chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: On 03-17-08, Mother reported that patient had received a chickenpox (2nd dose) and Tdap booster in her right arm on Friday, 03-14-08, about 4:30pm. On Saturday, 03/15/08, about 2:00pm patient complained of redness, swelling and discomfort at the Chickenpox injection site. No problems were noted at the Tdap injection site. She also complained of a headache and had a temp. of 99.5 degrees. Mother gave patient Advil for the fever and discomfort every 6 hours. On Sunday, 03/16/08, patient's Mother stopped the Advil and about 2:00pm patient's temp. went up to 101 degrees.  Patient's mother gave her another dose of Advil and her temp returned to normal within 30 minutes. Patient also had increased redness, swelling and discomforted  at the  chickenpox injection site. Today 03-17-08, patient was sent home from school complaining of nausea and dizziness. The swelling, redness and discomfort at the chickenpox inject site has gotten worse. The chickenpox injection site has a bull's eye type area of redness and swelling totally approx. 4 inches in diameter. It has a center area of dark redness  approx. 2 inches in diameter that is surrounded by a 1/2 inch ring of whitish discolored that is surrounded by another 1/8 ring of pinkish discoloration. One chickenpox pox is noted in the area of discoloration, swelling and discomfort. Patient mother states she is planning on taking her to the doctor. She was encouraged to do so, push fluids and instructed not to give any Aspirin products.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test, Oedema peripheral
Clinical narrative: After having the shot I complained about my upper arm constricted stared swelling, I was told that was normal?? it would be better the next day!! I was in a detox unit @ hospital, the next morning my upper arm swelled bigger then I ever seen it also I had a huge abscess on my elbow!! and the infection was on the move..after a few more hours it spead down my arm the "swelling" I taking by ambulance to the medical center. I was told I had a severe infection in my arm??? I was admitted from the E.R. and spent 4th, 5th 6th of March 2008 hospitalized!! OH sorry lol for got the name of the vaccine was  PNEUMOVAX 23 me/showed me a pamphlet saying only less then 1 percent have allergic reacations??? I GOT INFECTED!!!!!!! How can I find out who is the manufactuter??? 4/7/08-records received for DOS 3/4-3/6/08-DC DX: Cellulitis left upper extremity. Olecranon bursitis. C/O worsening swelling and redness after pneumococcal vaccine 2 days prior to admission. Low grade fever. Erythema over left elbow and left forearm.  Follow-up: To whom it may concern: I recently sent you a form about "getting infected" after receiving a vaccine for pneumonia 23. I tried saving the form as is, filled out, before sending it to you, so I hope that you received it properly filled out?? Can you please send me a copy back? via e-mail, and i was also wondering if you knew who the manufacture is for this vaccine?? Pneumococcal Polysaccharide thank you for your help.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Discomfort, Erythema, Injected limb mobility decreased, Rash, Swelling
Clinical narrative: Redness, swelling, rash lasting 3 days, discomfort when lifting right arm continues after 3rd day.  Doctor decided D/C 2nd and 3rd dose.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt had swelling, redness and itchiness at injection site. Injection site located left rear arm SQ. Pt noticed redness and mild pain on scale 3 on 3/8/08 Redness and swelling mild to moderate from site to elbow.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Nausea, Rash, Rash macular
Clinical narrative: Patient c/o slight nausea immediately after receiving injection (11:45 am 3/13/08). This passed in 5 minutes and patient felt fine and V.S. were stable. Patient c/o red blotches on neck, upper chest and (R) shoulder approximately 2 1/2 hrs later. V.S. stable. No other complaints.
Age: 40.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: Pt had vaccine 3/13 - came into the office today with a softball sized area on (L) deltoid of redness, warmth and swelling - started 24 hrs post inj. Was worse in 45 hrs. Getting better on her own. Given Rx for Oxycodone as "just in case".
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Body temperature increased, Rash, Rash papular
Clinical narrative: Within 12 hrs of receiving Pediarix, Prevnar, and flu vaccine temp to 103 and papular rash on shoulder, chest, back. Received Motrin.
Age: 38.0
Sex: M
Vaccine: FLUN3, TD
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: Fever, nausea, diarrhea, body ache
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal X-ray, Abdominal pain, Culture stool negative, Culture urine negative, Full blood count normal
Clinical narrative: Given FluMist - has complained of chronic abdominal pain since then - almost on daily basis. Periumbilical. no weight loss. Miralax and Prevacid no help.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Laboratory test normal, Protein urine absent, Red blood cell sedimentation rate normal, Stool analysis normal
Clinical narrative: Given FluMist - has complained of chronic abdominal pain since then - almost on daily basis. Periumbilical. no weight loss. Miralax and Prevacid no help.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Patient developed redness same day of getting shots, and itching.  Mom was using ice to arm.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Neck pain, Oedema peripheral
Clinical narrative: Site sore, neck pain, swollen right arm.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Abdominal pain upper, Decreased appetite, Oedema peripheral, Pain in extremity, Vomiting
Clinical narrative: Vomiting, stomach ache, poor appetite, pain and swelling to left arm.  Released with Tylenol.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Diffuse macular papular rash face trunk (pruritic) approx 24 hr after fever (evening after vaccines)
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Elevated fever, vomiting 24 hours after vaccines for 1 day.  Redness 8x6cm, firmness, swelling, hot, tenderness at injection sites.  Left deltoid onset that evening with red, warm, swelling.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Elevated fever, vomiting 24 hours after vaccines for 1 day.  Redness 8x6cm, firmness, swelling, hot, tenderness at injection sites.  Left deltoid onset that evening with red, warm, swelling.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Constipation, Intussusception, Ultrasound scan
Clinical narrative: 1/30/08 - 2/27/08 seen for constipation.  Diagnosis: Intussusception 12 d. post vaccine.  5/27/08-clinic records for DOS 1/15/08-C/O stuffy nose, cough. Clinic note 2/27/08-C/O constipation only 4 BMs since 1/24/08, soft pudding like forceful flatulence. Fussy. Uncomfortable. PE: Tight anal sphincter some gas after removing finger.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Feeling hot, Urticaria
Clinical narrative: Patient vaccinated a.m. of 3/6/08 - in afternoon of that date patient complained of "hives" on arms and face, "feeling feverish", trouble breathing - temperature at follow-up exam 97.3, no visible rash or swelling, lungs clear, no symptoms.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Swelling 3/3/08, with redness.  Noticed 3/4/08.  Induration, redness, swelling.  Denies pain on post left upper arm.  Induration 70 mm wide x 40 mm high, redness 130 x 130 mm.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Electroencephalogram
Clinical narrative: Child developed seizure within 48 hours of vaccination.  Questionable if child had "shaking motion" prior to vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Anorexia, Asthenia, Body temperature increased, Pain
Clinical narrative: She had high fever, loss of appetite, change of behavior, pain and weakness for 5 days. The treatment was with Tylenol for pain and fever.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: She had high fever, loss of appetite, change of behavior, pain and weakness for 5 days. The treatment was with Tylenol for pain and fever.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Full blood count, Lymphangitis, Pyrexia
Clinical narrative: High fevers (102.8 F); localized erythema right deltoid with lymphangitis and cellulitis.  Came to clinic 3/3/08 and was sent directly to ED where she was kept overnight on Vancomycin and released home the next morning on P.O. antibiotics.  T.C. to patient 3/6/08 "feeling fine.  Just a little tired."
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Irritability, Rash vesicular
Clinical narrative: Been slightly irritable - then broke out with rash, red bumps - becoming more vesicle-like.  Slight yellow color.  No other known Varicella history.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Stridor, Tachycardia, Urticaria, Wheezing
Clinical narrative: Wheals erythema, wheezing and stridor, tachcardia.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: Large local reaction to DTaP on (L) arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: Started with itchiness at site of injection - right arm then low grade fever that NOC - 99.5.  Site and below site became red/swollen and itchy.  Mother gave Benadryl - 2 days after vaccines administered, mother reports is no better.  Had mother contact physician.  Event/vaccine admin 3-11-08 with itchiness and fever that day - lasting 2 days later.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Full blood count, Injection site urticaria, Stomatitis, Streptococcal identification test negative, Urine analysis normal
Clinical narrative: 3/5/08 PM "welt" at injection site (right upper lateral thigh).  3/7/08 "welts" spaced over body - taken to urgent care hospital in AM and received steroids.  3/9/08 to hospital in PM and received histamine blocker.  3/10/08 to PCP and then to hospital ER and labs done.  Released to home.  3/11/08 to PCP for new symptom of mouth sono and sent back to hospital ER.  Not admitted.  Seen by PCP daily.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: 3/5/08 PM "welt" at injection site (right upper lateral thigh).  3/7/08 "welts" spaced over body - taken to urgent care hospital in AM and received steroids.  3/9/08 to hospital in PM and received histamine blocker.  3/10/08 to PCP and then to hospital ER and labs done.  Released to home.  3/11/08 to PCP for new symptom of mouth sono and sent back to hospital ER.  Not admitted.  Seen by PCP daily.
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Hep A given in placed of Hep B. Should have received Hep B on 3/16/08 appx 10:30am. No adverse reaction noted at time or an late observation.
Age: 44.0
Sex: M
Vaccine: HEP, TTOX
Symptoms: Nausea, Pain, Pyrexia, Rosacea, Vomiting
Clinical narrative: Starting 8-9 hours after vaccines started with fever, nausea, aches, vomiting 1 time - lasted 24 hours then resolved.  Also states flare-up of his ongoing Rosacea.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of swelling in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced swelling. The subject was hospitalised. At the time of reporting the outcome of the event was unspecified.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Accidental exposure, Retching, Underdose
Clinical narrative: Information has been received from a certified medical nurse concerning a 4 month old male who on 04-DEC-2007 was vaccinated PO with a dose of ROTATEQ (lot# 657048/0909U).  Concomitant vaccinations administered on that same day included a dose of PEDVAX HIB (OMPC) (MSD), a dose of PREVNAR, a dose of DtaP (unspecified) and a dose of poliovirus vaccine inactivated (unspecified).  Upon vaccination the infant spit ROTATEQ into the nurse's left eye (WAES# 0712USA01346).  It was unknown whether medical attention was sought.  Follow-up information indicated that on 04-DEC-2007 upon administration of ROTATEQ (lot# 657048/0909U) the 4 month old male gagged and spit out a "spray" of the vaccine into the nurse's face.  No medical attention was sought.  The patient was recovered.  Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old patient who on approximately 28-JAN-2008 last week, was vaccinated with the first dose of ROTATEQ.  No adverse events were reported.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/14/2008. Follow-up information has been received from the reporting registered nurse concerning a 6 month old female who on 29-JAN-2008 was vaccinated PO with her first dose of ROTATEQ vaccine (lot# 655317/0980F). No medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Retching, Underdose
Clinical narrative: Information has been received from a registered nurse concerning a patient with no drug allergies who on approximately 03-FEB-2008 was vaccinated PO with a 2.0 ml dose of ROTATEQ (lot# 658379/1388U).  Concomitant vaccinations administered on that same day included a dose of DTaP (unspecified), a dose of ACTHIB, a dose of PREVNAR and a dose of poliovirus vaccine inactivated (unspecified).  On 04-FEB-2008 the patient spit and gagged after vaccination while in the physician's office.  No labs or diagnostics studies were performed.  The outcome was unknown.  There was no product quality complaint.  This is one of several reports from the same source.  Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 13 week old (reported as "14 weeks of age") female and her twin (WAES# 0802USA01252) who on 19-NOV-2007 was vaccinated with her first dose of ROTATEQ. The patient was not experiencing any known symptoms. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PNC, RV5
Symptoms: Abnormal behaviour, Diet refusal
Clinical narrative: Information has been received from a registered nurse concerning a baby with no drug allergies who on 04-FEB-2008 was vaccinated PO with a 2.0 ml dose of Rotateq (lot# 658379/1388U). Concomitant vaccination administered on that same day included a dose of Prevnar. Subsequently the patient's mother contacted the office to mention that the patient was "acting odd" and not wanting to suck or swallow after vaccination. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The outcome was unknown at the time of this report. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on approximately 15-JAN-2008 in the middle of January, was vaccinated PO with her first 2.0 ml dose of ROTATEQ (no lot# provided). On that same day approximately, the patient experienced consistent vomiting and diarrhea for 4 days. The patient sought unspecified medical attention. On approximately 19-JAN-2008 the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 13 week old (reported as "14 weeks of age") female and her twin sister (WAES# 0802USA01046) who on 19-NOV-2007 was vaccinated with her first dose of Rotateq. The patient was not experiencing any known symptoms. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Culture stool, Diarrhoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 5.5 month old male who on 11-SEP-2007 and 27-NOV-2007 received an oral 2 ml first and second dose of ROTATEQ. On 11-SEP-2007 the patient experienced "almost constant diarrhea" that lasted 6 weeks. On 27-NOV-2007, following the second dose, the patient experienced diarrhea that lasted 2 weeks. "After it happened for the second time," the doctor discontinued therapy with ROTATEQ. The patient sought unspecified medical attention. On an unspecified date the patient had a stool culture performed. At the time of the report the patient's status was recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Convulsion, Infantile spitting up, Overdose
Clinical narrative: Information has been received from a physician concerning a 2 month old male who was vaccinated with Rotateq Lot # 658379/1388U 2 mL PO. The physician reported that the patient was given 2 mL doses of Rotateq threes times in one day. The first time, the patient "spit it up" and had a seizure. The same thing happened when the second dose was given. The third time the patient spit up pure stomach acid and had another seizure. It was reported that getting three doses in one day could potentially be an overdose. The patient sought unspecified medical attention. There was no product quality complaint. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. This is an amended report.  This is in follow-up to report(s) previously submitted on 3/14/2008. A code of overdose was added. This is a corrected report, as amended.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Anorexia
Clinical narrative: Information has been received from a physician concerning a 6 month old female who was vaccinated PO with her third 2.0 ml dose of ROTATEQ (lot# 658379/1388U).  Subsequently the patient experienced "loss of appetite."  The patient sought unspecified medical attention.  No labs or diagnostic studies were performed.  The outcome was unknown.  It was noted that there was no adverse event with the first two doses of ROTATEQ.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 12 week old female with a history of diarrhea the morning prior to vaccination (patient's mother mentioned) who on 25-JAN-2008 was vaccinated PO with her first dose of Rotateq. On that same day, the patient experienced diarrhea. The patient was brought in for a check-up on 31-JAN-2008 and still had diarrhea (about 10 times per day) and on 03-FEB-2008 the diarrhea was down to about 4 times a day. The office had not seen the baby since her last visit. The nurse also mentioned that the patient did not have any fever, blood in the stool or vomiting. There was no product quality complaint. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with her first and second doses of ROTATEQ.  Subsequently after the second dose, the patient experienced "throwing up" and "diarrhea" and was hospitalized.  At the hospital, the physician recommended that the patient receive no further doses of ROTATEQ because the child was at risk of intussusception.  Subsequently the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 16 week old patient who was vaccinated PO with the first dose of ROTATEQ (no lot# provided). No adverse event was involved. There was no product quality complaint. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Dermatitis diaper, Diarrhoea, Enterovirus infection
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old patient who was vaccinated PO with his first 2.0 ml dose of Rotateq (no lot# provided). The patient was diagnosed with enterovirus 48 hours after vaccination. The patient also experienced diarrhea and horrible diaper rash 48 hours after the diagnosis. The patient sought unspecified medical attention. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Culture stool, Gastroenteritis
Clinical narrative: Information has been received from a physician's assistant (P.A.) concerning a 22-week-old male with a history of bronchiolitis who on 07-NOV-2007 and 08-JAN-2008 was vaccinated orally with a 2 ml first and second dose of ROTATEQ (lot# 653754/0139F and 657668/1390U), respectively. Concomitant therapy included an unspecified antibiotic, unspecified oral steroid therapy and ZITHROMAX. On 09-FEB-2008 the patient developed gastroenteritis. The patient was seen at the clinic and a stool culture for bacterial infection was performed. No results were reported. It was reported that, at the time of this report (11-FEB-2008), the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Age: 1.33
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Feeling abnormal, Inappropriate schedule of drug administration, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 month old male who on 04-DEC-2006 and on other unspecified date was vaccinated PO with the first, second and third dose of Rotateq (no lot# given). On 08-FEB-2008 the patient "tested positive for rotavirus." It was also reported that on approximately 08-FEB-2008 "the patient had been feeling bad for 3-4 days and had experienced diarrhea." The patient sought unspecified medical attention. Lab diagnostic studies were performed but the specific test was unknown. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Clostridium difficile toxin test, Culture stool negative, Diarrhoea, Rotavirus test negative, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 6 month old female who was vaccinated PO with her first and second doses of ROTATEQ (lot# not available). Subsequently the patient experienced diarrhea for approximately 2 days after the first dose and prolonged diarrhea for approximately 2 weeks after the second dose. "They do not plan to administer the third dose of ROTATEQ." Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested. Follow-up information a consumer concerning a 6 month old white female (23.6 lbs. 32 in.) with a mild upper repiratory tract infection who on 24-APR-2007 in the evening (exact time unknown) was vaccinated PO with her second dose of ROTATEQ (lot# 656186/1235F). Suspect vaccination administered on that same day in the evening included the second dose of Hib conj vaccine (OMPC) (MSD) (lot# 654001/1019F) in the right vastus lateralis. Concomitant vaccinations administered on the same day in the evening included the second dose of PEDIARIX (lot# AC21B084BA) in the left vastus lateralis and the second dose of PREVNAR (lot# A5807714) in the right vastus lateralis. In May 2007, the patient experienced diarrhea for 3 weeks. No medical attention was sought. Laboratory diagnostic studies performed on 14-MAY-2007 included a negative stool culture, negative ova and parasite test, and negative results for C difficile toxin and rotavirus. Subsequently the symptoms resolved and the patient recovered. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Cholelithiasis, Faeces pale, Hepatic enzyme increased, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning a 5 month old male who in November 2007 and January 2008, was vaccinated with his first and second dose of Rotateq. In 2008 the patient experienced three stools lacking in color, slightly elevated liver function tests and gall stones. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. 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 15 day old patient who in December 2007, was vaccinated with a dose of ROTATEQ. As far as they know the infant experienced no side effects. The patient was a little over two months when it was realized that the event occurred and have not continued the series with ROTATEQ at this point. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a healthcare worker concerning a patient who in October 2007, 18-DEC-2007 and 07-JAN-2008 was vaccinated PO with the first, second and third 2.0 ml doses of ROTATEQ. On 07-JAN-2008 the third dose was administered 20 days after the second dose. The patient was not experiencing any known symptoms. There was no product quality complaint. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 6 month old male who was vaccinated PO with his first dose of ROTATEQ. No adverse event reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Constipation, Flatulence
Clinical narrative: Information has been received from a physician concerning a baby who was vaccinated PO with a dose of ROTATEQ (no lot# provided). A day after vaccination, the patient became constipated, very "gassy" and the gas smelled like the rotavirus. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. No further information is available.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with a first, second, and third oral dose of ROTATEQ on 08-OCT-2007, 26-DEC-2007, and 11-FEB-2008, respectively. No problems were reported. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 2 week old female infant who on 01-NOV-2007 was vaccinated with a 2 ml oral dose of Rotavirus (Lot# 657667/1392U). No product quality complaint was involved. No other information was provided. 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 health professional concerning a patient who was vaccinated with a first, second, third, and fourth dose of Rotateq in April 2007, June 2007, August 2007 and 20-FEB-2008 (Lot# 657983/1243U), respectively. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain upper, Flatulence
Clinical narrative: Information has been received from a physician concerning a 2 month old male, with no medical history and no allergies, who, "about 10 to 12 days ago", on approximately 10-FEB-2008, was vaccinated with a first 2 ml oral dose of ROTATEQ. Concomitant vaccines included "routine vaccinations". "Soon after receiving the vaccine", on approximately 10-FEB-2008, the patient experienced stomach pain and gas. "About two days after receiving the vaccines," on approximately 12-FEB-2008, the patient recovered. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Faeces pale
Clinical narrative: Information has been received from a physician concerning a 2 month old patient with no pertinent medical history who was vaccinated PO with the first dose of ROTATEQ (no lot# given).  Concomitant vaccinations were received "within the same visit but specifics unknown."  "About 1-2 weeks post vaccination, the patient experienced diarrhea that was yellowish and had a rotavirus smell to it."  The patient sought unspecified medical attention.  No labs or diagnostic studies were performed.  Subsequently, the patient "had improved" and was noted to be recovered.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a physician concerning his infant son (currently "2 years old") with no pertinent medical history who in approximately 2006 "about a year and a half ago," was vaccinated PO with the first dose of ROTATEQ (no lot# given). "In approximately 2006 about 1-2 weeks post vaccination, the patient experienced diarrhea that was yellowish and had a rotavirus smell to it." Subsequently, the patient "had improved" and was noted to be recovered. There was no product quality complaint. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 week old (also reported as "4 months old") female who on 21-FEB-2008 was vaccinated with her first dose of ROTATEQ.  There was no product quality complaint.  Additional information has been requested.
Age: 0.04
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received concerning a 15 day old white female with no pre-existing medical conditions or allergies who on 01-NOV-2007 was vaccinated PO at the incorrect time with her first dose of ROTATEQ (lot# 657667/1392U).  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day included the first dose of PEDIARIX (lot# AC21B130AA) in the left deltoid, the first dose of PREVNAR (lot#853981H) in the right deltoid and the first dose of ACTHIB (lot# UF295AA) in the right deltoid.  On 17-OCT-2007 patient was also vaccinated with a dose of RECOMBIVAX HB (MSD) at a hospital.  No adverse reaction was reported.  No medical attention was sought.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Drooling, Infantile spitting up, Regurgitation
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old male with no pertinent medical history or drug allergies who on 25-FEB-2008 was vaccinated PO with his first dose of Rotateq (lot# 659856/1731U).  There was no concomitant medication.  After vaccination the patient vomited an amount more than the dose that was given.  Medical attention was sought in the physician's office.  No labs or diagnostic studies were performed.  The nurse would not consider this type of action as "vomiting" but rather as normal drool or spitting up of some of the medication.  Also the nurse does not feel this event was attributable to the Rotateq.  Therefore, there was no more information to follow with regards to "an unspecified number of children who received Rotateq that have also vomited."  On that same day, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 10 week old male with no pertinent medical history or drug allergies who on 19-FEB-2008 was vaccinated PO with his first 2.0 ml dose of Rotateq (lot# 659771/1599U).  There was no concurrent medication.  On 23-FEB-2008 the patient had to go to the ER for excessive diarrhea.  A stool sample was taken which tested positive for rotavirus.  Therapy with Rotateq was discontinued.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Eructation, Flatulence, Irritability
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated with the first dose of ROTATEQ.  Subsequently at the four month visit, the patient's mother reported that the infant was gassy, burping and passed gas a lot, and was very, very fussy.  It was unknown whether medical attention was sought.  Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 4 week old female who on 27-FEB-2008 was inadvertently vaccinated PO with a dose of Rotateq (lot# 657519/1129U).  No adverse reactions were reported.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Rotavirus infection
Clinical narrative: Information has been received from a registered nurse concerning a 2 month old male with no pertinent medical history who on 23-JAN-2008 was vaccinated PO with his first dose of ROTATEQ. On 03-FEB-2008 the patient experienced diarrhea that lasted all month. On 27-FEB-2008 the patient experienced positive stool cultures for rotavirus. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from an office manager in a physician's office concerning an 8 month old female who on 10-DEC-2007 was vaccinated with her third dose of Rotateq when she was older than 32 weeks.  No symptoms or problems were noted.  The patient did not seek medical attention.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a few drops of a dose of ROTATEQ (lot# not provided) and vomited approximately 2-3 ounces of milk.  The physician gave the baby a few more drops and the baby vomited again.  The patient sought unspecified medical attention.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 3 & 1/2 month old patient who was vaccinated with the first dose of Rotateq.  The patient did not experience any difficulties.  The physician did administer the second dose ten weeks after the first dose which was not given at the reporting physician's office.  There was no product quality complaint.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score abnormal, Drug exposure during pregnancy, Gestational diabetes, Glucose tolerance test
Clinical narrative: Information has been received from the Merck pregnancy registry from a registered nurse concerning a 24 year old female with no allergies and a history of gestational diabetes, who on 12-DEC-2006 was vaccinated IM with a first 0.5 ml GARDASIL (lot# 653978/0955F). Concomitant therapy included prenatal vitamins. The nurse reported that the patient received the dose while pregnant. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the patient was placed on iron for anemia on 18-JUN-2007. Subsequently, the patient experienced gestational diabetes. Laboratory examination included a 3 hour glucose test and the patient was placed on a 1800 calorie "APA" diet with accuchecks five times a day. It was reported that the patient delivered a normal baby girl weighing 7 pounds and 8 ounces on 24-AUG-2007 at 38.5 weeks gestation. The patient was 21 inches and had a head circumference of 34.5. It was reported that the patient had a improved apgar score (2/6/7). Other complications included a "body cord." Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 61 year old white female (131 lbs., 64 inches) with a history of asthma and a penicillin allergy who on 26-JUL-2007 was vaccinated intramuscularly with the first dose of GARDASIL.  Concomitant therapy included estradiol (ESTRASORB), progesterone (PROMETRIUM), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and albuterol sulfate (PROVENTIL) "as needed".  On 26-JUL-2007 in the evening, the patient experienced an asthma attack.  The patient took some "Preventolin" and had some hot tea and felt better the next day.  The patient recovered from the asthma attack.  On 28-SEP-2007 the patient was vaccinated with the second dose of GARDASIL.  It was reported that the patient did not have any adverse experience afterwards.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial and follow up information has been received from a physician concerning a teenage female who in approximately November 2007 was vaccinated with her first dose of Gardasil via injection and fainted after receiving the dose.  The physician reported that this was probably due to a fear of needles as the patient had no problems with doses two and three.  No further information was provided regarding the adverse experience.  The patient recovered from her experience on an unspecified date.  No additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Chest pain, Delivery, Drug exposure during pregnancy, Dyspnoea
Clinical narrative: Information has  been received through the Merck pregnancy registry from a physician concerning a 25 year old female with a history of anxiety and depression who on 18-DEC-2006 was vaccinated with her first dose of GARDASIL (Lot # 654389/0961F). On 01-Mar-2007 the patient received her second dose of GARDASIL (Lot # 655849/0263U) and she subsequently became pregnant with LMP 11-Jun-2007. Concomitant therapy included LORAM. Subsequently the patient experienced shortness of breath, and chest pain secondary to anxiety. Additional information has been requested. 07/08/08 Follow up information received from the physician confirmed the second dose was given on 01-Mar-2007 and the patient's LMP was 11-Jun-2007. The primary reporter confirmed that the patient had the baby and was scheduled for a postpartum office visit. The reporter indicated that "she guesses" everything was normal with the delivery and the baby.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Injection site papule, Local reaction, Swelling
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who on 29-JAN-2008 was vaccinated with her third dose of GARDASIL (Lot #659653/1448U) in her right deltoid.  On 30-JAN-2008 the patient experienced a pimple at the injection site, and the whole deltoid swelled to 1 1/2 sizes larger than normal, and was warm to the touch.  The patient did not have a fever.  The patient sought unspecified medical treatment with a phone call and nurse states the patient will be seen for follow up.  The patient reports the symptoms are not resolved.  Follow-up information was received stating that upon evaluation, it was a local reaction.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fluid retention, Joint swelling, Laboratory test normal, Thyroid function test normal, Viral infection
Clinical narrative: Information has been received from a pharmacist concerning a 21 year old female with no medical history and drug reactions/allergies to SULFA, who on 04-DEC-2007 was vaccinated with her first dose of Gardasil (lot # not reported).  Concomitant therapy included hormonal contraceptives (unspecified).  On an unspecified date, three weeks prior to receiving vaccine the patient received the Flu vaccine.  On an unspecified date within a few weeks post the patients vaccination with Gardasil, she developed severe joint swelling with fluid retention in the joints as well as a 24 pounds weight gain.  On an unspecified date, the patient was seen in the office.  Laboratory results from an unspecified date, unspecified thyroid and rheumatology blood tests which were reported to be negative.  The patient was referred to rheumatologist, and on an unspecified date, was diagnosed with a viral infection which the rheumatologist felt was not related to Gardasil.  At the time of this report, the patient had not recovered.  No other information was provided.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a pharmacist concerning a 21 year old female with no medical history and drug reactions/allergies to SULFA, who on 04-DEC-2007 was vaccinated with her first dose of Gardasil (lot # not reported).  Concomitant therapy included hormonal contraceptives (unspecified).  On an unspecified date, three weeks prior to receiving vaccine the patient received the Flu vaccine.  On an unspecified date within a few weeks post the patients vaccination with Gardasil, she developed severe joint swelling with fluid retention in the joints as well as a 24 pounds weight gain.  On an unspecified date, the patient was seen in the office.  Laboratory results from an unspecified date, unspecified thyroid and rheumatology blood tests which were reported to be negative.  The patient was referred to rheumatologist, and on an unspecified date, was diagnosed with a viral infection which the rheumatologist felt was not related to Gardasil.  At the time of this report, the patient had not recovered.  No other information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a representative concerning a female who on unspecified date was vaccinated intramuscularly with her third dose of GARDASIL (lot# not reported) and a month after the injection developed a little lump at the injection site. The site is tender and "hurts to rub it." There was no report of rash or redness at the site. At the time of the report, the patient was still recovering. No other information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Smear cervix
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old daughter who in June 2007, was vaccinated with a first dose of Gardasil (lot# unknown) 0.5 mL injection.  In August 2007 the patient received a second dose of Gardasil (lot# unknown) 0.5 mL injection.  In October 2007, the patient skipped her period.  Medical attention was sought.  As per the nurse, the patient is not pregnant.  The nurse also reported that the patient received a third dose of Gardasil vaccine (lot# unknown) 0.5 mL injection in December 2007 and so far the patient is already one week later for her January period.  To date the patient had not had her period yet.  On an unspecified date the patient had a regular Pap smear performed.  No further information was provided.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Skin laceration, Syncope
Clinical narrative: Follow up information has been received from a physician's assistant concerning an 18 year old female with no previous medical history, who on 19-DEC-2007 was vaccinated with her first dose of Gardasil (lot number: 659055/1522U). No concomitant medications. On 19-DEC-2007, after the injection the patient got up to check out window and had syncopal episode. She hit her head on the plexiglass partition at the window with a minor laceration and bump. EMS was called second degree to patient hitting head, but the patient refused to go the hospital for evaluation. The physician assistant called the patient the next day and she felt well. No other adverse reactions. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope, Vomiting
Clinical narrative: Initial and follow up information has been received from a physician's assistant concerning a 17 year old white female student with no previous medical history, who on 25-JUL-2007 was vaccinated with the first dose, on 26-SEP-2007 with the second dose and on 30-JAN-2008 with the third dose of GARDASIL (lot number: 659055/1522U).  Concomitant therapy included minocycline HC1 (DENTOMYCIN (minocycline hydrochloride)) and drospirenone (+) ethinyl estradiol (YAZ).  On 30-JAN-2008 after the 3rd and final vaccination the patient at the check out window had a syncopal episode.  She regained awareness in a matter of < 1 minute.  She did have an episode of vomiting after regaining awareness.  Subsequently the patient recovered.  The patient did not experience any reaction or adverse effect after the 1st and 2nd dose of vaccines.  Additional information has been requested. 07/08/08 Initial and follow up information has been received from a physician's assistant concerning a 17 year old female student with no previous medical history, who on 25-JUL-2007 was vaccinated with the first dose, on 26-SEP-2007 with the second dose and on 10-JAN-2008 with the third dose of GARDASIL (lot number: 659055/1522U). Concomitant therapy included DENTOMYCIN and YAZ. On 30-JAN-2008 after the 3rd and final vaccination the patient at the check out window had a syncopal episode. She regained awareness in a matter of < 1 minute. She did have an episode of vomiting after regaining awareness. Subsequently the patient recovered. The patient did not experience any reaction or adverse effect after the 1st and 2nd dose of vaccines. Additional information has been requested.