chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 66 year old female physician with no allergies or medical history on 10-NOV-2006 was vaccinated IM in the left deltoid with an 0.65 ml dose of Zostavax (lot # 652936/0981F). Concomitant therapy included ULTRAM. Twenty-four hours later, on 11-NOV-2006, the patient developed a fever of 101 degrees. Her left arm and deltoid injection site injection site became red, swollen, and hot to the touch. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The patient recovered on 12-NOV-2006. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial information has been received from a medical assistant concerning a 66 year old female physician with no allergies or medical history who on 10-NOV-2006 was vaccinated SC (previously reported as IM) in the right (previously reported as left) deltoid with an 0.65 ml dose of ZOSTAVAX (lot # 652936/0981F). Additional information received from the physician indicated that the reaction was a reaction to the influenza virus vaccine (unspecified) (manufacturer unknown) (lot # 71829) and not ZOSTAVAX (Merck) (lot # 652936/0981F). No further information was reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of Zostavax. Subsequently, the patient experienced shingles. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a female who on an unspecified date was vaccinated with a dose of Zostavax. On day after vaccination the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint was involved. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old male who on 06-FEB-2007 was vaccinated with a dose of Zostavax (Merck). Concomitant therapy included lisinopril (manufacturer unknown) and lovastatin. On 13-FEB-2007, seven days after vaccination, the patient experienced a shingles rash. His rash was characterized as vesicular and extends from the left inguinal area to the left thigh and left lower back (L-1 distribution). The patient was seen in the emergency room and treated with prednisone, VALTREX and analgesic. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. The patient was enrolled in the Varicella Zoster Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild type (WT) VZV strain of with the OKA/Merck vaccine VZV strain. On 27-FEB-2007 a specimen was obtained from a dry and crusted lesion, no fluids was available. The results from the lesion identified the presence of WT VZV. Additional information indicated from the pharmacist indicated that the patient was convinced his shingles were due to the vaccination and that he was refusing to get a flu vaccine as well as any other recommend vaccines in the future. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Breast pain, Chest pain, Herpes zoster, Pain
Clinical narrative: Information has been received from a physician and registered nurse concerning a 78 year old female with hypertension and osteoporosis and a history of cold sores who on 20-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (lot # 654604/1406F). Concomitant therapy included SYNTHROID, atenolol (manufacturer unknown), lisinopril (manufacturer unknown) and alendronate sodium. On 22-FEB-2007, two days after vaccination, the patient developed 4 areas of rash with itching on her back. No lesions or vesicles were noted by the patient. She applied hydrocortisone lotion to the rash. On 24-FEB-2007 the patient began developing pain in her chest and back. She also had pain under her arm, through the breast area and to her waist. As of 26-FEB-2006 the rash was diminishing and the tenderness continued. On 02-MAR-2007 the patient was seen by the physician and she had 4 lesions on her right upper back with looks to be a case of shingles and the patient has pain. She was treated with FAMVIR 500 mg TID for 5 days, MEDROL dosepack and VICODIN. No laboratory tests were performed. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin lesion, Tenderness
Clinical narrative: Information has been received from a physician and registered nurse concerning a 78 year old female with hypertension and osteoporosis and a history of cold sores who on 20-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (lot # 654604/1406F). Concomitant therapy included SYNTHROID, atenolol (manufacturer unknown), lisinopril (manufacturer unknown) and alendronate sodium. On 22-FEB-2007, two days after vaccination, the patient developed 4 areas of rash with itching on her back. No lesions or vesicles were noted by the patient. She applied hydrocortisone lotion to the rash. On 24-FEB-2007 the patient began developing pain in her chest and back. She also had pain under her arm, through the breast area and to her waist. As of 26-FEB-2006 the rash was diminishing and the tenderness continued. On 02-MAR-2007 the patient was seen by the physician and she had 4 lesions on her right upper back with looks to be a case of shingles and the patient has pain. She was treated with FAMVIR 500 mg TID for 5 days, MEDROL dosepack and VICODIN. No laboratory tests were performed. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture negative, Rash, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 65-year-old female who on 12-FEB-2006 was vaccinated with a 0.65 ml dose of Zostavax. On 19-FEB-2007 the patient developed a breakthrough rash on her face. Unspecified medical attention was sought. There was no additional information. There was no product quality complaint.  Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 73 year old female with hypertension, chronic renal failure and hyperthyroidism who on 13 DEC 2007 at 11:15 was vaccinated intramuscularly with a first dose of ZOSTAVAX (Oka/Merck) (lot # 652925/0621F). There was no acute illness at the time of vaccination. Concomitant therapy included "doxazocin", EVISTA, ALLOPURINOL MSD, aspirin, TOPROL XL tablets and LEVOXYL. On 19-FEB-2007 the patient developed a zoster like rash on the right side of the forehead and bilateral intraorbital blisters. Unspecified medical attention was sought. A viral culture was obtained from the vesicles, on an unspecified date. The findings remain pending. There was no product quality complaint. At the time of reporting the final outcome was uknown.   Information has been received from a physician concerning a 73 year old female (weight 1318) with hypertension, chronic renal failure and hypothyroidism who on 13-FEB-2007 at 11:15 was vaccinated intramuscularly with a first dose of ZOSTAVAX (Merck) (lot # 652925/0621F). IM in the left arm. There was no acute illness at the time of vaccination. Concomitant therapy included "doxarocin", EVISTA, allupurinol (manufacturer unknown), aspirin, TOPROL XL tablets and LEVOXYL.  On 17-FEB-2007, the patient developed a zoster like rash on the right side of face and forehead, and bilateral intraorbital blisters. Unspecified medical attention was sought. On an unspecified date, a viral culture was obtained from the vesicles which were negative for varicella virus. There was no product quality complaint. On 13-MAR-2007, the patient recovered from the events.   Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female with no known allergies or pertinent medical history who on 14-FEB-2007 was vaccinated SC with a 0.5 ml dose of Zoster. There was no concomitant medication. Two days after vaccination, on 16-FEB-2007 the patient developed redness at the injection site that was about 5 cm in diameter. Unspecified medical attention was sought. There were no lab tests performed. The patient was self-treating the are with over the counter BENADRYL lotion and the redness was resolving. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Influenza like illness, Injection site erythema, Pain in extremity
Clinical narrative: Information has been received from a female pharmacist in her early 60's with a history of having a "strong reaction to medications" who on 12-FEB-2007 was vaccinated SC in the left arm with a dose of Zostavax. On approximately 12-FEB-2007 the patient developed a significant raised red area at the injection site that lasted 3-5 days, she also experienced radiation pain in the left arm going all the way to her chest area. The patient also developed flu like symptoms for 24 hours after receiving the vaccine. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Information has been received from a 55 year old female pharmacist with a history of having a "strong reaction to medciations" who on 29-JAN-2007 at 13:30 was vaccinated IM in the left arm with a first dose of ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. On 29-JAN-2007 at 18:30 the patient developed a significant raised red area at the injection site that lasted 3-5 days. She also experienced radiating pain in the left arm going all the way to her chest area. The patient developed flu like symptoms for 24 hours after receiving the vaccine. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality complaint involved. No further information was provided. Follow up information received from the patient indicated that she developed swelling and redness at the injection site. The area was reported to be round and about the size of a silver dollar. The iste stuck out about 1 inch. She was treated with BENADRYL and TYLENOL for 4 days. The patient's swelling and color was normal within 8 days. It was also noted that on 30-JAN-2007 the patient developed pain which radiated to her chest and shoulder blade. The patient recovered on 07-FEB-2007. The patient had no adverse events following prior vaccination/. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient with no known history or allergies who on 18-DEC-2006 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. Subsequently on 18-JAN-2007, one month after vaccination, the patient developed a rash and significant pain in one leg. Unspecified medical was sought. No laboratory test were performed. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 65 year old female who on 19-DEC-2006 was vaccinated SC with a dose of Zostavax (Merck) (lot # 652965/0622F). One week later on approximately 26-DEC-2006, the patient was diagnosed and treated for shingles at the injections site. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 3/14/2007. Additional information from the physician indicated that on approximately 26-DEC-2006, the patient developed a rash. She presented to an urgent care center and was diagnosed with shingles. The patient was treated with an unspecified prescription therapy. The duration was reported as one week. No further information is expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: Information has been received from a physician concerning a 69 year old female who on 01-FEB-2007 was vaccinated with a 0.5 ml dose of Zostavax. On 08-FEB-2007 the patient experienced pain and burning somewhere on her body, not at the injection site. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Zostavax. Subsequently the patient experienced redness at the injection site and soreness at the injection site. The patient recovered the next day. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PPV, VARCEL
Symptoms: Oedema peripheral, Pain of skin, Skin warm
Clinical narrative: Exteme swelling of Right Arm- I saw the arm about 36 hours after injection and at that time it was over the entire outer arm (60 % of circumference) and the whole outer arm 5-6 inches. Very warm and tender, ROM of arm was good and elbow and  hand normal  Rx with cold and tylenol adn 24 hrs later was almost normal
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Agitation, Anorexia, Crying, Diarrhoea, Gait disturbance
Clinical narrative: Encountered Rash with fever 4-5 days later. Severe Rash from Head to Toe. After about 2 weeks had a hard time walking and started to regress. Very pale and withdrawn. Not interested in eat. She was a very mellow baby and now cries a lot and becomes agitated. After many doctor visits and going to the hospital, no doctor can tell us if this is from the MMR shot. She now is getting severe diarrhea and doesn't show any sign of improvement.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pallor, Pyrexia, Rash generalised, Social avoidant behaviour
Clinical narrative: Encountered Rash with fever 4-5 days later. Severe Rash from Head to Toe. After about 2 weeks had a hard time walking and started to regress. Very pale and withdrawn. Not interested in eat. She was a very mellow baby and now cries a lot and becomes agitated. After many doctor visits and going to the hospital, no doctor can tell us if this is from the MMR shot. She now is getting severe diarrhea and doesn't show any sign of improvement.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase increased, Blood pressure diastolic increased, Catheterisation cardiac, Chest X-ray normal, Chest discomfort
Clinical narrative: Myopericarditis post SPV. See attached clinical summary. Patient is a 31 y/o, primary vaccine who was in good health until receiving smallpox vaccine on 13 Mar 03. On 24 Mar 2006 he noticed a feeling of "heaviness," described as if there was a weight" across his chest, accompanied by mild difficulty when breathing that waxed and waned for most of the day. At approximately 1:00 am the following morning, he was awakened by severe, sharp, stabbing pains occurring at the sides of his chest, radiating to the center and included both arms. He also complained of bilateral arm numbness, and nausea. He reports being unable to find a comfortable position-" standing up was worse", having some difficulty breathing-" it hurt more when I tried to take a deep breathe". He presented to the ER at hospital where an electrocardiogram showed diffuse ST segment elevation without a P-R segment depression. The T wave in lead V1 was inverted. His cardiac enzymes showed elevated CPKs with positive MB fraction and a positive troponin. He was sent to the hospital where an echocardiogram showed a low normal ejection fraction of 50-55% and was described as having a subtle wall motion abnormality of the anterolateral wall. He was airlifted and taken immediately to the cardiac catherization lab where a coronary angiography revealed normal coronary arteries. A left ventricular cineangogram showed a mild decrease in LV function but no segmental wall motion abnormalities. There was no significant mitral regurgitation. His left ventricular and diastolic pressure was elevated at 22mmHg. While hospitalized his chest discomfort ceased but he complained of severe, generalized headache - worse when he turns his head. He denied photophobia, visual changes or nausea. There were no reported meningeal signs. He was given Ibuprofen which decreased the headaches, but says"they lasted about three days". He is currently headache free.  03/20/2007 Clinical Summary and update received for dx. of Myopericarditis occuring 1 week following smallpox vax. in 2003.  Pt. initially noticed a "heaviness" in his chest with associated difficulty in breathing.  This  was followed by severe, stabbing chest pains occuring the following night.  Pain radiated into the arms and was exacerbated by taking a deep breath. He developed a severe generalized headache during hospitalization which lasted 3 days.  Tx with ibuprofen. DX:  Myopericarditis. F/U in April 2006 for probable smallpox related myopericarditis.  Pt. reports being asymptomatic with the exception of a general feeling of fatigue and getting worn out more quickly than prior to the episode.  He is able to run several miles 3X/week, although his recovery is slower than it once was.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram T wave inversion, Headache
Clinical narrative: Myopericarditis post SPV. See attached clinical summary. Patient is a 31 y/o, primary vaccine who was in good health until receiving smallpox vaccine on 13 Mar 03. On 24 Mar 2006 he noticed a feeling of "heaviness," described as if there was a weight" across his chest, accompanied by mild difficulty when breathing that waxed and waned for most of the day. At approximately 1:00 am the following morning, he was awakened by severe, sharp, stabbing pains occurring at the sides of his chest, radiating to the center and included both arms. He also complained of bilateral arm numbness, and nausea. He reports being unable to find a comfortable position-" standing up was worse", having some difficulty breathing-" it hurt more when I tried to take a deep breathe". He presented to the ER at hospital where an electrocardiogram showed diffuse ST segment elevation without a P-R segment depression. The T wave in lead V1 was inverted. His cardiac enzymes showed elevated CPKs with positive MB fraction and a positive troponin. He was sent to the hospital where an echocardiogram showed a low normal ejection fraction of 50-55% and was described as having a subtle wall motion abnormality of the anterolateral wall. He was airlifted and taken immediately to the cardiac catherization lab where a coronary angiography revealed normal coronary arteries. A left ventricular cineangogram showed a mild decrease in LV function but no segmental wall motion abnormalities. There was no significant mitral regurgitation. His left ventricular and diastolic pressure was elevated at 22mmHg. While hospitalized his chest discomfort ceased but he complained of severe, generalized headache - worse when he turns his head. He denied photophobia, visual changes or nausea. There were no reported meningeal signs. He was given Ibuprofen which decreased the headaches, but says"they lasted about three days". He is currently headache free.  03/20/2007 Clinical Summary and update received for dx. of Myopericarditis occuring 1 week following smallpox vax. in 2003.  Pt. initially noticed a "heaviness" in his chest with associated difficulty in breathing.  This  was followed by severe, stabbing chest pains occuring the following night.  Pain radiated into the arms and was exacerbated by taking a deep breath. He developed a severe generalized headache during hospitalization which lasted 3 days.  Tx with ibuprofen. DX:  Myopericarditis. F/U in April 2006 for probable smallpox related myopericarditis.  Pt. reports being asymptomatic with the exception of a general feeling of fatigue and getting worn out more quickly than prior to the episode.  He is able to run several miles 3X/week, although his recovery is slower than it once was.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Hypoaesthesia, Myopericarditis, Nausea
Clinical narrative: Myopericarditis post SPV. See attached clinical summary. Patient is a 31 y/o, primary vaccine who was in good health until receiving smallpox vaccine on 13 Mar 03. On 24 Mar 2006 he noticed a feeling of "heaviness," described as if there was a weight" across his chest, accompanied by mild difficulty when breathing that waxed and waned for most of the day. At approximately 1:00 am the following morning, he was awakened by severe, sharp, stabbing pains occurring at the sides of his chest, radiating to the center and included both arms. He also complained of bilateral arm numbness, and nausea. He reports being unable to find a comfortable position-" standing up was worse", having some difficulty breathing-" it hurt more when I tried to take a deep breathe". He presented to the ER at hospital where an electrocardiogram showed diffuse ST segment elevation without a P-R segment depression. The T wave in lead V1 was inverted. His cardiac enzymes showed elevated CPKs with positive MB fraction and a positive troponin. He was sent to the hospital where an echocardiogram showed a low normal ejection fraction of 50-55% and was described as having a subtle wall motion abnormality of the anterolateral wall. He was airlifted and taken immediately to the cardiac catherization lab where a coronary angiography revealed normal coronary arteries. A left ventricular cineangogram showed a mild decrease in LV function but no segmental wall motion abnormalities. There was no significant mitral regurgitation. His left ventricular and diastolic pressure was elevated at 22mmHg. While hospitalized his chest discomfort ceased but he complained of severe, generalized headache - worse when he turns his head. He denied photophobia, visual changes or nausea. There were no reported meningeal signs. He was given Ibuprofen which decreased the headaches, but says"they lasted about three days". He is currently headache free.  03/20/2007 Clinical Summary and update received for dx. of Myopericarditis occuring 1 week following smallpox vax. in 2003.  Pt. initially noticed a "heaviness" in his chest with associated difficulty in breathing.  This  was followed by severe, stabbing chest pains occuring the following night.  Pain radiated into the arms and was exacerbated by taking a deep breath. He developed a severe generalized headache during hospitalization which lasted 3 days.  Tx with ibuprofen. DX:  Myopericarditis. F/U in April 2006 for probable smallpox related myopericarditis.  Pt. reports being asymptomatic with the exception of a general feeling of fatigue and getting worn out more quickly than prior to the episode.  He is able to run several miles 3X/week, although his recovery is slower than it once was.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Hypoaesthesia, Loss of consciousness, Paraesthesia, Syncope
Clinical narrative: About 3rd day after receiving HPV #2 got up at night (early AM) and was looking in mirror trying to adjust nose ring-became frustrated at fit and put swollen ring back in. On way back to bed, felt numbness and tingling in legs, then "blacked out" few minutes as friend woke her up-felt tired all day.  Later afternoon, took shower and went up to room didn't "feel right" and had tingling and numbness of legs and arms for 5-10 minutes-resolved.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia, Loss of consciousness, Paraesthesia
Clinical narrative: About 3rd day after receiving HPV #2 got up at night (early AM) and was looking in mirror trying to adjust nose ring-became frustrated at fit and put swollen ring back in. On way back to bed, felt numbness and tingling in legs, then "blacked out" few minutes as friend woke her up-felt tired all day.  Later afternoon, took shower and went up to room didn't "feel right" and had tingling and numbness of legs and arms for 5-10 minutes-resolved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Diarrhoea haemorrhagic, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 18-SEP-2006 at 15:00 was vaccinated wit a first oral dose of Rotateq (lot #654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot #AC21B055AA), a first IM dose in the right arm of ActHib (lot UE830AA and a first IM dose in the right arm of Prevnar (lot B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-DEP-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal mass, Barium double contrast, Diarrhoea haemorrhagic, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 18-SEP-2006 at 15:00 was vaccinated wit a first oral dose of Rotateq (lot #654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot #AC21B055AA), a first IM dose in the right arm of ActHib (lot UE830AA and a first IM dose in the right arm of Prevnar (lot B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-DEP-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 18-SEP-2006 at 15:00 was vaccinated wit a first oral dose of Rotateq (lot #654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot #AC21B055AA), a first IM dose in the right arm of ActHib (lot UE830AA and a first IM dose in the right arm of Prevnar (lot B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-DEP-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal mass, Barium double contrast, Diarrhoea haemorrhagic, Hospitalisation, Intussusception
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 18-SEP-2006 at 15:00 was vaccinated wit a first oral dose of Rotateq (lot #654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot #AC21B055AA), a first IM dose in the right arm of ActHib (lot UE830AA and a first IM dose in the right arm of Prevnar (lot B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-DEP-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 18-SEP-2006 at 15:00 was vaccinated wit a first oral dose of Rotateq (lot #654504/0695F). Concomitant vaccination administered that day included a first IM dose in the left arm of Pediarix (lot #AC21B055AA), a first IM dose in the right arm of ActHib (lot UE830AA and a first IM dose in the right arm of Prevnar (lot B22930F). There were no other concomitant medications. There was no illness at the time of vaccination. On 25-DEP-2006 in the PM the patient was taken to the emergency department due to vomiting and bloody diarrhea. He was found to have intussusception and was hospitalized for one day. The patient underwent an abdominal ultrasound which showed a target fluid mass in the upper mid abdomen that was consistent with intussusception. A subsequent air contrast enema confirmed the presence of the intussusception and was able to successfully reduce it. The patient's final outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HIBV, MMRV, MMRV
Symptoms: Clumsiness, Cough, Gait disturbance, Insomnia, Nasal mucosal discolouration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old female who on 16-FEB-2007 was vaccinated subcutaneously in the left thigh with one 0.5 ml dose of ProQuad (lot # 656641/1555F). Concomitant therapy included AUGMENTIN 400 mg twice daily for 10 days for an ear infection that was present at the tiem of vaccination. The nurse reported that the patient was diagnosed by the physician with " full blown chicken pox.". There are 2-3 lesions in the mouth and an unknown number of vesicles on the face, chest, back, and extremities that are in various stages. The patient was given BENADRYL by the mother prior to the appointment to the office. The patient was treated with TYLENOL with CODEINE and comfort measures were provided. It was reported by the patient's mother that "the patient was doing much better and the pox were all scabbed over." No diagnostic laboratory test were performed. A lot check was requested. Chicken pox was considered to be an other important medical event by the nurse. This is one of several cases from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HIBV, MMRV, MMRV
Symptoms: Pyrexia, Rhinorrhoea, Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old female who on 16-FEB-2007 was vaccinated subcutaneously in the left thigh with one 0.5 ml dose of ProQuad (lot # 656641/1555F). Concomitant therapy included AUGMENTIN 400 mg twice daily for 10 days for an ear infection that was present at the tiem of vaccination. The nurse reported that the patient was diagnosed by the physician with " full blown chicken pox.". There are 2-3 lesions in the mouth and an unknown number of vesicles on the face, chest, back, and extremities that are in various stages. The patient was given BENADRYL by the mother prior to the appointment to the office. The patient was treated with TYLENOL with CODEINE and comfort measures were provided. It was reported by the patient's mother that "the patient was doing much better and the pox were all scabbed over." No diagnostic laboratory test were performed. A lot check was requested. Chicken pox was considered to be an other important medical event by the nurse. This is one of several cases from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HIBV, MMRV, MMRV
Symptoms: Blister, Oral soft tissue disorder, Scab, Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old female who on 16-FEB-2007 was vaccinated subcutaneously in the left thigh with one 0.5 ml dose of ProQuad (lot # 656641/1555F). Concomitant therapy included AUGMENTIN 400 mg twice daily for 10 days for an ear infection that was present at the tiem of vaccination. The nurse reported that the patient was diagnosed by the physician with " full blown chicken pox.". There are 2-3 lesions in the mouth and an unknown number of vesicles on the face, chest, back, and extremities that are in various stages. The patient was given BENADRYL by the mother prior to the appointment to the office. The patient was treated with TYLENOL with CODEINE and comfort measures were provided. It was reported by the patient's mother that "the patient was doing much better and the pox were all scabbed over." No diagnostic laboratory test were performed. A lot check was requested. Chicken pox was considered to be an other important medical event by the nurse. This is one of several cases from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, TD
Symptoms: Laboratory test, Rash, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Seriousness Criteria Other Medically significant. Initial report received on 12 March 2007 from an other manufacturer, report number A0642334A. This manufacturer had received the original report from a physician. Verbatim from the report: "This case was reported by a physician and described the occurrence of measles-like rash in an 18-year-old male subject who was vaccinated with Havrix and Menactra for prophylaxis. The subject's medical history included scoliosis. Concurrent medications included Amoxicillin trihydrate. On 27 February 2007 the subject received the 1st dose of Havrix (0.5 ml, unknown, left deltoid) and the 1st dose of Menactra (unknown). On 1 March 2007, 2 days after vaccination with Havrix and Menactra, the subject developed a systemic "measles-like rash". He was evaluated by his physician, and treatment included Benadryl. The physician considered that the event was clinically significant (or requiring intervention). At the time of reporting, on 05 March 2007, the event was unresolved. The physician considered the event was possibly related to vaccination with Havrix. Menactra was identified by the physician as a co-suspect vaccine. The lot number reported for the Havrix vaccine was AHABV139BA, and the lot number reported for the Menactra vaccine was U1597BA. At the time of this report, the subject had not recovered.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, TD
Symptoms: Urticaria
Clinical narrative: Seriousness Criteria Other Medically significant. Initial report received on 12 March 2007 from an other manufacturer, report number A0642334A. This manufacturer had received the original report from a physician. Verbatim from the report: "This case was reported by a physician and described the occurrence of measles-like rash in an 18-year-old male subject who was vaccinated with Havrix and Menactra for prophylaxis. The subject's medical history included scoliosis. Concurrent medications included Amoxicillin trihydrate. On 27 February 2007 the subject received the 1st dose of Havrix (0.5 ml, unknown, left deltoid) and the 1st dose of Menactra (unknown). On 1 March 2007, 2 days after vaccination with Havrix and Menactra, the subject developed a systemic "measles-like rash". He was evaluated by his physician, and treatment included Benadryl. The physician considered that the event was clinically significant (or requiring intervention). At the time of reporting, on 05 March 2007, the event was unresolved. The physician considered the event was possibly related to vaccination with Havrix. Menactra was identified by the physician as a co-suspect vaccine. The lot number reported for the Havrix vaccine was AHABV139BA, and the lot number reported for the Menactra vaccine was U1597BA. At the time of this report, the subject had not recovered.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, TD
Symptoms: Rash morbilliform
Clinical narrative: Seriousness Criteria Other Medically significant. Initial report received on 12 March 2007 from an other manufacturer, report number A0642334A. This manufacturer had received the original report from a physician. Verbatim from the report: "This case was reported by a physician and described the occurrence of measles-like rash in an 18-year-old male subject who was vaccinated with Havrix and Menactra for prophylaxis. The subject's medical history included scoliosis. Concurrent medications included Amoxicillin trihydrate. On 27 February 2007 the subject received the 1st dose of Havrix (0.5 ml, unknown, left deltoid) and the 1st dose of Menactra (unknown). On 1 March 2007, 2 days after vaccination with Havrix and Menactra, the subject developed a systemic "measles-like rash". He was evaluated by his physician, and treatment included Benadryl. The physician considered that the event was clinically significant (or requiring intervention). At the time of reporting, on 05 March 2007, the event was unresolved. The physician considered the event was possibly related to vaccination with Havrix. Menactra was identified by the physician as a co-suspect vaccine. The lot number reported for the Havrix vaccine was AHABV139BA, and the lot number reported for the Menactra vaccine was U1597BA. At the time of this report, the subject had not recovered.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Computerised tomogram normal, Convulsion, Drug screen negative, Malaise
Clinical narrative: Initial report received on 12 March 2007 from another manufacturer, report number WAES0702USA04033. The initial reporter to this manufacturer was a health care professional. Verbatim from the reporter: "This is in follow-up to report (s) previously submitted on 3/5/2007. Information has been received from a physician assistant concerning a 16 year old healthy male with no known medical history who on 14-Feb-2007 was vaccinated IM in the left deltoid with a first dose of hepatitis A (lot # 656320/1281F). Concomitant vaccination the same day included a dose of Menactra given in the right deltoid. On 17-Feb-2007 the patient wasn't "feeling well" and had malaise. He went to tell his mother how he was feeling and had a seizure. He was taken to th emergency room. The CT scan of his head and urine and drug screen were normal. The patient was sent home. He had a second seizure the same day and was taken back to the emergency room and Keppra was started. The patient was not hospitalized and was treated and released. The patient was seen for follow-up at the doctor's office on 19-Feb-2007. He was seen by a neurologist on 20-Feb-2007 who changed his medication from Keppra to Topamax.  The patient is scheduled to have a neurologist work-up including an EEG and MRI. At the time of the report, the patient was recovering. There was no product quality complaint involved. Upon internal review the patient's seizure was considered to be an other important medical event. Additional information has been requested."
Age: 1.09
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMRV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old patient who on 19-FEB-2007 was vaccinated with a 2 mL oral first dose of Rotateq. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMRV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old patient who on 19-FEB-2007 was vaccinated with a 2 mL oral first dose of Rotateq. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, UNK, HEP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypoaesthesia, Nausea
Clinical narrative: Information has been received from a healthcare worker concerning a 20 year old female old female patient with no allergies who on 23-FEB-2007 was vaccinated intramuscularly in the left deltoid with one 1 mL dose of Recombivax HB (lot# 654018/0655F). There was no concomitant medication. The healthcare worker reported that the patient visited the emergency room after vaccination with Recombivax HB. The patient developed symptoms about two hours after vaccination. Her symptoms included trouble breathing, itchy skin, heaviness in the chest, nausea and headache. The patient also had swelling of the left arm and a rash on her chest to the top of her tights. Both of these symptoms lasted for 3 days. Also, the patient mentioned that her left side was tingling and numb. The patient was ordered on BENADRYL, SOLUMEDROL and famotidine during her emergency room visit. No laboratory diagnostic tests were performed. The patient had recovered on 23-FEB-2007. A product quality complaint was not involved. Trouble breathing, itchy skin, heaviness in the chest, nausea, headache, swelling of the left arm, rash on her chest to the top of her tights and the tingling and numbness sensation were considered to be other important medical events. This is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, UNK, HEP
Symptoms: Oedema peripheral, Syncope
Clinical narrative: Information has been received from a healthcare worker concerning a 20 year old female old female patient with no allergies who on 23-FEB-2007 was vaccinated intramuscularly in the left deltoid with one 1 mL dose of Recombivax HB (lot# 654018/0655F). There was no concomitant medication. The healthcare worker reported that the patient visited the emergency room after vaccination with Recombivax HB. The patient developed symptoms about two hours after vaccination. Her symptoms included trouble breathing, itchy skin, heaviness in the chest, nausea and headache. The patient also had swelling of the left arm and a rash on her chest to the top of her tights. Both of these symptoms lasted for 3 days. Also, the patient mentioned that her left side was tingling and numb. The patient was ordered on BENADRYL, SOLUMEDROL and famotidine during her emergency room visit. No laboratory diagnostic tests were performed. The patient had recovered on 23-FEB-2007. A product quality complaint was not involved. Trouble breathing, itchy skin, heaviness in the chest, nausea, headache, swelling of the left arm, rash on her chest to the top of her tights and the tingling and numbness sensation were considered to be other important medical events. This is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, UNK, HEP
Symptoms: Chest discomfort, Dyspnoea, Headache, Hypoaesthesia, Nausea
Clinical narrative: Information has been received from a healthcare worker concerning a 20 year old female old female patient with no allergies who on 23-FEB-2007 was vaccinated intramuscularly in the left deltoid with one 1 mL dose of Recombivax HB (lot# 654018/0655F). There was no concomitant medication. The healthcare worker reported that the patient visited the emergency room after vaccination with Recombivax HB. The patient developed symptoms about two hours after vaccination. Her symptoms included trouble breathing, itchy skin, heaviness in the chest, nausea and headache. The patient also had swelling of the left arm and a rash on her chest to the top of her tights. Both of these symptoms lasted for 3 days. Also, the patient mentioned that her left side was tingling and numb. The patient was ordered on BENADRYL, SOLUMEDROL and famotidine during her emergency room visit. No laboratory diagnostic tests were performed. The patient had recovered on 23-FEB-2007. A product quality complaint was not involved. Trouble breathing, itchy skin, heaviness in the chest, nausea, headache, swelling of the left arm, rash on her chest to the top of her tights and the tingling and numbness sensation were considered to be other important medical events. This is one of several reports from the same reporter. Additional information has been requested.