chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal distension, Blood chloride increased, Dehydration, Diarrhoea, Dry mouth
Clinical narrative: Information has been received concerning a 2-month-old male who on 31-JUL-2006, at 1002, was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653755/0319F). Concomitant vaccinations administered on the same day and time included the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B066AA), a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08657E) and the first dose of Hib conj vaccine (tet toxoid) ACTHIB) (Lot#UE885AA).  Illness at the time of vaccination included right otitis media (treated with amoxicillin).  It was reported that in 2006, the patient was fussy and developed diarrhea. The patient was subsequently hospitalized for 2-4 days and was discharged.  At the time of this report, the outcome was unknown.  Additional information has been received via medical records concerning a 10-week-old male with no frequent illness and no known drug allergies (NKDA) who on 31-JUL-2006, after being vaccinated became cranky and developed stomach bloating nd diarrhea.  On 04-AUG-2006, the patient was hospitalized due to fever, irritability, abdominal bloating and diarrhea.  The diarrhea was eight times per day and was not improving and seemed to be getting worse.  The patient had been treated with Pedialyte but had not improved.  The patient also looked dehydrated, sick and acidotic.  At the time of admission, the patient was very very cranky but not cyanotic or tachypneic and had not slept well due to the fever and stomach bloating.  He was alert and awake .  There was no history of bloody stool.  The patient cried without tears.  His lips were dry, but occasionally had some redness but no cyanosis.  The diarrhea was watery and brownish and dark green in color.  The patient had not vomited.  The patient was treated with intravenous (IV) fluids and Pedialyte was gradually added.  When the patient improved, half strength Progestamil was given.  A stool  culture grew normal enteric flora (see laboratory/diagnostic section for additional results).  The patient gradually improved .  On 07-AUG-2006, the patient was discharged from the hospital with a discharge of acute gastroenteritis with dehydration and metabolic acidosis.  At the time of discharge the patient was being treated with half strength Progestamil for one day and then with full strength.  The mother was advised to bring her son back for follow up on 09-AUG-2006.  No information is available.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Faeces discoloured, Gastroenteritis, Irritability, Lacrimation decreased
Clinical narrative: Information has been received concerning a 2-month-old male who on 31-JUL-2006, at 1002, was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653755/0319F). Concomitant vaccinations administered on the same day and time included the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B066AA), a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08657E) and the first dose of Hib conj vaccine (tet toxoid) ACTHIB) (Lot#UE885AA).  Illness at the time of vaccination included right otitis media (treated with amoxicillin).  It was reported that in 2006, the patient was fussy and developed diarrhea. The patient was subsequently hospitalized for 2-4 days and was discharged.  At the time of this report, the outcome was unknown.  Additional information has been received via medical records concerning a 10-week-old male with no frequent illness and no known drug allergies (NKDA) who on 31-JUL-2006, after being vaccinated became cranky and developed stomach bloating nd diarrhea.  On 04-AUG-2006, the patient was hospitalized due to fever, irritability, abdominal bloating and diarrhea.  The diarrhea was eight times per day and was not improving and seemed to be getting worse.  The patient had been treated with Pedialyte but had not improved.  The patient also looked dehydrated, sick and acidotic.  At the time of admission, the patient was very very cranky but not cyanotic or tachypneic and had not slept well due to the fever and stomach bloating.  He was alert and awake .  There was no history of bloody stool.  The patient cried without tears.  His lips were dry, but occasionally had some redness but no cyanosis.  The diarrhea was watery and brownish and dark green in color.  The patient had not vomited.  The patient was treated with intravenous (IV) fluids and Pedialyte was gradually added.  When the patient improved, half strength Progestamil was given.  A stool  culture grew normal enteric flora (see laboratory/diagnostic section for additional results).  The patient gradually improved .  On 07-AUG-2006, the patient was discharged from the hospital with a discharge of acute gastroenteritis with dehydration and metabolic acidosis.  At the time of discharge the patient was being treated with half strength Progestamil for one day and then with full strength.  The mother was advised to bring her son back for follow up on 09-AUG-2006.  No information is available.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Malaise, Metabolic acidosis, Pyrexia, Sleep disorder
Clinical narrative: Information has been received concerning a 2-month-old male who on 31-JUL-2006, at 1002, was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653755/0319F). Concomitant vaccinations administered on the same day and time included the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B066AA), a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08657E) and the first dose of Hib conj vaccine (tet toxoid) ACTHIB) (Lot#UE885AA).  Illness at the time of vaccination included right otitis media (treated with amoxicillin).  It was reported that in 2006, the patient was fussy and developed diarrhea. The patient was subsequently hospitalized for 2-4 days and was discharged.  At the time of this report, the outcome was unknown.  Additional information has been received via medical records concerning a 10-week-old male with no frequent illness and no known drug allergies (NKDA) who on 31-JUL-2006, after being vaccinated became cranky and developed stomach bloating nd diarrhea.  On 04-AUG-2006, the patient was hospitalized due to fever, irritability, abdominal bloating and diarrhea.  The diarrhea was eight times per day and was not improving and seemed to be getting worse.  The patient had been treated with Pedialyte but had not improved.  The patient also looked dehydrated, sick and acidotic.  At the time of admission, the patient was very very cranky but not cyanotic or tachypneic and had not slept well due to the fever and stomach bloating.  He was alert and awake .  There was no history of bloody stool.  The patient cried without tears.  His lips were dry, but occasionally had some redness but no cyanosis.  The diarrhea was watery and brownish and dark green in color.  The patient had not vomited.  The patient was treated with intravenous (IV) fluids and Pedialyte was gradually added.  When the patient improved, half strength Progestamil was given.  A stool  culture grew normal enteric flora (see laboratory/diagnostic section for additional results).  The patient gradually improved .  On 07-AUG-2006, the patient was discharged from the hospital with a discharge of acute gastroenteritis with dehydration and metabolic acidosis.  At the time of discharge the patient was being treated with half strength Progestamil for one day and then with full strength.  The mother was advised to bring her son back for follow up on 09-AUG-2006.  No information is available.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Information has been received from a physician concerning a 9-week-old white male with no medical history who on 18-AUG-2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Concomitant vaccinations administered on that same day included the first IM dose in the left lateral thigh of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD), the first IM dose in the left anterior thigh of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, the first SC dose in the right lateral thigh of poliovirus vaccine inactivated (unspecified) and the first IM dose in the right anterior thigh of pneumococcal 4 6B 9V 114 18C 19F 23F conj vaccine (CRM197) (PREVNAR). There was no illness at the time of vaccination. The physician reported that on 19-AUG-2006 the patient experienced severe stomach cramping as indicated by the patient pulling his knees and arms to his chest and screaming. It was also reported, as per the patient's mother, that on 26-AUG-2006, one week after vaccination, the patient developed sudden explosive episodes of diarrhea (9-15 times daily). Unspecified medical attention was sought and bloodwork was performed (tests and results not provided). A stool culture for ova/parasites was negative and a stool culture was also negative. An abdominal x-ray was negative for mass. Subsequently, the patient recovered from the severe stomach cramping, screaming and diarrhea. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 9-week-old white male with no medical history who on 18-AUG-2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Concomitant vaccinations administered on that same day included the first IM dose in the left lateral thigh of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD), the first IM dose in the left anterior thigh of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, the first SC dose in the right lateral thigh of poliovirus vaccine inactivated (unspecified) and the first IM dose in the right anterior thigh of pneumococcal 4 6B 9V 114 18C 19F 23F conj vaccine (CRM197) (PREVNAR). There was no illness at the time of vaccination. The physician reported that on 19-AUG-2006 the patient experienced severe stomach cramping as indicated by the patient pulling his knees and arms to his chest and screaming. It was also reported, as per the patient's mother, that on 26-AUG-2006, one week after vaccination, the patient developed sudden explosive episodes of diarrhea (9-15 times daily). Unspecified medical attention was sought and bloodwork was performed (tests and results not provided). A stool culture for ova/parasites was negative and a stool culture was also negative. An abdominal x-ray was negative for mass. Subsequently, the patient recovered from the severe stomach cramping, screaming and diarrhea. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, MM
Symptoms: Breast disorder female, Tenderness
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Subsequently the patient experienced excessive breast tenderness. Unspecified medical attention was sought. No further details were provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, MM
Symptoms: Breast tenderness
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Subsequently the patient experienced excessive breast tenderness. Unspecified medical attention was sought. No further details were provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blister, Erythema, Hypersensitivity, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a female patient (age not reported) a physician mentioned who was vaccinated on an unspecified date with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient developed a poison ivy-like rash on her shoulder behind the area where she was administered the vaccine. The rash was reported to be itchy, vesicular and the size of a grapefruit. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a female patient (age not reported) a physician mentioned who was vaccinated on an unspecified date with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient developed a poison ivy-like rash on her shoulder behind the area where she was administered the vaccine. The rash was reported to be itchy, vesicular and the size of a grapefruit. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP, VARCEL, HEP
Symptoms: Coordination abnormal, Dizziness, Headache
Clinical narrative: Info has been received from a physician concerning a 19 year old male who on 5/20/06 and 6/22/06 was vaccinated IM with a 5mcg first and second dose of hepatitis B virus vaccine rHBsAg (yeast). On 7/28/06, one month after the second vaccination, the pt complains of dizziness, stating he "can't keep his balance". He was noted to have gait ataxia. MRI and spinal tap were conduced and the results were found to be normal. The outcome was recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Gait ataxia was considered to be disabling. Additional info has been requested.
Age: 19.0
Sex: M
Vaccine: HEP, VARCEL, HEP
Symptoms: Balance disorder, Coordination abnormal, Dizziness, Gait disturbance
Clinical narrative: Info has been received from a physician concerning a 19 year old male who on 5/20/06 and 6/22/06 was vaccinated IM with a 5mcg first and second dose of hepatitis B virus vaccine rHBsAg (yeast). On 7/28/06, one month after the second vaccination, the pt complains of dizziness, stating he "can't keep his balance". He was noted to have gait ataxia. MRI and spinal tap were conduced and the results were found to be normal. The outcome was recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Gait ataxia was considered to be disabling. Additional info has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Nurse reported on 10/14/06 that the "left upper deltoid w/ reddened, slightly raised area where pt had pneumovax given the night before.  Pt. reports that it itches, area slightly raised about 0.1 cm, measures about 1.25 cm x 1 cm."  Reported to pharmacist, stated was dermal reaction and to watch it for increase in swelling or warmth.  On 10/16/06 it measures 17 cm x 10 cm, is very tender to the touch, red, warm and swollen.  Reports her arm is aching.  Dr. thinks the area is possibly a secondary reaction and started her on Cipro 500 mg po BID for 7 days and started her on Vicodin for c/o pain.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Tachycardia
Clinical narrative: Pt developed Tachycardia and dizziness 24 hours after receiving the Tdap. It resolved 24-48 hrs later.  Mother did not call the office at the time but reported to nurse manager on 10/16/06.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Patient was found by her son, expired.  He states it looked like "she went in her sleep". 10/19/06 Received Death Certificate which states COD as Found Dead, CAD s/p angioplasty, and hypercholesterolemia with contributing factors of HTN, PVD and hypothyroidism.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 14-SEP-2006 was vaccinated intramuscularly with a first 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  About an hour after receiving the vaccine, the patient developed shortness of breath and a fever.  The patient was directed to the emergency room. It was noted that the patient's symptoms improved "on therapy" (unspecified).  No product quality compliant was involved.  Shortness of breath and fever were considered to be other important medical events.  Additional information has been requested. (OMIC)
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain, Hepatitis
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of HPV vaccine yeast. Subsequently the pt experienced a recurrence of hepatitis and abdominal pain. The physicians office manager reported that the pt tested positive for hepatitis after receiving the vaccine. The pts outcome was not reported. Recurrence of hepatitis and abdominal pain were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 12 week old female who "about a month ago", on approximately 09-SEP-2006, was vaccinated with an oral first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccines administered at the same time included several unspecified vaccines.  "About a month ago", on approximately 09-SEP-2006, the patient experienced bloody stool.  It was reported that since the patient was 100% breast fed, the patient's mother was being placed on a hypo allergenic diet.  The physician had also reported that the baby had been referred to a gastroenterologist.  At the time of the report the patient had not recovered.  No product quality complaint was involved.  The reporter considered the patient's bloody stool to be other important medical event, as the patient was referred to a gastroenterologist. Additional information has been requested. (OMIC)
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Acidosis, Dehydration, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old male, with no medical history and no allergies, who on 02-OCT-2006 was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  There was no concomitant medication.  On 04-OCT-2006 the patient developed vomiting.  He was seen at the physician's office on 06-OCT-2006 and by then was experiencing vomiting and loose stools.  He was admitted to the hospital on 09-OCT-2006 for vomiting, diarrhea, and acidotic dehydration.  He was being given intravenous fluids.  At the time of the report the patient had not recovered.  Vomiting, diarrhea, and acidotic dehydration were considered to disabling, life threatening, and other important medical events by the reporter.  Additional information has been requested. (OMIC)
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site oedema, Rash, Rash vesicular
Clinical narrative: Information has been received from a physician and a certified medical assistant concerning a 4-year-old female with no pertinent medical history or allergies, who on 02-OCT-2006 was vaccinated subcutaneously on the right arm with a second 0.5 ml dose of varicella virus vaccine live (lot#652664/1033R).  There was no concomitant medication.  On 03-OCT-2006 the patient developed swelling of her arm (approximately 10 x 12 cm) and a rash.  It was reported that there were about 15-20 vesicular lesions.  Unspecified medical attention was sought and there were no laboratory or diagnostic tests performed.  The patient was treated with cool packs, ibuprofen and elevation of the arm. The outcome was recovered as of 05-OCT-2006.  No product quality complaint was involved. The reporter considered the patient's experiences to be other medical events.  Additional information has been requested. (OMIC)
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 10/3/06 was vaccinated with 0.5ml of HPV. On 10/4/06, the pt developed muscle aches, fever and shortness of breath. The pt went to the ER. It was unknown if the pt was hospitalized. At the time of this report, the outcome of the event was unknown. The physician considered the events to be serious as other important medical events (OMIC). Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV, RV5
Symptoms: Acidosis, Anorexia, Dehydration, Diarrhoea, Hypersomnia
Clinical narrative: Information has been received from a physician concerning an approximately 2-month-old female who on 17-SEP-2006 was vaccinated by mouth with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that on 17-SEP-2006, the patient developed fever, vomiting and dehydration.  Unspecified medical attention was sought and the patient was subsequently hospitalized for two night.  A "rotavirus test" was performed (results not provided).  At the time of this report, the patient was recovering from the fever, vomiting and dehydration as she was noted to be "doing better". Additional information has been received from agency through the agency concerning a 10-week-old female with gastroesophageal reflux disease (GERD), kidney reflux and a spastic colon who on 15-SEP-2006, at 1415, was vaccinated by mouth with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations on that same date included a dose in the left leg of diphtheria toxoid (+) Pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose in the left leg of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown), a dose in the right leg of Hib conj vaccine (manufacturer unknown) and a dose of poliovirus vaccine live oral.  Illness at the time of vaccination included a kidney infection due to kidney reflux and e-coli bacteria.  Other concomitant therapy included famotidine.  On 17-SEP-2006, 48 hours after vaccination, the patient experienced low grade fever, diarrhea, vomiting and dehydration.  Unspecified medical attention was sought.  On 26-SEP-2006, at 1100, the patient was lethargic, had excessive sleeping and loss of appetite.  The patient was subsequently hospitalized.  The patient had a positive rotavirus stool test and other laboratory tests (not further specified) revealed dehydration with acidosis.  At the time of this report, the outcome of the diarrhea, lethargy, excessive sleeping, loss of appetite, positive rotavirus stool test and acidosis was unknown.  Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV, RV5
Symptoms: Lethargy, Pyrexia, Rotavirus test positive, Viral infection, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 2-month-old female who on 17-SEP-2006 was vaccinated by mouth with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that on 17-SEP-2006, the patient developed fever, vomiting and dehydration.  Unspecified medical attention was sought and the patient was subsequently hospitalized for two night.  A "rotavirus test" was performed (results not provided).  At the time of this report, the patient was recovering from the fever, vomiting and dehydration as she was noted to be "doing better". Additional information has been received from agency through the agency concerning a 10-week-old female with gastroesophageal reflux disease (GERD), kidney reflux and a spastic colon who on 15-SEP-2006, at 1415, was vaccinated by mouth with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations on that same date included a dose in the left leg of diphtheria toxoid (+) Pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose in the left leg of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown), a dose in the right leg of Hib conj vaccine (manufacturer unknown) and a dose of poliovirus vaccine live oral.  Illness at the time of vaccination included a kidney infection due to kidney reflux and e-coli bacteria.  Other concomitant therapy included famotidine.  On 17-SEP-2006, 48 hours after vaccination, the patient experienced low grade fever, diarrhea, vomiting and dehydration.  Unspecified medical attention was sought.  On 26-SEP-2006, at 1100, the patient was lethargic, had excessive sleeping and loss of appetite.  The patient was subsequently hospitalized.  The patient had a positive rotavirus stool test and other laboratory tests (not further specified) revealed dehydration with acidosis.  At the time of this report, the outcome of the diarrhea, lethargy, excessive sleeping, loss of appetite, positive rotavirus stool test and acidosis was unknown.  Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Amnesia, Anger, Anxiety, Arthralgia, Depression
Clinical narrative: Depression, angry, rash, lost memory, joint pain, fever, anxiety.  Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.  Records received-11/17/06-DX: Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.
Age: 43.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Gastritis, Hiatus hernia, Neuralgia, Peptic ulcer, Pyrexia
Clinical narrative: Depression, angry, rash, lost memory, joint pain, fever, anxiety.  Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.  Records received-11/17/06-DX: Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.
Age: 43.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Rash
Clinical narrative: Depression, angry, rash, lost memory, joint pain, fever, anxiety.  Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.  Records received-11/17/06-DX: Major depression, peptic ulcer disease, nonerosive gastritis of the antrum and the body of stomach, small hiatal hernia, H phylir positive. Pain in joint involving shoulder regions, subacromial shoulder injection, neuralgia of the nighth cranial nerve.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician assistant concerning an 18 year old female with on 8/30/06 was vaccinated with the first dose of HPV (lot 653650/0702F). The physician assistant reported that the pt received the first dose of HPV, about 12 days ago, and she still experiencing injection site pain. The pt sought unspecified medical attention. It was reported that the pt was being treated with ibuprofen (Advil). At the time of this report, the pt had not recovered from the event. The reporter considered the event to be serious as an other important medical event (OMIC). Additional information has been requested.
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Injection site pain, Medication error
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) with on known allergies or adverse drug reactions reported. On 9/27/06, the pt was vaccinated IM in the left deltoid with 1 ml (2 vials) of HPV vaccine (lot 0B37F). Concomitant therapy included a tetanus toxoid shot in the other arm. Subsequently, the pt experienced arm hurting. The registered nurse confirmed that the pain was at the injection site. The pt has not mentioned any other symptoms. The pt sought unspecified medical attention. The intervention to prevent serious criteria was 800 mg, of Motrin. The registered nurse reported that she did not know if the event would have worsened or improved without the intervention of Motrin. On 9/28/06, the pt returned to the physicians office and was fine, however her arm still hurt. At the time of this report, the pt had not recovered from the event. The reporter considered the event to be serious as an other important medical event (OMIC). Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever up to 102, body aches, redness, pain at site of injection, lasted 2-3 days.
Age: 13.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Red swollen square shaped area on right deltoid noticed next am after immunization. Mom gave Tylenol as pt c/o pain in that area. Still present at office visit 10/16/06 and painful.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: VZV and Hep A given at 11:30 10/7/06, redness on right arm noted 2 hours after with itching, swelling, hardness and pain noted 20 hours later.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Pruritus
Clinical narrative: VZV and Hep A given at 11:30 10/7/06, redness on right arm noted 2 hours after with itching, swelling, hardness and pain noted 20 hours later.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm red, swollen warm to the touch. 1st day measured 4.5 x 4 left arm to above elbow. 2nd day 5x5 all around arm. TX BENADRYL, cold compress, antibiotic.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm swollen, red warm to touch, 1st day measured 4x3, 2nd day 4x4. gave Benadryl, cold compress and antibiotic.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Within one hour after influenza shot pt had itching head. By that night itching head to toe. Hives developed with itching. Became flushed, bright red, left arm had swollen area at injection site, bright red, warm to touch, Treated with Benadryl, Medrol pack
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Within one hour after influenza shot pt had itching head. By that night itching head to toe. Hives developed with itching. Became flushed, bright red, left arm had swollen area at injection site, bright red, warm to touch, Treated with Benadryl, Medrol pack
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Rash
Clinical narrative: Rash/Pimple like on fact and neck. This is in follow-up to report (s) previously submitted on 11/14/2006. Initial and follow-up information has been received from a health professional concerning a 23 year old female with no known allergies who on 11-OCT-2006 at 9:00 was vaccinated with a second dose of GARDASIL (lot # 653978/0955P), intramusculary in the deltoid. Concomitant therapy included ORTHO TRI-CYCLEN. On 12-OCT-2006 at 9:00 AM the patient experienced 'face/neck rash, pimple like stinging.' It was also received from the FDA through the Freedom of Information Act. There is no additional information. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Rash
Clinical narrative: Rash/Pimple like on fact and neck. This is in follow-up to report (s) previously submitted on 11/14/2006. Initial and follow-up information has been received from a health professional concerning a 23 year old female with no known allergies who on 11-OCT-2006 at 9:00 was vaccinated with a second dose of GARDASIL (lot # 653978/0955P), intramusculary in the deltoid. Concomitant therapy included ORTHO TRI-CYCLEN. On 12-OCT-2006 at 9:00 AM the patient experienced 'face/neck rash, pimple like stinging.' It was also received from the FDA through the Freedom of Information Act. There is no additional information. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Shoulder pain
Clinical narrative: Fever, Sever right shoulder pain.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Injection site swelling
Clinical narrative: 15x12cm erythematous raised reaction.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Musculoskeletal stiffness, Pain
Clinical narrative: Sore, stiff arm, couldn't move at all had to see urgent care for antibiotics and pain medication (Keflex, vicodin).
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus
Clinical narrative: Severe itching on legs only 2 hours after immunization. No rash. Shot given in left deltoid.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Silver dollar size lump in left arm with fever and pain, fever, swelling and pain lasted for 7 days. Immunization given 8/29/06. Adacel C2491AA.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Local redness 4x5" and swelling reported by pts mother not seen.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Convulsion, Cough, Dyskinesia, Eye swelling
Clinical narrative: 4:30 pm cough, 7:30 chills, fever, seizures, swollen eyes, gue coming out of eyes, blurred vision whole body jerked for 12 hours.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vision blurred
Clinical narrative: 4:30 pm cough, 7:30 chills, fever, seizures, swollen eyes, gue coming out of eyes, blurred vision whole body jerked for 12 hours.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: PATIENT HAD A RED AREA 1 1/2 IN BY 1 3/4 NO FEVER NO PAIN.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed a hive and itching on her face- right side of the cheek and ear. Had bug bite on her forehead. Has respiratory allergies which have been worse this week (itchy throat and eyes)  Had a previous reaction to Compazine.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Pain, Swelling
Clinical narrative: Pneumonia vaccine in left deltoid 10/14 approx 1 p.m.  During the night of 10/14, I developed pain, swelling and extreme inflammation, which progressed during the following day to involve my arm from shoulder past elbow. On 10/16 I went to my internist who prescribed prednisone (Medrol 4 mg pak)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling, Tenderness
Clinical narrative: Pt. came in with left upper arm swollen and tender after receiving vaccination two days prior. Augmentin 12 days 1 1/4 tsp BID and Motrin 1 tsp every 4-6 hours. Parent advised to take pt. to ER with worsening of symptoms.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dyspnoea, Eye pain, Fatigue, Headache
Clinical narrative: Onset of Headache, Sinuses swelling, pain in eyes, nose, teeth, neck and chills about 3:15;  Temp 100.1 at 5:30 with severe body aches;  Temp of 101 with all previous symptoms and difficulty breathing through nose at 6:00.  Treated with: Excederin + oxycodone (per Emory Dr on call)- temp down to normal at 11:55.  Today (October 17th), body aches and extreme fatigue.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain, Rhinitis
Clinical narrative: Onset of Headache, Sinuses swelling, pain in eyes, nose, teeth, neck and chills about 3:15;  Temp 100.1 at 5:30 with severe body aches;  Temp of 101 with all previous symptoms and difficulty breathing through nose at 6:00.  Treated with: Excederin + oxycodone (per Emory Dr on call)- temp down to normal at 11:55.  Today (October 17th), body aches and extreme fatigue.
Age: 1.95
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Every time child has received a DTAP vaccination she has had an adverse reaction that includes a fever of up to 105*.  The fever usually lasts about a week and I have had to miss alot of time from work.  I have reported it to the Doctor's office and no-one seems to think it is of big concern or that anything can be done about it.  I have a friend who says his daughter was the same way until they found that the mercury in the shot was what was causing his child to get sick.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Face oedema, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Mother report:Temp 101-102 on 10/14-15. No higher as child has run frequent temps and mom familiar with how he responds. Itchy, red, raised (like mosquito bites) on hands, feet. Facial swelling followed by "huge" swelling of upper lip 10/15.  Benadryl q 4 hours post Dr. call 10-15.  Saw Dr. 10-16. Decreased swelling.  Dr. report: concurs with above, papular rash of abdomen.  Call to mom 10-17 and child recovered.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Developed L arm pain at injection site within 1 hour of immunization (9:30 am) Pain radiates down her arm to her fingers and up into her L neck & head. Developed a severe headache that persisted and some nausea despite Ibuprofen 600 mg at time of presentation to Employee Health 12noon.  Was released to return home from work today.
Age: 1.0
Sex: F
Vaccine: DTAP, IPV, PNC, VARCEL
Symptoms: Irritability, Malaise, Pyrexia
Clinical narrative: Developed a fever of 102.7 approximately a week after vaccination. She was irritable and obviously felt unwell for several days.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Abdominal distension, Crying, Decreased appetite, Drooling, Flushing
Clinical narrative: Irritable since Shots given 10-12-2006.  Crying more than usual; decreased appetite, drooling alot, abd gets tight, face gets red then starts to cry.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability
Clinical narrative: Irritable since Shots given 10-12-2006.  Crying more than usual; decreased appetite, drooling alot, abd gets tight, face gets red then starts to cry.
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: Immunization for yellow fever given at 3PM. Woke up at 4AM, followed by vomiting & diarrhea for 2.5 hours continue malaise throughout day and nausea.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Erythema, Injection site warmth, Pyrexia, Sleep disorder
Clinical narrative: Friday evening right arm swollen, hot, and red. Could not sleep.  Got up Sturday morning with chills and 102.4 fever.  Took aspirin.  Called school nurse.  She called back in afternoon and told me to call my doctor.  I called him and he told me to take 600 mg ADVIL every six hours and to continue the fluids.  I have been doing this since Saturday evening.  My are is still red, tender, and a little warm.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Swelling
Clinical narrative: Friday evening right arm swollen, hot, and red. Could not sleep.  Got up Sturday morning with chills and 102.4 fever.  Took aspirin.  Called school nurse.  She called back in afternoon and told me to call my doctor.  I called him and he told me to take 600 mg ADVIL every six hours and to continue the fluids.  I have been doing this since Saturday evening.  My are is still red, tender, and a little warm.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Erythema multiforme, Pyrexia, Upper respiratory tract infection
Clinical narrative: Erythema Multiforme Fever DC DX: erythema multiforme without mucositis or mucosal involvement. Febrile viral upper respiratory illness. HX: presented with 2 day hx of progressive rash, began on Friday evening 10/6/06. seen in urgent care on 10/7/06. Had been receiving amoxicillin for sinus infection had taken for approximately 1 week. Instructed to discontinue medication and begin Benadryl. At time of presentation ot urgent care the rash was mild in appearance, however, over 12-24 hours rash spread and now involves ears and remainder of body surface. Not febrile during this time.Sinus symptoms had resolved. PMX includes strep throat once and sinus infection once. Febrile during hospitalization temp max of 104.
Age: 55.0
Sex: M
Vaccine: HEP, TYP, YF
Symptoms: Arthralgia, Chills, Depression, Fatigue, Headache
Clinical narrative: 10/12 Fourteen days after receiving vaccines began experiencing fatigue, achiness, headache, joint pain, muscle weakness, depression and shivering.  Denied fever at anytime after vaccination.
Age: 55.0
Sex: M
Vaccine: HEP, TYP, YF
Symptoms: Muscular weakness, Pain
Clinical narrative: 10/12 Fourteen days after receiving vaccines began experiencing fatigue, achiness, headache, joint pain, muscle weakness, depression and shivering.  Denied fever at anytime after vaccination.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Dizziness, Hypersensitivity, Labyrinthitis
Clinical narrative: Cellulitis-left arm 2 hours after I received vaccine.  I noticed that my arm was swollen.  I went to Doctor's office and showed it to her.  She felt that it was nothing to worry about 24 hours later was given 500 mg of LEVAQUIN-to be taken for approximately 8 days.  5 hours after I received LEVAQUIN I noticed I was running a slight fever and I had trouble standing my husband took me to the hospital ER. There they diagnosed cellulitis cause preservative used in the vaccine.  They gave me a giant antibiotic took x-rays took blood from me and did numerous blood screening.  They released me after about 5 hours.  This was 09/12/06-one day after I received the vaccine.  To keep taking the LEVAQUIN.  09/19/06 I'm still feeling rotten and had a hard time navigating felt very weak and had been suffering from vertigo/dizziness.  My husband took me to the ER at hospital again where they took more blood and did more blood studies-they discharged me after about 6 hours.  My instructions were to go and see my primary care physician.  I did the next day.  Doctor denied that I had, had cellulitis but did take a sample of my urine.  I went back again for further treatment.  My husband and I were escorted out of their office.  I had to go and get a new primary care physician since 09/26/2006 he has been very helpful in directing the medical care I needed.  I now have vestibular labryinithis diagnosed by an ENT (ear, nose and throat) man: doctor name reported. He said that it was caused by a trauma: the vaccine  I received 09/11/06.  I now have to have therapy for this disorder-don't known how long I will have to go. 10/26/06-ER records for DOS 9/12/06: DC DX: Cellulitis and amp; ABSC upper arm. Presented for evaluation of erythema of left upper arm. Onset gradual. HX of cardiac disease with stent placement. Hypertension. HX of anxiety, panic attacks. Historian reports dizziness. No gait changes, lethargy, sensory changes, speech changes. RX with Septra. ER visit 9/19/06-DC DX: fatigue and weakness. C/O not feeling well, tearful, concerns regarding recent loss of weight of 10 pounds. Daughter recently DX with uterine cancer. Hasn't felt well in weeks not sleeping well. Patient states has been seen by cardiologist and Dr. for these complaints. PE: WNL. Psychiatric: anxious affect anxious with pressured speech. Workup discussed with Dr, states he had been getting calls from several other physicians about her showing up in ED and offices with similar complaints. Requested social services consult. DC home.  10/31/06-records received from the Doctor. for DOS 9/11-for arm swelling post vaccine. Exam revealed edema secondary to allergic response but cannot totally rule out cellulitis. Rx with antibiotics.  I was released from rehab Dec 2006 I am now able to drive and don't need a cane. It was 3 months of hell.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling, Vertigo
Clinical narrative: Cellulitis-left arm 2 hours after I received vaccine.  I noticed that my arm was swollen.  I went to Doctor's office and showed it to her.  She felt that it was nothing to worry about 24 hours later was given 500 mg of LEVAQUIN-to be taken for approximately 8 days.  5 hours after I received LEVAQUIN I noticed I was running a slight fever and I had trouble standing my husband took me to the hospital ER. There they diagnosed cellulitis cause preservative used in the vaccine.  They gave me a giant antibiotic took x-rays took blood from me and did numerous blood screening.  They released me after about 5 hours.  This was 09/12/06-one day after I received the vaccine.  To keep taking the LEVAQUIN.  09/19/06 I'm still feeling rotten and had a hard time navigating felt very weak and had been suffering from vertigo/dizziness.  My husband took me to the ER at hospital again where they took more blood and did more blood studies-they discharged me after about 6 hours.  My instructions were to go and see my primary care physician.  I did the next day.  Doctor denied that I had, had cellulitis but did take a sample of my urine.  I went back again for further treatment.  My husband and I were escorted out of their office.  I had to go and get a new primary care physician since 09/26/2006 he has been very helpful in directing the medical care I needed.  I now have vestibular labryinithis diagnosed by an ENT (ear, nose and throat) man: doctor name reported. He said that it was caused by a trauma: the vaccine  I received 09/11/06.  I now have to have therapy for this disorder-don't known how long I will have to go. 10/26/06-ER records for DOS 9/12/06: DC DX: Cellulitis and amp; ABSC upper arm. Presented for evaluation of erythema of left upper arm. Onset gradual. HX of cardiac disease with stent placement. Hypertension. HX of anxiety, panic attacks. Historian reports dizziness. No gait changes, lethargy, sensory changes, speech changes. RX with Septra. ER visit 9/19/06-DC DX: fatigue and weakness. C/O not feeling well, tearful, concerns regarding recent loss of weight of 10 pounds. Daughter recently DX with uterine cancer. Hasn't felt well in weeks not sleeping well. Patient states has been seen by cardiologist and Dr. for these complaints. PE: WNL. Psychiatric: anxious affect anxious with pressured speech. Workup discussed with Dr, states he had been getting calls from several other physicians about her showing up in ED and offices with similar complaints. Requested social services consult. DC home.  10/31/06-records received from the Doctor. for DOS 9/11-for arm swelling post vaccine. Exam revealed edema secondary to allergic response but cannot totally rule out cellulitis. Rx with antibiotics.  I was released from rehab Dec 2006 I am now able to drive and don't need a cane. It was 3 months of hell.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Mom called office 10/16/2006 at 1347.  Child had broke out in head to toe hives about 1/2 hour after flu shot.  Gave BENADRYL and improved.