chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a 22 year old female with sulfonamide allergy to an unspecified pertussis vaccine and a history of kidney stone and other kidney problems who in January 2008, was vaccinated with the first dose of GARDASIL (lot#, dose and route not reported).  Concomitant therapy included YAZ and ZOLOFT.  In January 2008, after first dose of GARDASIL the patient reported that the injection site was very swollen and painful for approximately 4 weeks.  She noted that after the second dose of GARDASIL (lot #, date, dose and route not reported) the injection site became swollen and painful.  The patient also noted that 5-6 hours after vaccination she developed a fever, began vomiting, and proceeded to feel nauseous and sick for approximately 3 weeks.  At the time of the report, the patient reported that she no longer felt sick; however the injection site was still swollen and painful.  Unspecified medical attention was sought.  No further information was available.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient with no medical history or known drug reactions who was vaccinated (date unknown) with a first dose of GARDASIL (lot # not provided).  There was no concomitant medication.  The patient was reported as HPV positive (PAP smear found cell abnormality).  The patient contacted the physician for unknown medical attention.  The patient has not recovered.  There was no product quality complaint involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Chills, Erythema, Herpes simplex serology negative, Herpes virus infection
Clinical narrative: Information has been received from a physician concerning a 13 year old female, with no relevant medical history and no known drug allergies, who on 16-MAY-2008 ("two weeks ago") was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). There was no concomitant medication. On 28-MAY-2008 the patient experienced multiple herpetic lesions, inguinal adenopathy and fever. The patient sought unspecified medical attention by seeing the physician. As of the time of third report, patient's multiple herpetic lesions and inguinal adenopathy and fever persisted. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previoulsy submitted on 6/13/2008. Information has been received from a physician concerning a 13 year old female, with a history of inguinal hernia repair, no history of type I herpes and no known drug allergies, who on 16-MAY-2008 "two weeks ago" was vaccinated with her first dose of GARDASIL vaccine (Lot #, site and route not reported). There was no concomitant medication. The patient had not been exposed to anybody witha herpes outbreak. On 28-MAY-2008 the patient felt like she had the flu, fever, chills and muscle pain. On 29-MAY-2008, the patient visitied the physician. The patient described the burning pain as sharp, "not too bad" it was worse with urination and more painful that day than the previous day. Physicial findings included: Bilateral inguinal adenopathies with erythema over the left inguinal area. The lymphnodes were not tender. The labia majora and minora, right more than left, were swollen with multiple sharply delineated "kissing" ulcerations of different sizes. The center of the unlcerations was covered with some fibrin and there were some dialted, purple colored blood vessels radiating off the edge of the ulcerations. The hyman appeared intact and there was no vaginal discharge. The patient denied intercourse and oral sex. The patient was diagnosed with vulvar ulcorations. VALTREX and XYLOCAINE were prescribed for the patient. Herpes simplex virus (HSV) culture was negative. As of 30-MAY-2008, the patient was not recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza, Labia enlarged, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Information has been received from a physician concerning a 13 year old female, with no relevant medical history and no known drug allergies, who on 16-MAY-2008 ("two weeks ago") was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). There was no concomitant medication. On 28-MAY-2008 the patient experienced multiple herpetic lesions, inguinal adenopathy and fever. The patient sought unspecified medical attention by seeing the physician. As of the time of third report, patient's multiple herpetic lesions and inguinal adenopathy and fever persisted. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previoulsy submitted on 6/13/2008. Information has been received from a physician concerning a 13 year old female, with a history of inguinal hernia repair, no history of type I herpes and no known drug allergies, who on 16-MAY-2008 "two weeks ago" was vaccinated with her first dose of GARDASIL vaccine (Lot #, site and route not reported). There was no concomitant medication. The patient had not been exposed to anybody witha herpes outbreak. On 28-MAY-2008 the patient felt like she had the flu, fever, chills and muscle pain. On 29-MAY-2008, the patient visitied the physician. The patient described the burning pain as sharp, "not too bad" it was worse with urination and more painful that day than the previous day. Physicial findings included: Bilateral inguinal adenopathies with erythema over the left inguinal area. The lymphnodes were not tender. The labia majora and minora, right more than left, were swollen with multiple sharply delineated "kissing" ulcerations of different sizes. The center of the unlcerations was covered with some fibrin and there were some dialted, purple colored blood vessels radiating off the edge of the ulcerations. The hyman appeared intact and there was no vaginal discharge. The patient denied intercourse and oral sex. The patient was diagnosed with vulvar ulcorations. VALTREX and XYLOCAINE were prescribed for the patient. Herpes simplex virus (HSV) culture was negative. As of 30-MAY-2008, the patient was not recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vulval ulceration
Clinical narrative: Information has been received from a physician concerning a 13 year old female, with no relevant medical history and no known drug allergies, who on 16-MAY-2008 ("two weeks ago") was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). There was no concomitant medication. On 28-MAY-2008 the patient experienced multiple herpetic lesions, inguinal adenopathy and fever. The patient sought unspecified medical attention by seeing the physician. As of the time of third report, patient's multiple herpetic lesions and inguinal adenopathy and fever persisted. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previoulsy submitted on 6/13/2008. Information has been received from a physician concerning a 13 year old female, with a history of inguinal hernia repair, no history of type I herpes and no known drug allergies, who on 16-MAY-2008 "two weeks ago" was vaccinated with her first dose of GARDASIL vaccine (Lot #, site and route not reported). There was no concomitant medication. The patient had not been exposed to anybody witha herpes outbreak. On 28-MAY-2008 the patient felt like she had the flu, fever, chills and muscle pain. On 29-MAY-2008, the patient visitied the physician. The patient described the burning pain as sharp, "not too bad" it was worse with urination and more painful that day than the previous day. Physicial findings included: Bilateral inguinal adenopathies with erythema over the left inguinal area. The lymphnodes were not tender. The labia majora and minora, right more than left, were swollen with multiple sharply delineated "kissing" ulcerations of different sizes. The center of the unlcerations was covered with some fibrin and there were some dialted, purple colored blood vessels radiating off the edge of the ulcerations. The hyman appeared intact and there was no vaginal discharge. The patient denied intercourse and oral sex. The patient was diagnosed with vulvar ulcorations. VALTREX and XYLOCAINE were prescribed for the patient. Herpes simplex virus (HSV) culture was negative. As of 30-MAY-2008, the patient was not recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a 23 year old female with genital warts and a history of papilloma viral infection who on 21-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot # not provided).  On 21-APR-2008 the patient reported she went to see her physician because she was "sick" (NOS) and was prescribed unspecified antibiotics.  She reported that she mentioned to her physician that she was due for her second dose of GARDASIL and was then given her second dose of GARDASIL (Lot # not provided) that same day.  On an unspecified date the patient returned to the clinic because she was concerned that she had received her second dose of GARDASIL when she was "sick and on antibiotics".  She was seen by a different physician who she reported stated that "she should not have taken the second dose of the vaccine because she was sick and her immune system was low at that time".  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Addison's disease
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on unspecified date was vaccinated with dose 1 and dose 2 of GARDASIL (Lot #'s not provided). Subsequently, on an unspecified date the patient was diagnosed with Addison's disease. Additional information has been requested.  07/14/2008 MR received for DOS 5/08-12/2008 with D/C DX: Addison's Disease, postural hypotension and hypoxia. Pt presented to ER with 1 wk hx of episodes of shortness of breath with tachycardia, most recently accompanied by emesis (last 3 days) and sometimes pain. BP did drop and HR&RR up with orthostatics.  With ambulation O2 sat dropped to 85%.   Treated with Cortisone. To f/u as outpt. 9/25/2008 MR received from PCP including various hospital diagnostics. Seen in F/U for above hospital visit./
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Palpitations, Pyrexia
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/13/08. Information has been received from a physician concerning a female with an upper respiratory infection who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not reported).  Subsequently, 12 or more hours after the vaccination, the patient experienced palpitations. The patient also had a cold at the time but had not taken any medication. She also had a low grade fever attributed to the cold. The patient's outcome was not reported.  Additional information has been requested. Follow up information received from the physicians office stated that the patient was never treated with GARDASIL. It was reported that the patient had received "other vaccines not manufactured by Merck" details of the "other vaccines" was not provided. On an unspecified date the patient had an electrocardiogram which was within normal limits and the patient was considered to have recovered from the event.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old white female with penicillin allergy and postpartum disorder at the time of vaccination who on 05-MAY-2008 was vaccinated with GARDASIL (lot# 659182/1757U) IM in the right deltoid at 4 PM. On 06-MAY-2008 at 11 AM the patient experienced hives. The physician recommended the patient to take BENADRYL and to call if not better. At the time of reporting it was unknown if the patient had recovered. The physician discontinued GARDASIL. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Feeling hot, Influenza like illness, Pain in extremity, Rash
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of GARDASIL (lot not reported).  After receiving the first dose the patient experienced a rash on her abdomen and her arm.  The patient took some BENADRYL and got prednisone (manufacturer unknown).  The patient came back to the physician's office because she wanted to get the second shot of GARDASIL (lot not reported).  About a week after the shot the patient broke out in to even more extensive rash and had to get prednisone again.  The nurse reported she will not administer the third dose of GARDASIL.  The patient's status was not reported.  Additional information has been requested.  02/18/2010 Follow up informatino was received. The patient was vaccinated with the first dose of GARDASIL (lot 659699/1086U) via IM in the left deltoid on 21-FEB-2008. The patient was vaccinated with the second dose of GARDASIL (lot 655604/0052X) via IM in the left deltoid on 28-APR-2008. On 23-FEB-2008 after the frist injections the patient developed a rash across abdomen and her legs. On 5-MAY-2008 the patient developed a rash on her right arm and shoulder and a burning feeling-cold type symptoms. The patient recovered on a unspecified date. The patient has penicillin allergy. No further information is expected. Follow-up information was received which reported that the 19 year patient experienced an adverse event after the first dose of GARDASIL. The patient then received a second dose of GARDASIL and had the same adverse event but to a great extend. The patient experienced a rash starting on her arms, then processing down her abdomen and legs. She also had flu like symptoms and joint and arm pain. The patient was prescribed a course of steroids, BENDADRYL and ATIVAN. The registered nurse considered the rash across abdomen and on her legs, a rash on her right arm and shoulder and a burning feeling - cold typ/flu-like symptoms to be an other important medical event. This is an amended report. The nurse considered the rash across the abdomen, on her legs, a rash on her right arm and shoulder, burning feeling, cold type/flue-like symptoms to be other important medical events. Follow-up information was received from a registered nurse (R.N.) who reported that she did not known if the patient recovered from arm pain and joint pain. The nurse did not indicate if the patient would receive the third dose of GARDASIL. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Skin burning sensation, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of GARDASIL (lot not reported).  After receiving the first dose the patient experienced a rash on her abdomen and her arm.  The patient took some BENADRYL and got prednisone (manufacturer unknown).  The patient came back to the physician's office because she wanted to get the second shot of GARDASIL (lot not reported).  About a week after the shot the patient broke out in to even more extensive rash and had to get prednisone again.  The nurse reported she will not administer the third dose of GARDASIL.  The patient's status was not reported.  Additional information has been requested.  02/18/2010 Follow up informatino was received. The patient was vaccinated with the first dose of GARDASIL (lot 659699/1086U) via IM in the left deltoid on 21-FEB-2008. The patient was vaccinated with the second dose of GARDASIL (lot 655604/0052X) via IM in the left deltoid on 28-APR-2008. On 23-FEB-2008 after the frist injections the patient developed a rash across abdomen and her legs. On 5-MAY-2008 the patient developed a rash on her right arm and shoulder and a burning feeling-cold type symptoms. The patient recovered on a unspecified date. The patient has penicillin allergy. No further information is expected. Follow-up information was received which reported that the 19 year patient experienced an adverse event after the first dose of GARDASIL. The patient then received a second dose of GARDASIL and had the same adverse event but to a great extend. The patient experienced a rash starting on her arms, then processing down her abdomen and legs. She also had flu like symptoms and joint and arm pain. The patient was prescribed a course of steroids, BENDADRYL and ATIVAN. The registered nurse considered the rash across abdomen and on her legs, a rash on her right arm and shoulder and a burning feeling - cold typ/flu-like symptoms to be an other important medical event. This is an amended report. The nurse considered the rash across the abdomen, on her legs, a rash on her right arm and shoulder, burning feeling, cold type/flue-like symptoms to be other important medical events. Follow-up information was received from a registered nurse (R.N.) who reported that she did not known if the patient recovered from arm pain and joint pain. The nurse did not indicate if the patient would receive the third dose of GARDASIL. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was inadvertently vaccinated with an unspecified dose of GARDASIL (lot number unspecified) in the hip. Subsequently the patient experienced numbness on her leg. The patient sought unspecified medical treatment. The patient's numbness in leg persisted. The patient was re-evaluated after 2 days. Her symptoms did not improve. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a health professional concerning a female teenager who in April 2008 (reported as a "month ago") was vaccinated intramuscularly with a first dose of GARDASIL (Lot # not reported).  Within 24-48 hours of vaccination, the patient experienced nausea, dizziness and feeling faint for a day.  Therapy with GARDASIL was discontinued, as her mother refused to allow her to receive the second and third doses.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/13/2008. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Information has been received from a physician concerning an unspecified number of female patients who were administered vaccinations with GARDASIL (Lot# not reported) in the buttocks. The patients outcomes are unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 month old female with 3-methylcrotonyl-coenzyme A (CoA) carboxylase deficiency who on 05-MAY-2008 was inadvertently vaccinated PO with her first 2.0 ml dose of ROTATEQ (lot # 660377/0274X). The child was not experiencing any reaction to the vaccine at this time. The patient sought unspecified medical attention at the office. No other ROTATEQ will be administered to this child. There was no product quality complaint. No other information. Additional information has been requested.
Age: 0.0
Sex: U
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 2 week old patient who on 05-MAY-2008 was vaccinated with a dose of ROTATEQ at another office. Concomitant vaccinations administered on that same day at another office included a dose of PEDIARIX and a dose of PREVNAR. The patient had no symptoms. No further information is available. There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Accidental overdose, Constipation
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 month old male with no pertinent medical history or drug allergies who on 01-MAY-2008 was vaccinated PO with a first and second dose of ROTATEQ (lot# 657987/1394U, 657987/1394U) on the same day.  Concomitant vaccinations administered on that same day included a dose of ACTHIB, a dose of PEDIARIX and a dose of PREVNAR.  On 02-MAY-2008 the patient experienced constipation.  The patient's mother contacted the office at the time of the event and the patient was scheduled to come into the office on 05-MAY-2008 to see the physician.  No labs or diagnostic studies were performed.  The outcome was unknown.  There was no product quality complaint.  No further information is available.  Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant and a physician concerning a male who on 27-NOV-2007, 08-FEB-2008 and 30-APR-2008 was vaccinated PO with his first, second and third doses of ROTATEQ.  It was noted that the third dose was late.  The patient was not experiencing any known symptoms.  There was no product quality complaint.  No further information is available.  Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 6-month-old male who on 07-MAY-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 659773/0020X).  No adverse effects reported.  The patient did not seek medical attention.  A product complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a dose of ROTATEQ.  On an unspecified date, post vaccination, the patient experienced diarrhea and was hospitalized (length of stay unspecified).  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Clostridium difficile toxin test, Culture stool negative, Diarrhoea, Frequent bowel movements, Rotavirus test negative
Clinical narrative: Information has been received from a physician concerning a 19 week old female who on 11-JAN-2008 was vaccinated with a second dose of ROTATEQ (lot # 657986/1205U) On the evening of 11-JAN-2008 the patient developed loose frequent stools, that persisted for two weeks. There was no report of fever or vomiting. The patient was seen "in the office". Diagnostic testing included "rotavirus and c.diff labs", both of which the results were negative. The patient recovered on approximately 25 JAN 2008. It was noted that on an unspecified date the third dose of ROTATEQ was administered. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Body temperature increased, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 6 month old female with no pertinent medical history or drug allergies who on 30-APR-2008 was vaccinated PO with her third 2.0 ml dose of ROTATEQ.  There was no concomitant medication.  On 08-MAY-2008 in the morning the patient experienced a fever of 102F and irritability.  That same evening the child had mild diarrhea.  The physician was called for medical attention.  The fever was improving with TYLENOL.  The patient's mild diarrhea and irritability persisted.  There was no product quality complaint.  No further information is available.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Stomach discomfort, Underdose, Vomiting projectile
Clinical narrative: Information has been received from a registered nurse concerning an 8 week old female with no pertinent medical history or drug allergies who on 08-MAY-2008 was vaccinated PO with a dose of ROTATEQ (lot# 660201/0142X) and experienced projectile vomiting upon administration. The patient sought medical attention in the physician's office. It was noted that family members of the child had been sick recently. The outcome was unknown. There was no product quality complaint. Follow-up information from the reporting administering registered nurse indicated that the 8 week old (11lb, 5oz., 23in.) white female who on 07-MAY-2008 at 15:30 (also reported as 08-MAY-2008) was vaccinated PO with her first dose of ROTATEQ (lot# 660201/0142X). There was no concomitant medication. At the time of vaccination the patient's family members were noted to have an intestinal virus including vomiting. On 07-MAY-2008 at 15:30 (also reported as 08-MAY-2008) the patient vomited a large amount of fluid while the vaccine was administered. Approximately 3/4 viral was given; the rest was discharged due to stomach upset. The doctor did not want the patient  to get the rest of the dose. No labs or diagnostic studies were performed. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who on 09-MAY-2008 was vaccinated with the second dose of ROTATEQ.  The patient was in the physician's office at the time of the event.  The infant was out of the country when the dose would have been administered.  It was noted that the patient received his first dose at 2 months old.  There was no product quality complaint.  No additional information at this time.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the second dose of ROTATEQ 12 weeks after the first dose.  The patient was not experiencing any known symptoms.  There was no product quality complaint.  No further information is available.  No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient who on approximately 14-JAN-2008 "2 months of age" and 14-MAY-2008 ("6 months of age") was vaccinated with a first and second dose of ROTATEQ.  No adverse symptoms were reported.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning two patients who were vaccinated with doses of ROTATEQ.  Within 72 hours of vaccination, the patients experienced a high fever and were both seen at the same emergency room.  Subsequently, the patients recovered.  There was no product quality complaint.  No further information was provided.  Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful.  No additional information is expected.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning an 18 week old male who on 13-MAY-2008 was vaccinated with the first dose of ROTATEQ. The patient sought medical attention in the physician's office. No adverse symptoms from the vaccine series were noted. There was no product quality complaint. No other information available. Follow-up information from the reporting physician and healthcare worker indicated that the 18 week old Indian male had no illness at the time of vaccination. No medical attention was sought. No labs or diagnostic studies were performed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning two patients who on an unknown date was vaccinated with a dose of ROTATEQ.  On an unspecified date, post vaccination, the patients experienced diarrhea.  At the time of the report the patients statuses were unknown.  A product quality complaint was not involved.  Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning some patients who were vaccinated with doses of ROTATEQ at intervals greater than 10 weeks between doses.  No adverse effect reported.  There was no product quality complaint.  No other information available.  Attempts made to obtain additional identifying information to distinguish individual patients mentioned in this report were unsuccessful.  Additional information is not expected.
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PPV, RV5
Symptoms: Culture stool, Diarrhoea, Frequent bowel movements
Clinical narrative: Information has been received from a physician concerning a female infant who was vaccinated PO with the first dose of ROTATEQ (lot# 659017/0110X).  Suspect vaccinations administered "within the same visit" included a dose of RECOMBIVAX HB (manufacturer unknown), a dose of PEDVAXHIB (manufacturer unknown) and a dose of PNEUMOVAX (manufacturer unknown).  Concomitant vaccinations administered "within the same visit" included a dose of PEDIARIX.  About 2 weeks ago on approximately 09-MAY-2008 the patient experienced diarrhea and had between 6-10 stools daily.  The patient sought unspecified medical attention.  Lab diagnostic studies performed included "stools sent in for culture, but the results were not back yet."  The patient's present status was noted to be "too early to tell."  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning an unknown number of patients who were vaccinated PO with doses (dose sequence unspecified) of ROTATEQ and experienced diarrhea after vaccination. The patients were seen by the physician or contacted the physician for medical attention. The outcome was unknown. There was no product quality complaint. No further details.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 4 and 1/2 week old patient who was vaccinated PO with one dose of ROTATEQ at another location. The baby was fine when seen at 11 months old. There was no product quality complaint. No other details. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated po with his first dose of ROTATEQ at just over thirteen weeks of age. No symptoms were reported. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 21 week old female who on 07-FEB-2008, 19-May-2008 and 23-May-2008 was vaccinated po with the first, second and third doses respectively of ROTATEQ (659854/0217X second dose ) (660380/0277X third dose). It was reported that on 19-MAY-2008 and 23-May-2008 the patient vomited after the vaccine was given. No other symptoms were reported. It was reported that the patient recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first, second and third doses of ROTATEQ and still developed rotavirus.  The outcome was unknown.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Blood test, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient who on an unspecified date was vaccinated orally with a first dose of ROTATEQ.  It was noted the patient received "routine vaccinations for second month visit given on the same day" as ROTATEQ.  On an unspecified date the patient experienced severe diarrhea for 3-4 days and was hospitalized.  On an unspecified date the patient had blood work performed.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Regurgitation, Underdose
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 28-MAY-2008 was vaccinated orally with a dose of ROTATEQ. On 28-MAY-2008 the patient received an incomplete dose of ROTATEQ because the patient regurgitated during administration. No adverse event was reported. A product quality complaint was not involved. No further information is available.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient who on 28-MAY-2008 was vaccinated orally with an incomplete first dose of ROTATEQ.  The patient spit up immediately after the oral administration.  No problems reported.  A product quality complaint was not involved.  No further information is available.
Age: 0.23
Sex: M
Vaccine: RV5
Symptoms: Bowel movement irregularity, Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 12-week-old male, with no pertinent medical history or allergies, who on 21-APR-2008 or 22-APR-2008 was vaccinated orally with 1 dose of ROTATEQ.  There was no concomitant medication.  On approximately 21-APR-2008, post vaccination the patient developed a relatively watery stool that day and a fever that night.  It has become more watery since, almost as watery as urine.  The patient used to have 2 stools per day that were seedy and typical of breast feeding stools.  Now the child has 1 stool every other day.  The patient sought medical attention at the office.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/13/2008. Follow-up information received 07-Aug-2008 and 11-Aug-2008. On 22-Apr-2008 the patient experienced watery stools approximately every other day for over a month (recovered approximately 05-Jun-2008. It was also reported the patient's symptoms eventially resolved. The patient was not immunized at the reporting healthcare facility. No further information is available.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 13 week, 1 day old patient who was vaccinated with the first dose of ROTATEQ.  No adverse experience was reported. There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAP, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated PO with the first dose of ROTATEQ. Concomitant vaccination administered within the same visit included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Subsequently the patient experienced diarrhea and was hospitalized for two days (specifics unknown). It was noted that the "event resolved on its own and the patient was fine." There was no product quality complaint. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 40 and 3/4 week old patient with no medical history or allergies who on 11-OCT-2007, 11-Feb-2008 and 23-May-2008 was vaccinated with the first, second and third doses respectively of ROTATEQ. There was no concomitant medication. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Cough, Infantile spitting up
Clinical narrative: Information has been received from a CMA concerning a baby who was vaccinated po with a dose of ROTATEQ (date and dose not provided). It was reported that the baby coughed and spit up the dose of ROTATEQ while it was being administered. Outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: Information has been received from a family nurse practitioner concerning a 24 year old female with no drug allergies and a history of BCG vaccination with a PPD skin test positive who on 13-AUG-2002 and 16-SEP-2002 was vaccinated with her first and second dose of MMR II. There was no concomitant medication. ON 31-JUL-2002 and 10-AUG-2007, lab diagnostic studies confirmed that the patient had measles titer drawn which showed negative titers and no immunity to measles. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: DT
Symptoms: Muscle spasms
Clinical narrative: From initial information received on 01/Jun/2005 from a health care professional regarding an adverse event, it was reported that a 43-year-old male patient received a dose of DECAVAC, lot number U1221AA, administered intra-muscularly in the right deltoid on 01/Jun/2005 following a nail puncture wound.  That same day (exact latency not reported), the patient developed muscle spasms in his face and neck.  The patient was treated with BENADRYL, administered intra-muscularly, and the spasms resolved.  Per the reporter, the patient recovered from these events.
Age: 56.0
Sex: F
Vaccine: DT
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 26-Jul-2005. A 56 year old female, with an Estrogen patch allergy, experienced lengthy arm pain and deep muscle soreness at injection site and down arm 24 hours after receiving an intra-muscular injection DECAVAC (lot number U1370BA) in the left deltoid on 20-Jun-2005. The patient was treated with Lipitor*, Estrace* and Allegra*. At the time of reporting, the patient's recovery status was unknown. Follow-up information received on 07/Dec/2005 from a health care professional. The patient had illness at the time of the vaccination. The patient has not recovered from these events at the time of this report. No further information is expected.
Age: 32.0
Sex: F
Vaccine: DT
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report received from a health care professional on 22/Jul/2005.  A 32-year-old female patient had received an intramuscular injection of DECAVAC, lot number U1220BA, in the left arm on 27/Jun/2005.  Two days later, she developed pain and decreased mobility of her left shoulder.  She was treated with anti-inflammatories and physical therapy was ordered.  As per the reporter, it is unknown whether the patient recovered from these events.  The reporter of this case is the same as for case 2005-01425.  Follow-up information received on 26-August-2005.  As per the reporter, an orthopedist ordered an MRI.  On 22-July-2005, the MRI of the left shoulder showed subdeltoid bursitis versus recent bursal injection.  There was no additional information at this time.  Follow-up information received on 14/Oct/2005 from a Healthcare Professional.  The recovery status of the patient was not reported.  The physician reviewed the case and no additional information was provided at this time.  No further information is expected.
Age: 61.0
Sex: F
Vaccine: DT
Symptoms: Diarrhoea, Muscular weakness, Pain, Pharyngeal oedema, Swollen tongue
Clinical narrative: Initial report received from the patient on 07/Sep/2005.  A 61-year-old female patient with a medical history of multiple food (eggs/chicken) and pollen allergies received in the left deltoid an injection of DECAVAC, lot number unknown, on 02/Sep/2005 at 4:00 pm.  Two and one half hours later, she felt left arm weakness and aches.  On 04/Sep/2005, she developed hives all over her left arm and swelling of her tongue and throat.  She medicated herself with Benadryl.  On 05/Sep/2005, she reported a black diarrhea episode.  She was scheduled for a follow up appointment with her physician on 07/Sep/2005.  At the time of this report, the patient had not recovered.  Follow-up information received on 01/Dec/2005.  As per responsible physician the patient has chronic illnesses of Schizophrenia and Asthma.  She reports these symptoms with every medication she is given.  The patient is on Serevent, Pulmicort, Nasarel, Levothyroid, Paxil, Singulair, Risperdal, Coumadin, Ativan, Atarax, Claritin, HCT and Aciphex.  As per physician the patient recovered.  No further information expected.
Age: 61.0
Sex: F
Vaccine: DT
Symptoms: Urticaria
Clinical narrative: Initial report received from the patient on 07/Sep/2005.  A 61-year-old female patient with a medical history of multiple food (eggs/chicken) and pollen allergies received in the left deltoid an injection of DECAVAC, lot number unknown, on 02/Sep/2005 at 4:00 pm.  Two and one half hours later, she felt left arm weakness and aches.  On 04/Sep/2005, she developed hives all over her left arm and swelling of her tongue and throat.  She medicated herself with Benadryl.  On 05/Sep/2005, she reported a black diarrhea episode.  She was scheduled for a follow up appointment with her physician on 07/Sep/2005.  At the time of this report, the patient had not recovered.  Follow-up information received on 01/Dec/2005.  As per responsible physician the patient has chronic illnesses of Schizophrenia and Asthma.  She reports these symptoms with every medication she is given.  The patient is on Serevent, Pulmicort, Nasarel, Levothyroid, Paxil, Singulair, Risperdal, Coumadin, Ativan, Atarax, Claritin, HCT and Aciphex.  As per physician the patient recovered.  No further information expected.
Age: 62.0
Sex: F
Vaccine: DT, HEPAB
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Initial report from a nurse on 20/Sep/2005. A 62 year old female developed a deep burning achy pain her left deltoid directly over the vaccination site 12 days after receiving the intramuscular injection of DECAVAC, lot number U12100A in the left deltoid on 07/Sep/2005. The patient received in concomitant the intramuscular injection of TWINRIX (GSK) in the right deltoid. The patient denies redness or swelling at the site. She is still able to use her arm, not sore when moving. The patient states when comparing to the other arm where she received TWINRIX it "feels odd". The patient received medical attention (not specified). Treatment was not reported. Recovery status reported as unknown.
Age: 39.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Back pain, Pain in extremity
Clinical narrative: From initial information received on 11/Mar/2005 from a registered nurse regarding an adverse event, it was reported that a 39-year-old male patient received a dose of DT and a first 720 EU dose of HAVRIX (manufacturer GSK), administered in the right arm on 07/Feb/2005.  The lot numbers are unknown and the routes of administration were not reported.  Approximately one day later, on 08/Feb/2005, the patient experienced left leg pain and lower back pain.  At the time of this report, the patient had not recovered from these events.  Follow up received on 19-Sep-2005.  As per the additional information, the patient did not have any illness at the time of the vaccination.  The vaccine administered was in the left deltoid and the patient recovered at the time of the report.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Initial report received on 29/Aug/2006 from a health care provider. A 17-year-old male patient had received an intramuscular, right deltoid injection of ADACEL, lot number C2457AA, on 10/Aug/2006. The next day, the patient developed "pain severe, nausea, vomiting, headache and fever of 101". At the time of this report, the patient had not recovered. Follow-up information on 03 October 2006 from a health care professional. The case was reviewed, and there was no additional information at this time. The reporter in this case is the same as in case 2006-02300.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: A 17-year-old female patient, with no significant past medical history or obstetrical history, had received a 0.5 mL left deltoid, intramuscular injection of ADACEL, lot number C2609AA, and a 0.5 mL, right deltoid, intra-muscular injection of MENACTRA, lot number U2154CA, on 26 October 2006. That afternoon, the patient found out that she was pregnant with her first child. The date of her last menstrual period was on 15 September 2006. The expected date of delivery was not reported. Per the reporter, the patient has not experienced any adverse events since the administration of the ADACEL and MENACTRA on 26/ October 2006.
Age: 21.0
Sex: M
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Patient started having chest pain with associated shortness of breath, the day after receivine smallpox vaccination.  Symptoms are not dependant on level of activity. 7/14/08-records received-C/O shortness of breath on 4/28/08 started day after smallpox vaccine. Precordium chest pain with palpitations rarely with dyspnea and worse with bending over.Atypical chest pain. 6/20/08-improved with Prilosec. However, during a run felt palpitations and winded.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Loss of consciousness, Palpitations, Visual disturbance
Clinical narrative: Started seeing spots, combination heart racing, numb finger, "blacking out aware but not aware" until she blacked out
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: patient given adult dose Hep A #1, patient 15 years old, no adverse effects reported.  Immunization Rep instructed me to complete VAERS
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received Zostavax on 6/9/08 and called on 6/13/08 and had outbreak of shingles.