chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Postpartum depression, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received through Pregnancy Registry for a 22 year old female consumer with 2 previous full term deliveries  who on 28-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (lot # 656050/0245U).  There was no concomitant medication.  On approximately 04-Sep-2007, the patient had a pregnancy test which was positive (LMP approximately 04-JUL-2007).  The patient reported having an ultrasound;  however, no additional information was provided.  The patient sought unspecified medical attention.  On 30-OCT-2007, the patient had a positive pregnancy test.   The estimated conception date is 27-JUL-2007.  The estimated  date of delivery is 09-APR-2008.  In further follow up, a nurse practitioner reported that the patient delivered a female baby on 23-MAY-2008.  The baby weighed 10 pounds 2 ounces, was 20 inches, and the APGAR score was unknown.  The infant was macrosomic and had no other abnormalities or complications.  During pregnancy, the patient experienced anemia (HgE 10.9).  The patient experienced failure to progress because of the large baby during the labor/delivery.  On 14-DEC-2007, the patient had an ultrasound which was within normal limits.  On an unspecified date, the patient had a positive alpha-fetoprotein test.  There were no infections or illnesses during pregnancy.  Follow-up information was received from a nursing supervisor who stated that the patient went to their offices on 11-JUN-2008 suffering post-partum depression and was referred to "psych".  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Initial and follow up information has been received as part of a Pregnancy registry for GARDASIL.  A nurse practitioner and a certified medical assistant reported that a 25 year old female patient with no allergies and two previous pregnancies with full term deliveries and a bilateral tubal ligation (2006), on 11-OCT-2007 was vaccinated with GARDASIL.  There was no concomitant medication.  Subsequently the patient had a positive home pregnancy test.  On 18-OCT-2007 the patient was seen in the office and underwent an ultrasound of the pelvis to confirm pregnancy.  The patient's LMP was 01-SEP-2007 (EDD 29-MAY-2007).  Follow-up information was received from a nurse who reported that the patient was scheduled at 39 weeks EGA for a repeat Cesarean section and delivered a healthy and normal male, weighing 7 lbs 3 oz.  According to the nurse, the patient recovered postoperatively without problems.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vulvovaginal candidiasis
Clinical narrative: Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a registered nurse concerning a 17 year old female with no known significant past medical history or no known concurrent medical condition, who on 14-SEP-2007 was vaccinated with the first dose of GARDASIL (Lot# 6585558/1061U), and was pregnant. On 14_SEP-2007, the patient experienced vaginal candida. Other medications used during the pregnancy was DIFLUCAN for vaginal candida. The patient's estimated LMP was 07-SEP-2007 and had a EDD of 14-JUN-2008. On an unknown date, the pregnancy was confirmed by a pregnancy test. The registered nurse wanted to have the patient added to the pregnancy registry. No further information is available.
Age: 0.15
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received form a medical assistant concerning a 55 day old female with a history of acute ocular conjunctivitis who on 06-NOV-2008 was vaccinated with ROTATEQ vaccine. Unspecified medical attention was sought. Subsequently,  on 06-NOV-2008, the patient recovered from vomiting. Additional information has been requested. 03/05/09 This is in follow-up to report(s) previously submitted on 12/12/2008. Information has been received from a medical assistant concerning 55 day old female with a history of acute ocular conjunctivitis who on 06-NOV-2008 was vaccinated with ROTATEQ. The patient vomited 2 minutes after receiving ROTATEQ. Unspecified medical attention was sought. Subsequently, on 06-NOV-2008, the patient recovered from vomiting. Follow up information was received that the patient with illness of acute follicular conjunctivitis at the time of vaccination spit up along with milk 30 seconds after the vaccine ROTATEQ was given. No further information is available.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Rash macular
Clinical narrative: This is in follow-up to report (s) previously submitted on 12/12/2008. Information has been received from a physician concerning an "around 4 months old" male who on an unspecified date, was vaccinated with the second dose of ROTATEQ vaccine, 2ml, oral (lot# not provided). Subsequently the patient experienced blotchy redness in face and around lips. It was reported that the patient had no reaction after first dose of ROTATEQ vaccine (lot# 663033/0894X) and the physician had decided not to administer the third dose. The patient's mother has not contacted the office since the last visit so the doctor is assuming that there have been no further problems. The doctor would be seeing the patient again in 2 weeks. Unspecified medical attention was sought. Additional information has been requested. Follow up information has been received from the physician reporting that the 17 week old male with no medical history or drug allergy received his second dose of ROTATEQ 2ml oral (lot# 661582-0595X) on 06-NOV-2008. On 06-NOV-2008, the nurse had just started to administer vaccine, the tube was just touching the patient's mouth and had started to transfer contents when a few pink/red blotches were noted on the patient's face. They resolved quickly. No vomit or respiration difficulty was reported. The physician instructed the nurse to try again and same rash appeared. The patient was observed in office for 30 minutes. No respiration and no rash noted before the patient left. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Ear infection
Clinical narrative: Information has been received from a consumer concerning her 4 month old daughter with no previous medical history and allergies reported who "around June 2008", was vaccinated with the second dose of ROTATEQ and "received other vaccination, but did not remember the names".  It was reported that "around 6 months of age (approximately in October 2008), the patient had developed an ear infection and because of the infection and was with antibiotics (name and manufacturer unspecified) she did not receive the third dose of ROTATEQ at 32 weeks of age".  The consumer reported that at the time of the report, the patient had not yet receive the third dose of ROTATEQ.  The reporter wanted to check what will happen if her daughter never received the third dose of ROTATEQ and was already 33 weeks old.  On an unspecified date, the patient recovered from ear infection.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Faeces discoloured
Clinical narrative: Information has been received from a physician concerning an approximately 11-week-old female who on an unspecified date was vaccinated orally with a first 2ml dose of ROTATEQ. After receiving ROTATEQ, the patient developed 2 black, seedy stools. She was seen by the physician. Subsequently, on an unspecified date, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician assistant concerning a patient who was vaccinated with ROTATEQ vaccine (dose and route not reported). On 10-JUL-2008 the patient received first dose of ROTATEQ vaccine. On 18-NOV-2008 the patient was in the office to receive the second dose. No adverse effect reported. Additional information has been requested
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 09-JUL-2008 was vaccinated with the third dose of ROTATEQ 2ml orally. The patient vomited while receiving the third dose of ROTATEQ. The patient did not experience any known symptoms. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Underdose, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an 2 month old infant who "2 months ago", on approximately 17-SEP-2008, was vaccinated orally with a first dose of ROTATEQ vaccine. It was reported that the infant received an incomplete first dose of ROTATEQ vaccine because the infant vomited immediately after the vaccine was administered. The outcome of the patient was not reported. No further information is available
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Auricular swelling, Cough, Erythema, Eye discharge, Irritability
Clinical narrative: Information has been received from a health professional and from a medical record which was reviewed concerning a four month old female infant who on 02-JUN-2008 was vaccinated with a first dose of ROTATEQ.  On 02-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ.  Concomitant therapy included Hib conj vaccine (OMPC) (manufacturer unknown), PEDIATRIX, PREVNAR and FLUZONE.  It was reported in the medical report that the infant visited the doctor's office on 18-JUL-2008.  The mother reported that her baby experienced mattering of left eye with redness for the last two days.  The infant also had runny nose.  She was treated with VIGAMOX one drop twice daily for five days and treated both eyes.  The infant had a very small bony prominence redness or pain noted.  The healthcare professional would continue to monitor the event.  No treatment was ordered.  The mom was instructed to call the office if symptoms worsen or had any new concerns.  On 06-AUG-2008 the patient  was seen in the doctor's office.  It was reported that the baby experienced fussiness, irritability.  Her nose was mildly congested and her throat was red.  The infant had a positive strep test.  Laboratory test result showed the infant's white count was elevated (14.4 10^3/uL).  She was treated with OMNICEF 125 mg per 5cc, 3cc a day for ten days.  On 10-SEP-2008 the infant came to the doctor's office and noted to have nasal drainage and fussiness.  It was reported that she had nasal drainage and fussiness for the last two days and had cough.  It was reported that the infant had mild right  ear effusion, sinusitis and mild external swelling of the ear canal.  She was treated with AMOXICILLIN 125 mg, 5cc three times a day for ten days.  The mother reported that on 10-OCT-2008 the infant was vaccinated with FLUZONE in the office in her thigh.  The infant came to the doctor's office on 22-OCT-2008 and it was reported that she experienced non productive cough, rhinorrhea.  There was no sign of infection.  At the time of this report the outcome of the events were unknown.  Additional information is not available.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Laboratory test abnormal, Middle ear effusion, Nasal congestion, Ocular hyperaemia, Pharyngeal erythema
Clinical narrative: Information has been received from a health professional and from a medical record which was reviewed concerning a four month old female infant who on 02-JUN-2008 was vaccinated with a first dose of ROTATEQ.  On 02-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ.  Concomitant therapy included Hib conj vaccine (OMPC) (manufacturer unknown), PEDIATRIX, PREVNAR and FLUZONE.  It was reported in the medical report that the infant visited the doctor's office on 18-JUL-2008.  The mother reported that her baby experienced mattering of left eye with redness for the last two days.  The infant also had runny nose.  She was treated with VIGAMOX one drop twice daily for five days and treated both eyes.  The infant had a very small bony prominence redness or pain noted.  The healthcare professional would continue to monitor the event.  No treatment was ordered.  The mom was instructed to call the office if symptoms worsen or had any new concerns.  On 06-AUG-2008 the patient  was seen in the doctor's office.  It was reported that the baby experienced fussiness, irritability.  Her nose was mildly congested and her throat was red.  The infant had a positive strep test.  Laboratory test result showed the infant's white count was elevated (14.4 10^3/uL).  She was treated with OMNICEF 125 mg per 5cc, 3cc a day for ten days.  On 10-SEP-2008 the infant came to the doctor's office and noted to have nasal drainage and fussiness.  It was reported that she had nasal drainage and fussiness for the last two days and had cough.  It was reported that the infant had mild right  ear effusion, sinusitis and mild external swelling of the ear canal.  She was treated with AMOXICILLIN 125 mg, 5cc three times a day for ten days.  The mother reported that on 10-OCT-2008 the infant was vaccinated with FLUZONE in the office in her thigh.  The infant came to the doctor's office on 22-OCT-2008 and it was reported that she experienced non productive cough, rhinorrhea.  There was no sign of infection.  At the time of this report the outcome of the events were unknown.  Additional information is not available.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Rhinorrhoea, Sinusitis, Streptococcal identification test positive, White blood cell count increased
Clinical narrative: Information has been received from a health professional and from a medical record which was reviewed concerning a four month old female infant who on 02-JUN-2008 was vaccinated with a first dose of ROTATEQ.  On 02-OCT-2008 the infant was vaccinated with a second dose of ROTATEQ.  Concomitant therapy included Hib conj vaccine (OMPC) (manufacturer unknown), PEDIATRIX, PREVNAR and FLUZONE.  It was reported in the medical report that the infant visited the doctor's office on 18-JUL-2008.  The mother reported that her baby experienced mattering of left eye with redness for the last two days.  The infant also had runny nose.  She was treated with VIGAMOX one drop twice daily for five days and treated both eyes.  The infant had a very small bony prominence redness or pain noted.  The healthcare professional would continue to monitor the event.  No treatment was ordered.  The mom was instructed to call the office if symptoms worsen or had any new concerns.  On 06-AUG-2008 the patient  was seen in the doctor's office.  It was reported that the baby experienced fussiness, irritability.  Her nose was mildly congested and her throat was red.  The infant had a positive strep test.  Laboratory test result showed the infant's white count was elevated (14.4 10^3/uL).  She was treated with OMNICEF 125 mg per 5cc, 3cc a day for ten days.  On 10-SEP-2008 the infant came to the doctor's office and noted to have nasal drainage and fussiness.  It was reported that she had nasal drainage and fussiness for the last two days and had cough.  It was reported that the infant had mild right  ear effusion, sinusitis and mild external swelling of the ear canal.  She was treated with AMOXICILLIN 125 mg, 5cc three times a day for ten days.  The mother reported that on 10-OCT-2008 the infant was vaccinated with FLUZONE in the office in her thigh.  The infant came to the doctor's office on 22-OCT-2008 and it was reported that she experienced non productive cough, rhinorrhea.  There was no sign of infection.  At the time of this report the outcome of the events were unknown.  Additional information is not available.
Sex: U
Vaccine: RV5
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ on an unspecified date (lot number was available). On an unspecified date the patient experienced nausea and fever after receiving a dose of ROTATEQ. Subsequently, the patient recovered from nausea and fever on unspecified dates. No further information was provided. The patients sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Stool analysis abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on 05-OCT-2007, at two months old, received the first dose of ROTATEQ vaccine (lot#657045/1053U), then at 4 months old on 13-DEC-2007, the patient received the second dose of ROTATEQ vaccine (lot#657668/139U), and finally on 06-MAR-2008 at 6 months old the patient received the third dose of ROTATEQ vaccine (lot#659682/1733U). the physician reported that just recently, no specified date was provided, the patient went to the emergency room and had a stool test done and was diagnosed with rotavirus. At the emergency room the patient was given electrolytes and I.V. fluids, and no admission was necessary. Subsequently, on an unspecified date the patient recovered from diagnosed rotavirus. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: RV5
Symptoms: Clostridium test, Clostridium test negative, Diarrhoea, Rotavirus infection, Stool analysis abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/12/2008. Initial and follow-up information has been received from a physician concerning an approximately 17 month old male patient who at 11 weeks old on 15-AUG-2007 was vaccinated with the first dose of ROTATEQ (Lot # 657522/0769U), the second dose of ROTATEQ (Lot # 657045/1053U) was given at 6 months old on 16-OCT-2007 and then the third dose of ROTATEQ (Lot # 657668/1390U) was given at 6 months old on 11-DEC-2007. Concomitant therapy included DTAP-IVP and PREVNAR. The physician reported that on 05-NOV-2008 the patient went to the emergency room and had a stool culture test, preliminary the test showed no Salmonella, Shigella, Campylobacter, or Shiga-toxins 1 and 2 producing strains of E. coli (including E. coli 0157) isolated in 24 hours and final results were positive to rotavirus: C Difficile Toxin Assay final result were negative for Clostridium difficile toxin A and/or B. The physician reported that the patient had diarrhea and rotavirus. The patient was not admitted to the hospital, on the emergency room was given 500cc and he felt much better on 10-NOV-2008. The patient was recovered. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: Information has been received from a physician concerning male patient who at two months old, on 12-NOV-2007, was vaccinated with the first dose of ROTATEQ (lot #657045/1053U), then at 4 months old, on 21-JAN-2008, the patient received the second dose of ROTATEQ (lot #657988/1193U), and the third dose of ROTATEQ (lot #659682/1733U) was given at 6 months old on 17-MAR-2008. The physician reported on 04-NOV-2008, the patient went to the office, had a stool test done and was diagnosed with rotavirus. The physician reported that the patient was given I.V. fluids, and subsequently, the patient recovered from rotavirus. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician, concerning a 14-week-old patient, who on an unspecified date received the first dose of ROTATEQ vaccine (lot number unknown) orally at 14 weeks of age. At the time of reporting, the patient did not experienced any known
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a health professional concerning a 9 week old female who on 30-OCT-2008 was vaccinated with the first dose of ROTATEQ (lot # 661031/0467X) orally.  Concomitant therapy included PENTACEL and PREVNAR.  On 31-OCT-2008 the patient experienced explosive diarrhea, which has been occurring after every feeding.  Parent of patient called the office.  There is no medical history and no labs were performed.  Health professional reported that the patient is showing some improvement.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Body temperature increased, Full blood count, Pyrexia, Urine analysis
Clinical narrative: Information has been received from a Registered Nurse concerning an 8 week old male infant who on 10-DEC-2007 was vaccinated IM into left thigh with a dose of COMVAX (lot # 657380/0377U). Concomitant suspect therapy included ROTATEQ (MSD). Other concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine, PREVNAR. The nurse reported that eight hours after the vaccination on 10-DEC-2007 the patient developed a fever of 105.4 degrees F. He was examined at the emergency room and no infection was discovered. The patient received no treatment. A complete blood count and Urinalysis was drawn but the result was not reported. On 11-DEC-2007 the patient recovered. No other information to report. Additional information has been requested.
Sex: F
Vaccine: HBHEPB
Symptoms: Infection
Clinical narrative: Information has been received from a mother concerning a 1 day old female with no pertinent medical history who on 11-DEC-2007 was vaccinated with either a dose of COMVAX or a dose of Hib conj vaccine, the mother was not sure. Concomitant therapy included unspecified shots required for a two month old. On 12-DEC-2007 the patient experienced infection on her neck behind her ear. The infection was spreading. The physician prescribed an unspecified topical ointment and unspecified oral therapy. There were no laboratory or diagnostic tests performed. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, HEPA, PNC
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Initial and follow-up information has been received from a physician and a licensed vocational nurse concerning a 15 month old male with small muscular ventricular septal defect who on 27-NOV-2007 was vaccinated IM, into the right leg, with a third dose of COMVAX (lot # 657380/0377U).  Concomitant suspect vaccination given on the same day included a first dose of VAQTA (lot # 659187/1259U) administered IM into the left thigh, a fourth dose of PREVNAR (lot # B0802D), administered IM into the right thigh and first dose of FLUZONE (lot U2461AA) administered IM into the right thigh.  Other concomitant vaccination on the same day, included a fourth dose of DIPTHERIA TOXOID (+) PERTUSSIS ACELLULAR vaccine (unspecified) (+) TETANUS TOXOID (Lot # C2760AA) administered IM into the left thigh.  On 27-NOV-2007, later the same day, the patient developed a fever which went up to 102 degrees.  Also, the patient's developed erythema and tenderness of the right thigh and right leg was swollen and she was "fussy and lethargic".  On 29-NOV-2007, the child came in to the physician's office and the physician recommended warm compresses and BENADRYL.  On 29-NOV-2007, the patient recovered from fever.  On an unspecified date, the patient recovered from erythema and tenderness of the right thigh.  Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, HEPA, PNC
Symptoms: Lethargy, Oedema peripheral, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician and a licensed vocational nurse concerning a 15 month old male with small muscular ventricular septal defect who on 27-NOV-2007 was vaccinated IM, into the right leg, with a third dose of COMVAX (lot # 657380/0377U).  Concomitant suspect vaccination given on the same day included a first dose of VAQTA (lot # 659187/1259U) administered IM into the left thigh, a fourth dose of PREVNAR (lot # B0802D), administered IM into the right thigh and first dose of FLUZONE (lot U2461AA) administered IM into the right thigh.  Other concomitant vaccination on the same day, included a fourth dose of DIPTHERIA TOXOID (+) PERTUSSIS ACELLULAR vaccine (unspecified) (+) TETANUS TOXOID (Lot # C2760AA) administered IM into the left thigh.  On 27-NOV-2007, later the same day, the patient developed a fever which went up to 102 degrees.  Also, the patient's developed erythema and tenderness of the right thigh and right leg was swollen and she was "fussy and lethargic".  On 29-NOV-2007, the child came in to the physician's office and the physician recommended warm compresses and BENADRYL.  On 29-NOV-2007, the patient recovered from fever.  On an unspecified date, the patient recovered from erythema and tenderness of the right thigh.  Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 9 week old white female with no illnesses at time of vaccination, pre-existing medical conditions, allergies, birth defects or concomitant medication usage who on 30-OCT-2007 was vaccinated intramuscularly in the right limb with the 1st dose of the hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot# 657380/0377U). On 30-OCT-2007, post vaccination, the patient developed redness and swelling at the injection site that lasted for 1 month. The patient had a fever that lasted for 24 hours and a slight lump at the injection site. No diagnostic lab test were performed. The patient has not recovered from the slight lump at the injection site. No additional information is expected.
Age: 1.1
Sex: F
Vaccine: HBHEPB
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Initial and follow up information has been received from a licensed visiting nurse, concerning a 12 month old Caucasian female child with no known allergies and no pertinent medical history, who on 22-DEC-2006 was vaccinated IM with the first dose, 0.5 ml, on 26-FEB-2007 with the second dose, and on 02-NOV-2007, at 11:30 am, was vaccinated IM in the thigh, with the third dose of COMVAX (third dose, lot # 657379/0376U).  There was no illness at the time of vaccination.  There was no concomitant medications.  Following the first and second doses, there were no adverse symptoms.  However, on 03-NOV-2007, the child developed vomiting, and lethargy, and an elevated temperature on 04-NOV-2007.  The mother contacted the physician by phone, though no treatment was required.  On 05-NOV-2007 the child recovered from the events.  Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Gait disturbance, Guillain-Barre syndrome, Movement disorder, No reaction on previous exposure to drug
Clinical narrative: November 2007: Patient continued with weakness in legs, weakness in arms, unable to swallow. Needed complete assistance with stairs. 12/8/07: Admitted to hospital. Aspiration pneumonia, dehydration, malnourished, failed Modified Barium Swallow, Cardiac Output=10%, Diagnosis-Neuropathy. 12/11/07: Patient transferred to ICU due to respiratory and cardiac problems. 12/12/07: G-tube inserted due to failed Modified Barium Swallow. 2/4/08: Patient discharged from hospital to rehab. 2/17/08: 911 was called, due to decrease in oxygen saturation. 2/21/08: 3:00pm - Discharged from hospital and returned to rehab. 7:00pm - Called 911 - Respiratory distress-intubated. Admitted to hospital. 2/27/08: Patient was transferred. Lumbar puncture-inconclusive. 3/1/08: Ex-tubated. 3/2/08: Re-intubated. 3/7/08: Tracheotomy performed. 3/22/08: Patient was transferred to another hospital. 4/2/08: Patient was discharged from hospital on home hospice to daughter's home. Patient required 8-10 hours of daily private-pay nursing. Remainder of care provided by son and daughter. 4/10/08: 911 was called. Patient had distended abdomen, vomiting. Patient admitted to hospital. 4/16/08: Discharged from hospital on Home Health to daughter's home. Patient still required 8-10 hours private-pay nursing. The remainder of care was provided by son and daughter. 6/21/08: Admitted to hospital. Patient had urinary tract infection, diarrhea, thick yellow discharge from tracheotomy. 6/30/08: Patient admitted to nursing home. Facility had an unsuccessful attempt to wean off tracheotomy. 8/8/08: Follow-up visit at outpatient center with Dr. Diagnosis: MADSAM-a variant of Guillain-Barre Syndrome causally related to the flu shot. 8/20/08: discharged from nursing home to his house on Home Health Care. He requires 8-10 hours of daily private-pay nursing. The remainder of care provided by son and daughter. 10/29/08: Admitted to facility for 30 days of respite care.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Surgery, Tracheostomy
Clinical narrative: November 2007: Patient continued with weakness in legs, weakness in arms, unable to swallow. Needed complete assistance with stairs. 12/8/07: Admitted to hospital. Aspiration pneumonia, dehydration, malnourished, failed Modified Barium Swallow, Cardiac Output=10%, Diagnosis-Neuropathy. 12/11/07: Patient transferred to ICU due to respiratory and cardiac problems. 12/12/07: G-tube inserted due to failed Modified Barium Swallow. 2/4/08: Patient discharged from hospital to rehab. 2/17/08: 911 was called, due to decrease in oxygen saturation. 2/21/08: 3:00pm - Discharged from hospital and returned to rehab. 7:00pm - Called 911 - Respiratory distress-intubated. Admitted to hospital. 2/27/08: Patient was transferred. Lumbar puncture-inconclusive. 3/1/08: Ex-tubated. 3/2/08: Re-intubated. 3/7/08: Tracheotomy performed. 3/22/08: Patient was transferred to another hospital. 4/2/08: Patient was discharged from hospital on home hospice to daughter's home. Patient required 8-10 hours of daily private-pay nursing. Remainder of care provided by son and daughter. 4/10/08: 911 was called. Patient had distended abdomen, vomiting. Patient admitted to hospital. 4/16/08: Discharged from hospital on Home Health to daughter's home. Patient still required 8-10 hours private-pay nursing. The remainder of care was provided by son and daughter. 6/21/08: Admitted to hospital. Patient had urinary tract infection, diarrhea, thick yellow discharge from tracheotomy. 6/30/08: Patient admitted to nursing home. Facility had an unsuccessful attempt to wean off tracheotomy. 8/8/08: Follow-up visit at outpatient center with Dr. Diagnosis: MADSAM-a variant of Guillain-Barre Syndrome causally related to the flu shot. 8/20/08: discharged from nursing home to his house on Home Health Care. He requires 8-10 hours of daily private-pay nursing. The remainder of care provided by son and daughter. 10/29/08: Admitted to facility for 30 days of respite care.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal distension, Asthenia, Barium swallow abnormal, Cardiac disorder, Dehydration
Clinical narrative: November 2007: Patient continued with weakness in legs, weakness in arms, unable to swallow. Needed complete assistance with stairs. 12/8/07: Admitted to hospital. Aspiration pneumonia, dehydration, malnourished, failed Modified Barium Swallow, Cardiac Output=10%, Diagnosis-Neuropathy. 12/11/07: Patient transferred to ICU due to respiratory and cardiac problems. 12/12/07: G-tube inserted due to failed Modified Barium Swallow. 2/4/08: Patient discharged from hospital to rehab. 2/17/08: 911 was called, due to decrease in oxygen saturation. 2/21/08: 3:00pm - Discharged from hospital and returned to rehab. 7:00pm - Called 911 - Respiratory distress-intubated. Admitted to hospital. 2/27/08: Patient was transferred. Lumbar puncture-inconclusive. 3/1/08: Ex-tubated. 3/2/08: Re-intubated. 3/7/08: Tracheotomy performed. 3/22/08: Patient was transferred to another hospital. 4/2/08: Patient was discharged from hospital on home hospice to daughter's home. Patient required 8-10 hours of daily private-pay nursing. Remainder of care provided by son and daughter. 4/10/08: 911 was called. Patient had distended abdomen, vomiting. Patient admitted to hospital. 4/16/08: Discharged from hospital on Home Health to daughter's home. Patient still required 8-10 hours private-pay nursing. The remainder of care was provided by son and daughter. 6/21/08: Admitted to hospital. Patient had urinary tract infection, diarrhea, thick yellow discharge from tracheotomy. 6/30/08: Patient admitted to nursing home. Facility had an unsuccessful attempt to wean off tracheotomy. 8/8/08: Follow-up visit at outpatient center with Dr. Diagnosis: MADSAM-a variant of Guillain-Barre Syndrome causally related to the flu shot. 8/20/08: discharged from nursing home to his house on Home Health Care. He requires 8-10 hours of daily private-pay nursing. The remainder of care provided by son and daughter. 10/29/08: Admitted to facility for 30 days of respite care.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Dysphagia, Endotracheal intubation, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: November 2007: Patient continued with weakness in legs, weakness in arms, unable to swallow. Needed complete assistance with stairs. 12/8/07: Admitted to hospital. Aspiration pneumonia, dehydration, malnourished, failed Modified Barium Swallow, Cardiac Output=10%, Diagnosis-Neuropathy. 12/11/07: Patient transferred to ICU due to respiratory and cardiac problems. 12/12/07: G-tube inserted due to failed Modified Barium Swallow. 2/4/08: Patient discharged from hospital to rehab. 2/17/08: 911 was called, due to decrease in oxygen saturation. 2/21/08: 3:00pm - Discharged from hospital and returned to rehab. 7:00pm - Called 911 - Respiratory distress-intubated. Admitted to hospital. 2/27/08: Patient was transferred. Lumbar puncture-inconclusive. 3/1/08: Ex-tubated. 3/2/08: Re-intubated. 3/7/08: Tracheotomy performed. 3/22/08: Patient was transferred to another hospital. 4/2/08: Patient was discharged from hospital on home hospice to daughter's home. Patient required 8-10 hours of daily private-pay nursing. Remainder of care provided by son and daughter. 4/10/08: 911 was called. Patient had distended abdomen, vomiting. Patient admitted to hospital. 4/16/08: Discharged from hospital on Home Health to daughter's home. Patient still required 8-10 hours private-pay nursing. The remainder of care was provided by son and daughter. 6/21/08: Admitted to hospital. Patient had urinary tract infection, diarrhea, thick yellow discharge from tracheotomy. 6/30/08: Patient admitted to nursing home. Facility had an unsuccessful attempt to wean off tracheotomy. 8/8/08: Follow-up visit at outpatient center with Dr. Diagnosis: MADSAM-a variant of Guillain-Barre Syndrome causally related to the flu shot. 8/20/08: discharged from nursing home to his house on Home Health Care. He requires 8-10 hours of daily private-pay nursing. The remainder of care provided by son and daughter. 10/29/08: Admitted to facility for 30 days of respite care.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malnutrition, Neuropathy peripheral, Pneumonia aspiration, Respiratory distress, Tracheostomy
Clinical narrative: November 2007: Patient continued with weakness in legs, weakness in arms, unable to swallow. Needed complete assistance with stairs. 12/8/07: Admitted to hospital. Aspiration pneumonia, dehydration, malnourished, failed Modified Barium Swallow, Cardiac Output=10%, Diagnosis-Neuropathy. 12/11/07: Patient transferred to ICU due to respiratory and cardiac problems. 12/12/07: G-tube inserted due to failed Modified Barium Swallow. 2/4/08: Patient discharged from hospital to rehab. 2/17/08: 911 was called, due to decrease in oxygen saturation. 2/21/08: 3:00pm - Discharged from hospital and returned to rehab. 7:00pm - Called 911 - Respiratory distress-intubated. Admitted to hospital. 2/27/08: Patient was transferred. Lumbar puncture-inconclusive. 3/1/08: Ex-tubated. 3/2/08: Re-intubated. 3/7/08: Tracheotomy performed. 3/22/08: Patient was transferred to another hospital. 4/2/08: Patient was discharged from hospital on home hospice to daughter's home. Patient required 8-10 hours of daily private-pay nursing. Remainder of care provided by son and daughter. 4/10/08: 911 was called. Patient had distended abdomen, vomiting. Patient admitted to hospital. 4/16/08: Discharged from hospital on Home Health to daughter's home. Patient still required 8-10 hours private-pay nursing. The remainder of care was provided by son and daughter. 6/21/08: Admitted to hospital. Patient had urinary tract infection, diarrhea, thick yellow discharge from tracheotomy. 6/30/08: Patient admitted to nursing home. Facility had an unsuccessful attempt to wean off tracheotomy. 8/8/08: Follow-up visit at outpatient center with Dr. Diagnosis: MADSAM-a variant of Guillain-Barre Syndrome causally related to the flu shot. 8/20/08: discharged from nursing home to his house on Home Health Care. He requires 8-10 hours of daily private-pay nursing. The remainder of care provided by son and daughter. 10/29/08: Admitted to facility for 30 days of respite care.
Age: 79.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urinary tract infection, Vomiting
Clinical narrative: November 2007: Patient continued with weakness in legs, weakness in arms, unable to swallow. Needed complete assistance with stairs. 12/8/07: Admitted to hospital. Aspiration pneumonia, dehydration, malnourished, failed Modified Barium Swallow, Cardiac Output=10%, Diagnosis-Neuropathy. 12/11/07: Patient transferred to ICU due to respiratory and cardiac problems. 12/12/07: G-tube inserted due to failed Modified Barium Swallow. 2/4/08: Patient discharged from hospital to rehab. 2/17/08: 911 was called, due to decrease in oxygen saturation. 2/21/08: 3:00pm - Discharged from hospital and returned to rehab. 7:00pm - Called 911 - Respiratory distress-intubated. Admitted to hospital. 2/27/08: Patient was transferred. Lumbar puncture-inconclusive. 3/1/08: Ex-tubated. 3/2/08: Re-intubated. 3/7/08: Tracheotomy performed. 3/22/08: Patient was transferred to another hospital. 4/2/08: Patient was discharged from hospital on home hospice to daughter's home. Patient required 8-10 hours of daily private-pay nursing. Remainder of care provided by son and daughter. 4/10/08: 911 was called. Patient had distended abdomen, vomiting. Patient admitted to hospital. 4/16/08: Discharged from hospital on Home Health to daughter's home. Patient still required 8-10 hours private-pay nursing. The remainder of care was provided by son and daughter. 6/21/08: Admitted to hospital. Patient had urinary tract infection, diarrhea, thick yellow discharge from tracheotomy. 6/30/08: Patient admitted to nursing home. Facility had an unsuccessful attempt to wean off tracheotomy. 8/8/08: Follow-up visit at outpatient center with Dr. Diagnosis: MADSAM-a variant of Guillain-Barre Syndrome causally related to the flu shot. 8/20/08: discharged from nursing home to his house on Home Health Care. He requires 8-10 hours of daily private-pay nursing. The remainder of care provided by son and daughter. 10/29/08: Admitted to facility for 30 days of respite care.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 4 month old Hispanic female with no pertinent medical history and no illness at the time of being vaccinated who on an unspecified date was vaccinated with a first dose of COMVAX and ROTATEQ. On 14-JAN-2008, the patient was vaccinated with a second dose of COMVAX (lot # 657699/0538U) 0.5 mL IM in the left. Concomitant suspect vaccination included a second dose of ROTATEQ (MSD) (lot # 657671/0902U) orally administered on 14-JAN-2008. Other concomitant vaccinations also given on 14-JAN-2008 included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (lot # AC14B067AA) IM in the right; poliovirus vaccine (lot # A02732) subcutaneously in the left; and PREVNAR (lot # C35169) IM in the right. On 15-JAN-2008, the day after vaccination, the patient developed urticaria. The patient was seen by the physician. There were no laboratory or diagnostic tests performed. It was reported that the urticaria seemed to be "improving at times and then at other times seems to get worse." At the time of the report, the patient had not recovered. Follow-up information was received from the physician. On 16-JAN-2008 (day 2) in the morning to 23-JAN-2008 (day 9) the patient experienced a mild rash over her body. On 09-APR-2008, the patient recovered. No additional information is expected.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Rash, Skin test negative, Urticaria
Clinical narrative: Information has been received from a physician concerning a 4 month old Hispanic female with no pertinent medical history and no illness at the time of being vaccinated who on an unspecified date was vaccinated with a first dose of COMVAX and ROTATEQ. On 14-JAN-2008, the patient was vaccinated with a second dose of COMVAX (lot # 657699/0538U) 0.5 mL IM in the left. Concomitant suspect vaccination included a second dose of ROTATEQ (MSD) (lot # 657671/0902U) orally administered on 14-JAN-2008. Other concomitant vaccinations also given on 14-JAN-2008 included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (lot # AC14B067AA) IM in the right; poliovirus vaccine (lot # A02732) subcutaneously in the left; and PREVNAR (lot # C35169) IM in the right. On 15-JAN-2008, the day after vaccination, the patient developed urticaria. The patient was seen by the physician. There were no laboratory or diagnostic tests performed. It was reported that the urticaria seemed to be "improving at times and then at other times seems to get worse." At the time of the report, the patient had not recovered. Follow-up information was received from the physician. On 16-JAN-2008 (day 2) in the morning to 23-JAN-2008 (day 9) the patient experienced a mild rash over her body. On 09-APR-2008, the patient recovered. No additional information is expected.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 4 month old Hispanic female with no pertinent medical history and no illness at the time of being vaccinated who on an unspecified date was vaccinated with a first dose of COMVAX and ROTATEQ. On 14-JAN-2008, the patient was vaccinated with a second dose of COMVAX (lot # 657699/0538U) 0.5 mL IM in the left. Concomitant suspect vaccination included a second dose of ROTATEQ (MSD) (lot # 657671/0902U) orally administered on 14-JAN-2008. Other concomitant vaccinations also given on 14-JAN-2008 included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (lot # AC14B067AA) IM in the right; poliovirus vaccine (lot # A02732) subcutaneously in the left; and PREVNAR (lot # C35169) IM in the right. On 15-JAN-2008, the day after vaccination, the patient developed urticaria. The patient was seen by the physician. There were no laboratory or diagnostic tests performed. It was reported that the urticaria seemed to be "improving at times and then at other times seems to get worse." At the time of the report, the patient had not recovered. Follow-up information was received from the physician. On 16-JAN-2008 (day 2) in the morning to 23-JAN-2008 (day 9) the patient experienced a mild rash over her body. On 09-APR-2008, the patient recovered. No additional information is expected.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE No-Preservatives 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was adducted. The patient had a pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 05 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to life, still tender to touch". No further information was provided at the time of the report. Follow-up information received on 13 June 2008 from a physician. This reporter had no additional information to add to the case. No other relevant medical information was added to the case. Follow-up information was received from the original physician on 03 July 2008. The physician had only seen the patient once, and was not aware of her recovery status. Per the physician, "I believe vaccine was injected into subacromial area accidentally by student nurse. Not problem with vaccine- bad placement- too high on arm".