been received from the FDA (VAER# 289041) through the CDC via medical records regarding a 24-week-old male who on 14-JUN-2007 was vaccinated with his second dose of Rotateq (lot# 656390/0236U). The patient was noted to be healthy the day of vaccination. Concomitant vaccination administered that same day included the second dose of PedvaxHIB (lot# 654679/1126F), the second dose of Pediarix (lot# AC21B114CA) and the second dose of Prevnar (lot# B08692H). On 04-AUG-2007 the patient experienced intussusception characterized by 1 day intermittent symptoms with colicky abdominal pain, blood tinged mucous stool. On 04-AUG-2007 the patient was hospitalized for 2 days for observation status post intussusception reduction. Overnight, the intussusception recurred as evidenced through a positive abdominal ultrasound then spontaneously resolved. Lab reports from the hospital included barium enema confirmation of intussusception in the transverse colon, abdominal ultrasound (+) for intussusception recurrence, ileocolic intussusception and mesenteric adenitis and blood work within normal limits. The final diagnosis was intussusception, enema reduced. The discharge summary indicated that the patient experienced mucousy emesis, decreased appetite, abdominal pain, fussiness, listlessness and refusal to lie prone for 1 day, & bloody mucousy stool on the day of admission. The patient was discharged to home on 05-AUG-2007. A follow up note in August 2007 indicated that the patient was doing well post-operation. The patient recovered. Intussusception was considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologicals Evaluation and Research (CBER) and was released by the regulatory agency. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium enema, Decreased appetite, Haematochezia, Intussusception
Clinical narrative: Information has been received from the FDA (VAER# 289041) through the CDC via medical records regarding a 24-week-old male who on 14-JUN-2007 was vaccinated with his second dose of Rotateq (lot# 656390/0236U). The patient was noted to be healthy the day of vaccination. Concomitant vaccination administered that same day included the second dose of PedvaxHIB (lot# 654679/1126F), the second dose of Pediarix (lot# AC21B114CA) and the second dose of Prevnar (lot# B08692H). On 04-AUG-2007 the patient experienced intussusception characterized by 1 day intermittent symptoms with colicky abdominal pain, blood tinged mucous stool. On 04-AUG-2007 the patient was hospitalized for 2 days for observation status post intussusception reduction. Overnight, the intussusception recurred as evidenced through a positive abdominal ultrasound then spontaneously resolved. Lab reports from the hospital included barium enema confirmation of intussusception in the transverse colon, abdominal ultrasound (+) for intussusception recurrence, ileocolic intussusception and mesenteric adenitis and blood work within normal limits. The final diagnosis was intussusception, enema reduced. The discharge summary indicated that the patient experienced mucousy emesis, decreased appetite, abdominal pain, fussiness, listlessness and refusal to lie prone for 1 day, & bloody mucousy stool on the day of admission. The patient was discharged to home on 05-AUG-2007. A follow up note in August 2007 indicated that the patient was doing well post-operation. The patient recovered. Intussusception was considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologicals Evaluation and Research (CBER) and was released by the regulatory agency. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Laboratory test normal, Listless, Mucous stools, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from the FDA (VAER# 289041) through the CDC via medical records regarding a 24-week-old male who on 14-JUN-2007 was vaccinated with his second dose of Rotateq (lot# 656390/0236U). The patient was noted to be healthy the day of vaccination. Concomitant vaccination administered that same day included the second dose of PedvaxHIB (lot# 654679/1126F), the second dose of Pediarix (lot# AC21B114CA) and the second dose of Prevnar (lot# B08692H). On 04-AUG-2007 the patient experienced intussusception characterized by 1 day intermittent symptoms with colicky abdominal pain, blood tinged mucous stool. On 04-AUG-2007 the patient was hospitalized for 2 days for observation status post intussusception reduction. Overnight, the intussusception recurred as evidenced through a positive abdominal ultrasound then spontaneously resolved. Lab reports from the hospital included barium enema confirmation of intussusception in the transverse colon, abdominal ultrasound (+) for intussusception recurrence, ileocolic intussusception and mesenteric adenitis and blood work within normal limits. The final diagnosis was intussusception, enema reduced. The discharge summary indicated that the patient experienced mucousy emesis, decreased appetite, abdominal pain, fussiness, listlessness and refusal to lie prone for 1 day, & bloody mucousy stool on the day of admission. The patient was discharged to home on 05-AUG-2007. A follow up note in August 2007 indicated that the patient was doing well post-operation. The patient recovered. Intussusception was considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologicals Evaluation and Research (CBER) and was released by the regulatory agency. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Information has been received from the FDA (VAER# 289041) through the CDC via medical records regarding a 24-week-old male who on 14-JUN-2007 was vaccinated with his second dose of Rotateq (lot# 656390/0236U). The patient was noted to be healthy the day of vaccination. Concomitant vaccination administered that same day included the second dose of PedvaxHIB (lot# 654679/1126F), the second dose of Pediarix (lot# AC21B114CA) and the second dose of Prevnar (lot# B08692H). On 04-AUG-2007 the patient experienced intussusception characterized by 1 day intermittent symptoms with colicky abdominal pain, blood tinged mucous stool. On 04-AUG-2007 the patient was hospitalized for 2 days for observation status post intussusception reduction. Overnight, the intussusception recurred as evidenced through a positive abdominal ultrasound then spontaneously resolved. Lab reports from the hospital included barium enema confirmation of intussusception in the transverse colon, abdominal ultrasound (+) for intussusception recurrence, ileocolic intussusception and mesenteric adenitis and blood work within normal limits. The final diagnosis was intussusception, enema reduced. The discharge summary indicated that the patient experienced mucousy emesis, decreased appetite, abdominal pain, fussiness, listlessness and refusal to lie prone for 1 day, & bloody mucousy stool on the day of admission. The patient was discharged to home on 05-AUG-2007. A follow up note in August 2007 indicated that the patient was doing well post-operation. The patient recovered. Intussusception was considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologicals Evaluation and Research (CBER) and was released by the regulatory agency. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Diarrhoea, Pyrexia, Rash, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 18 week old daughter with no pertinent medical history or drug allergies who on 11-JUL-2007 and 13-SEP-2007 was vaccinated PO with her first and second dose of Rotateq (lot numbers unknown). There was no concomitant medication. On 13-SEP-2007 the patient vomited after the dose any may have received an incomplete dose. On 04-OCT-2007 the patient developed rotavirus gastroenteritis characterized by diarrhea, low-grade fever, and loss of appetite. Medical attention was sought via telephone. On 09-OCT-2007 a stool sample antigen rotavirus test was performed which showed a positive result for rotavirus. On 15-OCT-2007 the patient recovered. There was no product quality complaint. Rotavirus gastroenteritis was considered to be disabling by the reporter. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Anorexia, Diarrhoea, Gastroenteritis rotavirus, Pyrexia, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse concerning her 18 week old daughter with no pertinent medical history or drug allergies who on 11-JUL-2007 and 13-SEP-2007 was vaccinated PO with her first and second dose of Rotateq (lot numbers unknown). There was no concomitant medication. On 13-SEP-2007 the patient vomited after the dose any may have received an incomplete dose. On 04-OCT-2007 the patient developed rotavirus gastroenteritis characterized by diarrhea, low-grade fever, and loss of appetite. Medical attention was sought via telephone. On 09-OCT-2007 a stool sample antigen rotavirus test was performed which showed a positive result for rotavirus. On 15-OCT-2007 the patient recovered. There was no product quality complaint. Rotavirus gastroenteritis was considered to be disabling by the reporter. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 18 week old daughter with no pertinent medical history or drug allergies who on 11-JUL-2007 and 13-SEP-2007 was vaccinated PO with her first and second dose of Rotateq (lot numbers unknown). There was no concomitant medication. On 13-SEP-2007 the patient vomited after the dose any may have received an incomplete dose. On 04-OCT-2007 the patient developed rotavirus gastroenteritis characterized by diarrhea, low-grade fever, and loss of appetite. Medical attention was sought via telephone. On 09-OCT-2007 a stool sample antigen rotavirus test was performed which showed a positive result for rotavirus. On 15-OCT-2007 the patient recovered. There was no product quality complaint. Rotavirus gastroenteritis was considered to be disabling by the reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 62 year old female retired teacher with a history of osteopenia and no known allergies who on 09-AUG-2007 was vaccinated SC in the left arm with a first dose of Zostavax (Oka/Merck) (Lot#656858/0356U). There was no illness at the time of vaccination. On 20-SEP-2007 at approximately 11:00 the patient developed a sudden onset of first seizure while in the a public place and fell and hit her head. The patient went to the ER and was seen by a neurologist. A CT/MRA were negative and a sleep deprived EEG was performed with results pending. On 20-SEP-2007 the patient recovered. There was no illness at the time of vaccination. There were no adverse events with prior vaccinations. No further information was provided. Additional information has been requested. Upon internal review the patient's seizure was determined to be an other important medical event.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram, Fall, Head injury
Clinical narrative: Information has been received from a physician concerning a 62 year old female retired teacher with a history of osteopenia and no known allergies who on 09-AUG-2007 was vaccinated SC in the left arm with a first dose of Zostavax (Oka/Merck) (Lot#656858/0356U). There was no illness at the time of vaccination. On 20-SEP-2007 at approximately 11:00 the patient developed a sudden onset of first seizure while in the a public place and fell and hit her head. The patient went to the ER and was seen by a neurologist. A CT/MRA were negative and a sleep deprived EEG was performed with results pending. On 20-SEP-2007 the patient recovered. There was no illness at the time of vaccination. There were no adverse events with prior vaccinations. No further information was provided. Additional information has been requested. Upon internal review the patient's seizure was determined to be an other important medical event.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 62 year old female retired teacher with a history of osteopenia and no known allergies who on 09-AUG-2007 was vaccinated SC in the left arm with a first dose of Zostavax (Oka/Merck) (Lot#656858/0356U). There was no illness at the time of vaccination. On 20-SEP-2007 at approximately 11:00 the patient developed a sudden onset of first seizure while in the a public place and fell and hit her head. The patient went to the ER and was seen by a neurologist. A CT/MRA were negative and a sleep deprived EEG was performed with results pending. On 20-SEP-2007 the patient recovered. There was no illness at the time of vaccination. There were no adverse events with prior vaccinations. No further information was provided. Additional information has been requested. Upon internal review the patient's seizure was determined to be an other important medical event.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Lethargy
Clinical narrative: Approximately two (2) hours after the shot, I experienced extreme fatigue and lethargy and went to bed at 7:00 pm and slept until 4:45 AM.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Heat therapy, Hypokinesia, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Initial report received from a health care professional on 17 October 2007. A 59-year-old female with a history of bilateral moderate mastectomy with reconstruction developed muscle aches and pain in the left shoulder on an unknown date after receiving a left deltoid intramuscular injection of Adacel (lot number C2825AA) on 01 October 2007. On 09 October 2007, the patient called her physician complaining of muscle aches and pain in the left shoulder and she was advised to take aspirin and Aleve and to use warm compresses. On 15 October 2007, the patient called her physician complaining of continued pain and soreness in her left shoulder joint; there was no redness or swelling to the arm. The patient could hardly lift her arm. It was reported that the pain shoots down from the shoulder to the arm at times. It was indicated that the patient was using a Lidocaine patch. On 17 October 2007, the patient called the physician and reported that the symptoms persisted and that the over-the-counter medications were not helping. The physician ordered Vicodin and scheduled an MRI for 18 October 2007. The patient was advised to continue using warm compresses. At the time of the report, the patient had not recovered.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received from a health care professional on 17 October 2007. A 59-year-old female with a history of bilateral moderate mastectomy with reconstruction developed muscle aches and pain in the left shoulder on an unknown date after receiving a left deltoid intramuscular injection of Adacel (lot number C2825AA) on 01 October 2007. On 09 October 2007, the patient called her physician complaining of muscle aches and pain in the left shoulder and she was advised to take aspirin and Aleve and to use warm compresses. On 15 October 2007, the patient called her physician complaining of continued pain and soreness in her left shoulder joint; there was no redness or swelling to the arm. The patient could hardly lift her arm. It was reported that the pain shoots down from the shoulder to the arm at times. It was indicated that the patient was using a Lidocaine patch. On 17 October 2007, the patient called the physician and reported that the symptoms persisted and that the over-the-counter medications were not helping. The physician ordered Vicodin and scheduled an MRI for 18 October 2007. The patient was advised to continue using warm compresses. At the time of the report, the patient had not recovered.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Information has been received from a 65 year old male, with no pertinent medical history, drug reactions or allergies who on 16-MAY-2007 was vaccinated with subcutaneously with 0.65 ml of Zostavax (Oka/Merck). There was no concomitant medication. On 28-JUN-2007, six weeks after receiving Zostavax (Oka/Merck) the patient developed Bell's Palsy. At the time of reporting the patient had not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. The event of Bell's Palsy was considered as a other medically important medical event (OME). Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a registered nurse concerning an approximately 80 or 90 year old immunocompromised male who was in the same room where the other residents of the retirement community where vaccinated with a dose of Zostavax (Oka/Merck). It was reported that the patient had spouse or contact (s) who lived in the independent residence within the community and who were vaccinated with a dose of Zostavax (MSD). The patient was not vaccinated with the vaccine. On 16-OCT-2007 the patient developed shingles. At the time of report the patient had not recovered. The patient's experience was considered to be an other important medical event and disabling by the reporter. Additional information has been requested. This is one of several reports received from the same source.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a registered nurse concerning an approximately 80 or 90 year old immunocompromised male who was in hospice care who was in the same room where the other residents of the retirement community were vaccinated with a dose of Zostavax (Oka/Merck). It was reported that the patient had a spouse or contact (s) who lived in the independent residences within the community and who were vaccinated with a dose of Zostavax vaccine (MSD). The patient was not vaccinated with the vaccine. On 16-OCT-2007 the patient developed shingles. At the time of report the patient had not recovered. The patient's experience was considered to be life threatening, an other important medical event and disabling by the reporter. Additional information has been requested. This is one of several reports received from the same source.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a registered nurse concerning an approximately 80 or 90 year old immunocompromised female who was in the same room where the other residents of the retirement community were vaccinated with a dose of Zostavax (Oka/Merck). It was reported that the patient had spouses or contact (s) who lived in the independent residences within the community and who were vaccinated with a dose of Zostavax (MSD). The patient was not vaccinated with the vaccine. On 10-OCT-2007 the patient developed shingles. At the time of report the patient had not recovered. The patient's experience was considered to be an other important medical event and disabling by the reporter. Additional information has been requested. This is one of several reports received from the same source.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection, Secondary transmission, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an approximately 80 or 90 year old immunocompromised female who was in the same room where the other residents of the retirement community were vaccinated with a dose of Zostavax (Oka/Merck). It was reported that the patient had spouse of contact (s) who lived in the independent residences within the community and who were vaccinated with a dose of Zostavax (MSD). The patient was not vaccinated with the vaccine. On approximately 09-OCT-2007 the patient developed shingles and had lesions on the back of the scalp. The patient was treated with valacyclovir hydrochloride (VALTREX) but the scalp area got infected and was draining so the resident was sent to the hospital. The patient was put on IV vancomycin. At the time of report the patient had not recovered. The patient's experience was considered to be an other important medical event and disabling by the reporter. Additional information has been requested. This is one of several reports received from the same source.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Appendicectomy, Faeces discoloured, Haematochezia, Mucous stools, Necrotising colitis
Clinical narrative: Information has been received from a physician concerning a 15 week premature female who on 14-AUG-2007 was vaccinated with the first 2 ml oral dose of Rotateq (Lot # 656838/0968U). There was no concomitant medication. On 19-SEP-2007, the patient experienced orange, bloody, mucous like stools which persisted for one day. The patient was brought to the emergency room and an X-ray was done which showed what appeared to be necrotizing entercolitis. The patient was hospitalized and scheduled for surgery. During surgery it was found that the patient's intestines were "fine". The patient had her appendix removed as a precautionary measure. The patient subsequently developed peritonitis which she was treated for in the hospital. The patient was in the hospital for five days before being discharged. The patient recovered on 24-SEP-2007. The orange, bloody mucous like stools and peritonitis were considered to be disabling. The orange, bloody, mucous like stools, experienced orange, bloody, mucous like stools and peritonitis were considered to be other important medical events. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Peritonitis, Surgery, X-ray abnormal
Clinical narrative: Information has been received from a physician concerning a 15 week premature female who on 14-AUG-2007 was vaccinated with the first 2 ml oral dose of Rotateq (Lot # 656838/0968U). There was no concomitant medication. On 19-SEP-2007, the patient experienced orange, bloody, mucous like stools which persisted for one day. The patient was brought to the emergency room and an X-ray was done which showed what appeared to be necrotizing entercolitis. The patient was hospitalized and scheduled for surgery. During surgery it was found that the patient's intestines were "fine". The patient had her appendix removed as a precautionary measure. The patient subsequently developed peritonitis which she was treated for in the hospital. The patient was in the hospital for five days before being discharged. The patient recovered on 24-SEP-2007. The orange, bloody mucous like stools and peritonitis were considered to be disabling. The orange, bloody, mucous like stools, experienced orange, bloody, mucous like stools and peritonitis were considered to be other important medical events. Additional information has been requested.
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PNC, RV5
Symptoms: Haematemesis, Vomiting
Clinical narrative: Information has been received from a physician concerning a 7 month old female with history of renal anomaly who on 21-SEP-2007 was vaccinated PO with her third dose of Rotateq (lot # 657660/0972U). Concomitant vaccinations administered on that day included a dose of PEDIARIX, a dose of PREVNAR, and a dose of influenza virus vaccine (unspecified). Other concomitant drug therapy included prophylactic antibiotics and BACTRIM. On that same day, the patient experienced vomiting of blood and vomiting. The patient was taken to the ER and was subsequently sent back to a hospital for further observation. Subsequently, the vomiting and vomiting of blood resolved quickly and the patient was recovered. There was no product quality complaint. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female with no pertinent medical history who on 22-FEB-2007 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (lot # 654702/0011U), on 26-APR-2007 with the second dose of Gardasil in the left deltoid (lot # 657622/0388U) and on 13-SEP-2007 with the third dose of Gardasil in the left deltoid (lot # 658563/1063U). There was no concomitant medication. On 13-SEP-2007 the patient developed pain and a large lump in her left deltoid at the injection site. The patient was seen in her physician's office on 05-OCT-2007 and was instructed to take cephalexin (KEFLEX) and diphenhydramine hydrochloride (BENADRYL) and apply warm compresses. At the time of this report, the outcome of the events was unknown. The reporter felt that the events were disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood culture, Blood thyroid stimulating hormone increased, Full blood count, Malaise, Pain in extremity
Clinical narrative: Information has been received from a physician, concerning an 18 year old female patient with no pertinent medical history and no known allergies, who on 22-JUN-2007 was vaccinated IM with the first dose, on 15-AUG-2007 with the second dose, and on 27-SEP-2007 ("43 days later") with the third dose of Gardasil (lot # not provided). There was no concomitant medication. Following the third dose on 27-SEP-2007 the patient experienced arm pain and reported not feeling well. On approximately 14-OCT-2007 ("three weeks after" and on "Sunday night") the patient developed a urinary tract infection and was hospitalized on an observation basis. Treatment included trimethoprim/ sulfamethoxazole (BACTRIM). Diagnostic labs included a blood culture, complete blood cell count, urinalysis (results not provided), and a thyroid function test that indicated an elevated thyroid stimulating hormone (TSH) (value not provided). The following day ("Monday"), she was discharged. At the time of this report, the patient had recovered from the urinary tract infection; the outcome of arm pain, not feeling well, and elevated TSH was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test abnormal, Urinary tract infection, Urine analysis
Clinical narrative: Information has been received from a physician, concerning an 18 year old female patient with no pertinent medical history and no known allergies, who on 22-JUN-2007 was vaccinated IM with the first dose, on 15-AUG-2007 with the second dose, and on 27-SEP-2007 ("43 days later") with the third dose of Gardasil (lot # not provided). There was no concomitant medication. Following the third dose on 27-SEP-2007 the patient experienced arm pain and reported not feeling well. On approximately 14-OCT-2007 ("three weeks after" and on "Sunday night") the patient developed a urinary tract infection and was hospitalized on an observation basis. Treatment included trimethoprim/ sulfamethoxazole (BACTRIM). Diagnostic labs included a blood culture, complete blood cell count, urinalysis (results not provided), and a thyroid function test that indicated an elevated thyroid stimulating hormone (TSH) (value not provided). The following day ("Monday"), she was discharged. At the time of this report, the patient had recovered from the urinary tract infection; the outcome of arm pain, not feeling well, and elevated TSH was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site abscess, Injection site cellulitis, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a 61 year old male who on 11-OCT-2007 was vaccinated SC in the left arm with a dose of Pneumovax 23 (lot #656233/0200U). Concomitant therapy included influenza virus vaccine (unspecified). On 11-OCT-2007, the patient developed an "enlarging" lump with pain, fever and tenderness in the left injection site arm. On 12-OCT-2007, the patient presented to an emergency room, and subsequently, was hospitalized with cellulitis and possible abscess at the injection site of the left upper extremity. On an unspecified date, the patient was discharged. At the time of this report, the patient was recovering. A concern regarding the lot was reported. Cellulitis and possible abscess at injection site were considered to be disabling events. Additional information has been requested. The medical assistant also reported another patient who developed an adverse experience after vaccination with Pneumovax 23 (lot # 656233/0200U) (WAES #0710USA03567).
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 61 year old male who on 11-OCT-2007 was vaccinated SC in the left arm with a dose of Pneumovax 23 (lot #656233/0200U). Concomitant therapy included influenza virus vaccine (unspecified). On 11-OCT-2007, the patient developed an "enlarging" lump with pain, fever and tenderness in the left injection site arm. On 12-OCT-2007, the patient presented to an emergency room, and subsequently, was hospitalized with cellulitis and possible abscess at the injection site of the left upper extremity. On an unspecified date, the patient was discharged. At the time of this report, the patient was recovering. A concern regarding the lot was reported. Cellulitis and possible abscess at injection site were considered to be disabling events. Additional information has been requested. The medical assistant also reported another patient who developed an adverse experience after vaccination with Pneumovax 23 (lot # 656233/0200U) (WAES #0710USA03567).
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Headache, Meningitis viral, Migraine, Nausea, Tenderness
Clinical narrative: Flu shot done on 10/2 then 4 hours later she had a reaction which got worse and caused her to have severe vertigo, large amount of pressure in her head, temp loss of vision in 1 eye, and septical (viral) meningitis; wants to find out if this from the flu and if the injection medication can be tested. Primary care an Neurologist were concerned and provided with the lot info. Manufacturer not notified but advised the complainant to do so. Complainant saw several specialist in the hospital including a Rheumotologist, ENT, Neurologist Had previous autoimmune disease since teenager. The complainant will try to return to work on Monday 10/22/07 and she works from 8a-5p. 10/19/07 complainant called back after she notified manufacturer of complaint and was provided a case number of NA07-005083.  12/18/07 Reviewed hospital medical records which reveal patient experienced right sided transient vision loss, HA & scalp tenderness.  Admitted 10/5-10/15/2007.  D/C on tapering steroid dose to f/u in rheumatology & neurology clinics. FINAL DX: vestibular neuronitis, possible antiphospholipid syndrome, migraine HA and possible aseptic vs viral meningitis. Per 60 day follow up: Diagnosed with viral meningitis. Still having neurology problems. Prognosis: Recovery could take up to 1 year. 1/15/2010 I am still having ongoing issues with nausea and vertigo. I wasl also diagnosed with Lupus.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vertigo
Clinical narrative: Flu shot done on 10/2 then 4 hours later she had a reaction which got worse and caused her to have severe vertigo, large amount of pressure in her head, temp loss of vision in 1 eye, and septical (viral) meningitis; wants to find out if this from the flu and if the injection medication can be tested. Primary care an Neurologist were concerned and provided with the lot info. Manufacturer not notified but advised the complainant to do so. Complainant saw several specialist in the hospital including a Rheumotologist, ENT, Neurologist Had previous autoimmune disease since teenager. The complainant will try to return to work on Monday 10/22/07 and she works from 8a-5p. 10/19/07 complainant called back after she notified manufacturer of complaint and was provided a case number of NA07-005083.  12/18/07 Reviewed hospital medical records which reveal patient experienced right sided transient vision loss, HA & scalp tenderness.  Admitted 10/5-10/15/2007.  D/C on tapering steroid dose to f/u in rheumatology & neurology clinics. FINAL DX: vestibular neuronitis, possible antiphospholipid syndrome, migraine HA and possible aseptic vs viral meningitis. Per 60 day follow up: Diagnosed with viral meningitis. Still having neurology problems. Prognosis: Recovery could take up to 1 year. 1/15/2010 I am still having ongoing issues with nausea and vertigo. I wasl also diagnosed with Lupus.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blindness transient, Deafness unilateral, Dizziness, Headache, Malaise
Clinical narrative: Flu shot done on 10/2 then 4 hours later she had a reaction which got worse and caused her to have severe vertigo, large amount of pressure in her head, temp loss of vision in 1 eye, and septical (viral) meningitis; wants to find out if this from the flu and if the injection medication can be tested. Primary care an Neurologist were concerned and provided with the lot info. Manufacturer not notified but advised the complainant to do so. Complainant saw several specialist in the hospital including a Rheumotologist, ENT, Neurologist Had previous autoimmune disease since teenager. The complainant will try to return to work on Monday 10/22/07 and she works from 8a-5p. 10/19/07 complainant called back after she notified manufacturer of complaint and was provided a case number of NA07-005083.  12/18/07 Reviewed hospital medical records which reveal patient experienced right sided transient vision loss, HA & scalp tenderness.  Admitted 10/5-10/15/2007.  D/C on tapering steroid dose to f/u in rheumatology & neurology clinics. FINAL DX: vestibular neuronitis, possible antiphospholipid syndrome, migraine HA and possible aseptic vs viral meningitis. Per 60 day follow up: Diagnosed with viral meningitis. Still having neurology problems. Prognosis: Recovery could take up to 1 year. 1/15/2010 I am still having ongoing issues with nausea and vertigo. I wasl also diagnosed with Lupus.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Meningitis viral, Vomiting
Clinical narrative: Flu shot done on 10/2 then 4 hours later she had a reaction which got worse and caused her to have severe vertigo, large amount of pressure in her head, temp loss of vision in 1 eye, and septical (viral) meningitis; wants to find out if this from the flu and if the injection medication can be tested. Primary care an Neurologist were concerned and provided with the lot info. Manufacturer not notified but advised the complainant to do so. Complainant saw several specialist in the hospital including a Rheumotologist, ENT, Neurologist Had previous autoimmune disease since teenager. The complainant will try to return to work on Monday 10/22/07 and she works from 8a-5p. 10/19/07 complainant called back after she notified manufacturer of complaint and was provided a case number of NA07-005083.  12/18/07 Reviewed hospital medical records which reveal patient experienced right sided transient vision loss, HA & scalp tenderness.  Admitted 10/5-10/15/2007.  D/C on tapering steroid dose to f/u in rheumatology & neurology clinics. FINAL DX: vestibular neuronitis, possible antiphospholipid syndrome, migraine HA and possible aseptic vs viral meningitis. Per 60 day follow up: Diagnosed with viral meningitis. Still having neurology problems. Prognosis: Recovery could take up to 1 year. 1/15/2010 I am still having ongoing issues with nausea and vertigo. I wasl also diagnosed with Lupus.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Ear discomfort, Headache, Intracranial pressure increased, Meningitis aseptic
Clinical narrative: Flu shot done on 10/2 then 4 hours later she had a reaction which got worse and caused her to have severe vertigo, large amount of pressure in her head, temp loss of vision in 1 eye, and septical (viral) meningitis; wants to find out if this from the flu and if the injection medication can be tested. Primary care an Neurologist were concerned and provided with the lot info. Manufacturer not notified but advised the complainant to do so. Complainant saw several specialist in the hospital including a Rheumotologist, ENT, Neurologist Had previous autoimmune disease since teenager. The complainant will try to return to work on Monday 10/22/07 and she works from 8a-5p. 10/19/07 complainant called back after she notified manufacturer of complaint and was provided a case number of NA07-005083.  12/18/07 Reviewed hospital medical records which reveal patient experienced right sided transient vision loss, HA & scalp tenderness.  Admitted 10/5-10/15/2007.  D/C on tapering steroid dose to f/u in rheumatology & neurology clinics. FINAL DX: vestibular neuronitis, possible antiphospholipid syndrome, migraine HA and possible aseptic vs viral meningitis. Per 60 day follow up: Diagnosed with viral meningitis. Still having neurology problems. Prognosis: Recovery could take up to 1 year. 1/15/2010 I am still having ongoing issues with nausea and vertigo. I wasl also diagnosed with Lupus.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tinnitus, Vertigo, Vomiting
Clinical narrative: Flu shot done on 10/2 then 4 hours later she had a reaction which got worse and caused her to have severe vertigo, large amount of pressure in her head, temp loss of vision in 1 eye, and septical (viral) meningitis; wants to find out if this from the flu and if the injection medication can be tested. Primary care an Neurologist were concerned and provided with the lot info. Manufacturer not notified but advised the complainant to do so. Complainant saw several specialist in the hospital including a Rheumotologist, ENT, Neurologist Had previous autoimmune disease since teenager. The complainant will try to return to work on Monday 10/22/07 and she works from 8a-5p. 10/19/07 complainant called back after she notified manufacturer of complaint and was provided a case number of NA07-005083.  12/18/07 Reviewed hospital medical records which reveal patient experienced right sided transient vision loss, HA & scalp tenderness.  Admitted 10/5-10/15/2007.  D/C on tapering steroid dose to f/u in rheumatology & neurology clinics. FINAL DX: vestibular neuronitis, possible antiphospholipid syndrome, migraine HA and possible aseptic vs viral meningitis. Per 60 day follow up: Diagnosed with viral meningitis. Still having neurology problems. Prognosis: Recovery could take up to 1 year. 1/15/2010 I am still having ongoing issues with nausea and vertigo. I wasl also diagnosed with Lupus.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Burning sensation, Guillain-Barre syndrome, Headache
Clinical narrative: 10/12 Headache, redness and swelling at injection site. 10/14 Low back pain. 10/15 Leg pain. 10/16 Severe leg and back pain, deep ache with burning sensation - to hosp. E.R. 10/19 Increased severe leg and back pain with weakness - to PMD. 10/20 Admitted to hospital. 1/22/08-records received for DOS 10/20-10/30/07 DC DX: Guillain-Barre syndrome with severe paresthesias and pain, bialteral muscle weakness, plsmapheresis. Pain, anxiety, plasmapheresis catheter infection with methicillin-sesnsitive Staphylococcus epiermidis. Dysuria with normal urinalysis, severe constipation, left foot pain with swelling, general deconditioning and symmetric peripheral weakness including facial weakness and pocketing food during meals. Then traveled out of state at which time had severe pain in buttock and thigh. Tingling and numbness.Transferred to rehab.   9/19/08 Received additional medical records. ER records of 10/16/07 reveal patient had HA & diarrhea week before.  Then developed low back pain, knee pain & skin sensitivity.  Labs were unremarkable.  Tx w/pain meds & d/c to home.  Rehab records of 10/30-11/5/2007 reveal patient tx w/IVIG x 5.  D/C to home w/walker & TENS unit.  Had continued paresthesias
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: 10/12 Headache, redness and swelling at injection site. 10/14 Low back pain. 10/15 Leg pain. 10/16 Severe leg and back pain, deep ache with burning sensation - to hosp. E.R. 10/19 Increased severe leg and back pain with weakness - to PMD. 10/20 Admitted to hospital. 1/22/08-records received for DOS 10/20-10/30/07 DC DX: Guillain-Barre syndrome with severe paresthesias and pain, bialteral muscle weakness, plsmapheresis. Pain, anxiety, plasmapheresis catheter infection with methicillin-sesnsitive Staphylococcus epiermidis. Dysuria with normal urinalysis, severe constipation, left foot pain with swelling, general deconditioning and symmetric peripheral weakness including facial weakness and pocketing food during meals. Then traveled out of state at which time had severe pain in buttock and thigh. Tingling and numbness.Transferred to rehab.   9/19/08 Received additional medical records. ER records of 10/16/07 reveal patient had HA & diarrhea week before.  Then developed low back pain, knee pain & skin sensitivity.  Labs were unremarkable.  Tx w/pain meds & d/c to home.  Rehab records of 10/30-11/5/2007 reveal patient tx w/IVIG x 5.  D/C to home w/walker & TENS unit.  Had continued paresthesias
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF test normal, Confusional state, Dysphagia, Encephalitis, Encephalopathy
Clinical narrative: Pt found to have dysphagia/confusion. Exact time of onset of s/s are unknown. Pt admitted to ED where stroke was ruled out. Pt continued to have changes in mental status/hallucinations. Pt also with lesions consistent with shingles. Pt diagnosed with encephalitis. Started on IV Acyclovir. Encephalopathy resolving after starting Acyclovir. Pt with possible VZV encephalitis that has markedly improved with continuing 14 days of IV Acyclovir. 1/28/08-records received-for DOS 4/6-4/18/07 and 4/29-5/4/07-DX: probable varicella zoster viurs encephalitis. E. coli urinary tract infection. Neurogenic bladder. Polymicrobial sepsis, resolving. Presented to ED with confusion and global aphasia. Shingles. Pruritus. Fever chills and abdominal pain.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, Herpes zoster, Mental status changes, Polymerase chain reaction, Syphilis test negative
Clinical narrative: Pt found to have dysphagia/confusion. Exact time of onset of s/s are unknown. Pt admitted to ED where stroke was ruled out. Pt continued to have changes in mental status/hallucinations. Pt also with lesions consistent with shingles. Pt diagnosed with encephalitis. Started on IV Acyclovir. Encephalopathy resolving after starting Acyclovir. Pt with possible VZV encephalitis that has markedly improved with continuing 14 days of IV Acyclovir. 1/28/08-records received-for DOS 4/6-4/18/07 and 4/29-5/4/07-DX: probable varicella zoster viurs encephalitis. E. coli urinary tract infection. Neurogenic bladder. Polymicrobial sepsis, resolving. Presented to ED with confusion and global aphasia. Shingles. Pruritus. Fever chills and abdominal pain.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Intussusception.  11/02/07 Reviewed medical records from 2nd ER of 10/19/07 which reveal patient experienced pulling up of legs, vomiting & apparent abdominal pain.  Seen in outlying ER & admitted overnight.  Tx w/IVF & serial abdominal exams.  D/c to home & had continued gagging, reduced oral intake, irritability, decreased sleep & uncomfortable abdomen.  BE reduced IS & admitted overnight for observation s/p reduction. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. 11/13/07 Reviewed hospital medical records which reveal patient experienced vomiting, fever & abdominal pain.  Admitted 10/18-10/19/2007. Abdomen was diffusely tender.  Tx w/IVF, antipyretic & antinausea meds.  Improved & d/c to home. ER Diagnosis: dehydration, vomiting & abdominal pain. Seen at outlying hospital for persistent vomiting where IS was dx & reduced by BE.  Admitted overnight for observation & d/c to home.   Continued to run fever & had diarrhea & returned to ER.  Temp 103 in ER.  Tx w/antipyretic & d/c to home. Final ER dx: fever secondary to vaccines. Records faxed to CDC. 11/16/07 Received vax record from pcp which confirms RO dose & lot as reported.  Record faxed to CDC.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Full blood count, Irritability
Clinical narrative: Temp to 104.1 (rectal temp) on Tylenol -  fussy.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Biopsy skin abnormal, Body temperature increased, Petechiae, Pruritus, Rash
Clinical narrative: Rash developed on elbow area (B), 8/26/07, rash spread to rest arms, legs, trunk 8/27/07. Macular-papular rash, no pustules, no vesicles. Injection site intact - mild pruritus. Low grade temp 100.4. Derm biopsy lesion - few petechiae. No new lesions 30 Aug 07 - skin completely cleared 26 Sept 07. Anthrax #2 given 26 Sept 07. F/U 10 Oct 07 - no sx.