chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia, Syncope
Clinical narrative: My daughter's first Guardsil shot was Sept 13th. She was out of school Sept 14, Sept 20, Oct 1, Oct 19, w/headache, nausea, weakness.  Oct 24 she had a seizure at school.  I called her doctor they were not that concerned but I brought her to the Doctor the next day becasue i was concerned. Blood work was order and an EEG. My daughter had another seizure/fainted (not a severe as the first seizure)on Nov 8th in school. She failed all her classes her first term.  She was absent 9 times.  Second shot Nov 19th.  She was very sick all week with all of the signs of Guillain-Barre Syndrome. Heavy Head, stiff neck, fever, back pains, muscle pain, weakness.  It was Thanskgiving week so she didn't miss that much school however when school began on Monday, Nov 26th she was in tears trying to get ready.  She was out of school again that day she was too sick to go. I gave her Motrin every 6 hours as nothing else seeemed to help i.e. Advil Tylenol.  I told all of the medical professionals that she had appointments with about receiving this shot but not one of them attributed her sickness/symptoms to the Guardsil shot. No one knew why my daughter was sick until one day a friend said "this all seemed to start with those shots" so I started to research this shot.  This is when I found out about the side effects of Gardasil. Many other young girls have had severe side effects just like my daughter. 12/14/07-records received for DOS 9/13/07-well visit, prescribed birth control pills-9/14/07-C/O blurry vision and does not remember anything till she woke up on floor. Observed to have tremors. Hands felt numb. Tired. Head a small bump. Had migraine last week. In class when event occurred discussing blood and things in science class felt uncomfortable and queasy. Likely syncopal episode, might be vagal in nature. Visit 10/25/07-seizure at school fell to floor after loosing vision. Observed as movements of arms and legs. Another fainting episode on 11/8/07. Parent concerned about 5 hour gap between breakfast and lunch.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Abnormal behaviour, Erythema, Hypersomnia, Increased appetite, Pyrexia
Clinical narrative: Father noted red face x 4 days.  Low grade fever x 2 days. Runny nose.  Behavioral changes...more defiant and much more energetic.  Sleeping more and eating more than normal.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: Father noted red face x 4 days.  Low grade fever x 2 days. Runny nose.  Behavioral changes...more defiant and much more energetic.  Sleeping more and eating more than normal.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy
Clinical narrative: Patient given the HPV vaccine unaware at the time the patient was pregnant.  No adverse reaction noted.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score abnormal, Drug exposure during pregnancy, Foetal disorder, Foetal growth retardation, Inappropriate schedule of drug administration
Clinical narrative: Initial and follow-up information has been received from a physician and a 27 year old female with hypertension, 2 prior pregnancies with 1 full term delivery via cesarean section and 1 miscarriage who on 09-MAR-2007 was vaccinated with the first dose of Gardasil (lot# 655619/1427F). Concomitant therapy included labetaolol HCl. Subsequently, the patient became pregnant within 2 weeks after Gardasil (LMP 07-MAR-2007; EDD 14-DEC-2007). On 01-MAY-2007, an ultrasound revealed a viable pregnancy. The patient was placed on pre-natal vitamins and hydromadinone. On an unspecified date the patient experienced intra-uterine growth retardation (IUGR) and a non reassuring tracing. On 10-OCT-2007, thirty weeks from the last menstrual period (LMP) the patient delivered a normal 1 pound 12 oz premature female. The labor and delivery were uncomplicated. The apgar scores were 5 and 5. At the time of the report the patient had recovered. The infant's outcome was unknown. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Premature baby, Ultrasound scan abnormal
Clinical narrative: Initial and follow-up information has been received from a physician and a 27 year old female with hypertension, 2 prior pregnancies with 1 full term delivery via cesarean section and 1 miscarriage who on 09-MAR-2007 was vaccinated with the first dose of Gardasil (lot# 655619/1427F). Concomitant therapy included labetaolol HCl. Subsequently, the patient became pregnant within 2 weeks after Gardasil (LMP 07-MAR-2007; EDD 14-DEC-2007). On 01-MAY-2007, an ultrasound revealed a viable pregnancy. The patient was placed on pre-natal vitamins and hydromadinone. On an unspecified date the patient experienced intra-uterine growth retardation (IUGR) and a non reassuring tracing. On 10-OCT-2007, thirty weeks from the last menstrual period (LMP) the patient delivered a normal 1 pound 12 oz premature female. The labor and delivery were uncomplicated. The apgar scores were 5 and 5. At the time of the report the patient had recovered. The infant's outcome was unknown. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: Information has been received from the administering pharmacist concerning a 78 year old retired female with no known allergies and no other pertinent medical history who on 23-AUG-2007 at 14:15 was vaccinated SC with a dose of Zostavax (Oka/Merck) (lot #658211/0884U) in the left deltoid. There was no illness at the time of vaccination. Concomitant drug therapy included lovastatin (manufacturer unknown). On 23-AUG-2007 th e patient experienced severe neuropathy type pain in the areas of a previous shingles rash. The patient phoned the reporting pharmacist and it was reported that no labs/diagnostics were performed. As of 04-SEP-2007, the pharmacist and it was reported that no labs/diagnostics were performed. As of 04-SEP-2007, the patient's severe neuropathy type pain persisted. Follow-up information from a pharmacist indicating that the patient had history of severe shingles but there was no rash or outbreak of shingles. On approximately 24-AUG-2007 (also reported as 23-AUG-2007) within a few days of receiving Zostavax (Oka/Merck) (lot #658211/0884U), the patient experienced severe neuropathy pain. The patient sought unspecified medical attention. It was also noted that the patient was still experiencing pain. The pharmacist considered severe neuropathic pain to be disabling.  Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: No adverse reaction noted.Flu shot administered at incorrect age.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Fall, Gait disturbance, Headache
Clinical narrative: Patient received vaccine at approx 5:30PM on 11/28. Later that evening, patient developed a mild headache, diffuse, 4/10. Patient did not take any over the counter analgesic medicine. Patient was able to sleep throughout the night without any apparent difficulty. Upon awakening in the morning for school, patient felt dizzy and light headed. He was able to get out of bed and ambulate without falling. Patient still had a headache at that time described as the same. Patient over all "did not feel good" with "slgiht upset stomach." Patient therefore went back to bed. At approximately 9am, Dr. called the family to discuss the cost of MRI with the family. At that time they discussed the patient's symptoms and I advised them to give him some motrin for the headache and to encourage fluids. The patient's right arm, where he recieved the shot, was slightly "tense" but without any erythema or swelling or pain per the family. Of note, the patient did not have any increased work of breathing, shortness of breath, hives, rash, or facial or tongue swelling. I advised the family to keep the patient hydrated today and to come to my office in the afternoon if he was not feeling better. At approx 5pm yesterday afternoon, the patient did come to my office. At that time he still complained of mild, 4/10, diffuse headache. His last motrin was in the morning. He felt less dizzy and lightheaded. His abdominal discomfort had resovled. He had general feeling of weakness but ambulated well. No Nausea or vomiting or diarrhea. no rhinorrhea or cough. The patient was stable. I advised the family to continue pushing fluids and to continue taking tylenol or motrin for the headache. I spoke with the family at approx 10 am today. The patient still had a residual headache with "slight upset stomach" without emesis or diarrhea. He did go to school today.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Malaise, Stomach discomfort
Clinical narrative: Patient received vaccine at approx 5:30PM on 11/28. Later that evening, patient developed a mild headache, diffuse, 4/10. Patient did not take any over the counter analgesic medicine. Patient was able to sleep throughout the night without any apparent difficulty. Upon awakening in the morning for school, patient felt dizzy and light headed. He was able to get out of bed and ambulate without falling. Patient still had a headache at that time described as the same. Patient over all "did not feel good" with "slgiht upset stomach." Patient therefore went back to bed. At approximately 9am, Dr. called the family to discuss the cost of MRI with the family. At that time they discussed the patient's symptoms and I advised them to give him some motrin for the headache and to encourage fluids. The patient's right arm, where he recieved the shot, was slightly "tense" but without any erythema or swelling or pain per the family. Of note, the patient did not have any increased work of breathing, shortness of breath, hives, rash, or facial or tongue swelling. I advised the family to keep the patient hydrated today and to come to my office in the afternoon if he was not feeling better. At approx 5pm yesterday afternoon, the patient did come to my office. At that time he still complained of mild, 4/10, diffuse headache. His last motrin was in the morning. He felt less dizzy and lightheaded. His abdominal discomfort had resovled. He had general feeling of weakness but ambulated well. No Nausea or vomiting or diarrhea. no rhinorrhea or cough. The patient was stable. I advised the family to continue pushing fluids and to continue taking tylenol or motrin for the headache. I spoke with the family at approx 10 am today. The patient still had a residual headache with "slight upset stomach" without emesis or diarrhea. He did go to school today.
Age: 62.0
Sex: F
Vaccine: DPP, PPV
Symptoms: Anorexia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Chills, fever of 102; sore, swollen, red upper right arm extending from injection site in pattern outward of 5 inches; nausea, anorexia, dry heaves.
Age: 62.0
Sex: F
Vaccine: DPP, PPV
Symptoms: Nausea, Pyrexia, Retching
Clinical narrative: Chills, fever of 102; sore, swollen, red upper right arm extending from injection site in pattern outward of 5 inches; nausea, anorexia, dry heaves.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Full blood count, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient has been experiencing repeated redness, swelling, and itching at the injection site. The skin is also slightly warm. The rash is about 2.5 X 2.5 inches. The rash will resolve without treatment. The rash will last from a few hours to all day. The rash develops off and on unpredictably from a few time a week to once in a few months. He has not had any other reactions with Anthrax immunizations. This is his 4th Anthrax vaccine injection. He has full and normal use of his arm when the rash develops.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site warmth, No reaction on previous exposure to drug, Red blood cell sedimentation rate decreased
Clinical narrative: Patient has been experiencing repeated redness, swelling, and itching at the injection site. The skin is also slightly warm. The rash is about 2.5 X 2.5 inches. The rash will resolve without treatment. The rash will last from a few hours to all day. The rash develops off and on unpredictably from a few time a week to once in a few months. He has not had any other reactions with Anthrax immunizations. This is his 4th Anthrax vaccine injection. He has full and normal use of his arm when the rash develops.
Age: 52.0
Sex: M
Vaccine: PNC
Symptoms: Blood thyroid stimulating hormone decreased, Chest pain, Dyspnoea, Echocardiogram, Thyroxine increased
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for chest pain and shortness of breath. Vaccination took place on 10/22/07 and hospital admission was 11/4/2007. Relationship to study treatment is 'None'. We would be happy to forward the Study's SAE report upon request. 11/30/07-report received for DOS 11/4-11/10/07-DC DX:Severe COPD. C/O SOB and chest pain.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Throat tightness
Clinical narrative: I received Influenza vaccine at work as recommended by employer at 1030 on 11/2/2007. Approx 1 hr after admin., I began to cough. As the course of the day progressed I became ill. At approx 5:00 pm I was at home and my throat and lungs felt as if they were "closed" I was unable to take a deep breath. Benadryl did not relieve symptoms. I went to ED at LMH and was given Epinephrine via breathing tx . My symptoms were immediately relieved. The ED had me stay for observation afterwards to ensure treatment.effects
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: According to Mo. Son's has full body rash with itching Tues nite after receiving imm on Tues am. Denied fever or any other symptoms. RN observed body rash from top of head to legs on arms and torso. Denied itching today. Rash 1s individual bumps. No pustusales noted.
Age: 1.42
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Medication error
Clinical narrative: Patient was to have received .25ml for flu vaccine and was given 0.5ml
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Abdominal pain, Dyspnoea, Feeling hot, Flushing, Nausea
Clinical narrative: 11/29/07:  15-20 minutes after vaccines were given patient left health department and went across the street to the store and complained of feeling feverish with shortness of breath; also complained of reflux, flushing of the skin lasting about 15 minutes; Feeling somewhat better she drove home but complained of some abdominal cramps and nausea lasting another 15 minutes.  Patient says she felt fine when she arrived home and went jogging.  Pt called to report this on 11/30/07 and said she feels fine today but wanted to report what happened.  Pt denies any other adverse events.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Reflux oesophagitis
Clinical narrative: 11/29/07:  15-20 minutes after vaccines were given patient left health department and went across the street to the store and complained of feeling feverish with shortness of breath; also complained of reflux, flushing of the skin lasting about 15 minutes; Feeling somewhat better she drove home but complained of some abdominal cramps and nausea lasting another 15 minutes.  Patient says she felt fine when she arrived home and went jogging.  Pt called to report this on 11/30/07 and said she feels fine today but wanted to report what happened.  Pt denies any other adverse events.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, MMR, MNQ, VARCEL
Symptoms: Rash
Clinical narrative: Rash on right lateral chest area under bra Bumps. Denied itching, fever or other symptoms.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Rash pruritic
Clinical narrative: According to Mom itchy body rash occurred Tues pm after receiving imm in am. Denied fever or any other symptoms. Rash are individual bumps without pustuales from head to legs on arms and torso. Denies any itching after Tues pm.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Patient had a an allergic reaction to the vaccine on the (R) upper arm which radiates down the entire arm.
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: pt was accidentally given a second dose of menatra today.  His last menactra 4/12/2007
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Asthenia, Disorientation, Weight bearing difficulty
Clinical narrative: The following morning the husband noted that patient was "talking out of her head". By noon she could not stand under her weight because of weakness.  She has continued to waiver between orientation and disorientation.  This is her second hospital day.  It is not known when she will be discharged.  12/21/07 Reviewed hospital medical records which reveal patient experienced right arm pain, warmth & swelling with fever, chills, dry mouth, weakness, lightheadedness, decreased oral intake & acute confusion.  Seen at outlying ER 3 days prior to admit for syncope & d/c to home when CT scan head WNL.  Admitted 11/29-12/03/2007.  Exam also revealed submandibular lymphadenopathy & breast tenderness.  Right deltoid w/large area of erythema & tenderness.  Tx w/IVF & IV antibiotics.  Improved & d/c to home. FINAL DX: Presyncope, likely secondary to dehydration; right arm cellulitis; hypokalemia.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Body temperature increased, Convulsion
Clinical narrative: Pt spiked temp of 101.3 and had seizure; was taken to ER
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: REACTION TO IMMUNIZATIONS, VARIVAX AND/OR PEDIARIX. LARGE SWOLLEN, VERY PAINFUL, RED LEFT ARM WITH BLISTERS IN IJECTION SITE
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: RECIEVED SHOTS 11/28/07 AND BROKE OUT IN HIVES- STARTED THAT NIGHT AFTER RECEIVING SHOTS.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: HIGH FEVER 103-106. NO PHYSICAL FINDINGS. FEVER STARTED A DAY AFTER THE SHOT WAS GIVEN
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: This patient had localized swelling, redness and pruritis for 3 days after the injection of varicella vaccine manufactured by Merck (lot # 1024U).
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria, Vomiting
Clinical narrative: Vaccine(Dtap) was given to child @1430. Foster caregiver called @1843 stated that child had hives to extremities and vomited four times since immunization given.  Caregiver asked to return to clinic for evaluation Per Md. @1904 Caregiver called and stated she had given Benadryl and was going to hospital ER due to traffic congestion enroute to clinic.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound uterus, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with no known medical history and/or drug reactions/allergies who on 02-MAR-2007 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (lot # 653736/0868F). On 14-MAY-2007 the patient was vaccinated with the second dose of Gardasil (lot # 655324/0089U). The physician reported that the patient had intercourse in early August 2007. On 05-SEP-2007 the patient took a home pregnancy test which was positive. She contacted her doctor. On 06-SEP-2007 a serum pregnancy test was performed with positive results. On 19-SEP-2007 the patient had an ultrasound done which showed that she was 8 weeks and 4 days pregnant. On 22-SEP-2007 the pregnancy was terminated. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Joint stiffness, Musculoskeletal discomfort, Musculoskeletal stiffness, Myalgia, Weight bearing difficulty
Clinical narrative: Initial information has been received from a health professional on 30-OCT-2007 concerning a 59 year old male with a history of heart problems who on 23-OCT-2007 was vaccinated with the first dose of Pneumovax 23 (lot number and batch number not reported). Concomitant therapy included aspirin. On 23-OCT-2007, six hours post vaccination, the patient experienced severe muscle pain with stiffness in the hip (site not reported) and was not able to weight bear. The patient received treatment with indomethacin and dihydrocodeine. The patient may have to cancel his forthcoming holiday due to the events. The patient has not yet recovered. Upon internal review on 01-NOV-2001 by company physician. This case has been upgraded from non-serious to serious due to significant disability/incapapcity as the patient was unable to weight bear due to muscle pain and stiffness in the hip. Other business partner numbers included: E2007-07545
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a Registered Nurse concerning a male in his 70's who was vaccinated with Pneumovax 23. Concomitant therapy included warfarin sodium (Coumadin) and influenza virus vaccine (unspecified). Subsequently the patient experienced a swollen and red arm. The patient went to the ER twice and it was not known whether he was admitted into the hospital. The patient was treated with IV antibiotics. As of 07-NOV-2007, the patient had recovered. The nurse felt that this was an other important medical event. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Arrhythmia, Blood pressure increased, Disability, Echocardiogram abnormal, Heart rate increased
Clinical narrative: Information has been received from a physician concerning a 52 year old female with asthma, hypertension, menopause, penicillin allergy, sulfonamide allergy and allergic reaction to antibiotics (macrodantin) who on 03-NOV-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (lot # 655501/1035F). Concomitant therapy included montelukast sodium (MSD) 10 mg once daily, estrogens, conjugated (PREMARIN0 0.625 once daily, sumatriptan (IMITREX (sumatriptan)) PRN, metoprolol tartrate (LOPRESSOR) 25 mg BID, valsartan (DIOVAN) 80 mg oral daily and baby aspirin daily. On 04-NOV-2007 the patient was not feeling well. Patient's blood pressure was 180/90 and heart rate went to 133. The patient went to the Emergency room and was hospitalized on 04-NOV-2007 with a diagnosis of viral syndrome, hypertension, cardiac dysrhythmia and allergy. The patient was discharged from the hospital on 07-NOV-2007. The patient also had redness at the injection site and swelling from the injection site down the arm. The patient called the doctor for follow up on approximately 13-NOV-2007. The patient's status was not reported. Not feeling well, viral syndrome, hypertension, cardiac dysrhythmia, allergy, redness at the injection site and swelling from the injection site down the arm were considered to be disabling, life threatening and other important medical events. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Hypertension, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Information has been received from a physician concerning a 52 year old female with asthma, hypertension, menopause, penicillin allergy, sulfonamide allergy and allergic reaction to antibiotics (macrodantin) who on 03-NOV-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (lot # 655501/1035F). Concomitant therapy included montelukast sodium (MSD) 10 mg once daily, estrogens, conjugated (PREMARIN0 0.625 once daily, sumatriptan (IMITREX (sumatriptan)) PRN, metoprolol tartrate (LOPRESSOR) 25 mg BID, valsartan (DIOVAN) 80 mg oral daily and baby aspirin daily. On 04-NOV-2007 the patient was not feeling well. Patient's blood pressure was 180/90 and heart rate went to 133. The patient went to the Emergency room and was hospitalized on 04-NOV-2007 with a diagnosis of viral syndrome, hypertension, cardiac dysrhythmia and allergy. The patient was discharged from the hospital on 07-NOV-2007. The patient also had redness at the injection site and swelling from the injection site down the arm. The patient called the doctor for follow up on approximately 13-NOV-2007. The patient's status was not reported. Not feeling well, viral syndrome, hypertension, cardiac dysrhythmia, allergy, redness at the injection site and swelling from the injection site down the arm were considered to be disabling, life threatening and other important medical events. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Viral infection
Clinical narrative: Information has been received from a physician concerning a 52 year old female with asthma, hypertension, menopause, penicillin allergy, sulfonamide allergy and allergic reaction to antibiotics (macrodantin) who on 03-NOV-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (lot # 655501/1035F). Concomitant therapy included montelukast sodium (MSD) 10 mg once daily, estrogens, conjugated (PREMARIN0 0.625 once daily, sumatriptan (IMITREX (sumatriptan)) PRN, metoprolol tartrate (LOPRESSOR) 25 mg BID, valsartan (DIOVAN) 80 mg oral daily and baby aspirin daily. On 04-NOV-2007 the patient was not feeling well. Patient's blood pressure was 180/90 and heart rate went to 133. The patient went to the Emergency room and was hospitalized on 04-NOV-2007 with a diagnosis of viral syndrome, hypertension, cardiac dysrhythmia and allergy. The patient was discharged from the hospital on 07-NOV-2007. The patient also had redness at the injection site and swelling from the injection site down the arm. The patient called the doctor for follow up on approximately 13-NOV-2007. The patient's status was not reported. Not feeling well, viral syndrome, hypertension, cardiac dysrhythmia, allergy, redness at the injection site and swelling from the injection site down the arm were considered to be disabling, life threatening and other important medical events. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: FLU3
Symptoms: Diet refusal, Listless, Pallor, Retching, Vomiting
Clinical narrative: Had flu vaccine 11/21/07 at 9:30am.  Around 12:30pm child wouldn't eat, seemed pale to parents, seemed listless.  Then started dry heaving and vomiting.  Fell asleep at 12:45pm, slept for a while, then mom woke him and gave Tylenol.  Since waking up seemed back to normal self & took sips of water which was kept down.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Neuropathy, Viral infection
Clinical narrative: Beginning Jan 07 fell and couldn't get up. Neighbors had to bodily pick me up. Could not control any part of my body, had walker and had to get a wheel chair couldn't walk or do anything. Seen doctor on Jan 10. Then seen him on Feb 7 and he threw me out of his office and said your got a walker and wheelchair use it, see your own physician. Hospital said I had neuropathy. My physician sent me to a neuro doctor. He did blood test and an EMG and told me I had a virus from my flu shot. April 2 2007 he sent me for intravenous some monoglobulin for one week every day. Had therapy for 3 months finally I am able to walk and I do have control of my body. He also said I had Guillain Barre a slight bit for a while. Thank God I am ok now.  1/8/07 Clinic medical records reviewed which reveal patient experienced difficulty climbing stairs, falls, weakness, tiredness, difficulty walking, numbness in lfingers & toes starting in 1/2007.  Her pain woke her at night.  Seen in Neuro clinic 3/6/07 & dx w/polyneuropathy.  Was already received home PT & had aide to assist w/ADLs.  Returned to clinic 3/28/07 for EMG/NCS & started tx w/IVIG for total of 4 doses.  Returned to clinic 5/14/07 able to ambulate w/cane but still had numbess of hands & feet. Returned to clinic 7/10/07 & continued to improve, using cane only when outside, paresthesias had resolved, no pain & had normal use of her hands.  Clinic records indicate flu shot given 11/2006, not 4/2007 as patient reported.  Shot record not available. FINAL DX: Guillain Barre syndrome, resolving.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: Beginning Jan 07 fell and couldn't get up. Neighbors had to bodily pick me up. Could not control any part of my body, had walker and had to get a wheel chair couldn't walk or do anything. Seen doctor on Jan 10. Then seen him on Feb 7 and he threw me out of his office and said your got a walker and wheelchair use it, see your own physician. Hospital said I had neuropathy. My physician sent me to a neuro doctor. He did blood test and an EMG and told me I had a virus from my flu shot. April 2 2007 he sent me for intravenous some monoglobulin for one week every day. Had therapy for 3 months finally I am able to walk and I do have control of my body. He also said I had Guillain Barre a slight bit for a while. Thank God I am ok now.  1/8/07 Clinic medical records reviewed which reveal patient experienced difficulty climbing stairs, falls, weakness, tiredness, difficulty walking, numbness in lfingers & toes starting in 1/2007.  Her pain woke her at night.  Seen in Neuro clinic 3/6/07 & dx w/polyneuropathy.  Was already received home PT & had aide to assist w/ADLs.  Returned to clinic 3/28/07 for EMG/NCS & started tx w/IVIG for total of 4 doses.  Returned to clinic 5/14/07 able to ambulate w/cane but still had numbess of hands & feet. Returned to clinic 7/10/07 & continued to improve, using cane only when outside, paresthesias had resolved, no pain & had normal use of her hands.  Clinic records indicate flu shot given 11/2006, not 4/2007 as patient reported.  Shot record not available. FINAL DX: Guillain Barre syndrome, resolving.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Bradycardia, Cold sweat, Crying, Heart rate decreased, Oxygen supplementation
Clinical narrative: Here for flu shot. See VAR; 1025- Flu shot given in left leg - laying on exam table-; 1027 sat up and was talking and crying to mom. Note face becoming pale and lips becoming pale. O2 placed nasal cannula at 1.5 liters - Called for help. O2 sats 94%-95% at 1 1/2 liter - HR - 70 - responded to pain and mom's voice - X 2 IV attempts unsuccessful on hands and X1 #24 jilco Left antecubital by RN - fluids bolus started by NS. Epi Jr given at 1032. 911 -called 1045. at this time sats 98-99% and heart rate 120, and crying and fighting with IV starts. 1050 ambulance personnel here - information given - and transferred to ER by ambulance - parent in attendance. Assisted dad to ran to go and meet wife and son in ER.: Addendum: History and events as above. Past history in May '07 of similar incident post - Hep A vaccine. Heart Rate went down very low (a 10 or so, very bradycardia): Color was just very pale, including buccal mucosa. Skin was cold and clammy. The eyes were closed. patient responsive to Mom's voice and pain stimuli with attempted I.V. insertions. After Epi Pen given and NSS started, color slowly returned to normal and EMT bought patient to ER where he was given Benadryl and Steroid. Vitals were stable and patient was transferred to Peds. Dx - Vasonagal reaction vs Anaphylactic Shock.   12/19/2007 MR received for ER visit 11/14/2007 who presented after a reaction to flu vaccine with the impression: Vasovagal reaction. Child received vaccine and became pale, hypotensive  and bradycardic with loss of consciousness.  Had previous rxn of hypotension to Hep A vax. EpiPen and IV fluids administered in PMD's office and transported. Child improved promptly with tx.  No local rxn.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Peripheral coldness, Syncope vasovagal, Tryptase
Clinical narrative: Here for flu shot. See VAR; 1025- Flu shot given in left leg - laying on exam table-; 1027 sat up and was talking and crying to mom. Note face becoming pale and lips becoming pale. O2 placed nasal cannula at 1.5 liters - Called for help. O2 sats 94%-95% at 1 1/2 liter - HR - 70 - responded to pain and mom's voice - X 2 IV attempts unsuccessful on hands and X1 #24 jilco Left antecubital by RN - fluids bolus started by NS. Epi Jr given at 1032. 911 -called 1045. at this time sats 98-99% and heart rate 120, and crying and fighting with IV starts. 1050 ambulance personnel here - information given - and transferred to ER by ambulance - parent in attendance. Assisted dad to ran to go and meet wife and son in ER.: Addendum: History and events as above. Past history in May '07 of similar incident post - Hep A vaccine. Heart Rate went down very low (a 10 or so, very bradycardia): Color was just very pale, including buccal mucosa. Skin was cold and clammy. The eyes were closed. patient responsive to Mom's voice and pain stimuli with attempted I.V. insertions. After Epi Pen given and NSS started, color slowly returned to normal and EMT bought patient to ER where he was given Benadryl and Steroid. Vitals were stable and patient was transferred to Peds. Dx - Vasonagal reaction vs Anaphylactic Shock.   12/19/2007 MR received for ER visit 11/14/2007 who presented after a reaction to flu vaccine with the impression: Vasovagal reaction. Child received vaccine and became pale, hypotensive  and bradycardic with loss of consciousness.  Had previous rxn of hypotension to Hep A vax. EpiPen and IV fluids administered in PMD's office and transported. Child improved promptly with tx.  No local rxn.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Excessive eye blinking, Gaze palsy, Irritability
Clinical narrative: About 18 hours after immunizations baby had stiffening, eyes rolled back, then blinked rapidly, lasted about 45 sec. No rhythmic body movement. Breathing movements noted during stiffening. Very sleepy after episode. Associated with fever up to 103. Generally fussy only. Has continued to be excessively irritable since event.  12/21/07 Reviewed hospital medical records which reveal patient experienced fever, seizure-like jerky movements, irritability,eyes rolling back in head, stiffness followed by period of being difficult to arouse.  Saw PCP who sent to ER. Had rhinorrhea & nasal congestion since vax.  Rash on face & arms.  Admitted 11/16-11/19/2007. Tx w/IV antibiotics.  Ped neuro consult done.   FINAL DX: seizure, likely febrile; viral exanthem. 1/4/08 Reviewed vax record which confirms lot #s as reported.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lumbar puncture, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pyrexia, Somnolence
Clinical narrative: About 18 hours after immunizations baby had stiffening, eyes rolled back, then blinked rapidly, lasted about 45 sec. No rhythmic body movement. Breathing movements noted during stiffening. Very sleepy after episode. Associated with fever up to 103. Generally fussy only. Has continued to be excessively irritable since event.  12/21/07 Reviewed hospital medical records which reveal patient experienced fever, seizure-like jerky movements, irritability,eyes rolling back in head, stiffness followed by period of being difficult to arouse.  Saw PCP who sent to ER. Had rhinorrhea & nasal congestion since vax.  Rash on face & arms.  Admitted 11/16-11/19/2007. Tx w/IV antibiotics.  Ped neuro consult done.   FINAL DX: seizure, likely febrile; viral exanthem. 1/4/08 Reviewed vax record which confirms lot #s as reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Pt got flu shot at outlying clinic 10/9/07. Presented to our facility 11/1/07 w/ lower extremity weakness and transferred to hospital - hospitalized there  and w/u was consistent with Guillain-Barre syndrome - treated w/ IVIG w/ improvement.  12/7/07 Reviewed ER medical records which reveal patient experienced ankle swelling & pain, bilateral LE weakness, difficulty walking & fever.   W/u for rheumatic fever & tx w/penicillin & high dose ASA w/o improvement.  Transferred to higher level of care for further w/u of systemic inflammatory process, felt to be unlikely GBS due to (+) DTRs. 12/7/07 Reviewed hospital medical records which reveal patient experienced bilateral leg pain.  Saw PCP, dx w/UTI & started antibiotics.  Leg pain worsened & developed SOB, warmth & bilateral LE edema, weakness & flat red rash over the next 10 days.  ER dx w/possible rheumatic fever.  Tx w/penicillin & ASA.  Had some imiprovement but when stopped ASA fever returned.  Continued w/tingling of bilateral LEs.  Returned to ER & transferred to higher level of care.  Admitted 11/1-11/8/2007.  Neuro consult obtained.  Tx w/IVIG x 5 days.  Improved & d/c to home. FINAL DX: Bilateral LE weakness, suspect Guillain-Barre syndrome; elevated transaminases; vitamin B12 deficiency; hyperlipidemia; elevated sed rate. CDC's CISA staff has reviewed VAERS 298327 and concluded it is not GBS. Follow-up Information 16-DEC-2008: By chart review, no persistent neuro symptoms. I do not see this patient personally. Follow-up Information 18-DEC-2007: Pt was seen for problem on 1/1/07 - symptoms started several days prior.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration Right upper arm. 01/02/2008 MR received for DOS 11/29-12/02/2007 with DX:  Cellulitis R upper arm.  Pt developed redness and itching morning after vax.  Txd with po abx by PCP however developed vessicles/blistering and presented to ER. Tx with IV abx with resolution.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: 2 1/2 year old male c/o swelling and redness with itching on day #2 (after flu shot) around injection site. No tenderness or other complaints. 10x8cm erythematous swelling and warm/itchy rash around left upper arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Paraesthesia
Clinical narrative: Patient experienced warmth and tingling at injection site of Zostavax vaccine. Patient was sent to Dr after 30 minutes.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Pain in extremity, Rash erythematous
Clinical narrative: Pt has red bumps around inject site and sore arm day after inject and is still having pain in arm for over 1 week.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Erythema, Pyrexia, Swelling, Tracheomalacia
Clinical narrative: Swelling, erythema, fever and chills 2 days after vaccine given. Gave Keflex 10 day course for possible cellulitis.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: -found a lump in right deltoid -some redness and swelling occurred
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Blister, Erythema, Lymphadenopathy, Pain in extremity, Skin warm
Clinical narrative: Redness, swelling, warmth, streaking down arm + pain, tenderness + blistering + lymph node enlargement.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Redness, swelling, warmth, streaking down arm + pain, tenderness + blistering + lymph node enlargement.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warm to touch. Left upper arm. Ibuprofen 800mg TID and Benadryl 25mg PRN
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Sleep disorder
Clinical narrative: Pt. reported pain in vaccinated arm beginning almost immediately after receiving Tdap, pain increased over time and by day 7 it extended from elbow to neck with limited ROM in shoulder. Pain interferred with sleep and ADLs. Temporary relief with heat, acetaminophen. No visible swelling, erythema. Started ibuprofen 600 mg tid with improved ROM. Pain still present but improving day 23.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Gait disturbance, Hypoaesthesia, Muscular weakness, Neuropathy peripheral
Clinical narrative: 13 Nov developed numbness from buttocks to toes, muscle weakness made it hard to walk. Seen by ortho 19 Nov - EMG - "mild distal peripheral neuropathy, delayed peroneal motor latencies, and variable peroneal F waves.  12/4/07 Reviewed vax records which confirm lot # as reported.  12/11/07 Reviewed neurologist medical records which reveal patient initially seen 11/29/07 after experienced sudden loss of feeling from waist down approx 2 wks prior.  Had gradually improved prior to visit but still had some numbness & pain in calves & was noted to walk w/a waddling limp.  Tx w/steroids.  Returned to neuro 12/3/07 continuing to improve FINAL DX: atypical Guillain Barre syndrome vs. transverse myelitis, improving.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Peroneal nerve palsy
Clinical narrative: 13 Nov developed numbness from buttocks to toes, muscle weakness made it hard to walk. Seen by ortho 19 Nov - EMG - "mild distal peripheral neuropathy, delayed peroneal motor latencies, and variable peroneal F waves.  12/4/07 Reviewed vax records which confirm lot # as reported.  12/11/07 Reviewed neurologist medical records which reveal patient initially seen 11/29/07 after experienced sudden loss of feeling from waist down approx 2 wks prior.  Had gradually improved prior to visit but still had some numbness & pain in calves & was noted to walk w/a waddling limp.  Tx w/steroids.  Returned to neuro 12/3/07 continuing to improve FINAL DX: atypical Guillain Barre syndrome vs. transverse myelitis, improving.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain, Axillary pain, Diarrhoea, Injected limb mobility decreased, Muscle spasms
Clinical narrative: A few hours after vaccine administered, very sudden shooting pain in left arm & under arm (arm pit area), could not raise arm.  Later followed by diarrhea, vomiting, pain in abdomen, muscle spasms.  Following day - still painful & still nauseous.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: A few hours after vaccine administered, very sudden shooting pain in left arm & under arm (arm pit area), could not raise arm.  Later followed by diarrhea, vomiting, pain in abdomen, muscle spasms.  Following day - still painful & still nauseous.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Nausea, Pain in extremity, Palpitations, Pollakiuria
Clinical narrative: 7:00 PM Felt queezy in stomach off and on in evening. 10:30P - 400 A Got chills with shaking - to bed. 130 A - 300 A Felt my heart pounding in my (L) ear. Had to urinate large amts several times in the night. 400 AM - warmed up - slept - ok next day - except both arms hurt about 3 days. (R) arm more than (L) arm.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Tremor
Clinical narrative: 7:00 PM Felt queezy in stomach off and on in evening. 10:30P - 400 A Got chills with shaking - to bed. 130 A - 300 A Felt my heart pounding in my (L) ear. Had to urinate large amts several times in the night. 400 AM - warmed up - slept - ok next day - except both arms hurt about 3 days. (R) arm more than (L) arm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Intense itching, hives, low grade fever 99.2 - 100.2
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: Hives/erythema multiforme whole body.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Rash vesicular
Clinical narrative: 120x200 mm erythem indurated area on (L) arm with 40 mm vesicular rxn and a slight fever 4 days (100.8)-Treatment Benadryl. Motrin, Keflex
Age: 1.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Body temperature increased, Catheter placement, Convulsion, Dyspnoea
Clinical narrative: Temperature of 103 F, very hot and cold. Had a seizure. Was given Motrin/Tylenol for 4 days. Went to the hospital. Was losing color and couldn't breathe. She was given oxygen.
Age: 1.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling of body temperature change, Oxygen supplementation, Pallor, Urine analysis
Clinical narrative: Temperature of 103 F, very hot and cold. Had a seizure. Was given Motrin/Tylenol for 4 days. Went to the hospital. Was losing color and couldn't breathe. She was given oxygen.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Anorexia, Back pain, Chills, Nasal congestion
Clinical narrative: LAIV on Thurs-am. Fri and Sat runny nose and congestion. Sat. evening 101.5 degrees fever and chills - Tylenol and Ibuprofen alternating. Sat. evening thru Sun. nite. sat evening backache and leg aches. Sun. stomach pain - no appetite, Fluids were "pushed" by mom, thru feverish days. Mon. a-m- fever broke appetite returned. Feels. better.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: LAIV on Thurs-am. Fri and Sat runny nose and congestion. Sat. evening 101.5 degrees fever and chills - Tylenol and Ibuprofen alternating. Sat. evening thru Sun. nite. sat evening backache and leg aches. Sun. stomach pain - no appetite, Fluids were "pushed" by mom, thru feverish days. Mon. a-m- fever broke appetite returned. Feels. better.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chest discomfort, Hypersomnia, Malaise, Nausea
Clinical narrative: body itched-back, shoulders and chest rib cage- sore felt physically sick nauseated slept for 1 week-night and day No energy-chest tight 1st week 10/25/07. Better 2nd week no energy body itched less 11/12/07. 3rd week almost back to normal
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pruritus generalised
Clinical narrative: body itched-back, shoulders and chest rib cage- sore felt physically sick nauseated slept for 1 week-night and day No energy-chest tight 1st week 10/25/07. Better 2nd week no energy body itched less 11/12/07. 3rd week almost back to normal
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site inflammation, Injection site pruritus, Injection site reaction
Clinical narrative: Swelling, itching, inflamed and hot to touch at upper arm where shot was given.  Emergency room doctor said it was a local allergic reaction or cellulitis and gave antibiotic for seven days.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling, itching, inflamed and hot to touch at upper arm where shot was given.  Emergency room doctor said it was a local allergic reaction or cellulitis and gave antibiotic for seven days.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: (R) shoulder is still painful at injection site when lifted above head in full extension 2 weeks after vaccine received. No redness or swelling at site. Symptoms remain at this time.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: 0.5 Tdap to (L) deltoid - immed onset pain down arm, gradually worsening over 30 min. Radial nerve sx's (pain/weakness), paresthesias radial dorsal hand.
Age: 18.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site rash, Rash macular
Clinical narrative: localized silver dollar size-Tdap localized silver dollar size-Hep B light red macular rash Flu no induration
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Rash pruritic
Clinical narrative: Patient called clinic today after receiving Influenza vaccine on 11-07-07 saying that she had a non-raised rash under her arms, breasts, and around her waist area that was itching. She said that it comes and out on 11-10-07 and has been there since. She also reported that she had swollen lymph nodes under her arms. She was instructed to call her MD and report back to us the outcome.