chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Pyrexia, Ultrasound abdomen abnormal, Ultrasound testes abnormal, 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 6 month old male patient with history of otitis media was vaccinated orally with a third dose of ROTATEQ (lot number 670237/0919AA) on 11-NOV-2011. Concomitant vaccination given on the same date included DAPTACEL (IM, site unknown, third dose, lot number C3944AA) and IPOL (IM, site unknown, third dose, lot number G1500). There were no other concomitant medications. It was reported that on 15-NOV-2011, the patient experienced intussusception. The following information was obtained through follow-up and/or provided by the government on 05-DEC-2011: ER, Hospital records and discharge summary from 15-NOV-2011 to 16-NOV-2011. The patient diagnosis was Intussusception. The patient presented with fever, vomiting, diarrhea with streaks of mucous/dark blood tinge, and abdominal pain. The patient was fussy and had bilateral hydrocele. Barium enema was administered with reduction of intussusception upon third attempt. The patient was discharged. At the time of the report the patient's outcome was unknown. Labs and diagnostics tests included abdominal ultrasound (Abnormal), testicular ultrasound (Abnormal), barium enema (Abnormal), potassium 5.8, CO2 18.4, creatinine <0.25, CBC - 4.80, platelets 500 and monocytes 21.0%. The events were serious due hospitalization and were considered by agency to be immediately life-threatening. The original reporting source was not provided. The VAERS ID number is 442968. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question 670237/0919AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 1.0
Sex: M
Vaccine: RV5, FLUX, RV5
Symptoms: Abdominal X-ray, Clostridium test, Culture stool negative, Dehydration, Enterocolitis
Clinical narrative: 1 year old male with Hirschsprung's disease s/p colectomy at 1 week of age with right ileostomy and pull through May 2011; presented with vomiting and diarrhea for 4 days prior to hospital admission on 11/7/11. One episode of emesis. No fever. No apparent abdominal pain, reported. Had recently been started on iron supplements approximately 10 days prior for anemia. Had 1 year vaccinations as well as influenza vaccine on 11/1/11. Dehydrated on admission with sodium to 129. Corrected with IV fluids. Discharged initially 11/8/11 and then readmitted with similar symptoms 11/10/11. Final discharge on 11/14/11. Final diagnosis was Hirschsprung's enterocolitis responsive to IV antibiotics with ampicillin/gentamycin and metronidazole. Discharge home on oral metronidazole to complete a non-specified duration of therapy at home, per note. Symptoms had resolved prior to discharge.
Age: 1.0
Sex: M
Vaccine: RV5, FLUX, RV5
Symptoms: Intestinal obstruction, Laboratory test normal, Polymerase chain reaction, Rotavirus test negative, X-ray abnormal
Clinical narrative: 1 year old male with Hirschsprung's disease s/p colectomy at 1 week of age with right ileostomy and pull through May 2011; presented with vomiting and diarrhea for 4 days prior to hospital admission on 11/7/11. One episode of emesis. No fever. No apparent abdominal pain, reported. Had recently been started on iron supplements approximately 10 days prior for anemia. Had 1 year vaccinations as well as influenza vaccine on 11/1/11. Dehydrated on admission with sodium to 129. Corrected with IV fluids. Discharged initially 11/8/11 and then readmitted with similar symptoms 11/10/11. Final discharge on 11/14/11. Final diagnosis was Hirschsprung's enterocolitis responsive to IV antibiotics with ampicillin/gentamycin and metronidazole. Discharge home on oral metronidazole to complete a non-specified duration of therapy at home, per note. Symptoms had resolved prior to discharge.
Age: 1.0
Sex: M
Vaccine: RV5, FLUX, RV5
Symptoms: Abdominal X-ray, Blood sodium decreased, Clostridium test negative, Condition aggravated, Congenital megacolon
Clinical narrative: 1 year old male with Hirschsprung's disease s/p colectomy at 1 week of age with right ileostomy and pull through May 2011; presented with vomiting and diarrhea for 4 days prior to hospital admission on 11/7/11. One episode of emesis. No fever. No apparent abdominal pain, reported. Had recently been started on iron supplements approximately 10 days prior for anemia. Had 1 year vaccinations as well as influenza vaccine on 11/1/11. Dehydrated on admission with sodium to 129. Corrected with IV fluids. Discharged initially 11/8/11 and then readmitted with similar symptoms 11/10/11. Final discharge on 11/14/11. Final diagnosis was Hirschsprung's enterocolitis responsive to IV antibiotics with ampicillin/gentamycin and metronidazole. Discharge home on oral metronidazole to complete a non-specified duration of therapy at home, per note. Symptoms had resolved prior to discharge.
Age: 1.0
Sex: M
Vaccine: RV5, FLUX, RV5
Symptoms: Culture stool negative, Dehydration, Diarrhoea, Enterocolitis, Polymerase chain reaction
Clinical narrative: 1 year old male with Hirschsprung's disease s/p colectomy at 1 week of age with right ileostomy and pull through May 2011; presented with vomiting and diarrhea for 4 days prior to hospital admission on 11/7/11. One episode of emesis. No fever. No apparent abdominal pain, reported. Had recently been started on iron supplements approximately 10 days prior for anemia. Had 1 year vaccinations as well as influenza vaccine on 11/1/11. Dehydrated on admission with sodium to 129. Corrected with IV fluids. Discharged initially 11/8/11 and then readmitted with similar symptoms 11/10/11. Final discharge on 11/14/11. Final diagnosis was Hirschsprung's enterocolitis responsive to IV antibiotics with ampicillin/gentamycin and metronidazole. Discharge home on oral metronidazole to complete a non-specified duration of therapy at home, per note. Symptoms had resolved prior to discharge.
Age: 1.0
Sex: M
Vaccine: RV5, FLUX, RV5
Symptoms: Rotavirus test negative, Vomiting, X-ray abnormal
Clinical narrative: 1 year old male with Hirschsprung's disease s/p colectomy at 1 week of age with right ileostomy and pull through May 2011; presented with vomiting and diarrhea for 4 days prior to hospital admission on 11/7/11. One episode of emesis. No fever. No apparent abdominal pain, reported. Had recently been started on iron supplements approximately 10 days prior for anemia. Had 1 year vaccinations as well as influenza vaccine on 11/1/11. Dehydrated on admission with sodium to 129. Corrected with IV fluids. Discharged initially 11/8/11 and then readmitted with similar symptoms 11/10/11. Final discharge on 11/14/11. Final diagnosis was Hirschsprung's enterocolitis responsive to IV antibiotics with ampicillin/gentamycin and metronidazole. Discharge home on oral metronidazole to complete a non-specified duration of therapy at home, per note. Symptoms had resolved prior to discharge.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Arthralgia, Blood thyroid stimulating hormone normal, Dizziness, Fatigue
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with allergy to penicillin and no pertinent medical history who on 15-NOV-2011, was vaccinated IM with the first dose of GARDASIL (Lot # not reported). There was no concomitant medication. Two weeks after receiving her first dose of GARDASIL, on approximately 29-NOV-2011, the patient experienced fatigue, malaise, dizziness and joint pain. Then, on an unknown date, the patient experienced abdominal pain, sensation of cold, foggy, sensitivity to loud noises, headaches and pain in the back of her knees. The patient was seen by the physician. No treatment for the AEs was given. The patient had complete blood count (CBC) performed (results not reported). At the time of the report, the patient did not recover. All the events were considered by the reporter to be disabling, because the patient missed school and sports. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count normal, Headache, Malaise, Metabolic function test, Temperature intolerance
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with allergy to penicillin and no pertinent medical history who on 15-NOV-2011, was vaccinated IM with the first dose of GARDASIL (Lot # not reported). There was no concomitant medication. Two weeks after receiving her first dose of GARDASIL, on approximately 29-NOV-2011, the patient experienced fatigue, malaise, dizziness and joint pain. Then, on an unknown date, the patient experienced abdominal pain, sensation of cold, foggy, sensitivity to loud noises, headaches and pain in the back of her knees. The patient was seen by the physician. No treatment for the AEs was given. The patient had complete blood count (CBC) performed (results not reported). At the time of the report, the patient did not recover. All the events were considered by the reporter to be disabling, because the patient missed school and sports. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tri-iodothyronine normal
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with allergy to penicillin and no pertinent medical history who on 15-NOV-2011, was vaccinated IM with the first dose of GARDASIL (Lot # not reported). There was no concomitant medication. Two weeks after receiving her first dose of GARDASIL, on approximately 29-NOV-2011, the patient experienced fatigue, malaise, dizziness and joint pain. Then, on an unknown date, the patient experienced abdominal pain, sensation of cold, foggy, sensitivity to loud noises, headaches and pain in the back of her knees. The patient was seen by the physician. No treatment for the AEs was given. The patient had complete blood count (CBC) performed (results not reported). At the time of the report, the patient did not recover. All the events were considered by the reporter to be disabling, because the patient missed school and sports. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Dizziness, Fatigue
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with allergy to penicillin and no pertinent medical history who on 15-NOV-2011, was vaccinated IM with the first dose of GARDASIL (Lot # not reported). There was no concomitant medication. Two weeks after receiving her first dose of GARDASIL, on approximately 29-NOV-2011, the patient experienced fatigue, malaise, dizziness and joint pain. Then, on an unknown date, the patient experienced abdominal pain, sensation of cold, foggy, sensitivity to loud noises, headaches and pain in the back of her knees. The patient was seen by the physician. No treatment for the AEs was given. The patient had complete blood count (CBC) performed (results not reported). At the time of the report, the patient did not recover. All the events were considered by the reporter to be disabling, because the patient missed school and sports. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal, Feeling cold, Full blood count, Headache, Hyperacusis
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with allergy to penicillin and no pertinent medical history who on 15-NOV-2011, was vaccinated IM with the first dose of GARDASIL (Lot # not reported). There was no concomitant medication. Two weeks after receiving her first dose of GARDASIL, on approximately 29-NOV-2011, the patient experienced fatigue, malaise, dizziness and joint pain. Then, on an unknown date, the patient experienced abdominal pain, sensation of cold, foggy, sensitivity to loud noises, headaches and pain in the back of her knees. The patient was seen by the physician. No treatment for the AEs was given. The patient had complete blood count (CBC) performed (results not reported). At the time of the report, the patient did not recover. All the events were considered by the reporter to be disabling, because the patient missed school and sports. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with allergy to penicillin and no pertinent medical history who on 15-NOV-2011, was vaccinated IM with the first dose of GARDASIL (Lot # not reported). There was no concomitant medication. Two weeks after receiving her first dose of GARDASIL, on approximately 29-NOV-2011, the patient experienced fatigue, malaise, dizziness and joint pain. Then, on an unknown date, the patient experienced abdominal pain, sensation of cold, foggy, sensitivity to loud noises, headaches and pain in the back of her knees. The patient was seen by the physician. No treatment for the AEs was given. The patient had complete blood count (CBC) performed (results not reported). At the time of the report, the patient did not recover. All the events were considered by the reporter to be disabling, because the patient missed school and sports. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Headache, Joint stiffness
Clinical narrative: Shortness of breath at 1:00PM and nausea at 3:30PM then vomiting at 5:00PM. 1/12/2011 Arms and legs became paralyzed with tingling of body and face it was at this time she went to the Emergency Room.
Age: 23.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Oedema peripheral, Pain, Paralysis, Pyrexia, Vomiting
Clinical narrative: Shortness of breath at 1:00PM and nausea at 3:30PM then vomiting at 5:00PM. 1/12/2011 Arms and legs became paralyzed with tingling of body and face it was at this time she went to the Emergency Room.
Age: 23.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Blood creatinine increased, Blood electrolytes normal, Blood urea normal, Chest X-ray normal, Diplegia
Clinical narrative: Shortness of breath at 1:00PM and nausea at 3:30PM then vomiting at 5:00PM. 1/12/2011 Arms and legs became paralyzed with tingling of body and face it was at this time she went to the Emergency Room.
Age: 23.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Dyspnoea, Electrocardiogram normal, Liver function test normal, Nausea, Paraesthesia
Clinical narrative: Shortness of breath at 1:00PM and nausea at 3:30PM then vomiting at 5:00PM. 1/12/2011 Arms and legs became paralyzed with tingling of body and face it was at this time she went to the Emergency Room.
Age: 23.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Shortness of breath at 1:00PM and nausea at 3:30PM then vomiting at 5:00PM. 1/12/2011 Arms and legs became paralyzed with tingling of body and face it was at this time she went to the Emergency Room.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1/2-1 hr after injection pt. notes itching at site. Redness/swelling Sat eve 2x2 1/2 knot warm, red thru Sun. Today, 1/17/12, 2 x 1 1/2 pink and warm. Pt. called Dr. office to report this. AM using Cortisone cream and TYLENOL Allergy and Sinus.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Headache, Pyrexia
Clinical narrative: Within 12 hours of vaccination, developed fever 102-103, headache, and dizziness, weakness.
Age: 40.0
Sex: M
Vaccine: HEPAB
Symptoms: Pruritus, Rash
Clinical narrative: Pt. not available to speak. Wife stated two days after last injection, pt. started rash and itching which became worse. Did go through ER for treatment, received steroids started up in one month. No long term effects. Physician instructed not to receive any more TWINRIX.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discharge, Injection site nodule, Neck pain, Pain in extremity
Clinical narrative: Received TDAP 12-8-11 rt. deltoid - knot came up next day at injection - not visible to naked eye - no redness - swelling - started draining 3 days ago - reddish yellow discharge - arm and neck aching. Noted 2 knots around area 3 days ago. No fever.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: Got influenza vaccine Oct 14, 2011. Within a day, itching which continued a week, followed by severe back pain. Blisters one-sided around trunk appeared Oct 24, 2011. Diagnosis: Shingles. Blisters healed in 3 weeks, but pain extreme for 7 weeks, but slowly abating. (Week 12 now).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Large reddened area at injection site, fever 2 days after injection 100-101. Cellulitis symptoms, pain arm, shoulder.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Muscle spasms, Nausea, Pain in extremity, Pyrexia
Clinical narrative: On 12/29/11 pt. reported fever (not measured), nausea and muscle cramps starting on 12/18/11 which resolved in 25 hrs. Pt. received dose #3 on 1/5/12 under observation of Physician x 1 hr. sans problems. 1/9/12 Pt. states sore arm only after dose #3 of RABAVERT on 1/5/12.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, FLUN3, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Child received vaccines left/right thighs on 1/10/12, PENTACEL & varicella on (L). MMR by itself in (R) thigh. Mother called approx 48 hrs. later to describe large 5 inch x 5 inch area of redness on (L) anterior thigh, slightly warm to touch. Child came into office, assessed, diagnosed with cellulitis, started on KEFLEX, oral. Follow-up 1/13/12, 24 hours later: area significantly improved no pain, no warmth redness almost completely resolved.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Pain in extremity
Clinical narrative: Within 8 hrs of the vaccine, patient's arm turned very sore and bright red. Injection site was very hot as well.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Activities of daily living impaired, Hot flush, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient with environmental allergy (allergy to: dust mite, molds, fall pollen and "sorel") and a history of hot flashes (start date unspecified) after allergy shots (from 22-JAN-2008) to 02-OCT-2009, type and manufacturer unspecified) who on 21-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z, expired data 18-JUL-2011). There was no concomitant medication. The physician reported that the patient did not have any hot flashes between the stop of the allergy shots on 02-OCT-2009 (also reported as 02-OCt-2011) and the vaccination with PNEUMOVAX 23 vaccine on 21-MAR-2011. On 21-MAR-2011, patient developed the hot flashes. The hot flashed occur daily (at least one per day, sometimes more) and least for a few hours. The physician considered hot flashes as disabling as the patient could not tolerate the hot flashes and the hot slashes interrupts study at school. On an unknown date, the patient had consulted with an endocrinologist and a neurologist. X-ray and MRI test were done (results and details unknown). No treatments was given for adverse events. At the time of the report the patient's status was not recovered. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Hot flush, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient with environmental allergy (allergy to: dust mite, molds, fall pollen and "sorel") and a history of hot flashes (start date unspecified) after allergy shots (from 22-JAN-2008) to 02-OCT-2009, type and manufacturer unspecified) who on 21-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z, expired data 18-JUL-2011). There was no concomitant medication. The physician reported that the patient did not have any hot flashes between the stop of the allergy shots on 02-OCT-2009 (also reported as 02-OCt-2011) and the vaccination with PNEUMOVAX 23 vaccine on 21-MAR-2011. On 21-MAR-2011, patient developed the hot flashes. The hot flashed occur daily (at least one per day, sometimes more) and least for a few hours. The physician considered hot flashes as disabling as the patient could not tolerate the hot flashes and the hot slashes interrupts study at school. On an unknown date, the patient had consulted with an endocrinologist and a neurologist. X-ray and MRI test were done (results and details unknown). No treatments was given for adverse events. At the time of the report the patient's status was not recovered. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood test normal, Diplopia, Headache, Hot flush
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient with environmental allergy (allergy to: dust mite, molds, fall pollen and "sorel") and a history of hot flashes (start date unspecified) after allergy shots (from 22-JAN-2008) to 02-OCT-2009, type and manufacturer unspecified) who on 21-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z, expired data 18-JUL-2011). There was no concomitant medication. The physician reported that the patient did not have any hot flashes between the stop of the allergy shots on 02-OCT-2009 (also reported as 02-OCt-2011) and the vaccination with PNEUMOVAX 23 vaccine on 21-MAR-2011. On 21-MAR-2011, patient developed the hot flashes. The hot flashed occur daily (at least one per day, sometimes more) and least for a few hours. The physician considered hot flashes as disabling as the patient could not tolerate the hot flashes and the hot slashes interrupts study at school. On an unknown date, the patient had consulted with an endocrinologist and a neurologist. X-ray and MRI test were done (results and details unknown). No treatments was given for adverse events. At the time of the report the patient's status was not recovered. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: MMR, TD
Symptoms: Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: (R) arm swollen, all the way down to hand, pain upper arm. Examined by Health Dept physician. Local reaction only.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Immunizations received 1/11/12 - fever developed that night followed by diarrhea. Diarrhea continues, every 30 min. Pt. seen by MD 1/17/12.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Feeling abnormal, Feeling cold, Feeling hot
Clinical narrative: 1500 - Flu shot administered; 1520 - Employee presented with c/o "not feeling well, tingly; hot, lightheaded" ice pack given, escorted to a cooler area to sit/be monitored 1526 : Vitals: BP: 130/76, HR = 80, Resp = 12. No labored breathing or skin color changes. States feeling of heat, tingly and lightheaded gone, but feels nauseated and "weird". 15:40 = Vitals stable 120/88; HR - 80, R = 16. 1600 = Occupational Services called - Dr. spoke with. 1650 - Patient states "I'm fine" - will stay at work and not operate machinery. Declines going to a Occ Services Clinic or going home. Approximately 1635 - Staff called 911 - vitals stable (130/84; BP) but patient shivering, is cold, and says her neck hurts. Approximately 1658 patient declines transport to hospital by ambulance and exists facility into daughter's car daughter to monitor her.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Neck pain, Paraesthesia
Clinical narrative: 1500 - Flu shot administered; 1520 - Employee presented with c/o "not feeling well, tingly; hot, lightheaded" ice pack given, escorted to a cooler area to sit/be monitored 1526 : Vitals: BP: 130/76, HR = 80, Resp = 12. No labored breathing or skin color changes. States feeling of heat, tingly and lightheaded gone, but feels nauseated and "weird". 15:40 = Vitals stable 120/88; HR - 80, R = 16. 1600 = Occupational Services called - Dr. spoke with. 1650 - Patient states "I'm fine" - will stay at work and not operate machinery. Declines going to a Occ Services Clinic or going home. Approximately 1635 - Staff called 911 - vitals stable (130/84; BP) but patient shivering, is cold, and says her neck hurts. Approximately 1658 patient declines transport to hospital by ambulance and exists facility into daughter's car daughter to monitor her.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Laboratory test normal, Unevaluable event
Clinical narrative: Possible seizures.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Patient had Varicella & MENACTRA injection to (R) arm 1-11-12. On 1-12-12 at school arm became swollen, itchy & red & warm. Continued to swell. Mother took to physician 1-12-12 - cellulitis vs allergy. On CLARITIN, BENADRYL, Cephalexin. Swelling worse & at night. Better 1/13/12.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Nausea, Syncope
Clinical narrative: Following GARDASIL vac. C/O weakness - syncope, vomiting, diarrhea, nausea, abd pain. Symptoms last 4 days.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Following GARDASIL vac. C/O weakness - syncope, vomiting, diarrhea, nausea, abd pain. Symptoms last 4 days.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Arm pain at injection site and entire upper left arm. Shoulder pain and extreme stiffness in upper arm. Numbness in middle fingers of hand at times. (500mg NAPROXEN daily).
Sex: U
Vaccine: UNK
Symptoms: Paraesthesia
Clinical narrative: Pt has residual very mild paresthesias in (L) 5th digit.
Age: 47.0
Sex: M
Vaccine: DT
Symptoms: Tetanus
Clinical narrative: Initial report was received from a health care professional on 11 January 2012. A 47-year-old male patient had received an injection of DECAVAC, sanofi pasteur Inc. (lot number, route, site and date of administration not reported) on 24 August 2006 for wound management and an unspecified amount of time later developed tetanus. It was unknown if the patient had any illness at the time of vaccination, had any pre-existing medical conditions, took any concomitant medications or received any other vaccinations within four weeks of DECAVAC. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: (L) Thigh with redness and swelling from hip to knee. Inconsolable crying for two hours.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Initial report was received on 11 January 2012 from a health care professional. A five year-old male patient who had no illness at the time vaccination had received on 23 September 2011 an intramuscular left deltoid injection of FLUZONE, lot number UH478AA and on 29 September 2011, experienced a widespread rash over the body and was itchy. The patient had no breathing difficulties. The patient was evaluated in the ER (emergency room) and treated with prednisone and hydroxizine. The patient was referred to an allergist. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injection site erythema, Pyrexia, Tenderness
Clinical narrative: 01-13-12 redness at injection site  01-15-12 increase in local redness and tenderness, also fever 101. Went to ER, was DX with cellulitis and admitted for antibodic therapy
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: (L) leg with redness and swelling from hip to knee and inconsolable crying for over one hour.
Age: 22.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: Noticed a rash (bright sun-burn red color) on both thighs. Client went to the emergency room where she received Benadryl. Rash began going away and was gone in an hour.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Pain in extremity, Throat tightness
Clinical narrative: Received flu shot without incident.  Then received pneumovax and throat "closed a bit". She  went home, suffering chills, fatique. Slept > 2 hours.  Left arm very painful but not swollen or hard.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Erythema, Mouth haemorrhage, Pharyngeal erythema, Swelling face
Clinical narrative: Initial report received on 07 October 2011 from a healthcare professional. This case involves 1 of a cluster of 2 patients from the same reporter, where the same vaccine was administered with the same lot number. Information pertaining to the other patient is captured in case number 2011-09782. A female patient (date of birth not reported) had received an intramuscular injection of FLUZONE (lot number UH477AB) on 05 October 2011 and approximately 7 hours later developed petechiae on the back of her soft palate and throat that was dark red in color. She also experienced hoarseness and redness in her cheeks. No other information was provided. At the time of this report, the patient had not recovered. Follow-up information was received on 09 January 2012 from a health care professional. Based upon the new information provided, this case has been upgraded to serious. The patient was a 56-year-old female. The patient had received the vaccination in the left deltoid. The patient experienced the petechiae on the soft palate/uvula and also experienced swelling of the tongue and face (date of onset not reported). The patient had no illness at time of vaccination and no pre-existing medical conditions. No further information was available at the time of the report. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Initial report received on 07 October 2011 from a healthcare professional. This case involves 1 of a cluster of 2 patients from the same reporter, where the same vaccine was administered with the same lot number. Information pertaining to the other patient is captured in case number 2011-09782. A female patient (date of birth not reported) had received an intramuscular injection of FLUZONE (lot number UH477AB) on 05 October 2011 and approximately 7 hours later developed petechiae on the back of her soft palate and throat that was dark red in color. She also experienced hoarseness and redness in her cheeks. No other information was provided. At the time of this report, the patient had not recovered. Follow-up information was received on 09 January 2012 from a health care professional. Based upon the new information provided, this case has been upgraded to serious. The patient was a 56-year-old female. The patient had received the vaccination in the left deltoid. The patient experienced the petechiae on the soft palate/uvula and also experienced swelling of the tongue and face (date of onset not reported). The patient had no illness at time of vaccination and no pre-existing medical conditions. No further information was available at the time of the report. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Initial report was received from a healthcare professional on 05 January 2012. A female patient (age and date of birth not reported) had received an injection in the left upper arm of FLUZONE Intradermal, sanofi pasteur Inc. lot number UT426AA (lot number UT426AA correspond with FLUZONE , not FLUZONE Intradermal) (route not reported) on 12 November 2011. On 25 November 2011, the patient developed a site reaction of redness and swelling and went to the emergency department (ED). The patient was prescribed analgesics and instructed to apply local heat to the site. The patient returned to the ED on 28 November 2011 and was administered BENADRYL and prednisone. The reporter informed the patient that this was not an allergic reaction. The patient also complained of left hip pain and facial numbness. The patient was evaluated by a neurologist and found nothing wrong. The patient denied any illness  at the time of vaccination. The patient had a medical history of hypertension (HTN) and claimed an allergy to latex and thimerosol. The patient's concomitant medications included LOPRESSOR and NORVASC. The patient had no other vaccinations within four weeks of FLUZONE. The patient had no previous doses of influenza vaccine. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Chills, Full blood count abnormal, Gait disturbance, Hemiparesis
Clinical narrative: Initial report was received from a healthcare professional on 05 January 2012. A female patient (age and date of birth not reported) had received an injection in the left upper arm of FLUZONE Intradermal, sanofi pasteur Inc. lot number UT426AA (lot number UT426AA correspond with FLUZONE , not FLUZONE Intradermal) (route not reported) on 12 November 2011. On 25 November 2011, the patient developed a site reaction of redness and swelling and went to the emergency department (ED). The patient was prescribed analgesics and instructed to apply local heat to the site. The patient returned to the ED on 28 November 2011 and was administered BENADRYL and prednisone. The reporter informed the patient that this was not an allergic reaction. The patient also complained of left hip pain and facial numbness. The patient was evaluated by a neurologist and found nothing wrong. The patient denied any illness  at the time of vaccination. The patient had a medical history of hypertension (HTN) and claimed an allergy to latex and thimerosol. The patient's concomitant medications included LOPRESSOR and NORVASC. The patient had no other vaccinations within four weeks of FLUZONE. The patient had no previous doses of influenza vaccine. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a healthcare professional on 05 January 2012. A female patient (age and date of birth not reported) had received an injection in the left upper arm of FLUZONE Intradermal, sanofi pasteur Inc. lot number UT426AA (lot number UT426AA correspond with FLUZONE , not FLUZONE Intradermal) (route not reported) on 12 November 2011. On 25 November 2011, the patient developed a site reaction of redness and swelling and went to the emergency department (ED). The patient was prescribed analgesics and instructed to apply local heat to the site. The patient returned to the ED on 28 November 2011 and was administered BENADRYL and prednisone. The reporter informed the patient that this was not an allergic reaction. The patient also complained of left hip pain and facial numbness. The patient was evaluated by a neurologist and found nothing wrong. The patient denied any illness  at the time of vaccination. The patient had a medical history of hypertension (HTN) and claimed an allergy to latex and thimerosol. The patient's concomitant medications included LOPRESSOR and NORVASC. The patient had no other vaccinations within four weeks of FLUZONE. The patient had no previous doses of influenza vaccine. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test abnormal, Local swelling, Pain, Pruritus generalised, Pyrexia
Clinical narrative: Initial report was received from a healthcare professional on 05 January 2012. A female patient (age and date of birth not reported) had received an injection in the left upper arm of FLUZONE Intradermal, sanofi pasteur Inc. lot number UT426AA (lot number UT426AA correspond with FLUZONE , not FLUZONE Intradermal) (route not reported) on 12 November 2011. On 25 November 2011, the patient developed a site reaction of redness and swelling and went to the emergency department (ED). The patient was prescribed analgesics and instructed to apply local heat to the site. The patient returned to the ED on 28 November 2011 and was administered BENADRYL and prednisone. The reporter informed the patient that this was not an allergic reaction. The patient also complained of left hip pain and facial numbness. The patient was evaluated by a neurologist and found nothing wrong. The patient denied any illness  at the time of vaccination. The patient had a medical history of hypertension (HTN) and claimed an allergy to latex and thimerosol. The patient's concomitant medications included LOPRESSOR and NORVASC. The patient had no other vaccinations within four weeks of FLUZONE. The patient had no previous doses of influenza vaccine. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling, Vaccination complication, White blood cell count increased
Clinical narrative: Initial report was received from a healthcare professional on 05 January 2012. A female patient (age and date of birth not reported) had received an injection in the left upper arm of FLUZONE Intradermal, sanofi pasteur Inc. lot number UT426AA (lot number UT426AA correspond with FLUZONE , not FLUZONE Intradermal) (route not reported) on 12 November 2011. On 25 November 2011, the patient developed a site reaction of redness and swelling and went to the emergency department (ED). The patient was prescribed analgesics and instructed to apply local heat to the site. The patient returned to the ED on 28 November 2011 and was administered BENADRYL and prednisone. The reporter informed the patient that this was not an allergic reaction. The patient also complained of left hip pain and facial numbness. The patient was evaluated by a neurologist and found nothing wrong. The patient denied any illness  at the time of vaccination. The patient had a medical history of hypertension (HTN) and claimed an allergy to latex and thimerosol. The patient's concomitant medications included LOPRESSOR and NORVASC. The patient had no other vaccinations within four weeks of FLUZONE. The patient had no previous doses of influenza vaccine. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Infection, Injection site erythema, Injection site pain
Clinical narrative: Initial report was received on 13 October 2011 from a health care professional, at which time this case was assessed as non-serious listed. Based upon follow-up information received on 09 January 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER-MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. A 55 year-old female patient, who had no illness at the time of vaccination had received FLUZONE Intradermal, lot number UT4163AA (route and site of administration not reported) on 04 October 2011 and an unspecified amount of time later, experienced soreness and redness at the injection site. The patient was treated with a ROCEPHIN shot for the "infection". No further information was available at the time of the report. The patient's outcome was reported as recovered. This report involves a cluster of unknown patients (exact number not reported). Upon follow-up information identifiers were reported for only one patient. According to the reporter, "no other patient had adverse reactions that they are aware of". Documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Hyperhidrosis, Loss of consciousness, Staring
Clinical narrative: Initial report was received 04 January 2012 from a health care professional. A 15-year-old male patient (age reported as 15 years of age; however, calculates to 14 years of age) had received a first dose intramuscular injection of FLUZONE (site not reported) on 31 December 2011 at 5:30 PM and within minutes of vaccination, the patient passed out after "feeling sweaty" and "staring up". The father of the patient told the reporter that the patient did not eat for 24 hours. The patient had no concurrent illness at the time of vaccination and he had not been taking any concomitant medications. The event did not require a doctor's visit. Outcome was recovered. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Left deltoid injection site 1" diameter red, warm & firm. Started with itching evening before & 4" below red area no dyspnea. Chest pain of severe reaction. T 97.5 p 65 R-16 BP 110/66. Seen by Dr. Started on ZYRTEC 12mg po x 5 day & Cephalexin 500mg one po q 6 hours x 7 days.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count normal
Clinical narrative: Left deltoid injection site 1" diameter red, warm & firm. Started with itching evening before & 4" below red area no dyspnea. Chest pain of severe reaction. T 97.5 p 65 R-16 BP 110/66. Seen by Dr. Started on ZYRTEC 12mg po x 5 day & Cephalexin 500mg one po q 6 hours x 7 days.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Pruritus, Urticaria
Clinical narrative: Angioedema & UrticariaPruritus.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Fainting within 5 minutes of receiving shots.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema, Injection site erythema
Clinical narrative: REDNESS AROUND THE INJECTION SITE THEN PROGRESS TO FULL BLOWN REDNESS THROUGH OUT THE BODY.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site warmth
Clinical narrative: Mom described "6 inch, red, raised, and hot area" on left thigh.  Due to holidays, medical attention was not sought out.  Mom states the area still looks bruised.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: Injection site swelling, redness, warmth.  Entire body aching and muscle pain and weakness lower limbs.  Nurse hardly able to ambulate.  Nurse Called her physician X 2 and rested with resolution of symptoms.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Injection site swelling, redness, warmth.  Entire body aching and muscle pain and weakness lower limbs.  Nurse hardly able to ambulate.  Nurse Called her physician X 2 and rested with resolution of symptoms.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever of 101.8 F, chills, muscle ache.
Age: 1.02
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Cold sweat, Cyanosis, Hypotonia, Retching, Screaming
Clinical narrative: Several nights after receiving her 12 month vaccinations, our daughter woke up screaming. When we picked her up, her body was limp, like picking up a newborn, her skin was grey and cold and clammy and her lips were blue. She was gagging as if she was trying to vomit. We called the pediatrician's office and they instructed us to bring her to the hospital. However, within 30 minutes she was perfectly fine and by the time we got there she was no longer showing symptoms. The next day I called the pediatricians office to see if she should be seen. A nurse told me that it sounded like she had a seizure as a result of her vaccines but we wouldn't know for sure unless it happened again and there was no point in bringing her back the next day.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site induration, Mobility decreased, Pyrexia, Respiratory tract infection, Restlessness
Clinical narrative: Hardness at injection site, High pitched screaming, Sleepiness, Fever, Loss of ability to rollover, (later that day) restlessness, sleep disturbances and respiratory infection.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Screaming, Sleep disorder, Somnolence
Clinical narrative: Hardness at injection site, High pitched screaming, Sleepiness, Fever, Loss of ability to rollover, (later that day) restlessness, sleep disturbances and respiratory infection.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash macular
Clinical narrative: Rash to face, bilateral arms, upper back- very itchy, macular in appearance.
Age: 0.62
Sex: F
Vaccine: RV5
Symptoms: Lethargy, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose, lethargy, low-grade fever of 101 degrees. On 12/21/11, two household members also began to suffer the same symptoms. Symptoms continued in everyone for 2- 3 days.
Age: 1.22
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Onset of acute generalized rash and fever approx 4 days after vaccines given. Erythematous macular/papular eruption, prevalent on cheeks & upper thighs.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin lesion, Tenderness
Clinical narrative: Per Dr, pt has 24 inch rash from thigh to ankle, 6 or more satellite lesions and was tender to touch.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: Injection site was "normally" sore for 1 day. Say after arm (below injection site & not at the site of injection) became sore. Sore for 4 days with inflammation & redness. Recovered by fifth day & no problem thereafter.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Aphthous stomatitis, Blood immunoglobulin G, Blood immunoglobulin M, Decreased appetite, Dehydration
Clinical narrative: Fever starting within four hours of immunizations, lasting 7 days (>101), anorexia, weight loss (secondary to dehydration) and oral aphthous ulcers.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Full blood count, Pyrexia, Weight decreased
Clinical narrative: Fever starting within four hours of immunizations, lasting 7 days (>101), anorexia, weight loss (secondary to dehydration) and oral aphthous ulcers.
Age: 1.03
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Skin lesion
Clinical narrative: Target-like red lesions on abdomen, legs, arms & neck.
Age: 23.0
Sex: F
Vaccine: HEP, HEPA, YF
Symptoms: Dehydration, Feeling hot, Oedema peripheral, Pain, Pruritus
Clinical narrative: Took 3 typhoid oral pills as directed, on empty stomach. After 3rd pill noted white rash patches on skin, itchy woke up with increasing amt of rash limbs, trunk, not face. Some fist size felling dehydrated, hot. Went to walk-in clinic. Stopped typhoid pills, prednisone given. No prob with breathing. Legs did swell, hurt to bend.
Age: 23.0
Sex: F
Vaccine: HEP, HEPA, YF
Symptoms: Rash
Clinical narrative: Took 3 typhoid oral pills as directed, on empty stomach. After 3rd pill noted white rash patches on skin, itchy woke up with increasing amt of rash limbs, trunk, not face. Some fist size felling dehydrated, hot. Went to walk-in clinic. Stopped typhoid pills, prednisone given. No prob with breathing. Legs did swell, hurt to bend.