chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: Initial report received on 28 September 2010 via a QScan search on the VAERS datebase, under reference number 391105. A 20-year-old male patient received the following vaccinations on 03 May 2010: ACAM2000 (lot number "VV04003A"), TYPHIM VI (lot number D0191), and anthrax (Manufacturer not reported, lot number FAV217) and 18 days post-vaccination, the patient had a possible vaccine related etiology of pruritic, papulo-vesicular rash on the upper arms and back of neck-predominantly on sun exposed areas. The patient also had several isolated lesions on the abdomen and legs bilaterally. There were no rashes on the trunk or back. The patient's tan line from his t-shirt marked the rash distribution on the upper body. Per the report, the rash began as a small patch located on the lateral aspect of the right upper arm that was extremely pruritic. The patient scratched the area excessively and about a day later the patient noticed that the rash had spread and required emergency visit. Other than the pruritic rash the patient was asymptomatic. At the time of vaccinations the patient had not experienced any recent colds or illnesses. He also had no known drug allergies. It was noted the patient was on detail pulling weeds and trimming grass the week prior to the adverse events. Laboratory tests included: Abnormal biopsy of skin, decreased eosinophil count, decreased lymphocyte percentage, and increased monocyte count. Normal laboratory tests included: negative cytomegalovirus test, herpes simplex serology, varicella virus test and viral test. The following were also normal: differential white blood cell count, haematocrit, haemoglobin, mean cell volume, mean cell haemoglobin, mean platelet volume, neutrophil count, and red blood cell count. Adenovirus test and mean cell haemoglobin concentration test results were not reported. Treatments received for the adverse events included ALLEGRA and ATARAX. The patient had no prior medical history with no known drug allergies, no recent colds, no concurrent illnesses. The patient recovered (date not reported). Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Cold sweat, Pruritus, Skin warm, Vomiting
Clinical narrative: This case was received on 28 September 2010 via a QScan search on the VAERS database, under reference number 391786. A 29-year-old female patient received the following vaccinations on 05 June 2010: a percutaneous left arm ACAM2000 (lot number VV04003A), TYPHIM Vi (lot number P04121-invalid lot number), BIOTHRAX (lot number FAV235). The patient had no illness at the time of vaccinations and no medical history. On 08 June 2010, the patient developed vomiting one time approximately 48-72 hours after vaccination. The patient presented to the clinic on 30 June 2010 complaining of itching, hot and clammy skin and vomiting for 2 days. She took BENADRYL for 3 days starting on 27 June 2010. The patient was examined and was able to proceed with vaccinations as normal. The outcome was reported as recovered. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chills, Dysgeusia, Erythema, Headache, Injection site erythema
Clinical narrative: This case was received on 30 September 2010 via a QScan search on the VAERS database, under reference number 393252. A 30-year-old male patient received the following vaccinations on 01 July 2010: a percutaneous ACAM2000 (lot number VV04003A), TYPHIM VI (lot number B10262), anthrax (Manufacturer unknown, lot number FAV230). The patient's denied any recent or past illness, exposures to illness (has 3 young children at home) or problems pre-vaccination. On 13 July 2010, the patient developed, at the site of the smallpox vaccination, red, tender with pustular formation (Robust take) reporting a small red lesion to the posterior edge of the smallpox vaccination tegaderm dressing about day 5-6 that had similar characteristics to existing smallpox vaccination site. This "blister" broke when the dressing was removed (tape pulled "blister" off). He had kept the site covered and protected similar to the smallpox vaccination site. On day 11 (12 July 2010) while enroute for transport, the patient felt feverish, had chills, a sore throat, frontal headache, and tingling to both hands (no radiation) and to the edges of his tongue. He complained of a bad taste in the mouth. He also noted an onset of singular red macules then papules scattered about upper chest and neck region. This rash was not to face, lower torso, extremities, or palms/soles. He denied any chest pain, nausea, vomiting, diarrhea or shortness of breath. On 13 July 2010 he was afebrile (97.0-98.0 Fahrenheit) with no current complaints of headache, fever, chills or hand paresthesia/tingling. The symptoms resolved in less than 24 hours from onset. However, he still had diffuse scattered single macules/papules to the upper chest, back, neck, and abdominal regions and a sore throat. The diagnosis was non-viral pustulosis and pharyngitis. The outcome was unknown. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site reaction, Injection site vesicles, Macule, Oropharyngeal pain, Papule
Clinical narrative: This case was received on 30 September 2010 via a QScan search on the VAERS database, under reference number 393252. A 30-year-old male patient received the following vaccinations on 01 July 2010: a percutaneous ACAM2000 (lot number VV04003A), TYPHIM VI (lot number B10262), anthrax (Manufacturer unknown, lot number FAV230). The patient's denied any recent or past illness, exposures to illness (has 3 young children at home) or problems pre-vaccination. On 13 July 2010, the patient developed, at the site of the smallpox vaccination, red, tender with pustular formation (Robust take) reporting a small red lesion to the posterior edge of the smallpox vaccination tegaderm dressing about day 5-6 that had similar characteristics to existing smallpox vaccination site. This "blister" broke when the dressing was removed (tape pulled "blister" off). He had kept the site covered and protected similar to the smallpox vaccination site. On day 11 (12 July 2010) while enroute for transport, the patient felt feverish, had chills, a sore throat, frontal headache, and tingling to both hands (no radiation) and to the edges of his tongue. He complained of a bad taste in the mouth. He also noted an onset of singular red macules then papules scattered about upper chest and neck region. This rash was not to face, lower torso, extremities, or palms/soles. He denied any chest pain, nausea, vomiting, diarrhea or shortness of breath. On 13 July 2010 he was afebrile (97.0-98.0 Fahrenheit) with no current complaints of headache, fever, chills or hand paresthesia/tingling. The symptoms resolved in less than 24 hours from onset. However, he still had diffuse scattered single macules/papules to the upper chest, back, neck, and abdominal regions and a sore throat. The diagnosis was non-viral pustulosis and pharyngitis. The outcome was unknown. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngitis, Pyrexia, Skin disorder
Clinical narrative: This case was received on 30 September 2010 via a QScan search on the VAERS database, under reference number 393252. A 30-year-old male patient received the following vaccinations on 01 July 2010: a percutaneous ACAM2000 (lot number VV04003A), TYPHIM VI (lot number B10262), anthrax (Manufacturer unknown, lot number FAV230). The patient's denied any recent or past illness, exposures to illness (has 3 young children at home) or problems pre-vaccination. On 13 July 2010, the patient developed, at the site of the smallpox vaccination, red, tender with pustular formation (Robust take) reporting a small red lesion to the posterior edge of the smallpox vaccination tegaderm dressing about day 5-6 that had similar characteristics to existing smallpox vaccination site. This "blister" broke when the dressing was removed (tape pulled "blister" off). He had kept the site covered and protected similar to the smallpox vaccination site. On day 11 (12 July 2010) while enroute for transport, the patient felt feverish, had chills, a sore throat, frontal headache, and tingling to both hands (no radiation) and to the edges of his tongue. He complained of a bad taste in the mouth. He also noted an onset of singular red macules then papules scattered about upper chest and neck region. This rash was not to face, lower torso, extremities, or palms/soles. He denied any chest pain, nausea, vomiting, diarrhea or shortness of breath. On 13 July 2010 he was afebrile (97.0-98.0 Fahrenheit) with no current complaints of headache, fever, chills or hand paresthesia/tingling. The symptoms resolved in less than 24 hours from onset. However, he still had diffuse scattered single macules/papules to the upper chest, back, neck, and abdominal regions and a sore throat. The diagnosis was non-viral pustulosis and pharyngitis. The outcome was unknown. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Skin lesion, Vaccination site pain, Vaccination site pustule
Clinical narrative: This case was received on 30 September 2010 via a QScan search on the VAERS database, under reference number 393252. A 30-year-old male patient received the following vaccinations on 01 July 2010: a percutaneous ACAM2000 (lot number VV04003A), TYPHIM VI (lot number B10262), anthrax (Manufacturer unknown, lot number FAV230). The patient's denied any recent or past illness, exposures to illness (has 3 young children at home) or problems pre-vaccination. On 13 July 2010, the patient developed, at the site of the smallpox vaccination, red, tender with pustular formation (Robust take) reporting a small red lesion to the posterior edge of the smallpox vaccination tegaderm dressing about day 5-6 that had similar characteristics to existing smallpox vaccination site. This "blister" broke when the dressing was removed (tape pulled "blister" off). He had kept the site covered and protected similar to the smallpox vaccination site. On day 11 (12 July 2010) while enroute for transport, the patient felt feverish, had chills, a sore throat, frontal headache, and tingling to both hands (no radiation) and to the edges of his tongue. He complained of a bad taste in the mouth. He also noted an onset of singular red macules then papules scattered about upper chest and neck region. This rash was not to face, lower torso, extremities, or palms/soles. He denied any chest pain, nausea, vomiting, diarrhea or shortness of breath. On 13 July 2010 he was afebrile (97.0-98.0 Fahrenheit) with no current complaints of headache, fever, chills or hand paresthesia/tingling. The symptoms resolved in less than 24 hours from onset. However, he still had diffuse scattered single macules/papules to the upper chest, back, neck, and abdominal regions and a sore throat. The diagnosis was non-viral pustulosis and pharyngitis. The outcome was unknown. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Erythema nodosum, Influenza like illness, Rash, Rash papular
Clinical narrative: This case was received on 30 September 2010 via a QScan search on the VAERS database, under reference number 393645. A 25-year-old male patient received the following vaccinations on 13 July 2010: a percutaneous ACAM2000 (lot number VV04003A), an intramuscular TYPHIM VI (lot number B10262), anthrax (Michigan DPH, lot number FAV242). The patient had no medical history and no current illness at the time of vaccination. The patient, 8 days after vaccination developed flu-like symptoms. On day 9, he developed a papular rash on the face and arms which required an emergency visit. He was diagnosed as erythema nodosum. The patient had a consultation with a dermatologist. The outcome was reported as not reported. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Dizziness, Dyspnoea, Feeling hot, Myocarditis
Clinical narrative: This case was received on 12 October 2010 via a QSCAN search on the VAERS database, under reference number 394964. A 21-year-old male patient received the following vaccinations on 05 May 2010: a percutaneous ACAM2000 (lot number VV04003A), TYPHIM VI (lot number D0191), anthrax (Emergent, lot number FAV231). The patient had no medical history and no illness at the time of vaccination. The patient had no history of upper respiratory infection (URI) or other viral illness in the last several months. He denied any over-the-counter (OTC) or prescribed medications and denied any supplement use. On 17 May 2010 at 0345, the patient was brought to the hospital by ambulance reporting an onset of mid-retrosternal chest pain, shortness of breath (SOB) and lightheadedness for about one hour prior. He described the pain as 9 out of 10 without nausea or diaphoresis but with slight lightheadedness and SOB. He had no palpitations and denied any episodes of similar symptoms. He stated that he had been hydrating well but felt overheated two days prior after doing hand to hand combat training. The patient was diagnosed with post-vaccinia myocarditis. The outcome was reported as not recovered. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: This case was received on 12 October 2010 via a QSCAN search on the VAERS database, under reference number 394964. A 21-year-old male patient received the following vaccinations on 05 May 2010: a percutaneous ACAM2000 (lot number VV04003A), TYPHIM VI (lot number D0191), anthrax (Emergent, lot number FAV231). The patient had no medical history and no illness at the time of vaccination. The patient had no history of upper respiratory infection (URI) or other viral illness in the last several months. He denied any over-the-counter (OTC) or prescribed medications and denied any supplement use. On 17 May 2010 at 0345, the patient was brought to the hospital by ambulance reporting an onset of mid-retrosternal chest pain, shortness of breath (SOB) and lightheadedness for about one hour prior. He described the pain as 9 out of 10 without nausea or diaphoresis but with slight lightheadedness and SOB. He had no palpitations and denied any episodes of similar symptoms. He stated that he had been hydrating well but felt overheated two days prior after doing hand to hand combat training. The patient was diagnosed with post-vaccinia myocarditis. The outcome was reported as not recovered. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: None.
Age: 0.15
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Combined immunodeficiency, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an approximately 12 weeks old (reported as 3 month old) patient who on an unspecified date was vaccinated with the first dose of ROTATEQ (lot #/ Exp. Date: unspecified). It was reported that the patient developed severe combined immunodeficiency disease (SCID) while on therapy with ROTATEQ. The patient had tested positive rotavirus in his stool. At the time of reporting, the patient's outcome was unknown. Patient sought unspecified medical attention. Follow-up information has been received from the physician indicating that the approximately 12 weeks old (this age was when happened the first AE) male patient with suspected genetic syndrome and "no acute-late premature or dysmorphic features" and history of a stay in neonatal intensive care unit (NICU) for 1 month who on 18-AUG-2010 was vaccinated with a first dose of ROTATEQ (lot # 667864/0686Z) orally, a second dose of RECOMBIVAX HB (manufacturer unknown), a first dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid and a first dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine . It was reported that the patient developed prolonged diarrhea, which prompted hospital admission. The patient diagnosed with having severe combine immunodeficiency. The patient was hospitalized for 3 months and had positive rotavirus Ag detection on several occasions throughout his stay (one test was on 22-SEP-2010, the last test positive was on 29-NOV-2010). At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Shots given too high. Flu in left arm and pneumonia in the right arm. Both hurt badly, but pneumonia was much worse and tensed up. As of 1/24/2011, continue to have pain in the right arm/shoulder. Pain intensifies with physical exertion. Pain sometimes radiates down arm to elbow and wrist and also around to back shoulder area (trapezious muscle?)
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Incorrect route of drug administration, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Shots given too high. Flu in left arm and pneumonia in the right arm. Both hurt badly, but pneumonia was much worse and tensed up. As of 1/24/2011, continue to have pain in the right arm/shoulder. Pain intensifies with physical exertion. Pain sometimes radiates down arm to elbow and wrist and also around to back shoulder area (trapezious muscle?)
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Shots given too high. Flu in left arm and pneumonia in the right arm. Both hurt badly, but pneumonia was much worse and tensed up. As of 1/24/2011, continue to have pain in the right arm/shoulder. Pain intensifies with physical exertion. Pain sometimes radiates down arm to elbow and wrist and also around to back shoulder area (trapezious muscle?)
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin, Drug exposure during pregnancy, Pregnancy test urine positive, Ultrasound scan
Clinical narrative: Patient miscarried one week after receiving flu vaccination.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Patient miscarried one week after receiving flu vaccination.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Rash macular, Urticaria
Clinical narrative: Reaction started 15 hrs after injection. Severe itchiness, raised red blotches, covering arms, legs, back, turning to a deep purple in color. Dr. gave cortisone injection and put on MEDROL 6 days.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash generalised, Rash macular, Rash pruritic, Skin burning sensation
Clinical narrative: Reaction started 15 hrs after injection. Severe itchiness, raised red blotches, covering arms, legs, back, turning to a deep purple in color. Dr. gave cortisone injection and put on MEDROL 6 days.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Reaction started 15 hrs after injection. Severe itchiness, raised red blotches, covering arms, legs, back, turning to a deep purple in color. Dr. gave cortisone injection and put on MEDROL 6 days.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Reaction started 15 hrs after injection. Severe itchiness, raised red blotches, covering arms, legs, back, turning to a deep purple in color. Dr. gave cortisone injection and put on MEDROL 6 days.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal faeces, Diarrhoea, Vomiting
Clinical narrative: Vomiting for 4 days with every bottle - diarrhea - with rotavirus like smell - Pedialyte, more frequent, smaller feedings.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting for 4 days with every bottle - diarrhea - with rotavirus like smell - Pedialyte, more frequent, smaller feedings.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Amnesia, Anger, Blindness unilateral, Convulsion, Deja vu
Clinical narrative: Patient began experiencing "lightning bolt" pains in the temporal region of her head.  Debilitating and completely prostrating migraine headaches which lasted up to 4 days at a time.  She was treated with Imitrex and Motrin 800 mg, and felt no relief.  She also experienced blindness in her left eye, and numbness and tingling in her extremities.  Then she began experiencing fatigue, anger, and dizziness.  After nine months of these symptoms, the symptoms progressed, and she began experiencing all of the above, with deja vu spells, associated with bitter tastes and smells, as well as memory loss.  The partial seizures, and lightning bolt headaches continued for several years, and then, on May 8, 2010, she experienced a grand mal seizure, and another on July 10, and September 14, and December 14.  Treatment began in December, 2010 after she was officially and finally diagnosed with seizures.  Keppra 750mg BID.  Patient experienced at times as many as 6 partial seizures per day, but now averages one per every two weeks.  Lightning bolt headaches are daily.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Dizziness, Dysgeusia, Electroencephalogram abnormal, Fatigue, Grand mal convulsion
Clinical narrative: Patient began experiencing "lightning bolt" pains in the temporal region of her head.  Debilitating and completely prostrating migraine headaches which lasted up to 4 days at a time.  She was treated with Imitrex and Motrin 800 mg, and felt no relief.  She also experienced blindness in her left eye, and numbness and tingling in her extremities.  Then she began experiencing fatigue, anger, and dizziness.  After nine months of these symptoms, the symptoms progressed, and she began experiencing all of the above, with deja vu spells, associated with bitter tastes and smells, as well as memory loss.  The partial seizures, and lightning bolt headaches continued for several years, and then, on May 8, 2010, she experienced a grand mal seizure, and another on July 10, and September 14, and December 14.  Treatment began in December, 2010 after she was officially and finally diagnosed with seizures.  Keppra 750mg BID.  Patient experienced at times as many as 6 partial seizures per day, but now averages one per every two weeks.  Lightning bolt headaches are daily.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Headache, Hypoaesthesia, Migraine, Paraesthesia, Parosmia
Clinical narrative: Patient began experiencing "lightning bolt" pains in the temporal region of her head.  Debilitating and completely prostrating migraine headaches which lasted up to 4 days at a time.  She was treated with Imitrex and Motrin 800 mg, and felt no relief.  She also experienced blindness in her left eye, and numbness and tingling in her extremities.  Then she began experiencing fatigue, anger, and dizziness.  After nine months of these symptoms, the symptoms progressed, and she began experiencing all of the above, with deja vu spells, associated with bitter tastes and smells, as well as memory loss.  The partial seizures, and lightning bolt headaches continued for several years, and then, on May 8, 2010, she experienced a grand mal seizure, and another on July 10, and September 14, and December 14.  Treatment began in December, 2010 after she was officially and finally diagnosed with seizures.  Keppra 750mg BID.  Patient experienced at times as many as 6 partial seizures per day, but now averages one per every two weeks.  Lightning bolt headaches are daily.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Partial seizures
Clinical narrative: Patient began experiencing "lightning bolt" pains in the temporal region of her head.  Debilitating and completely prostrating migraine headaches which lasted up to 4 days at a time.  She was treated with Imitrex and Motrin 800 mg, and felt no relief.  She also experienced blindness in her left eye, and numbness and tingling in her extremities.  Then she began experiencing fatigue, anger, and dizziness.  After nine months of these symptoms, the symptoms progressed, and she began experiencing all of the above, with deja vu spells, associated with bitter tastes and smells, as well as memory loss.  The partial seizures, and lightning bolt headaches continued for several years, and then, on May 8, 2010, she experienced a grand mal seizure, and another on July 10, and September 14, and December 14.  Treatment began in December, 2010 after she was officially and finally diagnosed with seizures.  Keppra 750mg BID.  Patient experienced at times as many as 6 partial seizures per day, but now averages one per every two weeks.  Lightning bolt headaches are daily.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site reaction, Skin lesion
Clinical narrative: At injection site, pt developed a skin lesion that appears consistent with erythema multiforme minor.  Skin changes are still present 1 month after vaccine administration.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diarrhoea, Faeces discoloured, Haemoglobin decreased, Leukoplakia oral
Clinical narrative: PATIENT'S GRANDMOTHER REFERS THE NEXT DAY OF VACCINATION HE BEGAN EXPERIECING DIARRHEA AND WHITE SPOTS IN THE MOUTH. THE NEXT DAY DARK RED STOOL, WAS HOSPITALIZED. LOW HEMOGLOBIN - 9.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Malaise, Pyrexia
Clinical narrative: Seizure, fever, very ill feeling.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Woke up in AM (1/19/11) with right arm red, swollen and warm to the touch.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ectopic pregnancy, Pregnancy test positive, Salpingectomy, Smear cervix abnormal
Clinical narrative: Information has been received from a 26 year old female registered nurse, for GARDASIL, a Pregnancy Registry product, concerning herself with a family history of cervical cancer and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot number not provided) in 2009, and the final dose (lot number not provided) on 19-OCT-2010. Concomitant therapy included methotrexate. On 22-NOV-2010 the patient later discovered she was 1 week pregnant with an ectopic pregnancy. She required surgery to remove her right fallopian tube. The patient sought medical attention by calling physician. Diagnostic laboratory test sonogram performed, no results provided. Pregnancy test was positive (unspecified for which time of pregnancy). On an unspecified date, the patient was hospitalized. At the time of this report, the patient's outcome was unknown. On 10-DEC-2010 the patient discovered she was pregnant again with another ectopic pregnancy, this time on the left side and had been on methotrexate, (WAES #1101USA01251). Follow-up information has been received from a licensed practical nurse reporting that GARDASIL were not administered by their office; vaccine dates and lot #s not known. No information available regarding any concurrent conditions or personal medical history. No LMP data available. The patient was seen from January 2009 to March 2010 for abnormal Papanicolaou (PAP) smears (pre cancerous cells). On 22-NOV-2010, the patient admitted to hospital; and emergency surgery performed. The patient was last seen on 03-JAN-2011. Methotrexate started with doses given on 07-JAN-2011 and 14-JAN-2011. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination and lot numbers. Follow-up information has been received from the patient reporting that she got her GARDASIL vaccines through a planned parenthood center. The patient's last normal period was on 23-SEP-2010. The first dose of methotrexate was "not successful in dissolving the ectopic pregnancy" on the left side. She was to see doctor for more blood work on 21-JAN-2011 to see if the second dose of methotrexate was successful. The patient's status was not recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a 26 year old female registered nurse, for GARDASIL, a Pregnancy Registry product, concerning herself with a family history of cervical cancer and no drug reactions/allergies who was vaccinated with the first dose of GARDASIL (lot number not provided) in 2009, and the final dose (lot number not provided) on 19-OCT-2010. Concomitant therapy included methotrexate. On 22-NOV-2010 the patient later discovered she was 1 week pregnant with an ectopic pregnancy. She required surgery to remove her right fallopian tube. The patient sought medical attention by calling physician. Diagnostic laboratory test sonogram performed, no results provided. Pregnancy test was positive (unspecified for which time of pregnancy). On an unspecified date, the patient was hospitalized. At the time of this report, the patient's outcome was unknown. On 10-DEC-2010 the patient discovered she was pregnant again with another ectopic pregnancy, this time on the left side and had been on methotrexate, (WAES #1101USA01251). Follow-up information has been received from a licensed practical nurse reporting that GARDASIL were not administered by their office; vaccine dates and lot #s not known. No information available regarding any concurrent conditions or personal medical history. No LMP data available. The patient was seen from January 2009 to March 2010 for abnormal Papanicolaou (PAP) smears (pre cancerous cells). On 22-NOV-2010, the patient admitted to hospital; and emergency surgery performed. The patient was last seen on 03-JAN-2011. Methotrexate started with doses given on 07-JAN-2011 and 14-JAN-2011. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination and lot numbers. Follow-up information has been received from the patient reporting that she got her GARDASIL vaccines through a planned parenthood center. The patient's last normal period was on 23-SEP-2010. The first dose of methotrexate was "not successful in dissolving the ectopic pregnancy" on the left side. She was to see doctor for more blood work on 21-JAN-2011 to see if the second dose of methotrexate was successful. The patient's status was not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient he heard about (it was unknown if this was a patient of a clinical colleague or an acquaintance of him), that "was healthy as a horse" who on an unspecified date was vaccinated with GARDASIL (it is unknown which dose this was in the series). The physician reported that "within two weeks of administration of the vaccine she is in the hospital with seizures and is a picture of death". At the time of the report, the patient had not recovered. The patient's symptoms were considered to be disabling and immediately life-threatening by the physician. No further information is available.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: Urticaria and whelps on arm where the flu immunization was administered.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Severe pain in injection site.  Limping for two days. SEVERE swelling - 6 by 6.5 inch area on leg.  Red, hot to the touch, extremely hard/swollen and sore area on leg where injection was given.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Severe pain in injection site.  Limping for two days. SEVERE swelling - 6 by 6.5 inch area on leg.  Red, hot to the touch, extremely hard/swollen and sore area on leg where injection was given.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Convulsion, Hypersomnia
Clinical narrative: Child started having seizures, lasting approx. 5-7 min. The next day was unable to do anything, other than sleep the majority of the day.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Child started having seizures, lasting approx. 5-7 min. The next day was unable to do anything, other than sleep the majority of the day.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Condition aggravated, Convulsion, Lethargy, Vaccine positive rechallenge
Clinical narrative: Child started having seizures, lasting approx. 5-7 min. The next day was unable to do anything, other than sleep the majority of the day.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Convulsion, Hypersomnia
Clinical narrative: seizure
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Condition aggravated, Convulsion
Clinical narrative: seizure
Age: 17.0
Sex: F
Vaccine: MEN, MNQ, MNQ
Symptoms: Condition aggravated, Convulsion, Lethargy, Vaccine positive rechallenge
Clinical narrative: seizure
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: On 09-23-10 Patient reported had a few hives the night of 09-22-10, awoke to find "covered with hives" the morning of 09-23-10. Pt stated in call that she had taken Benadryl and was instructed to continue to do so, and was instructed not to get final shot of series. Patient denied any airway swelling. Patient was instructed to call office if no relief or other concerns, and patient did not call office again for this event.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Sinus congestion, Sinus disorder, Sinus operation, Sinusitis
Clinical narrative: Ever since receiving the flu mist patient has had sinus congestion and drainage. On December 17, 2010 he was seen at the Doctors office and put on medication for a sinus infection.  It has not cleared up and needs to go in again.  He has not ever had a sinus infection before and things have not been right since receiving the flu mist.
Age: 1.3
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Child received TIV on 11-10-2010 and 12-27-2010 and 1 week after each TIV was administered the child vomited 6 - 7 times. Was afebrile no other symptoms.  Lot # to TIV received on 12-27-10 was U3784AA, into right thigh, IM.
Age: 0.56
Sex: M
Vaccine: FLU3
Symptoms: Aphagia, Cold sweat, Erythema, Irritability, Urticaria
Clinical narrative: Body covered in red bumps, hives, completely irritable, unable to eat, cold sweats.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: This medically confirmed spontaneous report (initial receipt 13-JAN-2011) concerns a 29 year old female patient. On 10-JAN-2011, the patient received AFLURIA Inj 0.5ml via intramuscular route for vaccination. A few hours after receiving the vaccination, the patient complained of her throat swelling and trouble breathing. About 15 minutes later, EMS (emergency medical services) was called to the patient's house. The event outcome was unknown.
Age: 15.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: C-reactive protein increased, Cellulitis, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt developed a fever along with swelling and pain over the left shoulder, at the site of the injection.  He presented to an outside ED, was diagnosed with cellulitis, and transferred to our facility for further management.  On exam here, his left shoulder was extremely tender to palpation with a large area of induration, warmth and swelling.  He was started on clindamycin initially, but switched to ancef after the rash spread.  He was later switched to vanco and ceftriaxone since he continued to be febrile with some spreading.  An MRI of the arm is pending at this report.
Age: 15.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia, Rash, White blood cell count increased
Clinical narrative: Pt developed a fever along with swelling and pain over the left shoulder, at the site of the injection.  He presented to an outside ED, was diagnosed with cellulitis, and transferred to our facility for further management.  On exam here, his left shoulder was extremely tender to palpation with a large area of induration, warmth and swelling.  He was started on clindamycin initially, but switched to ancef after the rash spread.  He was later switched to vanco and ceftriaxone since he continued to be febrile with some spreading.  An MRI of the arm is pending at this report.
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test, Convulsion, Febrile convulsion, Pyrexia, Urine analysis
Clinical narrative: Patient got a fever Sat 12-4-10 early afternoon of 101.3. I began giving her Tylenol every 4 hours. Around 3:00am she threw up twice. At 5:30pm Sun 12-5-10 her fever was 102.8. I took her to the Hospital right away and within an hour she had a seizure. They ran blood tests and did an xray and determined it was a febrile seizure.
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: Patient got a fever Sat 12-4-10 early afternoon of 101.3. I began giving her Tylenol every 4 hours. Around 3:00am she threw up twice. At 5:30pm Sun 12-5-10 her fever was 102.8. I took her to the Hospital right away and within an hour she had a seizure. They ran blood tests and did an xray and determined it was a febrile seizure.
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient got a fever Sat 12-4-10 early afternoon of 101.3. I began giving her Tylenol every 4 hours. Around 3:00am she threw up twice. At 5:30pm Sun 12-5-10 her fever was 102.8. I took her to the Hospital right away and within an hour she had a seizure. They ran blood tests and did an xray and determined it was a febrile seizure.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Rash macular
Clinical narrative: Pain and blotchy redness at injection site, fever of max 101
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Electroencephalogram, Full blood count, Pyrexia, Vomiting
Clinical narrative: Began running fever at 2pm 101.8 on 11/15/10 at daycare. Taken to MD - given MOTRIN then vomited. Temp at Dr. office 102.? (almost 103 degrees) gave acetaminophen suppository - Began with seizure at MD office.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Culture urine, Pyrexia, Urine analysis
Clinical narrative: Fever began 4 hours after PENTACEL, PREVNAR 13, ROTATEQ, Flu. Tm = 104 degrees 3d after shots, resolved 4d after shots. No other sx, no ill contacts.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Rash, Urticaria
Clinical narrative: Day after immunization patient states she had hives and burning sensation in face and a rash from the neck to belly. Patient brought prescriptions in from the ER on 12/17/10 patient received a MEDROL Dose pak and OMNICEF.
Age: 48.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, TYP
Symptoms: Dizziness, Pallor
Clinical narrative: 2:13pm After 3rd injection pt turned a little pale 4th injection given, pt states lightheaded, lowered head between knees, possible seizure lasting approx 30 seconds, cold compress applied, remained alert, state able to leave facility approx 30 mins afterwards.
Age: 30.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, X-ray
Clinical narrative: Pain, swelling, redness on L upper arm around injection site encompassing entire bicep. Patient started on Cephalexin, and then Levaquin was added. Symptoms worsened and patient was seen in Emergency Department and received one dose of IV Vancomycin, and then sent home with a course of Clindamycin.  Cellulitis resolved after the ER antibiotic treatments.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Mass
Clinical narrative: Somewhat hard lump under arm in same arm that was vaccinated. Lump is about the size of a walnut.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, No reaction on previous exposure to drug, Syncope
Clinical narrative: Brief fainting spell after vaccination occurred immediately after 3rd vaccine. Was fine with #1, #2 vaccines.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Received varicella vaccine 1/20/11 in R upper arm SC woke up this morning with swollen and itchy area 5.5cm induration with central vesiculated area warm no tender.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh swollen, red, and warm around injection site. Erythema extends to about 3 cm diameter.
Age: 15.0
Sex: F
Vaccine: FLUN3, TDAP
Symptoms: Expired drug administered
Clinical narrative: None. Note: FLUMIST expired 01-16-11.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Erythema, Urticaria
Clinical narrative: Patient sustained right lateral 3cm diameter oval shaped erythematous wheal.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Patient received Shingles vaccine in left arm (SC) on 1-14-11 & reports injection site irritation that has persisted. Report came in on the evening of 1 21 11 & patient complains that area injected is itchy & hurts and feels "hard". Pt presented 1 22 11 - area is red & hard under skin.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Skin warm
Clinical narrative: Received vaccine, PNEUMOVAX 23, on 1/19/2011. On 1/20/11, red, warm, pain & could not move arm. Saw NP, on 1/21/2011 & received cephalexin - return in 1 wk.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash on shoulder, neck, then waist, hands, inner thigh (R), forearm (R) x 3 weeks beginning 3 days after Hep B booster. Treated with topical steroids.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Cough, Diarrhoea, Measles, Pyrexia, Rash
Clinical narrative: Fever developed the day following immunizations.  She received Pentacel, MMR, Varivax 1/7/11.  Fever to 101 on the first day.  Intermittently running temps up to 99 since then.  She has had diarrhea for the past several days, up to 5 loose watery stools per day.  Cough 1/18/11, Rash started that evening night around her face, spread to the rest of her body by 1/19/11. On exam 1/19/11 had diffuse morbilliform rash and koplik spots.  Afebrile with normal VS, otherwise normal exam.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Fever developed the day following immunizations.  She received Pentacel, MMR, Varivax 1/7/11.  Fever to 101 on the first day.  Intermittently running temps up to 99 since then.  She has had diarrhea for the past several days, up to 5 loose watery stools per day.  Cough 1/18/11, Rash started that evening night around her face, spread to the rest of her body by 1/19/11. On exam 1/19/11 had diffuse morbilliform rash and koplik spots.  Afebrile with normal VS, otherwise normal exam.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Neck pain, Pain in extremity
Clinical narrative: severe pain up arm into neck, chills, fatigue, joint pain and diuressis x 3 days
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Polyuria
Clinical narrative: severe pain up arm into neck, chills, fatigue, joint pain and diuressis x 3 days
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Ear infection, Foaming at mouth, Gaze palsy, Incorrect dose administered
Clinical narrative: On 19 DEC 10, patient had a low-grade fever at 1400.  Dad administered fever reducer and the fever went down.  At 1830 patient's fever spiked to 105 and he had a full body seizure: unconscious, eyes rolled back, tongue sticking out, and foaming.  Clinic on cruise ship, administered antibiotics and examined him.  His physical exam was fine, noted that he probably had a viral infection.  Upon entry to the port on 20 DEC 10 a pediatrician also examined patient and also stated that his exam was good and felt that he had a viral infection.  Patient was immediately cleared to fly out of the country where he was seen four days later in by our pediatrician.  Our pediatrician on 24 DEC 10 noticed that patient had developed an ear infection and prescribed antibiotics.  An EEG was scheduled for 3 MAR 11.  On 20 JAN 11, a PSA reported that some children receiving flu vaccines recently were having seizures (Sanofi Pasteur FluZone brand).  Upon examining patient's vaccine record, dad noticed that not only did patient receive the "suspect" Sanofi Pasteur vaccine (initial and booster) he was also dosed with .5ml instead of .25ml on 2 DEC 10.  Therefore, patient was overdosed.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Pyrexia, Viral infection
Clinical narrative: On 19 DEC 10, patient had a low-grade fever at 1400.  Dad administered fever reducer and the fever went down.  At 1830 patient's fever spiked to 105 and he had a full body seizure: unconscious, eyes rolled back, tongue sticking out, and foaming.  Clinic on cruise ship, administered antibiotics and examined him.  His physical exam was fine, noted that he probably had a viral infection.  Upon entry to the port on 20 DEC 10 a pediatrician also examined patient and also stated that his exam was good and felt that he had a viral infection.  Patient was immediately cleared to fly out of the country where he was seen four days later in by our pediatrician.  Our pediatrician on 24 DEC 10 noticed that patient had developed an ear infection and prescribed antibiotics.  An EEG was scheduled for 3 MAR 11.  On 20 JAN 11, a PSA reported that some children receiving flu vaccines recently were having seizures (Sanofi Pasteur FluZone brand).  Upon examining patient's vaccine record, dad noticed that not only did patient receive the "suspect" Sanofi Pasteur vaccine (initial and booster) he was also dosed with .5ml instead of .25ml on 2 DEC 10.  Therefore, patient was overdosed.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Pain, Rash erythematous, Rash pruritic
Clinical narrative: Rash started on rear of left leg and progressed daily with itching and redness. Diagnosed as shingles on Jan 08.  Started treatment of valacyclovir HCL 1 gram twice a day.  Rash/itching has continued.  Minimal pain so far two weeks into the shingles.  We shall see.
Age: 67.0
Sex: F
Vaccine: DT, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: There was redness, swelling and tenderness at injection site. Right upper arm.