chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15 week male who on 06-JUN-2008 was vaccinated with the first dose of ROTATEQ (Lot number not reported). Concomitant therapy included the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), the first dose Hib conj vaccine (TET Toxoid) (ACTHIB) and the first dose of (PREVNAR). On 23-JUL-2008 the patient developed rash. The patient sought medical attention. The outcome of the patient was unknown. On 13-AUG-2008 the patient was vaccinated with his second dose of ROTATEQ, diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) (PEDIARIX), (ACTHIB) and (PREVNAR). No further information is available. This is in follow-up to report(s) previously submitted on 10/13/2008. Additional information was received from a nurse who reported that conflicting information was reported. The nurse reported that she received paperwork from the company regarding an adverse event report indicating that the patient developed a rash after he received his ROTATEQ. The nurse reported that she called the patient's mother, who said that the baby never had a rash. The nurse stated that the report was false, and that there was no way to tell which vaccine caused a rash anyway as babies usually get multiple vaccines on the same day. No further information is available.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: Information has been received from a medical assistant concerning a 2 month old patient who on 12-SEP-2008 was vaccinated with the first oral dose of ROTATEQ but spit up a few minutes later. No problems reported. No product quality complaint involved. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Drug dose omission, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a baby who was vaccinated with the first dose of ROTATEQ at two months, the second dose was skipped and the third dose was administered at 31 weeks. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, RV5
Symptoms: Aspartate aminotransferase increased, Blood creatinine decreased, Blood glucose abnormal, Blood glucose increased, Blood urea increased
Clinical narrative: Information has been received from a pediatric medical record and a physician concerning a 10 week old female who on 28-APR-2008 was vaccinated with a dose of ROTATEQ. Concomitant suspect vaccinations included a first dose of PREVANAR. Other concomitant vaccinations included Pertussis vaccine (unspecified), HIB conj vaccine (unspecified carrier), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (manufacturer unknown), and poliovirus vaccine. On 13-MAY-2008 the patient's cytomegalovirus antibody. IgG was positive. On 25-JUN-2008 the patient was seen at the office for her four month visit. At that time the patient was vaccinated with DTap, poliovirus vaccine, PREVNAR and HIB (unspecified carrier). On 27-AUG-2008 the patient was seen at the office for her 6 month visit. The patient was vaccinated with PREVNAR, (unspecified) and hepatitis B virus vaccine (unspecified) (manufacturer unknown). Laboratory diagnostics were performed and the results can be found in the laboratory section. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, RV5
Symptoms: Body height, Cytomegalovirus antibody positive, Lymphocyte percentage increased, Neutrophil percentage decreased, Platelet count increased
Clinical narrative: Information has been received from a pediatric medical record and a physician concerning a 10 week old female who on 28-APR-2008 was vaccinated with a dose of ROTATEQ. Concomitant suspect vaccinations included a first dose of PREVANAR. Other concomitant vaccinations included Pertussis vaccine (unspecified), HIB conj vaccine (unspecified carrier), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (manufacturer unknown), and poliovirus vaccine. On 13-MAY-2008 the patient's cytomegalovirus antibody. IgG was positive. On 25-JUN-2008 the patient was seen at the office for her four month visit. At that time the patient was vaccinated with DTap, poliovirus vaccine, PREVNAR and HIB (unspecified carrier). On 27-AUG-2008 the patient was seen at the office for her 6 month visit. The patient was vaccinated with PREVNAR, (unspecified) and hepatitis B virus vaccine (unspecified) (manufacturer unknown). Laboratory diagnostics were performed and the results can be found in the laboratory section. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, RV5
Symptoms: Protein total decreased, Rubella antibody test, Weight
Clinical narrative: Information has been received from a pediatric medical record and a physician concerning a 10 week old female who on 28-APR-2008 was vaccinated with a dose of ROTATEQ. Concomitant suspect vaccinations included a first dose of PREVANAR. Other concomitant vaccinations included Pertussis vaccine (unspecified), HIB conj vaccine (unspecified carrier), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (manufacturer unknown), and poliovirus vaccine. On 13-MAY-2008 the patient's cytomegalovirus antibody. IgG was positive. On 25-JUN-2008 the patient was seen at the office for her four month visit. At that time the patient was vaccinated with DTap, poliovirus vaccine, PREVNAR and HIB (unspecified carrier). On 27-AUG-2008 the patient was seen at the office for her 6 month visit. The patient was vaccinated with PREVNAR, (unspecified) and hepatitis B virus vaccine (unspecified) (manufacturer unknown). Laboratory diagnostics were performed and the results can be found in the laboratory section. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Condition aggravated, Infantile spitting up, Upper respiratory tract infection
Clinical narrative: Pediatric medical records were received and reviewed concerning an 8 week old male with cleft lip and a history of jaundice, spitting up, plagiocephaly and blood bilirubin abnormal (WAES # 0708USA01488) who on 27-MAY-2008 was vaccinated with the first dose of ROTATEQ. On 29-APR-2008 the patient. Was vaccinated with hepatitis B vaccine and on 19-MAY-2008 experienced plagiocephaly and on 27-MAY-2008 experienced spit up (WAES # 0809USA01661). On 27-MAY-2008 an 8 week male infant with no known allergies was examined. The weight was 11 pounds 4.5 ounces, the length 22 1/2 inches, head circumference 15 1/2 inch, temperature 99 degrees F, pulse 128, respiratory frequency 30. Feeding problems reported as "spit up". The infant was well. The baby was vaccinated on this same day with : PREVNAR IM right thigh. ROTATEQ (660596/0211X) PO. ACTHIB IM left thigh. On 26-JUN-2008 the patient was vaccinated with:  TRIPEDIA (C2934AA) IM in left thigh. IPOL (A0492) SC/IM in right thigh. On 28-JUL-2008 a 4 months male infant with no known allergies was examined. The weight was 13 pounds 7.5 ounces, the length 25 1/4 inches, head circumference 16 1/4 inch, temperature 98.5 degrees F, pulse 1389, respiratory frequency 32. The infant was well. The baby was vaccinated on this same day with: PREVNAR (C80901) IM in the left thigh. ACTHIB (UF370AB) IM in the left thigh. On 27-AUG-2008 the patient was vaccinated with: TRIPEDIA (C2955BA) IM inn the left thigh. IPOL (A0492) SC/IM in left thigh. On 27-AUG-2008 the patient had an upper respiratory infection. No additional information is expected.
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a female infant who on 15-SEP-2008 was vaccinated PO with a dose of ROTATEQ. On 15-SEP-2008, the LPN reported that the infant received an incomplete vaccine dose because of spitting up during the administration. The patient sought unspecified medical attention. The LPN reported the outcome as recovered on 15-SEP-2008. A product quality complaint was not involved. No further information is available.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a male patient who on 15-SEP-2008 was vaccinated with the first dose of ROTATEQ and vomited immediately. The patient sought medical attention in office. No product quality complaint involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Dermatitis contact, Rash generalised, Vaccine positive rechallenge
Clinical narrative: Information has been received from an office manager concerning a male with NKDA or pertinent medical history, who on 03-JUL-2008 was vaccinated with the first dose of ROTATEQ (lot # 660600/0281X). The patient received the second dose of ROTATEQ on 05-SEP-2008 (lot #661034/0470X). Suspect therapy included hepatitis B vaccine (MSD) given at the second visit. Concomitant therapy included (PREVNAR), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine inactivated (Vero) (IPOL) and Hib conj vaccine (CRM197) (HIBTITER). About 5 days after vaccination with the first dose of ROTATEQ, the patient developed a head to toe rash that resembled contact dermatitis. The rash resolved in 2 weeks without treatment. The patient developed the same AE after dose 2 but it has not yet resolved but he has been started on steroids. The patient sought medical attention, seen in office after second vaccination. No laboratory tests were performed. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning patients who developed diarrhea after the first dose of oral ROTATEQ. The physician did not state how many patients. No patient specific information was provided. No product quality complaint involved. No further information is expected.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 16-SEP-2008 was vaccinated with the first dose of oral ROTATEQ, 2 ml, at 22 weeks of age. The patient has not experienced any known symptoms. No product quality complaint involved. Additional information has been requested.
Age: 0.85
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 44 week old female who on 31-MAR-2008, was vaccinated with a second dose of ROTATEQ, oral, (lot number not reported). The patient never received the third dose of vaccine. The patient experienced inappropriate schedule of vaccine administration with no adverse effects reported. No product quality complaints were involved. Additional information has been requested.
Age: 0.9
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 10 month old male who on 17-SEP-2008 was vaccinated PO with a 2.0 ml dose of ROTATEQ (lot# 656836/0876U). The LPN reports that she inadvertently gave the ROTATEQ and that the child is not experiencing any adverse effects at this time. The patient sought medical attention at the office. The LPN reported that this is a "staff error only". A product quality complaint was not involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a healthcare professional concerning a 9 week old female with no medical history who on 12-MAY-2008 was vaccinated with ROTATEQ. Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), Hib conj vaccine (OMPC) (MSD) and (PREVNAR). It was reported after the initial dose of ROTATEQ the patient experienced diarrhea, fever and vomiting within 24 hours, on 13-MAY-2008, of receiving the vaccine. The patient was taken for unspecified medical attention. It was reported the patient tolerated subsequent doses of ROTATEQ without incident (specific 2nd and 3rd dose dates not provided, "final dose taken recently"). Subsequently, the patient recovered from diarrhea, fever and vomiting. A product quality complaint was not involved.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of ROTATEQ. The nurse reported that the patient may have received the first dose of ROTATEQ on 19-SEP-2008 at 16 weeks. It was reported the office documentation listed the patient's first dose was on 17-JUL-2008, but the patient's mother stated the first dose was on 19-SEP-2008. No adverse symptoms were reported. No other information was given. A product quality complaint was not involved. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 9 week old female who on 16-SEP-2008 was vaccinated po with the first 2 ml dose of ROTATEQ (lot# 660375/0196X). Concomitant therapy included PREVNAR, PEDIARIX and ACTHIB, all given on the same day (also reported as given 18-SEP-2008) as ROTATEQ. A nurse reported immediately after the vaccines were given (also reported as a half an hour after vaccination) the child vomited several times, several forceful episodes. The child recovered within 30 minutes on the same day and had medical attention in the office. No other information was given. A product quality complaint was not involved. Additional information has been requested. 12/3/08 This is in follow-up to report(s) previously submitted on 10/13/2008. No further information is expected.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Secondary transmission
Clinical narrative: Information has been received from a licensed practical nurse concerning a male whose child was vaccinated with a dose of ROTATEQ (which dose in series was not known) on 10-JUN-2008 (WAES #0811USA02623).  Following the administration, the mother reported the next time she was in the clinic, that the child's father had severe diarrhea in the next couple of days following the dose. The outcome is unknown. The reporter stated it was unknown if this was due to ROTATEQ, however the reporter thought maybe it was shedding. No further information is available. This is one of several reports from the same reporter. 03/05/09 This is in follow-up to report(s) previously submitted on 10/13/2008; 12/3/2008. Follow-up information received from the nurse concerning the father also had severe diarrhea which lasted 48 hours. No further information is available. This is one of several reports from the same reporter.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Condition aggravated, Food allergy
Clinical narrative: Information has been received from a registered nurse (RN) concerning an approximately 9 week old female with gastroesophageal reflux, milk, soy and protein intolerance who on 22-SEP-2008 was vaccinated PO with the first 2.0 ml dose of ROTATEQ (lot # 661037/0641X). Concomitant therapy included (ZANTAC). On an unspecified date between 22-SEP-2008 and 25-SEP-2008, the registered nurse reported that the patient's mild, soy and protein intolerance was aggravated after receiving the first dose of vaccine. The patient's symptoms were described as "colicky". No treatment was reported. The RN reported that the patient sought medical attention with a phone call. The outcome was reported as not recovered / not resolved. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who was vaccinated with a dose of ROTATEQ (date and dose not reported). The RN reported that the patient developed diarrhea after receiving ROTATEQ (date not reported). It is unknown if the patient sought medical attention. The outcome was not reported. A product quality complaint was not involved. The reporter refused to complete the adverse event questionnaire but stated will call back with more information. No further information is available.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from an office manager concerning a six month old female who on 25-SEP-2008 was inadvertently vaccinated with the first dose of ROTATEQ. The office manager reported that it was a staff error only. No adverse effects at the time of the report. The patient sought medical attention at the office. A product quality complaint was not involved. On 26-SEP-2008, a health care professional followed up with the patient's mother who reported no adverse events at that time. Additional information has been requested. 03/05/09 This is in follow-up to report(s) previously submitted on 10/13/2008. Initial and follow up information has been received from an office manager concerning a six month old female with no medical history who on 25-FEB-2008 was inadvertently vaccinated with the first dose of ROTATEQ (Lot# was unknown). The office manager reported that it was a staff error only. No adverse effects at the time of the report. The patient sought medical attention at the office. A product quality complaint was not involved. On 26-SEP-2008, a health care professional followed up with the patient's mother who reported no adverse events at that time. No further information is available.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 10 week old female with no medical history or allergies who on 26-SEP-2008 was vaccinated PO with one pouch of the first dose of ROTATEQ (lot # 660880/0923X). There was no concomitant medication. On 26-SEP-2008, the CMA reported that the patient vomited after receiving the vaccine. It was reported that the patient had just breast fed prior to receiving the ROTATEQ. The patient was in the office when the event occurred and the doctor was called and was asked "what to do" (the physicians' response was not reported). The outcome was not reported. A product quality complaint was not involved. This is one of several cases including the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a patient who was vaccinated PO with a dose of ROTATEQ. The CMA reported that the patient vomited after receiving the vaccine. It was reported that the patient had just breast fed prior to the vaccine dose. The patient did not seek medical attention. The outcome was not reported. This is one of several cases involving the same source. 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. Follow-up information has been received on 01-OCT-2008. The CMA reported that this event happened several months ago and that she could not remember who the patient was but was able to report that it was the first dose of ROTATEQ. Further information has been requested.
Age: 0.6
Sex: F
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 13 month old female patient with no pertinent medical history who on 25-FEB-2008 was vaccinated with a third dose of ROTATEQ. The first dose was administrated on 01-OCT-2007 and the second dose on 21-DEC-2007. On 08-SEP-2008 the patient developed diarrhea. The patient was seen by the physician on 18-SEP-2008 and a stool culture was obtained. The stool culture came back positive for rotavirus. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dermatitis diaper, Genital candidiasis
Clinical narrative: Initial information has been received from a pediatrician in the form of medical records concerning a 27 day female normal infant who on 5-DEC-2007 the was vaccinated with PREVNAR, ROTATEQ, PEDIARIX and PEDVAXHIB. On 18-DEC-2007, the approximately one month old patient was accompanied by her mother and presented with a chief complaint of yeast infection on buttocks, thrush concerns. Additional comments were: mother recently treated for mastitis, no fever, no vomiting or diarrhea, no changes in appetite or sleep. The infant was diagnosed with candidiasis urogenital and it was recommended for treatment CLOTRIMAZOLE cream, twice a day for seven days. The pain score assessment was 0. Physical examination revealed an awake and alert female infant with mild yeast diaper rash, normocephalic atraumatic, with normal tone and normal movements of all extremities. The baby's extremities were pink, warm, brisk capillary refill. On 26-MAR-2008, the four old female infant had a healthy appearing, the patient had breast formula feeding and may be able to start cereals and baby's "first food", no more than two new foods per week. Physician reported that the patient was also vaccinated with second dose of PREVNAR, ROTATEQ, and PEDIARIX. On 28-MAY-2008 the approximately 6 month infant weighted 22.35 pounds, her height was 27.5 inches, and her pulse rate was 132 and respiration 36. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dysphonia, Feeling hot, Migraine, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with allergy to ZITHROMAX who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 660618/0572X), IM in the deltoid. There was no concomitant medication. On 03-SEP-2008 the patient experienced a rash at the injection site arm that went to the abdomen, legs and the all over her body. The rash was described as slightly itchy. The patient took over the counter BENADRYL which seemed to help. The patient also felt feverish, but never documented a fever. The patient also developed a hoarse voice and had a slight sore throat. The patient also reported "GI puffiness", loose stools and migraine. The rash was still present as of the date of the report, but the patient was not complaining about the other symptoms at the time. The patient had called the office on 09-SEP-2008. No diagnostic test were performed. No other information to report. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with allergy to ZITHROMAX who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 660618/0572X), IM in the deltoid. There was no concomitant medication. On 03-SEP-2008 the patient experienced a rash at the injection site arm that went to the abdomen, legs and the all over her body. The rash was described as slightly itchy. The patient took over the counter BENADRYL which seemed to help. The patient also felt feverish, but never documented a fever. The patient also developed a hoarse voice and had a slight sore throat. The patient also reported "GI puffiness", loose stools and migraine. The rash was still present as of the date of the report, but the patient was not complaining about the other symptoms at the time. The patient had called the office on 09-SEP-2008. No diagnostic test were performed. No other information to report. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Diarrhoea, Dysphonia, Feeling hot, Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with allergy to ZITHROMAX who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 660618/0572X), IM in the deltoid. There was no concomitant medication. On 03-SEP-2008 the patient experienced a rash at the injection site arm that went to the abdomen, legs and the all over her body. The rash was described as slightly itchy. The patient took over the counter BENADRYL which seemed to help. The patient also felt feverish, but never documented a fever. The patient also developed a hoarse voice and had a slight sore throat. The patient also reported "GI puffiness", loose stools and migraine. The rash was still present as of the date of the report, but the patient was not complaining about the other symptoms at the time. The patient had called the office on 09-SEP-2008. No diagnostic test were performed. No other information to report. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Migraine, Oropharyngeal pain, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with allergy to ZITHROMAX who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 660618/0572X), IM in the deltoid. There was no concomitant medication. On 03-SEP-2008 the patient experienced a rash at the injection site arm that went to the abdomen, legs and the all over her body. The rash was described as slightly itchy. The patient took over the counter BENADRYL which seemed to help. The patient also felt feverish, but never documented a fever. The patient also developed a hoarse voice and had a slight sore throat. The patient also reported "GI puffiness", loose stools and migraine. The rash was still present as of the date of the report, but the patient was not complaining about the other symptoms at the time. The patient had called the office on 09-SEP-2008. No diagnostic test were performed. No other information to report. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP, HPV4, TDAP, HEP, HPV4, TDAP
Symptoms: Abdominal pain upper, Back pain, Dizziness, Pallor
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with no pertinent medical history reported who on 18-SEP-2008 was vaccinated with the first dose of GARDASIL 0.5 mL, intramuscularly in the left deltoid. Secondary suspect therapy included RECOMBIVAX HB. Concomitant therapy included ADACEL. The certified medical assistant reported that the patient got lightheaded following vaccination with GARDASIL and then developed back, abdominal and arm pain. After 10 to 15 minutes of vaccination the patient felt light headed. The patient was given a cracker and instructed to sit down. The patient then developed lower back pain then wrapped around the abdominal area. The patient was then instructed to lie down. The patient then complained that her arm (injection site arm) was cold and sore. The patient recovered in a few minutes with the exception of the sore arm. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP, HPV4, TDAP, HEP, HPV4, TDAP
Symptoms: Abdominal pain, Back pain, Dizziness, Injection site coldness, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with no pertinent medical history reported who on 18-SEP-2008 was vaccinated with the first dose of GARDASIL 0.5 mL, intramuscularly in the left deltoid. Secondary suspect therapy included RECOMBIVAX HB. Concomitant therapy included ADACEL. The certified medical assistant reported that the patient got lightheaded following vaccination with GARDASIL and then developed back, abdominal and arm pain. After 10 to 15 minutes of vaccination the patient felt light headed. The patient was given a cracker and instructed to sit down. The patient then developed lower back pain then wrapped around the abdominal area. The patient was then instructed to lie down. The patient then complained that her arm (injection site arm) was cold and sore. The patient recovered in a few minutes with the exception of the sore arm. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP, HPV4, TDAP, HEP, HPV4, TDAP
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with no pertinent medical history reported who on 18-SEP-2008 was vaccinated with the first dose of GARDASIL 0.5 mL, intramuscularly in the left deltoid. Secondary suspect therapy included RECOMBIVAX HB. Concomitant therapy included ADACEL. The certified medical assistant reported that the patient got lightheaded following vaccination with GARDASIL and then developed back, abdominal and arm pain. After 10 to 15 minutes of vaccination the patient felt light headed. The patient was given a cracker and instructed to sit down. The patient then developed lower back pain then wrapped around the abdominal area. The patient was then instructed to lie down. The patient then complained that her arm (injection site arm) was cold and sore. The patient recovered in a few minutes with the exception of the sore arm. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: CSF test abnormal, Headache, Leukoencephalomyelitis, Pyrexia
Clinical narrative: Initial report received on 09 October 2008 from a health care professional, and follow-up information was received on 13 October 2008 from the Centers for Disease Control and Prevention (CDC), VAERS ID# 326873. A 19-year-old male patient, with no concurrent illnesses, no pre-existing medical conditions or use of other medications, had received a first intramuscular deltoid injection of MENACTRA (Lot # U2664AA) on 19 August 2008. The site of administration was not provided. Approximately three weeks post-vaccination, on 07 September 2008, the patient experienced acute onset of fever (temperature reading not provided) and a headache. The patient was hospitalized the following day on 08 September 2008. Diagnostic testing included a "CSF" (Cerebrospinal Fluid) test that was abnormal, and an "MRI" (Magnetic Resonance Imaging) test that was consistent with encephalitis. The patient was diagnosed with acute disseminated encephalomyelitis, and received corrective treatment with intravenous antibiotics, antivirals, and intravenous steroids. Additional information that was received from the CDC on 13 October 2008 reported the patient was hospitalized on 09 October 2008. It is not known whether this information changes the previously reported hospitalization date of 08 September 2008, or represents a second hospitalization. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: CSF test abnormal, Headache, Leukoencephalomyelitis, Nuclear magnetic resonance imaging abnormal, Pyrexia
Clinical narrative: Initial report received on 09 October 2008 from a health care professional, and follow-up information was received on 13 October 2008 from the Centers for Disease Control and Prevention (CDC), VAERS ID# 326873. A 19-year-old male patient, with no concurrent illnesses, no pre-existing medical conditions or use of other medications, had received a first intramuscular deltoid injection of MENACTRA (Lot # U2664AA) on 19 August 2008. The site of administration was not provided. Approximately three weeks post-vaccination, on 07 September 2008, the patient experienced acute onset of fever (temperature reading not provided) and a headache. The patient was hospitalized the following day on 08 September 2008. Diagnostic testing included a "CSF" (Cerebrospinal Fluid) test that was abnormal, and an "MRI" (Magnetic Resonance Imaging) test that was consistent with encephalitis. The patient was diagnosed with acute disseminated encephalomyelitis, and received corrective treatment with intravenous antibiotics, antivirals, and intravenous steroids. Additional information that was received from the CDC on 13 October 2008 reported the patient was hospitalized on 09 October 2008. It is not known whether this information changes the previously reported hospitalization date of 08 September 2008, or represents a second hospitalization. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Computerised tomogram normal, Dehydration
Clinical narrative: Information has been received from an RN concerning a 14 year old female who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) into her left arm. The patient had since experienced extreme tiredness and nausea and vomiting. Mother of the patient told nurse she saw these were side effects of GARDASIL vaccine (yeast). The patient was being seen by gastrointestinal specialist at the office and also followed up with another gastrointestinal specialist. The patient had not recovered yet. The RN considered the events to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diet refusal, Endoscopy upper gastrointestinal tract normal, Fall, Gait disturbance, Headache
Clinical narrative: Information has been received from an RN concerning a 14 year old female who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) into her left arm. The patient had since experienced extreme tiredness and nausea and vomiting. Mother of the patient told nurse she saw these were side effects of GARDASIL vaccine (yeast). The patient was being seen by gastrointestinal specialist at the office and also followed up with another gastrointestinal specialist. The patient had not recovered yet. The RN considered the events to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hepatobiliary scan, Hypoaesthesia, Influenza like illness, Nausea, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Information has been received from an RN concerning a 14 year old female who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) into her left arm. The patient had since experienced extreme tiredness and nausea and vomiting. Mother of the patient told nurse she saw these were side effects of GARDASIL vaccine (yeast). The patient was being seen by gastrointestinal specialist at the office and also followed up with another gastrointestinal specialist. The patient had not recovered yet. The RN considered the events to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Paraesthesia, Ultrasound scan, Weight decreased, X-ray gastrointestinal tract normal
Clinical narrative: Information has been received from an RN concerning a 14 year old female who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) into her left arm. The patient had since experienced extreme tiredness and nausea and vomiting. Mother of the patient told nurse she saw these were side effects of GARDASIL vaccine (yeast). The patient was being seen by gastrointestinal specialist at the office and also followed up with another gastrointestinal specialist. The patient had not recovered yet. The RN considered the events to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Information has been received from an RN concerning a 14 year old female who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) into her left arm. The patient had since experienced extreme tiredness and nausea and vomiting. Mother of the patient told nurse she saw these were side effects of GARDASIL vaccine (yeast). The patient was being seen by gastrointestinal specialist at the office and also followed up with another gastrointestinal specialist. The patient had not recovered yet. The RN considered the events to be disabling. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Erythema, Feeling of body temperature change, Headache, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with allergic rhinitis, allergies to amoxicillin, AUGMENTIN, CEFZIL and dust mites allergies, who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X), 0.5 mL, I.M. Concomitant therapy include MENACTRA. About 5 hours after the receiving vaccination, the patient developed a "prickly feeling" and numbness on her face. She also experienced sensations of hot and cold on her face. The numbness increased the next day and included a "tingling" sensation of her lips. The patient's mother reported to the nurse that her daughter's cheeks looked puffy and "flushed." The patient also developed a headache. The patient was treated with BENADRYL and on 13-SEP-2008 recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Paraesthesia oral, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with allergic rhinitis, allergies to amoxicillin, AUGMENTIN, CEFZIL and dust mites allergies, who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X), 0.5 mL, I.M. Concomitant therapy include MENACTRA. About 5 hours after the receiving vaccination, the patient developed a "prickly feeling" and numbness on her face. She also experienced sensations of hot and cold on her face. The numbness increased the next day and included a "tingling" sensation of her lips. The patient's mother reported to the nurse that her daughter's cheeks looked puffy and "flushed." The patient also developed a headache. The patient was treated with BENADRYL and on 13-SEP-2008 recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Feeling of body temperature change, Flushing, Headache, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with allergic rhinitis, allergies to amoxicillin, AUGMENTIN, CEFZIL and dust mites allergies, who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X), 0.5 mL, I.M. Concomitant therapy include MENACTRA. About 5 hours after the receiving vaccination, the patient developed a "prickly feeling" and numbness on her face. She also experienced sensations of hot and cold on her face. The numbness increased the next day and included a "tingling" sensation of her lips. The patient's mother reported to the nurse that her daughter's cheeks looked puffy and "flushed." The patient also developed a headache. The patient was treated with BENADRYL and on 13-SEP-2008 recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Palpitations, Panic attack
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 29-APR-2008 was vaccinated with the first dose of GARDASIL.  The medical assistant reported that after arriving home on the same day of the vaccine the patient had a "panic attack", difficulty breathing.  The patient choose not to get the other 2 doses of GARDASIL.  At the time of the report the patient had recovered.  No further information is expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Panic attack
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 29-APR-2008 was vaccinated with the first dose of GARDASIL.  The medical assistant reported that after arriving home on the same day of the vaccine the patient had a "panic attack", difficulty breathing.  The patient choose not to get the other 2 doses of GARDASIL.  At the time of the report the patient had recovered.  No further information is expected.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Large raised round welt at injection site (half again larger than a half dolalr).  Solid welt (no pus or seepage), itching, pain.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) (date and dose was not reported).  Subsequently the patient experienced shingles and was hospitalized.  The outcome of the shingles was not reported.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, PNC
Symptoms: Haematochezia
Clinical narrative: Information has been received from a nurse concerning a 2 month old female with no pertinent medical history or allergies, who on 06-OCT-2008 was vaccinated with the first dose of 2 ml oral ROTATEQ (lot # 659916/0964X). Concomitant therapy included PREVNAR, ACTHIB, DTaP and IPOL. On 08-OCT-2008, the patient developed blood in her bowel movement after receiving her first dose of ROTATEQ. The patient is reported to be recovering. Unspecified medical attention was sought. No laboratory tests were performed. No quality complaint involved. Upon internal review, hematochezia was considered to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received via a pregnancy registry, from a registered nurse, concerning a 19 year old female patient with a history of abnormal papanicolaou (PAP) smears, who on 23-JUL-2007 was vaccinated IM, with the first dose, 0.5 ml (lot # 0469U) and on 23-OCT-2007 vaccinated IM with the second dose, 0.5 ml, of GARDASIL (lot # invalid). Concomitant therapy included prenatal vitamins (unspecified). On 29-NOV-2007 (currently 7 weeks and 6 days gestation), the patient was pregnant. The patient was seen in the office and the pregnancy was reported as normal (estimated date of delivery, 27-AUG-2008). In follow-up was reported that on 22-FEB-2008, at 14.6 weeks from LMP, the patient had an elective termination. Upon internal review, elective termination of pregnancy was considered to be an other important event. No further information is expected.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Ear discomfort, Headache, Pharyngeal oedema, Pharyngolaryngeal pain
Clinical narrative: Initial report was received 08 October 2008 from a consumer who is also the patient. A 47-year-old female patient with a history of pollen and dust allergies, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) and within two hours of vaccination (onset time not reported), she felt as if her throat was swelling, and complained of a sore raw throat, wheezing, headache, chills, a low grade fever of 99 degrees Fahrenheit, and her ears were plugged. The patient had no illness at the time of vaccination and she had not received any other vaccinations during the four weeks prior to receipt of FLUZONE. The patient self medicated with 25mg of BENADRYL and her symptoms resolved by 03:00 - 04:00am (date not reported). The patient had not been evaluated by a health care professional for the event. Concomitant medications included SINGULAIR 10mg q.d. and NECON q.d. At the time of the report, the patient reported that still continued to have symptoms of a slight headache and slight congestion and was not recovered from the event. No additional information was provided. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Upper respiratory tract congestion, Wheezing
Clinical narrative: Initial report was received 08 October 2008 from a consumer who is also the patient. A 47-year-old female patient with a history of pollen and dust allergies, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) and within two hours of vaccination (onset time not reported), she felt as if her throat was swelling, and complained of a sore raw throat, wheezing, headache, chills, a low grade fever of 99 degrees Fahrenheit, and her ears were plugged. The patient had no illness at the time of vaccination and she had not received any other vaccinations during the four weeks prior to receipt of FLUZONE. The patient self medicated with 25mg of BENADRYL and her symptoms resolved by 03:00 - 04:00am (date not reported). The patient had not been evaluated by a health care professional for the event. Concomitant medications included SINGULAIR 10mg q.d. and NECON q.d. At the time of the report, the patient reported that still continued to have symptoms of a slight headache and slight congestion and was not recovered from the event. No additional information was provided. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Sometime in 1968, she received 1/2 dose influenza vaccine due to "mother reporting allergy to everything" while in school. That night c/o fever, hot red face, site swelling and tenderness, pain with moving shoulder. Denied cp, sob, angioedema, wheezing, dysphagia, rashes, n/v/d, or any other discomfort. Treated with steroids and antibiotics and told allergic to influenza. No influenza vaccine since 1968.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain, 9/10, pain in left arm. Limited range of motion in left arm at least 9 days, post vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Dizziness, Pyrexia
Clinical narrative: Pt came in office with complaint of fever and dizziness. Had pt evaluated by provider. Had temp of 102 degrees. Treated with 3 teaspoons, MOTRIN.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dysphagia, Dyspnoea, Sensation of foreign body, Wheezing
Clinical narrative: Had immunization at 10 AM. At 2 PM, school nurse called reporting symptoms of wheezing, and feeling lump in throat. Advised to go to ER. ER report, said mild difficulty breathing and swallowing. Pt received SOLU-MEDROL and BENADRYL and PEPCID. Observed 3 hrs. Discharged on Prednisone and BENADRYL.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness noted underneath flu site injection. 3cm x 5cm in size, slightly warm to touch - Rt arm.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives - diffuse, beginning morning after vaccination.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Urticaria
Clinical narrative: Day after vaccine - just below injection site, developed a red welt, itching, 2" x 2" - welt, 2" circle (red) under the welt. Remain with.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Approx 48 hrs after vaccine (6 inch x 8 inch), red, warm, indurated area, surrounding injection site - tender to touch.