chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Laparotomy, Sepsis, Small intestinal anastomosis, Ultrasound abdomen, Vomiting
Clinical narrative: Initial report received on 12 March 2007 from an other manufacturer, report number WAES0702USA02967. This manufacturer had received the original report from the agency reported. Verbatim from report: "Information has been received from the agency reported concerning a male with gastrooesophageal reflux who on 03-Jan-2007, at 12:30 p.m. was vaccinated with a third oral dose Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of PEDIARIX (Lot# AC21B079BA) and a third intramuscular dose in the left leg of ACTHIB (Lot# ue992aa). Concomitant therapy included PREVACID. The patient had an upper respiratory infection at the time of vaccination. On 03-FEB-2007 the patient developed gastrointestinal symptoms. The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check has been requested. Additional information has been requested." The patient had an abdominal ultrasound on 07 February 2007 that demonstrated intussusception.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Gastrointestinal disorder, Intensive care, Intestinal anastomosis, Intestinal perforation
Clinical narrative: Initial report received on 12 March 2007 from an other manufacturer, report number WAES0702USA02967. This manufacturer had received the original report from the agency reported. Verbatim from report: "Information has been received from the agency reported concerning a male with gastrooesophageal reflux who on 03-Jan-2007, at 12:30 p.m. was vaccinated with a third oral dose Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of PEDIARIX (Lot# AC21B079BA) and a third intramuscular dose in the left leg of ACTHIB (Lot# ue992aa). Concomitant therapy included PREVACID. The patient had an upper respiratory infection at the time of vaccination. On 03-FEB-2007 the patient developed gastrointestinal symptoms. The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check has been requested. Additional information has been requested." The patient had an abdominal ultrasound on 07 February 2007 that demonstrated intussusception.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Intubation, Intussusception, Laparotomy, Sepsis, Ultrasound abdomen abnormal
Clinical narrative: Initial report received on 12 March 2007 from an other manufacturer, report number WAES0702USA02967. This manufacturer had received the original report from the agency reported. Verbatim from report: "Information has been received from the agency reported concerning a male with gastrooesophageal reflux who on 03-Jan-2007, at 12:30 p.m. was vaccinated with a third oral dose Rotateq (Lot# 655866/1110F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of PEDIARIX (Lot# AC21B079BA) and a third intramuscular dose in the left leg of ACTHIB (Lot# ue992aa). Concomitant therapy included PREVACID. The patient had an upper respiratory infection at the time of vaccination. On 03-FEB-2007 the patient developed gastrointestinal symptoms. The patient was diagnosed with intussusception on 07-FEB-2007. The patient suffered perforation of the intestine during an attempt to reduce by Barium enema, which required emergency laparotomy and reanastomosis of the small bowel. The patient suffered a second small bowel perforation on 12-FEB-2007. The patient's illness resulted in admission to intensive care unit, with intubation and probable sepsis. The patient's reactions were considered to be immediately life-threatening by the reporter. A lot check has been requested. Additional information has been requested." The patient had an abdominal ultrasound on 07 February 2007 that demonstrated intussusception.
Age: 0.33
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Gastrointestinal haemorrhage, Haematochezia
Clinical narrative: SERIOUSNESS CRITERIA; OTHER-MEDICALL SIGNIFICANT. Initial report received on 12 March 2007 from another manufacturer, report number WAES0702USA02961. The initial report to this manufacturer was a health care professional. Verbatim from the report: "This is in follow-up to report (s) previously submitted on 2/22/2007. Information has been received from a physician concerning a 4 month old female, with reflux, who, on 01-Nov-2006, was vaccinated with a first oral dose or Rotateq. Concomitant vaccines included a dose of IPOL, a dose of HIB (manufacturer unknown), and a dose of DTaP. "Two months ago," in approximately December 2006, the patient experienced a little gastrointestinal bleeding. Subsequently, the bleeding subsided.  On 08-Jan-2007, the patient was vaccinated with a second dose of Rotateq. Concomitant vaccines included a dose of IPOL, a dose of HIB (manufacturer unknown), and a dose of DTaP.  Concomitant therapy included amoxicillin/clavulanate potassium (Augmentin), which was discontinued just prior to the second dose of Rotateq. The patient was then put on cefdinir (Omnicef) and sulfamethoxazole/trimethoprim (Bactrim) for the treatment of a urinary tract infection and a fever. "Approximately one week after the second dose of Rotateq," on approximately 15-Jan-2007, the patient's mother reported to the physician that she saw blood in the patient's stool, without any other symptoms. It was noted that the patient was being worked up for a nephropathy. The reporter noted that the sulfamethoxazole/trimethoprim (Bactrim) had not caused any problems with the patient and that was why he was thinking that the blood in the stool was possibly related to the vaccination with Rotateq. Subsequently, the patient's bleeding subsided. At the time of the report, the patient was recovering." "Follow-up information from a physician indicated that the patient had fully recovered and was "doing great." The physician noted that the patient would receive her third dose of Rotateq." "Upon internal review, the patient's blood in stool was considered to be an other important medical event. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium double contrast, Diverticulitis Meckel's, Fatigue, Gastrointestinal necrosis, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 16-FEB-2007 was vaccinated with a 2ml oral dose of Rotateq. On 11-MAR-2007 the patient developed intussusception. The physician referred to the condition as Meckels diverticulum. The patient was hospitalized for an unspecified amount of time. The patient required surgery in which 4 cm of dead bowel was removed. The patient was reported to be recovering. There was no product quality complaint involved. The patient's intussusception and meckels diverticulum were considered to be other important medical events by the physician. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception, Irritability, Surgery
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 16-FEB-2007 was vaccinated with a 2ml oral dose of Rotateq. On 11-MAR-2007 the patient developed intussusception. The physician referred to the condition as Meckels diverticulum. The patient was hospitalized for an unspecified amount of time. The patient required surgery in which 4 cm of dead bowel was removed. The patient was reported to be recovering. There was no product quality complaint involved. The patient's intussusception and meckels diverticulum were considered to be other important medical events by the physician. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Diverticular hernia, Gastrointestinal necrosis, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 16-FEB-2007 was vaccinated with a 2ml oral dose of Rotateq. On 11-MAR-2007 the patient developed intussusception. The physician referred to the condition as Meckels diverticulum. The patient was hospitalized for an unspecified amount of time. The patient required surgery in which 4 cm of dead bowel was removed. The patient was reported to be recovering. There was no product quality complaint involved. The patient's intussusception and meckels diverticulum were considered to be other important medical events by the physician. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, FLUX
Symptoms: Delirium, Humerus fracture, Loss of consciousness
Clinical narrative: Initial information received from another manufacturer on 15 March 2007. The report was initially received by the other company from a consumer. A patient (no specific patient identification provided) received a dose of Influenza vaccine and a dose of pneumonia vaccine in November 2006. The trade names, manufacturer and lot numbers were not reported for either vaccine. An unspecified amount of time later, the patient experienced "stoke like symptoms". He was hospitalized and on life support for several days. No information regarding recovery status was provided at the time of this report. Follow-up information received on 19 March 2007 from the patient. This information was incorporated into this initial report. The patient stated that he received an influenza vaccine on approximately 18 November 2006. He had no immediate reaction following administration of the vaccine. Three days later, he received a pneumonia vaccine. The patient stated that he did not know the trade name, manufacturer or lot number for wither vaccine. The day after receiving the pneumonia vaccine, the patient stated that he had difficulty speaking and was dizzy. He was taken by EMS to the emergency room and was admitted to the hospital with stroke-like symptoms. He has loss of consciousness and was on life support for two to three days. During hospitalization, he was found to have a dislocated right shoulder and a 'cracked" left shoulder. He required surgery on both arms. The patient did not know what the discharge diagnosis was, but stated that it was determined that he had not experienced a stroke or heart attack. He has no history of allergies. At the time of vaccination he was taking Crestor for high cholesterol. At the time of this report, the patient has not recovered, as he still has pain in his left arm and shoulder, and cannot raise his right arm over his head.
Age: 68.0
Sex: M
Vaccine: PPV, FLUX
Symptoms: Dizziness, Joint dislocation, Life support, Loss of consciousness, Mobility decreased
Clinical narrative: Initial information received from another manufacturer on 15 March 2007. The report was initially received by the other company from a consumer. A patient (no specific patient identification provided) received a dose of Influenza vaccine and a dose of pneumonia vaccine in November 2006. The trade names, manufacturer and lot numbers were not reported for either vaccine. An unspecified amount of time later, the patient experienced "stoke like symptoms". He was hospitalized and on life support for several days. No information regarding recovery status was provided at the time of this report. Follow-up information received on 19 March 2007 from the patient. This information was incorporated into this initial report. The patient stated that he received an influenza vaccine on approximately 18 November 2006. He had no immediate reaction following administration of the vaccine. Three days later, he received a pneumonia vaccine. The patient stated that he did not know the trade name, manufacturer or lot number for wither vaccine. The day after receiving the pneumonia vaccine, the patient stated that he had difficulty speaking and was dizzy. He was taken by EMS to the emergency room and was admitted to the hospital with stroke-like symptoms. He has loss of consciousness and was on life support for two to three days. During hospitalization, he was found to have a dislocated right shoulder and a 'cracked" left shoulder. He required surgery on both arms. The patient did not know what the discharge diagnosis was, but stated that it was determined that he had not experienced a stroke or heart attack. He has no history of allergies. At the time of vaccination he was taking Crestor for high cholesterol. At the time of this report, the patient has not recovered, as he still has pain in his left arm and shoulder, and cannot raise his right arm over his head.
Age: 68.0
Sex: M
Vaccine: PPV, FLUX
Symptoms: Neurological symptom, Pain in extremity, Speech disorder, Surgery, Upper limb fracture
Clinical narrative: Initial information received from another manufacturer on 15 March 2007. The report was initially received by the other company from a consumer. A patient (no specific patient identification provided) received a dose of Influenza vaccine and a dose of pneumonia vaccine in November 2006. The trade names, manufacturer and lot numbers were not reported for either vaccine. An unspecified amount of time later, the patient experienced "stoke like symptoms". He was hospitalized and on life support for several days. No information regarding recovery status was provided at the time of this report. Follow-up information received on 19 March 2007 from the patient. This information was incorporated into this initial report. The patient stated that he received an influenza vaccine on approximately 18 November 2006. He had no immediate reaction following administration of the vaccine. Three days later, he received a pneumonia vaccine. The patient stated that he did not know the trade name, manufacturer or lot number for wither vaccine. The day after receiving the pneumonia vaccine, the patient stated that he had difficulty speaking and was dizzy. He was taken by EMS to the emergency room and was admitted to the hospital with stroke-like symptoms. He has loss of consciousness and was on life support for two to three days. During hospitalization, he was found to have a dislocated right shoulder and a 'cracked" left shoulder. He required surgery on both arms. The patient did not know what the discharge diagnosis was, but stated that it was determined that he had not experienced a stroke or heart attack. He has no history of allergies. At the time of vaccination he was taking Crestor for high cholesterol. At the time of this report, the patient has not recovered, as he still has pain in his left arm and shoulder, and cannot raise his right arm over his head.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Abnormal loss of weight, Arthralgia, Blindness, Blood glucose increased, Blood ketone body absent
Clinical narrative: 1/98-warts on hands-still have them today many treatments tried, nothing helped, see medical record. 1/06-Type I diabetes-take insulin multiple times a day. Loss of vision. 1/98-Muscle and joint aches-constipation, diarrhea, fatigue, no treatment. 6/19/07 Received tag 2 report along w/clinical summary of medical records.  Will accept that as case complete.  Summary reveals patient received anthrax vax between 10 & 12, 1997 ( no documentation in military records) & had no immediate reaction.  Developed warts on hands/feet within about 2 weeks of vax.  Vax administered closest to current dx of IDDM was Hep A in 8/1998.  Patient had visual changes after Hep A vax.  Patient noted onset of polydipsia/polyuria in approx 10/06 along w/unexplained weight loss, fatigue, leg cramps.  Patient did not receive any medical care from 1998-2005.  Seen by MD & sent to ER 1/06 for elevated glucose & hospitalized for 3 days for IDDM management.  Currently is on insulin pump.  Currently under treatment for PTSD. FINAL DX: Type I diabetes mellitus, diagnosed 8 years s/p anthrax vax. 1/5/2010 Patient has type I diabetes.02/02/2010 Patient has Type1 DM and is on insulin pump.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Constipation, Dependence on enabling machine or device, Diarrhoea, Fatigue, Glucose urine present
Clinical narrative: 1/98-warts on hands-still have them today many treatments tried, nothing helped, see medical record. 1/06-Type I diabetes-take insulin multiple times a day. Loss of vision. 1/98-Muscle and joint aches-constipation, diarrhea, fatigue, no treatment. 6/19/07 Received tag 2 report along w/clinical summary of medical records.  Will accept that as case complete.  Summary reveals patient received anthrax vax between 10 & 12, 1997 ( no documentation in military records) & had no immediate reaction.  Developed warts on hands/feet within about 2 weeks of vax.  Vax administered closest to current dx of IDDM was Hep A in 8/1998.  Patient had visual changes after Hep A vax.  Patient noted onset of polydipsia/polyuria in approx 10/06 along w/unexplained weight loss, fatigue, leg cramps.  Patient did not receive any medical care from 1998-2005.  Seen by MD & sent to ER 1/06 for elevated glucose & hospitalized for 3 days for IDDM management.  Currently is on insulin pump.  Currently under treatment for PTSD. FINAL DX: Type I diabetes mellitus, diagnosed 8 years s/p anthrax vax. 1/5/2010 Patient has type I diabetes.02/02/2010 Patient has Type1 DM and is on insulin pump.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Myalgia, Skin papilloma, Type 1 diabetes mellitus, Urine bilirubin increased, Urine ketone body present
Clinical narrative: 1/98-warts on hands-still have them today many treatments tried, nothing helped, see medical record. 1/06-Type I diabetes-take insulin multiple times a day. Loss of vision. 1/98-Muscle and joint aches-constipation, diarrhea, fatigue, no treatment. 6/19/07 Received tag 2 report along w/clinical summary of medical records.  Will accept that as case complete.  Summary reveals patient received anthrax vax between 10 & 12, 1997 ( no documentation in military records) & had no immediate reaction.  Developed warts on hands/feet within about 2 weeks of vax.  Vax administered closest to current dx of IDDM was Hep A in 8/1998.  Patient had visual changes after Hep A vax.  Patient noted onset of polydipsia/polyuria in approx 10/06 along w/unexplained weight loss, fatigue, leg cramps.  Patient did not receive any medical care from 1998-2005.  Seen by MD & sent to ER 1/06 for elevated glucose & hospitalized for 3 days for IDDM management.  Currently is on insulin pump.  Currently under treatment for PTSD. FINAL DX: Type I diabetes mellitus, diagnosed 8 years s/p anthrax vax. 1/5/2010 Patient has type I diabetes.02/02/2010 Patient has Type1 DM and is on insulin pump.
Age: 21.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Aspartate aminotransferase, Blood glucose decreased, Diabetes mellitus insulin-dependent, Glycosylated haemoglobin
Clinical narrative: 1/98-warts on hands-still have them today many treatments tried, nothing helped, see medical record. 1/06-Type I diabetes-take insulin multiple times a day. Loss of vision. 1/98-Muscle and joint aches-constipation, diarrhea, fatigue, no treatment. 6/19/07 Received tag 2 report along w/clinical summary of medical records.  Will accept that as case complete.  Summary reveals patient received anthrax vax between 10 & 12, 1997 ( no documentation in military records) & had no immediate reaction.  Developed warts on hands/feet within about 2 weeks of vax.  Vax administered closest to current dx of IDDM was Hep A in 8/1998.  Patient had visual changes after Hep A vax.  Patient noted onset of polydipsia/polyuria in approx 10/06 along w/unexplained weight loss, fatigue, leg cramps.  Patient did not receive any medical care from 1998-2005.  Seen by MD & sent to ER 1/06 for elevated glucose & hospitalized for 3 days for IDDM management.  Currently is on insulin pump.  Currently under treatment for PTSD. FINAL DX: Type I diabetes mellitus, diagnosed 8 years s/p anthrax vax. 1/5/2010 Patient has type I diabetes.02/02/2010 Patient has Type1 DM and is on insulin pump.
Age: 0.31
Sex: F
Vaccine: RV5
Symptoms: Crying, Diarrhoea haemorrhagic, Haematochezia, Muscle spasms, Ultrasound abdomen normal
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 22-week-old female with no medical history who on 13-NOV-2006 and 20-JAN-2007 was vaccinated PO with the first and second doses, respectively, of Rotateq (Lot #654247/0600F). There was no illness at the time of vaccination. The NP reported that on 05-MAR-2007, the patient had one episode of liquid dark brown stool with a small amount of bright red blood. Unspecified medical attention was sought. On that same day, the patient was also noted to have cramping and increased crying. On 06-MAR-2007, an abdominal ultrasound was negative for sonographic signs of intussusception. A diagnosis of bloody diarrhea was made. On 06-MAR-2006, the patient recovered. Upon internal review, bloody diarrhea was determined to be an other important medical event. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 3 month old patient who was vaccinated with the first dose of Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. Intussusception was considered to be immediately life-threatening and an other important medical event. The outcome was not reported. Additional information has been requested. 4/6/07 Received medical records from both hospitals today which reveal: Hospital #1 ER - seen 3/10/07 for blood in stool night before & that AM.  Also vomited that AM.  Was seen by PCP on 3/9 & thought to be possible allergy, tx w/benadryl.  After second bloody stool, went to ER.  Dx w/acute GI bleed.  Tx w/IVF & transferred to higher level of care.   Hospital #2 Admission 3/10/07-3/13/07.  Received into PICU & surg consult obtained.  Exam revealed patient to be lethargic & mildly dehydrated despite prior IVFs.  Abdomen was soft, nondistended w/+BS but also with a palpable mass along the left side of the abdomen, LLQ.  Rectal exam revealed mucosal mass almost protruding from rectum.  Air contrast enema x2 failed to reduce. Patient taken to OR for exp lap, reduction of  right colon-ileocecal IS w/difficulty due to edematous & ischemic cecum & appendectomy.  Patient progressed well & was able to tolerate oral diet prior to d/c on 3/13/07. FINAL DX: Ileocecal intussusception, surgically reduced.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Premature baby, Viral test negative
Clinical narrative: Information has been received from a physician through the pregnancy registry concerning a 20 year old female who on -18-JAN-2005 was vaccinated with a dose of Varivax (lot # 646665/0712N). Subsequently the patient has since tested positive for pregnancy, her LMP was 07-DEC-2004. No symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information from the physician indicated that the patient was tested for varicella antibodies on 04-JAN-2005 before vaccination and the result was negative. It was reported that the patient did not experience varicella or herpes zoster symptoms post vaccination. On 20-JUN-2005 the patient gave birth to a male infant who was born 27 6/7 weeks from LMP was considered an other important medical event. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest tube insertion, Pericardial effusion, Pericardial excision, Pleural effusion
Clinical narrative: Information has been received from a health professional concerning a 55 year old female who on 14-SEP-2006 was vaccinated with a dose of Varivax. On 25-NOV-2006, the patient was admitted to the hospital for bilateral pleural effusion and pericardial effusion. She needed bilateral chest tube insertion and a pericardial window. She was discharged on 05-DEC-2006. She was readmitted on 15-DEC-2006 with pleural effusion and was discharged on 23-Dec-2006. The reporter noted that the patient was vaccinated at another facility and did not have the lot number. The reporter also mentioned that the patient's physician felt that there were no other reasons for the patient's experiences other than the vaccination. Bilateral pleural effusion and pericardial effusion were considered to be immediately life threatening and other important medical events by the reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Ovarian cyst, Ovarian cyst ruptured, Ultrasound scan, Vomiting
Clinical narrative: Information has been received from an office receptionist concerning a 12 year old female who in January 2007 was vaccinated with the first dose of Gardasil. Concomitant mediation was not reported. In January 2007, the developed an ovarian cyst that ruptured 10 days after receiving the first dose of Gardasil. Initially, the patient started vomiting for a few days and then there was significant abdominal pain. The patient was examined and diagnosed with ruptured ovarian cyst. The patient's ovarian cyst and ruptured ovarian cyst persisted and were considered to be disabling. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient was noted to have 2 by 3 cm area of mildly raised, red, mild swelling in right deltoid area with no associated pain, warmth, itching or fever. This was first noted by parent approx 0800 on 3/21/07 and by time of visit that afternoon mom felt it was less red. Advised to use ice to area and Benadryl only if itching.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Cold compress therapy, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm, induration of right upper arm. Treatment Tylenol, cool compress
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Local reaction at injection site in left arm with erythema, swelling, and warmth to touch. Noted by parents 1 day after injection. Seen in ED 2 days after and again by PCP 4 days after- erythema still present 4 immunes given in total on 3/15. DTaP and Varivax given in left arm.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse event, Drug exposure during pregnancy, Lethargy, Pain in extremity, Pregnancy test positive
Clinical narrative: Initial report received from a patient on 01 February 2007. A 27 year old, female patient (with an allergy to erythromycin) experienced arm soreness and mild lethargy, 1 day after she received a 0.5 mL IM injection of Adacel (lot number unknown) in the left deltoid on 24 January 2007. She was not treated with medicines. She did not have any illness at the time of vaccination. She received her last Td 10 year ago. The patient recovered from the adverse events in 3 days. The patient had a positive home pregnancy test on 29 January 2007. Her last menstrual period was "16 December 2006" or "30 December 2006" and her expected date of delivery is "25 September 2007" or "05 October 2007" (dependent on OB/GYN exam). The pregnancy has not yet been confirmed by the patient's OB/GYN and no prenatal testing has been conducted as of yet. She has had 3 previous pregnancies, 1 of which was a full term delivery and 2 of which were pre-term births. All had normal/viable pregnancy outcomes.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Body temperature increased, Ear pain, Headache, Pharyngolaryngeal pain, Syncope
Clinical narrative: Initial report received on 27 November 2006, from a healthcare professional. A 13 year old female patient received on 15 November 2006 Adacel (lot number C2340AA), first dose, intramuscular, Vaqta (lot number 0613F), Fluvirin (lot number 69424). On the same day (15 November 2006), the patient eyes closed for a few minutes and she seemed faint, but then fully recovered. Her arms moved in tremor. The patient's parents reported low grade temperature of 100 (Fahrenheit), headache, earache and sore throat. Corrective treatment was not reported. The patient outcome was not reported. The patient's medical history was not reported.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Tremor
Clinical narrative: Initial report received on 27 November 2006, from a healthcare professional. A 13 year old female patient received on 15 November 2006 Adacel (lot number C2340AA), first dose, intramuscular, Vaqta (lot number 0613F), Fluvirin (lot number 69424). On the same day (15 November 2006), the patient eyes closed for a few minutes and she seemed faint, but then fully recovered. Her arms moved in tremor. The patient's parents reported low grade temperature of 100 (Fahrenheit), headache, earache and sore throat. Corrective treatment was not reported. The patient outcome was not reported. The patient's medical history was not reported.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 08 February 2007. A 40 year old, male patient developed cellulitis at the site of vaccination and fever after he received an injection of Adacel (lot number "C62644AA", route of administration not reported) on 29 January 2007. Additional information was not provided.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Initial report received on 15 January 2007 from a health care professional. A 50-year-old male patient, with no illness at the time of vaccination, had received an intramuscular, left deltoid injection of Adacel, lot number C2455AA, on 09 January 2007. Three days later, the patient developed pain and swelling of the left axilla that continues. At the time of this report, the patient had not recovered.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperaesthesia, Mouth ulceration
Clinical narrative: Initial report received on 15 January 2007 from a health care professional. A 41-year-old female patient, who denied any concurrent illnesses, and who is allergic to Septra, and has a history hypothyroidism, increase cholesterol and migraines, had received a left deltoid, intramuscular injection of ADACEL, lot number C2644AA, on 12 January 2007. At the time of the vaccination, the patient was taking concomitantly Levoxyl, Lipitor, Seasonale, Zyrtec, Midrin (prn), and multivitamins. Approximately eight hours post-immunization, the patient complained of rigors, headache, skin sensitivity, and mouth ulcers. The rigors lasted approximately 24-36 hours. The patient did not seek medical attention. Treatments received and diagnostic testing performed were not reported. At the time of this report, the patient was still complaining of headache and weakness, and it was unknown if the skin sensitivity and mouth ulcers were still persisting. The patient has not fully recovered. Follow-up information received on 31 January 2007. The patient did not have any illness at the time of vaccination. The patient did speak with a physician who advised Benadryl and Motrin. No testing done. The patient fully recovered in 3-4 days. The final diagnosis for the adverse events was unknown.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: A 45-year-old female patient, with a past medical history of migraines and who was taking blood pressure medication, had received an intramuscular, right deltoid injection of Adacel, lot number C2644AA, on 06 February 2007. Within one hour post-vaccination, the patient experienced dizziness. A few days post-immunization, the patient complained of nausea. She was examined during a doctor's visit and treated with Antivert and niacin "without effect." At the time of this report, the patient had not recovered.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site vesicles, Medication error
Clinical narrative: Initial report received on 14 February 2007 from a health care professional. A 35-year-old female patient , who had no illnesses, and a past medical history of allergy to gluten and nitrous oxide, had received a 0.1 ml, intradermal, left forearm, injection of Adacel, lot number C2556AA, on 11 February 2007. Intradermal injection of Adacel is not a recommended route of administration by the manufacturer. The patient was supposed to receive Tubersol intradermally instead of Adacel. Two days post-vaccination, the patient experienced redness, blisters, and 14 mm induration at the injection site. At the time of this report, the patient had not recovered.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Initial report received on 14 February 2007 from a health care professional. A 35-year-old female patient , who had no illnesses, and a past medical history of allergy to gluten and nitrous oxide, had received a 0.1 ml, intradermal, left forearm, injection of Adacel, lot number C2556AA, on 11 February 2007. Intradermal injection of Adacel is not a recommended route of administration by the manufacturer. The patient was supposed to receive Tubersol intradermally instead of Adacel. Two days post-vaccination, the patient experienced redness, blisters, and 14 mm induration at the injection site. At the time of this report, the patient had not recovered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Received shots on Wednesday, 3-14-07, started getting a little red and sore to touch on Thursday.  By Friday the right upper arm red, swollen, hot to touch down to the elbow.  Took child to MD at ER.  Child has cellulitis of right arm.  Treated with antibiotic Keflex by mouth
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Pain in extremity
Clinical narrative: Mom states the day after injection arm was red and sore.States this morning has "golf ball sizes lump" and redness on back of right arm where injection was given.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Full blood count normal, Oedema peripheral, Pain in extremity, Platelet count normal, Pyrexia
Clinical narrative: WOKE UP 03-17-07 WITH PAIN IN ARM, LG AMT OF SWELLING IN UPPER ARM AND SHOULDER.  TENSE, HOT TO TOUCH, FEBRILE.  TOOK TO ER FOR EVALUATION.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Skin warm, Tension
Clinical narrative: WOKE UP 03-17-07 WITH PAIN IN ARM, LG AMT OF SWELLING IN UPPER ARM AND SHOULDER.  TENSE, HOT TO TOUCH, FEBRILE.  TOOK TO ER FOR EVALUATION.
Age: 23.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold compress therapy, Headache, Pain, Swelling
Clinical narrative: Patient went to Doctor due to headache and swelling and pain under both arm pits around brachial artery.  Shots were given on March 21, 2007 at 4:45 p.m.  Doctor instructed patient to use cold compresses under arms and take Motrin.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal X-ray, Intestinal perforation, Intussusception
Clinical narrative: INTUSSUSCEPTION, BOWEL PERFPRATION  5/25/07 Received hospital medical records which reveal patient experienced bloody stools x 4 days prior to admit 3/22/07-4/6/07. Patient to OR after bowel perforation for exp lap  & colostomy was done.  ID consult done & started on multiple IV antibiotics.  Initially vented but able to extubate quickly.  To cath lab on 3/29 for dilation of coarctation.  Transfused for low H/H.  Tolerated oral feedings as well as NGT feedings.  GI consult revealed GERD & delayed gastric emptying.  Progressed well & was d/c to home w/close f/u by multiple specialties. FINAL DX: Intussception; bowel perforation secondary to BE; exp lap & colostomy.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Body temperature increased, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Td vaccine given to right arm on 3/21/07 at 9:30 am.  On 3/22/07 approximately 5:00 pm patient felt soreness to arm and soreness spread to entire right side of body. That same night around 9 pm he experienced fever of 102.0 and chills.  Today, 3/23/07 temp is 98.8, but has generalized body aches.  No pain medication taken.  Will see doctor today.  Sent home to rest.  Report back if symptoms persist or worsen.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Patient had complaints of lightheadedness/dizziness approx. 5-10 minutes after injection. Lasted for approx. 5 minutes. Patient was seated, cold cloth applied to neck and wrists, given water to drink. s/s resolved with intervention and seating. Patient with no other complaints.
Age: 16.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Urticaria
Clinical narrative: Pt developed uticaria on arms approximately 2hours after receiving vaccines
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Rash erythematous
Clinical narrative: Mother describes "red rash on face" at approximately 9am this morning.  At this time, 2:45pm, he has the same rash on face and now has rash on trunk and diaper area.  Mom reports having given the child Benadryl "around 8:30am, which seems to have helped some".
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Blood pressure, Chills, Confusional state, Dizziness, Muscle contracture
Clinical narrative: Adacel given first, appeared fine.  HPV then given and within a minute or two, client's chin fell to chest while arm contracted at elbow up off lap.  She did not respond to name or shaking of shoulders for approximately one minute (B/P 100/60, pulse 64).  Then became aroused, although very confused and unsure where she was.  Called out for her mom and asked where she was and said she felt dizzy.  Client then assisted off chair to floor.  Became extremely pale, c/o lips tingling, B/P 130/64 at 1800.  While resting c/o "heavy head" feeling and paresthia in R arm, R and L hands and feet as well as c/o of chills.  At 1805 EMS called and responded by 1810 (B/P 130/66, RR 18 at 1805).  Given oxygen per EMS.  Client transported to ER.  Client discharged from ER within a couple hours. Parent contacted at 2000 and states client was "fine now". Returned to school on 3/23/07 per mother.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Oxygen supplementation, Pallor, Paraesthesia, Paraesthesia oral, Posture abnormal
Clinical narrative: Adacel given first, appeared fine.  HPV then given and within a minute or two, client's chin fell to chest while arm contracted at elbow up off lap.  She did not respond to name or shaking of shoulders for approximately one minute (B/P 100/60, pulse 64).  Then became aroused, although very confused and unsure where she was.  Called out for her mom and asked where she was and said she felt dizzy.  Client then assisted off chair to floor.  Became extremely pale, c/o lips tingling, B/P 130/64 at 1800.  While resting c/o "heavy head" feeling and paresthia in R arm, R and L hands and feet as well as c/o of chills.  At 1805 EMS called and responded by 1810 (B/P 130/66, RR 18 at 1805).  Given oxygen per EMS.  Client transported to ER.  Client discharged from ER within a couple hours. Parent contacted at 2000 and states client was "fine now". Returned to school on 3/23/07 per mother.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Sensation of heaviness, Unresponsive to stimuli
Clinical narrative: Adacel given first, appeared fine.  HPV then given and within a minute or two, client's chin fell to chest while arm contracted at elbow up off lap.  She did not respond to name or shaking of shoulders for approximately one minute (B/P 100/60, pulse 64).  Then became aroused, although very confused and unsure where she was.  Called out for her mom and asked where she was and said she felt dizzy.  Client then assisted off chair to floor.  Became extremely pale, c/o lips tingling, B/P 130/64 at 1800.  While resting c/o "heavy head" feeling and paresthia in R arm, R and L hands and feet as well as c/o of chills.  At 1805 EMS called and responded by 1810 (B/P 130/66, RR 18 at 1805).  Given oxygen per EMS.  Client transported to ER.  Client discharged from ER within a couple hours. Parent contacted at 2000 and states client was "fine now". Returned to school on 3/23/07 per mother.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Chills, Confusional state, Dizziness, Extremity contracture, Head discomfort
Clinical narrative: Adacel given first, appeared fine.  HPV then given and within a minute or two, client's chin fell to chest while arm contracted at elbow up off lap.  She did not respond to name or shaking of shoulders for approximately one minute (B/P 100/60, pulse 64).  Then became aroused, although very confused and unsure where she was.  Called out for her mom and asked where she was and said she felt dizzy.  Client then assisted off chair to floor.  Became extremely pale, c/o lips tingling, B/P 130/64 at 1800.  While resting c/o "heavy head" feeling and paresthia in R arm, R and L hands and feet as well as c/o of chills.  At 1805 EMS called and responded by 1810 (B/P 130/66, RR 18 at 1805).  Given oxygen per EMS.  Client transported to ER.  Client discharged from ER within a couple hours. Parent contacted at 2000 and states client was "fine now". Returned to school on 3/23/07 per mother.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Hypersensitivity, Pallor, Paraesthesia, Paraesthesia oral, Posture abnormal
Clinical narrative: Adacel given first, appeared fine.  HPV then given and within a minute or two, client's chin fell to chest while arm contracted at elbow up off lap.  She did not respond to name or shaking of shoulders for approximately one minute (B/P 100/60, pulse 64).  Then became aroused, although very confused and unsure where she was.  Called out for her mom and asked where she was and said she felt dizzy.  Client then assisted off chair to floor.  Became extremely pale, c/o lips tingling, B/P 130/64 at 1800.  While resting c/o "heavy head" feeling and paresthia in R arm, R and L hands and feet as well as c/o of chills.  At 1805 EMS called and responded by 1810 (B/P 130/66, RR 18 at 1805).  Given oxygen per EMS.  Client transported to ER.  Client discharged from ER within a couple hours. Parent contacted at 2000 and states client was "fine now". Returned to school on 3/23/07 per mother.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Adacel given first, appeared fine.  HPV then given and within a minute or two, client's chin fell to chest while arm contracted at elbow up off lap.  She did not respond to name or shaking of shoulders for approximately one minute (B/P 100/60, pulse 64).  Then became aroused, although very confused and unsure where she was.  Called out for her mom and asked where she was and said she felt dizzy.  Client then assisted off chair to floor.  Became extremely pale, c/o lips tingling, B/P 130/64 at 1800.  While resting c/o "heavy head" feeling and paresthia in R arm, R and L hands and feet as well as c/o of chills.  At 1805 EMS called and responded by 1810 (B/P 130/66, RR 18 at 1805).  Given oxygen per EMS.  Client transported to ER.  Client discharged from ER within a couple hours. Parent contacted at 2000 and states client was "fine now". Returned to school on 3/23/07 per mother.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red, Hot to touch, Swelling on arm
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Patient called office with complaints of feeling feverish,dizziness,headache, and nausea. Onset 24-28 hours after injection. Symptoms lasted approx 24 hours. Patient used Tylenol with good effect.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Herpes zoster, Tremor, Vomiting
Clinical narrative: Patient states awoke during night with trembling, dizziness, vomiting x's 1 approx 5 days after injection#1. Pt with IDDM, BS elevated at that time. Episode lasted approx two hours. Also with similar complaints after Injection #2, will report as separate event. Of note, pt diagnosed with Shingles on 3-5-07.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Tremor, Vomiting
Clinical narrative: Patient awoke during night with shakiness, headache, and vomited x's one 3 days after vaccination with second dose of Gardasil. Episode lasted approx one hour. Pt has IDDM, BS normal at that time. Same occurred after dose #1 which was reported as separate event.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema, tenderness and induration at site of injection 24 hours after injection
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, RVX, VARCEL
Symptoms: Bacterial infection, Injection site cellulitis, Injection site erythema, Oedema peripheral, Pyrexia
Clinical narrative: Five vaccinations given on 3/21/07, 2 in left thigh, no reaction. 3 given in right thigh causing severe swelling, redness at site, and fever, cellulitis at injection site.  Required antibiotics for bacterial infection.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Blood culture, Erythema, Full blood count normal, Headache, Inflammation
Clinical narrative: Immunization/vaccinia placed 14 Mar 07.  Had left shoulder pain  extending into left pectoralis major musculature with minimal localized erythema.  Fever of 100.7 with headache, myalgias consistent with inflammatory response and viral syndrome.  Had normal WBC count, and treated with NSAIDS and monitoring.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Musculoskeletal pain, Myalgia, Pyrexia, Viral infection, White blood cell count normal
Clinical narrative: Immunization/vaccinia placed 14 Mar 07.  Had left shoulder pain  extending into left pectoralis major musculature with minimal localized erythema.  Fever of 100.7 with headache, myalgias consistent with inflammatory response and viral syndrome.  Had normal WBC count, and treated with NSAIDS and monitoring.
Age: 28.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Arthralgia, Blood sodium increased, Oedema peripheral, Rheumatoid factor negative
Clinical narrative: 5 days after vaccine, feet/ankles sore, 2.5 weeks after vaccine swelling in feet/ankles and aching in joints of extremities
Age: 28.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Arthralgia, Blood glucose normal, Blood sodium increased, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: 5 days after vaccine, feet/ankles sore, 2.5 weeks after vaccine swelling in feet/ankles and aching in joints of extremities
Age: 28.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Oedema peripheral, Rheumatoid factor
Clinical narrative: 5 days after vaccine, feet/ankles sore, 2.5 weeks after vaccine swelling in feet/ankles and aching in joints of extremities
Age: 40.0
Sex: M
Vaccine: YF
Symptoms: Dysphonia, Erythema, Lip swelling, Rash
Clinical narrative: Red rash on chest, upper arms back, hoarse voice, swollen lips. Benadryl 50 mg IM 1 dose.