chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Breech presentation, Caesarean section, Human chorionic gonadotropin positive, Live birth, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 28 year old female patient with hypertension, anxiety, hypothyroidism, hypercholesterolaemia, no drug reactions or allergies and a history of 18-19 week gestation pregnancy loss possibly in 2009, who on 21-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # and expire date not reported), intramuscularly. Concomitant therapy included SYNTHROID (also reported as SNYTHROID) and methyldopa (manufacturer unknown). On 05-NOV-2010, the patient was one week late for her menses and had a positive serum pregnancy test. She had one week of gestation. Her last menstrual period was approximately in September 2010 and estimate delivery date is in approximately June 2011. The patient sought medical attention in the office. Follow up information had been received from a register nurse concerning the patient who on 21-OCT-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot # and expire date not reported). On 03-OCT-2010 and 07-DEC-2010, the patient had 2 sets of varicella titers done and the results of both showed negative. The nurse also verified the patient's LMP was 01-OCT-2010 and her EDD was 09-JUL-2011. On 21-JUN-2011, the patient delivered a healthy  baby boy via C-section. The baby was delivered by C-section due to breech presentation (WAES# 1011USA00857 B1). There was no complication reported with the delivery and the baby boy had no congenital anomalies. Her gestational age of neonate was 37/2. The baby's weight was 6 pounds, 12 oz. Length and H.C. information was not available. C-section due to breech presentation was considered to be an other important medical event. No additional information is available.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Menstruation delayed, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 28 year old female patient with hypertension, anxiety, hypothyroidism, hypercholesterolaemia, no drug reactions or allergies and a history of 18-19 week gestation pregnancy loss possibly in 2009, who on 21-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # and expire date not reported), intramuscularly. Concomitant therapy included SYNTHROID (also reported as SNYTHROID) and methyldopa (manufacturer unknown). On 05-NOV-2010, the patient was one week late for her menses and had a positive serum pregnancy test. She had one week of gestation. Her last menstrual period was approximately in September 2010 and estimate delivery date is in approximately June 2011. The patient sought medical attention in the office. Follow up information had been received from a register nurse concerning the patient who on 21-OCT-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot # and expire date not reported). On 03-OCT-2010 and 07-DEC-2010, the patient had 2 sets of varicella titers done and the results of both showed negative. The nurse also verified the patient's LMP was 01-OCT-2010 and her EDD was 09-JUL-2011. On 21-JUN-2011, the patient delivered a healthy  baby boy via C-section. The baby was delivered by C-section due to breech presentation (WAES# 1011USA00857 B1). There was no complication reported with the delivery and the baby boy had no congenital anomalies. Her gestational age of neonate was 37/2. The baby's weight was 6 pounds, 12 oz. Length and H.C. information was not available. C-section due to breech presentation was considered to be an other important medical event. No additional information is available.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Client received flu vaccine at 12:47 PM. Patient stated she was feeling s/e from injection that was raised and hot.  Patient, arrived for assessment at 2:00 PM, left arm red and swollen at injection site. Vital Signs stable, no signs and symptoms of sever reaction. Local reaction only.  Client advised to contact primary care physician for follow up.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Rash macular, Swollen tongue, Throat tightness
Clinical narrative: Received vaccine at 1:08 PM. At approximately 1:30 PM participant came back to training room wanting to know if it was normal to feel like her throat was tight and tongue swollen. The nurse told her no that it was not normal and that the nurse would need to administer an epinephrine injection. Participant was conscious, alert and oriented. Appeared anxious, face red splotchy. Nurse sat participant down and administered epinephrine 1:1000 0.3mL SQ Right Upper Arm. EMS called. Pulse 84. Respirations 28. Skin warm and dry.  Transported by EMS to ER. Per EMS O2 98% Room Air, BP 150/90. Patient states feeling better on EMS departure.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot
Clinical narrative: Nurse administered flu vaccine at 2:30 PM. Patient had increased anxiety before shot was given. Nuirse had patient wait after administering flu vaccine and patient complained of feeling hot. Had patient remove sweatshirt and applied cold rag to back of the neck. Elevated patients legs. Patient was still feeling dizzy. Nurse placed patient on floor and elevated legs. Patient continued to complain of dizziness. BP 120/84, pulse 80, resp 24. Called EMS at 3:15 PM. EMS arrived at 3:25 PM. EMS assessed the patient and decided to take patient to the emergency room.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Amenorrhoea, Blood oestrogen decreased, Burning sensation, Compartment syndrome
Clinical narrative: This 18 year old female who was otherwise always healthy and active received a 3rd Gardasil injection in May 2008. The first two were administered in late 2007. This female was a top ranked soccer player and was getting ready to attend a Division1 program on a full scholarship. She was training for college soccer around July 2008 when she began to feel tightness in her calves upon running. The pain would cease once she stopped running and she continued to push through the tightness until she began to notice the tightness had spread to the anterior compartments of both lower legs. She described that pain as a burning pain. The pain began to increase with other exertions besides running i.e. jumping, squatting, flexing her feet and climbing stairs. She then was unable to continue playing soccer due to the pain. Of interest is that in addition to the extreme exertional muscle pain, she ceased menstruating for approximately 8 months and her menses only resumed after a course of LoEstrin FE. After a gynecological workup, the patient was found to have extremely low levels of estrogen. Her C4A levels have also been repeatedly extremely high and she tested positive for XMRV and mycoplasma pneumoniae. About a year and a half after the initial symptom of calf tightness, she began to notice a burning in her forearms and upper arms while performing exertions with her arms. These exertions were as simple as cutting a piece of paper, carrying a gallon of milk or blow drying her hair. Around this time, she also noticed the same symptoms she was experiencing in her lower legs, in her quadriceps as well. She has been examined by numerous medical specialists (orthopedic, neurology, vascular, rheumatology, Infectious Disease, neuromuscular, endocrinology, gynecology) all with relatively normal findings. She was diagnosed and attempted to be treated for the following: exertional compartment syndrome (three bilateral fascietomies), fibromyalgia, metabolic muscle disease, Lyme Disease and tick borne illness.  She has taken numerous vitamins and supplements, trials of Lyrica, Neurontin, Prednisone, antibiotics and parasite medications to no avail.  This female patient, in the matter of three and a half years, went from being a top level athlete who exercised every day, to experiencing extreme muscle pain upon any exertion and preventing her from participating in any physical activity due to her marked pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Complement factor C4 increased, Fasciectomy, Fibromyalgia, Lyme disease, Metabolic disorder
Clinical narrative: This 18 year old female who was otherwise always healthy and active received a 3rd Gardasil injection in May 2008. The first two were administered in late 2007. This female was a top ranked soccer player and was getting ready to attend a Division1 program on a full scholarship. She was training for college soccer around July 2008 when she began to feel tightness in her calves upon running. The pain would cease once she stopped running and she continued to push through the tightness until she began to notice the tightness had spread to the anterior compartments of both lower legs. She described that pain as a burning pain. The pain began to increase with other exertions besides running i.e. jumping, squatting, flexing her feet and climbing stairs. She then was unable to continue playing soccer due to the pain. Of interest is that in addition to the extreme exertional muscle pain, she ceased menstruating for approximately 8 months and her menses only resumed after a course of LoEstrin FE. After a gynecological workup, the patient was found to have extremely low levels of estrogen. Her C4A levels have also been repeatedly extremely high and she tested positive for XMRV and mycoplasma pneumoniae. About a year and a half after the initial symptom of calf tightness, she began to notice a burning in her forearms and upper arms while performing exertions with her arms. These exertions were as simple as cutting a piece of paper, carrying a gallon of milk or blow drying her hair. Around this time, she also noticed the same symptoms she was experiencing in her lower legs, in her quadriceps as well. She has been examined by numerous medical specialists (orthopedic, neurology, vascular, rheumatology, Infectious Disease, neuromuscular, endocrinology, gynecology) all with relatively normal findings. She was diagnosed and attempted to be treated for the following: exertional compartment syndrome (three bilateral fascietomies), fibromyalgia, metabolic muscle disease, Lyme Disease and tick borne illness.  She has taken numerous vitamins and supplements, trials of Lyrica, Neurontin, Prednisone, antibiotics and parasite medications to no avail.  This female patient, in the matter of three and a half years, went from being a top level athlete who exercised every day, to experiencing extreme muscle pain upon any exertion and preventing her from participating in any physical activity due to her marked pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle disorder, Muscle tightness, Myalgia, Mycoplasma test positive, Pain
Clinical narrative: This 18 year old female who was otherwise always healthy and active received a 3rd Gardasil injection in May 2008. The first two were administered in late 2007. This female was a top ranked soccer player and was getting ready to attend a Division1 program on a full scholarship. She was training for college soccer around July 2008 when she began to feel tightness in her calves upon running. The pain would cease once she stopped running and she continued to push through the tightness until she began to notice the tightness had spread to the anterior compartments of both lower legs. She described that pain as a burning pain. The pain began to increase with other exertions besides running i.e. jumping, squatting, flexing her feet and climbing stairs. She then was unable to continue playing soccer due to the pain. Of interest is that in addition to the extreme exertional muscle pain, she ceased menstruating for approximately 8 months and her menses only resumed after a course of LoEstrin FE. After a gynecological workup, the patient was found to have extremely low levels of estrogen. Her C4A levels have also been repeatedly extremely high and she tested positive for XMRV and mycoplasma pneumoniae. About a year and a half after the initial symptom of calf tightness, she began to notice a burning in her forearms and upper arms while performing exertions with her arms. These exertions were as simple as cutting a piece of paper, carrying a gallon of milk or blow drying her hair. Around this time, she also noticed the same symptoms she was experiencing in her lower legs, in her quadriceps as well. She has been examined by numerous medical specialists (orthopedic, neurology, vascular, rheumatology, Infectious Disease, neuromuscular, endocrinology, gynecology) all with relatively normal findings. She was diagnosed and attempted to be treated for the following: exertional compartment syndrome (three bilateral fascietomies), fibromyalgia, metabolic muscle disease, Lyme Disease and tick borne illness.  She has taken numerous vitamins and supplements, trials of Lyrica, Neurontin, Prednisone, antibiotics and parasite medications to no avail.  This female patient, in the matter of three and a half years, went from being a top level athlete who exercised every day, to experiencing extreme muscle pain upon any exertion and preventing her from participating in any physical activity due to her marked pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Viral test positive
Clinical narrative: This 18 year old female who was otherwise always healthy and active received a 3rd Gardasil injection in May 2008. The first two were administered in late 2007. This female was a top ranked soccer player and was getting ready to attend a Division1 program on a full scholarship. She was training for college soccer around July 2008 when she began to feel tightness in her calves upon running. The pain would cease once she stopped running and she continued to push through the tightness until she began to notice the tightness had spread to the anterior compartments of both lower legs. She described that pain as a burning pain. The pain began to increase with other exertions besides running i.e. jumping, squatting, flexing her feet and climbing stairs. She then was unable to continue playing soccer due to the pain. Of interest is that in addition to the extreme exertional muscle pain, she ceased menstruating for approximately 8 months and her menses only resumed after a course of LoEstrin FE. After a gynecological workup, the patient was found to have extremely low levels of estrogen. Her C4A levels have also been repeatedly extremely high and she tested positive for XMRV and mycoplasma pneumoniae. About a year and a half after the initial symptom of calf tightness, she began to notice a burning in her forearms and upper arms while performing exertions with her arms. These exertions were as simple as cutting a piece of paper, carrying a gallon of milk or blow drying her hair. Around this time, she also noticed the same symptoms she was experiencing in her lower legs, in her quadriceps as well. She has been examined by numerous medical specialists (orthopedic, neurology, vascular, rheumatology, Infectious Disease, neuromuscular, endocrinology, gynecology) all with relatively normal findings. She was diagnosed and attempted to be treated for the following: exertional compartment syndrome (three bilateral fascietomies), fibromyalgia, metabolic muscle disease, Lyme Disease and tick borne illness.  She has taken numerous vitamins and supplements, trials of Lyrica, Neurontin, Prednisone, antibiotics and parasite medications to no avail.  This female patient, in the matter of three and a half years, went from being a top level athlete who exercised every day, to experiencing extreme muscle pain upon any exertion and preventing her from participating in any physical activity due to her marked pain.
Age: 5.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blood test normal, Full blood count normal, Rash pustular, Rash vesicular, Viral test negative
Clinical narrative: Chicken pox like rash on torso, confirmed as chicken pox by physician. Treated with caladryl lotion and oatmeal baths. Had repeated outbreaks 5x during the next four months.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Flushing, Headache, Hyperhidrosis, Nausea
Clinical narrative: Employee received vaccine at 11:38 AM. At 12:48 PM she returned complaining of feeling flushed, headache, nausea, and sweating. Noted cool clammy skin & flushed appearance. Vital Signs 12:49 PM, BP 102/72, HR 88. Employee denies SOB, dysphagia, dizziness. Employee given cold drink and remained in nurses care for 30 minutes. 1:05 PM Vital signs, BP 110/72, HR 72. Refused offer to call 911 stating she felt somewhat better with lessening of headache. Referred employee to primary care phsycian.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: 11:56 AM Patient stated "I am afraid of needles." Nurse used distraction and slow breathing technique to help patient overcome apprehension of needles. Observed patient for 15 minutes with no signs and symptoms of adverse reaction. Patient stated "I feel fine." Patient went back to work. Approximately 12:30 PM patient returned with complaint of dizziness and nausea. Nurse assessed patient vital signs: BP 118/75, pulse 70 ans 2+, PERRLA, respirations 17 normal and non-labored. Patient denies and SOB, pain, dyspnea. Lung sounds clear all fields, no wheeze or stridor noted.
Age: 53.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Arthralgia
Clinical narrative: Joint pain was reported to pharmacist on January 2, 2012.
Age: 53.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Nerve conduction studies, X-ray
Clinical narrative: Joint pain was reported to pharmacist on January 2, 2012.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion missed, Abortion spontaneous, Foetal disorder, Human chorionic gonadotropin positive, Laboratory test
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.), for VARIVAX (Merck), a Pregnancy Registry product, concerning herself, a 24 year old female patient with no pertinent medical history and no drugs reactions or allergies who on 14-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # unknown). There was no concomitant medication. The nurse reported that on 20-SEP-2010 when she was her doctor, she had a positive urine test for pregnancy. Last menstrual period (LMP): 20-AUG-2010. Her estimated date of delivery (EDD) was 27-MAY-2011. At the time of this report, the patient's outcome was unknown. Follow up information has been received from another nurse reported that the patient's pregnancy ended in miscarriage; with dilation and curettage (D&C) performed on 25-OCT-2010, she verified that the patient's LMP was 20-AUG-2010 and EDD was 27-MAY-2011. This was the patient's first pregnancy. The following course of events leading up to the patient's miscarriage: The patient was seen by general practitioner doctor when her pregnancy was first determined in September 2010. When the discovery of vaccine exposure during pregnancy was determined, she was referred to Doctor for gestational counseling and prenatal care. Patient's first appointment with doctor was on 28-SEP-2010. It was determined in early October 2010 under doctor's care that the patient's HCG lab values were slowly decreasing, the urine beta-human chorionic gonadotropin test (HCG) values were not readily available. The patient had an ultrasound on 19-OCT-2010 which reported the following: Diagnosis of missed abortion, 7 week old fetus not viable. There was no fetal cardiac activity and yolk sac was small for gestation. The patient was scheduled for and underwent a dilation and curettage (D & C) on 25-OCT-2010. The contents of conception were examined for pathology and the results are as follows: The uterine contents showed immature placental villus tissue with mild hydropic features with a possible hydatidform mole. When asked if any cancer was seen, the reporter stated there was no mention of cancer in the pathology report. The reporter stated the patient was currently 8 weeks' pregnant (estimated LMP 27-JUL-2012) and doing well so far. Missed abortion, miscarriage and possible hydatidform mole were was considered to be an other important medical event. No further information is available.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure during pregnancy, Placental disorder, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.), for VARIVAX (Merck), a Pregnancy Registry product, concerning herself, a 24 year old female patient with no pertinent medical history and no drugs reactions or allergies who on 14-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # unknown). There was no concomitant medication. The nurse reported that on 20-SEP-2010 when she was her doctor, she had a positive urine test for pregnancy. Last menstrual period (LMP): 20-AUG-2010. Her estimated date of delivery (EDD) was 27-MAY-2011. At the time of this report, the patient's outcome was unknown. Follow up information has been received from another nurse reported that the patient's pregnancy ended in miscarriage; with dilation and curettage (D&C) performed on 25-OCT-2010, she verified that the patient's LMP was 20-AUG-2010 and EDD was 27-MAY-2011. This was the patient's first pregnancy. The following course of events leading up to the patient's miscarriage: The patient was seen by general practitioner doctor when her pregnancy was first determined in September 2010. When the discovery of vaccine exposure during pregnancy was determined, she was referred to Doctor for gestational counseling and prenatal care. Patient's first appointment with doctor was on 28-SEP-2010. It was determined in early October 2010 under doctor's care that the patient's HCG lab values were slowly decreasing, the urine beta-human chorionic gonadotropin test (HCG) values were not readily available. The patient had an ultrasound on 19-OCT-2010 which reported the following: Diagnosis of missed abortion, 7 week old fetus not viable. There was no fetal cardiac activity and yolk sac was small for gestation. The patient was scheduled for and underwent a dilation and curettage (D & C) on 25-OCT-2010. The contents of conception were examined for pathology and the results are as follows: The uterine contents showed immature placental villus tissue with mild hydropic features with a possible hydatidform mole. When asked if any cancer was seen, the reporter stated there was no mention of cancer in the pathology report. The reporter stated the patient was currently 8 weeks' pregnant (estimated LMP 27-JUL-2012) and doing well so far. Missed abortion, miscarriage and possible hydatidform mole were was considered to be an other important medical event. No further information is available.
Age: 1.11
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Rash
Clinical narrative: Rash, supportive care.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Patient claims arm became weak on Saturday, Dec. 17, 2011, but not sore, just weakness.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pruritus
Clinical narrative: Cellulitis, itching. Linezolid 600mg po ordered to treat cellulitis. BENADRYL 50mg TID prn - received 4 doses ordered to treat itching. Prednisone 60mg po x 1 dose 12/03 at 1600.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling, pain, tenderness, & warm to the touch 2 days after receiving FLUVIRIN & PNEUMOVAX injections in his right deltoid. His left arm could not be used, he had just had surgery on the shoulder. He was instructed to apply ice & use BENADRYL & hydrocortisone cream.
Age: 1.01
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash, Supportive care
Clinical narrative: Rash, supportive care.
Age: 1.5
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: KINRIX dose was given before age 4-6 yrs. Client called on 01/03/12 no adverse reactions noted.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: Pt fainted after flu & HPV vaccine.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Retching, Vomiting
Clinical narrative: Patient got a flu shot at 12:33 PM said he started throwing up at 5 PM (12/19/11) and continued throwing up at about 15 minute intervals till 7 AM 12-20-11 and also had chills and body aches. He said after he threw up everything he had dry heaves.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: (R) thigh became swollen and pt had a lump complained of pain RT measured 28cm LT measured 24cm.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray abnormal, Pneumonia, Urticaria
Clinical narrative: Hives - mostly around eyes & face but also on trunk she was also on AMOXIL (started 12/21/11) no wheezing or cough or fevers, on 12/29/11 AMOXIL stopped. CLARITIN & ORAPRED started.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Hallucination, Headache, Pallor, Pyrexia
Clinical narrative: 1 hour post nasal spray developed headache, pallor, mild fever and night time hallucinations. This lasted 2 days. Was tx'd with TYLENOL.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling abnormal, Rash
Clinical narrative: Rash, felt very bad and progressively got better after first day, had mild problems breathing, no treatment.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Patient's daughter reported to myself (RN and FNP) that the patient developed difficulty in breathing and swallowing later in the evening after having received the PNEUMOVAX vaccine. The medical staff strongly feels reaction was related to vaccine received. Pt. states she had vaccine administered 6 years ago with no adverse reaction.
Age: 1.63
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, erythema.
Age: 0.17
Sex: M
Vaccine: DTAP, RV1
Symptoms: Diarrhoea, Irritability, Vomiting
Clinical narrative: Vomiting, fussy behavior, diarrhea.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blister, Full blood count normal, Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Developed red, blistering rash at injection site 1-2 days after injection, spread to trunk, other arm.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Rash erythematous, Red blood cell sedimentation rate normal
Clinical narrative: Developed red, blistering rash at injection site 1-2 days after injection, spread to trunk, other arm.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on lower part of trunk, fever. Resolved with Tylenol and Benadryl oral.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Biopsy skin, Blood culture negative, Blood test abnormal, Computerised tomogram head
Clinical narrative: Papular/pustular rash developed on right arm, on 12/7 spread to left arm with development of arthralgias both knees and shoulders, on 12/8 rash spread to both legs and became pruritic in all areas, on 12/9 went to physician's office where blood work revealed acute renal failure {Cr 4.3}, sent to ER for admission. Admitted 12/9 - 12/14; readmitted 12/15 with altered mental status, discharge home 12/24.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Culture urine negative, Escherichia test positive, Inflammatory marker increased, Lumbar puncture normal
Clinical narrative: Papular/pustular rash developed on right arm, on 12/7 spread to left arm with development of arthralgias both knees and shoulders, on 12/8 rash spread to both legs and became pruritic in all areas, on 12/9 went to physician's office where blood work revealed acute renal failure {Cr 4.3}, sent to ER for admission. Admitted 12/9 - 12/14; readmitted 12/15 with altered mental status, discharge home 12/24.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mental status changes, Nuclear magnetic resonance imaging brain normal, Pruritus generalised, Rash, Rash papular
Clinical narrative: Papular/pustular rash developed on right arm, on 12/7 spread to left arm with development of arthralgias both knees and shoulders, on 12/8 rash spread to both legs and became pruritic in all areas, on 12/9 went to physician's office where blood work revealed acute renal failure {Cr 4.3}, sent to ER for admission. Admitted 12/9 - 12/14; readmitted 12/15 with altered mental status, discharge home 12/24.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pustular, Renal failure acute, Sputum culture positive, Viral test negative
Clinical narrative: Papular/pustular rash developed on right arm, on 12/7 spread to left arm with development of arthralgias both knees and shoulders, on 12/8 rash spread to both legs and became pruritic in all areas, on 12/9 went to physician's office where blood work revealed acute renal failure {Cr 4.3}, sent to ER for admission. Admitted 12/9 - 12/14; readmitted 12/15 with altered mental status, discharge home 12/24.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: At 10:37 AM client complained of tingling on right side of arm, face, and whole right side of body. 10:40 AM - BP 140/82, pulse 96, lungs clear no wheezing. Client drank some water, no difficulties swallowing, legs elevated. 10:45 AM BP 138/80, still complaints of symptoms. 10:55 AM client took 12.5mg liquid Benadryl, own Benadryl. 10:57 AM, "I feel better." 128/78, pulse 76. 11:05 AM symptoms abated. Client stable and released to work.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Participant returned one hour after receiving injection stating feeling lightheaded, queasy, "like I am going to throw up." States, "drank some OJ," has had this feeling before. Skin warm and dry, no chest pain, shortness of breath or dyspnea. No hives, swelling noted. 10:00 AM BP 140/76, pulse 72. Patient states feeling much better, no wheezing noted. 10:15 AM patient states feels fine, no difficulty swallowing. 10:20 AM instructed to return if any further problems.
Age: 0.36
Sex: F
Vaccine: HIBV, IPV
Symptoms: Autism, Crying, Developmental delay, Muscle twitching, Psychomotor skills impaired
Clinical narrative: High-pitched cry for 1.5 hours (never again before or since). Stopped babbling for about 6-12 weeks and got a twitch in left shoulder that still continues. Diagnosed with autism at 2 years.
Age: 0.36
Sex: F
Vaccine: HIBV, IPV
Symptoms: Speech disorder developmental
Clinical narrative: High-pitched cry for 1.5 hours (never again before or since). Stopped babbling for about 6-12 weeks and got a twitch in left shoulder that still continues. Diagnosed with autism at 2 years.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Erythema, edema, itching, pain at injection site.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Endotracheal intubation, Guillain-Barre syndrome, Hemiparesis, Hyporeflexia
Clinical narrative: Guillain Barre syndrome. (L) esotropia, left sided weakness & decreased DTR's, asymmetric flattened N-L fold on (L) - progressed to difficulty breathing requiring intubation & vented x ten days.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Mechanical ventilation, Strabismus
Clinical narrative: Guillain Barre syndrome. (L) esotropia, left sided weakness & decreased DTR's, asymmetric flattened N-L fold on (L) - progressed to difficulty breathing requiring intubation & vented x ten days.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Fatigue, Guillain-Barre syndrome, Laboratory test
Clinical narrative: Patient complained of being tired and weak with increasing back pain in late December 2010. Weakness continued and slight sore throat developed in January 2011. Sore throat got worse and leg and arm pain developed and she sought treatment Feb. 2, 2011. Doctor suspected strep, but did not test and prescribed antibodies. Feb. 4th went to ER. After extensive tests, doctor thought it might be Vertigo and prescribed medicine. Patient was partially paralyzed by Feb. 6 and went back to ER. ER doctor suspected Guillain-Barre Syndrome, admitted her and neurologist diagnosed GBS and began treatment Feb. 6 afternoon. She was in hospital, including their rehab center, for 34 days. She then went for more rehab before returning home April 16.  She has not fully recovered but her stamina and strength are at about 65-75 percent of her pre GBS level.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain in extremity, Paralysis, Streptococcal infection, Vertigo
Clinical narrative: Patient complained of being tired and weak with increasing back pain in late December 2010. Weakness continued and slight sore throat developed in January 2011. Sore throat got worse and leg and arm pain developed and she sought treatment Feb. 2, 2011. Doctor suspected strep, but did not test and prescribed antibodies. Feb. 4th went to ER. After extensive tests, doctor thought it might be Vertigo and prescribed medicine. Patient was partially paralyzed by Feb. 6 and went back to ER. ER doctor suspected Guillain-Barre Syndrome, admitted her and neurologist diagnosed GBS and began treatment Feb. 6 afternoon. She was in hospital, including their rehab center, for 34 days. She then went for more rehab before returning home April 16.  She has not fully recovered but her stamina and strength are at about 65-75 percent of her pre GBS level.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Tenderness
Clinical narrative: Immediately following IM injection of Flulaval 0.5cc to left arm the participants injection site had localized swelling of approximately 1 inch x 0.5in. Asked participant to remain in room for monitoring. Offered ice pack for the area and the participant refused. She returned to work after approxmiately 5 minutes. Condition unchanged. Checked participant again at 9:00 AM and 9:25 AM. Participant still experiencing swelling and tenderness. Advised to seek medical attention if condition worsens.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, IPV, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Child received duplicate dose of IPV. Given individual vaccine along with combination vaccine, which already contained IPV.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain
Clinical narrative: Left shoulder pain, near the site of the vaccine, but not overlying vaccine site. Pain has persisted for 2 weeks, beyond normal expected from localozed reaction. Uncertain if pain is related to vaccine.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: S: Patient stated, "I don't like seeing the needle." Within 5 minutes of the injection patient reports feeling weak, faint, nauseated." Should lie down with feet elevated. Pt stated, "Did not think I would have problems today, usually do flu shot at doctor's office or public health clinic." Denies medications. Denies allergies.  O: Alert and oriented, pleasant, NAD. Skin clean, warm, dry. 10:40 AM - Pt pale, diaphoretic. Denies chest pain and shortness of breath. Position changed from chair to carpeted floor, feet elevated. BP rt arm 74/52, pulse 64. Respirations silent, non-labored, no loss of consciousness, no confusion, speech clear, coherant, oriented. Facial pallor, diaphoresis. PERRLA. No tremor. 10:47 AM - Pt Feeling better, no nausea. BP 116/80, pulse 76. Facial skin warm, dry, pink. Arms warm, dry. Moving all extremities. No tremor, jerking, seated on floor without complaint. 10:55 AM - Standing walking about room. No sway, ataxia, tremor. Reports feeling recovered. Feels able to work. A: Presyncope; vasovagal response related to injection. P: Returned to work.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: S: Patient stated, "I don't like seeing the needle." Within 5 minutes of the injection patient reports feeling weak, faint, nauseated." Should lie down with feet elevated. Pt stated, "Did not think I would have problems today, usually do flu shot at doctor's office or public health clinic." Denies medications. Denies allergies.  O: Alert and oriented, pleasant, NAD. Skin clean, warm, dry. 10:40 AM - Pt pale, diaphoretic. Denies chest pain and shortness of breath. Position changed from chair to carpeted floor, feet elevated. BP rt arm 74/52, pulse 64. Respirations silent, non-labored, no loss of consciousness, no confusion, speech clear, coherant, oriented. Facial pallor, diaphoresis. PERRLA. No tremor. 10:47 AM - Pt Feeling better, no nausea. BP 116/80, pulse 76. Facial skin warm, dry, pink. Arms warm, dry. Moving all extremities. No tremor, jerking, seated on floor without complaint. 10:55 AM - Standing walking about room. No sway, ataxia, tremor. Reports feeling recovered. Feels able to work. A: Presyncope; vasovagal response related to injection. P: Returned to work.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain, Sleep disorder
Clinical narrative: Flu shot (Fluvirin) given high up in upper arm rather than all previously received shots in lower half of upper arm. Pain increased daily with pain in lifting and moving arm in many directions all leading back to upper arm. Taking 3 Advils nightly to sleep and still waking to pain. Reporting at 3 weeks because pain persists. Symptoms match other online who received vaccine in this location.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Day after injections, tenderness and erythema developed just inferior to injection site; fever of 102F.  Next day developed rigors and presented to ER; redness spreading.  HR 134.  Hospitalist admitted patient to hospital with diagnosis of cellulitis with sepsis for IV Vanco.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Sepsis, White blood cell count increased
Clinical narrative: Day after injections, tenderness and erythema developed just inferior to injection site; fever of 102F.  Next day developed rigors and presented to ER; redness spreading.  HR 134.  Hospitalist admitted patient to hospital with diagnosis of cellulitis with sepsis for IV Vanco.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: She developed weakness in the right face and was brought to the emergency room and diagnosed with Bell's palsy.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, MMR, VARCEL
Symptoms: Diarrhoea, Emotional distress, Fatigue, Gait disturbance, Irritability
Clinical narrative: Irritable, inconsolable, fever, loose stool, walk off balance, exhaustion. Contacted pediatric office after hours aprox. around 7:30 PM, representative advised, to give fluids, over the counter pediatric fever reducer meds, if no improvement, take to Emergency Room. Fell asleep.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Irritable, inconsolable, fever, loose stool, walk off balance, exhaustion. Contacted pediatric office after hours aprox. around 7:30 PM, representative advised, to give fluids, over the counter pediatric fever reducer meds, if no improvement, take to Emergency Room. Fell asleep.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, MMR, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Irritable, inconsolable, fever, loose stool, walk off balance, exhaustion. Contacted pediatric office after hours aprox. around 7:30 PM, representative advised, to give fluids, over the counter pediatric fever reducer meds, if no improvement, take to Emergency Room. Fell asleep.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity, X-ray normal
Clinical narrative: Constant pain in left shoulder and down arm to elbow.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Pt's mother called 12-21-11 relates pt had fever of 105.6 in his ear (pt had vaccines 12-20-11) during night, pt was given TYL & MOTRIN, fever did go down. Pt came into office on 12-21-11 saw CNP. Strep test neg, see office notes called mother 12-22-11; pt's mother related fever was 104 again during night. With MOTRIN fever is down pt acts ok. Eating & drinking ok - see next page and when MOTRIN wears off fever is back up again. On 12/23/11  dr prescribed amoxicillin 250/mg/5 ml for pt - 5ml po BID. Called mother on 12-27-11 so see how pt was doing - pt's mom related pt's fever back 12/24/11 and is doing fine now - pt's mother also related when fever broke. Pt broke out in a rash also.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Child rec'd KINRIX vaccine as booster for DTAP/Polio series and he is < 4 yrs of age. Vaccines were #4 DTAP and #3 IPV. Mom notified, No concerns or c/o.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, HEPA
Symptoms: Electromyogram abnormal, Endotracheal intubation, Guillain-Barre syndrome, Mechanical ventilation, Muscular weakness
Clinical narrative: 21 yo developed LE weakness on 12/26 that spread distal to proximal over the next day resulting in flaccid paralysis of his body up to the neck. He was intubated, placed on mechanical ventilation and cared for at Hospital. He remains hospitalized. Previous history of URI x 3 weeks. One other admitted with GBS last week.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, HEPA
Symptoms: Paralysis flaccid, Polyneuropathy
Clinical narrative: 21 yo developed LE weakness on 12/26 that spread distal to proximal over the next day resulting in flaccid paralysis of his body up to the neck. He was intubated, placed on mechanical ventilation and cared for at Hospital. He remains hospitalized. Previous history of URI x 3 weeks. One other admitted with GBS last week.
Age: 5.0
Sex: F
Vaccine: DTP, MMR, VARCEL
Symptoms: Blood test, Electroencephalogram, Obsessive-compulsive disorder, Streptococcus test
Clinical narrative: Acute Severe Obsessive Compulsive Disorder with 2 days of vaccination. Treated by Pediatric Neurologist, Allergist, Pediatrician, Psychiatrist. Condition remains unchanged.
Age: 20.0
Sex: M
Vaccine: SMALL, HEPAB, JEV, SMALL, TYP
Symptoms: Arthropathy, Blood culture, Blood folate normal, Blood thyroid stimulating hormone normal, CSF culture
Clinical narrative: HA, nausea, vomiting, photophobia, chest PX, lump in axilla.
Age: 20.0
Sex: M
Vaccine: SMALL, HEPAB, JEV, SMALL, TYP
Symptoms: CSF lymphocyte count increased, CSF white blood cell count increased, Clonus, Cytomegalovirus test, Enterovirus test
Clinical narrative: HA, nausea, vomiting, photophobia, chest PX, lump in axilla.
Age: 20.0
Sex: M
Vaccine: SMALL, HEPAB, JEV, SMALL, TYP
Symptoms: Extensor plantar response, Full blood count normal, HIV test, Headache, Herpes simplex serology
Clinical narrative: HA, nausea, vomiting, photophobia, chest PX, lump in axilla.
Age: 20.0
Sex: M
Vaccine: SMALL, HEPAB, JEV, SMALL, TYP
Symptoms: Hyperreflexia, Laboratory test normal, Metabolic function test normal, Muscular weakness, Nausea
Clinical narrative: HA, nausea, vomiting, photophobia, chest PX, lump in axilla.
Age: 20.0
Sex: M
Vaccine: SMALL, HEPAB, JEV, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal cord normal, Polymerase chain reaction, Viral test negative, Vitamin B12 normal
Clinical narrative: HA, nausea, vomiting, photophobia, chest PX, lump in axilla.
Age: 20.0
Sex: M
Vaccine: SMALL, HEPAB, JEV, SMALL, TYP
Symptoms: Vomiting
Clinical narrative: HA, nausea, vomiting, photophobia, chest PX, lump in axilla.
Age: 20.0
Sex: M
Vaccine: SMALL, HEPAB, JEV, SMALL, TYP
Symptoms: Axillary mass, Chest discomfort, Encephalitis, Encephalomyelitis, Headache
Clinical narrative: HA, nausea, vomiting, photophobia, chest PX, lump in axilla.
Age: 20.0
Sex: M
Vaccine: SMALL, HEPAB, JEV, SMALL, TYP
Symptoms: Nausea, Photophobia, Vomiting
Clinical narrative: HA, nausea, vomiting, photophobia, chest PX, lump in axilla.
Age: 0.14
Sex: F
Vaccine: DTAPIPV
Symptoms: Crying, Erythema, Muscle contractions involuntary
Clinical narrative: Uncontrollable crying and cringing, baby turned beet red.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Haematemesis, Nausea
Clinical narrative: Initial report was received from a consumer on 19 December 2011 who is also the patient. A 62-year-old male patient who has a history of mild chronic pancreatitis, high blood pressure and gastrointestinal sensitivities, had received an intramuscular (IM) injection of Tdap (lot number not reported) in his right arm on 14 December 2011. On an unspecified date following vaccination, the patient developed nausea for several days and one episode "spit up blood" in a small amount for five to ten minutes. Concomitant medication included lisinopril, selenium and herbs. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site pain, Pain
Clinical narrative: Received influenza injection on 12/9/11. On 12/10/11 arm (deltoid region) became sore and soreness has migrated to armpit and underarm as well as deltoid. No swelling/redness. Hurts with pressure and hurts to use arm.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Skin rash and Urticaria, Pruritus. Treatment: Diphenhydramine 50 MG PRN, Triamcinolone 40 MG Once, Prednisone.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Received immunization on 12/20/11. States arm became red, warm and swollen that evening. The next day site became more painful, and swelling and redness increased. Went to the doctor the next day and was dx with secondary staph infection. Was given antibiotic IM and orally for 10 days.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Staphylococcal infection
Clinical narrative: Received immunization on 12/20/11. States arm became red, warm and swollen that evening. The next day site became more painful, and swelling and redness increased. Went to the doctor the next day and was dx with secondary staph infection. Was given antibiotic IM and orally for 10 days.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion induced, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow up information has been received from a nurse practitioner, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient with no pertinent medical history or drug/allergies reported, and no previous pregnancies, who on 19-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 667317/0638Z), 0.5 mL, SC. There was no concomitant medication. It was reported that the patient received a dose of VARIVAX (Merck) while she was pregnant. Her last menstrual period was on 12-SEP-2010 and her date of delivery was 19-JUN-2011. Pregnancy was confirmed by pregnancy test. The patient was not tested for varicella antibodies before vaccination with VARIVAX (Merck). No adverse event symptoms were observed or reported by the patient. Follow up information was received via telephone call from a reporter located in the health care center where the patient was seen for prenatal care, who stated that on 27-SEP-2010, the patient underwent an elective abortion to end her pregnancy. The reporter stated that the fetus was viable and pregnancy had no problems; it was the patient's choice to terminate her pregnancy. Upon internal review, elective abortion was determined to be an other important medical event. No further information is available.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Red area on thigh about 24 hr. after shot. Not tender. Not warm.
Age: 1.24
Sex: M
Vaccine: FLU3, HIBV, MMR
Symptoms: Condition aggravated, Febrile convulsion, Hypotonia, Otitis media acute, Pyrexia
Clinical narrative: Patient seen on 12/21/11 for new onset right sided acute otitis media with fever. After patient left doctors office, had a flaccid febrile seizure.