chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Dysarthria, Hypoaesthesia, Mobility decreased, VIIth nerve paralysis
Clinical narrative: Initial report received on 28 June 2011 from a health care professional. A 12-year-old female patient with a past medical history of seasonal allergies received a first dose of ADACEL, lot number C3539AA, administered intramuscularly in the left deltoid; a first dose of MENACTRA, lot number U3538BA, administered intramuscularly in the left deltoid; and a dose of VARIVAX (manufacturer not reported), lot number 07162, administered intramuscularly in the right deltoid on 24 June 2011 at 11:45 a.m. 15 minutes later, on 24 June 2011 at 12:00 p.m., the patient came back into the office with symptoms of slurred speech, dizziness, and an intermittent inability to use portions of the right side of her body. In addition, the right side of her face and mouth was droopy, she was unable to speak, and she was unable to follow directions. The patient was sent to the emergency room via ambulance and was hospitalized for one night. it is unknown if any laboratory testing or diagnostic tests were completed. Per the reporter, the patient remembered the situation, but was unable to respond. She recovered on an unspecified date. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Aphasia, Apraxia, Dizziness, Dysarthria, Hemiparesis
Clinical narrative: Initial report received on 28 June 2011 from a health care professional. A 12-year-old female patient with a past medical history of seasonal allergies received a first dose of ADACEL, lot number C3539AA, administered intramuscularly in the left deltoid; a first dose of MENACTRA, lot number U3538BA, administered intramuscularly in the left deltoid; and a dose of VARIVAX (manufacturer not reported), lot number 07162, administered intramuscularly in the right deltoid on 24 June 2011 at 11:45 a.m. 15 minutes later, on 24 June 2011 at 12:00 p.m., the patient came back into the office with symptoms of slurred speech, dizziness, and an intermittent inability to use portions of the right side of her body. In addition, the right side of her face and mouth was droopy, she was unable to speak, and she was unable to follow directions. The patient was sent to the emergency room via ambulance and was hospitalized for one night. it is unknown if any laboratory testing or diagnostic tests were completed. Per the reporter, the patient remembered the situation, but was unable to respond. She recovered on an unspecified date. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Unresponsive to stimuli, VIIth nerve paralysis
Clinical narrative: Initial report received on 28 June 2011 from a health care professional. A 12-year-old female patient with a past medical history of seasonal allergies received a first dose of ADACEL, lot number C3539AA, administered intramuscularly in the left deltoid; a first dose of MENACTRA, lot number U3538BA, administered intramuscularly in the left deltoid; and a dose of VARIVAX (manufacturer not reported), lot number 07162, administered intramuscularly in the right deltoid on 24 June 2011 at 11:45 a.m. 15 minutes later, on 24 June 2011 at 12:00 p.m., the patient came back into the office with symptoms of slurred speech, dizziness, and an intermittent inability to use portions of the right side of her body. In addition, the right side of her face and mouth was droopy, she was unable to speak, and she was unable to follow directions. The patient was sent to the emergency room via ambulance and was hospitalized for one night. it is unknown if any laboratory testing or diagnostic tests were completed. Per the reporter, the patient remembered the situation, but was unable to respond. She recovered on an unspecified date. List of documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Agitation, Amblyopia, Arthralgia, Bladder disorder
Clinical narrative: See this form. Abdominal cramps. Abdominal pain. Ache joints. Aches joints and muscle. Aches muscle. Aches whole body. Agitation. Alpha intrusion. Amblyopia. Appetite loss. Blood high cholesterol. Blood pressure spikes and drops. Cold and flu-like symptoms. Concentration difficulty. Concentration loss of. Concentration trouble. Balance dizzy upon standing. Balance falling down. Balance dizzy spells. Balance vertigo and dizziness. Balance dizziness. Balance vertigo. Balance problems. Bladder problems. Blood pressure varies. Coordination problems. Cough. Cramps leg.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Blood cholesterol increased, Blood pressure fluctuation, Cough, Decreased appetite, Disturbance in attention
Clinical narrative: See this form. Abdominal cramps. Abdominal pain. Ache joints. Aches joints and muscle. Aches muscle. Aches whole body. Agitation. Alpha intrusion. Amblyopia. Appetite loss. Blood high cholesterol. Blood pressure spikes and drops. Cold and flu-like symptoms. Concentration difficulty. Concentration loss of. Concentration trouble. Balance dizzy upon standing. Balance falling down. Balance dizzy spells. Balance vertigo and dizziness. Balance dizziness. Balance vertigo. Balance problems. Bladder problems. Blood pressure varies. Coordination problems. Cough. Cramps leg.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Dizziness postural, Fall, Influenza like illness, Muscle spasms
Clinical narrative: See this form. Abdominal cramps. Abdominal pain. Ache joints. Aches joints and muscle. Aches muscle. Aches whole body. Agitation. Alpha intrusion. Amblyopia. Appetite loss. Blood high cholesterol. Blood pressure spikes and drops. Cold and flu-like symptoms. Concentration difficulty. Concentration loss of. Concentration trouble. Balance dizzy upon standing. Balance falling down. Balance dizzy spells. Balance vertigo and dizziness. Balance dizziness. Balance vertigo. Balance problems. Bladder problems. Blood pressure varies. Coordination problems. Cough. Cramps leg.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Nasopharyngitis, Pain, Vertigo
Clinical narrative: See this form. Abdominal cramps. Abdominal pain. Ache joints. Aches joints and muscle. Aches muscle. Aches whole body. Agitation. Alpha intrusion. Amblyopia. Appetite loss. Blood high cholesterol. Blood pressure spikes and drops. Cold and flu-like symptoms. Concentration difficulty. Concentration loss of. Concentration trouble. Balance dizzy upon standing. Balance falling down. Balance dizzy spells. Balance vertigo and dizziness. Balance dizziness. Balance vertigo. Balance problems. Bladder problems. Blood pressure varies. Coordination problems. Cough. Cramps leg.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Activities of daily living impaired, Arthralgia, Ear pain, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: Pain immediately following the shot. next day couldnt use my arm at work. Looked online and read that it was somewhat normal after tetanus shot. But a day went on my skin was raised half inch off my arm there was a circle 2 inches in diameter around injection site and the area was warm to touch. I gave it another day which brought me to Saturday. I was very worried and read online that it was probably infected. By Sunday evening it was throbbing dark red very sore, had pain shooting to my elbow and to my ear from my shoulder so I decided that I had to go to the hospital. Was admitted to immediate care was told I had cellulitis, somehow bacteria got into infection site. Meanwhile I took a shower right before I went to dr office that day. Anyway facility prescribed me 2 anitibiotica to take, 6 pills total a day which I finished on July 4th early morning. The swelling and redness went down but I still have a cyst like bump at site where needle was insrted also I am having joint and muscle pain still. I cant go to the gym for pilates or yoga because of my arm.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pain immediately following the shot. next day couldnt use my arm at work. Looked online and read that it was somewhat normal after tetanus shot. But a day went on my skin was raised half inch off my arm there was a circle 2 inches in diameter around injection site and the area was warm to touch. I gave it another day which brought me to Saturday. I was very worried and read online that it was probably infected. By Sunday evening it was throbbing dark red very sore, had pain shooting to my elbow and to my ear from my shoulder so I decided that I had to go to the hospital. Was admitted to immediate care was told I had cellulitis, somehow bacteria got into infection site. Meanwhile I took a shower right before I went to dr office that day. Anyway facility prescribed me 2 anitibiotica to take, 6 pills total a day which I finished on July 4th early morning. The swelling and redness went down but I still have a cyst like bump at site where needle was insrted also I am having joint and muscle pain still. I cant go to the gym for pilates or yoga because of my arm.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Pain immediately following the shot. next day couldnt use my arm at work. Looked online and read that it was somewhat normal after tetanus shot. But a day went on my skin was raised half inch off my arm there was a circle 2 inches in diameter around injection site and the area was warm to touch. I gave it another day which brought me to Saturday. I was very worried and read online that it was probably infected. By Sunday evening it was throbbing dark red very sore, had pain shooting to my elbow and to my ear from my shoulder so I decided that I had to go to the hospital. Was admitted to immediate care was told I had cellulitis, somehow bacteria got into infection site. Meanwhile I took a shower right before I went to dr office that day. Anyway facility prescribed me 2 anitibiotica to take, 6 pills total a day which I finished on July 4th early morning. The swelling and redness went down but I still have a cyst like bump at site where needle was insrted also I am having joint and muscle pain still. I cant go to the gym for pilates or yoga because of my arm.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Hypoaesthesia, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Pain in both legs day of and after administration (of rabies vaccine/& Human rabies immunoglobulin). Pain in right leg/knee on 6/22/2011. Muscle aches/pain in both legs & Feet 6/23/2011. MRI of knee taken on 7/1/2011 (waiting for results). Numbness in legs and tingling 7/4/2011. weakness in legs. Symptoms getting worse... given 800 mg of Motrin in Hospital 7/5/11, told to take ibuprofen - also told to come back if symptoms become worse// told to see PCP/Or other Doctor.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain in both legs day of and after administration (of rabies vaccine/& Human rabies immunoglobulin). Pain in right leg/knee on 6/22/2011. Muscle aches/pain in both legs & Feet 6/23/2011. MRI of knee taken on 7/1/2011 (waiting for results). Numbness in legs and tingling 7/4/2011. weakness in legs. Symptoms getting worse... given 800 mg of Motrin in Hospital 7/5/11, told to take ibuprofen - also told to come back if symptoms become worse// told to see PCP/Or other Doctor.
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Body aches, pain, low-grade fever, swollen glands.
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Started vomiting approximately 24 hrs after his second Rotavirus vaccine. Was hospitalized 6/9 6/10. In ED 48.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Clostridial infection, Infection, Malnutrition, Pyrexia, Spinal fracture
Clinical narrative: Please read all pages enclosed herewith. Check Dr's date against insurance correct info. Dr. reports wrong dates/wrong arm.
Age: 12.0
Sex: F
Vaccine: HEPA, MEN, VARCEL
Symptoms: Blister, Feeling abnormal, Pain, Pyrexia, Varicella
Clinical narrative: She didn't felt like herself, achy and high grade fever.  The following day, she came down with chickenpox rash mainly on her face and chest, and some little blisters on her arms and a few on her back.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PPV, VARCEL
Symptoms: Rash
Clinical narrative: RASH
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Ear pain, Feeling hot, Induration, Injection site erythema, Injection site pain
Clinical narrative: On Friday afternoon felt feverish and achy, with earache.  On Saturday noticed soreness and redness in arm localized around injection site.  Still felt achy and feverish.  Everyday since that time the redness and warmth with small amount of induration has increased and is down to about 3 fingers above elbow.  Being referred for treatment.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: On Friday afternoon felt feverish and achy, with earache.  On Saturday noticed soreness and redness in arm localized around injection site.  Still felt achy and feverish.  Everyday since that time the redness and warmth with small amount of induration has increased and is down to about 3 fingers above elbow.  Being referred for treatment.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Mass, Mobility decreased
Clinical narrative: Pt. is complaining of a red area with a dime size lump on her left arm. She also stated that she can not lift her arm up above her head. She says that this area has been present since she recieved her flu shot back in November. She went to see a physician a couple weeks ago and he prescribed a steroid ointment and she says that has not helped at all.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Body temperature increased, Rash, Rash morbilliform, Vomiting
Clinical narrative: vomiting, measles like rash on trunk, and arms, temperature of 101.5
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Medical assistant ordered to give shingles - gave VARIVAX. No adverse symptoms, signs (patient says even after 2 months).
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Blood electrolytes normal, Enterovirus infection, Full blood count normal, Loss of consciousness, Mouth ulceration
Clinical narrative: 28 hours after receiving DTaP had episode of sudden collapse and very short term loss of consciousness. No stiffening but acted post ictal. Temp 38 degrees at the time but was as high as 39.5 degrees. Normal exam in ER. Next day exam by me showed mouth ulcers - looked like enterovirus - still fever.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Syncope
Clinical narrative: 28 hours after receiving DTaP had episode of sudden collapse and very short term loss of consciousness. No stiffening but acted post ictal. Temp 38 degrees at the time but was as high as 39.5 degrees. Normal exam in ER. Next day exam by me showed mouth ulcers - looked like enterovirus - still fever.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Head injury, Headache, Neck pain, Syncope
Clinical narrative: Pt rec'd Td with no apparent problems directly after injection. Walked to front desk to check out. Within 5 min fainted while standing. Fell to floor & hit back of head on rug-covered carpet. Revived within a few minutes. Rested in lobby about 45 min. c/o of blurred periph. vision. Recommended MD visit - mom will take. 6/30 mom reports headache x 1 day with neck soreness - better today.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Pt rec'd Td with no apparent problems directly after injection. Walked to front desk to check out. Within 5 min fainted while standing. Fell to floor & hit back of head on rug-covered carpet. Revived within a few minutes. Rested in lobby about 45 min. c/o of blurred periph. vision. Recommended MD visit - mom will take. 6/30 mom reports headache x 1 day with neck soreness - better today.
Age: 39.0
Sex: U
Vaccine: PPV, TDAP
Symptoms: Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Pain & edema at site of injection (LUE) began 7pm 6/23 after rec'd vaccine around noon on 6/23. Subjective fever. Pain not resolved by next day - increased, actually. Did do homework as usual. Treated with MOTRIN 800mg, ice & rest arm. Resolved by Monday 6/27.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Amniocentesis normal, Apgar score normal, Drug exposure during pregnancy, Polyhydramnios, Shortened cervix
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female patient with no known medical history and no known drug reactions/allergies who on 22-SEP-2010 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot # 665768/1377Y). There was no concomitant medication. "The patient's mother called on 23-SEP-2010 to report that the patient is pregnant. Gestation was unknown at this time. No adverse effects reported." No diagnostic laboratory tests were performed. The patient's outcome was unknown. The patient sought unknown medical attention. Follow-up information was received from a nurse indicating that the patient received the first dose of GARDASIL (lot # 665768/1377Y) and concomitantly received a first 0.5ml dose of hepatitis A vaccine (unspecified manufacturer) on 22-SEP-2010. The patient's last menstrual period was 05-May-2010, and estimated delivery date was 09-Feb-2011. Ultrasound was performed on 23-SEP-2010 for normal fetal anatomy. Amniocentesis was done for anatomy. The patient had one previous pregnancy and one spontaneous abortion, and no birth defect in previous pregnancy. Follow-up information has been received from a nurse who reported that the female patient on 02-FEB-2011 delivered a male baby. The baby was normal and there were no congenital anomalies. Follow-up information has been received from a registered nurse who reported that the female with a history of one elective termination and with no other medical history or concurrent conditions who was admitted with cervical shortening from approximately 17-NOV-2010 (28 weeks of gestation) to 29-DEC-2010 (34 weeks of gestation) and experienced polyhydramnios on an unspecified date. During pregnancy, from 04-NOV-2010 to 05-NOV-2010 she was placed on PROCARDIA 20 mg Q6h for tocolysis and betamethasone 12 mg Q24h x2 doses for fetal lung maturation. 02-FEB-2011 at 39 weeks of gestation, the patient delivered a normal, healthy male baby weighing 5 pounds 15 ounces. Baby length was 19 inches and head circumference was 32.5 cm. Apgar score was 8/9. The patient did not experience any complications during labor. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Tocolysis, Ultrasound foetal, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female patient with no known medical history and no known drug reactions/allergies who on 22-SEP-2010 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot # 665768/1377Y). There was no concomitant medication. "The patient's mother called on 23-SEP-2010 to report that the patient is pregnant. Gestation was unknown at this time. No adverse effects reported." No diagnostic laboratory tests were performed. The patient's outcome was unknown. The patient sought unknown medical attention. Follow-up information was received from a nurse indicating that the patient received the first dose of GARDASIL (lot # 665768/1377Y) and concomitantly received a first 0.5ml dose of hepatitis A vaccine (unspecified manufacturer) on 22-SEP-2010. The patient's last menstrual period was 05-May-2010, and estimated delivery date was 09-Feb-2011. Ultrasound was performed on 23-SEP-2010 for normal fetal anatomy. Amniocentesis was done for anatomy. The patient had one previous pregnancy and one spontaneous abortion, and no birth defect in previous pregnancy. Follow-up information has been received from a nurse who reported that the female patient on 02-FEB-2011 delivered a male baby. The baby was normal and there were no congenital anomalies. Follow-up information has been received from a registered nurse who reported that the female with a history of one elective termination and with no other medical history or concurrent conditions who was admitted with cervical shortening from approximately 17-NOV-2010 (28 weeks of gestation) to 29-DEC-2010 (34 weeks of gestation) and experienced polyhydramnios on an unspecified date. During pregnancy, from 04-NOV-2010 to 05-NOV-2010 she was placed on PROCARDIA 20 mg Q6h for tocolysis and betamethasone 12 mg Q24h x2 doses for fetal lung maturation. 02-FEB-2011 at 39 weeks of gestation, the patient delivered a normal, healthy male baby weighing 5 pounds 15 ounces. Baby length was 19 inches and head circumference was 32.5 cm. Apgar score was 8/9. The patient did not experience any complications during labor. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Convulsion, Dehydration, Dizziness, Fungal infection
Clinical narrative: Information has been received from a consumer concerning her granddaughter, a 17 year old female with constant urinary tract infections and drug allergy to antibiotics (name unknown) who in April 2009, was vaccinated with the 3rd dose of GARDASIL (Lot# not reported). Concomitant therapy included birth control name unknown. On the date of last injection in April 2009, patient said she felt the injection itself was painful. A few weeks later in April 2009, she started to experience some side effects: fainting, nausea, dizzy, constant yeast infections, irregular periods, spotting between periods and overall not feeling well. 5 months later, grandmother had to take consumer several times back to her healthcare professional (HCP) for severe back pain, leg pain, raised bump on left leg, and still experiencing throwing up, severe dehydration for which consumer had to be hospitalized in 2011. Grandmother said the patient also while in hospital experienced a seizure, caller did not specify month or date. Caller also reported weight loss consumer went from 123 lbs to 98 lbs. Consumer continued to have the severe side effects which HCP had not found out how to treat consumer. It was also reported the laproscopy was performed on an unspecified date for this patient without giving the lab result. The adverse events was not improved and the patient had not recovered at the time of reporting. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Laparoscopy, Malaise, Menstruation irregular, Metrorrhagia
Clinical narrative: Information has been received from a consumer concerning her granddaughter, a 17 year old female with constant urinary tract infections and drug allergy to antibiotics (name unknown) who in April 2009, was vaccinated with the 3rd dose of GARDASIL (Lot# not reported). Concomitant therapy included birth control name unknown. On the date of last injection in April 2009, patient said she felt the injection itself was painful. A few weeks later in April 2009, she started to experience some side effects: fainting, nausea, dizzy, constant yeast infections, irregular periods, spotting between periods and overall not feeling well. 5 months later, grandmother had to take consumer several times back to her healthcare professional (HCP) for severe back pain, leg pain, raised bump on left leg, and still experiencing throwing up, severe dehydration for which consumer had to be hospitalized in 2011. Grandmother said the patient also while in hospital experienced a seizure, caller did not specify month or date. Caller also reported weight loss consumer went from 123 lbs to 98 lbs. Consumer continued to have the severe side effects which HCP had not found out how to treat consumer. It was also reported the laproscopy was performed on an unspecified date for this patient without giving the lab result. The adverse events was not improved and the patient had not recovered at the time of reporting. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain in extremity, Rash, Syncope, Vomiting
Clinical narrative: Information has been received from a consumer concerning her granddaughter, a 17 year old female with constant urinary tract infections and drug allergy to antibiotics (name unknown) who in April 2009, was vaccinated with the 3rd dose of GARDASIL (Lot# not reported). Concomitant therapy included birth control name unknown. On the date of last injection in April 2009, patient said she felt the injection itself was painful. A few weeks later in April 2009, she started to experience some side effects: fainting, nausea, dizzy, constant yeast infections, irregular periods, spotting between periods and overall not feeling well. 5 months later, grandmother had to take consumer several times back to her healthcare professional (HCP) for severe back pain, leg pain, raised bump on left leg, and still experiencing throwing up, severe dehydration for which consumer had to be hospitalized in 2011. Grandmother said the patient also while in hospital experienced a seizure, caller did not specify month or date. Caller also reported weight loss consumer went from 123 lbs to 98 lbs. Consumer continued to have the severe side effects which HCP had not found out how to treat consumer. It was also reported the laproscopy was performed on an unspecified date for this patient without giving the lab result. The adverse events was not improved and the patient had not recovered at the time of reporting. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from a consumer concerning her granddaughter, a 17 year old female with constant urinary tract infections and drug allergy to antibiotics (name unknown) who in April 2009, was vaccinated with the 3rd dose of GARDASIL (Lot# not reported). Concomitant therapy included birth control name unknown. On the date of last injection in April 2009, patient said she felt the injection itself was painful. A few weeks later in April 2009, she started to experience some side effects: fainting, nausea, dizzy, constant yeast infections, irregular periods, spotting between periods and overall not feeling well. 5 months later, grandmother had to take consumer several times back to her healthcare professional (HCP) for severe back pain, leg pain, raised bump on left leg, and still experiencing throwing up, severe dehydration for which consumer had to be hospitalized in 2011. Grandmother said the patient also while in hospital experienced a seizure, caller did not specify month or date. Caller also reported weight loss consumer went from 123 lbs to 98 lbs. Consumer continued to have the severe side effects which HCP had not found out how to treat consumer. It was also reported the laproscopy was performed on an unspecified date for this patient without giving the lab result. The adverse events was not improved and the patient had not recovered at the time of reporting. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Herpes zoster, Mobility decreased, Pain, Pain of skin
Clinical narrative: Information has been received from a 64 year old female Registered nurse, reporting on herself, with no pertinent medical history, no drug reactions or allergies, who in approximately 2008, about 2-3 years ago, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). There were no concomitant medications reported. Registered nurse reported that in March 2011, she developed a case of shingles. She described the shingles as a painful rash that started under her right breast and extended around to her back. Registered nurse reported that the shingles was painful to touch, and she did not move for a week (date unspecified). Registered nurse also reported that a week after the rash developed, she saw her physician, who treated her with an unspecified antiviral medication and LYRICA for a week, and the symptoms resolved. Registered nurse stated that she was now fully recovered. The case of shingles and did not move for a week were considered to be disabling by the registered nurse. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 64 year old female Registered nurse, reporting on herself, with no pertinent medical history, no drug reactions or allergies, who in approximately 2008, about 2-3 years ago, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). There were no concomitant medications reported. Registered nurse reported that in March 2011, she developed a case of shingles. She described the shingles as a painful rash that started under her right breast and extended around to her back. Registered nurse reported that the shingles was painful to touch, and she did not move for a week (date unspecified). Registered nurse also reported that a week after the rash developed, she saw her physician, who treated her with an unspecified antiviral medication and LYRICA for a week, and the symptoms resolved. Registered nurse stated that she was now fully recovered. The case of shingles and did not move for a week were considered to be disabling by the registered nurse. No further information is available.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old female who on 26-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (no lot number, expiration date provided). On 24-MAY-2011 the patient developed a case of shingles. Hydrocortisone and antibiotics (manufacturer unknown), rose hips (LITOZIN) were given for the treatment of shingles. The patient had sought unspecified medical attention. At the time of report, the patient's outcome was recovering. Follow-up information was received from a physician concerning the patient with allergies to DEMEROL, REQUIP, ZITHROMAX and no illness at time of vaccination who on 26-APR-2010 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (Lot number NDC 00006496341 is an invalid lot number for ZOSTAVAX (Merck)). On 24-MAY-2011 the patient was diagnosed with H. zoster. No rash occurred at the site of injection or elsewhere within 42 days of the vaccination. No other systemic symptom. It was unknown if the patient had a history of chickenpox. There was no recent exposure to chickenpox or herpes zoster. No direct fluorescent antibody was done. The patient has recovered from the event on an unspecified date. The event was considered to be an other important medical event by the physician. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Bordetella test positive, Cough, Headache, Pertussis, Polymerase chain reaction
Clinical narrative: Initial case received from a nurse on 27 June 2011. It pertains to 1 of 2 patients who experienced an adverse event following ADACEL administration. The event for the other patient is captured in case number 2011-03811. A 12-year-old female patient, with no reported medical history, was diagnosed with pertussis 16 months after receiving an intramuscular left arm injection of ADACEL (sanofi pasteur Ltd. lot number C3257, sanofi pasteur Inc. lot number U3042AA) on 03 February 2010. The patient also received a left arm intramuscular injection of MENACTRA (lot number U3333AA) on the same date. The patient presented to her physician on 09 June 2011 with a 3-week history of dry cough, headache, and occasional emesis. She had no complaints of fever. She underwent a pertussis smear, which was negative; subsequent PCR culture on 15 June 2011 was positive for pertussis. She was treated with 2 rounds of ZITHROMAX. Outcome was not reported. Of note, the reporting nurse stated that she was aware of 3 patients who had been diagnosed with pertussis; however, only 2 of the 3 were identified as having received ADACEL. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Smear site unspecified normal, Vomiting
Clinical narrative: Initial case received from a nurse on 27 June 2011. It pertains to 1 of 2 patients who experienced an adverse event following ADACEL administration. The event for the other patient is captured in case number 2011-03811. A 12-year-old female patient, with no reported medical history, was diagnosed with pertussis 16 months after receiving an intramuscular left arm injection of ADACEL (sanofi pasteur Ltd. lot number C3257, sanofi pasteur Inc. lot number U3042AA) on 03 February 2010. The patient also received a left arm intramuscular injection of MENACTRA (lot number U3333AA) on the same date. The patient presented to her physician on 09 June 2011 with a 3-week history of dry cough, headache, and occasional emesis. She had no complaints of fever. She underwent a pertussis smear, which was negative; subsequent PCR culture on 15 June 2011 was positive for pertussis. She was treated with 2 rounds of ZITHROMAX. Outcome was not reported. Of note, the reporting nurse stated that she was aware of 3 patients who had been diagnosed with pertussis; however, only 2 of the 3 were identified as having received ADACEL. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with DAPTACEL and other product. The event for the second patient was captured in case number 2011-03709. Initial report received from a health care professional on 22 June 2011. A 4-year-old male patient with medical history of gastroesophageal reflux disease (GERD), asthma, seasonal allergies, and developmental delay, received a left deltoid intramuscular injection of DAPTACEL, sanofi pasteur Ltd. lot number C3473AA and a right deltoid subcutaneous injection of VARIVAX, Merck lot number 13212, on 15 June 2011 in the AM. The patient's concomitant medications included NEXIUM, ZYRTEC, FLONASE and PROAIR as needed (prn). The patient had no illness at the time of vaccination and it was unknown if he had an adverse event following prior vaccinations. On 15 June 2011 in the PM, the patient developed symptoms of the left deltoid becoming hot to touch, swollen, reddened and tender. The patient was seen by a physician and diagnosed with cellulitis. He was treated with antibiotics, prednisone and BENADRYL. The outcome was reported as recovered. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Bordetella test positive, Cough, Pertussis, Polymerase chain reaction, Smear site unspecified normal
Clinical narrative: Initial case received from a nurse on 27 June 2011. It pertains to 1 of 2 patients who experienced an adverse event following ADACEL administration. The event for the other patient is captured in case number 2011-03810. An 11-year-old male patient, with a history of asthma and color blindness, was diagnosed with pertussis 8 months after receiving an intramuscular left arm injection of ADACEL (sanofi pasteur Ltd. lot number C3257, sanofi pasteur Inc. lot number U3042AA) on 11 October 2010. The patient also received a right arm intramuscular injection of MENACTRA (lot number U3333AA) on the same date. Concomitant medications included albuterol and EPI-PEN as needed. The patient presented to his physician on 14 June 2011 with a harsh cough without wheeze or fever. An initial pertussis smear on 15 June 2011 was negative; subsequent PCR on 20 June 2011 was positive for pertussis. Treatment included a nebulizer treatment. Outcome was not reported. Of note, the reporting nurse stated that she was aware of 3 patients who had been diagnosed with pertussis; however, only 2 of the 3 were identified as having received ADACEL. Documents held by sender: None.
Age: 1.07
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Rash, Scab, Viral infection
Clinical narrative: Fine pinpoint rash started on face; now on arms, legs & stomach - fine red pin points turning yellowish with some crusting - doctor notified - viral infection no treatment given.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, redness, tenderness & warmth to area vaccine given.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cough, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: I had the pneumonia vaccine 2 days ago and now my arm is red and swollen and painful and I am running temp at home 101 last eve, cough non prod cough. Treatment: Prednisone.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site pruritus, Vaccine positive rechallenge
Clinical narrative: Patient developed itching at injection site almost immediately after receiving vaccination. Pt states same thing happened 5 - 7 years ago (not received at clinic). Treated with diphenhydramine 25 mg oral.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Received vaccine 23 Jun that evening severe diarrhea followed by fever & vomiting, went to doc. 28 Jun. On quarters for 7 days. Able to eat 4 Jul for first time. Vomiting, nausea, diarrhea, fever, chills, fatigue.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Received vaccine 23 Jun that evening severe diarrhea followed by fever & vomiting, went to doc. 28 Jun. On quarters for 7 days. Able to eat 4 Jul for first time. Vomiting, nausea, diarrhea, fever, chills, fatigue.
Age: 1.32
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Convulsion, Febrile convulsion, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: Pt fever shortly after vaccine. Pt experienced seizure was taken to ER and dx'd with febrile seizure. Pt positive for strep throat the following day 6/30/11.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: "Baseball" sized swelling at injection site.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, RV5, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None noted.
Age: 55.0
Sex: F
Vaccine: DT
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itchy rash surrounding injection site.  Started one day later, started to improve 6 days later, still present 7 days later
Age: 38.0
Sex: M
Vaccine: YF
Symptoms: Blepharospasm, Headache, Neck pain, Oedema peripheral, Pain
Clinical narrative: Swelling of L Arm. Headache, Neck Pain, Body Aches, Fever, Eye-twiching, neck soreness & swelling of lower extremities. Pt reporting S&S are becoming progressively worse. PCM aware and assessed pt on this date (06July2011). Per pt report, PCM will monitor and instructed to report to urgent care if S&S become worse. VSS within range this AM.
Age: 38.0
Sex: M
Vaccine: YF
Symptoms: Pyrexia
Clinical narrative: Swelling of L Arm. Headache, Neck Pain, Body Aches, Fever, Eye-twiching, neck soreness & swelling of lower extremities. Pt reporting S&S are becoming progressively worse. PCM aware and assessed pt on this date (06July2011). Per pt report, PCM will monitor and instructed to report to urgent care if S&S become worse. VSS within range this AM.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Ultrasound scan normal
Clinical narrative: Redness and swelling of left upper arm where injection was given. Appeared like cellulitis.
Age: 1.34
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Misadministration. KINRIX was mistakenly ordered instead of INFANRIX & IPV separately for a 16 month old child. Thus far pt has had no adverse effects or symptomatology.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Oedema peripheral, Skin reaction
Clinical narrative: Spoke with patient 7/3/11. Arm bright red, itchy from injection site to elbow (3 inch wide). 7/6/11 less red & swollen, but still 3-4 inch wide.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site pain, Injection site rash
Clinical narrative: Rash and tender at location of varicella shot. Pt also had temp up to 103.8.
Age: 29.0
Sex: U
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching.
Age: 0.01
Sex: M
Vaccine: FLU3, HEP
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: F
Vaccine: FLU3, HEP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 64.0
Sex: F
Vaccine: TYP, YF
Symptoms: Hypersensitivity, Infection, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt returned to clinic x 1 week post vaccination to report a 4cm red circular area lt deltoid where the yellow fever vaccine was administered. Reports area red, sore, slightly warm and itchy x 3 days. Dx local allergic reaction vs infection. TX warm compresses, ASA or Tylenol prn. Call back if worse or not improving.
Age: 64.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Pt returned to clinic x 1 week post vaccination to report a 4cm red circular area lt deltoid where the yellow fever vaccine was administered. Reports area red, sore, slightly warm and itchy x 3 days. Dx local allergic reaction vs infection. TX warm compresses, ASA or Tylenol prn. Call back if worse or not improving.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Dry skin, Skin warm
Clinical narrative: Became lightheaded and clammy after Tdap vaccine administration.  Assisted to supine position with legs elevated x 45 minutes.  Assisted to sitting position.  Color pink, skin warm/dry.  Orange juice given after feeling better/sitting.  BP 108/50 HR 72 at time of discharge to home with parent.  States returned to feeling "normal" when leaving vaccine area.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Cold sweat, Dizziness, Electrocardiogram ambulatory, Pallor
Clinical narrative: The patient become sick to her stomach, pale, dizzy, clammy and slumped over in her chair.  It took an hour and a half for her to come somewhat back to her normal self and her color did not return until later that evening in the emergency room.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Posture abnormal, Ventricular extrasystoles
Clinical narrative: The patient become sick to her stomach, pale, dizzy, clammy and slumped over in her chair.  It took an hour and a half for her to come somewhat back to her normal self and her color did not return until later that evening in the emergency room.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Gaze palsy, Hypotonia, Loss of consciousness, Muscle rigidity
Clinical narrative: Clients eyes rolled back with body jerking with rigidity for a few seconds followed by going limp with LOC client sat straight up after a few seconds and stated "what happened" became alert and oriented times three PCP notified advised to go to emerg rm for eval. Mother took him directly to emerg rm per mom.
Age: 47.0
Sex: M
Vaccine: ANTH, FLUX, FLUX(H1N1), SMALL, UNK
Symptoms: Dry skin, Erythema, Fatigue, Hyperaesthesia, Multiple allergies
Clinical narrative: Dry skin, Hives, Itchy skin, redness, sensitive skin, fatigue, severe sinusitis, common allergies, prostate inflammation
Age: 47.0
Sex: M
Vaccine: ANTH, FLUX, FLUX(H1N1), SMALL, UNK
Symptoms: Prostatitis, Pruritus, Sinusitis, Urticaria
Clinical narrative: Dry skin, Hives, Itchy skin, redness, sensitive skin, fatigue, severe sinusitis, common allergies, prostate inflammation
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Balance disorder, Diplopia, Dizziness, Eye disorder, Feeling abnormal
Clinical narrative: ADMISSION HISTORY AND PHYSICAL: DATE OF ADMISSION:  07/02/11 CHIEF COMPLAINT:  Visual disturbance. HISTORY OF PRESENT ILLNESS:  Patient is a 34-year-old woman with no significant past medical history who reports visual disturbance for the past week.  Initially, the problem was intermittent and characterized by a sensation of the room lurching to the left when she opened her eyes.  This persisted for about 15 to 20 minutes after each time she slept or had a nap, but was not entirely consistent.  Two days ago, the patient noted double vision, but this also was only when trying to look at distant objects.  She denies any monocular vision loss and can correct the double vision by covering one eye or by focusing on something nearby.  She also reports that her eyes feel "stuck shut" when first opening in the morning, although there is no crusting or discharge. Yesterday, the day prior to the admission, she has felt lightheaded all day, but on further examination, she states that she was off balance when walking and could not quite figure out where her body was in space.  She denies any recent travel.  Denies any tick bites.  Her only recent medical procedure was hepatitis B vaccine, the first of her life that she knows of, approximately 2 weeks ago. She has been preparing to be a CNA and this vaccine was given as part of her training and readiness through the home health agency. PAST MEDICAL HISTORY:  Recurrent sinusitis and allergic rhinitis. PAST SURGICAL HISTORY:  C-section x3, tubal ligation on the third one. MEDICATIONS:  Tylenol p.r.n. and allergy medicines over-the-counter. DIAGNOSIS: internuclear ophthalmoplegia
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Nuclear magnetic resonance imaging normal, Ophthalmoplegia, Visual impairment
Clinical narrative: ADMISSION HISTORY AND PHYSICAL: DATE OF ADMISSION:  07/02/11 CHIEF COMPLAINT:  Visual disturbance. HISTORY OF PRESENT ILLNESS:  Patient is a 34-year-old woman with no significant past medical history who reports visual disturbance for the past week.  Initially, the problem was intermittent and characterized by a sensation of the room lurching to the left when she opened her eyes.  This persisted for about 15 to 20 minutes after each time she slept or had a nap, but was not entirely consistent.  Two days ago, the patient noted double vision, but this also was only when trying to look at distant objects.  She denies any monocular vision loss and can correct the double vision by covering one eye or by focusing on something nearby.  She also reports that her eyes feel "stuck shut" when first opening in the morning, although there is no crusting or discharge. Yesterday, the day prior to the admission, she has felt lightheaded all day, but on further examination, she states that she was off balance when walking and could not quite figure out where her body was in space.  She denies any recent travel.  Denies any tick bites.  Her only recent medical procedure was hepatitis B vaccine, the first of her life that she knows of, approximately 2 weeks ago. She has been preparing to be a CNA and this vaccine was given as part of her training and readiness through the home health agency. PAST MEDICAL HISTORY:  Recurrent sinusitis and allergic rhinitis. PAST SURGICAL HISTORY:  C-section x3, tubal ligation on the third one. MEDICATIONS:  Tylenol p.r.n. and allergy medicines over-the-counter. DIAGNOSIS: internuclear ophthalmoplegia
Age: 45.0
Sex: M
Vaccine: MMR, TD, MMR, TDAP
Symptoms: Erythema, Hypersensitivity, Swelling face
Clinical narrative: Facial Swelling and Facial Redness relieved by one dose of oral Benadryl.
Age: 45.0
Sex: M
Vaccine: MMR, TD, MMR, TDAP
Symptoms: Erythema, Swelling face
Clinical narrative: Facial Swelling and Facial Redness relieved by one dose of oral Benadryl.