chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Gram stain, Guillain-Barre syndrome, Headache, Hypoaesthesia, Hypoaesthesia facial
Clinical narrative: The pt reported to boot camp on 3/15/10 and was healthy at the time. He received multiple vaccinations on 3/16/10. The pt reported on medical on 3/29/10 with complaints of 4d hx of numbness and tingling in his great toes, back of his legs, finger tips, lower back and gluteus medias. The pt followed-up in medical on 3/30/10 with additional complaints of weakness in his thighs and balance problems. At this time he also mentioned that he had a 5 day history of a productive cough (white mucous; no other symptoms; many other platoon members with cough also). The pt was seen by a civilian neurologist who documented "mild leg weakness in association with absent deep tendon reflexes." See EMG and MRI results below. The pt was admitted to hospital with the diagnosis of lumbarsacral radiculopathy, carpal tunnel syndrome, GUYON's canal syndrome and tarsal tunnel syndrome. The pt was discharged on 3/31/10. On 4/3/10 the pt complained of facial numbness (left > right), no difficulty swallowing or breathing. An LP was performed in the ER and the pt was admitted to hospital with the diagnosis of GBS. He subsequently developed bilateral facial paresis in a peripheral nerve distribution. He did experience very mild dysphagia for thin liquids and was briefly placed on a thickened liquid diet. He received a 3 day course of IVIG at a dose of .8gm/kg/day. The pt did experience a few episodes of orthostasis with nausea, emesis and headache which were attributed to autonomic instability from the GBS. This has resolved. As of 4/16/10 his dysphagia has resolved and his bifacial paresis, ataxia and strength have improved significantly. Remaining deficits included: mild left peripheral facial weakness with diminished strength of lid closure of the left, absent deep tendon reflexes (except for bilateral biceps brachii).
Age: 25.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Immunoglobulin therapy, Intervertebral disc degeneration, Intervertebral disc protrusion, Laboratory test, Laboratory test normal
Clinical narrative: The pt reported to boot camp on 3/15/10 and was healthy at the time. He received multiple vaccinations on 3/16/10. The pt reported on medical on 3/29/10 with complaints of 4d hx of numbness and tingling in his great toes, back of his legs, finger tips, lower back and gluteus medias. The pt followed-up in medical on 3/30/10 with additional complaints of weakness in his thighs and balance problems. At this time he also mentioned that he had a 5 day history of a productive cough (white mucous; no other symptoms; many other platoon members with cough also). The pt was seen by a civilian neurologist who documented "mild leg weakness in association with absent deep tendon reflexes." See EMG and MRI results below. The pt was admitted to hospital with the diagnosis of lumbarsacral radiculopathy, carpal tunnel syndrome, GUYON's canal syndrome and tarsal tunnel syndrome. The pt was discharged on 3/31/10. On 4/3/10 the pt complained of facial numbness (left > right), no difficulty swallowing or breathing. An LP was performed in the ER and the pt was admitted to hospital with the diagnosis of GBS. He subsequently developed bilateral facial paresis in a peripheral nerve distribution. He did experience very mild dysphagia for thin liquids and was briefly placed on a thickened liquid diet. He received a 3 day course of IVIG at a dose of .8gm/kg/day. The pt did experience a few episodes of orthostasis with nausea, emesis and headache which were attributed to autonomic instability from the GBS. This has resolved. As of 4/16/10 his dysphagia has resolved and his bifacial paresis, ataxia and strength have improved significantly. Remaining deficits included: mild left peripheral facial weakness with diminished strength of lid closure of the left, absent deep tendon reflexes (except for bilateral biceps brachii).
Age: 25.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Lumbar puncture abnormal, Lumbar radiculopathy, Lymphocyte count increased, Mean cell volume increased, Mean platelet volume normal
Clinical narrative: The pt reported to boot camp on 3/15/10 and was healthy at the time. He received multiple vaccinations on 3/16/10. The pt reported on medical on 3/29/10 with complaints of 4d hx of numbness and tingling in his great toes, back of his legs, finger tips, lower back and gluteus medias. The pt followed-up in medical on 3/30/10 with additional complaints of weakness in his thighs and balance problems. At this time he also mentioned that he had a 5 day history of a productive cough (white mucous; no other symptoms; many other platoon members with cough also). The pt was seen by a civilian neurologist who documented "mild leg weakness in association with absent deep tendon reflexes." See EMG and MRI results below. The pt was admitted to hospital with the diagnosis of lumbarsacral radiculopathy, carpal tunnel syndrome, GUYON's canal syndrome and tarsal tunnel syndrome. The pt was discharged on 3/31/10. On 4/3/10 the pt complained of facial numbness (left > right), no difficulty swallowing or breathing. An LP was performed in the ER and the pt was admitted to hospital with the diagnosis of GBS. He subsequently developed bilateral facial paresis in a peripheral nerve distribution. He did experience very mild dysphagia for thin liquids and was briefly placed on a thickened liquid diet. He received a 3 day course of IVIG at a dose of .8gm/kg/day. The pt did experience a few episodes of orthostasis with nausea, emesis and headache which were attributed to autonomic instability from the GBS. This has resolved. As of 4/16/10 his dysphagia has resolved and his bifacial paresis, ataxia and strength have improved significantly. Remaining deficits included: mild left peripheral facial weakness with diminished strength of lid closure of the left, absent deep tendon reflexes (except for bilateral biceps brachii).
Age: 25.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Muscular weakness, Nausea, Nerve compression, Nerve conduction studies abnormal, Neutrophil count increased
Clinical narrative: The pt reported to boot camp on 3/15/10 and was healthy at the time. He received multiple vaccinations on 3/16/10. The pt reported on medical on 3/29/10 with complaints of 4d hx of numbness and tingling in his great toes, back of his legs, finger tips, lower back and gluteus medias. The pt followed-up in medical on 3/30/10 with additional complaints of weakness in his thighs and balance problems. At this time he also mentioned that he had a 5 day history of a productive cough (white mucous; no other symptoms; many other platoon members with cough also). The pt was seen by a civilian neurologist who documented "mild leg weakness in association with absent deep tendon reflexes." See EMG and MRI results below. The pt was admitted to hospital with the diagnosis of lumbarsacral radiculopathy, carpal tunnel syndrome, GUYON's canal syndrome and tarsal tunnel syndrome. The pt was discharged on 3/31/10. On 4/3/10 the pt complained of facial numbness (left > right), no difficulty swallowing or breathing. An LP was performed in the ER and the pt was admitted to hospital with the diagnosis of GBS. He subsequently developed bilateral facial paresis in a peripheral nerve distribution. He did experience very mild dysphagia for thin liquids and was briefly placed on a thickened liquid diet. He received a 3 day course of IVIG at a dose of .8gm/kg/day. The pt did experience a few episodes of orthostasis with nausea, emesis and headache which were attributed to autonomic instability from the GBS. This has resolved. As of 4/16/10 his dysphagia has resolved and his bifacial paresis, ataxia and strength have improved significantly. Remaining deficits included: mild left peripheral facial weakness with diminished strength of lid closure of the left, absent deep tendon reflexes (except for bilateral biceps brachii).
Age: 25.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Orthostatic hypotension, Paraesthesia, Polymerase chain reaction, Productive cough
Clinical narrative: The pt reported to boot camp on 3/15/10 and was healthy at the time. He received multiple vaccinations on 3/16/10. The pt reported on medical on 3/29/10 with complaints of 4d hx of numbness and tingling in his great toes, back of his legs, finger tips, lower back and gluteus medias. The pt followed-up in medical on 3/30/10 with additional complaints of weakness in his thighs and balance problems. At this time he also mentioned that he had a 5 day history of a productive cough (white mucous; no other symptoms; many other platoon members with cough also). The pt was seen by a civilian neurologist who documented "mild leg weakness in association with absent deep tendon reflexes." See EMG and MRI results below. The pt was admitted to hospital with the diagnosis of lumbarsacral radiculopathy, carpal tunnel syndrome, GUYON's canal syndrome and tarsal tunnel syndrome. The pt was discharged on 3/31/10. On 4/3/10 the pt complained of facial numbness (left > right), no difficulty swallowing or breathing. An LP was performed in the ER and the pt was admitted to hospital with the diagnosis of GBS. He subsequently developed bilateral facial paresis in a peripheral nerve distribution. He did experience very mild dysphagia for thin liquids and was briefly placed on a thickened liquid diet. He received a 3 day course of IVIG at a dose of .8gm/kg/day. The pt did experience a few episodes of orthostasis with nausea, emesis and headache which were attributed to autonomic instability from the GBS. This has resolved. As of 4/16/10 his dysphagia has resolved and his bifacial paresis, ataxia and strength have improved significantly. Remaining deficits included: mild left peripheral facial weakness with diminished strength of lid closure of the left, absent deep tendon reflexes (except for bilateral biceps brachii).
Age: 25.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Protein total increased, Radiculopathy, Red blood cell sedimentation rate normal, Tarsal tunnel syndrome, Ulnar nerve injury
Clinical narrative: The pt reported to boot camp on 3/15/10 and was healthy at the time. He received multiple vaccinations on 3/16/10. The pt reported on medical on 3/29/10 with complaints of 4d hx of numbness and tingling in his great toes, back of his legs, finger tips, lower back and gluteus medias. The pt followed-up in medical on 3/30/10 with additional complaints of weakness in his thighs and balance problems. At this time he also mentioned that he had a 5 day history of a productive cough (white mucous; no other symptoms; many other platoon members with cough also). The pt was seen by a civilian neurologist who documented "mild leg weakness in association with absent deep tendon reflexes." See EMG and MRI results below. The pt was admitted to hospital with the diagnosis of lumbarsacral radiculopathy, carpal tunnel syndrome, GUYON's canal syndrome and tarsal tunnel syndrome. The pt was discharged on 3/31/10. On 4/3/10 the pt complained of facial numbness (left > right), no difficulty swallowing or breathing. An LP was performed in the ER and the pt was admitted to hospital with the diagnosis of GBS. He subsequently developed bilateral facial paresis in a peripheral nerve distribution. He did experience very mild dysphagia for thin liquids and was briefly placed on a thickened liquid diet. He received a 3 day course of IVIG at a dose of .8gm/kg/day. The pt did experience a few episodes of orthostasis with nausea, emesis and headache which were attributed to autonomic instability from the GBS. This has resolved. As of 4/16/10 his dysphagia has resolved and his bifacial paresis, ataxia and strength have improved significantly. Remaining deficits included: mild left peripheral facial weakness with diminished strength of lid closure of the left, absent deep tendon reflexes (except for bilateral biceps brachii).
Age: 25.0
Sex: M
Vaccine: FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Vitamin B12 increased, Vomiting, White blood cell count increased
Clinical narrative: The pt reported to boot camp on 3/15/10 and was healthy at the time. He received multiple vaccinations on 3/16/10. The pt reported on medical on 3/29/10 with complaints of 4d hx of numbness and tingling in his great toes, back of his legs, finger tips, lower back and gluteus medias. The pt followed-up in medical on 3/30/10 with additional complaints of weakness in his thighs and balance problems. At this time he also mentioned that he had a 5 day history of a productive cough (white mucous; no other symptoms; many other platoon members with cough also). The pt was seen by a civilian neurologist who documented "mild leg weakness in association with absent deep tendon reflexes." See EMG and MRI results below. The pt was admitted to hospital with the diagnosis of lumbarsacral radiculopathy, carpal tunnel syndrome, GUYON's canal syndrome and tarsal tunnel syndrome. The pt was discharged on 3/31/10. On 4/3/10 the pt complained of facial numbness (left > right), no difficulty swallowing or breathing. An LP was performed in the ER and the pt was admitted to hospital with the diagnosis of GBS. He subsequently developed bilateral facial paresis in a peripheral nerve distribution. He did experience very mild dysphagia for thin liquids and was briefly placed on a thickened liquid diet. He received a 3 day course of IVIG at a dose of .8gm/kg/day. The pt did experience a few episodes of orthostasis with nausea, emesis and headache which were attributed to autonomic instability from the GBS. This has resolved. As of 4/16/10 his dysphagia has resolved and his bifacial paresis, ataxia and strength have improved significantly. Remaining deficits included: mild left peripheral facial weakness with diminished strength of lid closure of the left, absent deep tendon reflexes (except for bilateral biceps brachii).
Age: 20.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Headache, Inappropriate schedule of drug administration, Injection site erythema, Injection site induration
Clinical narrative: Less than 24 hours after injection of the vaccines pt develops erythema, warmth, pain, induration (2a 2a) in the injection site with generalized body aches, headaches and dizziness and nausea, erythema and induration and localized pain persist but no fever.
Age: 20.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site warmth, Nausea, Pain
Clinical narrative: Less than 24 hours after injection of the vaccines pt develops erythema, warmth, pain, induration (2a 2a) in the injection site with generalized body aches, headaches and dizziness and nausea, erythema and induration and localized pain persist but no fever.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: On April 12, 2010 patient c/o itchiness at site of injection. On April 13 site was red, 2 inches in diameter, raised & itched. Later in afternoon states redness was from shoulder to elbow was seen at primary's office treated for cellulitis. Treated by Dr. with prednisone and KEFLEX.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal blistering, Oropharyngeal pain
Clinical narrative: Information has been received from a 75 year old female consumer with bone disorder, high blood pressure since 35 years old and a history of back surgery who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included alendronate sodium (manufacturer unknown), "pain pills" for her back surgery and 3 different types of medication for blood pressure. The consumer stated that on 05-APR-2010 started like a sore throat and broke out with blisters in her mouth. The consumer went to "urgent care" and was given antibiotics (amoxicillin 870 mg) and acyclovir 800 mg for her blisters. Then she went to her ENT (ear, nose and throat) doctor and was given AUGMENTIN-XR 1000/62.5 and rothwells solution mouthwash. The consumer was told by her physician that "if the blisters in her mouth got worse it would obstruct her breathing and would require immediate admission to a hospital". At the time of the report, the consumer had not recovered. The reporting consumer considered blisters in her mouth to be immediately life-threatening. Additional information has been requested.
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Drug exposure during pregnancy, Influenza
Clinical narrative: Initial report received on 06 April 2010 from an article. "Pregnant women are at increased risk for severe illness and complications from infection with seasonal influenza and 2009 pandemic influenza A (H1N1). To characterize the severity of 2009 H1N1 infection in pregnant women, the department of health conducted active and passive surveillance for cases of 2009 H1N1 infection in pregnant women requiring intensive care. This report summarizes the results of that surveillance, which found that, during 2009, 16 pregnant women and one who was postpartum were admitted to intensive-care units (ICUs). Two women died. Of the 17 women, 12 had no recognized risk factors for severe influenza complications other than pregnancy. All 17 women received antiviral treatment with oseltamivir; however, treatment was initiated <or=2 days after symptom onset in only one woman and was begun >or=5 days after symptom onset in four women. Because initiation of antiviral treatment <or=2 days after onset is associated with better outcomes, pregnant women should be encouraged to seek medical care immediately if they develop influenza-like symptoms, and health-care providers should initiate empiric antiviral therapy for these women as soon as possible, even if >2 days after symptom onset. Health departments and healthcare-providers should educate pregnant and postpartum women regarding the risks posed by influenza and highlight the effectiveness and safety of influenza vaccination. Obstetricians and other health-care providers should offer influenza vaccination to their pregnant patients." Only one of the 17 patients had received 2009 H1N1 vaccine and seasonal influenza vaccine. This case is further described below. One pregnant adult woman (age unspecified) received an injection (site and route not reported) of INFLUENZA VACCINE (manufacturer and lot not number reported) greater than 8 weeks before hospitalization on an unspecified date and an injection (site and route not reported) of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number not reported) greater than 4 weeks before hospitalization on an unspecified date. The dates of the hospitalization were not reported; however, the patient had 2009 pandemic influenza A (H1N1). The patient's pregnancy information including gestational age was not reported. The outcome of the hospitalization was not reported. Documents held by sender: None.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Chest discomfort, Electrocardiogram normal
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Chest discomfort, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Hyperhidrosis, Laboratory test normal, Lymphadenopathy, Nausea, Troponin I
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Vaccination complication
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease, Troponin I
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Cardiac enzymes normal, Chest discomfort, Cough, Dyspnoea, Echocardiogram normal
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Electrocardiogram normal, Lymph node pain, Lymphadenopathy, Myopericarditis, Night sweats
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Orthopnoea
Clinical narrative: Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Chest discomfort, Crying, Dyspnoea, Erythema
Clinical narrative: Redface,tight chest, red trunk, hard to breath, crying began about 20 minutes after leaaving office. Benadryl given by school nurse then child returned to doctors. Given epinephrine and albuterol
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Haemorrhage, Loss of consciousness, Pregnancy test positive
Clinical narrative: Information has been received from a 24 year old female consumer with no known drug reactions or allergies and nausea who on 13-OCT-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included MACROBID and OTC nausea medicine. The consumer reported that on 20-OCT-2010, in the clinic were she works, she took a pregnancy test and she found that she was pregnant. It was reported that the consumer LMP was "3 weeks to a month" before, on approximately 13-SEP-2009 and the estimated date of delivery (EDD) is 20-JUN-2010. The consumer reported that on an unspecified date she had an ultrasound performed and it was found that the baby will need to have "open heart surgery when she is born" because the baby's "Tetralogy Fallot" condition. The consumer also reported that on unspecified dates, she had been in and out of the hospital (hospital unknown) due to her bleeding and that she had been passing out. It was noted that the patient had been seeing a number of specialist that performed several tests (results not provided) in regards to the baby's condition. At the time of the report, the patient's outcome was unknown. Fallot tetralogy was considered a congenital anomaly. The baby's experience has been captured in WAES 1004USA01925B1. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from a 24 year old female consumer with no known drug reactions or allergies and nausea who on 13-OCT-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included MACROBID and OTC nausea medicine. The consumer reported that on 20-OCT-2010, in the clinic were she works, she took a pregnancy test and she found that she was pregnant. It was reported that the consumer LMP was "3 weeks to a month" before, on approximately 13-SEP-2009 and the estimated date of delivery (EDD) is 20-JUN-2010. The consumer reported that on an unspecified date she had an ultrasound performed and it was found that the baby will need to have "open heart surgery when she is born" because the baby's "Tetralogy Fallot" condition. The consumer also reported that on unspecified dates, she had been in and out of the hospital (hospital unknown) due to her bleeding and that she had been passing out. It was noted that the patient had been seeing a number of specialist that performed several tests (results not provided) in regards to the baby's condition. At the time of the report, the patient's outcome was unknown. Fallot tetralogy was considered a congenital anomaly. The baby's experience has been captured in WAES 1004USA01925B1. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Congenital anomaly, Drug exposure during pregnancy, Fallot's tetralogy, Ultrasound scan abnormal
Clinical narrative: Information has been received from a consumer concerning her baby who on 13-OCT-2009 was exposed via her mother with the first dose of GARDASIL. Concomitant therapy included MACROBID and OTC nausea medicine. The consumer reported that on an unspecified date she had an ultrasound performed and it was found that her baby will need to have "open heart surgery when she is born" because the baby's "Tetralogy Fallot" condition. It was noted that the consumer had been seeing a number of specialist that performed several tests (results not provided) in regards to the baby's condition. At the time of the report, the baby's outcome was unknown. Tetralogy Fallot was considered a congenital anomaly. The mother's experience has been captured in WAES 1004USA01925. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin decreased, Drug exposure during pregnancy, Progesterone abnormal
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 27 year old female patient with no pertinent medical history and no drug reactions/allergies who in 2007, at the age of 25 year was vaccinated with a series of GARDASIL without incident. There was no concomitant medication. On approximately 09-JUL-2009, the patient became pregnant. Her LMP was approximately on 25-JUN-2009. Expected due date was April 2010. In August or September 2009, the patient miscarried at two months pregnant. Upon internal review, miscarriage was determined to be an other important medical event. The patient subsequently became pregnant again and experienced blood beta-human chorionic gonadotropin level decreased and progesterone level abnormal (WAES#1004USA02387). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood human chorionic gonadotropin decreased, Drug exposure during pregnancy, Progesterone abnormal
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 27 year old female patient with no pertinent medical history and no drug reactions/allergies who in 2007, at the age of 25 year was vaccinated with a series of GARDASIL without incident. There was no concomitant medication. On approximately 09-JUL-2009, the patient became pregnant. Her LMP was approximately on 25-JUN-2009. Expected due date was April 2010. In August or September 2009, the patient miscarried at two months pregnant. Upon internal review, miscarriage was determined to be an other important medical event. The patient subsequently became pregnant again and experienced blood beta-human chorionic gonadotropin level decreased and progesterone level abnormal (WAES#1004USA02387). Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Educational problem
Clinical narrative: Information has been received from a special education teacher, concerning a male student between 6 to 7 years old, who on an unspecified date received a dose of MMR II (Lot number not available) and on an unspecified date was hospitalized (hospital demographics not available) after he received MMR II. The teacher reported that the student was now in special education school (no further details available). At the time of reporting, the patient was not recovered. This is one of several reports from the same source. This is an amended report. Labeling was changed from Yes to No for the AE term of Adverse Event. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Educational problem
Clinical narrative: Information has been received from a special education teacher, concerning a male student between 6 to 7 years old, who on an unspecified date received a dose of MMR II (lot number not available) and on an unspecified date was hospitalized (hospital demographics not available) after he received MMR II. The teacher reported that the student was now in special education school (no further details available). At the time of reporting, the patient was not recovered. This is one of several reports from the same source. This is an amended report. Labeling was changed from yes to no for the AE term of Adverse Event. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Educational problem
Clinical narrative: Information has been received from a special education teacher, concerning a male student between 6 to 7 years old, who on an unspecified date received a dose of MMR II (Lot number not available) and on an unspecified date was hospitalized (Hospital demographics not available) after he received MMR II. The teacher reported that the student was now in special education school (no further details available). At the time of reporting, the patient was not recovered. This is one of several reports from the same source. This is an amended report. Labeling was changed from Yes to No for the AE term of Adverse Event. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Child noted to have numerous bruises all over his body that were not explainable by any injury. He was seen by the pediatrician two that following monday and his platelets were noted to be at 45. He was referred to a hematologist and diagnosed with ITP and his platelets droppped to 5.  He was admitted to the hospital and needed and infusion of IGG on 12/11/09.  He was released on 12/12/09.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Hyperventilation, Muscle contracture, Nausea
Clinical narrative: Patient became pale, nauseated and dizzy. Patient hyperventilating. Unable to control breathing. Bilateral hand and shoulder contractures noted. Patient placed in Trendelenburg. Color returned to normal and dizziness and nausea resolved. Contractures on left hand and shoulder resolved. Patient given juice and encouraged to breathe normally. Right hand remained contracted. Patient states she is "double jointed" and sometimes wakes in the morning with hand contractures. Patient ambulatory.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Patient became pale, nauseated and dizzy. Patient hyperventilating. Unable to control breathing. Bilateral hand and shoulder contractures noted. Patient placed in Trendelenburg. Color returned to normal and dizziness and nausea resolved. Contractures on left hand and shoulder resolved. Patient given juice and encouraged to breathe normally. Right hand remained contracted. Patient states she is "double jointed" and sometimes wakes in the morning with hand contractures. Patient ambulatory.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 4/14 PM, Pt c/o of arm hurting after school, 2 inch area of redness, swelling and heat at injection site.  No fever.  Advised to apply ice and use Tylenol or ibuprofen for discomfort. 4/15 6 am Pt vomiting and complaining of stomach ache.  Temp 100.7, area of redness at injection site is now 2.5 inches, arm warm and painful to the touch.  Advised appointment. 4/15, approximately 9am, appt. with Dr., arm painful, 4.5-5cm area of erythema and swelling at injection site.  Keflex 250mg bid x5 days for cellulitis.  Instructed to contact if continued fever or increase in pain. 4/15, PM  Redness has spread, fever 102.8 1 hour after 400mg ibuprofen administered.  Arm hot and painful, referred to ER. 4/16 appt with Dr. in allergy.  Rx alternating Tylenol and ibuprofen and icing the area as much as possible.  Prednisone 20mg x 3 days prescribed. Rx go to ER if symptoms/fever worsen over weekend, f/u appt. made for 4/20 with Dr.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm, Vomiting
Clinical narrative: 4/14 PM, Pt c/o of arm hurting after school, 2 inch area of redness, swelling and heat at injection site.  No fever.  Advised to apply ice and use Tylenol or ibuprofen for discomfort. 4/15 6 am Pt vomiting and complaining of stomach ache.  Temp 100.7, area of redness at injection site is now 2.5 inches, arm warm and painful to the touch.  Advised appointment. 4/15, approximately 9am, appt. with Dr., arm painful, 4.5-5cm area of erythema and swelling at injection site.  Keflex 250mg bid x5 days for cellulitis.  Instructed to contact if continued fever or increase in pain. 4/15, PM  Redness has spread, fever 102.8 1 hour after 400mg ibuprofen administered.  Arm hot and painful, referred to ER. 4/16 appt with Dr. in allergy.  Rx alternating Tylenol and ibuprofen and icing the area as much as possible.  Prednisone 20mg x 3 days prescribed. Rx go to ER if symptoms/fever worsen over weekend, f/u appt. made for 4/20 with Dr.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Malaise
Clinical narrative: Headache and malaise
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Dyspnoea, Pharyngeal oedema
Clinical narrative: Pt c/o swelling in throat and difficulty breathing approximately 5min after vaccine was recieved. Pts voice was noticably hoarse after recieving vaccine. Epi and Benadryl administered, vital signs were documented.
Age: 43.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Bone pain
Clinical narrative: Hearing noise wind blow in my ears and pain in my bone joints.  i dont know if i have to go see a doctor or is normal.
Age: 0.76
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash macular, Skin warm
Clinical narrative: Infant awoke after a nap and was red all over his body, with large white splotches. He was hot to the touch and at the injection sight it was very red and swollen. Baby was given Benadryl and taken back to the doctors office. He is fine now and we were told to continue to give Benadryl for 24 hours.
Age: 1.03
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever up to 101.9 rectally. Still having fevers on and off that come down with Tylenol and Motrin.
Age: 39.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Encephalitis, Headache, Laboratory test normal
Clinical narrative: Vaccine given 1/15/10, headache and encephalitis symptoms developed 1 wk later, hospitalized 2/5/10 for encephalitis.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Asthenia, Blood potassium decreased, Breast pain, Chills
Clinical narrative: No treatment given. No tests taken. Immediate effect upon returning home: soreness in arm and breast on side of shots, chills, fever, nausea, weakness, lack of appetite, weakness, continued to present time. Pt saw doctor (Nov. 10 2009) with weakness. (Nov 14), (Nov 20), (Nov 24) emergency room visits. Admitted to hospital (Nov. 24). Admitted to nursing home (Nov 30, 09). Pt needs assistance in all areas, (totally) incapacitated. Only walks with assistance.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Nausea, Pain in extremity, Pyrexia, Walking aid user
Clinical narrative: No treatment given. No tests taken. Immediate effect upon returning home: soreness in arm and breast on side of shots, chills, fever, nausea, weakness, lack of appetite, weakness, continued to present time. Pt saw doctor (Nov. 10 2009) with weakness. (Nov 14), (Nov 20), (Nov 24) emergency room visits. Admitted to hospital (Nov. 24). Admitted to nursing home (Nov 30, 09). Pt needs assistance in all areas, (totally) incapacitated. Only walks with assistance.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Walking disability
Clinical narrative: No treatment given. No tests taken. Immediate effect upon returning home: soreness in arm and breast on side of shots, chills, fever, nausea, weakness, lack of appetite, weakness, continued to present time. Pt saw doctor (Nov. 10 2009) with weakness. (Nov 14), (Nov 20), (Nov 24) emergency room visits. Admitted to hospital (Nov. 24). Admitted to nursing home (Nov 30, 09). Pt needs assistance in all areas, (totally) incapacitated. Only walks with assistance.
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Vertigo, Vomiting
Clinical narrative: Pt had "vertigo feeling" after receiving HPV vaccine - immediately. Then vomited stomach contents.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Red welts noted to (L) upper arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Local swelling/erythema/induration lasting x 2 days. No fever/rash at time of examination.  Decreased induration, still mild erythema - resolving.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: TDAP received on 3/30/10.  Nausea and vomiting later that day.  Next day had severe dizziness, weakness, fatigue and unmeasured fever.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: TDAP received on 3/30/10.  Nausea and vomiting later that day.  Next day had severe dizziness, weakness, fatigue and unmeasured fever.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Asthenia, Axillary pain, Dysphonia, Nausea
Clinical narrative: Received Tdap vaccine on 4-15-10. Left armpit sore on 4-16-10. No redness or swelling at injection site. Hoarseness started on 041810. Weakness, no energy, upset stomach (nausea, no vomiting). Low grade fever on 041810. No Md present.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Received Tdap vaccine on 4-15-10. Left armpit sore on 4-16-10. No redness or swelling at injection site. Hoarseness started on 041810. Weakness, no energy, upset stomach (nausea, no vomiting). Low grade fever on 041810. No Md present.
Age: 24.0
Sex: F
Vaccine: FLU3, HEP, MMR, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Client received a seasonal flu vaccine today but had already received one for the year on 12/7/09. No adverse reaction noted.
Age: 72.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: TD placed 4/12/10. Sore at site x 2 days. Then increased with redness, warmth, itching and swelling of left upper extremity. Placed on antibiotic with relief of sxs.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Shot site red, puffy, and very sore.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Chicken pox associated with vaccine.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Rash, Rash papular
Clinical narrative: Just over 24 hr after vaccine pt developed facial rash which spread over 24 hours.  Improved after 24 hr more then worsened.  4 days after vaccine - when I saw her faint perioral rash; trunk & extremities with discrete red papules.  (nonpruritic).
Age: 1.32
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccine PREVNAR 13 on 04-19-10.  Within 24 hours patient developed mild swelling and erythema over left thigh below injection site.  Mild tenderness.
Age: 1.32
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received vaccine PREVNAR 13 on 04-19-10.  Within 24 hours patient developed mild swelling and erythema over left thigh below injection site.  Mild tenderness.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat @ injection site extending to back.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Muscle spasms in neck, pain in quadriceps, pain in back, left arm felt heavy, headaches, hypertension, joint pain; numbness in fingers & ankles.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Muscle spasms, Sensation of heaviness
Clinical narrative: Muscle spasms in neck, pain in quadriceps, pain in back, left arm felt heavy, headaches, hypertension, joint pain; numbness in fingers & ankles.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Discomfort, Pain, Pain in extremity
Clinical narrative: Approx 36 hours after received 1st HPV and TDAP (had had 5 prior DTAP) pt had severe pain from waist down to feet. Pt then felt a somewhat tired and weak overall and laid in bed much of day but could walk normally. Then 48-72 hours after vaccines received, pt developed upper stomach ache and nausea. She was still somewhat tired but leg pain and weak feeling in legs resolved.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Nausea, Pain
Clinical narrative: Approx 36 hours after received 1st HPV and TDAP (had had 5 prior DTAP) pt had severe pain from waist down to feet. Pt then felt a somewhat tired and weak overall and laid in bed much of day but could walk normally. Then 48-72 hours after vaccines received, pt developed upper stomach ache and nausea. She was still somewhat tired but leg pain and weak feeling in legs resolved.