chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial information was received from a health care professional on 07 August 2008. An 11 year old female patient with no reported past medical history received an injection of ADACEL (lot number C2644AA)0 on 04 May 2007. On 07 May 2007 she experienced swelling, warmth, erythema, tenderness, and some dizziness. The patient's recovery status was not provided. No further information was reported. Follow-up information was received from the health professional on 05 September 2008. The ADACEL was administered in the left arm. On 07 May 2007, the patient was seen by her physician, at which time her left upper arm noted to be erythematous, warm, and tender. She also complained of dizziness. She was treated with KEFLEX, and her mother was instructed to call the office if the event had not recovered within 48 hours. No further contact was made, and the patient did not return for a follow-up visit. No additional information was available. The physician reported another AE for this patient which occurred on 06 June 2008 and is captured in case number 2008-01961.
Age: 28.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: A 28 year old male patient, with no medical history, received on 23 September 2008 a 0.5 ml right deltoid injection of IPOL (lot number "A0273"), a 0.5 ml left deltoid injection of ADACEL (lot number C2927AA), and a 0.1 ml left arm injection of TUBERSOL (lot number not reported). On the day of vaccination, the patient developed redness, swelling, firmness and itchiness at the right deltoid injection site. Corrective treatment was not reported. The patient had no illness at time of vaccination. Concomitant medication was a daily multivitamin and the patient received no other vaccines within the previous four weeks. At the time of the report, 26 September 2008, the patient had not recovered.
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site swelling, Pain in extremity
Clinical narrative: Case received from a healthcare professional on 26 September 2008 under the local reference number 08-0447. This case deals with a cluster of 5 male and female patients. Fifteen patients (staff members) had received their 1st intramuscular dose of ADACEL batch number C3027BA in the deltoid (right and left) on 23 September 2008. On 24 September 2008, i.e. the following day post-vaccination, five of the fifteen patients aged 20-50, developed local reactions described as slight swelling, swelling to 4" diameter, T 99.9 (37.C) and sore arm (X2). No diagnostic tests or lab data were preformed. All the patient received treatment symptomatically. The patient's events were not resolved at the time of the report. Follow-up information concerning six female patients was received from a health care professional on 08 December 2008. This case now refers to a specific adult female patient (age not reported). The patient had not received any additional vaccinations within four weeks of 23 September 2008. It was indicated that the patient recovered (date not provided). No additional information was reported concerning this patient. Follow-up information received 09 February 2009 from a health care professional.  ADACEL had been administered in the patient's right deltoid and the injection site swelling had been approximately one two inches (previously reported as "swelling to four inches diameter"). The patient had no illness at the time of vaccination and the symptoms resolved in seven to 10 days. No additional information was provided. Documents held by sender: None. The reporter of this case is the same as cases 2008-03923, 2008-03924, 2008-03926 and 2008-03927.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: A cluster of 2 adult patients who received TUBERSOL, lot number C2910AA, and developed injection site redness and induration four days after the test had been read as negative. Initial report received on 26 September 2008 from a healthcare professional. A 41 year old female patient, with no medical history and no known allergies, received on 16 September 2008 a first left foramen intradermal injection of TUBERSOL (lot number C2910AA) and a first right deltoid intramuscular injection of ADACEL (lot number C2995BA). The tuberculin test was read as "0/0 negative" (0 redness and 0 induration) on 18 September 2008. On 22 September 2008, four days after the negative test result, the patient had redness and induration of unknown size at the TUBERSOL injection site on the left forearm. Corrective treatment was not reported. The patient had no illness at the time of testing, was taking no concomitant medications and had no other vaccines given in the previous four weeks. At the time of the report, 26 September 2008, the patient had recovered. Case 2008-02998 with the same reporter and same TUBERSOL lot number was created for the other patient.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Initial non-serious case received from a healthcare professional on 16 October 2008. A 61-year-old female patient developed a 7.5cm by 9cm area of red and painful "flat cellulitis" at the injection site, four days after receiving a left deltoid intramuscular injection of ADACEL (lot number UF452BA). At the time of the report, patient outcome was unknown. No additional details were provided. Follow-up information was received 05 November 2008 from another manufacturer (service request number, 1-32688311245; document number 45207922), who received the report on 16 October 2008 from the initial reporting health care professional. According to the reporter, "the patient had received a dose of ADACEL on 10 October 2008 and three days ago developed cellulitis" (date not specified). No additional information was provided. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Initial information was received on 27 October 2008 from a health care professional. A 54 year old female received an intramuscular left deltoid injection of FLUARIX (manufacturer GSK, lot number AFLUA3808AA) on 21 October 2008. On 22 October 2008 she received an intramuscular left deltoid injection of ADACEL (lot number C3030AA) and TWINRIX (manufacturer GSK, lot number AHABB132AC) given in the right deltoid. The patient noted that she received the Td injection in 2003. On 23 October 2008 the patient had a "big local reaction" at the injection site (arm not specified). The patient also had an indurated area which was red, swollen and measured at 7.25 x 7.5 cm. The patient stated that at one point it was larger than 7.25 x 7.5 cm. The patient was seen by her physician. The patient was not recovered at the time of the report. Follow-up information received on 24 November 2008 from a health care professional. The patient's reaction was at the site of the ADACEL injection in the left deltoid. She was re-evaluated in the clinic on an unspecified date and treated with over the counter ADVIL and warm soaks. She recovered from the events on 04 November 2008. List of Documents held by Sender: None.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Gastrooesophageal reflux disease, Gene mutation identification test negative, Serology negative
Clinical narrative: Initial report received from a health care professional on 29 October 2008. A 37-year-old pregnant female patient had received a left deltoid intramuscular booster injection of ADACEL at the health department on 11 August 2008. Date of patient's last menstrual period was 28 June 2008 and estimated date of confinement is 04 April 2009. The patient reported that his is a twin pregnancy. The patient also reported having "tests" done (not specified). At the time of the report, the patient had not experienced any adverse events since she received ADACEL. Follow-up information received 09 February 2009 from a health care professional. The patient's date of last menstrual period was 27 June 2008 (previously reported as 28 June 2008) and her past obstetric history included one previous pregnancy which resulted in a live birth with no congenital anomalies. The patient is a health care professional and was receiving additional evaluation by another obstetrical facility due to advanced maternal age with twin gestation. The patient developed a urinary tract infection (date not specified) and received corrective treatment with KEFLEX (dose not specified) and MACROBID 100 mg b.i.d. on 20 October 2008. The patient subsequently developed an upper respiratory infection (date not specified) and received a Z-PACK (dose not specified) as corrective treatment on 14 November 2008. The patient also received PROTONIX 40 mg q.d. on 10 December 2008, and ZANTAC 150 mg b.i.d. on 15 December 2008 for acid reflux. Additional maternal drug exposures included CELEXA for depression?, nausea and vomiting were not reported. Relevant laboratory and diagnostic test results for alpha feto protein, serologies, serial (multiple) ultrasound, and genetic screening (AFP and Level II US) were normal. According to the reporter, the patient had not reported any adverse events secondary to the vaccine. The patient had been 28 weeks gestation, and was "living and well" at the time of the report. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan normal, Upper respiratory tract infection, Urinary tract infection
Clinical narrative: Initial report received from a health care professional on 29 October 2008. A 37-year-old pregnant female patient had received a left deltoid intramuscular booster injection of ADACEL at the health department on 11 August 2008. Date of patient's last menstrual period was 28 June 2008 and estimated date of confinement is 04 April 2009. The patient reported that his is a twin pregnancy. The patient also reported having "tests" done (not specified). At the time of the report, the patient had not experienced any adverse events since she received ADACEL. Follow-up information received 09 February 2009 from a health care professional. The patient's date of last menstrual period was 27 June 2008 (previously reported as 28 June 2008) and her past obstetric history included one previous pregnancy which resulted in a live birth with no congenital anomalies. The patient is a health care professional and was receiving additional evaluation by another obstetrical facility due to advanced maternal age with twin gestation. The patient developed a urinary tract infection (date not specified) and received corrective treatment with KEFLEX (dose not specified) and MACROBID 100 mg b.i.d. on 20 October 2008. The patient subsequently developed an upper respiratory infection (date not specified) and received a Z-PACK (dose not specified) as corrective treatment on 14 November 2008. The patient also received PROTONIX 40 mg q.d. on 10 December 2008, and ZANTAC 150 mg b.i.d. on 15 December 2008 for acid reflux. Additional maternal drug exposures included CELEXA for depression?, nausea and vomiting were not reported. Relevant laboratory and diagnostic test results for alpha feto protein, serologies, serial (multiple) ultrasound, and genetic screening (AFP and Level II US) were normal. According to the reporter, the patient had not reported any adverse events secondary to the vaccine. The patient had been 28 weeks gestation, and was "living and well" at the time of the report. Documents held by sender: None.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, DTAPHEPBIP, HEPA, HIBV, MMR, PNC, RV5, VARCEL
Symptoms: Enema administration, Intussusception, Surgery
Clinical narrative: Intussusception(nonsurgical)  vomiting, crying from stomach pain.   April 20,2008  Had to have a Barium enema to correct it.  On July 2, 2009 recurred and again on July 5, 2009. On last visit had to have surgery to remove part of bowel and appendix to correct the Intussusception.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, DTAPHEPBIP, HEPA, HIBV, MMR, PNC, RV5, VARCEL
Symptoms: Abdominal pain upper, Appendicectomy, Barium enema, Crying, Enema administration
Clinical narrative: Intussusception(nonsurgical)  vomiting, crying from stomach pain.   April 20,2008  Had to have a Barium enema to correct it.  On July 2, 2009 recurred and again on July 5, 2009. On last visit had to have surgery to remove part of bowel and appendix to correct the Intussusception.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, DTAPHEPBIP, HEPA, HIBV, MMR, PNC, RV5, VARCEL
Symptoms: Intestinal resection, Intussusception, Surgery, Vomiting
Clinical narrative: Intussusception(nonsurgical)  vomiting, crying from stomach pain.   April 20,2008  Had to have a Barium enema to correct it.  On July 2, 2009 recurred and again on July 5, 2009. On last visit had to have surgery to remove part of bowel and appendix to correct the Intussusception.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Abdominal X-ray, Enema administration, Exploratory operation, Intussusception, Lethargy
Clinical narrative: This case was reported by a healthcare professional via a GSK representative and described the occurrence of intussusception in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). There was no relevant medical history reported. It was reported as likely that the subject had received other scheduled vaccinations, and that the practice uses PEDIARIX for their DTaPs. However, it was not known whether the subject had received these vaccines. On 31 March 2009 the subject received 1st dose of ROTARIX (details unknown). On 31 March 2009, less than one day after vaccination with ROTARIX, the subject experienced intussusception. On 10 April 2009, the subject underwent surgery for an appendectomy. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with ROTARIX. Follow-up information received on 01 June 2009 via the physician indicated that the subject was a 10 week old female. On 31 March 2009, she received first dose of oral ROTARIX along with first dose each of concurrent vaccines PEDIARIX (GlaxoSmithKline), PREVNAR (Wyeth) and ACTHIB (Sanofi Pasteur) all given intramuscularly. On 09 April 2009 the subject experienced intussusception. The subject underwent surgery for an appendectomy, confirm reduced intussusception. The events resolved and were considered by the reporter to possibly be related to ROTARIX.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Surgery, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: This case was reported by a healthcare professional via a GSK representative and described the occurrence of intussusception in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). There was no relevant medical history reported. It was reported as likely that the subject had received other scheduled vaccinations, and that the practice uses PEDIARIX for their DTaPs. However, it was not known whether the subject had received these vaccines. On 31 March 2009 the subject received 1st dose of ROTARIX (details unknown). On 31 March 2009, less than one day after vaccination with ROTARIX, the subject experienced intussusception. On 10 April 2009, the subject underwent surgery for an appendectomy. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with ROTARIX. Follow-up information received on 01 June 2009 via the physician indicated that the subject was a 10 week old female. On 31 March 2009, she received first dose of oral ROTARIX along with first dose each of concurrent vaccines PEDIARIX (GlaxoSmithKline), PREVNAR (Wyeth) and ACTHIB (Sanofi Pasteur) all given intramuscularly. On 09 April 2009 the subject experienced intussusception. The subject underwent surgery for an appendectomy, confirm reduced intussusception. The events resolved and were considered by the reporter to possibly be related to ROTARIX.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Appendicectomy, Barium double contrast, Computerised tomogram abnormal, Enema administration, Intussusception
Clinical narrative: This case was reported by a healthcare professional via a GSK representative and described the occurrence of intussusception in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). There was no relevant medical history reported. It was reported as likely that the subject had received other scheduled vaccinations, and that the practice uses PEDIARIX for their DTaPs. However, it was not known whether the subject had received these vaccines. On 31 March 2009 the subject received 1st dose of ROTARIX (details unknown). On 31 March 2009, less than one day after vaccination with ROTARIX, the subject experienced intussusception. On 10 April 2009, the subject underwent surgery for an appendectomy. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with ROTARIX. Follow-up information received on 01 June 2009 via the physician indicated that the subject was a 10 week old female. On 31 March 2009, she received first dose of oral ROTARIX along with first dose each of concurrent vaccines PEDIARIX (GlaxoSmithKline), PREVNAR (Wyeth) and ACTHIB (Sanofi Pasteur) all given intramuscularly. On 09 April 2009 the subject experienced intussusception. The subject underwent surgery for an appendectomy, confirm reduced intussusception. The events resolved and were considered by the reporter to possibly be related to ROTARIX.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Surgery
Clinical narrative: This case was reported by a healthcare professional via a GSK representative and described the occurrence of intussusception in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). There was no relevant medical history reported. It was reported as likely that the subject had received other scheduled vaccinations, and that the practice uses PEDIARIX for their DTaPs. However, it was not known whether the subject had received these vaccines. On 31 March 2009 the subject received 1st dose of ROTARIX (details unknown). On 31 March 2009, less than one day after vaccination with ROTARIX, the subject experienced intussusception. On 10 April 2009, the subject underwent surgery for an appendectomy. The subject was hospitalised and the healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with ROTARIX. Follow-up information received on 01 June 2009 via the physician indicated that the subject was a 10 week old female. On 31 March 2009, she received first dose of oral ROTARIX along with first dose each of concurrent vaccines PEDIARIX (GlaxoSmithKline), PREVNAR (Wyeth) and ACTHIB (Sanofi Pasteur) all given intramuscularly. On 09 April 2009 the subject experienced intussusception. The subject underwent surgery for an appendectomy, confirm reduced intussusception. The events resolved and were considered by the reporter to possibly be related to ROTARIX.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Spreading rash from vaccine site. Fever, body aches, chills, N+V, weakness.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Asthenia, Chills, Injection site rash, Nausea, Pain
Clinical narrative: Spreading rash from vaccine site. Fever, body aches, chills, N+V, weakness.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Spreading rash from vaccine site. Fever, body aches, chills, N+V, weakness.
Age: 2.0
Sex: M
Vaccine: DTP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, REDNESS AND WARMTH ON THIGH.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Amnesia, Balance disorder, Colonoscopy normal, Disturbance in attention
Clinical narrative: Severe nausea; weight loss over 20 lbs; dizziness; balance problems; impaired concentration; vertigo; inflammation of esophagus; abdominal pain, especially 30 minutes to 1 hour after meals; difficulty with speech articulation, impaired short term memory/recall; bilateral hand tremors; extreme fatigue; shortness of breath.  7/29/09 Consultant medical records received DOS 6/30/09. Assessment: Cerebellar tonsillar ectopia. Patient presents with headaches, dizziness, nausea, weight loss, fatigue, and low-lying cerebellar tonsils. Lack of endurance when running. Can hear pulse in ears. Balance disturbance. Occasional high blood pressure. Nausea and pain after meals. Fasciitis. Vertigo.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysarthria, Dyspnoea, Fatigue, Hepatobiliary scan
Clinical narrative: Severe nausea; weight loss over 20 lbs; dizziness; balance problems; impaired concentration; vertigo; inflammation of esophagus; abdominal pain, especially 30 minutes to 1 hour after meals; difficulty with speech articulation, impaired short term memory/recall; bilateral hand tremors; extreme fatigue; shortness of breath.  7/29/09 Consultant medical records received DOS 6/30/09. Assessment: Cerebellar tonsillar ectopia. Patient presents with headaches, dizziness, nausea, weight loss, fatigue, and low-lying cerebellar tonsils. Lack of endurance when running. Can hear pulse in ears. Balance disturbance. Occasional high blood pressure. Nausea and pain after meals. Fasciitis. Vertigo.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test normal, Memory impairment, Nausea, Oesophagitis, Tremor
Clinical narrative: Severe nausea; weight loss over 20 lbs; dizziness; balance problems; impaired concentration; vertigo; inflammation of esophagus; abdominal pain, especially 30 minutes to 1 hour after meals; difficulty with speech articulation, impaired short term memory/recall; bilateral hand tremors; extreme fatigue; shortness of breath.  7/29/09 Consultant medical records received DOS 6/30/09. Assessment: Cerebellar tonsillar ectopia. Patient presents with headaches, dizziness, nausea, weight loss, fatigue, and low-lying cerebellar tonsils. Lack of endurance when running. Can hear pulse in ears. Balance disturbance. Occasional high blood pressure. Nausea and pain after meals. Fasciitis. Vertigo.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo, Weight decreased
Clinical narrative: Severe nausea; weight loss over 20 lbs; dizziness; balance problems; impaired concentration; vertigo; inflammation of esophagus; abdominal pain, especially 30 minutes to 1 hour after meals; difficulty with speech articulation, impaired short term memory/recall; bilateral hand tremors; extreme fatigue; shortness of breath.  7/29/09 Consultant medical records received DOS 6/30/09. Assessment: Cerebellar tonsillar ectopia. Patient presents with headaches, dizziness, nausea, weight loss, fatigue, and low-lying cerebellar tonsils. Lack of endurance when running. Can hear pulse in ears. Balance disturbance. Occasional high blood pressure. Nausea and pain after meals. Fasciitis. Vertigo.
Age: 0.9
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Abscess, Culture negative, Incisional drainage, Injection site abscess, Injection site mass
Clinical narrative: Patient developed small lump at site of injection which persisted unchanged for 2-3 mo. Then during the month of June. Lump elevated in size. Pt was seen 6/30/2009 - diagnosed with 2 cm abscess. Pt was seen 7/1/09 by surgeon and taken to OR for drainage of abscess. Culture negative. Suggestive of sterile abscess.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Cellulitis, Chills
Clinical narrative: Chills x 3 days ago. Cellulitis 6.5 cm surrounding blister. Doxycycline 100mg 2X a day.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis
Clinical narrative: Cellulitis secondary to smallpox vaccination.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at site.  Mostly resolved before pt back to office.  Crying a lot, but consolable.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Death
Clinical narrative: Information has been received from a case in litigation via a case report concerning a child patient who on 22-MAR-2006 was vaccinated with a dose of MMR II (Lot number not reported) and concomitantly on the same day with a dose of poliovirus vaccine inactivated (unspecified) and a dose of DTaP (unspecified). On an unknown date, the patient died. The family member alleged that as a result of the administration of the vaccines on 22-MAR-2006. No further information is available.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Contusion, Fall, Syncope
Clinical narrative: Pt. received 2 vaccines @ approximately 9:20am. Had fainting episode @ 9:30am fell off exam table. Mother had 911 called- did not transport to ER. Did received bruise on rt. inner thigh. Left clinic with mother, alert, oriented and ambulatory. On 7-8-09, mother reported no lasting effects.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 15 years old female who was vaccinated with GARDASIL last week, approximately in July 2009. After vaccination the patient waited 15 minutes before leaving the office. She hit her head when she fell. She also experienced vomiting later that day. The patient was hospitalized that day. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth of right upper arm + shoulder began eve 7/8/09. Decreased but persistent am 7/9/09.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Fatigue, Muscle spasms, Urine output decreased
Clinical narrative: Chills, cramps, severe weakness, decreased urine output the first day despite drinking lots of H2O.  C/o "contractions inside" vagina similar to contractions that occur with orgasm:  C/o weakness, fatigue lasting 5 days.  Symptoms resolved 0 Tx.  Symptoms started that night.  Seen for knee laceration 0 previous problems with TETANUS shots.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Coma
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who on an unknown date was vaccinated with a dose of GARDASIL. Within 24 hours of receiving GARDASIL the patient went into a coma. The patient sought unspecified medical attention. The patient's final outcome was not reported. Upon internal review coma was considered to be another important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This child developed hives within 48 hours of her first HPV. She had no other obvious cause for her hives.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cranial nerve disorder, Dyspnoea, Facial palsy, Laboratory test, Myasthenia gravis crisis
Clinical narrative: Information has been received from a Physician Assistant concerning a 12 year old female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on 15-JUL-2008 was vaccinated with a first dose of GARDASIL (lot # 660387/1967U) 0.5ml (also reported mg) intramuscularly. Concomitant therapy included prednisone and PRILOSEC. In March 2009 the patient experienced difficulty breathing. She was taken to the hospital and "as per mom she was given an adult dose of morphine and went into respiratory failure". She later was unable to smile or move her face. Her cranial nerves were affected and she was seen by neurology. Later she was sent to a hospital for myasthenia gravis crisis. She had been hospitalized 3-4 times and she had received rehabilitation therapy. Most recently approximately on 16-JUN-2009, she had a "thymomectomy", secondary to myasthenia. The Physician Assistant and Physician did not feel the events were connected with GARDASIL. At the time of the report on 07-JUL-2009 the patient was recovering. There were many unspecified laboratories and diagnostics tests performed results not reported. She had not received any additional doses of GARDASIL. Difficulty breathing, respiratory failure, cranial nerves affected, given adult dose of morphine, and myasthenia gravis crisis were considered to be immediately life-threatening, disabling and other important medical events. "Given adult dose of morphine" was considered to be an overdose. Additional information has been requested.  Medical records received DOS 7/15/08 to 7/7/09. Assessment: Myasthenia Gravis. Patient presents with continued fainting. Can't raise arms, not able to cough, laugh, very weak. Falls, drops things. Redness and inflammation where spinal tap was done. Facial weakness.  PMH: \ksk
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Overdose, Respiratory failure, Thymectomy
Clinical narrative: Information has been received from a Physician Assistant concerning a 12 year old female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on 15-JUL-2008 was vaccinated with a first dose of GARDASIL (lot # 660387/1967U) 0.5ml (also reported mg) intramuscularly. Concomitant therapy included prednisone and PRILOSEC. In March 2009 the patient experienced difficulty breathing. She was taken to the hospital and "as per mom she was given an adult dose of morphine and went into respiratory failure". She later was unable to smile or move her face. Her cranial nerves were affected and she was seen by neurology. Later she was sent to a hospital for myasthenia gravis crisis. She had been hospitalized 3-4 times and she had received rehabilitation therapy. Most recently approximately on 16-JUN-2009, she had a "thymomectomy", secondary to myasthenia. The Physician Assistant and Physician did not feel the events were connected with GARDASIL. At the time of the report on 07-JUL-2009 the patient was recovering. There were many unspecified laboratories and diagnostics tests performed results not reported. She had not received any additional doses of GARDASIL. Difficulty breathing, respiratory failure, cranial nerves affected, given adult dose of morphine, and myasthenia gravis crisis were considered to be immediately life-threatening, disabling and other important medical events. "Given adult dose of morphine" was considered to be an overdose. Additional information has been requested.  Medical records received DOS 7/15/08 to 7/7/09. Assessment: Myasthenia Gravis. Patient presents with continued fainting. Can't raise arms, not able to cough, laugh, very weak. Falls, drops things. Redness and inflammation where spinal tap was done. Facial weakness.  PMH: \ksk
Age: 39.0
Sex: M
Vaccine: MMR, TD, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated 6/22/09 ZOSTAVAX was given instead of VARIVAX-client was notified 6/25/09-PHN inquired if he experienced any local or general SE/symptoms, he states no symptoms noted. Informed client that vaccine given counts as 2nd dose of VARIVAX. Informed client that this will be call clinic for documentation. Clinic was called to report in client's chart 10/26/09, 10:50 AM.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a physician concerning a male patient who was approximately five years old was vaccinated with MMR II a few months ago and had an anaphylactic reaction. The physician stated that they were not sure why the patient had a reaction. The physician told that they think possibly it is the gelatin component but they don't know for sure. The physician told that the patient was hospitalized and everything resolved back to normal with this patient after approximately one day of hospitalization. The physician also stated that the patient was also given at the time DTAP and Poliovirus vaccine and the patient has also had an anaphylactic reaction to VARIVAX (Merck) (MSD, WAES 0907USA01481) in the past (date unknown). Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever up to 106 degrees and irritability following vaccines, brought to ER by parents approx 12 hours following immunizations.  Was observed and treated for fever in ER and discharged to home after several hours.  Pt. resting comfortably at home about 20 hours after vaccines.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: R arm swelling > 2 in width & length, red, hard, hot to the touch 1 days after vaccine given.  Ice compress tx.
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Body temperature increased, Immunology test, Livedo reticularis, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 45 year old female with sulfa and DEMEROL allergies who on 29-MAY-2009 was vaccinated with the first dose of RECOMBIVAX HB (Thimerosal Free) (lot # 663315/1446X). Secondary suspect therapy included MMR II (lot # 663164/1583X). Concomitant therapy included VICODIN, SEROQUEL and fentanyl. The patient had a rash "now" in June 2009. The nurse stated the patient was stating "the rash looks like measles" and was "on her face". The nurse also stated the patient reported have a fever of 101F. The patient sought medical attention by calling physician's office. The patient's outcome was unknown. Follow-up information has been received from the registered nurse concerning a 45 year old female patient smoker since age 21 who at 10:00 on 29-MAY-2009 was vaccinated IM in right deltoid with the first dose of RECOMBIVAX HB. Secondary suspect therapy included the first dose of MMR II given subcutaneously in left deltoid at 10:00 on 29-MAY-2009. In the morning of 15-JUN-2009, per patient, she awoke with fever of 101F and total body rash. She described rash as mottled and not raised. The rash was very itchy. The patient saw her own physician and was placed on MEDROL DOSEPAK. The patient had her second mantoux skin test (lot # C33036 AA) intradermal injection in right forearm at 10:00 on 29-MAY-2009 (first one on 19-MAY-2009). The patient's primary care physician drew titer on 18-JUN-2009. No results forwarded at that time. The physician told the patient she was immune to MMR II. The patient had recovered on 22-JUN-2009. The adverse events were considered to be an other important medical events by the registered nurse. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash morbilliform, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 45 year old female with sulfa and DEMEROL allergies who on 29-MAY-2009 was vaccinated with the first dose of RECOMBIVAX HB (Thimerosal Free) (lot # 663315/1446X). Secondary suspect therapy included MMR II (lot # 663164/1583X). Concomitant therapy included VICODIN, SEROQUEL and fentanyl. The patient had a rash "now" in June 2009. The nurse stated the patient was stating "the rash looks like measles" and was "on her face". The nurse also stated the patient reported have a fever of 101F. The patient sought medical attention by calling physician's office. The patient's outcome was unknown. Follow-up information has been received from the registered nurse concerning a 45 year old female patient smoker since age 21 who at 10:00 on 29-MAY-2009 was vaccinated IM in right deltoid with the first dose of RECOMBIVAX HB. Secondary suspect therapy included the first dose of MMR II given subcutaneously in left deltoid at 10:00 on 29-MAY-2009. In the morning of 15-JUN-2009, per patient, she awoke with fever of 101F and total body rash. She described rash as mottled and not raised. The rash was very itchy. The patient saw her own physician and was placed on MEDROL DOSEPAK. The patient had her second mantoux skin test (lot # C33036 AA) intradermal injection in right forearm at 10:00 on 29-MAY-2009 (first one on 19-MAY-2009). The patient's primary care physician drew titer on 18-JUN-2009. No results forwarded at that time. The physician told the patient she was immune to MMR II. The patient had recovered on 22-JUN-2009. The adverse events were considered to be an other important medical events by the registered nurse. Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Type III immune complex mediated reaction
Clinical narrative: Typical Arthur reaction at right deltoid injection site
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local vaccine reaction. Left arm extensive.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: 2cm swelling at injection site. No sign of systemic reaction.
Age: 20.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse reaction. MMR II given 1wk after VARIVAX (3/23/09).
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Denied any symptoms-soreness, fever etc.
Age: 40.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Myositis, Optic neuritis, Pollakiuria, Rash, Thirst
Clinical narrative: Inflammation of optical, nerves + muscles weight loss, excessive urinating and thirst, tiredness, rash, blurry vision. See attached letter!
Age: 40.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Weight decreased
Clinical narrative: Inflammation of optical, nerves + muscles weight loss, excessive urinating and thirst, tiredness, rash, blurry vision. See attached letter!
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, Swelling at site of injection and distally approx. 7 inches.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain of skin, Rash, Skin lesion
Clinical narrative: Shortly after admin of ZOSTAVAX pt noted asymmetric, tenderness over (L) scalp/neck. When seen 7/7/09 Red rash (not vesicular noted) posterior scalp red raised lesion (L) neck.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Fatigue, Feeling hot, Myalgia, Tremor
Clinical narrative: Pt. reports "severe pain" in muscles, knee joints, ankle joints, extreme fatigue, feeling feverish ((no confirmed fever per pt). Severe shaking beginning in the morning on 6/16/09 and increasing in severity until about 2:30 am 6/17/09. Not relieved with ibuprofen or muscle relaxants. Pt advised to contact PMD for F/U, but had not done so yet.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Hyperhidrosis, Pallor, Pollakiuria, Vomiting
Clinical narrative: Found vomiting x 2 in waiting room- 20 min after receiving HBV, + with acute onset LLQ pain. Pt diaphoretic, pale. B/P 122/82. Pt laid down in exam room, exam done - normal findings unable to elicit any tenderness, but pt went to urinate x 3 in 20 min span. Referred to U/C site for flu.
Age: 26.0
Sex: M
Vaccine: DT, HEPAB, TYP
Symptoms: Back pain, Pain, Pyrexia
Clinical narrative: Pt called 7/2/09 stating he became "achy with over all achyness & mostly back aching 5 days after receiving vaccinations. He had a fever of 100 Degrees for one day, 6 days after vaccines. He called his Dr. & was advised to alternate 2 MOTRINS & 2 TYLENOLS every two hours. 7/2/09, pt advised he have continued contact with his Dr or go to stat care if condition worsens. Medical Director at Medical Center notified 7/6/09. Pt called 7/6/09 & condition improved 7/4/09.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia, Rash, Screaming
Clinical narrative: Unconsolable crying/screaming x 3-6 hours. Fever of 101 x 24 degrees. Rash on (Rt) leg and torso < than 24 degrees.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Breath sounds abnormal, Injection site swelling, Urticaria
Clinical narrative: 1 -1/2 hrs after receiving vaccine patient developed swelling at site, diffuse urticaria, and noisy breathing. He was given ATARAX then EPI PEN which helped. He was taken to the E.D. The impression at the E.D. was that the allergic reaction had resolved at the time of discharge, patient to use BENADRYL and ATARAX over next 24 hrs.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Raised, red, round- approx. 2 inches in diameter area on pt's L thigh. Home care - included ice to area + Motrin, continued home care >cold compresses x 2 days. P/B  warm compresses + 2 days.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Myalgia, Pruritus generalised
Clinical narrative: Generalized pruritus. Fatigue. Myalgias.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mild erythema 4cm X 6cm at injection site on L thigh, tenderness, normal gait. Rec: ice, ibuprofen. Matthew's mother wanted this reaction reported to VAERS.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: approximately 42 hours post Zostavax vaccination I began to have itching, redness, soreness and swelling at the injection site (about 2 inches in diameter) lasting 2 days.  I treated with topical Temovate cream, topical neosporin with pain relief and ice packs.  At this point there is only mild discoloration at the site w/o symptoms
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Pyrexia, Vomiting
Clinical narrative: 3 year old male brought in by his mother with acute onset of vomiting and fever to 104 @ 4am 7/14/09. Recieved Hepatitis A vaccine 7/13/09. Has had a decreased appetite but has been drinking milk. Advised tylenol or motrin as needed for fever. If vomiting persists and is unable to keep fluids down or if fever persists, advised to call or seek urgent medical attention.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Nausea, Vomiting
Clinical narrative: Within 1 hour of administration patient became nauseated, fatigued and light headed. Nausea increased to vomiting & inability to keep food or liquid down. Treated with fluids & phenergan PRN over following 3 days.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Back pain, Dizziness, Echocardiogram normal, Erythema
Clinical narrative: He had a varivax booster on Monday July 13,2009 and yesterday he felt sore. His R arm is swollen, red and sore. He is c/o HA and backaches too. He denies a fever but feels feverish. He feels weak and dizzy today.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Oedema peripheral, Pain
Clinical narrative: He had a varivax booster on Monday July 13,2009 and yesterday he felt sore. His R arm is swollen, red and sore. He is c/o HA and backaches too. He denies a fever but feels feverish. He feels weak and dizzy today.
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Vaccinia
Clinical narrative: She has developed generalized vaccinia
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Burning sensation, Mass
Clinical narrative: Patient developed a burning sensation in right armpit within an hour after receiving vaccine. Two hours later developed a lump in the same area. By the next morning the lump was the size of a golf ball. He was evaluated by Work-Med and referred to personal physician. Personal Physician did not symptoms were related to the vaccine. He was treated with an antibiotic.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Dizziness, Malaise
Clinical narrative: 1-2 days later: dizziness, malaise followed by rapid atrial fibrillation at day 3 requiring overnight stay in the hospital 10/16/2009 received records from ED visit 7/2/2009. Patient with 2 day hx of c/o's dizziness, malaise, headache and increased heart rate. PE was normal, EKG abnormal with atrial fib, HR of 162, patient also hypertensive. Patient admitted for Observation on telemetry and cardiology consult. DX: New Onset Atrial Fib
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Activities of daily living impaired, Anorexia, Cough, Fatigue
Clinical narrative: Hour after immunization, experienced deltoid pain and headache.  Deltoid pain experienced for 72 hours and had poor range of motion causing a disruption in daily activities.  Motrin at 800mg did not help.  Nausea for 72 hours and abdominal discomfort.  Extreme fatigue for 72 hours and anorexia.  Fever of 101 and body aches with head ache for the first 48 hours.  No redness to the injection site only mild warmth.   Symptoms resolved by 7/13/09.  Then patient developed mild cough on day of form submission.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site warmth, Nausea, Pain
Clinical narrative: Hour after immunization, experienced deltoid pain and headache.  Deltoid pain experienced for 72 hours and had poor range of motion causing a disruption in daily activities.  Motrin at 800mg did not help.  Nausea for 72 hours and abdominal discomfort.  Extreme fatigue for 72 hours and anorexia.  Fever of 101 and body aches with head ache for the first 48 hours.  No redness to the injection site only mild warmth.   Symptoms resolved by 7/13/09.  Then patient developed mild cough on day of form submission.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Hour after immunization, experienced deltoid pain and headache.  Deltoid pain experienced for 72 hours and had poor range of motion causing a disruption in daily activities.  Motrin at 800mg did not help.  Nausea for 72 hours and abdominal discomfort.  Extreme fatigue for 72 hours and anorexia.  Fever of 101 and body aches with head ache for the first 48 hours.  No redness to the injection site only mild warmth.   Symptoms resolved by 7/13/09.  Then patient developed mild cough on day of form submission.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, TD, VARCEL
Symptoms: Erythema, Oedema peripheral, Rash
Clinical narrative: Child was given a double dose of Varicella vaccine.  Once when he was 15 months old, then again when he was 5 years old (7/13/09).  On his left leg, he had MMR and Varicella vaccine.  This leg has been swollen from top of the thigh to mid-knee, and a red rash has occurred. The child has been given Benadryl, Tylenol, warm compresses, and elevated, but reactions have not sub-sided after 48 hours.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 12 1/2 x 10cm Circular, swollen leasion on lt upper thigh. Red, hard, and tender
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthma, Chest pain, Diarrhoea, Nausea
Clinical narrative: Nausea, chest pain, asthsma, diarrhea. 7/17/09 Medical records received DOS 7/13/09 to 7/17/09. PAP test and Gardasil administered. Next day patient c/o pain at injection site, mild chest pain. Doesn't feel well, sent home from work. Wheezing, stomach pain, diarrhea. Advised to see PCP.