chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a 0.5mL dose of Gardasil. Subsequently, the patient fainted about 10 minutes after the vaccination. No other symptoms were noted. The patient was seen at the office. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a registered nurse concerning a 16 year old female student with a history of orthostatic hypotension, who, on 25-SEP-2007 at 11:28 was vaccinated intramuscularly in the right upper arm with a 0.5mL first dose of GARDASIL (Lot# 657006/0188U). Concomitant vaccinations included a first dose of MENACTRA (Lot# U23557AA), administered intramuscularly into the left upper arm at 11:29. There were no illnesses at the time of the vaccinations. On 25-SEP-2007 (reported as at approximately 9:00), the patient experienced a "dizzy spell" after vaccination. There was no syncope (previously reported as the patient fainted about 10 minutes after the vaccination). No other symptoms were noted. The patient was seen at the office. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disorientation, Dizziness, Electrocardiogram, Fall, Head injury
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 23 year old female patient who on 24-JUL-2007 was vaccinated IM with a first dose of Gardasil lot #654539/0742U and on 25-SEP-2006 she received the second dose of Gardasil.  The nurse reported that the patient fainted after receiving the second injection.  The patient passed out about 5 minutes after the vaccination and hit her head on the wall.  The patient was made conscious with smelling salt.  She was sent to an emergency room for evaluation for a head injury.  She did not have a reaction on her first injection.  No further information was available.  The patient was recovering.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 23 year old female patient who on 24-JUL-2007 was vaccinated IM with a first dose of Gardasil lot #654539/0742U and on 25-SEP-2006 she received the second dose of Gardasil.  The nurse reported that the patient fainted after receiving the second injection.  The patient passed out about 5 minutes after the vaccination and hit her head on the wall.  The patient was made conscious with smelling salt.  She was sent to an emergency room for evaluation for a head injury.  She did not have a reaction on her first injection.  No further information was available.  The patient was recovering.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, Loss of consciousness, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 23 year old female patient who on 24-JUL-2007 was vaccinated IM with a first dose of Gardasil lot #654539/0742U and on 25-SEP-2006 she received the second dose of Gardasil.  The nurse reported that the patient fainted after receiving the second injection.  The patient passed out about 5 minutes after the vaccination and hit her head on the wall.  The patient was made conscious with smelling salt.  She was sent to an emergency room for evaluation for a head injury.  She did not have a reaction on her first injection.  No further information was available.  The patient was recovering.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dizziness, Malaise, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female with an allergy to morphine (caused anxiety) and a history with of leukaemia (5 years of age) who on 05-SEP-2007 was vaccinated IM in the deltoid (unspecified) with a 0.5 mL dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On 06-SEP-2007, the same day of vaccination, the patient experienced nausea and dizziness. On 07-SEP-2007 and 08-SEP-2007, the patient felt nauseous and dizzy for the entire day felt worse the night of 09-SEP-2007. The patient felt "a little better" on the morning of 10-SEP-2007. The nurse reported that the patient contacted the office by phone. At the time of this report, the patient was not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female with an allergy to morphine (caused anxiety) and a history with of leukaemia (5 years of age) who on 05-SEP-2007 was vaccinated IM in the deltoid (unspecified) with a 0.5 mL dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On 06-SEP-2007, the same day of vaccination, the patient experienced nausea and dizziness. On 07-SEP-2007 and 08-SEP-2007, the patient felt nauseous and dizzy for the entire day felt worse the night of 09-SEP-2007. The patient felt "a little better" on the morning of 10-SEP-2007. The nurse reported that the patient contacted the office by phone. At the time of this report, the patient was not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count, Loss of consciousness, Pallor, Thyroid function test normal
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on 23-AUG-2007 was vaccinated IM in the left arm with the first dose of Gardasil (Lot #655620/0171U).  About 30 minutes after receiving the vaccination, the patient underwent venipuncture and fainted.  The patient's blood pressure was 100/60.  The patient was monitored in the office for an hour and is fully recovered.  The patient had a history of reacting poorly to TDAP and reportedly cried 6 hours after receiving the injection.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Syncope
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on 23-AUG-2007 was vaccinated IM in the left arm with the first dose of Gardasil (Lot #655620/0171U).  About 30 minutes after receiving the vaccination, the patient underwent venipuncture and fainted.  The patient's blood pressure was 100/60.  The patient was monitored in the office for an hour and is fully recovered.  The patient had a history of reacting poorly to TDAP and reportedly cried 6 hours after receiving the injection.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAP, IPV, RV5, RV5
Symptoms: Computerised tomogram, Enema administration, Intussusception, Urinary system X-ray
Clinical narrative: Information has been received from a physician concerning a 5 month old male with no pertinent medical history or allergies, who on 17-SEP-2007, was vaccinated with an oral dose of Rotateq. Concomitant vaccines included DTaP and poliovirus vaccine. On 01-OCT-2007, he went to the hospital after developing bloody diarrhea and was hospitalized with intussusception. Diagnostics included "cultures" (results not reported). Subsequently, he underwent surgery. The patient recovered from intussusception and bloody diarrhea and was released from the hospital (date not reported). A product quality complaint was not reported. No further information was available. Intussusception was considered to be life-theatening and an other important medical event by the reporter as it required surgery. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAP, IPV, RV5, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception, Surgery, Vomiting, X-ray
Clinical narrative: Information has been received from a physician concerning a 5 month old male with no pertinent medical history or allergies, who on 17-SEP-2007, was vaccinated with an oral dose of Rotateq. Concomitant vaccines included DTaP and poliovirus vaccine. On 01-OCT-2007, he went to the hospital after developing bloody diarrhea and was hospitalized with intussusception. Diagnostics included "cultures" (results not reported). Subsequently, he underwent surgery. The patient recovered from intussusception and bloody diarrhea and was released from the hospital (date not reported). A product quality complaint was not reported. No further information was available. Intussusception was considered to be life-theatening and an other important medical event by the reporter as it required surgery. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAP, IPV, RV5, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 5 month old male with no pertinent medical history or allergies, who on 17-SEP-2007, was vaccinated with an oral dose of Rotateq. Concomitant vaccines included DTaP and poliovirus vaccine. On 01-OCT-2007, he went to the hospital after developing bloody diarrhea and was hospitalized with intussusception. Diagnostics included "cultures" (results not reported). Subsequently, he underwent surgery. The patient recovered from intussusception and bloody diarrhea and was released from the hospital (date not reported). A product quality complaint was not reported. No further information was available. Intussusception was considered to be life-theatening and an other important medical event by the reporter as it required surgery. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAP, IPV, RV5, RV5
Symptoms: Barium double contrast, Haematochezia, Intussusception, Surgery, Vomiting
Clinical narrative: Information has been received from a physician concerning a 5 month old male with no pertinent medical history or allergies, who on 17-SEP-2007, was vaccinated with an oral dose of Rotateq. Concomitant vaccines included DTaP and poliovirus vaccine. On 01-OCT-2007, he went to the hospital after developing bloody diarrhea and was hospitalized with intussusception. Diagnostics included "cultures" (results not reported). Subsequently, he underwent surgery. The patient recovered from intussusception and bloody diarrhea and was released from the hospital (date not reported). A product quality complaint was not reported. No further information was available. Intussusception was considered to be life-theatening and an other important medical event by the reporter as it required surgery. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 25 year old female consumer with no pertinent medical history, who on an unknown date was vaccinated with the first dose of GARDASIL with no reported problems, on an unknown date with the second dose of GARDASIL (lot # not provided).  Following the second vaccination, she developed hives.  Treatment included BENADRYL, with relief of the symptoms.  In July 2007, she was vaccinated with the third dose of GARDASIL (lot # not provided).  There was no concomitant medication.  In July 2007, she again developed hives after receiving her third dose.  Treatment again included diphenhydramine, but this time the hives did not resolve.  At the time of this report, the consumer had not recovered.  Additional information has been requested. Follow up information from the patient's mother, indicated that her daughter had been treated with prednisone, but continued to develop "hives" when the prednisone was discontinued. Her daughter was referred to an allergist. Physician contact information was provided. Follow up information from the nurse added that MEDROL DOSEPAK was prescribed. At the time of this report, the consumer had recovered. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: No reaction on previous exposure to drug, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 25 year old female consumer with no pertinent medical history, who on an unknown date was vaccinated with the first dose of GARDASIL with no reported problems, on an unknown date with the second dose of GARDASIL (lot # not provided).  Following the second vaccination, she developed hives.  Treatment included BENADRYL, with relief of the symptoms.  In July 2007, she was vaccinated with the third dose of GARDASIL (lot # not provided).  There was no concomitant medication.  In July 2007, she again developed hives after receiving her third dose.  Treatment again included diphenhydramine, but this time the hives did not resolve.  At the time of this report, the consumer had not recovered.  Additional information has been requested. Follow up information from the patient's mother, indicated that her daughter had been treated with prednisone, but continued to develop "hives" when the prednisone was discontinued. Her daughter was referred to an allergist. Physician contact information was provided. Follow up information from the nurse added that MEDROL DOSEPAK was prescribed. At the time of this report, the consumer had recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Fall
Clinical narrative: PT REPORTED SEEING SPOTS, FEELING DIZZY, AND "SHAKING" APPROX. 5 MIN AFTER RECEIVING INJECTION (PER MOTHER'S ASSESSMENT).  MOTHER CALLED NURSING INTO EXAM ROOM AND PT LOST CONSCIOUSNESS AND CONTINUED TO HAVE "SEIZURE LIKE" ACTIVITY FOR APPROX. 60-90 SECONDS.  PT BEGAN ALERT AND ORIENTED QUICKLY AFTER EVENT, BUT DID NOT REMEMBER NURSES MOVING HER FROM THE CHAIR TO THE FLOOR. SHE ALSO CONTINUED TO BE A LITTLE SHAKY AFTERWARDS. FSBS WAS 77 AND WAS LATER CONFIRMED ON A BASIC METABOLIC PANEL.  HGB A1C WAS ALSO 5.2. PT REPORTED NOT HAVING BREAKFAST THAT AM. FNPC BELIEVED EVENT TO BE A VASAL-VAGAL REACTION TO THE INJECTION.  PT WAS DISCHARGED HOME WITH MOTHER, HAD NO H/O SEIZURE ACTIVITY PRIOR AND HAS HAD NONE SINCE.  AN EEG WAS PERFORMED THIS WED TO F/U EVENT BUT RESULTS ARE PENDING.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Dizziness, Electroencephalogram, Glycosylated haemoglobin, Loss of consciousness
Clinical narrative: PT REPORTED SEEING SPOTS, FEELING DIZZY, AND "SHAKING" APPROX. 5 MIN AFTER RECEIVING INJECTION (PER MOTHER'S ASSESSMENT).  MOTHER CALLED NURSING INTO EXAM ROOM AND PT LOST CONSCIOUSNESS AND CONTINUED TO HAVE "SEIZURE LIKE" ACTIVITY FOR APPROX. 60-90 SECONDS.  PT BEGAN ALERT AND ORIENTED QUICKLY AFTER EVENT, BUT DID NOT REMEMBER NURSES MOVING HER FROM THE CHAIR TO THE FLOOR. SHE ALSO CONTINUED TO BE A LITTLE SHAKY AFTERWARDS. FSBS WAS 77 AND WAS LATER CONFIRMED ON A BASIC METABOLIC PANEL.  HGB A1C WAS ALSO 5.2. PT REPORTED NOT HAVING BREAKFAST THAT AM. FNPC BELIEVED EVENT TO BE A VASAL-VAGAL REACTION TO THE INJECTION.  PT WAS DISCHARGED HOME WITH MOTHER, HAD NO H/O SEIZURE ACTIVITY PRIOR AND HAS HAD NONE SINCE.  AN EEG WAS PERFORMED THIS WED TO F/U EVENT BUT RESULTS ARE PENDING.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test normal, Syncope vasovagal, Tremor
Clinical narrative: PT REPORTED SEEING SPOTS, FEELING DIZZY, AND "SHAKING" APPROX. 5 MIN AFTER RECEIVING INJECTION (PER MOTHER'S ASSESSMENT).  MOTHER CALLED NURSING INTO EXAM ROOM AND PT LOST CONSCIOUSNESS AND CONTINUED TO HAVE "SEIZURE LIKE" ACTIVITY FOR APPROX. 60-90 SECONDS.  PT BEGAN ALERT AND ORIENTED QUICKLY AFTER EVENT, BUT DID NOT REMEMBER NURSES MOVING HER FROM THE CHAIR TO THE FLOOR. SHE ALSO CONTINUED TO BE A LITTLE SHAKY AFTERWARDS. FSBS WAS 77 AND WAS LATER CONFIRMED ON A BASIC METABOLIC PANEL.  HGB A1C WAS ALSO 5.2. PT REPORTED NOT HAVING BREAKFAST THAT AM. FNPC BELIEVED EVENT TO BE A VASAL-VAGAL REACTION TO THE INJECTION.  PT WAS DISCHARGED HOME WITH MOTHER, HAD NO H/O SEIZURE ACTIVITY PRIOR AND HAS HAD NONE SINCE.  AN EEG WAS PERFORMED THIS WED TO F/U EVENT BUT RESULTS ARE PENDING.
Age: 0.17
Sex: F
Vaccine: DTAP, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, RVX, HBHEPB, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Incessant and unconsolable crying beginning 3 hours after vaccinations were given and lasting longer than 6 hours.  Crying then became intermittent, continuing for 2 days.  Within 5 hours of vaccination, fever onset of 104.2 degrees, not responsive to 1/2 tspn Tylenol administered every 4 hours.  Decreased appetite.  Refused to nurse for more than 12 hours after crying began.  Skin rash appeared withing 24 hours of vaccination and remained for 3-4 days.
Age: 0.17
Sex: F
Vaccine: DTAP, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, RVX, HBHEPB, RV5
Symptoms: Crying, Decreased appetite, Pyrexia, Rash
Clinical narrative: Incessant and unconsolable crying beginning 3 hours after vaccinations were given and lasting longer than 6 hours.  Crying then became intermittent, continuing for 2 days.  Within 5 hours of vaccination, fever onset of 104.2 degrees, not responsive to 1/2 tspn Tylenol administered every 4 hours.  Decreased appetite.  Refused to nurse for more than 12 hours after crying began.  Skin rash appeared withing 24 hours of vaccination and remained for 3-4 days.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Pain, Stress
Clinical narrative: HPV vaccine for age 28, needed is CPT code for age 28, it is not fair to only recommend the vaccine for ages 9 to 28, insurance companies are refusing to pay for the vaccine for anyone 27 and older, due to this when there are women 27 and older who have HPV who get the vaccine and need their insurance to pay for the vaccine, but the CPT code is being refused to be paid by the insurance because FDA and Gardasil claim the FDA claims Gardasil is for ages 9 to 26 because of the FDA, this is not fair to women ages 27 and older, like me who need the vaccine to be paid for by their insurance, this is insurance fraud, due to FDA not using wording that the vaccine can be used for women over age 26.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unevaluable event
Clinical narrative: HPV vaccine for age 28, needed is CPT code for age 28, it is not fair to only recommend the vaccine for ages 9 to 28, insurance companies are refusing to pay for the vaccine for anyone 27 and older, due to this when there are women 27 and older who have HPV who get the vaccine and need their insurance to pay for the vaccine, but the CPT code is being refused to be paid by the insurance because FDA and Gardasil claim the FDA claims Gardasil is for ages 9 to 26 because of the FDA, this is not fair to women ages 27 and older, like me who need the vaccine to be paid for by their insurance, this is insurance fraud, due to FDA not using wording that the vaccine can be used for women over age 26.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Severe local reaction after 24 hours, patient's right arm was red, swollen and extremely sore, patient to take diphenhydramine and go to ER if have SOB, patient went to MD and got RX (unknown) and he is doing much better, swelling is almost gone.
Age: 1.75
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMRV, PNC
Symptoms: Skin lesion, Varicella
Clinical narrative: Initial information received on 02 October 2007 from another manufacturer, report number WAES0708USA05829. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a registered nurse concerning six patients who were vaccinated with Varivax (Oka/Merck). Subsequently, the patients experienced breakthrough chickenpox. A product quality complaint was not involved." "Follow-up received 20-SEP-2007: Follow-up information has been received from a registered nurse concerning a 21-month-old female with no pertinent medical history or allergies who on 20-JAN-2007 was vaccinated in her left thigh with her first dose of ProQuad (Oka/Merck upgrade process) (lot # 656165/1387F). It was unknown if there were any illnesses at the time of vaccination. On 20-JAN-2007 concomitant vaccines included fourth dose of Trihibit (Sanofi Pasteur) (Lot # V1465AA & VE959AA), a fourth dose of (Prevnar) (Wyeth) (Lot # B08684A), and first 0.25 mg dose of influenza virus vaccine (unspecified) (Sanofi Pasteur) (Lot # UT2176JA). On 18-AUG-2007 the patient developed numerous lesions on her face. The patient was prescribed with acyclovir (ZOVIRAX) 200mg-5 mL three times a day for 5 days. The patient recovered from the adverse event at an unspecified date. The event was considered to be an other important medical event by the reporter. It was noted that the patient's sibling (WAES # 0709USA03345) experienced an adverse event. This is one of several reports from the same source. Additional information has been requested." Tripedia lot numbers reported as V1465AA and VE959AA are not valid sanofi pasteur lot numbers.
Sex: U
Vaccine: MEN
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Initial report received on 03 October 2007 from another manufacturer, report number not provided. The initial reporter to this manufacturer had been a health care professional. A patient (age and gender not specified) had received an injection of Menomune A/C/Y/W-135, lot number not reported, route and site of administration not reported, on an unspecified date approximately four to five years ago. On an unspecified date post-vaccination, the patient developed a Stevens Johnson reaction. Additional information was not provided.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Syncope
Clinical narrative: Initial information received from a health care provider on 07 October 2007. A 71-year-old female patient received a dose of Fluzone SV 2007-2008, lot number unknown, on 04 October 2007 at 10:00 AM. The route and site of administration were not reported. Thirteen minutes post-vaccination, the patient fainted. Her blood pressure was 188/90. The patient's medical history included non-insulin dependent diabetes mellitus and hypertension. Following the event, the patient was taken to the emergency room and was discharged. It was not reported whether the patient received any treatment or whether any laboratory testing was completed. The patient's recovery status is unknown.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Oedema mouth, Oedema peripheral, Pharyngeal oedema, Swollen tongue
Clinical narrative: Initial report received on 09 October 2007 from the patient.  54-year-old male patient, with no illness at the time of vaccination, had received a first dose, left deltoid, intramuscular injection of Adacel, lot number unknown; and a second dose, right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number unknown; on 01 October 2007. Three days post-vaccination, the patient experienced swelling of his fingers, mouth, throat, and tongue. He had no shortness of breath. He was examined by a physician four days later, and the swelling had decreased although his feet, arms, and mouth were still swollen. The patient was treated with cortisone and was to follow-up with an allergist. Relevant diagnostic testing was none. At the time of this report, the patient had not recovered.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Musculoskeletal pain, Radiculitis brachial
Clinical narrative: Initial report received from a health care provider on 09 October 2007. A 43-year-old male patient had received an intramuscular right deltoid injection of Adacel, lot number C2824AA and two days later complained of lymphadenopathy under his right axilla and right shoulder pain radiating to the right axilla. The patient had diagnosed them self with brachial neuritis based on an Internet search and refused to be evaluated by a physician. The patient last received a dose of Tetanus and Diphtheria vaccine in 2000. No further information was provided and the patient's recovery status was unknown at the time of the report.
Sex: F
Vaccine: DTP
Symptoms: Convulsion
Clinical narrative: A patient (gender not reported) experienced a seizure as a child after receiving "DPT vaccine" (manufacturer, lot number, route, site and date of administration not reported). No other information was available. Follow-up information was received from the health professional on 08 October 2007 which provided patient identifiers. The patient, a female in her early 20's, had experienced a seizure following DPT administration as a child. Per the reporter, no other information was available, and she had no other contact information for the administering physician. Due to the additional patient identifiers provided, this case will be reported to the health authority.
Sex: F
Vaccine: TYP
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer on 03 October 2007. A female patient received a Typhoid vaccination (manufacturer and lot number not reported) "about 50 years ago" and subsequently was hospitalized due to a "drug reaction". According to the patient, she is allergic to horse products. No additional information was provided.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Induced labour, Intra-uterine death, Premature labour
Clinical narrative: Information has been received from a physician concerning a 22 year old female with a history of abnormal papanicolaou smears with no treatment who on 30-NOV-2006 was vaccinated with a first dose of Gardasil. On 07-JAN-2007, the patient tested positive for pregnancy (type unspecified). The date of her last menstrual period was not reported. Medical attention was sought. On an unspecified date in 2007, at 19 weeks gestation, the mother's "water broke", and she was taken to the hospital where labor was induced. The baby did not live. At the time of reporting, the status of the mother was unspecified. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 9-week-old male who on 10-SEP-2007 was vaccinated with a dose of Rotateq. Concomitant therapy included Pediarix, Prevnar and PedvaxHib (manufacturer unknown). On 14-SEP-2007, the infant experienced "horrible diarrhea." The infant had diarrhea 15 times per day. On 17-Sep-2007, the infant was admitted to the hospital and was positive for rotavirus.  The outcome was not reported. This is one of several reports by the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Gastroenteritis rotavirus, Haematochezia, Occult blood
Clinical narrative: Information has been received from a physician concerning a 60 day old male who on 25-SEP-2007, was orally vaccinated with his first dose of Rotateq (lot# 647100/0875N). On 02-OCT-2007, the patient was seen in the office by his physician after he had developed mucousy diarrhea with occult blood. His stools tested positive for rotavirus. He was initially breast fed, then switched to a soy formula, and on 02-OCT-2007, was switched to Nutramigen. He did improve on "therapy" and is recovering. No product quality complaint was reported. No further information was available. Upon internal review, haematochezia was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Mood altered, Surgery
Clinical narrative: Information has been received from a physician concerning a patient who on 20-AUG-2007 received an oral dose of Rotateq. It was reported that the patient's mother contacted their physician because her baby on 27-AUG-2007, had experienced intussusception and that the patient was being quiet". The patient was hospitalized and subsequently under went surgery, "but specifics were unknown". It was reported that the patient recovered. A product quality complaint was not reported. No further information was available. Intussusception was considered to be an other important medical event by the reporter as it required surgery. Additional information has been requested. 10/22/07-records received for DOS 8/27-/8/28/07-DC DX: Ileocolic intussusception. Two days prior to admission onset of crampy abdominal pain and diarrhea. Hydrostatic reduction attemtped, unsuccessful. Surgical reduction.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning ten approximately 75 year old patients who on unspecified dates were vaccinated with Pneumovax 23 vaccine (lot 657526/0555U). The pharmacist reported that the patients developed "serious adverse events" post vaccination. Subsequently the patients experienced pain and swelling at injection site moving downward on the arm. The patients sought unspecified medical attention. Some of the patients had to go to the hospital, but it was unknown if any of the patients were admitted to the hospital. At the time of this report, outcome was unknown.  The pharmacist requested a lot check on Pneumovax 23 (lot# 657526/0555U). Pain and  swelling at injection site moving downward on the arm was considered to be disabling. 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. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TTOX
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician through the Merck Pregnancy Registry concerning a 14 year old female who on 30-MAY-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (lot # 654535/0960F). Concomitant therapy on 30-MAY-2007 included Menactra and tetanus toxoid. A second 0.5 ml IM dose of Gardasil (lot # 654535/0960F). Subsequently the patient had a miscarriage at 9 weeks. Upon internal review, miscarriage was considered an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female who on approximately 05-MAY-2007 was vaccinated with a dose of Gardasil. On approximately 05-MAY-2007 five minutes after vaccination the patient experienced convulsions. Unspecified medical attention was sought. At the time of the report the patient had recovered. Upon internal review, convulsions was considered to be another important medical event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse concerning a male physician with no medical history or allergies who on 02-OCT-2007 was vaccinated SC once with a 0.65 ml dose of Zostavax. There was no concomitant medication. On 02-OCT-2007, after vaccination the patient developed high fever, nausea and vomiting. The patient received some intravenous fluids. It was reported that the physician could not work on 03-OCT-2007 due to symptoms. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthropathy, Arthroscopy, Aspiration joint, C-reactive protein increased
Clinical narrative: Subject reports that within 2 hrs. of receiving the Anthrax vaccine in Nov. 2002, he had sharp pains in his right knee along with swelling. Reports that within 4-6 days later his right knee was paralyzed and he experienced excruciating pain in the knee. He went to the ER and reports he had x-rays which were negative. He reports that subsequently his knee bursa sack filled up and was aspirated for 90cc straw colored fluid. He received Motrin for pain. He reports he was deployed and during deployment received a second AVA in December 2002. Upon return, he states an orthopedic physician performed an arthroscopy. He reports that there were white deposits found in the knee, specimens were sent to pathology. Subject states he believes that he has auto-immune problems related to the anthrax vaccine. Subject states a VAERS report has been submitted by his physicians.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Joint swelling, Laboratory test, Paralysis, X-ray normal
Clinical narrative: Subject reports that within 2 hrs. of receiving the Anthrax vaccine in Nov. 2002, he had sharp pains in his right knee along with swelling. Reports that within 4-6 days later his right knee was paralyzed and he experienced excruciating pain in the knee. He went to the ER and reports he had x-rays which were negative. He reports that subsequently his knee bursa sack filled up and was aspirated for 90cc straw colored fluid. He received Motrin for pain. He reports he was deployed and during deployment received a second AVA in December 2002. Upon return, he states an orthopedic physician performed an arthroscopy. He reports that there were white deposits found in the knee, specimens were sent to pathology. Subject states he believes that he has auto-immune problems related to the anthrax vaccine. Subject states a VAERS report has been submitted by his physicians.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 72-year-old white, non-immunocompromised, healthy female who on 25-JUL-2007 was vaccinated subcutaneously with a 0.5 ml dose of Zostavax (lot# 656385/0290U). "Two days later", reported as "26-JUL-2007" the injection site arm became very swollen and very red. The swelling was from the deltoid down the entire arm to the elbow. Medical treatment was sought, the patient was given antibiotics and the reaction dissipated. The outcome was recovered. No product quality complaint was involved. The reporter considered the patient's local swelling/inflammation and erythema to be other important medical events. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Abdominal pain upper, Fluid replacement, Inappropriate schedule of drug administration, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a Register Nurse (R.N.) concerning a 49 year old female patient who on 22-SEP-2007 was vaccinated subcutaneous into the left arm with a dose of Pneumovax 23 Lot #657143/0380U. Concomitant therapy included DTaP (unspecified) and influenza virus vaccine (unspecified), both vaccines were given in the right deltoid, On 24-SEP-2007 the patient called stating she had a fever all weekend, was vomiting, and developed a hand sized redness which started at the injection site of left arm travelling downward. She mentioned that the injection site was hot to touch. She was taking (Advil) and (Tylenol). The nurse called the patient on Tuesday morning as a follow-up. Patient told the nurse she was feeling terrible, and it was recommended she go to the Community Medical clinic. Tuesday, 25-SEP-2007 she went to the clinic. Her temperature was down and her white blood count was within normal limits. No blood cultures drawn. Patient was treated with Intravenous (IV) antibiotics and then released. On Wednesday, 24-SEP-2007 patient went back to the clinic, complaining her stomach was hurting and feeling achy over her body. She was treated with IV antibiotics and 2 liters of IV fluids and then released. On Thursday, 27-SEP-2007 client went to clinic, treated with IV antibiotics and released. It was reported that she would get IV antibiotics treatment on 28-SEP-2007 at the clinic. Physician at the clinic diagnosed client with stph infection, but no blood cultures were drawn. Patient was also treated with oral antibiotics (the names of the therapy was unspecified). Patient told the nurse that she was off due to the symptoms. As of this reports day the client had not recovered. The reporter indicated that the patient's adverse events fever, stomach hurting, feeling terrible, feeling achy all over her body and vomiting and being diagnosed having saph infection were disabling. The reporter also felt that getting IV antibiotics, IV fluids was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Malaise, Pain, Pyrexia, Staphylococcal infection, Vomiting
Clinical narrative: Information has been received from a Register Nurse (R.N.) concerning a 49 year old female patient who on 22-SEP-2007 was vaccinated subcutaneous into the left arm with a dose of Pneumovax 23 Lot #657143/0380U. Concomitant therapy included DTaP (unspecified) and influenza virus vaccine (unspecified), both vaccines were given in the right deltoid, On 24-SEP-2007 the patient called stating she had a fever all weekend, was vomiting, and developed a hand sized redness which started at the injection site of left arm travelling downward. She mentioned that the injection site was hot to touch. She was taking (Advil) and (Tylenol). The nurse called the patient on Tuesday morning as a follow-up. Patient told the nurse she was feeling terrible, and it was recommended she go to the Community Medical clinic. Tuesday, 25-SEP-2007 she went to the clinic. Her temperature was down and her white blood count was within normal limits. No blood cultures drawn. Patient was treated with Intravenous (IV) antibiotics and then released. On Wednesday, 24-SEP-2007 patient went back to the clinic, complaining her stomach was hurting and feeling achy over her body. She was treated with IV antibiotics and 2 liters of IV fluids and then released. On Thursday, 27-SEP-2007 client went to clinic, treated with IV antibiotics and released. It was reported that she would get IV antibiotics treatment on 28-SEP-2007 at the clinic. Physician at the clinic diagnosed client with stph infection, but no blood cultures were drawn. Patient was also treated with oral antibiotics (the names of the therapy was unspecified). Patient told the nurse that she was off due to the symptoms. As of this reports day the client had not recovered. The reporter indicated that the patient's adverse events fever, stomach hurting, feeling terrible, feeling achy all over her body and vomiting and being diagnosed having saph infection were disabling. The reporter also felt that getting IV antibiotics, IV fluids was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: White blood cell count normal
Clinical narrative: Information has been received from a Register Nurse (R.N.) concerning a 49 year old female patient who on 22-SEP-2007 was vaccinated subcutaneous into the left arm with a dose of Pneumovax 23 Lot #657143/0380U. Concomitant therapy included DTaP (unspecified) and influenza virus vaccine (unspecified), both vaccines were given in the right deltoid, On 24-SEP-2007 the patient called stating she had a fever all weekend, was vomiting, and developed a hand sized redness which started at the injection site of left arm travelling downward. She mentioned that the injection site was hot to touch. She was taking (Advil) and (Tylenol). The nurse called the patient on Tuesday morning as a follow-up. Patient told the nurse she was feeling terrible, and it was recommended she go to the Community Medical clinic. Tuesday, 25-SEP-2007 she went to the clinic. Her temperature was down and her white blood count was within normal limits. No blood cultures drawn. Patient was treated with Intravenous (IV) antibiotics and then released. On Wednesday, 24-SEP-2007 patient went back to the clinic, complaining her stomach was hurting and feeling achy over her body. She was treated with IV antibiotics and 2 liters of IV fluids and then released. On Thursday, 27-SEP-2007 client went to clinic, treated with IV antibiotics and released. It was reported that she would get IV antibiotics treatment on 28-SEP-2007 at the clinic. Physician at the clinic diagnosed client with stph infection, but no blood cultures were drawn. Patient was also treated with oral antibiotics (the names of the therapy was unspecified). Patient told the nurse that she was off due to the symptoms. As of this reports day the client had not recovered. The reporter indicated that the patient's adverse events fever, stomach hurting, feeling terrible, feeling achy all over her body and vomiting and being diagnosed having saph infection were disabling. The reporter also felt that getting IV antibiotics, IV fluids was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dyskinesia, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no known allergies and no pertinent medical history who during the week of 23-SEP-2007 came in for her first dose of Gardasil 0.5 ml intramuscularly in her arm. There was no concomitant medication. Some day during the week of 23-SEP-2007, the patient experienced syncope and "a mild seizure." The patient closed her eyes and jerked her arms. No labs or diagnostic studies were performed. The patient was observed in the exam room and fully recovered without further symptoms. Upon internal review, "a mild seizure" was considered to be an Other Important Medical Event. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Inappropriate schedule of drug administration, Respiratory distress
Clinical narrative: Information has been received from a physician's assistant concerning a 50 year old female with rheumatoid arthritis, "shogun's syndrome", scoliosis, hypertension, diabetes, seafood allergy, allergy to nuts (almonds) and multiple medications drug hypersensitivity (unspecified) who on 01-OCT-2007 was vaccinated with a first dose of Gardasil. Concomitant medication was unspecified. On 01-OCT-2007, within one or two hours after being vaccinated, the patient experienced respiratory distress. The patient went to the emergency room and was treated for an allergic reaction. She was given epinephrine injection, albuterol inhaler, and (Benadryl). At the time of reporting, 02-OCT-2007, the patient was still experiencing mild to moderate respiratory distress. The reporter considered the respiratory distress and allergic reaction as serious to disability, immediately life-threatening, and as Other Important Medical Events because epinephrine injection was required. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Headache, Nausea, Pyrexia, Rash papular
Clinical narrative: Pt had c/o nausea, H/A, fever and rash on right side of face.  Rash is papular of 0.5mm.  Max temp was at home of 101.3F.   Pt given Benadryl, 25mg, prednisone 40mg, lortab 5mg, and reglan 10mg IV.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Local reaction, Skin warm
Clinical narrative: Seen in our office on 10/9/07 for 4 year old WCU.  Rec'd DTAP, MMR, IPV, and Influenza.  Woke up on 10/11/07 with left arm slightly swollen, red,and warm to touch.  Progessivly got worse seen again in our office and diagnosed with post vaccine local reaction with cellulitis.  Treated with Keflex and Benadryl.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Blisters and rash on nape of neck, rash on throat, rash on right  shoulder. The physician on- call prescribed Zovirax 1000 mg and Neosporin. Patient still has rash and blisters and is being compliant with treatment but it has only been two days so far.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: in the evening, after vaccination with influenza and PPV-23, the patient developed fever and chills. she also developed redness and swelling at the site of the PPV-23 (right arm, SQ inf to delt). She missed one day of work. She is recovering; no more fever or chills, erythema is diminishing. Appears patient is recovering.
Age: 64.0
Sex: F
Vaccine: PPV, TTOX, VARZOS
Symptoms: Erythema, Face oedema, Headache, Herpes zoster, Nausea
Clinical narrative: Pt reports day after injection was feverish, achey, experienced n/v, headache.  Then her face broke out in swollen, red, painful areas.  Nurse Practioner felt could be shingles, had her come back this am for follow up with Doctor.
Age: 64.0
Sex: F
Vaccine: PPV, TTOX, VARZOS
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Pt reports day after injection was feverish, achey, experienced n/v, headache.  Then her face broke out in swollen, red, painful areas.  Nurse Practioner felt could be shingles, had her come back this am for follow up with Doctor.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Nausea, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Patient fainted for 10-15 seconds after administration.  On 10-12-2007, her father reports that since that incident she has experienced every few days a rash that is slightly erythemic, progressively pruritic and lsats 3-4 days, on the chest and upper thighs, and lower abdomen that fades away. Fatigue, fever and nausea associated.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted for 10-15 seconds after administration.  On 10-12-2007, her father reports that since that incident she has experienced every few days a rash that is slightly erythemic, progressively pruritic and lsats 3-4 days, on the chest and upper thighs, and lower abdomen that fades away. Fatigue, fever and nausea associated.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Eye pain, Fatigue, Headache, Pain
Clinical narrative: The day after receiving flu shot, felt like "hit by sledge hammer" - achy and tired feeling - spent whole day on couch, dozing off and on - no appetite; severe headache with pain behind right eye.  Symptoms lasted one day.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Blood test, Injection site pain, Ultrasound scan
Clinical narrative: L arm pain at injection site since injection administered 9/24/07
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: severe vomiting occured approximately 20 to 30 minutes after flu shot was administered.  Vomiting continued for approximately 8 hours.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Supraclavicular adenopathy and tenderness with soft tissue swelling on same side vaccine was administered.  Axillary adenopathy on same side as vaccine.  No fever, no malaise, no angioedema.  Site of vaccine administration appeared clear without evidence of infection.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Pallor
Clinical narrative: PATIENT WAS GIVEN VACCINATION IN LEFT DELTOID AND THEN ASKED TO WAIT 15 MINUTES AFTER RECEIVING INJECTION. I WAS NOTIFIED ABOUT 5 MINUTES LATER THAT PATIENT FELT FAINT. PATIENT WAS PALE IN COLOR AND FELT DIZZY. PATIENT WAS LIED DOWN ON FLOOR WITH FEET ELEVATED UNTIL SYMPTOMS SUBSIDED ABOUT 5 MINUTES LATER. PATIENTS BP WAS CHECKED AND DR WAS NOTIFIED. PATIENT WAS THEN ALLOWED TO LEAVE WITH FATHER.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Muscle tightness, Oedema peripheral, Rash
Clinical narrative: Patient has swelling of the left arm along with redness and tightness of the muscle. Also, a rash has developed on the side of the torso.  Symptoms and signs appeared within 24 hrs. of the vaccination.