chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who on 10-AUG-2007 was vaccinated with Gardasil (lot # 657872/0515U) 0.5 ml IM in the left deltoid.  Concomitant therapy included hormonal contraceptives (unspecified).  On 10-AUG-2007, a few minutes after leaving the physician's office, the patient experienced a swollen sensation in her throat and tongue.  She took BENADRYL and slept for one hour.  This relieved her symptom (recovered on 10-AUG-2007).  No further information was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no current illnesses and an allergy to Bactrim and amoxicillin who on 09-AUG-2007 at 1030 hours was vaccinated in the left deltoid with the first dose of Gardasil.  At 1035 hours, the patient left the exam room and walked to the check out window stating that she did not feel well and was placed in a chair.  The patient became non-responsive with jerky movements X2 of the upper body.  A cold cloth was placed to her face.  Ammonia salts was given.  After approximately 1-2 minutes, she became responsive and was assisted to the exam table.  Her blood pressure was 102/64.  She rested for approximately 5 minutes and sat up stating she felt better.  The patient's sister reported that she had a prior history of fainting with injections.  The patient left and was accompanied under arm by her sister.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Dyskinesia, Malaise, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no current illnesses and an allergy to Bactrim and amoxicillin who on 09-AUG-2007 at 1030 hours was vaccinated in the left deltoid with the first dose of Gardasil.  At 1035 hours, the patient left the exam room and walked to the check out window stating that she did not feel well and was placed in a chair.  The patient became non-responsive with jerky movements X2 of the upper body.  A cold cloth was placed to her face.  Ammonia salts was given.  After approximately 1-2 minutes, she became responsive and was assisted to the exam table.  Her blood pressure was 102/64.  She rested for approximately 5 minutes and sat up stating she felt better.  The patient's sister reported that she had a prior history of fainting with injections.  The patient left and was accompanied under arm by her sister.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Malaise, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who on 24-JUL-2007, was vaccinated with a second dose of Gardasil in her left deltoid (Lot# 658222/0927U).  On 24-JUL-2007, after receiving the vaccination, the patient stated that she wasn't feeling well.  She became unresponsive, jerking movements of the upper body times two.  After approximately one to two minutes, the patient began to respond and speak to the reporter.  A cold cloth was applied to her face and neck.  Her blood pressure was assessed at 90/64.  Emergency medical technicians were called and responded.  They assessed the patient and the patient refused to transfer via the ambulance to the hospital emergency room.  The patient awaited a family member who stated that the patient had had this same type of reaction to injections before (not further specified).  On 24-JUL-2007, the patient recovered from the events.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Blood pressure, Pallor, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of Gardasil.  "Almost immediately after vaccination" the patient fainted.  It was reported that patient also fainted when her wisdom teeth were removed.  Unspecified medical attention was sought.  The patient left the office fully recovered.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician and a registered nurse concerning an 18 year old female student with a history of fainting after the removal of her wisdom teeth, who on 31-JUL-2007 at 9:30 am was vaccinated intramuscularly in the right arm with the first dose of GARDASIL (lot # 658488/0930U). Concomitant vaccination on 31-JUL-2007 included the second dose of VARIVAX (Oka/Merck) (lot # 658019/0828U) given subcutaneously in the left arm, and the first dose of MENACTRA (lot # U23786A) given intramuscularly in the left arm. There were no illnesses at the time of vaccination. It was reported that the nurse applied a PPD test to the patient's left forearm (lot C2316AC) and then administered the GARDASIL, VARIVAX (Oka/Merck) (MSD) and MENACTRA. The patient asked for a bandaid on the PPD site because she did not want to look at it. She then became pale and fainted onto the exam table. She sat up after a few seconds and seemed fine. Her BP was 130/80. The patient waited in the office for 30 minutes. Her BP was then 100/64. She then stated that she felt fine and went home. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of Gardasil.  "Almost immediately after vaccination" the patient fainted.  It was reported that patient also fainted when her wisdom teeth were removed.  Unspecified medical attention was sought.  The patient left the office fully recovered.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician and a registered nurse concerning an 18 year old female student with a history of fainting after the removal of her wisdom teeth, who on 31-JUL-2007 at 9:30 am was vaccinated intramuscularly in the right arm with the first dose of GARDASIL (lot # 658488/0930U). Concomitant vaccination on 31-JUL-2007 included the second dose of VARIVAX (Oka/Merck) (lot # 658019/0828U) given subcutaneously in the left arm, and the first dose of MENACTRA (lot # U23786A) given intramuscularly in the left arm. There were no illnesses at the time of vaccination. It was reported that the nurse applied a PPD test to the patient's left forearm (lot C2316AC) and then administered the GARDASIL, VARIVAX (Oka/Merck) (MSD) and MENACTRA. The patient asked for a bandaid on the PPD site because she did not want to look at it. She then became pale and fainted onto the exam table. She sat up after a few seconds and seemed fine. Her BP was 130/80. The patient waited in the office for 30 minutes. Her BP was then 100/64. She then stated that she felt fine and went home. No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sensation of heaviness
Clinical narrative: Inital and follow up information has been received from a physician concerning a 12 year old female student with no medical history and no allergies, who on 15-AUG-2007 ( previously reported as 16-AUG-2007), was vaccinated in the right arm with a third (previously reported as second) 0.5ml dose of Gardasil. There was no concomitant medication and no illnesses at the time of vaccination. On 16-AUG-2007, the patient experienced numbness in entire arm (also reported no adverse reaction). Unspecified medical attention was sought. No laboratiry diagnostics were performed. At this time of the report, the patient's outcome was unknown (previously reported that on 17-AUG-2007, the patient recovered). No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Inital and follow up information has been received from a physician concerning a 12 year old female student with no medical history and no allergies, who on 15-AUG-2007 ( previously reported as 16-AUG-2007), was vaccinated in the right arm with a third (previously reported as second) 0.5ml dose of Gardasil. There was no concomitant medication and no illnesses at the time of vaccination. On 16-AUG-2007, the patient experienced numbness in entire arm (also reported no adverse reaction). Unspecified medical attention was sought. No laboratiry diagnostics were performed. At this time of the report, the patient's outcome was unknown (previously reported that on 17-AUG-2007, the patient recovered). No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye pruritus, Eyelid oedema
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old female with a history of asthma and no drug reactions/allergies and no illness at the time of vaccination who on 03-AUG-2007 was vaccinated with Gardasil (lot# 0355U) 0.5 mL in the right deltoid IM. There was no concomitant medication. On approximately 03-AUG-2007 the patient developed both swelling and pruritus of both the eyelids 12 to 18 hours after receiving the dose of Gardasil. Medical attention was sought. At the time of reporting the outcome of the event was unspecified. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Follow-up information was received. The lot number was updated. The patient was given BENADRYL at home and again in the office the next day on 04-AUG-2007. The patient was given ORAPRED for 3 to 5 days and ZYRTEC. On an unspecified date the patient recovered. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eyelid oedema, Eyelids pruritus
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old female with a history of asthma and no drug reactions/allergies and no illness at the time of vaccination who on 03-AUG-2007 was vaccinated with Gardasil (lot# 0355U) 0.5 mL in the right deltoid IM. There was no concomitant medication. On approximately 03-AUG-2007 the patient developed both swelling and pruritus of both the eyelids 12 to 18 hours after receiving the dose of Gardasil. Medical attention was sought. At the time of reporting the outcome of the event was unspecified. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Follow-up information was received. The lot number was updated. The patient was given BENADRYL at home and again in the office the next day on 04-AUG-2007. The patient was given ORAPRED for 3 to 5 days and ZYRTEC. On an unspecified date the patient recovered. Additional information is not expected.
Age: 21.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Headache, Malaise, Nausea
Clinical narrative: Information has been received concerning a 21 year old patient with a history of Crohn's disease with no recent flares who on 20-AUG-2007 at 11:00 AM was vaccinated with Gardasil in the left deltoid (lot 658556/1060U). On 20-AUG-2007 the patient went to work at an area mall and began to feel sick at 13:45 and complained of headache, nausea, stomach cramps and generalized malaise. The office worker advised the patient to call a parent for a ride home and once home to take 25 mg diphenhydramine Hcl (BENADRYL) and rest. The patient was further instructed if the patient experienced more severe symptoms (SOB and chest pain) to call the ER. No labs or diagnostic tests were performed. On 20-AUG-2007 the patient recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Convulsion, Eye rolling, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 21-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil concomitantly with a dose of therapy included Vaqta (MSD) and MENACTRA into the opposite arm.  The patient immediately began shaking and eyes were in the back of head which lasted for 5-10 seconds.  Within a minute of vaccination, the patient became pale and fainted.  The patient was given oxygen.  On 13-AUG-2007, the patient recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 21-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil concomitantly with a dose of therapy included Vaqta (MSD) and MENACTRA into the opposite arm.  The patient immediately began shaking and eyes were in the back of head which lasted for 5-10 seconds.  Within a minute of vaccination, the patient became pale and fainted.  The patient was given oxygen.  On 13-AUG-2007, the patient recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Eye rolling, Pallor, Syncope, Tremor
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 21-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil concomitantly with a dose of therapy included Vaqta (MSD) and MENACTRA into the opposite arm.  The patient immediately began shaking and eyes were in the back of head which lasted for 5-10 seconds.  Within a minute of vaccination, the patient became pale and fainted.  The patient was given oxygen.  On 13-AUG-2007, the patient recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TD, HPV4, TTOX
Symptoms: Dizziness, Malaise, Nausea, Presyncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with an allergy to pertussis, who on 16-AUG-2007 was vaccinated with a first dose of Gardasil (Lot# 658488/0930U).  Concomitant vaccination included tetanus toxoid.  Subsequently, after receiving the first dose of Gardasil the patient felt like she was going to pass out.  The nurse practitioner laid her down and waited about 15 minutes.  The nurse practitioner then vaccinated the patient with the tetanus toxoid because of the allergy to pertussis.  Subsequently, after receiving the tetanus toxoid the patient felt dizzy.  The patient was laid back down for another 15 minutes and then was fine so they let her go home.  While the patient was about to leave the lot, she felt dizzy again, but they decided just to go home because her mom was a nurse and decided it would be better.  During the next couple days after the vaccination, the patient experienced being really tired, nausea, and dizziness.  No laboratory diagnostic studies were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TD, HPV4, TTOX
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with an allergy to pertussis, who on 16-AUG-2007 was vaccinated with a first dose of Gardasil (Lot# 658488/0930U).  Concomitant vaccination included tetanus toxoid.  Subsequently, after receiving the first dose of Gardasil the patient felt like she was going to pass out.  The nurse practitioner laid her down and waited about 15 minutes.  The nurse practitioner then vaccinated the patient with the tetanus toxoid because of the allergy to pertussis.  Subsequently, after receiving the tetanus toxoid the patient felt dizzy.  The patient was laid back down for another 15 minutes and then was fine so they let her go home.  While the patient was about to leave the lot, she felt dizzy again, but they decided just to go home because her mom was a nurse and decided it would be better.  During the next couple days after the vaccination, the patient experienced being really tired, nausea, and dizziness.  No laboratory diagnostic studies were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Gaze palsy, Pallor
Clinical narrative: Initial and follow up information has been received from a physician concerning a 10 year old female with asthma, who on 16-AUG-2007 at 12:00 was vaccinated with a dose of Gardasil (Lot# 658488/0930U).  On 16-AUG-2007 the child felt lightheaded and 10 minutes later while sitting, her eyes rolled back and she turned pale.  The patient did not experience a loss of consciousness.  The duration was reported as 10 to 15 seconds (previously reported as the patient fainted 10 minutes after injection and was out for about 2 minutes).  She also experienced nausea.  The patient was not hurt.  She did not hit herself because she was sitting on a chair at the time she fainted.  It was reported that the patient was fine when she left the office.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Eye rolling, Nausea, Pallor
Clinical narrative: Initial and follow up information has been received from a physician concerning a 10 year old female with asthma, who on 16-AUG-2007 at 12:00 was vaccinated with a dose of Gardasil (Lot# 658488/0930U).  On 16-AUG-2007 the child felt lightheaded and 10 minutes later while sitting, her eyes rolled back and she turned pale.  The patient did not experience a loss of consciousness.  The duration was reported as 10 to 15 seconds (previously reported as the patient fainted 10 minutes after injection and was out for about 2 minutes).  She also experienced nausea.  The patient was not hurt.  She did not hit herself because she was sitting on a chair at the time she fainted.  It was reported that the patient was fine when she left the office.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Blood pressure decreased, Hyperhidrosis, Oxygen saturation normal, Syncope
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 20-AUG-2007 was vaccinated intramuscularly with her third dose of 0.5 mL of Gardasil. Concomitant therapy included hepatitis A vaccine (MSD) and medroxprogesterone acetate (PROVERA). On 20-AUG-2007 the patient "completely passed out" after receiving Gardasil. The patient sought unspecified medical attention. On 20-AUG-2007 the patient recovered. Additional information has been requested. Initial and follow-up information has been received from a physician concerning an 11 year old (previously reported as 10 year old) female with a history of reflux, encopresis, and allergies to AUGMENTION and CEFZIL, who on 20-AUG-2007 at 11:30 was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (Lot# 656991/0001U) administered in intramuscularly in the left deltoid. Concomitant therapies included PROVERA, TYLENOL, and MOTRIN. There were no illness at the time of vaccinations. On 20-AUG-2007 at 11:40 the patient fainted in the hallway of the clinic for approximately 5 to 10 minutes (also reported as "completely passed out") after receiving GARDASIL. The patient was sweaty. Her blood pressure was 98/60, heart rate was 70, and oxygen saturation was 98%. The patient was kept lying down. After 15 minutes her blood pressure was 110/70, heart rate was 82 and oxygen saturation was 94. The patient was sent home to rest. On 20-AUG-2007 the patient recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 20-AUG-2007 was vaccinated intramuscularly with her third dose of 0.5 mL of Gardasil. Concomitant therapy included hepatitis A vaccine (MSD) and medroxprogesterone acetate (PROVERA). On 20-AUG-2007 the patient "completely passed out" after receiving Gardasil. The patient sought unspecified medical attention. On 20-AUG-2007 the patient recovered. Additional information has been requested. Initial and follow-up information has been received from a physician concerning an 11 year old (previously reported as 10 year old) female with a history of reflux, encopresis, and allergies to AUGMENTION and CEFZIL, who on 20-AUG-2007 at 11:30 was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (Lot# 656991/0001U) administered in intramuscularly in the left deltoid. Concomitant therapies included PROVERA, TYLENOL, and MOTRIN. There were no illness at the time of vaccinations. On 20-AUG-2007 at 11:40 the patient fainted in the hallway of the clinic for approximately 5 to 10 minutes (also reported as "completely passed out") after receiving GARDASIL. The patient was sweaty. Her blood pressure was 98/60, heart rate was 70, and oxygen saturation was 98%. The patient was kept lying down. After 15 minutes her blood pressure was 110/70, heart rate was 82 and oxygen saturation was 94. The patient was sent home to rest. On 20-AUG-2007 the patient recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 21-AUG-2007 was vaccinated with a second dose of Gardasil lot # 0530U.  Concomitant therapy included ZYRTEC.  The physician reported that on 21-AUG-2007 the patient developed red itchy rash on her face that spread to her arms and chest.  The outcome was unknown.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site mass, Pain in extremity
Clinical narrative: 8 days after shot patient has a large hard lump at infection site - also complains of soreness and it hurting to move arm above head.  Lump is bigger today 9/19/07 then it was two days ago.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Influenza like illness, Injection site induration, Pain, Pruritus
Clinical narrative: FLU LIKE SYMPTOMS, INDURATION AT SITE AND BEYOND, APPROX 14 CM BY 7 AND ONE HALF CM ACCOMPANIED BY PAIN, ITCHING, REDNESS, AND SWELLING. SIGNS AND SYMPTOMS LASTED 10 DAYS.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: FLU LIKE SYMPTOMS, INDURATION AT SITE AND BEYOND, APPROX 14 CM BY 7 AND ONE HALF CM ACCOMPANIED BY PAIN, ITCHING, REDNESS, AND SWELLING. SIGNS AND SYMPTOMS LASTED 10 DAYS.
Age: 12.0
Sex: F
Vaccine: DTPHIB, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female with a history of convulsion who on an unspecified date was vaccinated with Gardasil (lot#unknown) 0.5mL IM. Concomitant therapy included diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis vaccine (unspecified) (+) tetanus toxoid administered the same day as the Gardasil. On an unspecified date, after the administration of Gardasil the patient experienced syncope and brief seizure-like activity. Subsequently, the patient recovered from syncope and brief seizure-like activity prior to leaving the clinic. No further information is available. Upon internal review, brief seizure-like activity is considered to be an other medical event (OME). Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Body temperature increased, Haematochezia, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 4 month old female who was vaccinated with an oral second dose of Rotateq. "Within 24 hours," the patient experienced hematochezia, vomiting and fever and was hospitalized. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No further information is available. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Body temperature increased, Faeces discoloured, Gastroenteritis rotavirus, Pyrexia, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 11 week old male with no pertinent medical history or drug allergies, who on 23-AUG-2007 was vaccinated with his first dose of Rotateq. There was no concomitant medication. On 11-SEP-2007 the patient developed a 102.3 F fever, vomited once and produced a large stool greenish color. Medical attention was sought by contacting the physician's office. On 12-SEP-2007 the patient was admitted to the hospital due to a high fever. The patient also vomited one more time at the hospital. Lab diagnostic studies performed a rotavirus test and it came back positive. The patient's recovery status was unknown.  There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 week old male with no pertinent medical history or drug allergies, who on 23-AUG-2007 was vaccinated with his first dose of Rotateq. There was no concomitant medication. On 11-SEP-2007 the patient developed a 102.3 F fever, vomited once and produced a large stool greenish color. Medical attention was sought by contacting the physician's office. On 12-SEP-2007 the patient was admitted to the hospital due to a high fever. The patient also vomited one more time at the hospital. Lab diagnostic studies performed a rotavirus test and it came back positive. The patient's recovery status was unknown.  There was no product quality complaint. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Barium enema, Diarrhoea haemorrhagic, Intussusception, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 25-week-old female with no pertinent medical history and no drug reactions/allergies who on 16-MAY-2007 and 12-JUL-2007 was vaccinated PO with the first and second 2mL doses of Rotateq (Lot #'s 656385/0030U and 657292/0551U, respectively). There was no concomitant medication. On 04-SEP-2007 the patient experienced symptoms of intussusception. The patient initially experienced vomiting that was followed by bloody diarrhea 12 hours later. The patient was brought to the emergency room and then transferred to another hospital. The intussusception was treated with a barium enema and the patient was discharged on 05-SEP-2007. On 05-SEP-2007, the patient recovered from intussusception. There were no lab diagnostic studies performed. No further information is available. There was no product quality complaint. The event was considered to be immediately life-threatening and other important medical event by the reporter. Additional information has been requested.  9/28/07 Received hospital x 2 medical records which reveal patient seen in outlying ER for intermittent abdominal pain, vomiting, lethargy, pallor, dehydration & bloody diarrhea.  Transferred to higher level of care for successful air contrast enema reduction.  Admitted & d/c on 9/5/2007 w/o complication.   FINAL DX: Intussusception, enema reduced. 10/5/07 Received vax record.  VAERS database updated w/same.  Records faxed to CDC.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Appendicectomy, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 7-month-old male who on 11-JUN-2007 was vaccinated with a third dose of Rotateq. Concomitant therapy included Prevnar, PedvaxHIB, IPOL and Daptacel. On 07-JUL-2007 the patient went to the emergency room in a hospital and had surgeries for intussusception and appendectomy (not further specified). It is unknown how long the patient was hospitalized. On an unspecified date, the patient recovered and was discharged. No product quality complaint was involved. The reporter considered intussusception to be an other important medical event and life threatening. Additional information has been requested. 9/20/07-records received with report-presented to ED 7/19/07 with 2 day C/O fever, vomiting, no stool.  Surgical repair of Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Enema administration, Irritability, Pyrexia, Somnolence, Ultrasound abdomen
Clinical narrative: Information has been received from a physician concerning a 7-month-old male who on 11-JUN-2007 was vaccinated with a third dose of Rotateq. Concomitant therapy included Prevnar, PedvaxHIB, IPOL and Daptacel. On 07-JUL-2007 the patient went to the emergency room in a hospital and had surgeries for intussusception and appendectomy (not further specified). It is unknown how long the patient was hospitalized. On an unspecified date, the patient recovered and was discharged. No product quality complaint was involved. The reporter considered intussusception to be an other important medical event and life threatening. Additional information has been requested. 9/20/07-records received with report-presented to ED 7/19/07 with 2 day C/O fever, vomiting, no stool.  Surgical repair of Intussusception.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting, X-ray
Clinical narrative: Information has been received from a physician concerning a 7-month-old male who on 11-JUN-2007 was vaccinated with a third dose of Rotateq. Concomitant therapy included Prevnar, PedvaxHIB, IPOL and Daptacel. On 07-JUL-2007 the patient went to the emergency room in a hospital and had surgeries for intussusception and appendectomy (not further specified). It is unknown how long the patient was hospitalized. On an unspecified date, the patient recovered and was discharged. No product quality complaint was involved. The reporter considered intussusception to be an other important medical event and life threatening. Additional information has been requested. 9/20/07-records received with report-presented to ED 7/19/07 with 2 day C/O fever, vomiting, no stool.  Surgical repair of Intussusception.
Age: 0.5
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Appendicectomy, Intussusception, Surgery
Clinical narrative: This is a 7-month-old male with a two-day history of fever measured up to 102. He has also had increasing sleepiness and fussiness over the last 24 hours and today had increasing vomiting, seven times today noted to be "brown and green." He has not had diarrhea and his fever has since resolved. There has been no significant cough or congestion. He had previously been given Tylenol for symptoms but no other new medicines.
Age: 0.5
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Enema administration, Irritability, Pyrexia, Somnolence, Ultrasound abdomen
Clinical narrative: This is a 7-month-old male with a two-day history of fever measured up to 102. He has also had increasing sleepiness and fussiness over the last 24 hours and today had increasing vomiting, seven times today noted to be "brown and green." He has not had diarrhea and his fever has since resolved. There has been no significant cough or congestion. He had previously been given Tylenol for symptoms but no other new medicines.
Age: 0.5
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting, X-ray
Clinical narrative: This is a 7-month-old male with a two-day history of fever measured up to 102. He has also had increasing sleepiness and fussiness over the last 24 hours and today had increasing vomiting, seven times today noted to be "brown and green." He has not had diarrhea and his fever has since resolved. There has been no significant cough or congestion. He had previously been given Tylenol for symptoms but no other new medicines.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Respiratory syncytial virus infection
Clinical narrative: Information has been received from a physician concerning a 2 month old male with a history of being 27 week premature baby on 17-AUG-2007 was vaccinated with a dose of Rotateq. Concomitant therapy included Prevnar, PedvaxHib and Pediarix. In August 2007, the patient experienced apnea and respiratory syncytial virus and was hospitalized. The reporter felt that apnea was related to therapy with Rotateq. The physician considered Apnea and respiratory syncytial virus serious due to hospitalization and were considered to be immediately life-threatening. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral haemorrhage
Clinical narrative: Information has been received from a physician concerning a female consumer with no pertinent history who on approximately 05-SEP-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. On approximately 05-SEP-2007 the patient developed a cerebral hemorrhage and was hospitalized. The condition was considered to be immediately life-threatening per the physician. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 68-year-old female who in the "spring of 2007" was vaccinated with a dose of Zostavax (Oka/Merck) (lot# not available). On 11-SEP-2007 the patient was diagnosed with shingles. Unspecified medical attention was sought. The outcome is reported as not recovered. No product quality complaint was involved. The reporter considered shingles to be disabling or incapacitating. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Angiotensin converting enzyme, Antinuclear antibody negative, Blood folate, Blood magnesium decreased, Blood phosphorus decreased
Clinical narrative: Left facial weakness approximately 12 hours following receipt of AVA dose #1; left upper chest burning, SOB, left arm/hand paresthesias, left hand weakness approximately 24 hours following receipt of AVA dose #1. Inability to smile or wrinkle forehead (CN VII) Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Chest Pain Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Dyspnoea Start: 08/11/2007 End: 09/04/2007 Symptoms: Paresthesia Start: 08/11/2007 Comment: Left arm, left index finger & medial thumb Symptoms: Weakness Start: 08/11/2007 Comment: Left hand 11/19/07-records received for DOS- 9/4-9/7/07-DC DX: Serum reaction/adverse effect fo Anthrax. Unspecified disease of pericardium/pericaditis. Disturbance of skin sensastion. Facial weakness. Swelling/mass/or lump in head and neck. headache. Bacterial vaccine causing adverse effects in therapeutic use. Presented 3 weeks status post anthrax vaccination with left hand tingling, left arm pain and left facial weakness. Symptoms began on morning following injection with left sided swelling of face and tenderness and redness at injection site. Developed trouble swallowing and chest tightness and left upper extremity complaints. Diagnosed with Bell's palsy and pericarditis.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Blood potassium decreased, Blood thyroid stimulating hormone normal, Borrelia burgdorferi serology negative, Cardiac enzymes normal, Chest pain
Clinical narrative: Left facial weakness approximately 12 hours following receipt of AVA dose #1; left upper chest burning, SOB, left arm/hand paresthesias, left hand weakness approximately 24 hours following receipt of AVA dose #1. Inability to smile or wrinkle forehead (CN VII) Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Chest Pain Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Dyspnoea Start: 08/11/2007 End: 09/04/2007 Symptoms: Paresthesia Start: 08/11/2007 Comment: Left arm, left index finger & medial thumb Symptoms: Weakness Start: 08/11/2007 Comment: Left hand 11/19/07-records received for DOS- 9/4-9/7/07-DC DX: Serum reaction/adverse effect fo Anthrax. Unspecified disease of pericardium/pericaditis. Disturbance of skin sensastion. Facial weakness. Swelling/mass/or lump in head and neck. headache. Bacterial vaccine causing adverse effects in therapeutic use. Presented 3 weeks status post anthrax vaccination with left hand tingling, left arm pain and left facial weakness. Symptoms began on morning following injection with left sided swelling of face and tenderness and redness at injection site. Developed trouble swallowing and chest tightness and left upper extremity complaints. Diagnosed with Bell's palsy and pericarditis.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Computerised tomogram normal, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Electromyogram normal
Clinical narrative: Left facial weakness approximately 12 hours following receipt of AVA dose #1; left upper chest burning, SOB, left arm/hand paresthesias, left hand weakness approximately 24 hours following receipt of AVA dose #1. Inability to smile or wrinkle forehead (CN VII) Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Chest Pain Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Dyspnoea Start: 08/11/2007 End: 09/04/2007 Symptoms: Paresthesia Start: 08/11/2007 Comment: Left arm, left index finger & medial thumb Symptoms: Weakness Start: 08/11/2007 Comment: Left hand 11/19/07-records received for DOS- 9/4-9/7/07-DC DX: Serum reaction/adverse effect fo Anthrax. Unspecified disease of pericardium/pericaditis. Disturbance of skin sensastion. Facial weakness. Swelling/mass/or lump in head and neck. headache. Bacterial vaccine causing adverse effects in therapeutic use. Presented 3 weeks status post anthrax vaccination with left hand tingling, left arm pain and left facial weakness. Symptoms began on morning following injection with left sided swelling of face and tenderness and redness at injection site. Developed trouble swallowing and chest tightness and left upper extremity complaints. Diagnosed with Bell's palsy and pericarditis.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Facial paresis, Full blood count normal, Glycosylated haemoglobin, HIV test negative, Haemoglobin
Clinical narrative: Left facial weakness approximately 12 hours following receipt of AVA dose #1; left upper chest burning, SOB, left arm/hand paresthesias, left hand weakness approximately 24 hours following receipt of AVA dose #1. Inability to smile or wrinkle forehead (CN VII) Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Chest Pain Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Dyspnoea Start: 08/11/2007 End: 09/04/2007 Symptoms: Paresthesia Start: 08/11/2007 Comment: Left arm, left index finger & medial thumb Symptoms: Weakness Start: 08/11/2007 Comment: Left hand 11/19/07-records received for DOS- 9/4-9/7/07-DC DX: Serum reaction/adverse effect fo Anthrax. Unspecified disease of pericardium/pericaditis. Disturbance of skin sensastion. Facial weakness. Swelling/mass/or lump in head and neck. headache. Bacterial vaccine causing adverse effects in therapeutic use. Presented 3 weeks status post anthrax vaccination with left hand tingling, left arm pain and left facial weakness. Symptoms began on morning following injection with left sided swelling of face and tenderness and redness at injection site. Developed trouble swallowing and chest tightness and left upper extremity complaints. Diagnosed with Bell's palsy and pericarditis.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Liver function test normal, Muscular weakness, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: Left facial weakness approximately 12 hours following receipt of AVA dose #1; left upper chest burning, SOB, left arm/hand paresthesias, left hand weakness approximately 24 hours following receipt of AVA dose #1. Inability to smile or wrinkle forehead (CN VII) Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Chest Pain Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Dyspnoea Start: 08/11/2007 End: 09/04/2007 Symptoms: Paresthesia Start: 08/11/2007 Comment: Left arm, left index finger & medial thumb Symptoms: Weakness Start: 08/11/2007 Comment: Left hand 11/19/07-records received for DOS- 9/4-9/7/07-DC DX: Serum reaction/adverse effect fo Anthrax. Unspecified disease of pericardium/pericaditis. Disturbance of skin sensastion. Facial weakness. Swelling/mass/or lump in head and neck. headache. Bacterial vaccine causing adverse effects in therapeutic use. Presented 3 weeks status post anthrax vaccination with left hand tingling, left arm pain and left facial weakness. Symptoms began on morning following injection with left sided swelling of face and tenderness and redness at injection site. Developed trouble swallowing and chest tightness and left upper extremity complaints. Diagnosed with Bell's palsy and pericarditis.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Red blood cell sedimentation rate normal, Syphilis test negative, Vitamin B12
Clinical narrative: Left facial weakness approximately 12 hours following receipt of AVA dose #1; left upper chest burning, SOB, left arm/hand paresthesias, left hand weakness approximately 24 hours following receipt of AVA dose #1. Inability to smile or wrinkle forehead (CN VII) Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Chest Pain Start: 08/11/2007 End: 09/04/2007 Comment: Left-sided Symptom: Dyspnoea Start: 08/11/2007 End: 09/04/2007 Symptoms: Paresthesia Start: 08/11/2007 Comment: Left arm, left index finger & medial thumb Symptoms: Weakness Start: 08/11/2007 Comment: Left hand 11/19/07-records received for DOS- 9/4-9/7/07-DC DX: Serum reaction/adverse effect fo Anthrax. Unspecified disease of pericardium/pericaditis. Disturbance of skin sensastion. Facial weakness. Swelling/mass/or lump in head and neck. headache. Bacterial vaccine causing adverse effects in therapeutic use. Presented 3 weeks status post anthrax vaccination with left hand tingling, left arm pain and left facial weakness. Symptoms began on morning following injection with left sided swelling of face and tenderness and redness at injection site. Developed trouble swallowing and chest tightness and left upper extremity complaints. Diagnosed with Bell's palsy and pericarditis.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Vomiting
Clinical narrative: Pt c/o headaches x 5 days. 9/10/07 pt /co H/A with vomiting. Pt sent to ER for CT scan. Pt received Meningitis vaccine; 8/01/07 (Menactra). 10/25/07-records received from facility for DOS 9/11-9/15/07-DC DX: Viral meningitis. Herpes Zoster. presented with 5 day history of headache, photophobia, vomiting and new rash on his right flank. Dermatomal rash. Vesicular lesions. Developed throbbing frontal headache, presumed concussion after playing lacrosse. Increased fatigue and decreased appetite.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, CSF culture negative, Grand mal convulsion, Pyrexia
Clinical narrative: Child with fever and generalized tonic-clonic seizure for less than 10 minutes.  10/9/07 Reviewed hospital medical records which reveal patient experienced fever & seizure including shaking lasting approx 10 min followed by period of unresponsiveness.  Seen in outlying ER, given antibiotics & antipyretic & transferred to higher level of care.  Admitted 9/12-9/13/2007.  Neuro consult done. FINAL DX: febrile seizire. 10/18/07 Received vax record but no lot #s provided.  Lot numbers & dose confirmed via phone as correct on report.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site cellulitis, Injection site inflammation, Oedema peripheral, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old male with asthma, hyperlipidaemia and pulmonary hypertension and a history of nasal polyps and dislocated shoulder who on 12-SEP-2007 was vaccinated with a dose of Pneumovax 23 (lot #657143/0380U), IM in the right deltoid. Concomitant therapy included DTaP, prednisone, omalizumab (XOLAIR), mometasone furoate (ASNANEX), atorvastatin calcium (LIPITOR) and albuterol. On 13-SEP-2007, the patient developed a cellulitis at the injection site. The patient returned to the physician's office on 13-SEP-2007 with cellulitis in the injection site arm. The cellulitis was described as painful, red and warm. The elbow was inflamed and the arm was swollen distal to the injection site. Unspecified medical attention was sought. At the time of reporting, the patient was recovering from the events. Cellulitis at injection site, elbow inflamed and arm swollen distal to injection site were considered to be disabling and an other important medical event. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old male with asthma, hyperlipidaemia and pulmonary hypertension and a history of nasal polyps and dislocated shoulder who on 12-SEP-2007 was vaccinated with a dose of Pneumovax 23 (lot #657143/0380U), IM in the right deltoid. Concomitant therapy included DTaP, prednisone, omalizumab (XOLAIR), mometasone furoate (ASNANEX), atorvastatin calcium (LIPITOR) and albuterol. On 13-SEP-2007, the patient developed a cellulitis at the injection site. The patient returned to the physician's office on 13-SEP-2007 with cellulitis in the injection site arm. The cellulitis was described as painful, red and warm. The elbow was inflamed and the arm was swollen distal to the injection site. Unspecified medical attention was sought. At the time of reporting, the patient was recovering from the events. Cellulitis at injection site, elbow inflamed and arm swollen distal to injection site were considered to be disabling and an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cyanosis, Death, Irritability
Clinical narrative: On 9/19/07 between 11:30-12N child received 4 vaccinations (see below). Dr saw infant 3 hrs later and he appeared well. Parents state between 6p-8p infant fussy. In AM of 9/20/07 child found "blue" 911 called but infant died.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hyperhidrosis, Nausea, Urticaria
Clinical narrative: C/O dizziness, diaphoretic, hives, nausea, and headache
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Irritability, Oedema peripheral
Clinical narrative: Rotateq, Pediarix, HIB, and Prevnar given as ordered, no distress noted after baby discharged from Clinic to home mother called clinic within 1-2 hrs states "baby won't stop crying" instructed to give Tylenol as directed and comfort baby. Mother called clinic again between 2-3 pm 7/19/07-Instructed to return to clinic. 7/19/07 3:30 Children's Motrin 1/2 tsp po given @ clinic and examined baby/Dr. (Mother stated on phone today baby fussy and edema in leg-not noticed at office. Within 20-30 min after Motrin baby less fussy, also order for Benadryl 1/2 tsp po every 6 hr. Called mother at home 9/20/07-Baby calm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Raised, hard, oval shaped, hot, itchy, redness on skin (2-3 inches), no fever, 40 hours after injection
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Erythema, Pruritus, Urticaria
Clinical narrative: 9-17-07 pt awoke around 3:30 with hives all over body, getting worse throughout the day. Very large, red, itching. denies difficulty breathing.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: No reaction at site - given deltoid. + Axillary lymph node - swollen/painful
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: 7.5 cm local erythema at site of injection, tender fever 102.0