chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who in February 2009, was vaccinated with the third dose of GARDASIL. Subsequently, 3 weeks after the 3rd dose administration, the patient had a Pap test. The Pap test was positive for high risk HPV. No other information provided. The patient called office for medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue, Infectious mononucleosis, Pallor, Rash
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old female with penicillin allergy and sulfonamide allergy who on 05-JUN-2008 was vaccinated with a first dose of GARDASIL (lot number 659657/1487U). On 05-AUG-2008 the patient was vaccinated with a second dose of GARDASIL (lot number 659657/1487U) (injection site and route not reported). There was no concomitant medication. The patient developed a rash around her stomach lasting one week after the first vaccination. The rash came and went since the first vaccination. The patient also developed extreme fatigue, joint pain and was pale. The patient was tested positive for a variety of medical conditions. The patient had been tested for rheumatoid arthritis and mononucleosis but the results had not been received. The patient was prescribed prenatal vitamins, but she was not pregnant. The patient was seen in the physician's office. Laboratory test included pregnancy test, mononucleosis, AlC, blood cell count, MMA, thyroid and swallow study H. pylori Complete medical panel (results unspecified). The patient's mother refused the third dose due to the adverse events. At time of this report, the patient's events persisted. Follow-up information was received from the physician assistant concerning the 16 year old female. The Physician's assistant reported that it was determined on 27-MAR-2009 that the patient's mononucleosis and not the fact that she received two of three doses of GARDASIL resulted in the reported adverse events. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Petechiae
Clinical narrative: Information has been received from a Doctor of Pharmacy (Pharm. D.) student concerning a 27 year old female with no medical history or drug allergies who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. There was no concomitant medication. It was reported the patient developed a widespread petechial rash after administration of the vaccine. The reporter is unable to provide the dates of administration of GARDASIL or the date of onset of the rash. The patient sought medical attention. She was seen in a hospital emergency department on 24-MAR-2009 and was treated with BENADRYL and prednisone. The patient was released from the emergency department and did not require hospitalization. At the time of reporting the patient was not recovered. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who was vaccinated with all 3 doses of GARDASIL. That after the patient received her first or second dose of GARDASIL, she had fainted a "couple months ago". The patient felt dizzy and did not eat anything before her visit. The nurse did state that she did not faint when she received her third dose of GARDASIL. Not lot number was provided. Subsequently the patient recovered. The patient sought unspecified medical attention.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a 26 year old female who in December 2008 was vaccinated with a first dose of GARDASIL. On 17-MAR-2009 was vaccinated with a second dose of GARDASIL and when the nurse gave the injection she squeezed her arm and put the needle in. There was no concomitant medication. Then on Saturday 21-MAR-2009 the patient had a very large lump at the injection site that was the size of a half dollar and a little sore that day. As of 26-MAR-2009, the consumer stated the lump had gone down to the size of a pencil eraser and she had no pain. The consumer stated that she was unsure if she should get the third dose of the series. The patient sought medical attention by talking to the nurse. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms
Clinical narrative: Information has been received from a physician assistant concerning a 24 year old female with asthma and a history of urinary tract infection who on 25-MAR-2009 was vaccinated with the first dose of GARDASIL (lot# not provided) for cervical dysplasia. On 25-MAR-2009 the patient experienced muscle cramps in her calf and thigh about one hour after vaccination. The patient was a healthy personal trainer who worked out on a new piece of equipment 2 days ago. The patient was not admitted but referred to a neurologist for follow up. The patient's muscle cramps in her calf and thigh persisted. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Red oval (3/8" x l-l/8") around injection site. Forgot to check the site of injection until just now.  12:15 PM 04/18/2009. Zostavax INJ
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Red oval (3/8" x l-l/8") around injection site. Forgot to check the site of injection until just now.  12:15 PM 04/18/2009. Zostavax INJ
Age: 20.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Expired drug administered
Clinical narrative: Patient inadverently given expired dose of smallpox vaccine.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Dizziness, Hypersomnia
Clinical narrative: Extreme fatigue (20 hours of sleep for five days)Extreme body ache, confusion, dizziness 4/20/09 Received PCP medical records of 4/13/2009. FINAL DX: none provided Records reveal pt seen for HPV #2 & breakthrough bleeding on BCP.  Reported no AE to HPV #1 other than pain at injection site.  t/c to office on 4/17 to c/o fatigue, achy muscles & fever since 4/14.  4/29/09 Received additional PCP medical records of 1/30/08-1/16/2009. FINAL DX: none provided. Records reveal patient experienced lower abdominal pain & diarrhea 7/08.  Colonoscopy done 8/22 abnormal w/congested mucosa left colon, redundant colon & internal hemorrhoids.  Tx w/diet & meds.  RTC 1/09 w/runny nose, achy, cough, fever & head congestion.  Dx w/sinusitis & URI & tx w/antibiotics.  RTC 5/08 w/weight gain, psych meds ineffective & pharyngitis.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Left deltoid area induration 10- to 15cm with swelling and erythema, fine vesicles around the injection site. po benadryl ,  Po Motrin for pain and cephalexin for possible bacterial skin infection and  celluitis
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: patient experienced an oval rash 5/8 inch to 1 1/8 inch in diameter around injection site
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: patient experienced an oval rash 5/8 inch to 1 1/8 inch in diameter around injection site
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from an office manager that the physician heard from the physician's colleague that a 16 year old female colleague's patient was given an unspecified dose of GARDASIL (Lot not reported) on a Friday and on Monday the patient passed away (specific dates were unknown).  The reporter considered the event as disabling and life threatening.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Information was received from an investigator for a study concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. On an unspecified date on week 8 the patient experienced injection site pain and edema/swelling/induration (tox grade 3). The reporting investigator felt that injection site pain and edema/swelling/induration were definitely related to study therapy. Injection site pain and edema/swelling/induration, were considered to be an other important medical event. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer reporting that she knew some friends who had their children vaccinated with a dose of MMR II and later developed autism. Upon internal review, autism was determined to be an other important medical event. This is one of several reports from the same source. Attempts to verify the existence of identifiable patients have been unsuccessful.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a couple of her friend's children who were vaccinated with MMR II (lot# not provided) and other vaccines (unspecified) and were later diagnosed with autism. Upon internal review, autism was considered to be an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Information has been received from a 26 year old female for GARDASIL, a pregnancy registry product, concerning herself with no pertinent medical history or no allergies who in December 2007, was vaccinated with the first dose of GARDASIL. In February 2008 the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. In March 2008 she found out she was one month pregnant by doing many pregnancy test which all came out positive. The patient reported that all the sonograms that she had during the pregnancy were normal, and at the time of delivery the babies head was turned in the cervix and the umbilical cord was caught so the patient had a c-section. The patient was at hospital for three days. The patient reported that the baby was delivered on 26-DEC-2008 and the baby was healthy. On 10-APR-2009 the patient was vaccinated with the third dose of GARDASIL. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Similar reaction on previous exposure to drug, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 11 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL and experienced fainting. When the patient received the second dose of GARDASIL, she experienced mild seizure. On 09-FEB-2009 the patient received the third dose of GARDASIL and again, experienced mild seizure (Lot number not provided). The reporter added that when the patient rested she improved that same day and they even called the patient a week later to check how she was doing and she recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Herpes simplex
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 22 year old female with no medical history and no drug allergies, who on 13-NOV-2007 was vaccinated with a first dose of GARDASIL. On 11-JAN-2008 the patient was vaccinated with a second dose of GARDASIL. There was no concomitant medication. Subsequently, the patient was approximately four or five weeks pregnant. The patient's last menstrual period was 24-DEC-2007 and her estimated delivery date was 29-SEP-2008. It was reported that the patient had not seen a physician but would be seeing a nurse practitioner. No laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow-up information was received from the nurse practitioner regarding the outcome of the patient. It was reported that the patient had a primary cesarean section at 37+6/7 weeks secondary to an active outbreak of HSV (herpes simplex virus). The baby weight 2785 grams and had Apgar scores of 9&10. The reporter also stated the baby was fine without any problems. There were no reported complications for the mother or baby. Upon internal review, active outbreak of HSV (herpes simplex virus) was determined to be an other important event. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Immunisation reaction
Clinical narrative: Information has been received from a physician via agency concerning a patient who was enrolled in a study. This report was part of a post-marketing surveillance program. On an unspecified date, (Eighteen week after vaccination) the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient experienced immunization/vaccine reaction (Tox grade 2 and 3). The reporting physician felt that immunization/vaccine reaction was related to PNEUMOVAX 23. Immunization/vaccine reaction was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HEP, PPV
Symptoms: Erythema
Clinical narrative: Information has been received from an investigator via agency concerning a patient who was enrolled in a study. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 and RECOMBIVAX HB (manufacturer unknown). This report was part of a post-marketing surveillance program. Subsequently the patient experienced erythema (grade 3). The reporting investigator felt that erythema (grade 3) was definitely related to PNEUMOVAX 23 and was not related to RECOMBIVAX HB (manufacturer unknown). Erythema (grade 3) was considered to be an other important medical event.
Sex: U
Vaccine: HEP, PPV
Symptoms: Immunisation reaction
Clinical narrative: Information has been received from an investigator via agency concerning a patient with HIV infection who was enrolled in a study. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (manufacturer unknown) and RECOMBIVAX HB. On an unspecified date, one week after vaccination, the patient experienced immunization/vaccine reaction. The reporting investigator felt that immunization/vaccine reaction was related to therapy with PNEUMOVAX 23 and not related to therapy with RECOMBIVAX HB. Immunization/vaccine reaction was considered to be an other important medical event.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Cerebral infarction, Computerised tomogram abnormal, Death, Haemorrhage intracranial, International normalised ratio fluctuation
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Rectal haemorrhage, Unresponsive to stimuli
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin decreased, Blood bilirubin normal, Blood product transfusion
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Brain herniation, Brain mass, Computerised tomogram abnormal, Death, Haematocrit decreased
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Haemoglobin decreased, Haemorrhagic infarction, International normalised ratio increased, Platelet count normal, Rectal haemorrhage
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Computerised tomogram abnormal, Computerised tomogram head, Death, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Haemorrhagic cerebral infarction, Heart rate normal, International normalised ratio increased, Platelet count normal, Rectal haemorrhage
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Respiratory rate, Unresponsive to stimuli
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Cerebral infarction, Computerised tomogram abnormal, Death, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLU3
Symptoms: Haemorrhagic infarction, International normalised ratio increased, Platelet count normal, Rectal haemorrhage, Unresponsive to stimuli
Clinical narrative: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
Sex: U
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from an investigator via agency concerning a child patient with HIV infection who was enrolled in a study who was vaccinated with a dose of PNEUMOVAX 23 (Lot not reported). This report was part of a post-marketing surveillance program. Subsequently, the patient experienced erythema. The reporting investigator felt that erythema was definitively related to PNEUMOVAX 23. Erythema was considered to be an other important medical event. No further information is available.
Sex: U
Vaccine: MMR, PPV
Symptoms: Induration, Oedema, Pyrexia, Swelling
Clinical narrative: Information has been received from an investigator via agency concerning a patient who was enrolled in a study. On an unspecified date, the patient was vaccinated with MMR II and PNEUMOVAX 23 vaccine. This report was part of a post-marketing surveillance program. Subsequently the patient experienced edema/swelling/induration and fever. The patient outcomes were not provided. The reporting investigator felt that the patient's fever was possibly related to the MMR II and the PNEUMOVAX 23 vaccine. The investigator considered the edema, swelling and induration to be definitely related to the PNEUMOVAX 23 and not related to the MMR II vaccine. Edema/swelling/induration and fever were considered to be other important medical events. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Skin induration
Clinical narrative: Information has been received from the agency concerning a patient who entered a study and was vaccinated iwth a dose of PNEUMOVAX 23. This report was part of a post-marketing surveillance program. The patient experienced erythema (study week 1) and skin induration (study week 8). The reporting investigator felt that skin induration and erythema were definitely related to study therapy. Skin induration and erythema were considered to be an other important medical event. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Induration, Oedema, Swelling
Clinical narrative: Information has been received from an investigator concerning a patient who on an unspecified date was enrolled in a study. This report was part of a post-marketing surveillance program. It was reported that 8 weeks post vaccination the patient experienced edema/swelling/induration/due. The reporting investigator felt that edema/swelling/induration/due were definitely related to study therapy. Edema/swelling/induration/due were considered to be other important medical events. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from an investigator concerning a patient who was enrolled in a study. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). On an unknown date, the patient experienced erythema. The patient's outcome was unknown. The reporting investigator felt that erythema was related to study therapy. Erythema was considered to be an other important medical event. This report was part of a post-marketing surveillance program. No further information is available.
Age: 78.0
Sex: M
Vaccine: TTOX
Symptoms: Anorexia, Blood test, Computerised tomogram, Drooling, Dysarthria
Clinical narrative: Drooling, very slurred speech, loss of appetite. Vaccine was given 7 weeks ago, week by week condition deteriorated, no diagnosis made.  7/7/09 Hospital records received DOS 3/25/09 to 4/4/09. Assessment: Delirium Encephalopathy with possible association with gouty arthritis. Patient presented with mental status changes, confusion, hallucinations, delirium. Poor appetite, weight loss. Broad based gait.  ICD-9 Codes: 599.0, 348.30, 784.3, 293.0, 263.9, 414.01, 403.90, 427.31, 332.0, 9V5861, 331.82, 294.10, 296.80, 600.00, 553.3, 412, 585.9, 530.81, 780.9, 296.40, 790.6, V5869, 294.10
Age: 78.0
Sex: M
Vaccine: TTOX
Symptoms: Electroencephalogram, General physical health deterioration, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Drooling, very slurred speech, loss of appetite. Vaccine was given 7 weeks ago, week by week condition deteriorated, no diagnosis made.  7/7/09 Hospital records received DOS 3/25/09 to 4/4/09. Assessment: Delirium Encephalopathy with possible association with gouty arthritis. Patient presented with mental status changes, confusion, hallucinations, delirium. Poor appetite, weight loss. Broad based gait.  ICD-9 Codes: 599.0, 348.30, 784.3, 293.0, 263.9, 414.01, 403.90, 427.31, 332.0, 9V5861, 331.82, 294.10, 296.80, 600.00, 553.3, 412, 585.9, 530.81, 780.9, 296.40, 790.6, V5869, 294.10
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Papular rash, left groin area, about 21 papules with deep red flat areas around papules alternate burning and itching. I noticed rash on 4/6/09 - 3 days later, I noted 8 papules on left flank and 2 mid-back. No treatment - experienced pruritis and erythema at all sites and mild URT sign and symptom.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Upper respiratory tract infection
Clinical narrative: Papular rash, left groin area, about 21 papules with deep red flat areas around papules alternate burning and itching. I noticed rash on 4/6/09 - 3 days later, I noted 8 papules on left flank and 2 mid-back. No treatment - experienced pruritis and erythema at all sites and mild URT sign and symptom.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt woke up this am with redness to inj. site, warm to touch and states that area is tender.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt noticed itching to right arm 2d after injection came home from school and mom noticed redness and swelling to right arm. TYLENOL, cold compresses and rest.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Varicella
Clinical narrative: Pt here in clinic today with chicken pox - 3/23/09 1st vaccine 7/3/8 2nd vaccine 2/24/9.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt's mom states that pt c/o pain with some swelling @ injection site. Mom states following day worse, w/ redness, swelling and tender to touch. Still w/ redness and swelling today and not better.
Age: 13.0
Sex: F
Vaccine: IPV, MMR, MNQ, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Client state "notice bumps on body and itchy" on 4/14/09. Seen by ER physician and prescribed BENADRYL by mouth. Client came to clinic today 4/20/2009 to report bumps previously on body from 4/14/09. States feeling better today.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash
Clinical narrative: PNEUMOVAX given on 4/1/09 - had pain that day. Rash developed on 4/2/09 - Seen in our office 4/3/09 txd with MEDROL dose pack (5 day tx) and BENADRYL - Per Pt symptoms  totally resolved by 4/5/09.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site swelling
Clinical narrative: As per mom Pt swollen to Lt thigh.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient developed pain/tenderness to the injected area 8 hrs after the vaccination.  The following day developed redness, swelling & nausea symptoms symptoms have resolved.