chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Autopsy, Benign neoplasm of thymus, Breath sounds abnormal, Death, Obstructive airways disorder
Clinical narrative: This case was reported by a regulatory authority (353311) and described the occurrence of airway obstruction in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), ENGERIX B, PREVNAR (non-gsk), and PENTACEL (non-gsk). There were no concurrent medications. On 5 August 2009 the subject received 1st dose of ROTARIX (oral), 2nd dose of ENGERIX B (intramuscular, left thigh), 1st dose of PREVNAR (intramuscular, right thigh), 1st dose of PENTACEL (intramuscular, left thigh). On 5 August 2009, less than one day after vaccination with ENGERIX B, PENTACEL, PREVNAR and ROTARIX, the subject experienced airway obstruction, benign neoplasm of thymus, not responsive, noisy breathing, abnormal breathing sounds and "prone" [unspecified event]. The autopsy reported the "cause of death was probably partial mechanical obstruction of airway by ectopic thymus. By history baby developed 'noisy breathing' by evening. Found prone and unresponsive. Only explanation for abnormal breathing sounds was a benign growth, an extra thymus gland, growing in the wrong place next to his trachea". The subject died on 6 August 2009 from airway obstruction and benign neoplasm of thymus. An autopsy was performed.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Respiration abnormal, Thymus disorder, Unresponsive to stimuli
Clinical narrative: This case was reported by a regulatory authority (353311) and described the occurrence of airway obstruction in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), ENGERIX B, PREVNAR (non-gsk), and PENTACEL (non-gsk). There were no concurrent medications. On 5 August 2009 the subject received 1st dose of ROTARIX (oral), 2nd dose of ENGERIX B (intramuscular, left thigh), 1st dose of PREVNAR (intramuscular, right thigh), 1st dose of PENTACEL (intramuscular, left thigh). On 5 August 2009, less than one day after vaccination with ENGERIX B, PENTACEL, PREVNAR and ROTARIX, the subject experienced airway obstruction, benign neoplasm of thymus, not responsive, noisy breathing, abnormal breathing sounds and "prone" [unspecified event]. The autopsy reported the "cause of death was probably partial mechanical obstruction of airway by ectopic thymus. By history baby developed 'noisy breathing' by evening. Found prone and unresponsive. Only explanation for abnormal breathing sounds was a benign growth, an extra thymus gland, growing in the wrong place next to his trachea". The subject died on 6 August 2009 from airway obstruction and benign neoplasm of thymus. An autopsy was performed.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), UNK
Symptoms: Paraesthesia
Clinical narrative: Initial information received on 18 February 2010 from a health care professional. A 43 year old female patient developed numbness and tingling in her arms, legs, and occasionally her face one hour after she received PANDEMIC INFLUENZA VACCINE (manufacturer unknown) on 27 January 2010. The numbness and tingling comes and goes. The patient required a doctor's visit; date not provided. The patient had not recovered by the time of the report. Follow-up information was received 06 May 2010 from a health care professional. The patient received an intramuscular upper arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP051AA at 3:30pm on 27 January 2010. According to the reporter, she experienced additional symptoms of chills, neck pain and ear ringing. The event of tingling occurred in the patient's hands and feet (previously reported as occurring in her arms and legs). The events began one hour post vaccination at 4:30pm. The patient had no past medical history and she had not been taking any concomitant medications. According to the reporter, the events required numerous doctor's visits. The patient has received ongoing evaluations by her primary care physician and neurologist since 01 February 2010. On 04 February 2010, blood tests and EMG nerve conduction studies were performed (results not reported). On 11 February 2010, she was evaluated by an acupuncturist and received an unspecified treatment. An MRI of the brain was performed on 12 March 2010 (results not reported). The patient was subsequently evaluated by a chiropractor on 25 March 2010, and by a physiologist on 15 April 2010 (results of evaluations not reported). She also received a MRI of the cervical spine on 20 April 2010 and a hearing test on 21 April 2010 (results not reported). She began physical therapy for her neck on 29 April 2010. At the time of the report, evaluations continued and the patient continued to have ongoing symptoms. Outcome was reported as not recovered. List of Documents held by Sender: none.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), UNK
Symptoms: Acoustic stimulation tests, Blood test, Chills, Electromyogram, Hypoaesthesia
Clinical narrative: Initial information received on 18 February 2010 from a health care professional. A 43 year old female patient developed numbness and tingling in her arms, legs, and occasionally her face one hour after she received PANDEMIC INFLUENZA VACCINE (manufacturer unknown) on 27 January 2010. The numbness and tingling comes and goes. The patient required a doctor's visit; date not provided. The patient had not recovered by the time of the report. Follow-up information was received 06 May 2010 from a health care professional. The patient received an intramuscular upper arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP051AA at 3:30pm on 27 January 2010. According to the reporter, she experienced additional symptoms of chills, neck pain and ear ringing. The event of tingling occurred in the patient's hands and feet (previously reported as occurring in her arms and legs). The events began one hour post vaccination at 4:30pm. The patient had no past medical history and she had not been taking any concomitant medications. According to the reporter, the events required numerous doctor's visits. The patient has received ongoing evaluations by her primary care physician and neurologist since 01 February 2010. On 04 February 2010, blood tests and EMG nerve conduction studies were performed (results not reported). On 11 February 2010, she was evaluated by an acupuncturist and received an unspecified treatment. An MRI of the brain was performed on 12 March 2010 (results not reported). The patient was subsequently evaluated by a chiropractor on 25 March 2010, and by a physiologist on 15 April 2010 (results of evaluations not reported). She also received a MRI of the cervical spine on 20 April 2010 and a hearing test on 21 April 2010 (results not reported). She began physical therapy for her neck on 29 April 2010. At the time of the report, evaluations continued and the patient continued to have ongoing symptoms. Outcome was reported as not recovered. List of Documents held by Sender: none.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), UNK
Symptoms: Hypoaesthesia facial, Neck pain, Nerve conduction studies, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: Initial information received on 18 February 2010 from a health care professional. A 43 year old female patient developed numbness and tingling in her arms, legs, and occasionally her face one hour after she received PANDEMIC INFLUENZA VACCINE (manufacturer unknown) on 27 January 2010. The numbness and tingling comes and goes. The patient required a doctor's visit; date not provided. The patient had not recovered by the time of the report. Follow-up information was received 06 May 2010 from a health care professional. The patient received an intramuscular upper arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP051AA at 3:30pm on 27 January 2010. According to the reporter, she experienced additional symptoms of chills, neck pain and ear ringing. The event of tingling occurred in the patient's hands and feet (previously reported as occurring in her arms and legs). The events began one hour post vaccination at 4:30pm. The patient had no past medical history and she had not been taking any concomitant medications. According to the reporter, the events required numerous doctor's visits. The patient has received ongoing evaluations by her primary care physician and neurologist since 01 February 2010. On 04 February 2010, blood tests and EMG nerve conduction studies were performed (results not reported). On 11 February 2010, she was evaluated by an acupuncturist and received an unspecified treatment. An MRI of the brain was performed on 12 March 2010 (results not reported). The patient was subsequently evaluated by a chiropractor on 25 March 2010, and by a physiologist on 15 April 2010 (results of evaluations not reported). She also received a MRI of the cervical spine on 20 April 2010 and a hearing test on 21 April 2010 (results not reported). She began physical therapy for her neck on 29 April 2010. At the time of the report, evaluations continued and the patient continued to have ongoing symptoms. Outcome was reported as not recovered. List of Documents held by Sender: none.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), UNK
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Initial information received on 18 February 2010 from a health care professional. A 43 year old female patient developed numbness and tingling in her arms, legs, and occasionally her face one hour after she received PANDEMIC INFLUENZA VACCINE (manufacturer unknown) on 27 January 2010. The numbness and tingling comes and goes. The patient required a doctor's visit; date not provided. The patient had not recovered by the time of the report. Follow-up information was received 06 May 2010 from a health care professional. The patient received an intramuscular upper arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP051AA at 3:30pm on 27 January 2010. According to the reporter, she experienced additional symptoms of chills, neck pain and ear ringing. The event of tingling occurred in the patient's hands and feet (previously reported as occurring in her arms and legs). The events began one hour post vaccination at 4:30pm. The patient had no past medical history and she had not been taking any concomitant medications. According to the reporter, the events required numerous doctor's visits. The patient has received ongoing evaluations by her primary care physician and neurologist since 01 February 2010. On 04 February 2010, blood tests and EMG nerve conduction studies were performed (results not reported). On 11 February 2010, she was evaluated by an acupuncturist and received an unspecified treatment. An MRI of the brain was performed on 12 March 2010 (results not reported). The patient was subsequently evaluated by a chiropractor on 25 March 2010, and by a physiologist on 15 April 2010 (results of evaluations not reported). She also received a MRI of the cervical spine on 20 April 2010 and a hearing test on 21 April 2010 (results not reported). She began physical therapy for her neck on 29 April 2010. At the time of the report, evaluations continued and the patient continued to have ongoing symptoms. Outcome was reported as not recovered. List of Documents held by Sender: none.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), UNK
Symptoms: Blood test, Chills, Diarrhoea, Dizziness, Facial pain
Clinical narrative: Initial information received on 18 February 2010 from a health care professional. A 43 year old female patient developed numbness and tingling in her arms, legs, and occasionally her face one hour after she received PANDEMIC INFLUENZA VACCINE (manufacturer unknown) on 27 January 2010. The numbness and tingling comes and goes. The patient required a doctor's visit; date not provided. The patient had not recovered by the time of the report. Follow-up information was received 06 May 2010 from a health care professional. The patient received an intramuscular upper arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP051AA at 3:30pm on 27 January 2010. According to the reporter, she experienced additional symptoms of chills, neck pain and ear ringing. The event of tingling occurred in the patient's hands and feet (previously reported as occurring in her arms and legs). The events began one hour post vaccination at 4:30pm. The patient had no past medical history and she had not been taking any concomitant medications. According to the reporter, the events required numerous doctor's visits. The patient has received ongoing evaluations by her primary care physician and neurologist since 01 February 2010. On 04 February 2010, blood tests and EMG nerve conduction studies were performed (results not reported). On 11 February 2010, she was evaluated by an acupuncturist and received an unspecified treatment. An MRI of the brain was performed on 12 March 2010 (results not reported). The patient was subsequently evaluated by a chiropractor on 25 March 2010, and by a physiologist on 15 April 2010 (results of evaluations not reported). She also received a MRI of the cervical spine on 20 April 2010 and a hearing test on 21 April 2010 (results not reported). She began physical therapy for her neck on 29 April 2010. At the time of the report, evaluations continued and the patient continued to have ongoing symptoms. Outcome was reported as not recovered. List of Documents held by Sender: none.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), UNK
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Nausea, Neck pain, Nerve conduction studies
Clinical narrative: Initial information received on 18 February 2010 from a health care professional. A 43 year old female patient developed numbness and tingling in her arms, legs, and occasionally her face one hour after she received PANDEMIC INFLUENZA VACCINE (manufacturer unknown) on 27 January 2010. The numbness and tingling comes and goes. The patient required a doctor's visit; date not provided. The patient had not recovered by the time of the report. Follow-up information was received 06 May 2010 from a health care professional. The patient received an intramuscular upper arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP051AA at 3:30pm on 27 January 2010. According to the reporter, she experienced additional symptoms of chills, neck pain and ear ringing. The event of tingling occurred in the patient's hands and feet (previously reported as occurring in her arms and legs). The events began one hour post vaccination at 4:30pm. The patient had no past medical history and she had not been taking any concomitant medications. According to the reporter, the events required numerous doctor's visits. The patient has received ongoing evaluations by her primary care physician and neurologist since 01 February 2010. On 04 February 2010, blood tests and EMG nerve conduction studies were performed (results not reported). On 11 February 2010, she was evaluated by an acupuncturist and received an unspecified treatment. An MRI of the brain was performed on 12 March 2010 (results not reported). The patient was subsequently evaluated by a chiropractor on 25 March 2010, and by a physiologist on 15 April 2010 (results of evaluations not reported). She also received a MRI of the cervical spine on 20 April 2010 and a hearing test on 21 April 2010 (results not reported). She began physical therapy for her neck on 29 April 2010. At the time of the report, evaluations continued and the patient continued to have ongoing symptoms. Outcome was reported as not recovered. List of Documents held by Sender: none.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), UNK
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Paraesthesia, Tinnitus
Clinical narrative: Initial information received on 18 February 2010 from a health care professional. A 43 year old female patient developed numbness and tingling in her arms, legs, and occasionally her face one hour after she received PANDEMIC INFLUENZA VACCINE (manufacturer unknown) on 27 January 2010. The numbness and tingling comes and goes. The patient required a doctor's visit; date not provided. The patient had not recovered by the time of the report. Follow-up information was received 06 May 2010 from a health care professional. The patient received an intramuscular upper arm injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative, lot number UP051AA at 3:30pm on 27 January 2010. According to the reporter, she experienced additional symptoms of chills, neck pain and ear ringing. The event of tingling occurred in the patient's hands and feet (previously reported as occurring in her arms and legs). The events began one hour post vaccination at 4:30pm. The patient had no past medical history and she had not been taking any concomitant medications. According to the reporter, the events required numerous doctor's visits. The patient has received ongoing evaluations by her primary care physician and neurologist since 01 February 2010. On 04 February 2010, blood tests and EMG nerve conduction studies were performed (results not reported). On 11 February 2010, she was evaluated by an acupuncturist and received an unspecified treatment. An MRI of the brain was performed on 12 March 2010 (results not reported). The patient was subsequently evaluated by a chiropractor on 25 March 2010, and by a physiologist on 15 April 2010 (results of evaluations not reported). She also received a MRI of the cervical spine on 20 April 2010 and a hearing test on 21 April 2010 (results not reported). She began physical therapy for her neck on 29 April 2010. At the time of the report, evaluations continued and the patient continued to have ongoing symptoms. Outcome was reported as not recovered. List of Documents held by Sender: none.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Oedema, Oedema peripheral, Skin warm
Clinical narrative: Patient developed edema and erythema to anterior and posterior surface of right arm proximal lower and distal upper region, which patient states started 5May10.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Oedema
Clinical narrative: Patient developed edema and erythema to anterior and posterior surface of right arm proximal lower and distal upper region, which patient states started 5May10.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site hypersensitivity, Injection site pain, Rash
Clinical narrative: Patient started with rash on the left side of face. Redness worsened and severe pain and hypersensitivity at the site.  Including branch 1&2 from trigeminal nerve.  Earlier in the day patient with vomiting and diarrhea.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Trigeminal neuralgia, Vomiting
Clinical narrative: Patient started with rash on the left side of face. Redness worsened and severe pain and hypersensitivity at the site.  Including branch 1&2 from trigeminal nerve.  Earlier in the day patient with vomiting and diarrhea.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Blood human chorionic gonadotropin negative, Blood pressure decreased, Differential white blood cell count, Fall, Full blood count
Clinical narrative: This 15 yo had a near syncope episode, falling to floor approximately 5 to 10 minutes after 4 vaccines were given. No head injury. No loss of consciousness (BP at time low 96/62, HR 112). (Before vaccines given 4-23-10 BP 110/60, P 82 all WNL).
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Metabolic function test, Presyncope
Clinical narrative: This 15 yo had a near syncope episode, falling to floor approximately 5 to 10 minutes after 4 vaccines were given. No head injury. No loss of consciousness (BP at time low 96/62, HR 112). (Before vaccines given 4-23-10 BP 110/60, P 82 all WNL).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Death
Clinical narrative: None stated.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Autopsy, Death
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Drug hypersensitivity, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Copied and pasted triage note from call center: HAD DTAP/POLIO IN L ARM YESTERDAY. TODAY MOM NOTED AREA OF REDNESS AND SWELLING AT SITE. NOT C/O PAIN, BUT CHILD DOESN'T WANT HER TO TOUCH IT. FEELS HARD AT SITE. FELT WARM EARLIER, BUT DIDN'T TAKE TEMP. GAVE TYLENOL. CHILD PLAYING. Patient was seen in urgent care 05/8/10. Copied and pasted provider note: Reviewed intake note. SUBJECTIVE: Patient is a 4 yr old female who presents with erythema and tenderness.   Location: left upper arm   Onset: acute   Duration: 1 days and symptoms are worsening   Patient Active Problem List:   CLOSED FX FEMUR, SUPRACONDYLAR LESION SIZE/LOCATION: Left upper arm from tip of shoulder to just above elbow, in a circular area LESION DESCRIPTION: erythema and swelling    A/P:Cellulitis vs local reaction to immunisations. Will treat with Keflex and Benadryl as directed. To return PRN. Patient seen again by PCP on 5/8/10 for allergic reaction to Keflex Per PCP:LIKELY EXTREME LOCAL REACTION TO KINRIX (DAPT-POL), COULD BE TO VARICELLA
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Local reaction, Skin warm
Clinical narrative: Copied and pasted triage note from call center: HAD DTAP/POLIO IN L ARM YESTERDAY. TODAY MOM NOTED AREA OF REDNESS AND SWELLING AT SITE. NOT C/O PAIN, BUT CHILD DOESN'T WANT HER TO TOUCH IT. FEELS HARD AT SITE. FELT WARM EARLIER, BUT DIDN'T TAKE TEMP. GAVE TYLENOL. CHILD PLAYING. Patient was seen in urgent care 05/8/10. Copied and pasted provider note: Reviewed intake note. SUBJECTIVE: Patient is a 4 yr old female who presents with erythema and tenderness.   Location: left upper arm   Onset: acute   Duration: 1 days and symptoms are worsening   Patient Active Problem List:   CLOSED FX FEMUR, SUPRACONDYLAR LESION SIZE/LOCATION: Left upper arm from tip of shoulder to just above elbow, in a circular area LESION DESCRIPTION: erythema and swelling    A/P:Cellulitis vs local reaction to immunisations. Will treat with Keflex and Benadryl as directed. To return PRN. Patient seen again by PCP on 5/8/10 for allergic reaction to Keflex Per PCP:LIKELY EXTREME LOCAL REACTION TO KINRIX (DAPT-POL), COULD BE TO VARICELLA
Age: 1.24
Sex: M
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: FACIAL SWELLING OF CHEEKS, BENADRYL GIVEN BY PARENT.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood culture negative, Cellulitis, Oedema peripheral, Pain in extremity, Ultrasound scan
Clinical narrative: Vaccine was adminstered on 4/30/10 patient c/o pain and swelling of left arm shortly after administration and progressed over the next 3 days.  Patient was then seen in the ED and admitted to the hospital for cellulitis.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine was adminstered on 4/30/10 patient c/o pain and swelling of left arm shortly after administration and progressed over the next 3 days.  Patient was then seen in the ED and admitted to the hospital for cellulitis.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 4 x 4 cm red, warm edematous area at injection site on left arm (ADACEL).
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a registered nurse concerning a patient with milk allergy and egg allergy who at age 15-18 months of age was vaccinated with a dose of MMR II. Subsequently the patient showed symptoms of autism. It was unknown if the patient sought any medical attention. At the time of this report, the now 36 month old patient had not recovered. Upon internal review, autism was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Quarter size annular area with erythema: blanches to right anterior thigh with firm center at injection site (PREVNAR 13).
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Body temperature normal, Diarrhoea, Vomiting, Wrong drug administered
Clinical narrative: After receiving the wrong formula patient noted w/ temp of 101 and vomiting and diarrhea. Possible reaction to vaccines.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a registered nurse concerning a patient with milk allergy and egg allergy who at age 15-18 months of age was vaccinated with a dose of MMR II. Subsequently the patient showed symptoms of autism. It was unknown if the patient sought any medical attention. At the time of this report the patient was now 8 years old and was not recovered. Upon internal review, autism was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal labour, Alpha 1 foetoprotein normal, Amniocentesis abnormal, Apgar score normal, Breech presentation
Clinical narrative: Information has been received from a female, for the Pregnancy Registry for GARDASIL, concerning her 16 year old daughter with no pertinent medical history or drug reactions/allergies who on 10-APR-2009 was vaccinated with one dose of GARDASIL. The patient became pregnant. The urine pregnancy test was performed in the office. The patient's last menstrual period was 25-MAR-2009, her estimated delivery date was 30-DEC-2009. It was reported that her pregnancy was normal to date. Additional information was received from a health professional concerning that a 16-year-old female patient with no per-existing allergies, birth defects or medical conditions was vaccinated IM in the deltoid region of the right arm with the first dose of GARDASIL vaccine (Lot # 661046/0546X) at 16:00 PM on 10-SEP-2009. The patient was unaware of pregnant at the time of injection. There were no adverse events reported. The patient had no illness at time of vaccination. The patient had no other concomitant medications. Follow-up information has been received from a physician indicated that the patient with no significant past medical history and no family history or smoking history with no obesity and with no previous pregnancies, no pre-term deliveries, no spontaneous abortions, no elective terminations, no stillbirths and on full term delivery who was vaccinated with the first dose of GARDASIL on 10-APR-2009. Concomitant medication included prenatal vitamins from June 2009 to December 2009 daily for pregnancy. The prenatal testing included: On 23-JUN-2009 at 13 weeks and on 18-AUG-2009 at 21 weeks ultrasound for survey of anatomy revealed normal female, on an unspecified date amniocentesis revealed fetus, on 23-JUL-2009 MSAFP for screening for anomalies revealed WNL. On approximately 22-DEC-2009 the patient experienced protracted labor as complication during labor/delvery. On 22-DEC-2009 the patient delivery a normal female infant with weight 6 pound 13 oz, length 19.5 inch, Apgar score 7/9, head circumference 14 inch. The weeks from LMP were 39 weeks. There were no congenital anomalies and no other complications or abnormalities. There was no complication during pregnancy. The diagnostic test during pregnancy were ultrasounds at 13 and 21 weeks respectively. There was no infection or illness during pregnancy. Follow-up information has been received from a physician indicated that on 22-DEC-2009 the patient delivered a normal female infant with a weight of 6 pounds 13 oz by caesarean section due to failure to progress and breech position. The newborn noted as MMC had no known drug allergies looked good overall and well hydrated. All the examinations for the baby were normal. Upon internal review, caesarean section due to failure to progress and breech position was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Prolonged labour, Ultrasound scan normal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a female, for the Pregnancy Registry for GARDASIL, concerning her 16 year old daughter with no pertinent medical history or drug reactions/allergies who on 10-APR-2009 was vaccinated with one dose of GARDASIL. The patient became pregnant. The urine pregnancy test was performed in the office. The patient's last menstrual period was 25-MAR-2009, her estimated delivery date was 30-DEC-2009. It was reported that her pregnancy was normal to date. Additional information was received from a health professional concerning that a 16-year-old female patient with no per-existing allergies, birth defects or medical conditions was vaccinated IM in the deltoid region of the right arm with the first dose of GARDASIL vaccine (Lot # 661046/0546X) at 16:00 PM on 10-SEP-2009. The patient was unaware of pregnant at the time of injection. There were no adverse events reported. The patient had no illness at time of vaccination. The patient had no other concomitant medications. Follow-up information has been received from a physician indicated that the patient with no significant past medical history and no family history or smoking history with no obesity and with no previous pregnancies, no pre-term deliveries, no spontaneous abortions, no elective terminations, no stillbirths and on full term delivery who was vaccinated with the first dose of GARDASIL on 10-APR-2009. Concomitant medication included prenatal vitamins from June 2009 to December 2009 daily for pregnancy. The prenatal testing included: On 23-JUN-2009 at 13 weeks and on 18-AUG-2009 at 21 weeks ultrasound for survey of anatomy revealed normal female, on an unspecified date amniocentesis revealed fetus, on 23-JUL-2009 MSAFP for screening for anomalies revealed WNL. On approximately 22-DEC-2009 the patient experienced protracted labor as complication during labor/delvery. On 22-DEC-2009 the patient delivery a normal female infant with weight 6 pound 13 oz, length 19.5 inch, Apgar score 7/9, head circumference 14 inch. The weeks from LMP were 39 weeks. There were no congenital anomalies and no other complications or abnormalities. There was no complication during pregnancy. The diagnostic test during pregnancy were ultrasounds at 13 and 21 weeks respectively. There was no infection or illness during pregnancy. Follow-up information has been received from a physician indicated that on 22-DEC-2009 the patient delivered a normal female infant with a weight of 6 pounds 13 oz by caesarean section due to failure to progress and breech position. The newborn noted as MMC had no known drug allergies looked good overall and well hydrated. All the examinations for the baby were normal. Upon internal review, caesarean section due to failure to progress and breech position was considered to be an other important medical event. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse for GARDASIL, a pregnancy registry product, concerning a 19 year old female patient with medical history of smoke and might have conceived on NUVARING, plan B who on 31-AUG-2007 was vaccinated IM with 0.5 ml dose of GARDASIL (Lot#661846/1312X) at left deltoid. There was no concomitant medication. On 21-AUG-2009 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL. On 31-AUG-2009 the patient took a urine home pregnancy test and it was positive. The patient came into the office for a pregnancy visit on 22-SEP-2009. On this visit ultrasound performed and estimated due date would be 05-MAY-2010. The last menstruation period was approximately 31-JUL-2009. The patient was not experiencing any problems, there were no adverse effects report. Follow up information has been received from the nurse who reported that on 20-OCT-2009 the patient called to cancel her appointment. Message stated cancellation due to possible miscarriage or termination of pregnancy. No further information noted. On 19-NOV-2009, the nurse left a message for the patient to call the office. There was no follow up phone calls from patient. The nurse was unable to contact again in April 2010 because the phone number is no longer in service. There was no further information and none was anticipated. Possible miscarriage or termination of pregnancy was considered to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Nervous system disorder, Wheelchair user
Clinical narrative: Information has been received from a physician who reported that one of his patient's mother mentioned that at some point last year, in 2009, a young woman was vaccinated with a dose of GARDASIL (lot # not reported) and the patient developed neurologic disorders. Unspecified medical attention was sought. The patient went through many tests and was currently in a wheelchair. At the time of this report, the patient's outcome was unknown. Neurologists did not believe that it was due to receiving GARDASIL. Neurologic disorder was considered to be disabling by the reporter. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Autopsy, Death, Headache
Clinical narrative: Information has been received from a physician who found out from another treating physician who was also the father of the patient, concerning a 16 year old female patient who on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient developed a severe headache. Then the patient went to sleep that night and passed away. The autopsy was performed which revealed no cause of death. It is unknown if the patient sought medical attention. Severe headache was considered to be immediately life-threatening. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HIBV, IPV, PNC, RV5
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: KINRIX administered by accident instead of DTAP.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme, Rash
Clinical narrative: Administered PREVNAR 13 on 5/7/10, woke up on 5/10/10 with hive like rash, which progressed to erythema multiforme.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lumbar puncture, Paraesthesia, Paralysis, Urinary incontinence
Clinical narrative: Initial report was received on 28 April 2010 from a consumer, who is also the patient's daughter. A 72-year-old female patient (also reported as 71 year-old) who had a history of hypertension, had received an injection of FLUZONE SV 2009-2010, lot number U3378AB on 13 January 2010 and three days later, she developed tingling and a sensation of pin pricks in her lower right leg. These symptoms spread across her waist and to her right leg. According to the reporter, the patient became paralyzed from the waist down and she became incontinent of urine and feces. The patient was taken to the emergency room and was hospitalized for seven days (dates not reported). Diagnostic testing included an MRI, brain scan and lumbar puncture (results not reported). Corrective treatments were not reported; however the patient was being seen by both "ortho and neuro". The patient had been taking DIOVAN 80 mg concomitantly and she had no concurrent illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE SV 2009-2010. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Faecal incontinence, Lumbar puncture, Nuclear magnetic resonance imaging, Paraesthesia, Paralysis
Clinical narrative: Initial report was received on 28 April 2010 from a consumer, who is also the patient's daughter. A 72-year-old female patient (also reported as 71 year-old) who had a history of hypertension, had received an injection of FLUZONE SV 2009-2010, lot number U3378AB on 13 January 2010 and three days later, she developed tingling and a sensation of pin pricks in her lower right leg. These symptoms spread across her waist and to her right leg. According to the reporter, the patient became paralyzed from the waist down and she became incontinent of urine and feces. The patient was taken to the emergency room and was hospitalized for seven days (dates not reported). Diagnostic testing included an MRI, brain scan and lumbar puncture (results not reported). Corrective treatments were not reported; however the patient was being seen by both "ortho and neuro". The patient had been taking DIOVAN 80 mg concomitantly and she had no concurrent illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE SV 2009-2010. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Scan brain, Urinary incontinence
Clinical narrative: Initial report was received on 28 April 2010 from a consumer, who is also the patient's daughter. A 72-year-old female patient (also reported as 71 year-old) who had a history of hypertension, had received an injection of FLUZONE SV 2009-2010, lot number U3378AB on 13 January 2010 and three days later, she developed tingling and a sensation of pin pricks in her lower right leg. These symptoms spread across her waist and to her right leg. According to the reporter, the patient became paralyzed from the waist down and she became incontinent of urine and feces. The patient was taken to the emergency room and was hospitalized for seven days (dates not reported). Diagnostic testing included an MRI, brain scan and lumbar puncture (results not reported). Corrective treatments were not reported; however the patient was being seen by both "ortho and neuro". The patient had been taking DIOVAN 80 mg concomitantly and she had no concurrent illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE SV 2009-2010. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Dizziness, Gait disturbance, Nuclear magnetic resonance imaging brain, Urinary incontinence
Clinical narrative: Loss of bladder and bowel control. Unsteady gait; dizzy.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Loss of bladder and bowel control. Unsteady gait; dizzy.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal tenderness, Asthma, Headache, Irritable bowel syndrome, Malaise
Clinical narrative: Severe asthma attack "worse one ever"; received relief w/ albuterol inhaler; body aches; general malaise; N/V 30 min. post asthma attack; headache; tender abdomen; lingering nausea w/o vomiting. Day 2 post reaction: Small amount of IBS lingering.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Severe asthma attack "worse one ever"; received relief w/ albuterol inhaler; body aches; general malaise; N/V 30 min. post asthma attack; headache; tender abdomen; lingering nausea w/o vomiting. Day 2 post reaction: Small amount of IBS lingering.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Pyrexia, Rash
Clinical narrative: 1 day after vaccine patchy rash then this morning quarter size red pattern started growing in size - not tender to touch 1-2 day fever. Started on abx for cellulitis.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), HPV4
Symptoms: Electrocardiogram, Fall, Loss of consciousness
Clinical narrative: Client passed out in Lobby - witness stated didn't hit head - had reached for chair then fell to floor. Had the 2 immunizations and a blood draw. States fainted after blood donation in the past.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Injection site erythema
Clinical narrative: Red mark at injection site, dizzy.
Age: 46.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Headache, Influenza like illness, Swelling
Clinical narrative: Flu like symptoms for following two weeks. Severe (helmet-like) headaches still happening. Increase of knee joint pain. Left hip pain onset - Severe joint pain. Week 4 started creaking noise (like knees) swelling. Does not respond to OTC pain killer. Two falls due to hip pain so far.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 10 X 9 1/2 cm erythematous indurated area at site of vaccine.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash over chest and upper arms has taken Benadryl with some relief has taken x 1 today.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Local reaction. 8cm by 9cm area redness. Slight swelling.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diplopia, Gait disturbance, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Acute weakness, Double vision, stumbling legs, collapsed.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Acute weakness, Double vision, stumbling legs, collapsed.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever/pain and redness at site of pneumonia vaccine. H1N1 was above that.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling, hard lump 6.5 cm X 2.5 cm left thigh.  Hematoma; apply heat, observation.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt had pain in left leg and stopped moving the leg around 6-8 hours after the vaccine shot in left leg. Now in clinic she is walking with a limp No h/o seizures, hives, shortness of breath. No neurological deficit on exam. Recommend - MOTRIN, TYLENOL.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Patient's mom reports patient complained of hives-red, raised, itchy areas to entire body except shins that first started at injection site.  Patient's mother gave patient Benadryl with continued hives for 2 days post injection. Hives diminished on 5/5/10 with any further complications or treatment needed. Patient's mother reports no new lotion, detergent, soap or other contacts.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: VACCINE ADMINISTERED IM INSTEAD OF SC-NO REACTION TO VACCINE.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Left arm injection site area red, warm, swollen- approx. size of baseball. Tender to touch. Child with fever, n/v, or diarrhea. Pt. presented to school nurse.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tenderness, Vomiting
Clinical narrative: Left arm injection site area red, warm, swollen- approx. size of baseball. Tender to touch. Child with fever, n/v, or diarrhea. Pt. presented to school nurse.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1), PNC13
Symptoms: Injection site erythema, Vaccination complication
Clinical narrative: Mom returned to clinic with complaint of redness to injection site.  MD evaluated and was diagnosed with "Local vaccine reaction versus a possible early cellulitis." Was started on Keflex to treat.
Age: 1.27
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash over anterior, posterior trunk and facial area.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Inappropriate schedule of drug administration, Lethargy, Pyrexia, Vomiting
Clinical narrative: On the afternoon of the day of vaccination, patient vomited several times and felt "lethargic." By early evening, pt had chills and tactile fever. Motrin was given. Complained of shortness of breath intermittently. No lip/tongue swelling noted.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Skin warm
Clinical narrative: Patient's left deltoid burning, very red in color from area of injection to elbow and warm to touch.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right leg red & swollen.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Local reaction, Pyrexia
Clinical narrative: Local reaction 2" X 1 3/4 inch. Fever of 100.5.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Differential white blood cell count normal, Full blood count normal, Laboratory test normal, Pyrexia, Rash erythematous
Clinical narrative: The pt. developed a fever the day after vaccines were administered. The fever was 102 and lasted for five days. It resolved on 5/4/10. On 5/3/10, the child developed erythematous, macular rash to trunk & diaper area.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: The pt. developed a fever the day after vaccines were administered. The fever was 102 and lasted for five days. It resolved on 5/4/10. On 5/3/10, the child developed erythematous, macular rash to trunk & diaper area.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Swelling, urticaria at site (only).
Age: 68.0
Sex: F
Vaccine: HEPA, IPV, MEN, TD, TYP, YF
Symptoms: Pain, Urticaria, Vomiting
Clinical narrative: Vomiting on day of vaccine achiness throughout body since day of vaccine "hives" developed across body 7 days after receiving vaccine.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Joint range of motion decreased, Pain, Staphylococcal skin infection, Staphylococcus test positive, Surgery
Clinical narrative: Staph aureus infection (R) shoulder 23Jul08. Two surgeries 23Jul08 and 5Jan09. Decreased ROM, chronic pain (R) shoulder.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inflammation, Oedema peripheral, Tenderness
Clinical narrative: Following a meningitis shot, pt's arm was swollen "like a baseball", inflamed & tender. Pt. "didn't feel good." Afebrile - appetite ok.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Lymph node pain, Lymphadenopathy, Tenderness
Clinical narrative: Felt soreness in clavicular lymphnode near collarbone.  One felt tender and quite enlarged, another was smaller but also tender.  Both nodes located on right side of neck, close to collarbone, but not on the collarbone.  Felt less sore the day after, so it seems to be getting better and returning to normal, though the node is still enlarged.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood test normal, Dehydration, Diarrhoea, Vomiting
Clinical narrative: Received ROTATEQ 5/5/10, vomiting and diarrhea started 24 hours later patient seen in ER for IVFP for dehydration. Attended daycare 1 day at the start of illness. Vomiting has stopped. Still with very loose stool. All blood work done in ER was normal.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmness and soreness at injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes zoster rash developed on L trunk in dermatomal distribution approximately 5 days after vaccine was given 4/26/10.  Seen in clinic 5/11/10 for this by MD and verified zoster rash.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, HEPA, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Redness and slight swelling.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed pain swelling erythema at site of vaccine next morning.