chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Oedema peripheral, Pain, Rash macular
Clinical narrative: This is in follow-up to report (s) previously submitted on 03/26/2008. After recieving the injection my arm started to burn at the injection site. and then started to spread across to my shoulder towards my clavicle midway, down my arm mid way towards my elbow. There are blotches of reddened areas that feel like burns. Sensitive to touch and feel warm. It hurts to extend my arm. Dr. has seen the area and has perscribed Keflex and has told me that it has developed into cellulitis. He told me to use ice to the site. Thru out each day it has gotten worse. The injection was given 4:30PM on Monday 3/24/08 and each day there is more red areas and an increase in pain. There is swelling of the arm also. Initial and follow-up information has been received from a healthcare worker concerning a 51 year old female registered nurse (employee nurse) with allergies to penicillin and BIAXIN, who on 24-MAR-2008 at 16:30 was vaccinated IM in the left arm with a first dose of PNEUMOVAX 23 (lot #659150/1384U). There were no illnesses at the time of the vaccination. On 24-MAR-2008 at 16:30 the patient experienced burning at the injection site that spread across the shoulder midway towards the clavicle and then down the arm midway towards the elbow. The patient developed blotches of reddened areas that were reported to feel like burns. The area was sensitive and warm to touch. The patient reported that it hurt to extend her arm. On 27-MAR-2008, the nurse presented to the office with shoulder pain and welts over her entire arm (treatment not specified). The doctor examined the area and said tht it had developed into cellulitis. The patient was prescribed KEFLEX and was advised to apply ice to the site. It was reported that each day the symptoms have gotton worse, there are more red areas, an increase in pain, and swelling of the arm. At the time of this report, the nurse was not recovered. A healthcare worker requested a lot check be performed. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satifactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This in one of 2 reports from the same source. No further information is available.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Burning sensation, Cellulitis, Erythema, Injection site irritation, Musculoskeletal pain
Clinical narrative: This is in follow-up to report (s) previously submitted on 03/26/2008. After recieving the injection my arm started to burn at the injection site. and then started to spread across to my shoulder towards my clavicle midway, down my arm mid way towards my elbow. There are blotches of reddened areas that feel like burns. Sensitive to touch and feel warm. It hurts to extend my arm. Dr. has seen the area and has perscribed Keflex and has told me that it has developed into cellulitis. He told me to use ice to the site. Thru out each day it has gotten worse. The injection was given 4:30PM on Monday 3/24/08 and each day there is more red areas and an increase in pain. There is swelling of the arm also. Initial and follow-up information has been received from a healthcare worker concerning a 51 year old female registered nurse (employee nurse) with allergies to penicillin and BIAXIN, who on 24-MAR-2008 at 16:30 was vaccinated IM in the left arm with a first dose of PNEUMOVAX 23 (lot #659150/1384U). There were no illnesses at the time of the vaccination. On 24-MAR-2008 at 16:30 the patient experienced burning at the injection site that spread across the shoulder midway towards the clavicle and then down the arm midway towards the elbow. The patient developed blotches of reddened areas that were reported to feel like burns. The area was sensitive and warm to touch. The patient reported that it hurt to extend her arm. On 27-MAR-2008, the nurse presented to the office with shoulder pain and welts over her entire arm (treatment not specified). The doctor examined the area and said tht it had developed into cellulitis. The patient was prescribed KEFLEX and was advised to apply ice to the site. It was reported that each day the symptoms have gotton worse, there are more red areas, an increase in pain, and swelling of the arm. At the time of this report, the nurse was not recovered. A healthcare worker requested a lot check be performed. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satifactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This in one of 2 reports from the same source. No further information is available.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Oedema peripheral, Pain in extremity, Rash macular, Skin warm, Urticaria
Clinical narrative: This is in follow-up to report (s) previously submitted on 03/26/2008. After recieving the injection my arm started to burn at the injection site. and then started to spread across to my shoulder towards my clavicle midway, down my arm mid way towards my elbow. There are blotches of reddened areas that feel like burns. Sensitive to touch and feel warm. It hurts to extend my arm. Dr. has seen the area and has perscribed Keflex and has told me that it has developed into cellulitis. He told me to use ice to the site. Thru out each day it has gotten worse. The injection was given 4:30PM on Monday 3/24/08 and each day there is more red areas and an increase in pain. There is swelling of the arm also. Initial and follow-up information has been received from a healthcare worker concerning a 51 year old female registered nurse (employee nurse) with allergies to penicillin and BIAXIN, who on 24-MAR-2008 at 16:30 was vaccinated IM in the left arm with a first dose of PNEUMOVAX 23 (lot #659150/1384U). There were no illnesses at the time of the vaccination. On 24-MAR-2008 at 16:30 the patient experienced burning at the injection site that spread across the shoulder midway towards the clavicle and then down the arm midway towards the elbow. The patient developed blotches of reddened areas that were reported to feel like burns. The area was sensitive and warm to touch. The patient reported that it hurt to extend her arm. On 27-MAR-2008, the nurse presented to the office with shoulder pain and welts over her entire arm (treatment not specified). The doctor examined the area and said tht it had developed into cellulitis. The patient was prescribed KEFLEX and was advised to apply ice to the site. It was reported that each day the symptoms have gotton worse, there are more red areas, an increase in pain, and swelling of the arm. At the time of this report, the nurse was not recovered. A healthcare worker requested a lot check be performed. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satifactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This in one of 2 reports from the same source. No further information is available.
Age: 25.0
Sex: M
Vaccine: HEPA, IPV, TDAP
Symptoms: Activities of daily living impaired, Hypoaesthesia, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: My left arm started hurting, and things got worse hour after hour. At around 11:30PM that night, I took Tylenol PM (had taken regular Tylenol at 5:30PM that day, for this purpose). When I mention Tylenol, I mean 1000mg of acetaminophen. Next day, I could barely move my arm. It is now 4:45pm on 3/26/2008, my arm is now swollen (visible, with no coloring) and the pain increased. My left arm occasionally feels numb/sleeping. I cannot raise anything with that hand, and taking clothes off or putting them on has become a hassle. Driving too. Plus, I am left handed. I did research online, that is why I decided to report this. I have had the vaccine before without any problems (DTP and DT). This one is a Tdap (unsure of differences). I will be contacting my physician tomorrow if my condition does not improve. Will continue Tylenol every 4-5 hours.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Baseball sized swelling with redness.  No pain afebrile with slight itching.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: PT. REC. VARICELLA VACCINE LT.ARM LATERAL ASPECT SUBCUT ON 3/24/08- MOM CALLED AND STATED THAT PT'S ARM HAD REDNESS AND SLIGHT SWELLING. ASKED PARENT TO BRING PT IN. MEASURED REDNESS 3CM X 4CM HAD SLIGHT SWELLING. NO PAIN OR ITCHING. I TALKED WITH N.P- WHO ADVISED ME TO TELL PARENT TO GIVE TYLENOL FOR PAIN AND BENADRYL FOR ITCHING IF NEEDED AND TO COME BACK IN IF SHE WASN'T ANY BETTER.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Rash papular, Swelling
Clinical narrative: same day as vaccine, noted quarter-size swelling, redness, and painful.  Increased over the second day, has not necessarily increased today but remains constant. Today measures at 32 mm circumference, irregular, indurated, has papular lesion 10mm.  Has used ice briefly with little effect.  Plans to use ibuprofen and ice, will seek medical care if not improving in 48 hours, sooner if it gets worse.  Advised to seek medical care sooner if she desires. Will follow up in 48 hours with me.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: 4 x 3 inch lump, red at site of Varivax.  No fever.  Now looks like Red sunburn 3-26-08.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Fatigue, Food aversion
Clinical narrative: Achy muscles, stiff neck and back, extreme fatigue, nausea, migraines, diarrhea, ringing in ears, sharp stabbing pains in belly, severe abdominal cramping, numbness and tingling in limbs, impaired thinking, aversions to foods, strong aversion/nausea upon smelling strong scents, trouble sleeping, fevers.  4/2/2008 MR received for OV 3/27/2008 and PMH back to 12/2006. Pt presented to office with c/o ? reaction to 3rd Gardasil vax. Pt reports migraines x 10 in the week following vax, now with constant, throbbing pain in the R eye area with pressure.  Pt also reports diarrhea and abd cramping, 10 stools yesterday.  Legs go numb during BM. Smells bother pt now. Pt reports fevers. Temp 99.8 at OV.  Pt reports paresthesias in the L leg which began 3/25/08. Pt also reports weakness, fatigue and twitching.  PE WNL. Assessment:  R Frontal Headaches.  Abdominal Pain, cramping & diarrhea. Paresthesias of the legs. Tag2 received from PCP (308590 to be linked). 4/7/08 RN in PCP office reports pt's sx have improved with Medrol dose pack.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Insomnia, Migraine, Musculoskeletal stiffness, Myalgia
Clinical narrative: Achy muscles, stiff neck and back, extreme fatigue, nausea, migraines, diarrhea, ringing in ears, sharp stabbing pains in belly, severe abdominal cramping, numbness and tingling in limbs, impaired thinking, aversions to foods, strong aversion/nausea upon smelling strong scents, trouble sleeping, fevers.  4/2/2008 MR received for OV 3/27/2008 and PMH back to 12/2006. Pt presented to office with c/o ? reaction to 3rd Gardasil vax. Pt reports migraines x 10 in the week following vax, now with constant, throbbing pain in the R eye area with pressure.  Pt also reports diarrhea and abd cramping, 10 stools yesterday.  Legs go numb during BM. Smells bother pt now. Pt reports fevers. Temp 99.8 at OV.  Pt reports paresthesias in the L leg which began 3/25/08. Pt also reports weakness, fatigue and twitching.  PE WNL. Assessment:  R Frontal Headaches.  Abdominal Pain, cramping & diarrhea. Paresthesias of the legs. Tag2 received from PCP (308590 to be linked). 4/7/08 RN in PCP office reports pt's sx have improved with Medrol dose pack.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Paraesthesia, Pyrexia, Thinking abnormal, Tinnitus
Clinical narrative: Achy muscles, stiff neck and back, extreme fatigue, nausea, migraines, diarrhea, ringing in ears, sharp stabbing pains in belly, severe abdominal cramping, numbness and tingling in limbs, impaired thinking, aversions to foods, strong aversion/nausea upon smelling strong scents, trouble sleeping, fevers.  4/2/2008 MR received for OV 3/27/2008 and PMH back to 12/2006. Pt presented to office with c/o ? reaction to 3rd Gardasil vax. Pt reports migraines x 10 in the week following vax, now with constant, throbbing pain in the R eye area with pressure.  Pt also reports diarrhea and abd cramping, 10 stools yesterday.  Legs go numb during BM. Smells bother pt now. Pt reports fevers. Temp 99.8 at OV.  Pt reports paresthesias in the L leg which began 3/25/08. Pt also reports weakness, fatigue and twitching.  PE WNL. Assessment:  R Frontal Headaches.  Abdominal Pain, cramping & diarrhea. Paresthesias of the legs. Tag2 received from PCP (308590 to be linked). 4/7/08 RN in PCP office reports pt's sx have improved with Medrol dose pack.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood count normal, Computerised tomogram normal, Headache, Muscle spasms, Nausea
Clinical narrative: Achy muscles, stiff neck and back, extreme fatigue, nausea, migraines, diarrhea, ringing in ears, sharp stabbing pains in belly, severe abdominal cramping, numbness and tingling in limbs, impaired thinking, aversions to foods, strong aversion/nausea upon smelling strong scents, trouble sleeping, fevers.  4/2/2008 MR received for OV 3/27/2008 and PMH back to 12/2006. Pt presented to office with c/o ? reaction to 3rd Gardasil vax. Pt reports migraines x 10 in the week following vax, now with constant, throbbing pain in the R eye area with pressure.  Pt also reports diarrhea and abd cramping, 10 stools yesterday.  Legs go numb during BM. Smells bother pt now. Pt reports fevers. Temp 99.8 at OV.  Pt reports paresthesias in the L leg which began 3/25/08. Pt also reports weakness, fatigue and twitching.  PE WNL. Assessment:  R Frontal Headaches.  Abdominal Pain, cramping & diarrhea. Paresthesias of the legs. Tag2 received from PCP (308590 to be linked). 4/7/08 RN in PCP office reports pt's sx have improved with Medrol dose pack.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain
Clinical narrative: Achy muscles, stiff neck and back, extreme fatigue, nausea, migraines, diarrhea, ringing in ears, sharp stabbing pains in belly, severe abdominal cramping, numbness and tingling in limbs, impaired thinking, aversions to foods, strong aversion/nausea upon smelling strong scents, trouble sleeping, fevers.  4/2/2008 MR received for OV 3/27/2008 and PMH back to 12/2006. Pt presented to office with c/o ? reaction to 3rd Gardasil vax. Pt reports migraines x 10 in the week following vax, now with constant, throbbing pain in the R eye area with pressure.  Pt also reports diarrhea and abd cramping, 10 stools yesterday.  Legs go numb during BM. Smells bother pt now. Pt reports fevers. Temp 99.8 at OV.  Pt reports paresthesias in the L leg which began 3/25/08. Pt also reports weakness, fatigue and twitching.  PE WNL. Assessment:  R Frontal Headaches.  Abdominal Pain, cramping & diarrhea. Paresthesias of the legs. Tag2 received from PCP (308590 to be linked). 4/7/08 RN in PCP office reports pt's sx have improved with Medrol dose pack.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injected limb mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Sore arm left upper radiating down to the elbow and to chest area. Aggravated by movement. Exam left deltoid firm and painful to touch. Warm to touch, no redness.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse reaction, Pregnancy, Pyrexia, Urine human chorionic gonadotropin positive
Clinical narrative: No reaction - patient did not know of pregnancy at time of vaccination.  Patient found out after ER visit 3 days later for persistent fever - patient was found positive.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Left deltoid swollen, red, tender 6cm x 6cm
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient has erythema, raised and warm to touch, slight pain.
Age: 66.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Redness - inflammation around injection site, itchiness.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Rash papular
Clinical narrative: Multiple red papules on trunk and limbs; Some with appearance of early vesicles
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of facial rash in a 46-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 8 November 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm). On 15 November 2007, 7 days after vaccination with Fluarix, the subject experienced facial rash. The subject was treated with Xyzal. At the time of reporting the event was improved. The physician considered the event was possibly related to vaccination with Fluarix. Follow-up information was received on 11 February 2008 via a physician, who reported that no biopsy was performed on the rash. At the time of reporting, the event was resolved.
Age: 38.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of joint pain in a 38-year-old male subject who was vaccinated with Fluarix (GlaxoSmithKline).  On 10 January 2008 the subject received a dose of Fluarix at 0.5 ml in the left thigh.  On the same day of Fluarix vaccination, 10 January 2008 (time not known) the subject experienced joint pain and limitation of movement.  Pain in the shoulder joint and restricted shoulder movement at the joint were described.  All events except pain in the shoulder joint were improved at the time of reporting.  Pain in the shoulder joint was unresolved.  Follow-up received on 20 February 2008 via the pharmacist.  She reported that the subject received Fluarix in the left deltoid.  She indicated that the outcome of the events were unknown at the time of this report.  She noted that pain in the shoulder joint was unresolved and movement was still restricted.  She considered that the events were related to the use of Fluarix.
Age: 38.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Hypokinesia, Joint range of motion decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of joint pain in a 38-year-old male subject who was vaccinated with Fluarix (GlaxoSmithKline).  On 10 January 2008 the subject received a dose of Fluarix at 0.5 ml in the left thigh.  On the same day of Fluarix vaccination, 10 January 2008 (time not known) the subject experienced joint pain and limitation of movement.  Pain in the shoulder joint and restricted shoulder movement at the joint were described.  All events except pain in the shoulder joint were improved at the time of reporting.  Pain in the shoulder joint was unresolved.  Follow-up received on 20 February 2008 via the pharmacist.  She reported that the subject received Fluarix in the left deltoid.  She indicated that the outcome of the events were unknown at the time of this report.  She noted that pain in the shoulder joint was unresolved and movement was still restricted.  She considered that the events were related to the use of Fluarix.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Asthenia, Diarrhoea, Dizziness, Heart rate increased, Nausea
Clinical narrative: Patient was administered vaccines. Mom reported to administrator that patient was feeling light-headed and refused to lie down or stay in the office for observation because she thought it was because it was so hot in the office. We left a message at home at 1940 that same evening requesting an update and did not receive a call until the next morning. Mom called to report patient was still feeling nauseated, dizzy, and unable to eat since receiving vaccines. She was referred to Hospital at that time.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Syncope
Clinical narrative: Patient was administered vaccines. Mom reported to administrator that patient was feeling light-headed and refused to lie down or stay in the office for observation because she thought it was because it was so hot in the office. We left a message at home at 1940 that same evening requesting an update and did not receive a call until the next morning. Mom called to report patient was still feeling nauseated, dizzy, and unable to eat since receiving vaccines. She was referred to Hospital at that time.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Dizziness, Feeling hot, Nausea, Oral intake reduced
Clinical narrative: Patient was administered vaccines. Mom reported to administrator that patient was feeling light-headed and refused to lie down or stay in the office for observation because she thought it was because it was so hot in the office. We left a message at home at 1940 that same evening requesting an update and did not receive a call until the next morning. Mom called to report patient was still feeling nauseated, dizzy, and unable to eat since receiving vaccines. She was referred to Hospital at that time.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Asthenia, Blood test, Computerised tomogram normal, Decreased appetite, Dizziness
Clinical narrative: Patient was administered vaccines. Mom reported to administrator that patient was feeling light-headed and refused to lie down or stay in the office for observation because she thought it was because it was so hot in the office. We left a message at home at 1940 that same evening requesting an update and did not receive a call until the next morning. Mom called to report patient was still feeling nauseated, dizzy, and unable to eat since receiving vaccines. She was referred to Hospital at that time.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, HPV4
Symptoms: Heart rate increased, Laboratory test normal, Nausea, Syncope, Weight decreased
Clinical narrative: Patient was administered vaccines. Mom reported to administrator that patient was feeling light-headed and refused to lie down or stay in the office for observation because she thought it was because it was so hot in the office. We left a message at home at 1940 that same evening requesting an update and did not receive a call until the next morning. Mom called to report patient was still feeling nauseated, dizzy, and unable to eat since receiving vaccines. She was referred to Hospital at that time.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes zoster L1 Rt 2 days post vaccine.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster L1 Rt 2 days post vaccine.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 week old female with no medical history or allergies who was vaccinated with ROTATEQ 2 ML PO first dose on 25-FEB-2008. There was no concomitant medication. The physician reported that the patient received the first dose of ROTATEQ and three weeks later experienced diarrhoea and vomiting. The patient was seen in the office and was dehydrated. The patient was sent to the hospital for blood tests and was positive for rotavirus. The patient was hospitalized overnight. The physician reported that the patient is: "She's good today( 20-MAR-2008)" The patient sought medical attention. The physician reported that the rotavirus caused the hospitalization and was an other important medical event. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: HIBV, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a nurse practitioner concerning a "previously healthy" 4 month old male who was vaccinated with the first dose of ROTATEQ. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, PREVNAR, Hib conj vaccine (unspecified carrier (manufacturer unknown), and poliovirus vaccine. At the end of January or early February 2008, the patient was observed for 23 hours in the hospital for intussusception after receiving his first dose of ROTATEQ. No lot number was provided. Subsequently, the patient recovered from intussusception on an unspecified date. Therapy with ROTATEQ was not reintroduced. There was no product quality complaint. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLUX, HEPAB, IPV, MMR, TDAP, TYP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Information has been received from a certified nurse practitioner concerning a 31 year old female with no pertinent medical history reported. The patient had her last menstrual period on 20-JAN-2008. On 30-JAN-2008, the patient was vaccainted with MMR II (lot # 1312U). Concomitant therapy also administered on 30-JAN-2008 included TWINRIX, influenza virus vaccine (unspecified) (manufacturer unspecified). poliovirus vaccine inactivated (Vero) (manufacturer unspecified), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and typhoid vaccine live oral (Ty21a) (manufacturer unspecified). Concomitant therapy administered on 06-FEB-2008 included Japanese encephalitis virus vaccine (manufacturer unspecified), and rabies vaccine (unspecified) (manufacturer unspecified). Subsequently, she became pregnant. Her estimated date of delivery was 26-OCT-2008. On 27-FEB-2008, the patient had a pregnancy test. On 28-FEB-2008, the patient miscarried. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, the spontaneous miscarriage was determined to be an Other Important Medical Event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count normal, Laboratory test normal, Muscular weakness, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Information has been received from a physician, concerning a white female student (age not reported), with no pertinent medical history, who on 23-NOV-2007 was vaccinated with the first dose, and on 26-JAN-2008 was vaccinated, IM, with the second dose of GARDASIL (lot #659653/1448U). The physician noted that on 06-NOV-2007, the patient had been vaccinated with a dose of HAVRIX and a dose of MENACTRA. There was no illness at the time of vaccination. On 02-FEB-2008 the patient experienced paresthesias of both feet and up her legs, with some weakness, that continued through the month. On 26-FEB-2008 she experienced "pins and needles" of her arms and shoulders. The patient visited the physician, and on an unknown date, diagnostic testing included a magnetic resonance imaging (MRI) of the head and spine, a complete blood count (CBC), blood chemistries and a thyroid panel, all with normal results. At the time of this report, the outcome of the events was not recovered. The physician considered the events to be serious as disabling or incapacitating. Additional information has been requested. 6/3/08-records received-seen on 2/6/08 with C/O chronic back pain (pine and needles) both legs, hip and ankle. Trouble sleeping. Began on Monday. Feels unbalanced when standing. Urinary incontinence. PE Babinski decreased on right. Unable to stand on tiptoes. Romberg wobbly. Reflexes normal. Sensation in left toe dull. 4/30/08 symptoms continue but improving now intermittent. Neurologist: post viral syndrome. Flu vaccine administered in November along with  Gardasil. Meningitis vaccine in November.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thyroid function test normal
Clinical narrative: Information has been received from a physician, concerning a white female student (age not reported), with no pertinent medical history, who on 23-NOV-2007 was vaccinated with the first dose, and on 26-JAN-2008 was vaccinated, IM, with the second dose of GARDASIL (lot #659653/1448U). The physician noted that on 06-NOV-2007, the patient had been vaccinated with a dose of HAVRIX and a dose of MENACTRA. There was no illness at the time of vaccination. On 02-FEB-2008 the patient experienced paresthesias of both feet and up her legs, with some weakness, that continued through the month. On 26-FEB-2008 she experienced "pins and needles" of her arms and shoulders. The patient visited the physician, and on an unknown date, diagnostic testing included a magnetic resonance imaging (MRI) of the head and spine, a complete blood count (CBC), blood chemistries and a thyroid panel, all with normal results. At the time of this report, the outcome of the events was not recovered. The physician considered the events to be serious as disabling or incapacitating. Additional information has been requested. 6/3/08-records received-seen on 2/6/08 with C/O chronic back pain (pine and needles) both legs, hip and ankle. Trouble sleeping. Began on Monday. Feels unbalanced when standing. Urinary incontinence. PE Babinski decreased on right. Unable to stand on tiptoes. Romberg wobbly. Reflexes normal. Sensation in left toe dull. 4/30/08 symptoms continue but improving now intermittent. Neurologist: post viral syndrome. Flu vaccine administered in November along with  Gardasil. Meningitis vaccine in November.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Information has been received from a physician, concerning a white female student (age not reported), with no pertinent medical history, who on 23-NOV-2007 was vaccinated with the first dose, and on 26-JAN-2008 was vaccinated, IM, with the second dose of GARDASIL (lot #659653/1448U). The physician noted that on 06-NOV-2007, the patient had been vaccinated with a dose of HAVRIX and a dose of MENACTRA. There was no illness at the time of vaccination. On 02-FEB-2008 the patient experienced paresthesias of both feet and up her legs, with some weakness, that continued through the month. On 26-FEB-2008 she experienced "pins and needles" of her arms and shoulders. The patient visited the physician, and on an unknown date, diagnostic testing included a magnetic resonance imaging (MRI) of the head and spine, a complete blood count (CBC), blood chemistries and a thyroid panel, all with normal results. At the time of this report, the outcome of the events was not recovered. The physician considered the events to be serious as disabling or incapacitating. Additional information has been requested. 6/3/08-records received-seen on 2/6/08 with C/O chronic back pain (pine and needles) both legs, hip and ankle. Trouble sleeping. Began on Monday. Feels unbalanced when standing. Urinary incontinence. PE Babinski decreased on right. Unable to stand on tiptoes. Romberg wobbly. Reflexes normal. Sensation in left toe dull. 4/30/08 symptoms continue but improving now intermittent. Neurologist: post viral syndrome. Flu vaccine administered in November along with  Gardasil. Meningitis vaccine in November.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Biopsy skin abnormal, Condition aggravated, Hepatic function abnormal, Polyarteritis nodosa
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient with an allergic reaction to CECLOR and no other pertinent medical history, who in August 2007, was vaccinated with the first dose and in October 2007 was vaccinated with the second dose of GARDASIL (lot #'s not reported). After the second dose, in November 2007, the patient's mother noticed early lesions. In February 2008, the patient was administered the third dose of GARDASIL (lot # not reported). Concomitant therapy also possibly initiated in February 2008 ("a few weeks ago") included CELEBREX. Following the third vaccination of GARDASIL, the lesions worsened. Diagnostic studies included liver functions tests, elevated; renal function test, normal, a skin biopsy, medium vesicle vasculitis. The physician indicated the patient had polyarteritis nodosa, which he described as "another name" for medium vesicle vasculitis. The patient was a runner, and was uncomfortable and had difficulty running due to the symptoms. The patient's polyarteritis nodosa persisted. The physician considered the event to be disabling/incapacitating. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Renal impairment, Skin lesion
Clinical narrative: Information has been received from a physician, concerning a 17 year old female patient with an allergic reaction to CECLOR and no other pertinent medical history, who in August 2007, was vaccinated with the first dose and in October 2007 was vaccinated with the second dose of GARDASIL (lot #'s not reported). After the second dose, in November 2007, the patient's mother noticed early lesions. In February 2008, the patient was administered the third dose of GARDASIL (lot # not reported). Concomitant therapy also possibly initiated in February 2008 ("a few weeks ago") included CELEBREX. Following the third vaccination of GARDASIL, the lesions worsened. Diagnostic studies included liver functions tests, elevated; renal function test, normal, a skin biopsy, medium vesicle vasculitis. The physician indicated the patient had polyarteritis nodosa, which he described as "another name" for medium vesicle vasculitis. The patient was a runner, and was uncomfortable and had difficulty running due to the symptoms. The patient's polyarteritis nodosa persisted. The physician considered the event to be disabling/incapacitating. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood product transfusion, Contusion, Laboratory test, Thrombocytopenia
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 05-OCT-2007 and 29-NOV-2007 was vaccinated with the first and second doses of GARDASIL, respectively. It was reported that post vaccination the patient complained of severe bruising on her arm and leg, without impact. It is unknown exactly where on the arm or leg bruising occurred. The patient was hospitalized and "lots of tests were performed" leading to a diagnosis of immune thrombocytopenia. The patient was treated with "Immunoglobulin Intravenous," and was discharged from the hospital. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Immune thrombocytopenia was considered to be an other medically important event. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: MNQ
Symptoms: Crying, Febrile convulsion, Hypotonia, Skin warm, Unresponsive to stimuli
Clinical narrative: Initial report received on 18 March 2008 from an investigator participating in the above-mentioned trial under the reference number MTA37. A ten-month-old female subject experienced a febrile seizure 5 days after receiving an intramuscular right thigh injection of Menactra (lot number U010253) on 13 March 2008. On the evening of 17 March 2008, the subject's mother noted that she felt warm to the touch. The following morning the subject awoke crying and, according to her mother, felt warm (temperature not reported). She was treated with Motrin, and shortly afterwards had an episode of vomiting. She subsequently turned "limp and unresponsive" for approximately 15 minutes; no cyanosis or upward rolling of eyes was noted. The subject presented to the investigator's clinic for medical evaluation, and her temperature at the time was noted to be 102.6 degrees Fahrenheit. She was treated with a tepid sponge bath, and after 15 minutes her temperature had decreased to 99.9 degrees Fahrenheit. Laboratory testing was performed, including CBC, urine culture and sensitivity, and blood cultures (results not provided). She was treated with Tylenol and observed for two hours, at which time her temperature was noted at 99.3 degrees Fahrenheit. The event was considered to be resolved on 18 March 2008. The subject had no history of convulsions or seizures, and no concomitant medications were reported. She recovered, and continued on the trial. According to the investigator, the event was related to the study vaccine.
Age: 0.8
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Initial report received on 18 March 2008 from an investigator participating in the above-mentioned trial under the reference number MTA37. A ten-month-old female subject experienced a febrile seizure 5 days after receiving an intramuscular right thigh injection of Menactra (lot number U010253) on 13 March 2008. On the evening of 17 March 2008, the subject's mother noted that she felt warm to the touch. The following morning the subject awoke crying and, according to her mother, felt warm (temperature not reported). She was treated with Motrin, and shortly afterwards had an episode of vomiting. She subsequently turned "limp and unresponsive" for approximately 15 minutes; no cyanosis or upward rolling of eyes was noted. The subject presented to the investigator's clinic for medical evaluation, and her temperature at the time was noted to be 102.6 degrees Fahrenheit. She was treated with a tepid sponge bath, and after 15 minutes her temperature had decreased to 99.9 degrees Fahrenheit. Laboratory testing was performed, including CBC, urine culture and sensitivity, and blood cultures (results not provided). She was treated with Tylenol and observed for two hours, at which time her temperature was noted at 99.3 degrees Fahrenheit. The event was considered to be resolved on 18 March 2008. The subject had no history of convulsions or seizures, and no concomitant medications were reported. She recovered, and continued on the trial. According to the investigator, the event was related to the study vaccine.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 70 year old white male elevated cholesterol levels, hypertension, atrial fibrillation and impaired fasting glucose who on 19-SEP-2007 was vaccinated subcutaneously with a first dose of ZOSTAVAX (Lot #658083/0885U). Concomitant therapy included NORVASC, LIPITOR, aspirin, COUMADIN,  atenolol and MAG-OX 400 TABLETS. On 02-OCT-2007 the patient developed itching at the injection site, which proceeded into diffuse, pruritic, papular rash over trunk and arms. The rash resolved with a course of oral steroids. The patient was considered recovered on 15 OCT 2007. There was no illness at the time of vaccination. No diagnostic studies were performed. The patient had no prior history of adverse events with previous vaccinations. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest discomfort, Pruritus, Rash pruritic, Rhinorrhoea, Urticaria
Clinical narrative: 2-3 minutes after administering Varicella SC vaccine - child had profuse nasal discharge, feeling chest discomfort.  Hives face - 125/5 EPI 0.3cc SC right arm 8AM - 3:40PM.  15cc Benadryl PO.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood test, Haematemesis, Haematochezia, Intussusception
Clinical narrative: Received 4 month immunization in AM.  Vomiting blood and blood in stool in afternoon.  Went to hospital ER - transported via ambulance to another hospital.  Diagnosis with interruption.  04/09/2008 MR received for DOS 3/20-22/2008 with DX: Intussusception.  Pt presented to local hospital with bloody stools and vomit and inconsolable crying. Intubated electively and transported to current facility.  Palpable mass noted in LLQ on PE.  Barium enema initially unsuccessful at reduction on first try.  Reduction later sucessful. Pt extubated with mild WOB and decreased BS noted on L with mild stridor.  Resolved with albuterol nebs. Pt to baseline 3/22/08 and D/c.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Enema administration, Intussusception, Peritonitis
Clinical narrative: Intussusception 4/4/08-records received for DOS 12/28/17-1/15/08-DC DX: Intussusception. Suspected post intussusception peritonitis. Presented day prior to admission with 16 hours non-bilious non-bloody vomiting. Decreased appetite and urine output. No diarrhea. Day of admission developed current jelly/bloody stool. Barium enema showed irreducible intussusception and 2 unsuccessful attempts made. Laparotomy revealed no evidence of intussusception. Post operatively developed increasing abdominal distension and tenderness. Coagulopathy improved with FFP and blood transfusion. Recurrent vomiting and loose stools. Fever. Follow-up: Rotavirus vaccine given after incident without adverse events.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Flushing, Nausea, Tongue disorder
Clinical narrative: Employee given Flu shot on 2/11/08 at 3:50/pm and at 4pm she stated she felt flushed and nauseated. Her B/P was up at 162/92 p 110 R 24. Employee stated her tongue felt thick. I gave her a dose of Solu Medrol 125 mg im and called 911 for assistance. She went to ER and received. Solu Medrol Epi Follow-up: It has happened 2x the past 2 years and I don't think drive by flu shots should be permitted.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood culture, Chest X-ray, Culture urine, Pyrexia, X-ray limb
Clinical narrative: After imm administered pt developed a high fever and experienced possible seizure activity - taken to local ER and transferred to another hospital by parents.  04/30/2008 MR received for DOS 2/19-21/2008 with D/C DX: Rigors related to high fevers. Pt presented to ER after 2 episodes of extremity shaking and eyes gazing upward associated with fever 1 day s/p vaccines. First episode ~1 minute, 2nd ~5 min. Temp 39.5'C. PE WNL otherwise. No further episodes.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain, Blood immunoglobulin G normal, Blood immunoglobulin M, CSF cell count normal, CSF culture negative
Clinical narrative: Pt had N/V, fever, nasal congestion, sore throat, decreased sleep, facial rash, HA, myalgia. No relieve w/ OTC Benadryl. Exam at ED found neck pain w/ flexion consistent with meningismus and RUA tenderness, (+) Murphy sign. Admitted to hospital, IV fluids and IV antibiotics. Discharged home in improving condition.  03/28/2008 MR received with VAERS report for DOS 3/2-4/2008 with D/C DX:  Acute sinusitis/viral syndrome (respiratory syncytial virus) and myalgias possibly due to immunizations that she received last week.  Gastritis. Pt presented to ER with fever, sore throat, vomiting and facial rash.  Pt with c/o stiff neck and h/a. PE (+) for facial petechiae, neck pain c/w meningismus and RUQ tenderness. Txd with abx and IVF and d/c improved 3/4/08.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Culture urine negative, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, HIV antibody negative, Headache
Clinical narrative: Pt had N/V, fever, nasal congestion, sore throat, decreased sleep, facial rash, HA, myalgia. No relieve w/ OTC Benadryl. Exam at ED found neck pain w/ flexion consistent with meningismus and RUA tenderness, (+) Murphy sign. Admitted to hospital, IV fluids and IV antibiotics. Discharged home in improving condition.  03/28/2008 MR received with VAERS report for DOS 3/2-4/2008 with D/C DX:  Acute sinusitis/viral syndrome (respiratory syncytial virus) and myalgias possibly due to immunizations that she received last week.  Gastritis. Pt presented to ER with fever, sore throat, vomiting and facial rash.  Pt with c/o stiff neck and h/a. PE (+) for facial petechiae, neck pain c/w meningismus and RUQ tenderness. Txd with abx and IVF and d/c improved 3/4/08.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Influenza serology negative, Insomnia, Liver function test, Meningism, Mononucleosis heterophile test negative
Clinical narrative: Pt had N/V, fever, nasal congestion, sore throat, decreased sleep, facial rash, HA, myalgia. No relieve w/ OTC Benadryl. Exam at ED found neck pain w/ flexion consistent with meningismus and RUA tenderness, (+) Murphy sign. Admitted to hospital, IV fluids and IV antibiotics. Discharged home in improving condition.  03/28/2008 MR received with VAERS report for DOS 3/2-4/2008 with D/C DX:  Acute sinusitis/viral syndrome (respiratory syncytial virus) and myalgias possibly due to immunizations that she received last week.  Gastritis. Pt presented to ER with fever, sore throat, vomiting and facial rash.  Pt with c/o stiff neck and h/a. PE (+) for facial petechiae, neck pain c/w meningismus and RUQ tenderness. Txd with abx and IVF and d/c improved 3/4/08.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Murphy's sign positive, Myalgia, Nasal congestion, Nausea, Neck pain
Clinical narrative: Pt had N/V, fever, nasal congestion, sore throat, decreased sleep, facial rash, HA, myalgia. No relieve w/ OTC Benadryl. Exam at ED found neck pain w/ flexion consistent with meningismus and RUA tenderness, (+) Murphy sign. Admitted to hospital, IV fluids and IV antibiotics. Discharged home in improving condition.  03/28/2008 MR received with VAERS report for DOS 3/2-4/2008 with D/C DX:  Acute sinusitis/viral syndrome (respiratory syncytial virus) and myalgias possibly due to immunizations that she received last week.  Gastritis. Pt presented to ER with fever, sore throat, vomiting and facial rash.  Pt with c/o stiff neck and h/a. PE (+) for facial petechiae, neck pain c/w meningismus and RUQ tenderness. Txd with abx and IVF and d/c improved 3/4/08.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pharyngolaryngeal pain, Pregnancy test negative, Pyrexia, Rash, Streptococcal identification test negative
Clinical narrative: Pt had N/V, fever, nasal congestion, sore throat, decreased sleep, facial rash, HA, myalgia. No relieve w/ OTC Benadryl. Exam at ED found neck pain w/ flexion consistent with meningismus and RUA tenderness, (+) Murphy sign. Admitted to hospital, IV fluids and IV antibiotics. Discharged home in improving condition.  03/28/2008 MR received with VAERS report for DOS 3/2-4/2008 with D/C DX:  Acute sinusitis/viral syndrome (respiratory syncytial virus) and myalgias possibly due to immunizations that she received last week.  Gastritis. Pt presented to ER with fever, sore throat, vomiting and facial rash.  Pt with c/o stiff neck and h/a. PE (+) for facial petechiae, neck pain c/w meningismus and RUQ tenderness. Txd with abx and IVF and d/c improved 3/4/08.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Tenderness, Ultrasound abdomen normal, Urine analysis normal, Virus serology test, Vomiting
Clinical narrative: Pt had N/V, fever, nasal congestion, sore throat, decreased sleep, facial rash, HA, myalgia. No relieve w/ OTC Benadryl. Exam at ED found neck pain w/ flexion consistent with meningismus and RUA tenderness, (+) Murphy sign. Admitted to hospital, IV fluids and IV antibiotics. Discharged home in improving condition.  03/28/2008 MR received with VAERS report for DOS 3/2-4/2008 with D/C DX:  Acute sinusitis/viral syndrome (respiratory syncytial virus) and myalgias possibly due to immunizations that she received last week.  Gastritis. Pt presented to ER with fever, sore throat, vomiting and facial rash.  Pt with c/o stiff neck and h/a. PE (+) for facial petechiae, neck pain c/w meningismus and RUQ tenderness. Txd with abx and IVF and d/c improved 3/4/08.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: White blood cell count increased
Clinical narrative: Pt had N/V, fever, nasal congestion, sore throat, decreased sleep, facial rash, HA, myalgia. No relieve w/ OTC Benadryl. Exam at ED found neck pain w/ flexion consistent with meningismus and RUA tenderness, (+) Murphy sign. Admitted to hospital, IV fluids and IV antibiotics. Discharged home in improving condition.  03/28/2008 MR received with VAERS report for DOS 3/2-4/2008 with D/C DX:  Acute sinusitis/viral syndrome (respiratory syncytial virus) and myalgias possibly due to immunizations that she received last week.  Gastritis. Pt presented to ER with fever, sore throat, vomiting and facial rash.  Pt with c/o stiff neck and h/a. PE (+) for facial petechiae, neck pain c/w meningismus and RUQ tenderness. Txd with abx and IVF and d/c improved 3/4/08.