chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on 18-SEP-2007 was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil vaccine (lot# not reported). On approximately 20-NOV-2007, the patient was vaccinated intramuscularly (site not reported) with the 2nd 0.5mL dose of Gardasil vaccine (lot# 657617/0384U). The nurse reported that after the patient received the 2nd dose she developed soreness a the the injection site. The area was hot to the touch, warm, red and twice the size of her regular arm. It was not reported if the patient sought medical attention. At the time of this report the patient was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Initial and follow up information has been received from a registered nurse (RN) concerning a 24 year old female with no known drug allergies, who on 18-SEP-2007 was vaccinated IM (site not reported) with the first dose 0.5ml. of GARDASIL vaccine (lot # not reported), and on 20-NOV-2007 vaccinated IM in the left deltoid with the second dose 0.5ml. of GARDASIL vaccine (lot# 657617/0384U). There was no illness at the time of vaccination. On 29-NOV-2007, the RN reported that the patient called the office to report that on 20-NOV-2007, after she received the second dose, she developed a "severe local reaction," described as soreness at the injection site, with the area feeling hot to touch, red, and swollen to twice the size of her regular arm. The patient did not required a visit to the physician's office. At the time of this report the patient had recovered (duration and date not provided), though she was considering not completing the vaccination series. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner, concerning an unspecified number of patients who were vaccinated IM with a dose, 0.5 mL, of Gardasil vaccine (lot #657621/0387U or 657736/0389U) (dates not provided), and experienced "stinging" when vaccinated. At the time of this report the outcome of the event was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Initail and follow-up information has been received froma nurse practitioner, concerning "several" female patients who were vaccinated IM with a dose, 0.5 ml of HPV vaccine (lot # 657621/0387U or 657716/0389U) (dates not provided), and experienced "stinging" when vaccinated. At the time of this report the outcome of the event was unknown. This is one of several reports received from the same source. Addiitonal information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female (age and gender unknown), who, on unspecified dates, was vaccinated with a first and second dose of GARDASIL. Subsequently within twelve hours of receiving both doses the patient fainted. The patient was referred to a cardiologist. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Throat irritation
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female with no medical history and no drug allergies, who on 27-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL. Concomitant therapy included a second dose of HAVARIX. On 27-NOV-2007, within 5-10 minutes of leaving the office, the patient stated that her throat was "on fire" and raw feeling. The patient had a cold drink and the feeling lasted for 1.5 hours and then subsided. The patient contacted the office by phone. No laboratory diagnostics were performed. The patient recovered on 27-NOV-2007. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on approximately 29-MAY-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine. There was no adverse events reported. On an unspecified date the patient was vaccinated with a second dose of Gardasil vaccine. Subsequently, one day after vaccination the patient experienced flu-like symptoms including fever and nausea. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. 02/12/2010 The patient was vaccinated with a third dose of GARDASIL on an unspecified date. It was reported that the patient did not experience any symptoms after the first and third vaccinations. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Stomach discomfort, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 25 year old female with a history of cervical cancer who in October 2007, was vaccinated intramuscularly with a first dose of GARDASIL. Eleven hours later she "got sick to her stomach and could not hold anything down for about 24-30 hours". The patient was planning on receiving the next dose of GARDASIL. There were no laboratory or diagnostic tests performed. The patient did not seek medical attention. Subsequently, the patient recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syringe issue, Underdose
Clinical narrative: Information has been received from a medical assistant, concerning her 13 year old daughter, who on 26-NOV-2007 was vaccinated IM with the second dose of Gardasil vaccine (lot # not reported). On 26-NOV-2007, while being vaccinated, the needle broke in her daughter's arm and less than a full dose was administered (details not provided). The MA's daughter sought unspecified medical attention. Additional information has been requested. Initial and follow-up information has been received from a medical assistant and a physician, concerning the physician's 13 year old daughter, a student, who on 26-NOV-2007 was vaccinated IM with the second dose of HPV vaccine (lot # not reported). On 26-NOV-2007, while being vaccinated, the needle broke in her daughter's arm, and less than a full dose was administered (details not provided). Follow-up informatiom form the physician indicated that it was not certain if any of dose was actually administered on 26-NOV-2007. On 10-NOV-2007, a full second dose was administered with no complications reported. Additional follow-up information received from a licensed practical nurse indicated that the needle did not break when the vaccine was being administered, but rather separated from the syringe when the vaccine was pushed through. The vaccine sprayed out into the room. The physician's daughter sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: Information has been received from a consumer who was vaccinated with her second dose of GARDASIL and experienced a "white ring" at the injection site. Consumer reported that she is not sure if she should get the third dose. Consumer did not provide additional information. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Concomitant therapy included MENACTRA. The physician heard that the patient fainted after receiving GARDASIL. The physician does not wish to be contacted. The patient sought unspecified medical attention.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Musculoskeletal discomfort
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first and third dose of Gardasil vaccine in the upper arm deltoid area. The patient's second dose of Gardasil vaccine was administered in the buttocks and the patient has been experiencing hip problems. Physician reported that they have no update on the patient's status because the patient is currently away at law school. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a 17 year old female patient who on an unspecified date was vaccinated at school, with a dose of GARDASIL (lot # not provided). Concomitant therapy included "a number of other vaccines" (therapy unspecified) on the same day. The nurse reported that the patient had "a significant fainting episode" (details not provided). After an unknown duration of time, the patient regained consciousness. At the time of this report, the outcome of events was unknown. This is one of two reports received from the same source (0711USA04213). The patient sought unspecified medical attention. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash, Skin irritation
Clinical narrative: Information has been received from a medical assistant concerning a 21 year old female patient with no medical history and no known drug reactions or allergies who on 20-NOV-2007 was vaccinated in the right arm with the first dose of GARDASIL (Lot # 658563/1063U). There was no concomitant medication. The reporter indicated that on 24-NOV-2007, the patient developed an irritation from her bra line to her neck and from shoulder to shoulder after her first dose of the vaccine. She was unable to describe what kind of irritation the patient had. On 27-NOV-2007, the irritation became red and raised. On 28-NOV-2007, the area of irritation spread to her right arm and left breast. No treatment was prescribed. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow up information was received from the doctor on 29-JAN-2008 indicating the muscle pain was not at the injection site and was unrelated. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Fear of needles, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a female "between 11 and 13 years old" who on an unspecified date was vaccinated with the "first dose" of Gardasil vaccine. Suspect vaccination included Menactra and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The medical assistant reported that after the patient was vaccinated with all the vaccines, the patient fainted. It was also reported that the patient "was afraid of needles." It was reported that the adverse effect "improved on therapy." There was no product quality complaint involved. No further information is available.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Activated partial thromboplastin time normal, Contusion, Erythema nodosum, Full blood count normal, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 24-SEP-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast). The patient developed erythema nodosum on her legs which lasted for over one month. On 23-Nov-2007, the patient received her second dose of GARDASIL vaccine (yeast). Subsequently the patient experienced erythema nodosum on her legs again. The patient received the influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE USP) on 22-Oct-2007. The patient sought unspecified medical treatment in the office. No treatment required for either AE. The patient's erythema nodosum persisted. Additional information has been requested. Information has been received from a physician concerning a 17 year old female who on 24-SEP-2007 was vaccinated with her first dose of HPV vaccine. The patient developed erythema nodosum on her legs which lasted for over one month. On 23-Nov-2007, the patient received her second dose of HPV vaccine (lot # 658560/1062U) IM in the left deltoid. Subsequemtly the patient experienced erythema nodosum on her legs again. The patient received the influenza virus vaccine (unspecified) on 22-Oct-2007. The patient sought unspecified medical treatment in the office. No treatment required for eith AE. The patient's erythema nodisum persisted. Follow-up information was received from the physician. Illness at the time of vaccination was erythema nodosum. "Bruises" on lower legs with erythema nodosum on the exam. The patient reported getting lesions in October 2007, one month post first HPV vaccine dose. The patient was seen in November 2007 and was given a second dose of HPV vaccine. The patient reported worsening/increase in lesions after the second dose. A complete blood cell count prothrombin time and activated partial thromboplastin was performed and were normal. On an unspecified date the patient recovered as per telephone conversation 19-DEC-2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Diarrhoea, Loss of consciousness, Vomiting
Clinical narrative: Information has been received from a company representative about a physician's daughter who was vaccinated with her second dose of GARDASIL and experienced severe vomiting, diarrhea, dehydration and passed out in an emergency room four days after receiving the vaccine. Subsequently, the patient recovered at an unspecified time. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse, concerning "other patients" (gender and ages not reported), who were vaccinated with a dose of GARDASIL (dates and lot # not reported). After the vaccination, the patients became dizzy. The nurse added this appears to happen when the patient's who have not eaten breakfast are vaccinated in the morning. SHe added that they now ask the patients if they have eaten breakfast and "pay close attention" when they're being vaccinated, to observe for dizziness. At the time of this report, the outcome of the event was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received anonymously concerning a female who was vaccinated with GARDASIL. Subsequently the patient experienced an adverse event. Caller disconnected before any further information could be obtained. The patient sought unspecified medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Face injury, Fall, Laceration, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female, who on 15-OCT-2007 was vaccinated in the arm with a dose of Gardasil. Concomitant vaccinations included MENACTRA and Dtap, administered in the other arm. On 15-OCT-2007, as the medical assistant was pulling the needle out of the patient's arm, the patient fainted. the patient was on top of the exam table and she fell forward onto the medical assistant and then hit her face on the floor. The patient got cut right below her chin. The patient went to the hospital to get stitches. It was reported that the patient was out for 30 seconds. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 04-MAY-2007 was vaccinated with her first dose of Gardasil. On an unspecified date, the patient was vaccinated with her second dose of Gardasil. On 27-NOV-2007, the patient was vaccinated with her third dose of Gardasil (Lot # 659435/1265U). On 28-NOV-2007 the patient experienced flu-like symptoms, a headache, fatigue and arm pain. Patient outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Attention deficit/hyperactivity disorder, Rash papular, Rash pruritic, Sickle cell anaemia
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with a history of attention deficit disorder and sickle cell disease who in September 2007, was vaccinated with her first dose of Gardasil. Concomitant therapy included STRATTERA and FLUVIRIN(unspecified). On 27-NOV-2007 the patient was vaccinated intramuscularly with her second dose of Gardasil. A few hours post dose two, the patient experienced many, small, slightly raised, itchy bumps on both arms. Subsequently, the patient recovered from many, small, slightly raised, itchy bumps on both arms after she was given 50mg of over the counter BENADRYL. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a health professional concerning a black 15 year old female with a history of attention deficit disorder and sickle cell disease who in September 2007, was vaccinated with her dose of GARDASIL. Concomitant therapy included STRATTERA. On 27-NOV-2007 the patient was vaccinated intramuscularly in the left deltoid with her second dose of GARDASIL (lot# 98219/0680U). Concomitant therapy included FLUVIRIN intramuscularly in the right deltoid (lot# 80432). A few hours post dose two, the patient experienced many, small, slightly raised, itchy bumps on both arms. Subsequently, the patient recovered from many, small, slightly raised, itchy bumps on both arms after she was given 50 mg of over the counter BENADRYL.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician assistant concerning a female patient who on 26-NOV-2007, was vaccinated IM with a second dose of Gardasil. That evening, the patient developed a skin rash. On 28-NOV-2007, the patient went back to the physician's office for a follow up visit. At the time of this report, the patient's outcome was unknown. It was reported that the Gardasil was given a week after the flu vaccine. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pyrexia, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female patient with no medical history and a penicillin allergy and a sulfonamide allergy who on 30-JUL-2007, was vaccinated IM into the left deltoid with a prefilled syringe of Gardasil (Lot# 658282/0929U). Concomitant therapy included PROZAC and LOESTRIN 24 FE. Subsequently, the patient experienced dizziness after the first dose> on 19-SEP-2007, the patient received a second dose of Gardasil (Lot# 654539/0742U). Fifteen minutes later after leaving the office, the patient broke out in hives and a fever. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. It was reported that the third dose of the vaccine will not be given. No product quality complaint was involved. Additional information has been requested. Information has been received from a medical assistant concerning an 18 year old female patient with no medical history and a penicillin allergy and a sulfonamide allergy who on 30-JUL-2007 in the "PM", was vaccinated IM into the left deltoid with a prefille dsyringe of HPV vaccine (Lot# 658282/0929U). Subsequently, the patient experienced dizziness after the first dose. On 19-SEP-2007 in the "PM" the patient was vaccinated IM into the left deltoid with a second hose of HPV vaccine (lot # 65439/0742U). Fifteen minutes later, after leaving the office, the patient broke out in hives and a fever. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On 29-NOV-2007, at an office visit, the patient recovered. It was reported that the third dose of the vaccine will not be given. No product quality complaint was involved.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Blood immunoglobulin G, Blood immunoglobulin M, Blood test, Pyrexia
Clinical narrative: Information has bee received from a consumer concerning her 17 year old daughter with no medical history and an allergy to sulfa, who on 28-SEP-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and homeopathic medications (unspecified). Prior to being vaccinated with Gardasil the patient was tested for HPV and genital warts and all her test came back negative. On 15-OCT-2007 (also reported as 19-OCT-2007) the patient experienced a fever, and broke out with white bumps that were diagnosed as genital warts. The patient was treated with an unspecified medication. Approximately one week later the patients genital warts had completely went away. The patient was seen by the physician. A blood test for HIgG and IgM were performed (no results provided). The patient recovered on an unspecified date. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician's assistant concerning a 21 year old female with no known drug or food allergies who on an unspecified date was vaccinated with a second dose of Gardasil (lot#659437/1226U). Concomitant therapy included MIRAPEX. On an unspecified date, 2 days after receiving Gardasil the patient experienced a generalized rash. Medical attention was sought. At the time of reporting it was unknown if the patient had recovered. No other information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Device leakage, Injection site pain
Clinical narrative: Information has been received from a female who on 19-NOV-2007 was vaccinated intramuscularly with the first dose of Gardasil. On 19-NOV-2007the patient experienced injection site pain and maladministration when she jerked and some of the vaccine spilled over her arm. Subsequently, the patient recovered from injection site pain and maladministration at an unspecified date. the patient sought unspecified medical treatment. Additional information has been requested. Follow up information received from the patient reported that she does not have insurance and received her vaccinations from a clinic that does not have her other medical records. No additional information  has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, TDAP, VARCEL, DTAP, HPV4, IPV, MMR, UNK, VARCEL
Symptoms: Anaphylactic reaction, Bronchospasm, Cough, Flushing, Ocular hyperaemia
Clinical narrative: Information has been received from an agency concerning a 16 year old female with chronic malaria and a possible history of spleen enlargement per an overseas physical, who on 24-JUL-2007 was vaccinated intramuscularly in the right arm with a first dose of Gardasil (Lot # 654741/1208F). Concomitant suspect vaccinations included a first dose of Varivax (Lot# 657752/0780U) administered subcutaneously and a first dose of MMR (Lot# 655280/1468F) administered subcutaneously into the right arm. Other concomitant vaccinations included a first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot# C2734AA) administered intramuscularly in the left arm, a first dose of poliovirus vaccine (Lot# Y0824) administered subcutaneously in the right arm, a first dose of hepatitis virus vaccine (unspecified) (Lot# AHBVB340AA) administered intramuscularly in the right arm, and possible malaria medication. On 24-JUL-2007, the patient developed an anaphylactic reaction within 10 minutes of receiving the vaccination as evidenced by hives, flushed skin, blood shot eyes, bronchospams, cough, and tightness in the throat. Emergency room protocols were initiated per health department policy as well as doctor and immunization supervisors were notified. At 11:30 the patient was treated with 8ml of BENADRYL. At 11:35 8L of Oxygen per nasal cannula was initiated. At 11:45 the patient was treated with .4mL of Epi given by the registered nurse. The patient was discharged to the hospital in good condition for further followup. The patient's vital signs were monitored throughout. At the time of the report, the patient's outcome was unknown. The VAERS ID was 285964-1. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, TDAP, VARCEL, DTAP, HPV4, IPV, MMR, UNK, VARCEL
Symptoms: Throat tightness, Urticaria
Clinical narrative: Information has been received from an agency concerning a 16 year old female with chronic malaria and a possible history of spleen enlargement per an overseas physical, who on 24-JUL-2007 was vaccinated intramuscularly in the right arm with a first dose of Gardasil (Lot # 654741/1208F). Concomitant suspect vaccinations included a first dose of Varivax (Lot# 657752/0780U) administered subcutaneously and a first dose of MMR (Lot# 655280/1468F) administered subcutaneously into the right arm. Other concomitant vaccinations included a first dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot# C2734AA) administered intramuscularly in the left arm, a first dose of poliovirus vaccine (Lot# Y0824) administered subcutaneously in the right arm, a first dose of hepatitis virus vaccine (unspecified) (Lot# AHBVB340AA) administered intramuscularly in the right arm, and possible malaria medication. On 24-JUL-2007, the patient developed an anaphylactic reaction within 10 minutes of receiving the vaccination as evidenced by hives, flushed skin, blood shot eyes, bronchospams, cough, and tightness in the throat. Emergency room protocols were initiated per health department policy as well as doctor and immunization supervisors were notified. At 11:30 the patient was treated with 8ml of BENADRYL. At 11:35 8L of Oxygen per nasal cannula was initiated. At 11:45 the patient was treated with .4mL of Epi given by the registered nurse. The patient was discharged to the hospital in good condition for further followup. The patient's vital signs were monitored throughout. At the time of the report, the patient's outcome was unknown. The VAERS ID was 285964-1. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL, FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ataxia, Convulsion, Headache
Clinical narrative: Initial report received on 10 December 2007 from another manufacturer, report# WAES 0712USA01240, The initial reporter to this manufacturer had been the FDA. Verbatim from the report: "Information has been received from the FDA through the Freedom of Information Act concerning a 11 year old female with no medical history or pre-existing illnesses who on 19-OCT-2007 was vaccinated in the left arm (route not reported) with the 1st dose of Gardasil (lot# 65503/0012U). The patient was concomitantly vaccination with Varivax (lot# 656691/0127U) in the left arm, influenza virus vaccine (unspecified) (lot# U2435AA) in the left arm, BOOSTRIX (lot#AC52B013AA) in the left arm and MENACTRA (lot# U2208AA) in the left arm. On 27-OCT-2007, approximately 2 weeks after vaccine administration, the patient developed ataxia, headache and seizures requiring antiepileptics, steroids and antibiotics. The patient was hospitalized. It is unknown if patient recovered." The VAERS ID number is 295526. No additional information is expected.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal faeces, Acidosis, Choking, Cyanosis, Diarrhoea
Clinical narrative: 2 1/2 mo. old male with mild reflux had episode of (11/14) choking (not breathing) requiring stimulation. Admitted and vomited and had diarrhea with mild dehydration. Rotavirus +. Given IVF's. UGI test negative. Blood Cx -. Rotavirus vaccine given 6 days ago.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dry skin, Full blood count, Liver function test, Metabolic function test abnormal, Pyrexia
Clinical narrative: 2 1/2 mo. old male with mild reflux had episode of (11/14) choking (not breathing) requiring stimulation. Admitted and vomited and had diarrhea with mild dehydration. Rotavirus +. Given IVF's. UGI test negative. Blood Cx -. Rotavirus vaccine given 6 days ago.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: 2 1/2 mo. old male with mild reflux had episode of (11/14) choking (not breathing) requiring stimulation. Admitted and vomited and had diarrhea with mild dehydration. Rotavirus +. Given IVF's. UGI test negative. Blood Cx -. Rotavirus vaccine given 6 days ago.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, Choking, Dehydration, Diarrhoea, Full blood count
Clinical narrative: 2 1/2 mo. old male with mild reflux had episode of (11/14) choking (not breathing) requiring stimulation. Admitted and vomited and had diarrhea with mild dehydration. Rotavirus +. Given IVF's. UGI test negative. Blood Cx -. Rotavirus vaccine given 6 days ago.
Age: 0.2
Sex: M
Vaccine: DTAP, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test, Respiratory arrest, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: 2 1/2 mo. old male with mild reflux had episode of (11/14) choking (not breathing) requiring stimulation. Admitted and vomited and had diarrhea with mild dehydration. Rotavirus +. Given IVF's. UGI test negative. Blood Cx -. Rotavirus vaccine given 6 days ago.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Herpes zoster, Oral disorder, Otorrhoea, Rash
Clinical narrative: Information has been received from a physician concerning an 87 year old male who on 16-NOV-2007 was vaccinated in the left arm with a dose of Zostavax (lot number: 658084/0888U). On 23-NOV-2007 the patient developed shingles on the left side of his face from ear to the side of his face to his mouth and improvement was noted as of 28-NOV-2007. The physician reported that the patient experienced a stroke and passed away. No further information provided. There was no product quality complaint. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Swelling face, Tympanic membrane perforation
Clinical narrative: Information has been received from a physician concerning an 87 year old male who on 16-NOV-2007 was vaccinated in the left arm with a dose of Zostavax (lot number: 658084/0888U). On 23-NOV-2007 the patient developed shingles on the left side of his face from ear to the side of his face to his mouth and improvement was noted as of 28-NOV-2007. The physician reported that the patient experienced a stroke and passed away. No further information provided. There was no product quality complaint. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Death, Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 87 year old male who on 16-NOV-2007 was vaccinated in the left arm with a dose of Zostavax (lot number: 658084/0888U). On 23-NOV-2007 the patient developed shingles on the left side of his face from ear to the side of his face to his mouth and improvement was noted as of 28-NOV-2007. The physician reported that the patient experienced a stroke and passed away. No further information provided. There was no product quality complaint. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Culture stool negative, Decreased appetite, Diarrhoea, Faeces discoloured, Haematochezia
Clinical narrative: Diarrhea began approximately 36 hours after 2nd Rotateq dose. (6 watery Bms per day) Blood streaked stool in Four bowel movements.  No vomiting.  Decreased appetite. Exam normal, questionable anal fissure. Green stool in office with maroon colored blood streaking, heme test positive. Treatment consisted of continuing breast feeding and giving pedialyte after diarrheal stools.  Infant was improved within 5 days.  Rotateq #3 dose was subsequently not administered.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Occult blood positive
Clinical narrative: Diarrhea began approximately 36 hours after 2nd Rotateq dose. (6 watery Bms per day) Blood streaked stool in Four bowel movements.  No vomiting.  Decreased appetite. Exam normal, questionable anal fissure. Green stool in office with maroon colored blood streaking, heme test positive. Treatment consisted of continuing breast feeding and giving pedialyte after diarrheal stools.  Infant was improved within 5 days.  Rotateq #3 dose was subsequently not administered.
Age: 44.0
Sex: M
Vaccine: HEP, SMALL
Symptoms: Skin lesion
Clinical narrative: Several Sores on scalp
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Injection site erythema, Injection site induration, Pruritus, Skin warm
Clinical narrative: Pt vaccinated on 12/14/07, reported itching begining 12/18/07 with the formation of a 3/4" x 3" hard red area at the site of injection. Daughter, who is an RN, says it is not a cellulitis, but is just a dry area with no flaking or scaling and a little warm to the touch.
Age: 31.0
Sex: F
Vaccine: FLU3, MMR, MNQ, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Adm vaccine on 12/06/2007 and client inform us of pregnancy 12/14/2007
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Pain, Skin warm
Clinical narrative: Swollen left arm with stiffness, pain, and very high temperature in the arm. Treated with Medrol 4 MG Pak 21 Tab and Cephalexin 500mg, one capsule by mouth 3x daily for 7 days. Treatment began on 11-15-06, arm was better by 11-17-07. Completed med regimen as prescribed.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site streaking, Injection site swelling
Clinical narrative: Swelling at the site of administration that lasted approximately 1 week.  A red streak appeared on my arm, approx. 2" long,the day after I received my shot and remained about 1 week.
Sex: M
Vaccine: HEPA, IPV, TD
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: CALLED STATED HAS RASH ON ARMS FACE AND TRUNK OF BODY POSSIBLE HIVES STATES THAT IT ITCHES STARTED 12/16/07, CALL RECIEVED FROM CLT 12/19/07 RECOMMENDED THAT HE CALL PRIVAT MD AND BE SEEN TODAY FOR POSSIBLE IMMUNIZATION REACTION, TAKE IMMUNIZATION RECORD WITH HIM TO DR OFFICE.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Patient developed Bell's Palsy 4 days after receiving Sanofi Pasteur Influenza vaccine.  01/16/2008 MR received for DOS 12/18-19/2008 with DX: Left Bell Palsy.  Pt presented to ER with c/o L sided facial weakness since that morning.  Numbness of the tongue x 2 days.  PE (+) L Cranial Nerve VII impairment, otherwise WNL. Tx with Valtrex and prednisone and D/C.
Age: 1.0
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Induration, Skin nodule
Clinical narrative: L nodule on ant. lat thigh 2cm in lenght and 1 1/2 cm in width. the nodule is firm.
Age: 3.0
Sex: F
Vaccine: DTAP, FLUN3, HEPA
Symptoms: Unevaluable event
Clinical narrative: Guardian states that no adverse reactions occurred after vaccine was given.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Ataxia, Blood test abnormal, Encephalitis
Clinical narrative: Dysdiadochokinesia. C/O headache and pain in idiopathic autoimmune cerebellitis; symptoms of ataxia began on 11/27 getting progressively worse until admitted to facility on 11/30.  Inpatient care including high dose steroids 12/4-12/7 with discharge 12/7 - baseline balance obtained.  Follow up care includes pediatrician, blood work, and PT. 3/3/08-records received-for DOS 11/31-12/7/07-DC DX: likely idiopathic autoimmune cerebritis. Presented with 3 days of clumsiness and stumbling, wobbly gait and intermittent fevers to a max of 101, 3 episodes of emesis after car rides. Decreased p.o. intact. In ED had bilateral dysmetria, positive Romberg sign broad based ataxia. Dysdiadochokinesia. C/O headache and pain in legs.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood test normal, Chest X-ray normal, Joint stiffness, Joint swelling
Clinical narrative: Initial report received on 22 October 2007 from a health care professional. A 62-year-old female patient, with a history of cirrhosis of the liver, had received a left deltoid, intramuscular infection of Fluzone SV 2007-2008, lot number U2500AA, on 11 October 2007. One to two days post-vaccination, the patient experienced joint pain and entire body pain. She was examined in an emergency room on 15 October 2007 and was treated with prednisone and morphine and discharged with a prescription for OxyContin. The patient returned to the emergency room on 22 October 2007 and was complaining of generalized pain throughout her body to the point of having difficulty moving. she was again treated with morphine. Diagnostic testing included a full blood profile, chest x-ray and sedimentation rate. Results of the testing were not provided. At the time of this report, the patient had not recovered. Follow-up information was received on 10 December 2007 from a health care professional. Based upon the new information provided in this follow-up, this case has been upgraded to serious. It was reported that the patient experienced joint pain and "wheezing" the same day she received Fluzone SV 2007-2008. She was treated in the emergency room. A chest x-ray was negative. The patient had no fever at the time of examination, but did complain of diffuse joint pain. Laboratory work done in the emergency room was negative. The patient was started on a Medrol dose pack (methylprednisolone) was given oxycodone. She was seen for a follow-up visit on 19 October 2007 and was "feeling back to normal" at that time. On 26 October 2007, the patient was seen in the physician's office with complaints of a stiff neck, shoulder, and wrist (right). She was in mild discomfort, but no distress. There was no lymphadenopathy. Range of motion was limited secondary to pain from the base of the skull radiating down the trapezius and bilateral shoulder. There was no bruising or apparent swelling. The patient was diagnosed with polyarthralgia, myalgia and cervical spasm with no meningeal sign. She was prescribed Flexeril and Vicoprofen for pain. The patient was seen by the physician again on 29 October 2007 for follow-up. At that time it was reported that the patient had been diagnosed with polymyalgia rheumatica and per the reporter, the polymyalgic rheumatica was "perhaps related to Flu shot but it would seem unlikely based on the temporal relation of onset (i.e. less than 24 hours)". The patient's medications at the time of examination included Nexium, Albuterol inhaler, prednisone, and Caltrate. Upon examination, it was noted that the patient had mild swelling and pain with range of motion of large and medium joints. The treatment plan included continuing with current management and follow-up with a rheumatologist. It was reported by the physician that the patient recovered from her symptoms on an unspecified date.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle spasms, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Initial report received on 22 October 2007 from a health care professional. A 62-year-old female patient, with a history of cirrhosis of the liver, had received a left deltoid, intramuscular infection of Fluzone SV 2007-2008, lot number U2500AA, on 11 October 2007. One to two days post-vaccination, the patient experienced joint pain and entire body pain. She was examined in an emergency room on 15 October 2007 and was treated with prednisone and morphine and discharged with a prescription for OxyContin. The patient returned to the emergency room on 22 October 2007 and was complaining of generalized pain throughout her body to the point of having difficulty moving. she was again treated with morphine. Diagnostic testing included a full blood profile, chest x-ray and sedimentation rate. Results of the testing were not provided. At the time of this report, the patient had not recovered. Follow-up information was received on 10 December 2007 from a health care professional. Based upon the new information provided in this follow-up, this case has been upgraded to serious. It was reported that the patient experienced joint pain and "wheezing" the same day she received Fluzone SV 2007-2008. She was treated in the emergency room. A chest x-ray was negative. The patient had no fever at the time of examination, but did complain of diffuse joint pain. Laboratory work done in the emergency room was negative. The patient was started on a Medrol dose pack (methylprednisolone) was given oxycodone. She was seen for a follow-up visit on 19 October 2007 and was "feeling back to normal" at that time. On 26 October 2007, the patient was seen in the physician's office with complaints of a stiff neck, shoulder, and wrist (right). She was in mild discomfort, but no distress. There was no lymphadenopathy. Range of motion was limited secondary to pain from the base of the skull radiating down the trapezius and bilateral shoulder. There was no bruising or apparent swelling. The patient was diagnosed with polyarthralgia, myalgia and cervical spasm with no meningeal sign. She was prescribed Flexeril and Vicoprofen for pain. The patient was seen by the physician again on 29 October 2007 for follow-up. At that time it was reported that the patient had been diagnosed with polymyalgia rheumatica and per the reporter, the polymyalgic rheumatica was "perhaps related to Flu shot but it would seem unlikely based on the temporal relation of onset (i.e. less than 24 hours)". The patient's medications at the time of examination included Nexium, Albuterol inhaler, prednisone, and Caltrate. Upon examination, it was noted that the patient had mild swelling and pain with range of motion of large and medium joints. The treatment plan included continuing with current management and follow-up with a rheumatologist. It was reported by the physician that the patient recovered from her symptoms on an unspecified date.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate normal, Wheezing
Clinical narrative: Initial report received on 22 October 2007 from a health care professional. A 62-year-old female patient, with a history of cirrhosis of the liver, had received a left deltoid, intramuscular infection of Fluzone SV 2007-2008, lot number U2500AA, on 11 October 2007. One to two days post-vaccination, the patient experienced joint pain and entire body pain. She was examined in an emergency room on 15 October 2007 and was treated with prednisone and morphine and discharged with a prescription for OxyContin. The patient returned to the emergency room on 22 October 2007 and was complaining of generalized pain throughout her body to the point of having difficulty moving. she was again treated with morphine. Diagnostic testing included a full blood profile, chest x-ray and sedimentation rate. Results of the testing were not provided. At the time of this report, the patient had not recovered. Follow-up information was received on 10 December 2007 from a health care professional. Based upon the new information provided in this follow-up, this case has been upgraded to serious. It was reported that the patient experienced joint pain and "wheezing" the same day she received Fluzone SV 2007-2008. She was treated in the emergency room. A chest x-ray was negative. The patient had no fever at the time of examination, but did complain of diffuse joint pain. Laboratory work done in the emergency room was negative. The patient was started on a Medrol dose pack (methylprednisolone) was given oxycodone. She was seen for a follow-up visit on 19 October 2007 and was "feeling back to normal" at that time. On 26 October 2007, the patient was seen in the physician's office with complaints of a stiff neck, shoulder, and wrist (right). She was in mild discomfort, but no distress. There was no lymphadenopathy. Range of motion was limited secondary to pain from the base of the skull radiating down the trapezius and bilateral shoulder. There was no bruising or apparent swelling. The patient was diagnosed with polyarthralgia, myalgia and cervical spasm with no meningeal sign. She was prescribed Flexeril and Vicoprofen for pain. The patient was seen by the physician again on 29 October 2007 for follow-up. At that time it was reported that the patient had been diagnosed with polymyalgia rheumatica and per the reporter, the polymyalgic rheumatica was "perhaps related to Flu shot but it would seem unlikely based on the temporal relation of onset (i.e. less than 24 hours)". The patient's medications at the time of examination included Nexium, Albuterol inhaler, prednisone, and Caltrate. Upon examination, it was noted that the patient had mild swelling and pain with range of motion of large and medium joints. The treatment plan included continuing with current management and follow-up with a rheumatologist. It was reported by the physician that the patient recovered from her symptoms on an unspecified date.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Anorexia, Back pain, Dizziness, Muscular weakness, Sensation of heaviness
Clinical narrative: Initial report received on 06 December 2007 from a health care professional. A 50-year-old female patient, with no illness at the time of vaccination, had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, and route and site of administration not reported, on 29 October 2007. Seven hours post-vaccination, the patient experienced heaviness in her arms, weakness in her legs, a backache in the lumbar and dorsal spines, a loss of appetite, and dizziness. She was examined in a physician's office, and physical therapy was ordered. Relevant diagnostic testing was unknown, and past medical history was not provided. At the time of this report, the patient had not recovered.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning an approximately 8 month old female with no pertinent medical history who on 19-JUN-2007 was vaccinated PO with a 2.0 ml dose of Rotateq. On 20-JUN-2007 the next day, the patient experienced blood spots in her diaper. On approximately 20-NOV-2007 the patient also experienced watery stools (about 10 to 15 of them) for 6 to 7 weeks." It was unknown whether medical attention was sought. In June 2007, a stool specimen was performed and confirmed it was rotavirus. There was no product quality complaint. Upon internal review blood spots were determined to be an other important medical event. Additional information has been requested.