chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Had Menactra (.5ml) on 5/1/07. On 5/5/07 around 8pm he c/o itching. It gradually increased with hives over entire body. No trouble breathing so mom call ER they suggested 2 tab Benadryl Q 4 hrs throughout night. Within 48 hrs all hives were gone.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in jaw, Rash maculo-papular, Skin lesion
Clinical narrative: Erythematous maculo papular lesion noted over R lower jaw with pain within 3 days after Zostavax. Did not improve with Valtrex 1g ID Q 8 hrs x 7 days
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Severe swelling of L thigh down to the knee - resolved in 5 days.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Pruritus, Rash maculo-papular, Skin lesion
Clinical narrative: Itchy maculopapular lesions, generalized, x5 days. Treated with Calamine lotion, Benadryl for itchiness.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local reaction swelling and redness L deltoid region, resolved without treatment
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pain and itchiness started at the site on 5/10/07. Became progressively worse with redness. Swelling and tenderness over R upper arm. On 5/11/7 febrile, unable to move upper arm due to pain. Redness 10cm x 13cm. Induration 5cm x 3.7cm. RX Augmentin, Benadryl, cool compress.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Pain and itchiness started at the site on 5/10/07. Became progressively worse with redness. Swelling and tenderness over R upper arm. On 5/11/7 febrile, unable to move upper arm due to pain. Redness 10cm x 13cm. Induration 5cm x 3.7cm. RX Augmentin, Benadryl, cool compress.
Age: 45.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, TYP
Symptoms: Injection site pain, Medication error, Wrong drug administered
Clinical narrative: Dtap (peds) given instead of Tdap. Called Pt 5/15/07. Pt reported only minor pain at injection site.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Crying inconsolably - no treatment given. Child was never brought: for evaluation. Crying began to improve 5/12, improving daily
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Cyanosis, Erythema, Hyperhidrosis
Clinical narrative: Extreme perspiring, reddening of face, turning blue almost looking bruising around eyes, mouth, sides of face.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash, Urticaria
Clinical narrative: Rash began this morning after the vaccine. Worse at injection site (left deltoid) generalized urticarial. Treated with Benadryl. Then 1D later Prednisolone by PCP.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Full blood count
Clinical narrative: Patient had check up on 5-9-07 at 2:00 PM and received vaccines. parents took him to ER that evening for questionable seizure activity. See attached records.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician and nurse concerning a 63 year old female patient who was "immunocompromised" and on 21-NOV-2006 was vaccinated SC in the left arm with a dose of ZOSTAVAX vaccine (Merck). Subsequently the patient developed a fairly severe case of shingles. The patient has fully recovered and did not develop post-herpetic neuralgia. No additional information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. Additional information from the physician indicated that the patient developed shingles four days after vaccination on 15-NOV-2006. The patient was treated with VALTREX and VICODIN. Subsequently the patient recovered. No further information is expected.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Culture positive, Inappropriate schedule of drug administration, Staphylococcus test positive, Swelling
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 04 May 2007 from another manufacture, report# WAES0703USA00509. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 17 year old male with chronic respiratory failure (oxygen dependent), chronic swelling along scar tissue on the upper back, severe kyphoscoliosis and Klippel-Feil syndrome and a history of multiple back surgeries, cleft palate repair, atrial septal defect repair (1995) and craniotomy (1994) who on 22-FEB-2007 was vaccinated, intramuscularly into the right deltoid, with a 3 ml first dose of Pneumovax (lot #655289/0958F) concomitantly with a first dose of MENACTRA (lot #U2208AA) intramuscularly into the left deltoid. Other concomitant therapy included, PULMICORT and albuterol. On 02-MAR-2007, one of two chronic abscess on scar tissue on the upper back ruptured and drained pus and blood. On 05-MAR-2007, culture of the back abscess revealed scant growth of staphylococcus aureus sensitive to CIPRO, amoxicillin (+) clavulanate potassium, cefazolin, clindamycin, oxacillin sodium, etc. On 05-MAR-2007, the second chronic abscess on scar tissue on the upper back started draining. At the time of the report, the patient had not recovered. The reporting physician considered chronic abscess on scar tissue on upper back ruptured and second abscess started draining to be other important medical event. No further information is available."
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Abscess rupture, Culture positive, Incorrect dose administered, Staphylococcal abscess
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 04 May 2007 from another manufacture, report# WAES0703USA00509. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 17 year old male with chronic respiratory failure (oxygen dependent), chronic swelling along scar tissue on the upper back, severe kyphoscoliosis and Klippel-Feil syndrome and a history of multiple back surgeries, cleft palate repair, atrial septal defect repair (1995) and craniotomy (1994) who on 22-FEB-2007 was vaccinated, intramuscularly into the right deltoid, with a 3 ml first dose of Pneumovax (lot #655289/0958F) concomitantly with a first dose of MENACTRA (lot #U2208AA) intramuscularly into the left deltoid. Other concomitant therapy included, PULMICORT and albuterol. On 02-MAR-2007, one of two chronic abscess on scar tissue on the upper back ruptured and drained pus and blood. On 05-MAR-2007, culture of the back abscess revealed scant growth of staphylococcus aureus sensitive to CIPRO, amoxicillin (+) clavulanate potassium, cefazolin, clindamycin, oxacillin sodium, etc. On 05-MAR-2007, the second chronic abscess on scar tissue on the upper back started draining. At the time of the report, the patient had not recovered. The reporting physician considered chronic abscess on scar tissue on upper back ruptured and second abscess started draining to be other important medical event. No further information is available."
Age: 17.0
Sex: M
Vaccine: MNQ, PPV, MNQ, PPV, MNQ, PPV
Symptoms: Abscess drainage, Abscess rupture, Culture positive, Culture wound positive, Staphylococcal abscess
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 04 May 2007 from another manufacture, report# WAES0703USA00509. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 17 year old male with chronic respiratory failure (oxygen dependent), chronic swelling along scar tissue on the upper back, severe kyphoscoliosis and Klippel-Feil syndrome and a history of multiple back surgeries, cleft palate repair, atrial septal defect repair (1995) and craniotomy (1994) who on 22-FEB-2007 was vaccinated, intramuscularly into the right deltoid, with a 3 ml first dose of Pneumovax (lot #655289/0958F) concomitantly with a first dose of MENACTRA (lot #U2208AA) intramuscularly into the left deltoid. Other concomitant therapy included, PULMICORT and albuterol. On 02-MAR-2007, one of two chronic abscess on scar tissue on the upper back ruptured and drained pus and blood. On 05-MAR-2007, culture of the back abscess revealed scant growth of staphylococcus aureus sensitive to CIPRO, amoxicillin (+) clavulanate potassium, cefazolin, clindamycin, oxacillin sodium, etc. On 05-MAR-2007, the second chronic abscess on scar tissue on the upper back started draining. At the time of the report, the patient had not recovered. The reporting physician considered chronic abscess on scar tissue on upper back ruptured and second abscess started draining to be other important medical event. No further information is available."
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Explorative laparotomy, Intussusception, Laparotomy
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA04523. Verbatim from the report: "Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and has surgery." "Follow-up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot# AC21B069AA), a third dose of ACTHIB (Lot# B08678K). The patient was vaccinated with the first dose of Rotateq (Lot# 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and blood mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/labarotomy showed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 04-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. Additional information has been requested. ActHib lot# UF021AB corresponds to manufacturer lot# Z0908-2.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal mass, Barium enema, Colectomy, Haematochezia, Intussusception
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA04523. Verbatim from the report: "Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and has surgery." "Follow-up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot# AC21B069AA), a third dose of ACTHIB (Lot# B08678K). The patient was vaccinated with the first dose of Rotateq (Lot# 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and blood mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/labarotomy showed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 04-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. Additional information has been requested. ActHib lot# UF021AB corresponds to manufacturer lot# Z0908-2.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Mucous stools, Surgery, Tenderness, Ultrasound abdomen abnormal
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA04523. Verbatim from the report: "Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and has surgery." "Follow-up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot# AC21B069AA), a third dose of ACTHIB (Lot# B08678K). The patient was vaccinated with the first dose of Rotateq (Lot# 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and blood mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/labarotomy showed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 04-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. Additional information has been requested. ActHib lot# UF021AB corresponds to manufacturer lot# Z0908-2.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA04523. Verbatim from the report: "Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and has surgery." "Follow-up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot# AC21B069AA), a third dose of ACTHIB (Lot# B08678K). The patient was vaccinated with the first dose of Rotateq (Lot# 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and blood mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/labarotomy showed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 04-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. Additional information has been requested. ActHib lot# UF021AB corresponds to manufacturer lot# Z0908-2.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Surgery, Tenderness, Vomiting
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA04523. Verbatim from the report: "Information has been received concerning a 6-month-old patient who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). On 03-FEB-2007 the patient experienced intussusception and has surgery." "Follow-up information received concerning a previously health infant who on 27-DEC-2006 was vaccinated with a second dose of Rotateq (Lot# 655082/0779F). Concomitant vaccinations that day included a third dose of PEDIARIX (Lot# AC21B069AA), a third dose of ACTHIB (Lot# B08678K). The patient was vaccinated with the first dose of Rotateq (Lot# 655050/0778F) within 4 weeks of 27-DEC-2006. Subsequently, the patient developed emesis and blood mucoid stools. Upon physician exam, all was within normal limits except for a large palpable mass in the mid left abdomen which was mobile, firm, and somewhat tender to palpation. A barium enema/labarotomy showed intussusception. On 03-FEB-2007, 38 days post vaccination, the patient was hospitalized for intussusception. On 04-FEB-2007, an exploratory laparotomy was done with right hemicolectomy and partial ilectomy. Diagnosis intussusception status post right hemicolectomy. The patient was discharged on 10-FEB-2007. The patient recovered. Additional information has been requested. ActHib lot# UF021AB corresponds to manufacturer lot# Z0908-2.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Bone pain, Erythema, Gait disturbance, Hypokinesia, Myalgia
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a registered nurse concerning a 65 year old male physician who on an unspecified date was vaccinated with one dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced severe swelling at the injection site which was prolonged and reached to his elbow. It was reorted that he experienced redness and swelling on the left upper arm extending to the forearms, extensive erythema from mid upper to mid lower arm and significant soft tissue edema over dorsum of upper arm on elecranon process of the elbow. No antibiotics were needed. On 01-MAR-2007, the physician recovered. There was no product quality complaint  involved. No further information was provided. Unspecified medical attention was sought and it was reported that the patient was recovering on therapy. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Oedema peripheral, Pain
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a registered nurse concerning a 65 year old male physician who on an unspecified date was vaccinated with one dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced severe swelling at the injection site which was prolonged and reached to his elbow. It was reorted that he experienced redness and swelling on the left upper arm extending to the forearms, extensive erythema from mid upper to mid lower arm and significant soft tissue edema over dorsum of upper arm on elecranon process of the elbow. No antibiotics were needed. On 01-MAR-2007, the physician recovered. There was no product quality complaint  involved. No further information was provided. Unspecified medical attention was sought and it was reported that the patient was recovering on therapy. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Erythema, Generalised erythema, Injection site swelling, Oedema, Oedema peripheral
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a registered nurse concerning a 65 year old male physician who on an unspecified date was vaccinated with one dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced severe swelling at the injection site which was prolonged and reached to his elbow. It was reorted that he experienced redness and swelling on the left upper arm extending to the forearms, extensive erythema from mid upper to mid lower arm and significant soft tissue edema over dorsum of upper arm on elecranon process of the elbow. No antibiotics were needed. On 01-MAR-2007, the physician recovered. There was no product quality complaint  involved. No further information was provided. Unspecified medical attention was sought and it was reported that the patient was recovering on therapy. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception, Laboratory test, Ultrasound scan
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report WAES0704USA04528. Verbatim from the report: "Information has been received concerning  a 14-week-old patient who on 23-JAN-2007 was vaccinated with the a first dose of Rotateq (Lot# 655407/1115F). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done." On 23-JAN-2007, the patient was vaccinated with a first dose Rotateq (Lot# 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot# AC21B089AA), ACTHIB (Lot#UF052AA), and PREVNAR (Lot# B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physical exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Blood cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. Additional information has been requested." ActHib Lot# UF052AA corresponds to manufacturer lot# Z0992-2.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium enema, Blood culture negative, Dehydration, Diarrhoea haemorrhagic
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report WAES0704USA04528. Verbatim from the report: "Information has been received concerning  a 14-week-old patient who on 23-JAN-2007 was vaccinated with the a first dose of Rotateq (Lot# 655407/1115F). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done." On 23-JAN-2007, the patient was vaccinated with a first dose Rotateq (Lot# 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot# AC21B089AA), ACTHIB (Lot#UF052AA), and PREVNAR (Lot# B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physical exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Blood cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. Additional information has been requested." ActHib Lot# UF052AA corresponds to manufacturer lot# Z0992-2.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report WAES0704USA04528. Verbatim from the report: "Information has been received concerning  a 14-week-old patient who on 23-JAN-2007 was vaccinated with the a first dose of Rotateq (Lot# 655407/1115F). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done." On 23-JAN-2007, the patient was vaccinated with a first dose Rotateq (Lot# 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot# AC21B089AA), ACTHIB (Lot#UF052AA), and PREVNAR (Lot# B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physical exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Blood cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. Additional information has been requested." ActHib Lot# UF052AA corresponds to manufacturer lot# Z0992-2.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Blood culture negative, Dehydration, Diarrhoea haemorrhagic
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report WAES0704USA04528. Verbatim from the report: "Information has been received concerning  a 14-week-old patient who on 23-JAN-2007 was vaccinated with the a first dose of Rotateq (Lot# 655407/1115F). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done." On 23-JAN-2007, the patient was vaccinated with a first dose Rotateq (Lot# 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot# AC21B089AA), ACTHIB (Lot#UF052AA), and PREVNAR (Lot# B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physical exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Blood cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. Additional information has been requested." ActHib Lot# UF052AA corresponds to manufacturer lot# Z0992-2.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Laboratory test, Ultrasound scan abnormal
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report WAES0704USA04528. Verbatim from the report: "Information has been received concerning  a 14-week-old patient who on 23-JAN-2007 was vaccinated with the a first dose of Rotateq (Lot# 655407/1115F). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done." On 23-JAN-2007, the patient was vaccinated with a first dose Rotateq (Lot# 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot# AC21B089AA), ACTHIB (Lot#UF052AA), and PREVNAR (Lot# B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physical exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Blood cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. Additional information has been requested." ActHib Lot# UF052AA corresponds to manufacturer lot# Z0992-2.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report WAES0704USA04528. Verbatim from the report: "Information has been received concerning  a 14-week-old patient who on 23-JAN-2007 was vaccinated with the a first dose of Rotateq (Lot# 655407/1115F). On 10-MAR-2007 the patient experienced intussusception. A barium enema was done." On 23-JAN-2007, the patient was vaccinated with a first dose Rotateq (Lot# 655407/1115F). Concomitant vaccinations that day included PEDIARIX (Lot# AC21B089AA), ACTHIB (Lot#UF052AA), and PREVNAR (Lot# B08666A). On 10-MAR-2007, 46 days post vaccination, the patient developed intussusception and was hospitalized. The patient was noted to have a 2 day history of bloody stools. Physical exam was within normal limits, abdomen soft, nondistended, and nontender. Admission diagnosis included bloody diarrhea, dehydration, abdominal pain, and vomiting. Intussusception was diagnosed by ultrasound. The patient was treated with enema, and was noted to have an ileocolonic intussusception with successful reduction by air enema. Labs were within normal limits. Blood cultures were negative. The patient recovered on 13-MAR-2007 and was discharged from the hospital on 20-MAR-2007. Additional information has been requested." ActHib Lot# UF052AA corresponds to manufacturer lot# Z0992-2.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Zostavax. Subsequently the patient developed a moderately severe rash at the injection site and elsewhere on the patient's body. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/14/2007. Initial information has been received from a health professional concerning a patient who was vaccinated with a dose of ZOSTAVAX (Oka.Merck). Follow-up information has been received from a physician concerning this 76 year old female with no pertinent medical history who on 14-MAR-2007 was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (lot # 656412/1476F). There was no illness at the time of injection site. It was also noted that the patient had a "reaction Type III" and cellulitis of the left upper arm. Unspecified medical attention was sought. No further information was provided. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Zostavax. Subsequently the patient developed a moderately severe rash at the injection site and elsewhere on the patient's body. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/14/2007. Initial information has been received from a health professional concerning a patient who was vaccinated with a dose of ZOSTAVAX (Oka.Merck). Follow-up information has been received from a physician concerning this 76 year old female with no pertinent medical history who on 14-MAR-2007 was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (lot # 656412/1476F). There was no illness at the time of injection site. It was also noted that the patient had a "reaction Type III" and cellulitis of the left upper arm. Unspecified medical attention was sought. No further information was provided. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Nausea
Clinical narrative: Information has been received from a 88 year old male consumer with no reported medical history or allergies who on 12-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included lisinopril (manufacturer unknown), clopidogrel bisulfate, Protonix, losartan potassium-HCTZ, Norvasc, "prevestatin" and Lyrica. Around 4 days after vaccination, on approximately 16-MAR-2007, the patient developed shingles and nausea. Unspecified medical attention was sought. There were no laboratory tests performed. Subsequently, about "a week after the outbreak" the patient recovered. There was no product complaint involved. No further information is available.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nausea
Clinical narrative: Information has been received from a 88 year old male consumer with no reported medical history or allergies who on 12-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included lisinopril (manufacturer unknown), clopidogrel bisulfate, Protonix, losartan potassium-HCTZ, Norvasc, "prevestatin" and Lyrica. Around 4 days after vaccination, on approximately 16-MAR-2007, the patient developed shingles and nausea. Unspecified medical attention was sought. There were no laboratory tests performed. Subsequently, about "a week after the outbreak" the patient recovered. There was no product complaint involved. No further information is available.
Age: 48.0
Sex: F
Vaccine: HEPA, TD, HEPA, TD
Symptoms: Hemiparesis, Hypoaesthesia, Multiple sclerosis
Clinical narrative: Initial report received on 02 May 2007 from an other manufacturer, report number A06456B9A. The initial report to the other manufacturer was a physician. Verbatim from report: "This case was reported by a physician and described the occurrence of weakness in a 47-year-old female subject who was vaccinated with Havrix, Tetanus + diphtheria toxoids for prophylaxis. On 28 June 2006 the subject received 1st dose of Havrix at 0.5 mL in the left arm and a booster dose of Tetanus + diphtheria toxoids. Within approximately 7 weeks of vaccination with Havrix and Tetanus + diphtheria toxoids, on 13 August 2006, the subject experienced weakness and numbness primarily on the left side in both the upper and lower extremities. At the time, no other cause could be identified for the events other than possible multiple sclerosis. The physician considered the events were disabling. No treatment was required and the events resolved approximately 6 months later on 16 February 2007. In the reporter's opinion, the events were possibly related to treatment with Havrix. MRI of the brain and thoracic C-spine were negative."A search of the manufacturer product system revealed a lot number for the Tetanus + diphtheria toxoid vaccine (Decavac) to be U1731AA.
Age: 48.0
Sex: F
Vaccine: HEPA, TD, HEPA, TD
Symptoms: Hypoaesthesia, Multiple sclerosis, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial report received on 02 May 2007 from an other manufacturer, report number A06456B9A. The initial report to the other manufacturer was a physician. Verbatim from report: "This case was reported by a physician and described the occurrence of weakness in a 47-year-old female subject who was vaccinated with Havrix, Tetanus + diphtheria toxoids for prophylaxis. On 28 June 2006 the subject received 1st dose of Havrix at 0.5 mL in the left arm and a booster dose of Tetanus + diphtheria toxoids. Within approximately 7 weeks of vaccination with Havrix and Tetanus + diphtheria toxoids, on 13 August 2006, the subject experienced weakness and numbness primarily on the left side in both the upper and lower extremities. At the time, no other cause could be identified for the events other than possible multiple sclerosis. The physician considered the events were disabling. No treatment was required and the events resolved approximately 6 months later on 16 February 2007. In the reporter's opinion, the events were possibly related to treatment with Havrix. MRI of the brain and thoracic C-spine were negative."A search of the manufacturer product system revealed a lot number for the Tetanus + diphtheria toxoid vaccine (Decavac) to be U1731AA.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old patient with arthritis who was vaccinated with a 0.65ml dose of Zostavax. Concomitant therapy included methotrexate. Subsequently the patient experienced hugh rash on the upper arm and a fever of 101 F to 102 F, the next day after vaccination. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested. Follow-up information received from the pharmacist indicating that the patient was a 78 year old female who received a subcutaneous dose of Zostavax (Oka/Merck) (Lot #656607/0163U) on 27-Mar-2007. Concomitant therapy included PRINIVIL, PREMARIN and LEVAQUIN. The patient required a doctor visit. The patient developed a rash that involved the entire upper arm. Also developed a low grade fever of 101.f. Patient reported "not feeling very well". Patient was started on antibiotics and steroid taper 2 days after vaccination. The event resolved on 02-APR-2007. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Malaise, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old patient with arthritis who was vaccinated with a 0.65ml dose of Zostavax. Concomitant therapy included methotrexate. Subsequently the patient experienced hugh rash on the upper arm and a fever of 101 F to 102 F, the next day after vaccination. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested. Follow-up information received from the pharmacist indicating that the patient was a 78 year old female who received a subcutaneous dose of Zostavax (Oka/Merck) (Lot #656607/0163U) on 27-Mar-2007. Concomitant therapy included PRINIVIL, PREMARIN and LEVAQUIN. The patient required a doctor visit. The patient developed a rash that involved the entire upper arm. Also developed a low grade fever of 101.f. Patient reported "not feeling very well". Patient was started on antibiotics and steroid taper 2 days after vaccination. The event resolved on 02-APR-2007. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, Malaise, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old patient with arthritis who was vaccinated with a 0.65ml dose of Zostavax. Concomitant therapy included methotrexate. Subsequently the patient experienced hugh rash on the upper arm and a fever of 101 F to 102 F, the next day after vaccination. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested. Follow-up information received from the pharmacist indicating that the patient was a 78 year old female who received a subcutaneous dose of Zostavax (Oka/Merck) (Lot #656607/0163U) on 27-Mar-2007. Concomitant therapy included PRINIVIL, PREMARIN and LEVAQUIN. The patient required a doctor visit. The patient developed a rash that involved the entire upper arm. Also developed a low grade fever of 101.f. Patient reported "not feeling very well". Patient was started on antibiotics and steroid taper 2 days after vaccination. The event resolved on 02-APR-2007. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Abnormal faeces, Barium double contrast, Explorative laparotomy, Intussusception
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA01794. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 23-weed-old male with no pre-existing physician-diagnosed allergies, birth defect, medical conditions who in December 2006 and 27-FEB-2007 (Lot# 655296/0979F) was vaccinated PO with the first and second 2mL doses of Rotateq. Concomitant therapy that day included a second dose of PEDIARIX (Lot# AC21B097AB) administered IM in the right thigh, a second dose of ACTHIB (Lot# UF014AA) administered IM in the right thigh, and a second dose of PREVNAR (Lot# B08674) administered IM in the left thigh. On 07-APR-2007 the patient experienced intussusception and was hospitalized. The patient has surgery to correct the problem and was recovering in the hospital at the time of the report. No further information was provided." "Follow up information received indicated that on 08-APR-2007 the patient developed abdomen pain, and "Carren and gelley" stools, and was diagnosed with intussusception and was hospitalized. The intussusception was not able to be reduced via gastrgarafin enema, and the patient was brought to the operating room for an exploratory laporoscopy. The intussusception was reduced manually. The patient was recovered." "A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. The event was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested." ActHib lot# UF014AA corresponds to manufacturer lot# Z0814-2.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Surgery
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA01794. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 23-weed-old male with no pre-existing physician-diagnosed allergies, birth defect, medical conditions who in December 2006 and 27-FEB-2007 (Lot# 655296/0979F) was vaccinated PO with the first and second 2mL doses of Rotateq. Concomitant therapy that day included a second dose of PEDIARIX (Lot# AC21B097AB) administered IM in the right thigh, a second dose of ACTHIB (Lot# UF014AA) administered IM in the right thigh, and a second dose of PREVNAR (Lot# B08674) administered IM in the left thigh. On 07-APR-2007 the patient experienced intussusception and was hospitalized. The patient has surgery to correct the problem and was recovering in the hospital at the time of the report. No further information was provided." "Follow up information received indicated that on 08-APR-2007 the patient developed abdomen pain, and "Carren and gelley" stools, and was diagnosed with intussusception and was hospitalized. The intussusception was not able to be reduced via gastrgarafin enema, and the patient was brought to the operating room for an exploratory laporoscopy. The intussusception was reduced manually. The patient was recovered." "A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. The event was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested." ActHib lot# UF014AA corresponds to manufacturer lot# Z0814-2.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA01794. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 23-weed-old male with no pre-existing physician-diagnosed allergies, birth defect, medical conditions who in December 2006 and 27-FEB-2007 (Lot# 655296/0979F) was vaccinated PO with the first and second 2mL doses of Rotateq. Concomitant therapy that day included a second dose of PEDIARIX (Lot# AC21B097AB) administered IM in the right thigh, a second dose of ACTHIB (Lot# UF014AA) administered IM in the right thigh, and a second dose of PREVNAR (Lot# B08674) administered IM in the left thigh. On 07-APR-2007 the patient experienced intussusception and was hospitalized. The patient has surgery to correct the problem and was recovering in the hospital at the time of the report. No further information was provided." "Follow up information received indicated that on 08-APR-2007 the patient developed abdomen pain, and "Carren and gelley" stools, and was diagnosed with intussusception and was hospitalized. The intussusception was not able to be reduced via gastrgarafin enema, and the patient was brought to the operating room for an exploratory laporoscopy. The intussusception was reduced manually. The patient was recovered." "A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. The event was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested." ActHib lot# UF014AA corresponds to manufacturer lot# Z0814-2.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Abnormal faeces, Intussusception, Laparoscopy, Surgery
Clinical narrative: Initial report received on 04 May 2007 from another manufacturer, report# WAES0704USA01794. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 23-weed-old male with no pre-existing physician-diagnosed allergies, birth defect, medical conditions who in December 2006 and 27-FEB-2007 (Lot# 655296/0979F) was vaccinated PO with the first and second 2mL doses of Rotateq. Concomitant therapy that day included a second dose of PEDIARIX (Lot# AC21B097AB) administered IM in the right thigh, a second dose of ACTHIB (Lot# UF014AA) administered IM in the right thigh, and a second dose of PREVNAR (Lot# B08674) administered IM in the left thigh. On 07-APR-2007 the patient experienced intussusception and was hospitalized. The patient has surgery to correct the problem and was recovering in the hospital at the time of the report. No further information was provided." "Follow up information received indicated that on 08-APR-2007 the patient developed abdomen pain, and "Carren and gelley" stools, and was diagnosed with intussusception and was hospitalized. The intussusception was not able to be reduced via gastrgarafin enema, and the patient was brought to the operating room for an exploratory laporoscopy. The intussusception was reduced manually. The patient was recovered." "A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released. The event was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested." ActHib lot# UF014AA corresponds to manufacturer lot# Z0814-2.