chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: DTP, VARZOS
Symptoms: Pain, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 54 year old female patient with high blood pressure, high cholesterol, lupus, diabetes, low thyroid activity, allergy to adhesive bandage, iodinated contrast dye and avocado and with a drug allergy to COMPAZINE who on 18-MAY-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number: 672867/0241AE). Concomitant therapy included diphtheria toxoid (+)( pertussis acellular vaccine (unspecified) (+) tetanus toxoid, GLUMETZA, BYSTOLIC, MAXZIDE, levothyroxine Na, CRESTOR, cholecalciferol, ALLEGRA and multivitamins. It was reported that, on 05-JUN-2012 a patient developed chickenpox-like blisters on her body. She had a clear painful blister on her genital area. She also had a clear painful blister on her right thumb and a clear blister on her right pharynx. The patient developed a low grade fever which lasted until 10-JUN-2012. The patient sought medical attention via calling physician. No lab diagnostic studies were performed. There was no treatment given for AE. By 11-JUN-2012 fever had resolved and blisters were gone. Follow up information has been received from a physician refers to a 54 years old female patient with, hypertension, dyslipidemia, II diabetes and hypothyroidism with none illness at the time of vaccination. The patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported), (lot # 672867/0241AE) on 18-MAY-2012. It was reported that on 05-JUN-2012 the patient reported a clear painful blister developed in the genital area. It was very important. She then developed a similar blister on the pad of her right thumb, very painful. On 08-JUN-2012 she developed a low grade fever, diffuse body aches, malaise, sore throat. She noted a sore blister on the throat, painful. It was reported that fever resolved on 10-JUN-2012 and blister on 19-JUN-2012 (generally patient was resolved from adverse event between 06 and 19 of June 2012). Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report has been received from a registered pharmacist refers to a 64 years old female patient with no drug allergy and pertinent medical history who was vaccinated with a dose of ZOSTAVAX on 14-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 25-JUL-2012 the patient experienced unspecified condition and brought in a prescription for prednisone (manufacture unknown) 4 week therapy to treat an unspecified condition. There was no lab diagnostics studies performed. At the time of report, the patient was not recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with a dose of 0.5 ml VARIVAX (Merck) subcutaneously on 24-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was intended to received ZOSTAVAX, was inadvertently administered VARIVAX (Merck) due to human error. No adverse effects reported. No PQC. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium enema, Enema administration, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.5 year old female patient without medical history and illness at time of vaccine treated on 09-JAN-2012 orally with the third dose of ROTATEQ (Lot# 670539/0678AA). Second suspect therapy included RECOMBIVAX HB (IM into the left leg with the third dose, Lot# 669934/0571AA). Concomitant medications included: PREVNAR 13 (intramuscularly into right leg with the third dose, Lot # 916979), PENTACEL (intramuscularly into left leg with the third dose, Lot # C3834AA) and FLUZONE (vaccine date: 13-JAN-2012, Lot # UT4176CA). On 12-FEB-2012, the patient experienced intussusception with recurrence x1. The patient presented 4 hours history of lethargy, irritability, decreased tone, pallor alternating with periods of looking well, intermittent abdominal pain. The patient was with viral URI (fever, cough, rhinitis) 2-3 wks prior to admission. In ER the patient alternated between looking well & periods of being pale, clammy, irritable, floppy, crying, arching back. PE included: hypotonia alternating with normal tone & movements, sleepy. Barium enema successfully reduced intussusception. The patient kept overnight for observation. The patient presented with lethargy, decreased appetite, arching back, loose stool (no diarrhea), pale, dry heaves. US revealed re-intussusception, successfully reduced with air enema. The patient kept overnight for observation. With diagnosis: gastroenteritis. The patient presented vomiting, decreased PO intake, loose stool. PE and US was unremarkable. Tolerating PO intake was without difficulty. The patient was discharged home in good condition with care and follow up instructions. Lab data included abdominal X-RAY (result not provided), abdominal US (revealed re-intussusception), barium enema abnormal. No further information is available. The original reporting source was not provided. The VAERS ID # is 452805-1.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Cold sweat, Cough
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.5 year old female patient without medical history and illness at time of vaccine treated on 09-JAN-2012 orally with the third dose of ROTATEQ (Lot# 670539/0678AA). Second suspect therapy included RECOMBIVAX HB (IM into the left leg with the third dose, Lot# 669934/0571AA). Concomitant medications included: PREVNAR 13 (intramuscularly into right leg with the third dose, Lot # 916979), PENTACEL (intramuscularly into left leg with the third dose, Lot # C3834AA) and FLUZONE (vaccine date: 13-JAN-2012, Lot # UT4176CA). On 12-FEB-2012, the patient experienced intussusception with recurrence x1. The patient presented 4 hours history of lethargy, irritability, decreased tone, pallor alternating with periods of looking well, intermittent abdominal pain. The patient was with viral URI (fever, cough, rhinitis) 2-3 wks prior to admission. In ER the patient alternated between looking well & periods of being pale, clammy, irritable, floppy, crying, arching back. PE included: hypotonia alternating with normal tone & movements, sleepy. Barium enema successfully reduced intussusception. The patient kept overnight for observation. The patient presented with lethargy, decreased appetite, arching back, loose stool (no diarrhea), pale, dry heaves. US revealed re-intussusception, successfully reduced with air enema. The patient kept overnight for observation. With diagnosis: gastroenteritis. The patient presented vomiting, decreased PO intake, loose stool. PE and US was unremarkable. Tolerating PO intake was without difficulty. The patient was discharged home in good condition with care and follow up instructions. Lab data included abdominal X-RAY (result not provided), abdominal US (revealed re-intussusception), barium enema abnormal. No further information is available. The original reporting source was not provided. The VAERS ID # is 452805-1.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Decreased appetite, Diarrhoea, Enema administration, Gastroenteritis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.5 year old female patient without medical history and illness at time of vaccine treated on 09-JAN-2012 orally with the third dose of ROTATEQ (Lot# 670539/0678AA). Second suspect therapy included RECOMBIVAX HB (IM into the left leg with the third dose, Lot# 669934/0571AA). Concomitant medications included: PREVNAR 13 (intramuscularly into right leg with the third dose, Lot # 916979), PENTACEL (intramuscularly into left leg with the third dose, Lot # C3834AA) and FLUZONE (vaccine date: 13-JAN-2012, Lot # UT4176CA). On 12-FEB-2012, the patient experienced intussusception with recurrence x1. The patient presented 4 hours history of lethargy, irritability, decreased tone, pallor alternating with periods of looking well, intermittent abdominal pain. The patient was with viral URI (fever, cough, rhinitis) 2-3 wks prior to admission. In ER the patient alternated between looking well & periods of being pale, clammy, irritable, floppy, crying, arching back. PE included: hypotonia alternating with normal tone & movements, sleepy. Barium enema successfully reduced intussusception. The patient kept overnight for observation. The patient presented with lethargy, decreased appetite, arching back, loose stool (no diarrhea), pale, dry heaves. US revealed re-intussusception, successfully reduced with air enema. The patient kept overnight for observation. With diagnosis: gastroenteritis. The patient presented vomiting, decreased PO intake, loose stool. PE and US was unremarkable. Tolerating PO intake was without difficulty. The patient was discharged home in good condition with care and follow up instructions. Lab data included abdominal X-RAY (result not provided), abdominal US (revealed re-intussusception), barium enema abnormal. No further information is available. The original reporting source was not provided. The VAERS ID # is 452805-1.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypophagia, Hypotonia, Intussusception, Irritability, Lethargy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.5 year old female patient without medical history and illness at time of vaccine treated on 09-JAN-2012 orally with the third dose of ROTATEQ (Lot# 670539/0678AA). Second suspect therapy included RECOMBIVAX HB (IM into the left leg with the third dose, Lot# 669934/0571AA). Concomitant medications included: PREVNAR 13 (intramuscularly into right leg with the third dose, Lot # 916979), PENTACEL (intramuscularly into left leg with the third dose, Lot # C3834AA) and FLUZONE (vaccine date: 13-JAN-2012, Lot # UT4176CA). On 12-FEB-2012, the patient experienced intussusception with recurrence x1. The patient presented 4 hours history of lethargy, irritability, decreased tone, pallor alternating with periods of looking well, intermittent abdominal pain. The patient was with viral URI (fever, cough, rhinitis) 2-3 wks prior to admission. In ER the patient alternated between looking well & periods of being pale, clammy, irritable, floppy, crying, arching back. PE included: hypotonia alternating with normal tone & movements, sleepy. Barium enema successfully reduced intussusception. The patient kept overnight for observation. The patient presented with lethargy, decreased appetite, arching back, loose stool (no diarrhea), pale, dry heaves. US revealed re-intussusception, successfully reduced with air enema. The patient kept overnight for observation. With diagnosis: gastroenteritis. The patient presented vomiting, decreased PO intake, loose stool. PE and US was unremarkable. Tolerating PO intake was without difficulty. The patient was discharged home in good condition with care and follow up instructions. Lab data included abdominal X-RAY (result not provided), abdominal US (revealed re-intussusception), barium enema abnormal. No further information is available. The original reporting source was not provided. The VAERS ID # is 452805-1.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Opisthotonus, Pallor, Pyrexia, Retching, Rhinitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.5 year old female patient without medical history and illness at time of vaccine treated on 09-JAN-2012 orally with the third dose of ROTATEQ (Lot# 670539/0678AA). Second suspect therapy included RECOMBIVAX HB (IM into the left leg with the third dose, Lot# 669934/0571AA). Concomitant medications included: PREVNAR 13 (intramuscularly into right leg with the third dose, Lot # 916979), PENTACEL (intramuscularly into left leg with the third dose, Lot # C3834AA) and FLUZONE (vaccine date: 13-JAN-2012, Lot # UT4176CA). On 12-FEB-2012, the patient experienced intussusception with recurrence x1. The patient presented 4 hours history of lethargy, irritability, decreased tone, pallor alternating with periods of looking well, intermittent abdominal pain. The patient was with viral URI (fever, cough, rhinitis) 2-3 wks prior to admission. In ER the patient alternated between looking well & periods of being pale, clammy, irritable, floppy, crying, arching back. PE included: hypotonia alternating with normal tone & movements, sleepy. Barium enema successfully reduced intussusception. The patient kept overnight for observation. The patient presented with lethargy, decreased appetite, arching back, loose stool (no diarrhea), pale, dry heaves. US revealed re-intussusception, successfully reduced with air enema. The patient kept overnight for observation. With diagnosis: gastroenteritis. The patient presented vomiting, decreased PO intake, loose stool. PE and US was unremarkable. Tolerating PO intake was without difficulty. The patient was discharged home in good condition with care and follow up instructions. Lab data included abdominal X-RAY (result not provided), abdominal US (revealed re-intussusception), barium enema abnormal. No further information is available. The original reporting source was not provided. The VAERS ID # is 452805-1.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Somnolence, Ultrasound abdomen abnormal, Viral upper respiratory tract infection, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 0.5 year old female patient without medical history and illness at time of vaccine treated on 09-JAN-2012 orally with the third dose of ROTATEQ (Lot# 670539/0678AA). Second suspect therapy included RECOMBIVAX HB (IM into the left leg with the third dose, Lot# 669934/0571AA). Concomitant medications included: PREVNAR 13 (intramuscularly into right leg with the third dose, Lot # 916979), PENTACEL (intramuscularly into left leg with the third dose, Lot # C3834AA) and FLUZONE (vaccine date: 13-JAN-2012, Lot # UT4176CA). On 12-FEB-2012, the patient experienced intussusception with recurrence x1. The patient presented 4 hours history of lethargy, irritability, decreased tone, pallor alternating with periods of looking well, intermittent abdominal pain. The patient was with viral URI (fever, cough, rhinitis) 2-3 wks prior to admission. In ER the patient alternated between looking well & periods of being pale, clammy, irritable, floppy, crying, arching back. PE included: hypotonia alternating with normal tone & movements, sleepy. Barium enema successfully reduced intussusception. The patient kept overnight for observation. The patient presented with lethargy, decreased appetite, arching back, loose stool (no diarrhea), pale, dry heaves. US revealed re-intussusception, successfully reduced with air enema. The patient kept overnight for observation. With diagnosis: gastroenteritis. The patient presented vomiting, decreased PO intake, loose stool. PE and US was unremarkable. Tolerating PO intake was without difficulty. The patient was discharged home in good condition with care and follow up instructions. Lab data included abdominal X-RAY (result not provided), abdominal US (revealed re-intussusception), barium enema abnormal. No further information is available. The original reporting source was not provided. The VAERS ID # is 452805-1.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient with loeys-dietz syndrome, autism, seizure disorder who was vaccinated IM on the left arm with the second dose of GARDASIL (lot # 1139AA ) on 27-MAR-2012. Concomitant medications included VERAMYST, STRATTERA, LAMICTAL, COZAAR, magnesia [milk of], fiber (unspecified), CLARITIN, XOPENEX and MENACTRA (lot # U4019AA). On 28-MAR-2012 the patient experienced large area of warmth, induration, erythema around site of MENACTRA administration (right deltoid). At time of the report, the patient's outcome was unknown. The original reporting source was not provided. Additional information is not expected. The adverse events were considered to be no conditions, not serious. The VAERS ID # is 452908.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyskinesia, Hunger, Nausea, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 years old female patient was vaccinated IM into left arm with lot # (668819/0477AA) dose 3 GARDASIL on 31-MAY-2012 at 10:35 am local time (also reported vaccine date 30-MAY-2012). No other co-suspects were reported. No concomitant medications were reported. This incident happened on 31-MAY-2012 at 10:40 am local time (also reported as 30-MAY-2012). Patient started jerking motion while she was sitting in waiting area after immunization, for approximately 10 seconds. Patient responded nurse after jerking motion and complained of nausea and dizziness, vomited X1, Vital signs at 10:42 temperature (Temp): 98, blood pressure (BP): 96/56, Pulse: 50, Oxygen saturation (SPO2): 99. Placed Patient in supine position, elevated feet. Vital signs at 10:47 Temp: 97.9, BP: 110/67, Pulse: 74, SPO2: 97. Vital signs at 10:52 were Temp: 98.3, BP 102/62, Pulse: 72, SPO2: 98. Vital signs at 10:57 were temp: 98.6, BP: 100/62, Pulse: 80, SPO2: 98. Patient said she was hungry, and felt better and ate spam rice ball at 11:00. Patient denied dizziness. Vital signs at 11:02 were Temp: 98.6, BP: 121/72, Pulse: 69, SPO2: 98. Patient talked with mother and friend. Vital signs at 11:17 were temp: 98.4, BP: 118/76, Pulse: 72, SPO2: 98. Patient denied dizziness, nor weakness. Patient was discharged at 11:25. The original reporting source was not provided. The VAERS ID # is 456483-1. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyskinesia, Nausea, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 years old female patient was vaccinated IM into left arm with lot # (668819/0477AA) dose 3 GARDASIL on 31-MAY-2012 at 10:35 am local time (also reported vaccine date 30-MAY-2012). No other co-suspects were reported. No concomitant medications were reported. This incident happened on 31-MAY-2012 at 10:40 am local time (also reported as 30-MAY-2012). Patient started jerking motion while she was sitting in waiting area after immunization, for approximately 10 seconds. Patient responded nurse after jerking motion and complained of nausea and dizziness, vomited X1, Vital signs at 10:42 temperature (Temp): 98, blood pressure (BP): 96/56, Pulse: 50, Oxygen saturation (SPO2): 99. Placed Patient in supine position, elevated feet. Vital signs at 10:47 Temp: 97.9, BP: 110/67, Pulse: 74, SPO2: 97. Vital signs at 10:52 were Temp: 98.3, BP 102/62, Pulse: 72, SPO2: 98. Vital signs at 10:57 were temp: 98.6, BP: 100/62, Pulse: 80, SPO2: 98. Patient said she was hungry, and felt better and ate spam rice ball at 11:00. Patient denied dizziness. Vital signs at 11:02 were Temp: 98.6, BP: 121/72, Pulse: 69, SPO2: 98. Patient talked with mother and friend. Vital signs at 11:17 were temp: 98.4, BP: 118/76, Pulse: 72, SPO2: 98. Patient denied dizziness, nor weakness. Patient was discharged at 11:25. The original reporting source was not provided. The VAERS ID # is 456483-1. Additional information is not expected.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Disorientation, Dizziness, Excoriation, Eye swelling, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 21 years old male patient with history of attention deficit/hyperactivity disorder (ADHD) and Acne was vaccinated IM into left arm with a dose of GARDASIL (lot # 672834/0131AE) on 24-MAY-2012. No other co-suspects were reported. The patient was also vaccinated IM into left arm with a dose of BOOSTRIX (lot # AC52B076AA). Concomitant medication included CONCERTA (27 mg q am prn). The patient stated he felt dizzy about 5 min after being given 2 vaccines listed above. Doctor stepped out of room to get patient water. Door to room slammed shut within 5-10 seconds. Doctor ran to room. Patient face down on floor, doctor rolled him over. He was looking at the doctor but unaware of surroundings and shaking. He recovered in about 10 seconds. He had abrasion to right temple & swelling about right eye. He complained of headache and vision changes. Vision changes resolved about 1 hour. He threw up once 2-3 hours after event. He went home after 1 hour of observation. The original reporting source was not provided. The VAERS ID # is 456526-1. Additional information is not expected.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Tremor, Visual impairment, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 21 years old male patient with history of attention deficit/hyperactivity disorder (ADHD) and Acne was vaccinated IM into left arm with a dose of GARDASIL (lot # 672834/0131AE) on 24-MAY-2012. No other co-suspects were reported. The patient was also vaccinated IM into left arm with a dose of BOOSTRIX (lot # AC52B076AA). Concomitant medication included CONCERTA (27 mg q am prn). The patient stated he felt dizzy about 5 min after being given 2 vaccines listed above. Doctor stepped out of room to get patient water. Door to room slammed shut within 5-10 seconds. Doctor ran to room. Patient face down on floor, doctor rolled him over. He was looking at the doctor but unaware of surroundings and shaking. He recovered in about 10 seconds. He had abrasion to right temple & swelling about right eye. He complained of headache and vision changes. Vision changes resolved about 1 hour. He threw up once 2-3 hours after event. He went home after 1 hour of observation. The original reporting source was not provided. The VAERS ID # is 456526-1. Additional information is not expected.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Disorientation, Dizziness, Excoriation, Headache, Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 21 years old male patient with history of attention deficit/hyperactivity disorder (ADHD) and Acne was vaccinated IM into left arm with a dose of GARDASIL (lot # 672834/0131AE) on 24-MAY-2012. No other co-suspects were reported. The patient was also vaccinated IM into left arm with a dose of BOOSTRIX (lot # AC52B076AA). Concomitant medication included CONCERTA (27 mg q am prn). The patient stated he felt dizzy about 5 min after being given 2 vaccines listed above. Doctor stepped out of room to get patient water. Door to room slammed shut within 5-10 seconds. Doctor ran to room. Patient face down on floor, doctor rolled him over. He was looking at the doctor but unaware of surroundings and shaking. He recovered in about 10 seconds. He had abrasion to right temple & swelling about right eye. He complained of headache and vision changes. Vision changes resolved about 1 hour. He threw up once 2-3 hours after event. He went home after 1 hour of observation. The original reporting source was not provided. The VAERS ID # is 456526-1. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site induration, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female patient with no pertinent medical history was IM vaccinated into left arm with a dose of GARDASIL (lot # 670049/1261AA) on 30-MAY-2012. No other co-suspects were reported. There was no concomitant medication. Historical vaccine included: Hep A (unspecified), MENACTRA, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and VARIVAX (Merck). There was no illness at time of vaccination. On 30-MAY-2012 the patient developed nausea and vomiting, headache and visual changes. Reported "I feel like I was dying". Injection site with 4x6 cm red hard area. The events required ER visit. The original reporting source was not provided. The VAERS ID # is 456582-1. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual impairment, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female patient with no pertinent medical history was IM vaccinated into left arm with a dose of GARDASIL (lot # 670049/1261AA) on 30-MAY-2012. No other co-suspects were reported. There was no concomitant medication. Historical vaccine included: Hep A (unspecified), MENACTRA, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and VARIVAX (Merck). There was no illness at time of vaccination. On 30-MAY-2012 the patient developed nausea and vomiting, headache and visual changes. Reported "I feel like I was dying". Injection site with 4x6 cm red hard area. The events required ER visit. The original reporting source was not provided. The VAERS ID # is 456582-1. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Colitis, Condition aggravated, Crohn's disease, Fatigue, Menstruation irregular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with allergy to penicillin and amoxicillin was vaccinated IM with the first (lot # 658556/1060U), the second (lot # 658560/1062U) and the third dose (lot #659439/1267U) of GARDASIL on 12-SEP-2007, 08-NOV-2007 and 29-FEB-2008, respectively. No other co-suspects were reported. The patient was also vaccinated IM with the second dose of ADACEL (lot #LC2824AA). There was no concomitant medication. The patient was seen by specialist due to colitis flare and was told symptoms started after GARDASIL was given. The patient also had fatigue, body aches, irregular menses and Crohn's disease flare. The following information  was obtained through follow-up and/or provided by the government. On 13-JUN-2012 hospital records received for date of service from 17-MAY-2012 to 18-MAY-2012 with diagnostics: 1) constipation; 2) acute abdominal pain probably r/t constipation; 3) hx of Crohn's disease, no evidence of Crohn's flare. Patient c/o sharp stabbing right lower quadrant pain, constipation, nausea, vomiting, not eating solid foods, low grade fever. Physical examination: right lower quadrant tenderness. Patient admitted for evaluation and management of Crohn's (diagnosed in Feb 2010), discharged home with care and follow up instructions. Lab/diagnostic records received for date of service from 17-MAY-2012 to 18-MAY-2012. CT abdomen: wall thickening of terminal ileum, moderate amount fecal material. Blood: White blood cell 6.4 K/mm3 (N), Neutrophil 33% (L), lymphocyte 47.5% (H), Monocyte 12.2% (H), Red blood cell 3.94 M/ul (L), Haemoglobin 11.4 g/dl (L), Haematocrit 32.2% (L), Cl 110 mmol/L (H). The original reporting source was not provided. The VAERS ID # is 457315-1. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with allergy to penicillin and amoxicillin was vaccinated IM with the first (lot # 658556/1060U), the second (lot # 658560/1062U) and the third dose (lot #659439/1267U) of GARDASIL on 12-SEP-2007, 08-NOV-2007 and 29-FEB-2008, respectively. No other co-suspects were reported. The patient was also vaccinated IM with the second dose of ADACEL (lot #LC2824AA). There was no concomitant medication. The patient was seen by specialist due to colitis flare and was told symptoms started after GARDASIL was given. The patient also had fatigue, body aches, irregular menses and Crohn's disease flare. The following information  was obtained through follow-up and/or provided by the government. On 13-JUN-2012 hospital records received for date of service from 17-MAY-2012 to 18-MAY-2012 with diagnostics: 1) constipation; 2) acute abdominal pain probably r/t constipation; 3) hx of Crohn's disease, no evidence of Crohn's flare. Patient c/o sharp stabbing right lower quadrant pain, constipation, nausea, vomiting, not eating solid foods, low grade fever. Physical examination: right lower quadrant tenderness. Patient admitted for evaluation and management of Crohn's (diagnosed in Feb 2010), discharged home with care and follow up instructions. Lab/diagnostic records received for date of service from 17-MAY-2012 to 18-MAY-2012. CT abdomen: wall thickening of terminal ileum, moderate amount fecal material. Blood: White blood cell 6.4 K/mm3 (N), Neutrophil 33% (L), lymphocyte 47.5% (H), Monocyte 12.2% (H), Red blood cell 3.94 M/ul (L), Haemoglobin 11.4 g/dl (L), Haematocrit 32.2% (L), Cl 110 mmol/L (H). The original reporting source was not provided. The VAERS ID # is 457315-1. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Abdominal pain, Abdominal pain lower, Abdominal tenderness, Blood chloride increased, Colitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with allergy to penicillin and amoxicillin was vaccinated IM with the first (lot # 658556/1060U), the second (lot # 658560/1062U) and the third dose (lot #659439/1267U) of GARDASIL on 12-SEP-2007, 08-NOV-2007 and 29-FEB-2008, respectively. No other co-suspects were reported. The patient was also vaccinated IM with the second dose of ADACEL (lot #LC2824AA). There was no concomitant medication. The patient was seen by specialist due to colitis flare and was told symptoms started after GARDASIL was given. The patient also had fatigue, body aches, irregular menses and Crohn's disease flare. The following information  was obtained through follow-up and/or provided by the government. On 13-JUN-2012 hospital records received for date of service from 17-MAY-2012 to 18-MAY-2012 with diagnostics: 1) constipation; 2) acute abdominal pain probably r/t constipation; 3) hx of Crohn's disease, no evidence of Crohn's flare. Patient c/o sharp stabbing right lower quadrant pain, constipation, nausea, vomiting, not eating solid foods, low grade fever. Physical examination: right lower quadrant tenderness. Patient admitted for evaluation and management of Crohn's (diagnosed in Feb 2010), discharged home with care and follow up instructions. Lab/diagnostic records received for date of service from 17-MAY-2012 to 18-MAY-2012. CT abdomen: wall thickening of terminal ileum, moderate amount fecal material. Blood: White blood cell 6.4 K/mm3 (N), Neutrophil 33% (L), lymphocyte 47.5% (H), Monocyte 12.2% (H), Red blood cell 3.94 M/ul (L), Haemoglobin 11.4 g/dl (L), Haematocrit 32.2% (L), Cl 110 mmol/L (H). The original reporting source was not provided. The VAERS ID # is 457315-1. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Computerised tomogram abdomen abnormal, Condition aggravated, Constipation, Crohn's disease, Decreased appetite
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with allergy to penicillin and amoxicillin was vaccinated IM with the first (lot # 658556/1060U), the second (lot # 658560/1062U) and the third dose (lot #659439/1267U) of GARDASIL on 12-SEP-2007, 08-NOV-2007 and 29-FEB-2008, respectively. No other co-suspects were reported. The patient was also vaccinated IM with the second dose of ADACEL (lot #LC2824AA). There was no concomitant medication. The patient was seen by specialist due to colitis flare and was told symptoms started after GARDASIL was given. The patient also had fatigue, body aches, irregular menses and Crohn's disease flare. The following information  was obtained through follow-up and/or provided by the government. On 13-JUN-2012 hospital records received for date of service from 17-MAY-2012 to 18-MAY-2012 with diagnostics: 1) constipation; 2) acute abdominal pain probably r/t constipation; 3) hx of Crohn's disease, no evidence of Crohn's flare. Patient c/o sharp stabbing right lower quadrant pain, constipation, nausea, vomiting, not eating solid foods, low grade fever. Physical examination: right lower quadrant tenderness. Patient admitted for evaluation and management of Crohn's (diagnosed in Feb 2010), discharged home with care and follow up instructions. Lab/diagnostic records received for date of service from 17-MAY-2012 to 18-MAY-2012. CT abdomen: wall thickening of terminal ileum, moderate amount fecal material. Blood: White blood cell 6.4 K/mm3 (N), Neutrophil 33% (L), lymphocyte 47.5% (H), Monocyte 12.2% (H), Red blood cell 3.94 M/ul (L), Haemoglobin 11.4 g/dl (L), Haematocrit 32.2% (L), Cl 110 mmol/L (H). The original reporting source was not provided. The VAERS ID # is 457315-1. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Fatigue, Haematocrit decreased, Haemoglobin decreased, Lymphocyte percentage increased, Menstruation irregular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with allergy to penicillin and amoxicillin was vaccinated IM with the first (lot # 658556/1060U), the second (lot # 658560/1062U) and the third dose (lot #659439/1267U) of GARDASIL on 12-SEP-2007, 08-NOV-2007 and 29-FEB-2008, respectively. No other co-suspects were reported. The patient was also vaccinated IM with the second dose of ADACEL (lot #LC2824AA). There was no concomitant medication. The patient was seen by specialist due to colitis flare and was told symptoms started after GARDASIL was given. The patient also had fatigue, body aches, irregular menses and Crohn's disease flare. The following information  was obtained through follow-up and/or provided by the government. On 13-JUN-2012 hospital records received for date of service from 17-MAY-2012 to 18-MAY-2012 with diagnostics: 1) constipation; 2) acute abdominal pain probably r/t constipation; 3) hx of Crohn's disease, no evidence of Crohn's flare. Patient c/o sharp stabbing right lower quadrant pain, constipation, nausea, vomiting, not eating solid foods, low grade fever. Physical examination: right lower quadrant tenderness. Patient admitted for evaluation and management of Crohn's (diagnosed in Feb 2010), discharged home with care and follow up instructions. Lab/diagnostic records received for date of service from 17-MAY-2012 to 18-MAY-2012. CT abdomen: wall thickening of terminal ileum, moderate amount fecal material. Blood: White blood cell 6.4 K/mm3 (N), Neutrophil 33% (L), lymphocyte 47.5% (H), Monocyte 12.2% (H), Red blood cell 3.94 M/ul (L), Haemoglobin 11.4 g/dl (L), Haematocrit 32.2% (L), Cl 110 mmol/L (H). The original reporting source was not provided. The VAERS ID # is 457315-1. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Monocyte percentage increased, Nausea, Neutrophil percentage decreased, Pain, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with allergy to penicillin and amoxicillin was vaccinated IM with the first (lot # 658556/1060U), the second (lot # 658560/1062U) and the third dose (lot #659439/1267U) of GARDASIL on 12-SEP-2007, 08-NOV-2007 and 29-FEB-2008, respectively. No other co-suspects were reported. The patient was also vaccinated IM with the second dose of ADACEL (lot #LC2824AA). There was no concomitant medication. The patient was seen by specialist due to colitis flare and was told symptoms started after GARDASIL was given. The patient also had fatigue, body aches, irregular menses and Crohn's disease flare. The following information  was obtained through follow-up and/or provided by the government. On 13-JUN-2012 hospital records received for date of service from 17-MAY-2012 to 18-MAY-2012 with diagnostics: 1) constipation; 2) acute abdominal pain probably r/t constipation; 3) hx of Crohn's disease, no evidence of Crohn's flare. Patient c/o sharp stabbing right lower quadrant pain, constipation, nausea, vomiting, not eating solid foods, low grade fever. Physical examination: right lower quadrant tenderness. Patient admitted for evaluation and management of Crohn's (diagnosed in Feb 2010), discharged home with care and follow up instructions. Lab/diagnostic records received for date of service from 17-MAY-2012 to 18-MAY-2012. CT abdomen: wall thickening of terminal ileum, moderate amount fecal material. Blood: White blood cell 6.4 K/mm3 (N), Neutrophil 33% (L), lymphocyte 47.5% (H), Monocyte 12.2% (H), Red blood cell 3.94 M/ul (L), Haemoglobin 11.4 g/dl (L), Haematocrit 32.2% (L), Cl 110 mmol/L (H). The original reporting source was not provided. The VAERS ID # is 457315-1. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Red blood cell count decreased, Vomiting, White blood cell count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 22 years old female patient with allergy to penicillin and amoxicillin was vaccinated IM with the first (lot # 658556/1060U), the second (lot # 658560/1062U) and the third dose (lot #659439/1267U) of GARDASIL on 12-SEP-2007, 08-NOV-2007 and 29-FEB-2008, respectively. No other co-suspects were reported. The patient was also vaccinated IM with the second dose of ADACEL (lot #LC2824AA). There was no concomitant medication. The patient was seen by specialist due to colitis flare and was told symptoms started after GARDASIL was given. The patient also had fatigue, body aches, irregular menses and Crohn's disease flare. The following information  was obtained through follow-up and/or provided by the government. On 13-JUN-2012 hospital records received for date of service from 17-MAY-2012 to 18-MAY-2012 with diagnostics: 1) constipation; 2) acute abdominal pain probably r/t constipation; 3) hx of Crohn's disease, no evidence of Crohn's flare. Patient c/o sharp stabbing right lower quadrant pain, constipation, nausea, vomiting, not eating solid foods, low grade fever. Physical examination: right lower quadrant tenderness. Patient admitted for evaluation and management of Crohn's (diagnosed in Feb 2010), discharged home with care and follow up instructions. Lab/diagnostic records received for date of service from 17-MAY-2012 to 18-MAY-2012. CT abdomen: wall thickening of terminal ileum, moderate amount fecal material. Blood: White blood cell 6.4 K/mm3 (N), Neutrophil 33% (L), lymphocyte 47.5% (H), Monocyte 12.2% (H), Red blood cell 3.94 M/ul (L), Haemoglobin 11.4 g/dl (L), Haematocrit 32.2% (L), Cl 110 mmol/L (H). The original reporting source was not provided. The VAERS ID # is 457315-1. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash macular, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: Information has been received from a physician's assistant concerning a 20 year old female patient with no pertinent medical history or drug reactions/allergies who on 02-MAY-2012 was vaccinated IM with the first 0.5 mL dose of GARDASIL in her left deltoid (lot # 672653/1860AA, expiration date on 30-SEP-2012). There was no concomitant medication. The physician assistant reported that on 04-MAY-2012, the patient developed a severely swollen labia. The patient was treated with prednisone EMLA cream, PENICILLIN VK, BENADRYL and TYLENOL with codeine #3. No laboratory tests were performed. At the time of the report, the patient had not recovered from the event. The patient sought medical attention at the physician's office. Follow up information has been received from physician assistant, refers to a 20 year old female patient with none illness at the time of vaccination and none drug allergies who on 02-MAY-2012 at 13:07 was vaccinated intramuscularly with a first dose of GARDASIL (dose not reported) Lot # 672653/1860AA. On 04-MAY-2012 the patient experienced severe vulvar pain and severe vulvar swelling worsening over 5 days and mild macular allergic appearing rash on arm and upper back. The outcome was not reported. Reported terms "severe vulvar pain, severe vulvar swelling and mild, macular allergic appearing rash" were considered as disability/incapacity. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness, Muscle tightness
Clinical narrative: Patient with history of syncope. After after administering HPv4#1 and MCV#2 patient felt faint and passed out with muscle tightening x 2 within 15 min of each event.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient had injection site swelling & pain of R arm gradually getting larger to max size of 5x6 inches of induration - treated with ice, ibuprofen, antihistamine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Blister, Pruritus, Pyrexia
Clinical narrative: Fever, itching, vesicle formation
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Blood culture negative, CSF test normal, Computerised tomogram normal, Electroencephalogram normal, Febrile convulsion
Clinical narrative: Started with low grade fever the same day as immunizations. Approx 3 days later pt was transported to facility and then transported by ambulance to hospital where he was dx with complex febrile seizure and viral infection.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Pyrexia, Viral infection
Clinical narrative: Started with low grade fever the same day as immunizations. Approx 3 days later pt was transported to facility and then transported by ambulance to hospital where he was dx with complex febrile seizure and viral infection.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Asthenia, Blood test normal, Cardiac monitoring normal, Computerised tomogram normal, Cyanosis
Clinical narrative: Started with low grade fever the same day as immunizations. Approx 3 days later pt was transported to facility and then transported by ambulance to hospital where he was dx with complex febrile seizure and viral infection.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Electroencephalogram normal, Febrile convulsion, Foaming at mouth, Hypotonia, Lumbar puncture normal
Clinical narrative: Started with low grade fever the same day as immunizations. Approx 3 days later pt was transported to facility and then transported by ambulance to hospital where he was dx with complex febrile seizure and viral infection.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Pyrexia, Rash, Rash erythematous, Salivary hypersecretion, Tonic clonic movements
Clinical narrative: Started with low grade fever the same day as immunizations. Approx 3 days later pt was transported to facility and then transported by ambulance to hospital where he was dx with complex febrile seizure and viral infection.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, DTAP, HEPA, HIBV
Symptoms: Unresponsive to stimuli
Clinical narrative: Started with low grade fever the same day as immunizations. Approx 3 days later pt was transported to facility and then transported by ambulance to hospital where he was dx with complex febrile seizure and viral infection.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Local swelling, Pruritus, Rash
Clinical narrative: Localized swelling and erythema at injection site of anterior left thigh. Also, localized itching. No systemic reactions noted. Varicella vaccination given approx 1430 on 16 July 12 itching began that evening and localized rash noticed in morning 17 July 12. Treatment- cold compress.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, PNC13, RVX
Symptoms: Haematochezia, Irritability, Milk soy protein intolerance, Screaming
Clinical narrative: This is a spontaneous report from Pfizer Medical Information from a contactable reporter. This mother reported about her 2 months old female daughter that received a dose of PREVNAR 13 on 15May2012 as per pediatricians recommendation (as per Nurse and Pediatrics Association). Infants relevant medical history was unknown. The relevant concomitant medication included DTaP vaccine, rotavirus vaccine and HIB, all administered on 15May2012. On unknown date in June 2012, the infant had blood in stools. On unknown date in July 2012, she also experienced fussiness which was elaborated as yelling. The mother further reported that on an unknown date in 2012, the infant was diagnosed with milk soy protein intolerance (MSPI) due to PREVNAR 13 culture in soy. Therapeutic measures taken in response to the reported events, if any, were unknown. At the time of this report, clinical outcome of the events were was unknown.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site erythema, Skin warm
Clinical narrative: Arm was red. Extending roughly 1 inch from injection site the redness was at the elbow 3 days after injection but had receded greatly when seen on 8/6, 5 days after. Area was warm initially but subsided after a couple days. Also reported arthralgia in the shoulders. Counseled to take Ibuprofen and follow-up in 1 mo.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Hypersensitivity, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Vaccine given on 7/16-2012. 7/16 Shingles vaccine given in arm. 7/18 redness & swelling at site and cellulitis (L) arm. (L) upper arm tender to touch. 7/19 numbness & tingling for hands & feet. (more in hands than feet) 7/20 E&A Emergency room visit to assess - (L) arm. 7/23 Emerge. Room visit again for numbness & tingling in hands - Topical analgesic cream given. 7/25 rash (R) hand - Dx: allergic reaction from MD. 7/16 - present still numbness (R) hand.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: Vaccine given on 7/16-2012. 7/16 Shingles vaccine given in arm. 7/18 redness & swelling at site and cellulitis (L) arm. (L) upper arm tender to touch. 7/19 numbness & tingling for hands & feet. (more in hands than feet) 7/20 E&A Emergency room visit to assess - (L) arm. 7/23 Emerge. Room visit again for numbness & tingling in hands - Topical analgesic cream given. 7/25 rash (R) hand - Dx: allergic reaction from MD. 7/16 - present still numbness (R) hand.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chills, Dizziness, Fatigue, Headache
Clinical narrative: 12-24 after administrator, muscle soreness, body aches, fever, HA, chills, N/V x1, last day, severe back/shoulder pain (R) side, dizziness, fatigue blistered at site, red & warm.