chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Monocyte count increased, White blood cell count decreased
Clinical narrative: Initial report received on 15 July 2009 from a health care professional in the country. A copy of an online VAERS report was provided VAERS E-report number E-30400. A 42-year-old female patient, who has allergy to Penicillin and history of situational stress, and who was also experiencing a lot of stress from recent death of father, had received (at an annual exam) on 30 June 2009 at 15:00 pm a 0.5 mL intramuscular left deltoid injection of ADACEL (lot number C3158AA). The patient was taking concomitant medications of ATIVAN 0.5 mg (less than five tablets/month) and was using NUVARING. The patient called the reporter the evening of the vaccination around 17:00 pm, complaining of pain at the injection site. The patient used ice and took ibuprofen with some relief. The following day, the patient was examined by a physician and no redness or swelling was noted at the injection site, but the patient had some tenderness on moving the shoulder. Two days later, the patient went to the emergency room and was evaluated by a physician who consulted with an orthopedist on call. The patient received steroids (trade name and route not reported) and pain medications (trade name, route any type not reported). The physician's note stated "Lab Ok, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa synovial joint inflamed 2nd to high placement of DT." Diagnostic laboratory data from the emergency room visit was reported as CBC: 4,200, WBC (L), H/H 12.1/35.1, grans 45.6 (L), Monos 12.1 (H); and the CMP was unremarkable. Five days later, the patient reported she had been taking pain medications and using a sling which helped some, but it was hard for her to work. She was still having considerable pain but was better than before the emergency room visit. The patient reported she was to have an appointment with orthopedics on 13 July 2009; however the result of that visit was not reported. At the time of this report the patient had not recovered. The reporter for this case is the same as for case 2009-03133. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Arthritis, Bursitis, Full blood count, Granulocyte count decreased
Clinical narrative: Initial report received on 15 July 2009 from a health care professional in the country. A copy of an online VAERS report was provided VAERS E-report number E-30400. A 42-year-old female patient, who has allergy to Penicillin and history of situational stress, and who was also experiencing a lot of stress from recent death of father, had received (at an annual exam) on 30 June 2009 at 15:00 pm a 0.5 mL intramuscular left deltoid injection of ADACEL (lot number C3158AA). The patient was taking concomitant medications of ATIVAN 0.5 mg (less than five tablets/month) and was using NUVARING. The patient called the reporter the evening of the vaccination around 17:00 pm, complaining of pain at the injection site. The patient used ice and took ibuprofen with some relief. The following day, the patient was examined by a physician and no redness or swelling was noted at the injection site, but the patient had some tenderness on moving the shoulder. Two days later, the patient went to the emergency room and was evaluated by a physician who consulted with an orthopedist on call. The patient received steroids (trade name and route not reported) and pain medications (trade name, route any type not reported). The physician's note stated "Lab Ok, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa synovial joint inflamed 2nd to high placement of DT." Diagnostic laboratory data from the emergency room visit was reported as CBC: 4,200, WBC (L), H/H 12.1/35.1, grans 45.6 (L), Monos 12.1 (H); and the CMP was unremarkable. Five days later, the patient reported she had been taking pain medications and using a sling which helped some, but it was hard for her to work. She was still having considerable pain but was better than before the emergency room visit. The patient reported she was to have an appointment with orthopedics on 13 July 2009; however the result of that visit was not reported. At the time of this report the patient had not recovered. The reporter for this case is the same as for case 2009-03133. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Haematocrit decreased, Haemoglobin normal, Injection site pain, Metabolic function test, Monocyte count increased
Clinical narrative: Initial report received on 15 July 2009 from a health care professional in the country. A copy of an online VAERS report was provided VAERS E-report number E-30400. A 42-year-old female patient, who has allergy to Penicillin and history of situational stress, and who was also experiencing a lot of stress from recent death of father, had received (at an annual exam) on 30 June 2009 at 15:00 pm a 0.5 mL intramuscular left deltoid injection of ADACEL (lot number C3158AA). The patient was taking concomitant medications of ATIVAN 0.5 mg (less than five tablets/month) and was using NUVARING. The patient called the reporter the evening of the vaccination around 17:00 pm, complaining of pain at the injection site. The patient used ice and took ibuprofen with some relief. The following day, the patient was examined by a physician and no redness or swelling was noted at the injection site, but the patient had some tenderness on moving the shoulder. Two days later, the patient went to the emergency room and was evaluated by a physician who consulted with an orthopedist on call. The patient received steroids (trade name and route not reported) and pain medications (trade name, route any type not reported). The physician's note stated "Lab Ok, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa synovial joint inflamed 2nd to high placement of DT." Diagnostic laboratory data from the emergency room visit was reported as CBC: 4,200, WBC (L), H/H 12.1/35.1, grans 45.6 (L), Monos 12.1 (H); and the CMP was unremarkable. Five days later, the patient reported she had been taking pain medications and using a sling which helped some, but it was hard for her to work. She was still having considerable pain but was better than before the emergency room visit. The patient reported she was to have an appointment with orthopedics on 13 July 2009; however the result of that visit was not reported. At the time of this report the patient had not recovered. The reporter for this case is the same as for case 2009-03133. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: White blood cell count decreased
Clinical narrative: Initial report received on 15 July 2009 from a health care professional in the country. A copy of an online VAERS report was provided VAERS E-report number E-30400. A 42-year-old female patient, who has allergy to Penicillin and history of situational stress, and who was also experiencing a lot of stress from recent death of father, had received (at an annual exam) on 30 June 2009 at 15:00 pm a 0.5 mL intramuscular left deltoid injection of ADACEL (lot number C3158AA). The patient was taking concomitant medications of ATIVAN 0.5 mg (less than five tablets/month) and was using NUVARING. The patient called the reporter the evening of the vaccination around 17:00 pm, complaining of pain at the injection site. The patient used ice and took ibuprofen with some relief. The following day, the patient was examined by a physician and no redness or swelling was noted at the injection site, but the patient had some tenderness on moving the shoulder. Two days later, the patient went to the emergency room and was evaluated by a physician who consulted with an orthopedist on call. The patient received steroids (trade name and route not reported) and pain medications (trade name, route any type not reported). The physician's note stated "Lab Ok, better post meds, I do not think she needs needle aspiration at this time, does not seem to be infected. Bursa synovial joint inflamed 2nd to high placement of DT." Diagnostic laboratory data from the emergency room visit was reported as CBC: 4,200, WBC (L), H/H 12.1/35.1, grans 45.6 (L), Monos 12.1 (H); and the CMP was unremarkable. Five days later, the patient reported she had been taking pain medications and using a sling which helped some, but it was hard for her to work. She was still having considerable pain but was better than before the emergency room visit. The patient reported she was to have an appointment with orthopedics on 13 July 2009; however the result of that visit was not reported. At the time of this report the patient had not recovered. The reporter for this case is the same as for case 2009-03133. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Ataxia, Blister, Blood test
Clinical narrative: See papers included with this form. I am an RN, BSN. So I have described my symptoms with the nerves that have been involved. Many neurological symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation mucosal, Contusion, Dizziness, Dyspnoea, Fall
Clinical narrative: See papers included with this form. I am an RN, BSN. So I have described my symptoms with the nerves that have been involved. Many neurological symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Herpes zoster, Hypoaesthesia, Incorrect dose administered, Lumbar puncture
Clinical narrative: See papers included with this form. I am an RN, BSN. So I have described my symptoms with the nerves that have been involved. Many neurological symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Oral discomfort, Oropharyngeal blistering, Sensory loss, Thrombosis
Clinical narrative: See papers included with this form. I am an RN, BSN. So I have described my symptoms with the nerves that have been involved. Many neurological symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tongue ulceration, Walking aid user
Clinical narrative: See papers included with this form. I am an RN, BSN. So I have described my symptoms with the nerves that have been involved. Many neurological symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test, Blood test, Computerised tomogram, Electroencephalogram, Electromyogram
Clinical narrative: See papers included with this form. I am an RN, BSN. So I have described my symptoms with the nerves that have been involved. Many neurological symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture, Neurological examination, Neurological symptom, Nuclear magnetic resonance imaging
Clinical narrative: See papers included with this form. I am an RN, BSN. So I have described my symptoms with the nerves that have been involved. Many neurological symptoms.
Age: 30.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TYP, HEPAB
Symptoms: Dizziness, Malaise, Pallor, Syncope
Clinical narrative: First vaccine in series was given on 6/12/09.  Patient felt light-headed after receiving Twinrix and typhoid injectable shots.  The patient rested and drank water, and felt better within 10 minutes.  After careful observation, it was determined that the room temperature was a little warm and that may have contributed to the patient's symptoms of light-headedness.  After waiting another 20 minutes, patient requested the Polio and Meningitis immunizations be administered to him.  No immediate adverse reactions were noted after that.
Age: 30.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TYP, HEPAB
Symptoms: Dizziness
Clinical narrative: First vaccine in series was given on 6/12/09.  Patient felt light-headed after receiving Twinrix and typhoid injectable shots.  The patient rested and drank water, and felt better within 10 minutes.  After careful observation, it was determined that the room temperature was a little warm and that may have contributed to the patient's symptoms of light-headedness.  After waiting another 20 minutes, patient requested the Polio and Meningitis immunizations be administered to him.  No immediate adverse reactions were noted after that.
Age: 30.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Malaise, Pallor, Syncope
Clinical narrative: Twinrix dose #2 given on 7/13/09.  Patient experienced another episode of light headedness and brief syncope (for a few seconds) within 5 minutes of receiving the vaccination.  He experienced a similar experience with the first Twinrix dose as well.  Patient stated that the room felt warm, and that he felt the vaccine penetrate his arm, and then felt lightheaded within a few minutes.  Patient rested, drank water, ate a candy bar, and the staff put a fan on in the room.  Within 15 minutes of the episode, patient felt much better and the symptoms resolved without further incident. Patient did not respond to several follow up calls to determine if he needed further medical attention.
Age: 30.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Syncope, Vaccine positive rechallenge
Clinical narrative: Twinrix dose #2 given on 7/13/09.  Patient experienced another episode of light headedness and brief syncope (for a few seconds) within 5 minutes of receiving the vaccination.  He experienced a similar experience with the first Twinrix dose as well.  Patient stated that the room felt warm, and that he felt the vaccine penetrate his arm, and then felt lightheaded within a few minutes.  Patient rested, drank water, ate a candy bar, and the staff put a fan on in the room.  Within 15 minutes of the episode, patient felt much better and the symptoms resolved without further incident. Patient did not respond to several follow up calls to determine if he needed further medical attention.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Allergy test positive, Antinuclear antibody negative, Arthralgia, Asthenia
Clinical narrative: Nausea & vomiting, abdominal pain, joint pain, numbness & tingling in hands & feet, fatigue, weight loss. Unable to eat certain foods.  Developed allergy to wheat. These symptoms started 1 to 2 weeks after 1st vaccine. Pt stated felt like "she was 80 yrs old."  Started wheat free diet, visited doctor, lab tests for celiac disease negative, numerous lab tests (lyme titer, cbc, rheumatoid workup, ANA, Sed rate, lupus and all negative.  2 months after vaccine peripheral neuropathy, joint pain symptoms improved.  Continues with abdominal pain, weakness, weight loss & difficulty with foods.  Diarrhea begins and continues to present. Work up by GI specialist includes EGD, colonoscopy, CT's, MRI, GI series, video capsule endoscopy, numerous lab studies.  Allergy testing showing allergy to wheat. Positive for fructose malabsorption. Wheat free & fructose free diet.  Work up continues after 1 year to find source of abdominal pain and watery diarrhea.  7/30/09  PCP records received 7/11/08 to note written 7/28/09.  Initially presented 7/11/08 request to be tested for celiac disease. Reports 2 yr hx of abdominal pain, recently improved on wheat-free diet.  Returned 8/11/08 with c/o 2 months hx of "everything hurting"- joints and muscles, fatigue, decreased sleep, sensitive hearing.  Labs all WNL except (+) EBV Ab IgG showing recent infection.  10/8/09 Hospital records, DC summary received, service dates 3/16/09 to 3/18/09. Assessment: Chronic complex of abdominal pain with diarrhea. Patient developed myalgias, asthenia, fatigue, arthralgias, nausea and vomiting - now resolved. Lost weight. Constipated. Patient now presents with abdominal pain and postprandial diarrhea. Abdomen - diffuse tenderness to palpation.  ICD-9 Codes: 564.1 Irritable bowel syndrome, 787.91 Diarrhea.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy intestine abnormal, Borrelia burgdorferi serology negative, Colonoscopy, Computerised tomogram, Diarrhoea
Clinical narrative: Nausea & vomiting, abdominal pain, joint pain, numbness & tingling in hands & feet, fatigue, weight loss. Unable to eat certain foods.  Developed allergy to wheat. These symptoms started 1 to 2 weeks after 1st vaccine. Pt stated felt like "she was 80 yrs old."  Started wheat free diet, visited doctor, lab tests for celiac disease negative, numerous lab tests (lyme titer, cbc, rheumatoid workup, ANA, Sed rate, lupus and all negative.  2 months after vaccine peripheral neuropathy, joint pain symptoms improved.  Continues with abdominal pain, weakness, weight loss & difficulty with foods.  Diarrhea begins and continues to present. Work up by GI specialist includes EGD, colonoscopy, CT's, MRI, GI series, video capsule endoscopy, numerous lab studies.  Allergy testing showing allergy to wheat. Positive for fructose malabsorption. Wheat free & fructose free diet.  Work up continues after 1 year to find source of abdominal pain and watery diarrhea.  7/30/09  PCP records received 7/11/08 to note written 7/28/09.  Initially presented 7/11/08 request to be tested for celiac disease. Reports 2 yr hx of abdominal pain, recently improved on wheat-free diet.  Returned 8/11/08 with c/o 2 months hx of "everything hurting"- joints and muscles, fatigue, decreased sleep, sensitive hearing.  Labs all WNL except (+) EBV Ab IgG showing recent infection.  10/8/09 Hospital records, DC summary received, service dates 3/16/09 to 3/18/09. Assessment: Chronic complex of abdominal pain with diarrhea. Patient developed myalgias, asthenia, fatigue, arthralgias, nausea and vomiting - now resolved. Lost weight. Constipated. Patient now presents with abdominal pain and postprandial diarrhea. Abdomen - diffuse tenderness to palpation.  ICD-9 Codes: 564.1 Irritable bowel syndrome, 787.91 Diarrhea.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Endoscopy, Fatigue, Feeling abnormal, Food allergy, Food intolerance
Clinical narrative: Nausea & vomiting, abdominal pain, joint pain, numbness & tingling in hands & feet, fatigue, weight loss. Unable to eat certain foods.  Developed allergy to wheat. These symptoms started 1 to 2 weeks after 1st vaccine. Pt stated felt like "she was 80 yrs old."  Started wheat free diet, visited doctor, lab tests for celiac disease negative, numerous lab tests (lyme titer, cbc, rheumatoid workup, ANA, Sed rate, lupus and all negative.  2 months after vaccine peripheral neuropathy, joint pain symptoms improved.  Continues with abdominal pain, weakness, weight loss & difficulty with foods.  Diarrhea begins and continues to present. Work up by GI specialist includes EGD, colonoscopy, CT's, MRI, GI series, video capsule endoscopy, numerous lab studies.  Allergy testing showing allergy to wheat. Positive for fructose malabsorption. Wheat free & fructose free diet.  Work up continues after 1 year to find source of abdominal pain and watery diarrhea.  7/30/09  PCP records received 7/11/08 to note written 7/28/09.  Initially presented 7/11/08 request to be tested for celiac disease. Reports 2 yr hx of abdominal pain, recently improved on wheat-free diet.  Returned 8/11/08 with c/o 2 months hx of "everything hurting"- joints and muscles, fatigue, decreased sleep, sensitive hearing.  Labs all WNL except (+) EBV Ab IgG showing recent infection.  10/8/09 Hospital records, DC summary received, service dates 3/16/09 to 3/18/09. Assessment: Chronic complex of abdominal pain with diarrhea. Patient developed myalgias, asthenia, fatigue, arthralgias, nausea and vomiting - now resolved. Lost weight. Constipated. Patient now presents with abdominal pain and postprandial diarrhea. Abdomen - diffuse tenderness to palpation.  ICD-9 Codes: 564.1 Irritable bowel syndrome, 787.91 Diarrhea.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Hypoaesthesia, Laboratory test normal, Nausea, Neuropathy peripheral
Clinical narrative: Nausea & vomiting, abdominal pain, joint pain, numbness & tingling in hands & feet, fatigue, weight loss. Unable to eat certain foods.  Developed allergy to wheat. These symptoms started 1 to 2 weeks after 1st vaccine. Pt stated felt like "she was 80 yrs old."  Started wheat free diet, visited doctor, lab tests for celiac disease negative, numerous lab tests (lyme titer, cbc, rheumatoid workup, ANA, Sed rate, lupus and all negative.  2 months after vaccine peripheral neuropathy, joint pain symptoms improved.  Continues with abdominal pain, weakness, weight loss & difficulty with foods.  Diarrhea begins and continues to present. Work up by GI specialist includes EGD, colonoscopy, CT's, MRI, GI series, video capsule endoscopy, numerous lab studies.  Allergy testing showing allergy to wheat. Positive for fructose malabsorption. Wheat free & fructose free diet.  Work up continues after 1 year to find source of abdominal pain and watery diarrhea.  7/30/09  PCP records received 7/11/08 to note written 7/28/09.  Initially presented 7/11/08 request to be tested for celiac disease. Reports 2 yr hx of abdominal pain, recently improved on wheat-free diet.  Returned 8/11/08 with c/o 2 months hx of "everything hurting"- joints and muscles, fatigue, decreased sleep, sensitive hearing.  Labs all WNL except (+) EBV Ab IgG showing recent infection.  10/8/09 Hospital records, DC summary received, service dates 3/16/09 to 3/18/09. Assessment: Chronic complex of abdominal pain with diarrhea. Patient developed myalgias, asthenia, fatigue, arthralgias, nausea and vomiting - now resolved. Lost weight. Constipated. Patient now presents with abdominal pain and postprandial diarrhea. Abdomen - diffuse tenderness to palpation.  ICD-9 Codes: 564.1 Irritable bowel syndrome, 787.91 Diarrhea.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Oesophagogastroduodenoscopy, Paraesthesia, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Nausea & vomiting, abdominal pain, joint pain, numbness & tingling in hands & feet, fatigue, weight loss. Unable to eat certain foods.  Developed allergy to wheat. These symptoms started 1 to 2 weeks after 1st vaccine. Pt stated felt like "she was 80 yrs old."  Started wheat free diet, visited doctor, lab tests for celiac disease negative, numerous lab tests (lyme titer, cbc, rheumatoid workup, ANA, Sed rate, lupus and all negative.  2 months after vaccine peripheral neuropathy, joint pain symptoms improved.  Continues with abdominal pain, weakness, weight loss & difficulty with foods.  Diarrhea begins and continues to present. Work up by GI specialist includes EGD, colonoscopy, CT's, MRI, GI series, video capsule endoscopy, numerous lab studies.  Allergy testing showing allergy to wheat. Positive for fructose malabsorption. Wheat free & fructose free diet.  Work up continues after 1 year to find source of abdominal pain and watery diarrhea.  7/30/09  PCP records received 7/11/08 to note written 7/28/09.  Initially presented 7/11/08 request to be tested for celiac disease. Reports 2 yr hx of abdominal pain, recently improved on wheat-free diet.  Returned 8/11/08 with c/o 2 months hx of "everything hurting"- joints and muscles, fatigue, decreased sleep, sensitive hearing.  Labs all WNL except (+) EBV Ab IgG showing recent infection.  10/8/09 Hospital records, DC summary received, service dates 3/16/09 to 3/18/09. Assessment: Chronic complex of abdominal pain with diarrhea. Patient developed myalgias, asthenia, fatigue, arthralgias, nausea and vomiting - now resolved. Lost weight. Constipated. Patient now presents with abdominal pain and postprandial diarrhea. Abdomen - diffuse tenderness to palpation.  ICD-9 Codes: 564.1 Irritable bowel syndrome, 787.91 Diarrhea.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, Weight decreased, Wheat-free diet
Clinical narrative: Nausea & vomiting, abdominal pain, joint pain, numbness & tingling in hands & feet, fatigue, weight loss. Unable to eat certain foods.  Developed allergy to wheat. These symptoms started 1 to 2 weeks after 1st vaccine. Pt stated felt like "she was 80 yrs old."  Started wheat free diet, visited doctor, lab tests for celiac disease negative, numerous lab tests (lyme titer, cbc, rheumatoid workup, ANA, Sed rate, lupus and all negative.  2 months after vaccine peripheral neuropathy, joint pain symptoms improved.  Continues with abdominal pain, weakness, weight loss & difficulty with foods.  Diarrhea begins and continues to present. Work up by GI specialist includes EGD, colonoscopy, CT's, MRI, GI series, video capsule endoscopy, numerous lab studies.  Allergy testing showing allergy to wheat. Positive for fructose malabsorption. Wheat free & fructose free diet.  Work up continues after 1 year to find source of abdominal pain and watery diarrhea.  7/30/09  PCP records received 7/11/08 to note written 7/28/09.  Initially presented 7/11/08 request to be tested for celiac disease. Reports 2 yr hx of abdominal pain, recently improved on wheat-free diet.  Returned 8/11/08 with c/o 2 months hx of "everything hurting"- joints and muscles, fatigue, decreased sleep, sensitive hearing.  Labs all WNL except (+) EBV Ab IgG showing recent infection.  10/8/09 Hospital records, DC summary received, service dates 3/16/09 to 3/18/09. Assessment: Chronic complex of abdominal pain with diarrhea. Patient developed myalgias, asthenia, fatigue, arthralgias, nausea and vomiting - now resolved. Lost weight. Constipated. Patient now presents with abdominal pain and postprandial diarrhea. Abdomen - diffuse tenderness to palpation.  ICD-9 Codes: 564.1 Irritable bowel syndrome, 787.91 Diarrhea.
Age: 32.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, HEPAB, MMR, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: This case was received from a health care professional on 22 June 2009. A 32-year-old female received the following vaccinations on 04 June 2009: an intramuscular left deltoid injection of ADACEL (lot number C2966AA); an intramuscular left deltoid injection of MMR (Merck, lot number 0357X); and an intramuscular right deltoid injection of TWINRIX (GSK, lot number AHABB091BA). At the time of vaccination, the patient was pregnant; date of last menstrual period was not known by the patient. Per the reporter, a pregnancy test administered at the time of vaccination was inconclusive (test registered positive, then disappeared). Another test was sent home by the patient, which was subsequently positive. Obstetric history included three previous pregnancies, including one set of twins, resulting in four full-term infants. The patient was taking medication for blood pressure, however no medical history was reported. At the time of the report, no adverse events had been reported. Follow-up information was received 20 July 2009 from a health care professional. The patient began spotting, then miscarried and had a D & C (Dilation and Curettage) on 14 July 2009: her date of last menstrual period was reported as unknown. According to the reporter, the patient recovered from the event. The patient's past obstetric history included five prior pregnancies (previously reported as three), with full term delivery of three children (previously reported as four) and two spontaneous abortions which occurred prior to 20 weeks gestation. It was not clarified if this history included the current event. ADACEL, MMR and TWINRIX which had been administered on 04 June 2009 had all been first dose injections. From this new information received, this case meets seriousness criteria and was upgraded to serious. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, HEPAB, MMR, TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: This case was received from a health care professional on 22 June 2009. A 32-year-old female received the following vaccinations on 04 June 2009: an intramuscular left deltoid injection of ADACEL (lot number C2966AA); an intramuscular left deltoid injection of MMR (Merck, lot number 0357X); and an intramuscular right deltoid injection of TWINRIX (GSK, lot number AHABB091BA). At the time of vaccination, the patient was pregnant; date of last menstrual period was not known by the patient. Per the reporter, a pregnancy test administered at the time of vaccination was inconclusive (test registered positive, then disappeared). Another test was sent home by the patient, which was subsequently positive. Obstetric history included three previous pregnancies, including one set of twins, resulting in four full-term infants. The patient was taking medication for blood pressure, however no medical history was reported. At the time of the report, no adverse events had been reported. Follow-up information was received 20 July 2009 from a health care professional. The patient began spotting, then miscarried and had a D & C (Dilation and Curettage) on 14 July 2009: her date of last menstrual period was reported as unknown. According to the reporter, the patient recovered from the event. The patient's past obstetric history included five prior pregnancies (previously reported as three), with full term delivery of three children (previously reported as four) and two spontaneous abortions which occurred prior to 20 weeks gestation. It was not clarified if this history included the current event. ADACEL, MMR and TWINRIX which had been administered on 04 June 2009 had all been first dose injections. From this new information received, this case meets seriousness criteria and was upgraded to serious. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope, Tremor
Clinical narrative: Fainted briefly after - body was shaking - Immunization  in this order: (1) MENACTRA - (2) ADACEL - (3) GARDASIL
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin lesion
Clinical narrative: Pt developed red lesions with itching itching 24 hours after immunization, lesions started an ankles legs then both wrists and lower face.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Mother reports, 7/17/09 Pt. had redness, swelling, tingling of left arm approximately from elbow to slightly below shoulder, area was very hot. Pt. was lethargic and had a head ache. Most symptoms resolved by 7/19/2009 am. Pt still has pink around injection site as of date of report.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Paraesthesia
Clinical narrative: Mother reports, 7/17/09 Pt. had redness, swelling, tingling of left arm approximately from elbow to slightly below shoulder, area was very hot. Pt. was lethargic and had a head ache. Most symptoms resolved by 7/19/2009 am. Pt still has pink around injection site as of date of report.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Screaming
Clinical narrative: Prolonged high pitched screaming and crying (unconsolable) day following immunization
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Received TDAP 4/21/09.  At 7/7/09 visit c/o achy left shoulder to fore arm with increased pain with movement since injection.  Stated when she was a baby she had some kind of vaccine reaction & was given a smaller dose.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Began having painful needle like pricks in nerve endings in various parts of my body. After a couple of days of this, the feeling continued mostly in my feet & calves of both legs. There is a lot of feeling of pins & needles, painful burning sensation as well as some numbness in my feet. It is still continuing.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Chills, Computerised tomogram, Dysgraphia
Clinical narrative: Initially cold, chills, achy, arm pain T 99.4. By 7/16/09 progressive loss of strength both arms T increase 100.4. Saw MD 7/17/09 sent pt to ER for testing CT, X-Rays, MRI, Spinal Tap, Labwork all testing inconclusive yet numbness and weakness persisted. By 7-22-09 hands improved some difficulty writing yet seems to be resolving.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Laboratory test, Lumbar puncture, Nasopharyngitis, Nuclear magnetic resonance imaging
Clinical narrative: Initially cold, chills, achy, arm pain T 99.4. By 7/16/09 progressive loss of strength both arms T increase 100.4. Saw MD 7/17/09 sent pt to ER for testing CT, X-Rays, MRI, Spinal Tap, Labwork all testing inconclusive yet numbness and weakness persisted. By 7-22-09 hands improved some difficulty writing yet seems to be resolving.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Initially cold, chills, achy, arm pain T 99.4. By 7/16/09 progressive loss of strength both arms T increase 100.4. Saw MD 7/17/09 sent pt to ER for testing CT, X-Rays, MRI, Spinal Tap, Labwork all testing inconclusive yet numbness and weakness persisted. By 7-22-09 hands improved some difficulty writing yet seems to be resolving.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Blister, Dry skin, Injection site pain, Injection site swelling, Similar reaction on previous exposure to drug
Clinical narrative: Patient experienced severe adverse reaction to PENTACEL given 7-17-09 left arm.  Had swelling, pain, huge bullae which when pressed caused vesicles to enlarge - skin was leathery, orange peel texture.  Prescribed KEFLEX by ER doctor. Note:  Mother failed to mention adverse reaction to DTAP at previous pediatrician's office in 5 of '06.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Patient experienced severe adverse reaction to PENTACEL given 7-17-09 left arm.  Had swelling, pain, huge bullae which when pressed caused vesicles to enlarge - skin was leathery, orange peel texture.  Prescribed KEFLEX by ER doctor. Note:  Mother failed to mention adverse reaction to DTAP at previous pediatrician's office in 5 of '06.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site macule, Injection site rash, Myalgia, Neck pain
Clinical narrative: Macular rash 4 x 4 cm surrounding injection site. Myalgias B/L posterior neck pain, ache 7/10, non radiating. HA developed 12 hrs post injection, resolved within 72 hrs of injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The vaccine was to prevent further outbreaks of shingles.  I have now had two outbreaks of shingles since the vaccine and Dr. suggested I let your department know of the failure with me of the vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and mild fever X 2 days started 15July2009 1 day after the shot. Pt was advised to see provider, pt called for telephone consults.
Age: 1.8
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Rash 3 cm X 4 cm patch of erythema posterior upper LEFT arm were varicella vacc. was given. Mild warmth - Tenderness to palpation, no sign of infection. (Vacc given on 7/14/09; Poss allergic reaction on 7/15/09).
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with no pertinent medical history who in approximately March 2009, was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). There was no concomitant medication.  Subsequently the patient determined to be pregnant. The patient's menstrual period was not reported. The patient experienced a spontaneous miscarriage on an unspecified date. The patient had sought unspecified medical attention. At the time of report, the patient had recovered on an unspecified date. The physician felt that spontaneous miscarriage was not related to therapy with GARDASIL. Upon internal review, spontaneous miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test, Cardiac monitoring, Myalgia, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her 19 or 20 year old niece with no known drug reactions/allergies and no pertinent medical history who over a year ago was vaccinated with the third dose of GARDASIL. There were no concomitant medications. The consumer reported that since receiving the third dose her niece had experienced ongoing occasional joint pain, muscle pain, tingling in her hands, and fainting spells ever since and was hospitalized. Labs diagnostic studies performed included checked heart and blood work (results not provided). At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a consumer concerning her 19 or 20 year old niece with no known drug reactions/allergies and no pertinent medical history who over a year ago was vaccinated with the third dose of GARDASIL. There were no concomitant medications. The consumer reported that since receiving the third dose her niece had experienced ongoing occasional joint pain, muscle pain, tingling in her hands, and fainting spells ever since and was hospitalized. Labs diagnostic studies performed included checked heart and blood work (results not provided). At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated IM "either with the first or third 0.5 mL dose" of GARDASIL. The nurse reported that when she gave the patient GARDASIL, the patient started to pass out. The nurse gave the patient water and she seemed okay. Later the nurse noticed the patient looked like she was having seizure. It was reported that the patient's mother was trying to blow air into the patient's mouth, but it is unknown if she tried to it during or after the patient looked like she was having a seizure. The patient sought unspecified medical attention. The patient's final outcome was unknown. Upon internal review seizure was considered to be another important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Haemoglobin decreased, Idiopathic thrombocytopenic purpura, Platelet count decreased, White blood cell count normal
Clinical narrative: Diagnosed with Idiopathic thrombocytopenic purpura on 7/24/09; platelet count = 0.  8/17/09 Hospital records received DOS 7/24/09 to 7/29/09. Assessment: Thrombocytopenia.  Parent noted bruises on left mid abdomen and top of head follwed by multiple bruises on trunk and extremities. Whiny and cried. Reddish material in perianal region. Patient presnts with right lower gum hematoma, petechia along soft palate, bright red blood in saliva. Shotty cervical and inguinal lymph nodes. Petechia inguinal area. Multiple bruises on arms and legs, frontal bone and right forehead. Fever. IV Ig administered.  ICD-9 Codes: 28731 Immune thrombocytopenic purpura, 78060 Fever unspecified.
Age: 1.7
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Had a small outbreak of  pox with fever of 103 degrees.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: (R) deltoid - MENACTRA - large swollen red area from shoulder to mid upper arm - felt feverish and hot to touch - painful. (L) deltoid - BOOSTRIX - swollen red area from just above inj. site to just below site - hot to touch and painful - Patient given Ibuprofen
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Injection given 7/20/09 right deltoid; Pt states "later that eve" site with redness edema pn.  Sxs cont'd and increased.  Pt presented to clinic 7-23-08 for assessment.  Cool compresses and Rx for HYDROXYEINE recommended.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Head titubation, Tremor
Clinical narrative: 10 seconds head & hands shaking.
Age: 2.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Heart rate increased
Clinical narrative: Fever to 102 degrees F nausea, vomiting -> (severe) dizziness, rapid heartbeat, rash, aches/pain in legs, knees, ankles, weakness/ extreme fatigue.  Onset about 6-7 hours after inoculation, treated with TYLENOL, MOTRIN, Dr. prescribed ZOFRAN for nausea.  6 PM through the night.  Fever broke by 10 am following day
Age: 2.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Fever to 102 degrees F nausea, vomiting -> (severe) dizziness, rapid heartbeat, rash, aches/pain in legs, knees, ankles, weakness/ extreme fatigue.  Onset about 6-7 hours after inoculation, treated with TYLENOL, MOTRIN, Dr. prescribed ZOFRAN for nausea.  6 PM through the night.  Fever broke by 10 am following day
Age: 2.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Fever to 102 degrees F nausea, vomiting -> (severe) dizziness, rapid heartbeat, rash, aches/pain in legs, knees, ankles, weakness/ extreme fatigue.  Onset about 6-7 hours after inoculation, treated with TYLENOL, MOTRIN, Dr. prescribed ZOFRAN for nausea.  6 PM through the night.  Fever broke by 10 am following day
Age: 52.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: General physical health deterioration, Insomnia, Limb discomfort
Clinical narrative: Leg problems, sleep difficulties, physical ailments.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Faeces discoloured, Feeling abnormal, Haematochezia, Mucous stools
Clinical narrative: ROTATEQ given 12/17/07.  12/19/07 infant had blood flecks in stool on & off for 3 days, in about 1/2 of BM's.  He is breast fed and has about 19 stool 1 day.  Amount of flecks was "a few".  Was not seen by medical provider.  Mom did call & was referred to another CHN in this CHN absence.  Infant "miserable" for 1 wk temp 102 degrees, no V/D but stool dark green from normal yellow.  Stool with mucus.  No abdominal swelling.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Frequent bowel movements, Haematochezia
Clinical narrative: Received immunization 9/11/08- PEDIARIX, HIB, PCV7,ROTATEQ. On 9/18/08 baby had diarrhea and blood in stool x 4. Day before had increased frequency but not diarrhea. Bm 9/18 is running. Baby acting normal, eating normal no fussing, tummy not hard and swollen by report was receiving Tylenol. On 9/25/08 baby was ok and did ok.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Blood culture, Chest X-ray, Full blood count, Pyrexia
Clinical narrative: Fever 105(R) 2 days after immunization.  Required ER visit.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: 12 yr old received VARIVAX and TDAP and MENACTRA on 7/9/09 - developed Zoster lesions 7/11/09
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Erythema, Pain, Pallor, Pleuritic pain
Clinical narrative: Local redness, swelling, blanching, pain, itching, migratory pleuritic type chest pain.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Local redness, swelling, blanching, pain, itching, migratory pleuritic type chest pain.
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Pallor
Clinical narrative: Varivax on 7/20/09 - Developed, 2 days later a 3X3.5 cm area of light pink induration with surrounding blanching.  5x7cm area of mod. erythema - no streaking - no axillary nodes.  Keflex for 5 days.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Received VARIVAX #2 on 7/22/09, developed a 2x2.5 inch, firm, erythematous, warm area at injection site. (Lot# 0694Y)
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Pt stated it started hurting right away and continued to hurt over next 2 days. On the night of the 23rd. Pt began to look red + felt warm. No fever. Pt came into office on 7/24 Dx'd with cellulitis Tx with 500mg Cephalexin BID.
Age: 0.53
Sex: M
Vaccine: IPV
Symptoms: Tremor
Clinical narrative: 5 seconds hands shaking w/ head shaking
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site oedema, Injection site rash, Injection site warmth
Clinical narrative: Rash 5 X 5 to right arm, around injection site.  Warm to touch with slight edema.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Body temperature increased, Depressed level of consciousness
Clinical narrative: Elevated temperature with diminished responsiveness within 24 hours of vaccines.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Erythema, heat, mild edema, pain
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives on cheeks, chest, arms & legs
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion, Hyperventilation, Muscle rigidity, Syncope
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 17 year old female with a history of neuro- surgery in 2001 for malformation and laparoscopic surgery on left ovary for cyst who on 22-JUL-2009 was vaccinated with a first dose of GARDASIL (lot # not reported) 0.5ml, intramuscularly. There was no concomitant medication. On 22-JUL-2009 after vaccination the patient experienced syncope. Afterwards for 1-2 minutes, the patient experienced what appeared to be a seizure. The symptoms include tightening and straightening of the body with heavy breathing. An ammonia capsule was used. Also, it was mentioned that the patient vomited at home. In the afternoon, the patient was oriented and recovered. The mother of the patient mentioned that the patient had had previous experiences with seizures: First time occurred at the age of 10 years (unspecified cause), second occurrence happened at 14 years of age (unspecified cause) and the third time occurred in December 2008 when the patient had her bellybutton pierced. There were no laboratories diagnostics studies performed. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 17 year old female with a history of neuro- surgery in 2001 for malformation and laparoscopic surgery on left ovary for cyst who on 22-JUL-2009 was vaccinated with a first dose of GARDASIL (lot # not reported) 0.5ml, intramuscularly. There was no concomitant medication. On 22-JUL-2009 after vaccination the patient experienced syncope. Afterwards for 1-2 minutes, the patient experienced what appeared to be a seizure. The symptoms include tightening and straightening of the body with heavy breathing. An ammonia capsule was used. Also, it was mentioned that the patient vomited at home. In the afternoon, the patient was oriented and recovered. The mother of the patient mentioned that the patient had had previous experiences with seizures: First time occurred at the age of 10 years (unspecified cause), second occurrence happened at 14 years of age (unspecified cause) and the third time occurred in December 2008 when the patient had her bellybutton pierced. There were no laboratories diagnostics studies performed. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: BCG
Symptoms: Skin lesion
Clinical narrative: Rcvd BCG vaccine in another country 5/23/09.  Reports to Dr. 7/8/09 & finds 1.8 cm X 2.5 cm round bullous lesion right upper arm.  No erythema pus blood, & drainage noted.  Mother indicates pt w/o pain.  Mother covering lesion.  Returning to clinic monthly to recheck.