chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Autism, Developmental delay, Grunting, Immobile, Paralysis
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in an 18-month-old female subject who was vaccinated with Engerix B (GlaxoSmithKline), Hepatitis A (Merck). A physician or other health care professional has not verified this report. Concurrent medications included Paracetamol (Tylenol). On 21 October 2005, the subject received 3rd dose of Engerix B (unknown, left thigh). On 10 October 2006, the subject received the 1st dose of Hepatitis A vaccine (unknown). On 12 October 2006, 48 hours after vaccination with Hepatitis A vaccine, and approximately one year after vaccination with Engerix B, the subject experienced regression in development, speech deterioration, screaming, and grunting. On unspecified dates in December of 2006, the subject experienced periods of immobility or paralysis, which occurred on two separate episodes. On 10 April 2007, the subject received the 2nd dose of Hepatitis A vaccine (unknown) and experienced five episodes of immobility within the next six months. The reporter was the subject's mother, who reported that her daughter was diagnosed with mild autism (date of diagnosis unspecified). The subject's mother considered the events to be disabling. The subject's mother stated that she is in the early stages of investigating vaccines that her daughter has received which may contain ingredients the child may be allergic to. Per the subject's mother, there were no signs of regression until 12 October 2006. At the time of this report, the child has been in therapy for 19 months and her condition has improved, but she remains behind her peers.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Regressive behaviour, Screaming, Speech disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in an 18-month-old female subject who was vaccinated with Engerix B (GlaxoSmithKline), Hepatitis A (Merck). A physician or other health care professional has not verified this report. Concurrent medications included Paracetamol (Tylenol). On 21 October 2005, the subject received 3rd dose of Engerix B (unknown, left thigh). On 10 October 2006, the subject received the 1st dose of Hepatitis A vaccine (unknown). On 12 October 2006, 48 hours after vaccination with Hepatitis A vaccine, and approximately one year after vaccination with Engerix B, the subject experienced regression in development, speech deterioration, screaming, and grunting. On unspecified dates in December of 2006, the subject experienced periods of immobility or paralysis, which occurred on two separate episodes. On 10 April 2007, the subject received the 2nd dose of Hepatitis A vaccine (unknown) and experienced five episodes of immobility within the next six months. The reporter was the subject's mother, who reported that her daughter was diagnosed with mild autism (date of diagnosis unspecified). The subject's mother considered the events to be disabling. The subject's mother stated that she is in the early stages of investigating vaccines that her daughter has received which may contain ingredients the child may be allergic to. Per the subject's mother, there were no signs of regression until 12 October 2006. At the time of this report, the child has been in therapy for 19 months and her condition has improved, but she remains behind her peers.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Blepharospasm, Dyskinesia, Eyelid disorder, Facial palsy, Hypoaesthesia facial
Clinical narrative: This female subject was enrolled in the prophylactic open study 107682 (HPV-018). On 03 April 2007, the subject received the 1st dose of Gardasil (IM left upper deltoid) and the dose of Boostrix (IM right upper deltoid). On 14 May 2007, the subject received the 2nd dose of Gardasil (IM left upper deltoid) and the dose of Aventis Pasteur's (Menactra, IM right upper deltoid) On 12 September 2007, the subject received the 3rd dose of Gardasil (IM left upper deltoid). On 19 February 2008, five months after the 3rd dose of Gardasil, nine months after the 1st dose of Menactra, 10 months after the 1st dose of Boostrix, this 13-year-old subject developed Bell's palsy. The event was disabling. The subject was treated with acyclovir and prednisolone. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the Bell's palsy may have been caused by Gardasil 16-18, Menactra and Boostrix. Investigator's comments: On 19 February 2008, left eyelid starting twitching. The eyelid felt numb + left side of face was numb. She could not close her eyes, mouth angle twists to right when smiling. Continues to worsen. On 20 February 2008, patient given Zovirax and prednisolone. On 28 February 2008, patient returned to clinic for recheck-no improvement-referred for a neurology consult- patient did not get a neuro consult. On 09 April 2008, recheck in clinic- Bell's Palsy worsening. On 25 April 2008, patient not improved, worsened. Patient is receiving physical therapy. On 01 May 2008, no improvement. On 08 May 2008, the Bell's Palsy is probably related to the study.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Fever highest 103.7, body joint aches, headache, itchy and painful injection site, injection site red, swollen hard 10" x 6" area.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever highest 103.7, body joint aches, headache, itchy and painful injection site, injection site red, swollen hard 10" x 6" area.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Anorexia, Erythema, Fatigue, Headache, Pyrexia
Clinical narrative: Right upper arm redness, fever, headache, loss of appetite, fatigue.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: None.  (ADACEL given IM to 10 yr old instead of BOOSTRIX).
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: None. ADACEL given to 10 yr old girl instead of BOOSTRIX.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: None.  ADACEL given to 10 yr old instead of BOOSTRIX.
Age: 6.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Redness/erythema of upper arm - (R) upper arm with slight induration surrounding the injection site. No tenderness. Started the night following the vaccine administration. Mild itching. NO fever or systemic signs. Benadryl PO PRN given.
Age: 0.55
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Body temperature increased, Diarrhoea, Otitis media, Rash
Clinical narrative: Shots 5/8/08.  On 5/10/08 temperature 103, vomit x 1, to urgent care.  Diagnosed with OM started Omnicef.  4 loose stools and rash on her back.  5/13 3 hours screaming but afebrile and ears normal, stopped Omnicef.
Age: 0.55
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Screaming, Vomiting
Clinical narrative: Shots 5/8/08.  On 5/10/08 temperature 103, vomit x 1, to urgent care.  Diagnosed with OM started Omnicef.  4 loose stools and rash on her back.  5/13 3 hours screaming but afebrile and ears normal, stopped Omnicef.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal X-ray, Full blood count, Haemorrhage, X-ray normal
Clinical narrative: Pt presented to clinic 24 hours after well child visit with complaint of blood flecks in diaper.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Pyrexia
Clinical narrative: Per, mother felt, pt developed fever of 102 F, axillary, Thursday evening. He received vaccines the day before. She gave him 1500 mg ibuprofen and fever began to decrease with 3 hrs. He was afebrile by Friday. She notified her MD and made appt but did not take him in because fever resolved. I followed up with M.D. to let them know the family was refusing to keep appt because fever resolved. Mother did not notify me until Mday. Vis sheets and signs of reaction education provided to parent after vaccine given.
Age: 1.5
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Immediate hive reaction at site between where MMR & VARIVAX were given on left thigh.  Called 5/12/08 at 4:30pm reaction diminished by night time.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Around injection site, red, swollen area on (R) arm; diameter 7 inches long, 10 1/4 inches, warm to touch.
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling below site of injection.  Advised ice/TYLENOL/ADVIL.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Body temperature, Injection site erythema, Injection site swelling, Rash generalised, Urticaria
Clinical narrative: Pt received DTaP #4 5/10/08 -> 5/11/08 with swelling & redness at vaccine site -> 5/12/08 with rash all over.  No subjective fever per mom.  Pt brought into clinic 5/16/08: Temp=99.6, on exam with diffuse urticaria.  Rx'd BENADRYL 12.5/5 ml 1 tspn Q6 hours PRN & hydrocortisone cream.  Will follow up in clinic 5/20/08.
Age: 48.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 24 hours after vaccine, deltoid site became red, swollen, tender.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site pain, Injection site swelling
Clinical narrative: Site swollen and sore, diarrhea.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: ~24 hr after 2nd varicella imm. tender reddened area the size of a tennis ball.  In 48 hr increased redness, sl firm warm to touch.  72 hours later much improved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: R thigh swelled from the knee up pt.  Came to doctor the very next day.  Is doing fine now.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 4 month old patient with a history of prematurity at 29 weeks of gestational age who on 01-APR-2008 was vaccinated with the first dose of ROTARIX. No symptoms were noted. There was no product quality complaint. No further information is available.
Age: 0.54
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning an infant who one month prior to the time they were scheduled to receive a third dose of ROTARIX, they were taken to the hospital and diagnosed with rotavirus. At the time of reporting it was unknown if the infant was hospitalized or had just received treatment in the emergency room. Unspecified medical attention was sought. There was no product quality complaint. The patient's status was not provided at the time of reporting. Additional information has been requested.  09/02/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a physician concerning a 7 month old male who on 12-NOV-2007 was vaccinated with a second dose of ROTATEQ (lot # 657045/1053U). It was noted that a first dose had been administered on 29 AUG 2007 (lot # 657515/0668U). On 07-DEC-2007, one month prior to the time the patient was scheduled to receive their third dose of ROTATEQ the patient was taken to the emergency room, at which time a stool culture was obtained. Results of the stool culture were positive for rotavirus. It was noted that patient was not admitted to the hospital, but received unspecified medical treatment in the ER. There was no product quality complaint. The patient's status was not provided at the time of reporting. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Bronchiolitis, Diarrhoea, Pneumonia
Clinical narrative: Information has been received from a nurse concerning premature 9 month old female twins with numerous medical problems who on 22-JAN-2008 were vaccinated with ROTATEQ. The nurse reported that the twins were born prematurely and have had lots of medical problems. The nurse reported that they put some of the vaccine in a preemie nipple and had the patient suck on it. One of the twins developed pneumonia and one developed bronchiolitis. On 24-JAN-2008 the patient developed pneumonia. Subsequently, the patient recovered from pneumonia. One of the twins was put on antibiotic and developed diarrhea. It was reported that the twins were given their 4th month vaccine and were fine. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse and the consumer (patient's father) concerning a 10 week old male with no pertinent medical history or known drug allergies who on 02-APR-2008 was PO with a 2.0 ml dose of ROTATEQ (lot# 659915/0015X). There was no concomitant medication. On that same day in the evening, the patient experienced vomiting. There were no other symptoms or treatment information noted. The father notified the physician's office by phone for medical attention. No labs or diagnostic studies were performed. The patient's vomiting persisted. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a (bottle-fed) female who on approximately 08-MAR-2008 was vaccinated with a dose of ROTATEQ. In approximately March 2008, the patient experienced diarrhea for about one month. The patient's parent contacted the physician's office via phone call for medical attention. The diarrhea resulted in about 10 diapers per day. The patient's diarrhea persisted. It was noted that the child was received NUTRAMIGEN. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporters registered nurse indicated that she had no more information as this was a random phone call for the event. The patient was referred to her pediatrician. No further information is available.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 4 1/2-month-old male who was vaccinated with a first 2 ml oral dose of ROTATEQ. He was vaccinated with the second dose 6 weeks later. It was reported that this happened at another practice and no other details are known. No product quality complaint was involved. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 12 week, 4 day old patient who on approximately 30-JAN-2008 was vaccinated PO with the first dose of ROTATEQ. No adverse experience was related to this event. There was no product quality complaint. No further information is available.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Bronchiolitis, Diarrhoea, Pneumonia
Clinical narrative: Information has been received from a nurse concerning premature 9 month old female twins with numerous medical problems who on 22-JAN-2008 were vaccinated with ROTATEQ. The nurse reported that the twins were born prematurely and have had lots of medical problems. The nurse reported that they put some of the vaccine on a preemie nipple and had the patient suck on it. One of the twins developed pneumonia and one developed bronchiolitis. On 24-JAN-2008 the patient bronchiolitis. Subsequently, the patient recovered from pneumonia. One of the twins was put on antibiotic and developed diarrhea. It was reported that the twins were given 4th month vaccination and were fine. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Stomatitis
Clinical narrative: Information has been received from a registered nurse concerning an infant who was vaccinated PO with the third dose of ROTATEQ. Subsequently the patient experienced mouth sores. The patient sought medical attention through a phone call. The outcome was unknown. There was no product quality complaint. No further information is available.
Age: 0.27
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician and a registered nurse concerning an active infant female who in March 2008, was vaccinated PO with a dose of ROTATEQ (no lot# available). In 2008, the patient experienced diarrhea. The physician added that the patient had non-bloody diarrhea, no vomiting and no fever. The patient sought unspecified medical attention. subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.
Age: 2.0
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the first, second and third doses of ROTATEQ.  Subsequently after the first dose the child experienced severe vomiting for 24 hours after administration.  Subsequently the patient recovered.  With the second dose, the child vomited a couple of times then recovered.  On 06-JUN-2007 the child was vomiting several times within 24 hours from administration (similar to the first dose).  The patient sought medical attention through a nurse (mother).  The child got better within 24-36 hours of the third dose.  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 physician concerning a 4 month old patient who was placed on therapy with ROTATEQ, (first dose) (Lot # not provided).  The physician administered the first dose of ROTATEQ, to a four month old baby and no adverse reactions were reported.  Further information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Rash, Retching
Clinical narrative: Information has been received from a physician concerning a 17-week-old female who on 25-MAR-2008 was vaccinated orally with a second dose of ROTATEQ ("lot # 0618X").  Concomitant vaccines included a dose of PEDVAXHIB (manufacturer unknown), PEDIARIX and PREVNAR.  On 25-MAR-2008 the patient experienced gagging, developed a rash and diarrhea, post vaccination.  It was noted that the gagging would not subside.  It is unclear how long the patient "gagged" post vaccination.  On 01-APR-2008 the patient was examined in the office and was reported to be recovering.  A product quality complaint was not involved.  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 patient who at 2 months of age received the first dose of ROTATEQ.  The patient on 11-APR-2008 had returned to the office (12 weeks from the first dose) to receive the second dose of ROTATEQ.  The patient had not experienced any difficulties.  The patient sought medical attention in the physician's office.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Pyrexia, Rotavirus infection
Clinical narrative: Information has been received from a health professional concerning an 11 month old female with no pertinent medical history, drug reactions or allergies who on 21-FEB-2008 was vaccinated orally with a first dose of ROTATEQ (656183/0767U).  There was no concomitant medication.  On 21-FEB-2008 the patient developed a fever.  On 24-FEB-2008 the patient developed diarrhea.  Medical attention was sought.  On 24 FEB 2008 a stool culture revealed rotavirus.  The patient fully recovered on 31 MAR 2008 without requiring any treatment.  There was no product quality complaint.  Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who on 19-DEC-2007 was vaccinated with a first dose of ROTATEQ.  On 15-APR-2008 the patient was vaccinated with a second dose of ROTATEQ.  It is unknown if medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: DTAP, DTAPHEPBIP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a ten month old female with no pertinent medical history, drug reactions or allergies who on 15 APR 2008 was vaccinated orally with 2 ml, a second dose, of ROTATEQ ( Lot # 659914/1732U).  Concomitant therapy included DTaP-IPV-HIB (OMPC) (manufacturer unknown), pneumococcal vaccine (unspecified) and PEDIARIX.  On 15-APR-2008 the patient developed diarrhea two hours after receiving a second dose of ROTATEQ.  Medical attention was not sought.  It was noted that the patient received a first dose of ROTATEQ on 15-AUG-2007, at eight weeks of age.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 7 month old patient who on 16-APR-2008 was vaccinated with the first dose of ROTATEQ (lot# 660292/1832U).  No symptoms have been reported.  No further information was available.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning an infant who was vaccinated PO with an incomplete dose of ROTATEQ because the patient vomited during or after administration of the vaccine.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  No further information is available.  This is one of several reports from the same source.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning three patients who were recently vaccinated PO with doses of ROTATEQ.  Subsequently the patients experienced rotavirus.  The patients sought unspecified medical attention.  The outcome was unknown.  No other information was available.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Laboratory test, Rotavirus infection
Clinical narrative: Information has been received from a physician concerning an 8 week old female with no pertinent medical history or drug allergies who on approximately 26-MAR-2008 was vaccinated PO with her first dose of ROTATEQ (lot# not provided).  The next day on approximately 27-MAR-2008, the patient experienced rotavirus.  The patient sought unspecified medical attention.  Lab diagnostic studies were performed, but unspecified.  No further information was provided.  There was no product quality complaint.  Follow-up information indicated that the patient had a past medical history of gastroesophogeal reflux disease (GERD) upon vaccination with the first dose of ROTATEQ (lot# 659855/1692U).  No other information is available at this time.  Additional information has been requested.  This is one of several reports from the same source.
Sex: U
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning an infant who was vaccinated PO with an incomplete dose of ROTATEQ because the patient vomited during or after the administration of the vaccine.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.
Sex: U
Vaccine: RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning an infant who was treated with an incomplete dose of ROTATEQ because the patient vomited during or after administration of the vaccine.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  No further information is available.  This is one of several reports from the same source.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a (breast fed) female who in April 2008, was vaccinated PO with her first dose of ROTATEQ.  In April 2008, the patient experienced diarrhea four hours after vaccination which continued with 10-12 episodes per day for more than a week.  On 21-APR-2008 the patient was seen in the physician's office and was still having diarrhea but had not had any blood in her stool.  The patient's diarrhea persisted.  The patient was referred to a gastroenterologist at a hospital.  No additional information at this time.  There was no product quality complaint.  Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 9 month old female who on 07-APR-2008 was vaccinated with her third dose of ROTATEQ.  The patient was administered her first dose on 12-SEP-2007 and her second dose on 06-DEC-2007.  No other information.  There was no product quality complaint.  Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Rash
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who about ten months ago in approximately June 2007, was vaccinated PO with the first dose of ROTATEQ. Subsequently the patient experienced diarrhea and developed a rash on its buttocks. Therapy with ROTATEQ was discontinued. Subsequently, both symptoms resolved and the patient was recovered. No other information was available. There was no product quality complaint. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Angiogram normal, Asthenopia, Erythema, Eye haemorrhage
Clinical narrative: Information has been received from a registered nurse and physician concerning a 52 year old female registered nurse with hypertension and sulfonamide allergy who upon administration of ROTATEQ (lot# 660291/1829U) to an infant (WAES# 0804USA04929) on 18-APR-2008, the infant coughed some of the dose into the nurse's right eye. The nurse immediately used an eye wast eye with cold water. On 19-APR-2008 through 20-APR-2008 the nurse experienced a fever and tiredness. On that same day the patient experienced malaise since the incident occurred. On 22-APR-2008 the patient experienced ocular symptoms including erythema, pain, burning, had "heavy unusual" feeling in the eye and sclera with a "hemorrhage spot." The patient was seen by the physician for medical attention. Lab diagnostic studies performed included a fluorescein test which was negative. The patient's symptoms of malaise and ocular events persisted. There was no product quality complaint. Additional information has been requested. Follow-up information from a licensed practical nurse indicated that the 52 year old female registered nurse who on 18-APR-2009 at 10:45 upon administration of vaccine (WAES0804USA04929) the infant coughed and split vaccine into her right eye. She also experienced burning and heaviness in the right eye on 21-APR-2008 (also reported as 22-APR-2008. On 22-APR-2008 the eye was painful and burning with red aclera. The patient had an office visit on 23-April-2008 with an ophthamologist, no treatment was recommended. The patient was recovered on 25-APR-2008. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: RV5
Symptoms: Eye irritation, Eye pain, Fatigue, Laboratory test, Malaise
Clinical narrative: Information has been received from a registered nurse and physician concerning a 52 year old female registered nurse with hypertension and sulfonamide allergy who upon administration of ROTATEQ (lot# 660291/1829U) to an infant (WAES# 0804USA04929) on 18-APR-2008, the infant coughed some of the dose into the nurse's right eye. The nurse immediately used an eye wast eye with cold water. On 19-APR-2008 through 20-APR-2008 the nurse experienced a fever and tiredness. On that same day the patient experienced malaise since the incident occurred. On 22-APR-2008 the patient experienced ocular symptoms including erythema, pain, burning, had "heavy unusual" feeling in the eye and sclera with a "hemorrhage spot." The patient was seen by the physician for medical attention. Lab diagnostic studies performed included a fluorescein test which was negative. The patient's symptoms of malaise and ocular events persisted. There was no product quality complaint. Additional information has been requested. Follow-up information from a licensed practical nurse indicated that the 52 year old female registered nurse who on 18-APR-2009 at 10:45 upon administration of vaccine (WAES0804USA04929) the infant coughed and split vaccine into her right eye. She also experienced burning and heaviness in the right eye on 21-APR-2008 (also reported as 22-APR-2008. On 22-APR-2008 the eye was painful and burning with red aclera. The patient had an office visit on 23-April-2008 with an ophthamologist, no treatment was recommended. The patient was recovered on 25-APR-2008. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: RV5
Symptoms: Pyrexia, Scleral discolouration
Clinical narrative: Information has been received from a registered nurse and physician concerning a 52 year old female registered nurse with hypertension and sulfonamide allergy who upon administration of ROTATEQ (lot# 660291/1829U) to an infant (WAES# 0804USA04929) on 18-APR-2008, the infant coughed some of the dose into the nurse's right eye. The nurse immediately used an eye wast eye with cold water. On 19-APR-2008 through 20-APR-2008 the nurse experienced a fever and tiredness. On that same day the patient experienced malaise since the incident occurred. On 22-APR-2008 the patient experienced ocular symptoms including erythema, pain, burning, had "heavy unusual" feeling in the eye and sclera with a "hemorrhage spot." The patient was seen by the physician for medical attention. Lab diagnostic studies performed included a fluorescein test which was negative. The patient's symptoms of malaise and ocular events persisted. There was no product quality complaint. Additional information has been requested. Follow-up information from a licensed practical nurse indicated that the 52 year old female registered nurse who on 18-APR-2009 at 10:45 upon administration of vaccine (WAES0804USA04929) the infant coughed and split vaccine into her right eye. She also experienced burning and heaviness in the right eye on 21-APR-2008 (also reported as 22-APR-2008. On 22-APR-2008 the eye was painful and burning with red aclera. The patient had an office visit on 23-April-2008 with an ophthamologist, no treatment was recommended. The patient was recovered on 25-APR-2008. Additional information has been requested.
Age: 0.83
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 10 month old patient who on 22-APR-2008 was vaccinated with the third dose of ROTATEQ. No adverse symptoms were reported. It was also noted that the patient received the first and second doses on time (dates unspecified). No other information available. There was no product quality complaint. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Accidental exposure, Underdose
Clinical narrative: Information has been received from a licensed practical nurse and physician concerning a 2 month old male who on 18-APR-2008 was vaccinated with his first dose of ROTATEQ (lot# 660291/1829U). Upon administration the patient coughed some of dose into the administering nurse's eye (WAES# 0804USA04714). No symptoms were reported for this patient. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporting licensed practical nurse indicated that the 9 week old (15lb, 2oz., 23 in.) male who on 18-APR-2008 at 10:45 was vaccinated PO with his first dose of ROTATEQ (lot# 660291/1829U). There was no illness at the time of vaccination. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a (bottle fed) patient who was vaccinated PO with his first dose of ROTATEQ and vomited immediately after receiving the dose. The patient sought medical attention at the physician's office. The physician stated he did not want to file a report and said the event was unrelated to therapy  with ROTATEQ. The patient had just received a bottled feeding which caused the vomiting. No other details. There was no product quality complaint. No further information is available.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal rigidity, Biopsy kidney, Constipation, Crying, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 9 week old white male who was vaccinated PO with the second dose of ROTATEQ. Subsequently the patient experienced constipation, a "hard stomach," and appeared to be in pain for about 4 weeks. The patient was seen for a physician office visit and was referred to a gastrointestinal specialist. Subsequently, the patient's symptoms have resolved. Follow-up information has been received from a physician concerning this 14 week white male infant with gastrooesophageal reflux disease, allergic colitis, milk and niacin allergies and a history of minor feeding problems and blood in the stool (30-OCT-2006). It was noted that the patient was seen by a of doctor and started on nutramigen (prior to vaccination). After the nutramigen was started. It was noted that the patient's constipation (previously reported) had improved and there was no blood in his stool. On 02-NOV-2006 the patient had a KUB, which was normal and his hemoccult test was negative. The patient was vaccinated with a first (lot # 654663/0942F). Second (lot # 653581/0411P) and third (lot # 656102/1165p) dose of ROTATEQ. On 12-DEC-2006. 10-FEB-2007, and 12-APR-2007 respectively. Subsquently, on 03-JAN-2007 the patient developed vomiting and was crying. On 19-JAN-2007 the patient developed diarrhea. On 12-FEB-2007 the patient was seen by a GI doctor. It was noted that the patient's gastrooesophageal reflux disease continued. There were no medications given. On 04-APR-2007 the patient developed vomiting and diarrhea. On 05-DEC-2007 the patient developed diarrhea. It was noted that the patient was placed on amoxicillin (AMOXIL) at that time. At the time of the report, the patient recovered on an unspecified date. Additional information is not expected. This is on of the several reports from the ssame source. There was no product quality complaint.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Occult blood negative, Pain, Urinary system x-ray normal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old white male who was vaccinated PO with the second dose of ROTATEQ. Subsequently the patient experienced constipation, a "hard stomach," and appeared to be in pain for about 4 weeks. The patient was seen for a physician office visit and was referred to a gastrointestinal specialist. Subsequently, the patient's symptoms have resolved. Follow-up information has been received from a physician concerning this 14 week white male infant with gastrooesophageal reflux disease, allergic colitis, milk and niacin allergies and a history of minor feeding problems and blood in the stool (30-OCT-2006). It was noted that the patient was seen by a of doctor and started on nutramigen (prior to vaccination). After the nutramigen was started. It was noted that the patient's constipation (previously reported) had improved and there was no blood in his stool. On 02-NOV-2006 the patient had a KUB, which was normal and his hemoccult test was negative. The patient was vaccinated with a first (lot # 654663/0942F). Second (lot # 653581/0411P) and third (lot # 656102/1165p) dose of ROTATEQ. On 12-DEC-2006. 10-FEB-2007, and 12-APR-2007 respectively. Subsquently, on 03-JAN-2007 the patient developed vomiting and was crying. On 19-JAN-2007 the patient developed diarrhea. On 12-FEB-2007 the patient was seen by a GI doctor. It was noted that the patient's gastrooesophageal reflux disease continued. There were no medications given. On 04-APR-2007 the patient developed vomiting and diarrhea. On 05-DEC-2007 the patient developed diarrhea. It was noted that the patient was placed on amoxicillin (AMOXIL) at that time. At the time of the report, the patient recovered on an unspecified date. Additional information is not expected. This is on of the several reports from the ssame source. There was no product quality complaint.
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a baby's mother who had rotavirus after her baby was vaccinated with a dose of ROTATEQ. The baby's grandmother (WAES# 0805USA00049) also experienced rotavirus. The physician was contacted by phone for medical attention. The outcome was unknown. No additional information at this time. There was no product quality complaint. Additional information has been requested. Follow-up information from the administering health professional in the reporting physician's office indicated that on 14-Apr-2008 the baby was vaccinated and in April 2008, the baby's mother experienced rotavirus.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Abdominal rigidity, Constipation, Crying, Diarrhoea, Flatulence
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with the second dose of ROTATEQ. Subsequently the patient experienced constipation, a "hard stomach," and appeared to be in pain for about 4 weeks. The patient was seen for a physician office visit and was referred to a gastrointestinal specialist. The outcome was unknown. No other information is available at this time. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source. Follow-up information has been received from a physician concerning this 7 month old male infant with gastrooesophageal reflux disease (September 2007) and bronchitis and a history of pyloric stenosis repair (03-SEP-2007), urinary tract infection, otitis media and methicillin-resistant staphylococcal aureus infection who on 15-FEB-2008 was vaccinated with a third dose of ROTATEQ (lot # 659772/1636U) on 14-DEC-2007. Subsquently, on 14-MAR-2008 the patient vomited and had diarrhea. On 20-MAR-2008 the patient complained of stomach tightening, gas problems and had crying episodes. It was noted that the diarrhea continued but there was no vomiting. A GI doctor was consulted, but was never seen. It was noted that the patient was started on soy formula. At the time of the report, the patient recovered on 15-MAY-2008. Additional information is not expected. This is one of several reports from the same source.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with the second dose of ROTATEQ. Subsequently the patient experienced constipation, a "hard stomach," and appeared to be in pain for about 4 weeks. The patient was seen for a physician office visit and was referred to a gastrointestinal specialist. The outcome was unknown. No other information is available at this time. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source. Follow-up information has been received from a physician concerning this 7 month old male infant with gastrooesophageal reflux disease (September 2007) and bronchitis and a history of pyloric stenosis repair (03-SEP-2007), urinary tract infection, otitis media and methicillin-resistant staphylococcal aureus infection who on 15-FEB-2008 was vaccinated with a third dose of ROTATEQ (lot # 659772/1636U) on 14-DEC-2007. Subsquently, on 14-MAR-2008 the patient vomited and had diarrhea. On 20-MAR-2008 the patient complained of stomach tightening, gas problems and had crying episodes. It was noted that the diarrhea continued but there was no vomiting. A GI doctor was consulted, but was never seen. It was noted that the patient was started on soy formula. At the time of the report, the patient recovered on 15-MAY-2008. Additional information is not expected. This is one of several reports from the same source.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a healthcare professional concerning a 2-month-old male, with no pertinent medical history or allergies, who on 25-FEB-2008 was vaccinated orally with his first dose of ROTATEQ (lot # 659708/1621U). Concomitant vaccines included PEDIATRIX, PREVNAR and ACTHIB. On 25-FEB-2008, post vaccination, the patient experienced diarrhea, vomiting and fever. The patient's mother sought medical attention via a call to the physician. Two months later during an office visit with the physician the patient had fully recovered, but the second dose of ROTATEQ was not given. No diagnostic labs were performed. A product quality complaint was not involved.  Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured, Mucous stools, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 week old male with no pertinent medical history, drug reactions or allergies who on 14-APR-2008 was vaccinated orally with "one pouch", a first dose, of ROTATEQ (lot # 659855/1692U).  Concomitant therapy included POLY-VI-SOL.  On 15-APR-2008 the patient developed diarrhea.  At the time of reporting the stools were described as "mucousy and browner than before".  On 26 APR 2008 the patient began vomiting.  There was no fever.  It was noted that there were no signs of dehydration, and that the child "was still happy".  At the time of reporting the patient was recovering.  Unspecified medical attention was sought.  There were no lab diagnostic studies performed.  There was no product quality complaint.  Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Rotavirus test positive, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 9 week old female with gastrooesophageal reflux disease who on 17-APR-2008 was vaccinated PO with a 2.0 ml dose ROTATEQ (lot# 659855/1692U) . On 23-APR-2008 the patient experienced severe diarrhea. A stool sample was preformed which was positive for rotavirus. The patient sought medical attention through a physician office visit. The patient was not recovered at the time of this report. No other information is available at this time. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source. Follow-up information has been received from an administering health professinal and medical records concerning a 9 week old female with GERD and apnea who on 17-APR-2008 was vaccinated PO with her first dose of ROTATEQ (lot#059855/16920U). There was no illness at the time of vacciantion. Concomitant vaccinations administered on that same day included the firse IM doseof PREVENAR (lot# 057543) in the right thigh, th first IM dose of PEDIARIX (lot#AC218145AA) in the left thigh and the first dose of ACTIB (lot#UF256AB) in the left thigh. On 23-APR-2008 the patient experienced explosive diarrhea that was green and foul-smelling with 12 stools on 11-APR-2008. 8 stools on 14-APR-2008 and 7 stools on 15-APR-2008 which lasted approximately 7 days. The patient was seen for a doctor visit and was treated with push fluids and monitored for dehydration. On 26-APR-2008 a stool rotavirus antigen test was positive for rotavirus. On 01-MAY-2008 the patient recovered. Additional information has been requested. This is one of several reports from the same source. All available medical records will be provided upon request.
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a baby's grandmother who had rotavirus after her grandchild was vaccinated with a dose of ROTATEQ.  The baby's mother (WAES# 0804USA05564) also experienced rotavirus.  The physician was contacted by phone for medical attention.  The outcome was unknown.  No additional information at this time.  There was no product quality complaint.  Additional information has been requested. Follow-up information from the administering health professional in the reporting physician's office indicated that on 14-APR-2009 the baby was vaccinated (WAES #0805USA04720) and in April 2008, the baby's grandmother experienced rotavirus. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old male who 2 months ago, was vaccinated PO with his first 2.0 ml dose of ROTATEQ.  The patient experienced severe diarrhea within 24 hours of receiving the vaccine.  The patient contacted the physician for medical attention.  The outcome was unknown.  No further information is available.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5, UNK
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a 2 or 4 month old patient who was vaccinated with a dose of ROTATEQ.  Concomitant vaccinations administered on that same day included all the other vaccines normally given at that time.  The next day the mother brought the baby back in to say the baby had an adverse experience which she thought was from the oral vaccine.  During the night the baby was colicky and had abdominal which she felt was from the oral vaccine.  When the doctor saw the baby the next day he/she was fine; the baby didn't seem to be suffering from any type of adverse reaction.  The baby will continue treatment.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Gastrointestinal disorder
Clinical narrative: Information has been received from a company representative concerning her 8 week old bottle-fed son with no drug allergies who on 14-FEB-2008 was vaccinated PO with his first dose of ROTATEQ.  Concomitant vaccinations administered on that same day included a dose of PEDIARIX, a dose of ACTHIB and a dose of PREVNAR.  Within 2 hours of the vaccination, the patient experienced diarrhea which lasted 10 days and then there was a "continuous" diarrhea for the next 5 weeks.  The gastroenterologist indicated that her son had a problem breaking down proteins (due to damage to the gastrointestinal tract brush border) and was put on special formula.  Therapy with ROTATEQ was discontinued for further doses.  On 25-MAR-2008 the patient recovered.  No other information to report.  There was no product quality complaint.  Additional information has been requested.