chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Abnormal behaviour, Aggression, Constipation, Convulsion, Crying
Clinical narrative: Summary:  neurological/motor problems, movement disorder, significant decrease in receptive and expressive language, muscle seizures, aggression, screaming, crying, mood swings. Details: Loss of appetite for 2 days after the vaccination and constipation for approximately a week.  Within 30 hours of the vaccination, she began having motor problems and some type of movement disorder.  She would "pause" while walking (from seconds to minutes).  She would get "stuck" in one spot.  She would often walk backwards several steps before proceeding forward.  She could walk but it was if her brain was having trouble telling her limbs what to do.  She would writhe or squirm with her waist and shoulders, making slow contortions with her hips and upper body.  She has spells where she lays on the ground and writhes uncontrollably.  She began asking us to get things for her, as she didn't want to move as much.  Her pediatrician wondered if it was Dystonia.  This behavior has never subsided, and over the past few months she has continued to decline.  Her pre-existing autism has made the diagnosis more difficult to determine.  Prior to the vaccine, her general state of interaction with others was about 60-80% of the time, with 20-40% of the time she enjoyed time alone playing games and listening to music, but was happy to include us if we joined her.  After the vaccination, she became more difficult to reach, with her interaction level decreasing to about 30-50% of the time, with 50-70% of the time in her own world.  Previously she was a cheerful and happy child, but since the vaccine she is often unhappy and sad, with sudden outbursts of crying.  She has indicated that she does not want to make these movements and that she needs to go to the hospital.  We have seen neurologists.  We have also seen a doctor at the neurology clinic.  Currently there is no clear diagnosis.  In November and December, her movement episodes have been accompanied with increased behavioral problems.  Over the last six weeks she has hit her teacher, hit a student, and hit her parents.  She had never done this before.  At other times she becomes destructive, and has broken or attempted to break various things in the house. She has difficulty sleeping through the night, and sometimes wakes up screaming and runs through the house.  She has also gained about 15 pounds since the vaccine.  We believe the tetanus vaccine adversely affected her nervous system.  She is not the same.  It has drastically decreased her ability to think, speak, and move like she had been able to prior to the vaccine.  She now needs almost constant supervision.  She began taking medication (Clonidine, began 12/25/2012) to try to help calm her.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Decreased appetite, Depressed mood, Insomnia, Mental impairment, Mixed receptive-expressive language disorder
Clinical narrative: Summary:  neurological/motor problems, movement disorder, significant decrease in receptive and expressive language, muscle seizures, aggression, screaming, crying, mood swings. Details: Loss of appetite for 2 days after the vaccination and constipation for approximately a week.  Within 30 hours of the vaccination, she began having motor problems and some type of movement disorder.  She would "pause" while walking (from seconds to minutes).  She would get "stuck" in one spot.  She would often walk backwards several steps before proceeding forward.  She could walk but it was if her brain was having trouble telling her limbs what to do.  She would writhe or squirm with her waist and shoulders, making slow contortions with her hips and upper body.  She has spells where she lays on the ground and writhes uncontrollably.  She began asking us to get things for her, as she didn't want to move as much.  Her pediatrician wondered if it was Dystonia.  This behavior has never subsided, and over the past few months she has continued to decline.  Her pre-existing autism has made the diagnosis more difficult to determine.  Prior to the vaccine, her general state of interaction with others was about 60-80% of the time, with 20-40% of the time she enjoyed time alone playing games and listening to music, but was happy to include us if we joined her.  After the vaccination, she became more difficult to reach, with her interaction level decreasing to about 30-50% of the time, with 50-70% of the time in her own world.  Previously she was a cheerful and happy child, but since the vaccine she is often unhappy and sad, with sudden outbursts of crying.  She has indicated that she does not want to make these movements and that she needs to go to the hospital.  We have seen neurologists.  We have also seen a doctor at the neurology clinic.  Currently there is no clear diagnosis.  In November and December, her movement episodes have been accompanied with increased behavioral problems.  Over the last six weeks she has hit her teacher, hit a student, and hit her parents.  She had never done this before.  At other times she becomes destructive, and has broken or attempted to break various things in the house. She has difficulty sleeping through the night, and sometimes wakes up screaming and runs through the house.  She has also gained about 15 pounds since the vaccine.  We believe the tetanus vaccine adversely affected her nervous system.  She is not the same.  It has drastically decreased her ability to think, speak, and move like she had been able to prior to the vaccine.  She now needs almost constant supervision.  She began taking medication (Clonidine, began 12/25/2012) to try to help calm her.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Mood swings, Motor dysfunction, Movement disorder, Nervous system disorder, Screaming
Clinical narrative: Summary:  neurological/motor problems, movement disorder, significant decrease in receptive and expressive language, muscle seizures, aggression, screaming, crying, mood swings. Details: Loss of appetite for 2 days after the vaccination and constipation for approximately a week.  Within 30 hours of the vaccination, she began having motor problems and some type of movement disorder.  She would "pause" while walking (from seconds to minutes).  She would get "stuck" in one spot.  She would often walk backwards several steps before proceeding forward.  She could walk but it was if her brain was having trouble telling her limbs what to do.  She would writhe or squirm with her waist and shoulders, making slow contortions with her hips and upper body.  She has spells where she lays on the ground and writhes uncontrollably.  She began asking us to get things for her, as she didn't want to move as much.  Her pediatrician wondered if it was Dystonia.  This behavior has never subsided, and over the past few months she has continued to decline.  Her pre-existing autism has made the diagnosis more difficult to determine.  Prior to the vaccine, her general state of interaction with others was about 60-80% of the time, with 20-40% of the time she enjoyed time alone playing games and listening to music, but was happy to include us if we joined her.  After the vaccination, she became more difficult to reach, with her interaction level decreasing to about 30-50% of the time, with 50-70% of the time in her own world.  Previously she was a cheerful and happy child, but since the vaccine she is often unhappy and sad, with sudden outbursts of crying.  She has indicated that she does not want to make these movements and that she needs to go to the hospital.  We have seen neurologists.  We have also seen a doctor at the neurology clinic.  Currently there is no clear diagnosis.  In November and December, her movement episodes have been accompanied with increased behavioral problems.  Over the last six weeks she has hit her teacher, hit a student, and hit her parents.  She had never done this before.  At other times she becomes destructive, and has broken or attempted to break various things in the house. She has difficulty sleeping through the night, and sometimes wakes up screaming and runs through the house.  She has also gained about 15 pounds since the vaccine.  We believe the tetanus vaccine adversely affected her nervous system.  She is not the same.  It has drastically decreased her ability to think, speak, and move like she had been able to prior to the vaccine.  She now needs almost constant supervision.  She began taking medication (Clonidine, began 12/25/2012) to try to help calm her.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Social avoidant behaviour, Weight increased
Clinical narrative: Summary:  neurological/motor problems, movement disorder, significant decrease in receptive and expressive language, muscle seizures, aggression, screaming, crying, mood swings. Details: Loss of appetite for 2 days after the vaccination and constipation for approximately a week.  Within 30 hours of the vaccination, she began having motor problems and some type of movement disorder.  She would "pause" while walking (from seconds to minutes).  She would get "stuck" in one spot.  She would often walk backwards several steps before proceeding forward.  She could walk but it was if her brain was having trouble telling her limbs what to do.  She would writhe or squirm with her waist and shoulders, making slow contortions with her hips and upper body.  She has spells where she lays on the ground and writhes uncontrollably.  She began asking us to get things for her, as she didn't want to move as much.  Her pediatrician wondered if it was Dystonia.  This behavior has never subsided, and over the past few months she has continued to decline.  Her pre-existing autism has made the diagnosis more difficult to determine.  Prior to the vaccine, her general state of interaction with others was about 60-80% of the time, with 20-40% of the time she enjoyed time alone playing games and listening to music, but was happy to include us if we joined her.  After the vaccination, she became more difficult to reach, with her interaction level decreasing to about 30-50% of the time, with 50-70% of the time in her own world.  Previously she was a cheerful and happy child, but since the vaccine she is often unhappy and sad, with sudden outbursts of crying.  She has indicated that she does not want to make these movements and that she needs to go to the hospital.  We have seen neurologists.  We have also seen a doctor at the neurology clinic.  Currently there is no clear diagnosis.  In November and December, her movement episodes have been accompanied with increased behavioral problems.  Over the last six weeks she has hit her teacher, hit a student, and hit her parents.  She had never done this before.  At other times she becomes destructive, and has broken or attempted to break various things in the house. She has difficulty sleeping through the night, and sometimes wakes up screaming and runs through the house.  She has also gained about 15 pounds since the vaccine.  We believe the tetanus vaccine adversely affected her nervous system.  She is not the same.  It has drastically decreased her ability to think, speak, and move like she had been able to prior to the vaccine.  She now needs almost constant supervision.  She began taking medication (Clonidine, began 12/25/2012) to try to help calm her.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Small dot like rash all over both arms and 5 minutes later, also noticed signs of rash on legs too.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Malaise, Migraine, Myalgia
Clinical narrative: Migraine headache, nausea, muscle aches, weakness, fatigue, malaise.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Migraine headache, nausea, muscle aches, weakness, fatigue, malaise.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine, Varicella virus test positive, Viral test positive
Clinical narrative: Presented with clusters of vesicles on his back one day after receiving 2012 Flumist vaccine.  Viral culture revealed Varicella Zoster.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt had syncope after administration of FLUZONE vaccine. Pt passed out approximately 30 sec then regained consciousness. Pt requested 911 called, paramedics checked vitals, had pt drink gatorade & left approximately 20 min after.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental exposure, Needle issue
Clinical narrative: Needle used in vaccination did not auto-retract. Upon pulling needle out, caused fluid to splash back at provider. No harm to patient, just the provider.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling abnormal, Nausea, Tremor, Vision blurred
Clinical narrative: Approx 12-15 minutes after vaccine was administered, pt said she "didn't feel good". When asked how she felt, she started shaking, saying her vision was blurry, she felt nauseous. A few minutes later she said it was getting difficult to breathe. An ambulance was called.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients. The Physician called to report that an unspecified number of unspecified patients may have been administered M-M-R II (Lot#, dose/frequency, route unspecified) that were improperly stored on unspecified dates from May 2012 to December 2012 at an unspecified healthcare facility. No adverse effects reported. This was one of several reports that received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients. The Physician called to report that an unspecified number of unspecified patients may have been administered ZOSTAVAX (Lot#, dose/frequency, route unspecified) that were improperly stored on unspecified dates from May 2012 to December 2012 at an unspecified healthcare facility. No adverse effects reported. This was one of several reports that received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who on an unknown date in 2012 ("few days ago") was vaccinated with ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient came back to the clinic to receive an antiviral medication (date unspecified). The pharmacist did not know the reason for the antiviral medication. The reporter did not think that it was related to the ZOSTAVAX vaccination. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients. The Physician called to report that an unspecified number of unspecified patients may have been administered VARIVAX (Merck) (Lot#, dose/frequency, route unspecified) that were improperly stored on unspecified dates from May 2012 to December 2012 at an unspecified healthcare facility. No adverse effects reported. This was one of several reports that received from the same source. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Myalgia
Clinical narrative: C/o muscle pain in left arm 2 hours after injection given, pain from injection site to elbow, pain is decreasing as time goes on.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Chest X-ray normal, Convulsion, Laboratory test normal, Pyrexia, Respiratory tract congestion
Clinical narrative: Seen at ER on 12/18/2012 around 11:40 PM with fever, congestion, as seizure activity. Pt was given 4mg of ATIVAN and transferred to medical center. Arrived at ER (0157 12/19/12) while seizing, approx 45 minutes. TYLENOL given at ER at 8:06 AM for fever. Highest temp at ER was 100.8 (R).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender who on unspecified date was vaccinated with the third dose of GARDASIL (dose, route, and lot # not reported) after the second dose had been given approximately in December 2010 (two years ago) (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Dysarthria, Headache, Hypoaesthesia oral, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to a 19 years old male patient with no medical history. On unknown dates the patient was vaccinated with the first and the second dose of GARDASIL respectively (dose, route and lot # not specified). Patient developed dizziness after his first dose of GARDASIL. After the 2nd dose of GARDASIL the patient passed out in the office, his tongue became numb and he slurred his speech. The patient was home and had developed a headache and had some blurred vision. The outcome of adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: This spontaneous report as received from a physician refers to a 19 years old male patient with no medical history. On unknown dates the patient was vaccinated with the first and the second dose of GARDASIL respectively (dose, route and lot # not specified). Patient developed dizziness after his first dose of GARDASIL. After the 2nd dose of GARDASIL the patient passed out in the office, his tongue became numb and he slurred his speech. The patient was home and had developed a headache and had some blurred vision. The outcome of adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: Patient was given PNEUMOVAX 23 vaccine IM (Deltoid (0.5 mL). The next day patient arm was sore and red. Patient went to urgent care. Patient was told that she had cellulitis. Patient was put on clindamycin 300mg.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Laboratory test, Unevaluable event, Urine analysis
Clinical narrative: Please send all information relating to carcinogenicity or mutagenicity of this drug relating to lot H015863.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Diabetes mellitus, Feeling abnormal, Heart rate increased, Palpitations
Clinical narrative: Please send all information relating to carcinogenicity or mutagenicity of this drug relating to lot H015863.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Pneumonia
Clinical narrative: Case number PHEH2012US025598 is an initial spontaneous report from the consumer received on 28 Dec 2012. This report refers to a 69-year-old female patient. She had a past history of vaccination with FLUVIRIN (unknown manufacturer) but had developed no reactions. The patient was vaccinated with FLUVIRIN intramuscularly (batch number: 12252P and expiration date: May 2013) on 13 Oct 2012. On 15 Oct 2012, two days after vaccination, the patient experienced pneumonia. The patient was treated with Z-PAK which was prescribed by the ENT (ear, nose and throat) doctor. It was reported that, from an unknown date the patient was lethargic for several weeks. The seriousness, outcome and causality of the events were not reported.
Age: 4.0
Sex: F
Vaccine: DTP, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This medical assistant reports that a currently 4 year old female patient was vaccinated with MMR II, 0.5 mL unknown frequency on an unknown date for an unknown indication and VARIVAX (Merck), 0.5 mL unknown frequency on an unknown date for an unknown indication, and FLUMIST of an unknown dose, frequency and indication. She has no relevant medical history or concomitant medications (concomitant medication also reported as DTP). Her relevant past drug history was unknown. On 21-DEC-2012, she received FLUMIST. On 26-DEC-2012, the patient was given booster shots of MMR II and VARIVAX (Merck) within the same one month interval that she received her last dose of FLUMIST. As of 26-DEC-2012, she was not experiencing any adverse reaction. She had no relevant laboratory data. As of 26-DEC-2012, it was unknown if the patient will continue receiving MMR II, VARIVAX (Merck) or FLUMIST together within one month interval and the outcome of the event was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Bacterial test negative, Headache, Joint fluid drainage, Joint swelling
Clinical narrative: Case number PHEH2012US025599, is an initial spontaneous report received from a consumer on 28 Dec 2012. This report refers to 69-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 12252P, expiry date: Jun 2013) on 13 Oct 2012. On 06 Dec 2012, the patient developed pain in knees, wrists, hands, shoulders, and neck and had really bad headaches. His knees were swollen to the size of a small basketball. He had fever of 102 degrees Fahrenheit went to emergency room and was hospitalized for 3-4 days. None of his cultures tested positive for bacterial diseases and his white blood cell count was low. Fluid was drained from knees. He continued to run a low fever after being discharged from the hospital. He followed up an orthopedic doctor and internist who referred him to a rheumatologist to rule out autoimmune causes. He had FLUVIRIN in the past without any reactions. The final outcome of the events and causality assessment was not reported.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Pyrexia, White blood cell count decreased
Clinical narrative: Case number PHEH2012US025599, is an initial spontaneous report received from a consumer on 28 Dec 2012. This report refers to 69-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 12252P, expiry date: Jun 2013) on 13 Oct 2012. On 06 Dec 2012, the patient developed pain in knees, wrists, hands, shoulders, and neck and had really bad headaches. His knees were swollen to the size of a small basketball. He had fever of 102 degrees Fahrenheit went to emergency room and was hospitalized for 3-4 days. None of his cultures tested positive for bacterial diseases and his white blood cell count was low. Fluid was drained from knees. He continued to run a low fever after being discharged from the hospital. He followed up an orthopedic doctor and internist who referred him to a rheumatologist to rule out autoimmune causes. He had FLUVIRIN in the past without any reactions. The final outcome of the events and causality assessment was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Accidental exposure, Foreign body in eye, Syringe issue
Clinical narrative: Case number PHEH2012US025571 is an initial spontaneous report received from a healthcare professional on 13 Nov 2012. This report refers to a unspecified age and gender patient. The patient was vaccinated with FLUVIRIN (batch number: 12245P and expiry date: May 2013) on an unspecified date. The reporter reported that, two separate times after attaching safety needle to prefilled syringe (PFS), an employee got glass in the eye once the syringe broke at the hub. No information on person/employee. No additional information provided by reporter.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Dizziness, Fatigue, Heart rate increased
Clinical narrative: 12/22: Fatigue 12/23 AM-12/30: Severe joint pain, fast heart rate & high blood pressure, fever, dizziness, wheezing and coughing, chest congestion. 01/02/2013: Still coughing, wheezing and chest congestion along with fatigue.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Respiratory tract congestion, Wheezing
Clinical narrative: 12/22: Fatigue 12/23 AM-12/30: Severe joint pain, fast heart rate & high blood pressure, fever, dizziness, wheezing and coughing, chest congestion. 01/02/2013: Still coughing, wheezing and chest congestion along with fatigue.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from healthcare worker (pharmacy technician) who reported that a dose of PROQUAD (Merck) lot number reported as H015644 exp. date 23-FEB-2014 (dose and route not reported) that was improperly stored at 36-46 degrees F in the refrigerator for possibly 816 hours on 01-NOV-2012 was administered on 28-NOV-2012. The patient's identifiers were not available at the time of the call (age, gender not provided). No adverse effect reported. This is one of several reports from the same source (MAARS # 1212USA011255, 1212USA011256, 1212USA001732). Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia
Clinical narrative: Weakness.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 17 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated (route unknown) with dose 1 GARDASIL (lot number and expiry date not reported) on 18-AUG-2011. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of NOV-2012. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1. On 14-DEC-2012 the patient received her first dose of GARDASIL on 18-AUG-2011 and the second on 14-DEC-2012, 119 days after onset of therapy. A recent pregnancy test was positive. Pregnancy is normal to date. No treatment information was reported. The outcome of received her first dose on 08/18/2011 and the second on 12/14/2012 and pregnant is unknown. Received her first dose on 08/18/2011 and the second on 12/14/2012 and pregnant is not related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from healthcare worker (pharmacy technician) who reported that a dose of PROQUAD lot number reported as H015644 exp. date 23-FEB-2014 (dose and route not reported) that was improperly stored at 36-46 degrees F in the refrigerator for possibly 816 hours on 01-NOV-2012 was administered on 07-NOV-2012. The patient's identifiers were not available at the time of the call (age, gender not provided). No adverse effect reported. This is one of several reports from the same source (MAARS # 1212USA011256, 1212USA011257, 1212USA001732). Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Patient left a message at office of Dr. regarding a severe reaction to the flu vaccine he had on 12/12/12. Patient requested a VAERS report be filed but did not give any further information. I contacted the patient to get further information regarding the type of reaction he had but the patient refused to talk to RN or given any further information. Patient hung up the phone on RN. Form has been completed with the information I have in his chart. Dr. has been made aware of the incident and the patient's response.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Immunoglobulin therapy, Petechiae, Platelet transfusion
Clinical narrative: Pt noticed bruises and petechia on both legs from the knees down and large bruise on front torso. Pt went to urgent care and then sent to ER where she was admitted. She was transfused with platelets and given immunoglobulins. She is still currently still under MD care.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Severe pain in left arm (2 - weeks) nausea for two days and general aches & pains in body for two weeks. I was feeling great before the injection. (Horrible side effects).
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Cough, Pyrexia
Clinical narrative: Patient is experiencing extreme weakness dry cough. Low grade fever.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Movement disorder, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: 2 days after receiving flu shot, my knees swelled & continued to swell. Lot of pain in knees & legs. Very difficult to get up & down on 11-8-12 & went to Dr. He said flu shot caused problems as did another Dr. Dr drew 30cc of fluid off of right knee. Not able to do lift knee and on 11-21-12 he started me on prednisone which I still am taking. Not able to lay in bed and sleep for over 2 months. Improving now but not fully recovered.
Age: 17.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt with full body hives. No wheezing or difficulty breathing. Given topical steroid cream, loratadine & BENADRYL for itch. Has f/u in 1 wk.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Soreness/stiffness in arm. Unable to use arm. Pain went away with steroids but came right back once completed. Currently starting 2nd round of steroids.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes simplex, Simplex virus test positive, Vulvovaginal pain
Clinical narrative: Pain on the outer left labia, worsend in hrs., lasted most of the night. Felt like a shock on top of a deep bruise. Body tensed w/ea. shock. Next day notice of outbreak of HSV Type 1 inner left labia. Cld gyno. did not return call. Treated myself and saw dr. 12/19/12 as prev. scheduled. Test proved type 1. Nvr had before. One sex partner in life, celebate since 1992, ex hus. was faithful.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Insomnia, Pain, Rash vesicular, Simplex virus test positive
Clinical narrative: Pain on the outer left labia, worsend in hrs., lasted most of the night. Felt like a shock on top of a deep bruise. Body tensed w/ea. shock. Next day notice of outbreak of HSV Type 1 inner left labia. Cld gyno. did not return call. Treated myself and saw dr. 12/19/12 as prev. scheduled. Test proved type 1. Nvr had before. One sex partner in life, celebate since 1992, ex hus. was faithful.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Parent (father) reports he noticed a small bump resembling a mosquito bite on child's left thigh and 2 days later he noticed child scratching and saw that it looked like a small blister.  Dad reports child had a flu shot in left arm on Dec. 21st.  Denies child having any rash or swelling and no difficulty breathing.  As of 12/27, has not visited doctor for exam.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Electromyogram, Lumbar puncture, Muscular weakness, Paraesthesia
Clinical narrative: Tingling on face, feet, legs, arms, hands, difficulty swallowing, leg weakness. Began on face, then feet, legs, arms, hands, then difficulty swallowing, then legs became weak. Began 10/25/12, not resolved as yet.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient stopped talking, had slight twitching. Slouched over, & was unresponsive for 45-60 seconds. I prevented her from falling, she came to slowly & we talked to her to make sure she knew who she is & where she was. She then knelt down & rested her head on the chair. Her state improved gradually. Then EMS took over.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's Palsy (facial paralysis) diagnosed at ED visit later that day. Started on valacyclovir and prednisone for 2 week.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Thirst, Vomiting
Clinical narrative: Vomiting and excessive thirst. Child woke up from sleep vomited, requested water. Vomited again, requested water, and continued to vomit and drink water for the next 48 hours. No treatment, child rested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: DEVELOPED PAIN LEFT DELTOID AREA IMMEDIATELY AFTER VACCINATION. PAIN PROGRESSED SAME AREA AND NOW CAN'T LIFT HER LEFT ARM AND HAS WEAKNESS IN LEFT HAND. NO SENSORY DEFICIT. NO PAIN RADIATION. TOOK IBUPROFEN, NOT HELPING.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Blood glucose increased, Blood pH decreased, Diabetic ketoacidosis, Respiratory syncytial virus test positive, Type 1 diabetes mellitus
Clinical narrative: Type 1 DM, presented with DKA with pH 6.87 on 12/31/2012.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza A virus test positive
Clinical narrative: Positive influenza type A. After influenza vaccine on 09/22/12.
Age: 0.85
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Pyrexia, Vomiting
Clinical narrative: Fever up to 103 degrees x 2 days, very fussy; emesis x 1 1st day; symptoms started 30 minutes after IZ administration.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain in extremity, Tenderness
Clinical narrative: 12/16 had pain (L) upper arm shortly after getting shot 12/17/12 - (L) neck pain, (L) upper arm pain radiating to distal forearm, (L) thigh pain - tenderness of (L) upper arm and (L) thigh. 12/18 - neck pain resolved but still had (L) upper arm and (L) thigh pain - ibuprofen 400 q 6 hours, see if no improvement.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Hypoaesthesia, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling in left arm and back. Sensation of numbness. Patient went to ER, (2 wks after) they did MRI and said could be paresthesia due to FLUVIRIN.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who in about July 2011, was vaccinated with the first dose of GARDASIL intramuscularly (dose and lot number not provided). Other co-suspects were not reported. Concomitant medications were not reported. It was reported that the patient on 26-JUL-2012, was vaccinated with the second dose of GARDASIL intramuscularly (dose and lot number not provided). At the time of the report, no known adverse effects. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Activities of daily living impaired, Dermatitis contact, Hyperaesthesia, Pain
Clinical narrative: This spontaneous report as received from a consumer refers his a 62 year old wife with none drug reactions or allergies and none pertinent medical history. At the end of October 2012, the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (dose, route, lot number not reported). No other co-suspects were reported. There was no concomitant medications. It was reported that 12 hours after vaccination (at the end of October 2012), the patient broke out in a rash that started at her arms and spread across her chest, back and legs. Her rash was a red raised area with small rash like pimples, some areas had larger hive looking pastorals. The patient was in a burning pain and could not leave her bed or have anything touch her body. Their dermatologist diagnosed the rash as contact dermatitis. Unspecified ointment was given as a treatment for adverse event. No laboratory tests were performed. At the time of the report the patient's outcome was reported as not recovered. The patient sought medical attention, saw their doctor and an unspecified dermatologist. The relatedness for contact dermatitis was not reported for ZOSTAVAX. Upon internal review, contact dermatitis was determined to be disabling. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: This spontaneous report as received from a consumer refers his a 62 year old wife with none drug reactions or allergies and none pertinent medical history. At the end of October 2012, the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (dose, route, lot number not reported). No other co-suspects were reported. There was no concomitant medications. It was reported that 12 hours after vaccination (at the end of October 2012), the patient broke out in a rash that started at her arms and spread across her chest, back and legs. Her rash was a red raised area with small rash like pimples, some areas had larger hive looking pastorals. The patient was in a burning pain and could not leave her bed or have anything touch her body. Their dermatologist diagnosed the rash as contact dermatitis. Unspecified ointment was given as a treatment for adverse event. No laboratory tests were performed. At the time of the report the patient's outcome was reported as not recovered. The patient sought medical attention, saw their doctor and an unspecified dermatologist. The relatedness for contact dermatitis was not reported for ZOSTAVAX. Upon internal review, contact dermatitis was determined to be disabling. Additional information is not expected.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient reported shot given at approximately 12pm on 10/29/12 & at approximately 3pm same day, he developed a rash from his left shoulder to elbow. Applied ice & went away by end of day.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Decreased interest, Eating disorder, Irritability, Personality change, Rash
Clinical narrative: Severe restlessness/irritability, rash and vomiting. Also no interest/has not been eating- this personality change with change in eating habits have now lasted a month and have not subsided.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Restlessness, Vomiting
Clinical narrative: Severe restlessness/irritability, rash and vomiting. Also no interest/has not been eating- this personality change with change in eating habits have now lasted a month and have not subsided.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Swelling
Clinical narrative: Pt reports mild swelling and tenderness at injection site the following day, started to subside on Day 2, then had a return of further swelling on lateral upper arm where vaccine was administered along with axillary swelling on the same side.
Age: 14.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, slight erythema and large area of induration at immunization site on right arm.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Blood test, Chills, Ear congestion, Fatigue
Clinical narrative: Next day: Fever spikes, chills, extreme fatigue, headache, running nose, nausea, sinus, ear congestion.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Pyrexia, Rhinorrhoea, Sinus congestion
Clinical narrative: Next day: Fever spikes, chills, extreme fatigue, headache, running nose, nausea, sinus, ear congestion.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Injection site pain, Muscular weakness, Pain
Clinical narrative: At the time the vaccine was given, it felt like it was too high in the arm (although the patient isn't certain this was the case). General achy, muscular symptoms (similar to flu symptoms) were noticed later that day as well as local pain at the injection site. The generalized symptoms went away within a day or so, but the localized pain in the left shoulder and upper arm has persisted, gotten worse, and the arm is weak. Some days it's worse than others. The following motions cause pain in the left shoulder and upper arm: a motion similar to a back swing while playing tennis, turning the steering wheel of the car, holding a jacket with the left hand to put onto the right arm, sometimes when immobile, and then need to adjust positions. The patient has not consulted with a medical doctor, but may do so if the pain persists. We feel that this adverse reaction is severe enough to report and especially considering that it does not seem to be improving. There were no other possible causes of this pain - no falls or other medical problems.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Blood urine present, Chills, Pyrexia, Rash, Rash erythematous
Clinical narrative: High fever (over 102.9), chills, urinary incontinence with blood in urine. This was from Friday evening (12/28) until Tuesday morning (1/1/13) when his fever was gone. Wednesday (1/2/13) a small red bump rash appeared on his chest and stomach. The Pediatrician suggested it was a virus, but I am positive it was a vaccine reaction. He had no other symptoms of viral infection and his brother and sister have remained healthy.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Urinary incontinence, Viral infection
Clinical narrative: High fever (over 102.9), chills, urinary incontinence with blood in urine. This was from Friday evening (12/28) until Tuesday morning (1/1/13) when his fever was gone. Wednesday (1/2/13) a small red bump rash appeared on his chest and stomach. The Pediatrician suggested it was a virus, but I am positive it was a vaccine reaction. He had no other symptoms of viral infection and his brother and sister have remained healthy.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: VIIth nerve paralysis
Clinical narrative: Rt facial paralysis (Bell's palsy).  Seen in office 1/2/13, started on oral steroids, referred to neurology.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Computerised tomogram abnormal, Full blood count normal, Infection, Lymphadenopathy
Clinical narrative: 12/20/12 STIFF NECK & LUMPS ON BACK OF NECK & SORE TO THE TOUCH. 12/21/12 LUMP UNDER CHIN SORE TO TOUCH 12/22-23/12 LUMPS INCREASED IN SIZE & PAIN WORSENED - ACETAMINOPHEN HELPED WITH PAIN 12/24/12 EMPLOYEE HEALTH CLOSED FOR THE DAY I CALLED EMERGENCY DEPT & WAS TOLD TO COME TO ED AND BE CHECKED. MD EXAMINED, ORDERED BLOOD WORK & A CT SCAN OF NECK. THE BLOOD WORK WERE NORMAL & CT SCAN OF NECK SHOWED NO ABSCESS, WITH LYMPHADENOPATHY. WAS GIVEN A RX FOR AZITHROMYCIN 250MG (Z-PACK) AND TOLD TO FOLLOW UP WITH MY PCP.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Lymphoma, Mass, Metabolic function test normal, Musculoskeletal stiffness, Neck pain
Clinical narrative: 12/20/12 STIFF NECK & LUMPS ON BACK OF NECK & SORE TO THE TOUCH. 12/21/12 LUMP UNDER CHIN SORE TO TOUCH 12/22-23/12 LUMPS INCREASED IN SIZE & PAIN WORSENED - ACETAMINOPHEN HELPED WITH PAIN 12/24/12 EMPLOYEE HEALTH CLOSED FOR THE DAY I CALLED EMERGENCY DEPT & WAS TOLD TO COME TO ED AND BE CHECKED. MD EXAMINED, ORDERED BLOOD WORK & A CT SCAN OF NECK. THE BLOOD WORK WERE NORMAL & CT SCAN OF NECK SHOWED NO ABSCESS, WITH LYMPHADENOPATHY. WAS GIVEN A RX FOR AZITHROMYCIN 250MG (Z-PACK) AND TOLD TO FOLLOW UP WITH MY PCP.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Malaise, Mastication disorder, Muscle tightness
Clinical narrative: Intermittent right jaw spasm which increased with frequency, difficulty opening mouth and chewing on right side, felt like my jaw was going to lock up in place. These symptoms lasted for four days. Also expected symptoms of fever 100.4, generalize body and joint pain, malaise, chills.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Trismus
Clinical narrative: Intermittent right jaw spasm which increased with frequency, difficulty opening mouth and chewing on right side, felt like my jaw was going to lock up in place. These symptoms lasted for four days. Also expected symptoms of fever 100.4, generalize body and joint pain, malaise, chills.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: She developed diffuse warts over lower body, buttock and right arm after the third HPV vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Asthenia, Cold sweat, Hyperhidrosis, Pallor, Retching
Clinical narrative: Following patients vaccinations, almost immediately, she started to gag as if she was going to vomit, but did not.  She became very pale, grey like, became clammy, sweaty and weak. I sat her down in the lobby chair, gave her some water and within a few minutes was looking and feeling much better.
Age: 32.0
Sex: F
Vaccine: FLU3, HEP, TYP, YF
Symptoms: Fatigue, Injection site pruritus, Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: Feeling fatigued, swelling, pain and itching at site of YF vaccine.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: CSF white blood cell count increased, Encephalitis, Nuclear magnetic resonance imaging brain abnormal, Pleocytosis
Clinical narrative: Patient developed encephalitis. He was admitted to hospital. He receieved LP which showed pleocytosis. Other infectious workup negative.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Deafness unilateral, Dysphagia, Herpes zoster oticus, Laboratory test
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 years old male patient with no drug reactions/allergies. The patient's medical history included cancer. The patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as H013900) subcutaneously on 13-NOV-2012. No concomitant medications were reported. The nurse called stating the patient received ZOSTAVAX on 13-NOV-2012 developing Ramsey Hunt Syndrome and was hospitalized. The patient started to experience symptoms on 20-NOV-2012. The patient saw his primary care physician initially. He was also referred to an ENT (Ear, Nose and Throat) specialist on 07-DEC-2012. CT scan, lab work and spinal tab were performed without any results. However his symptoms exacerbated and he was hospitalized on 12-DEC-2012 and spent 3 to 4 days in the hospital. The patient was still experiencing deafness in one ear, trouble swallowing and partial paralysis of his throat. He was still recuperating at home. He was prescribed acyclovir for his condition. The patient had a history of cancer however he was in remission for the past year and had not received any therapy related to cancer in the past year. At the time of reporting, the outcome was reported as recovering. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Lumbar puncture, Paralysis
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 years old male patient with no drug reactions/allergies. The patient's medical history included cancer. The patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as H013900) subcutaneously on 13-NOV-2012. No concomitant medications were reported. The nurse called stating the patient received ZOSTAVAX on 13-NOV-2012 developing Ramsey Hunt Syndrome and was hospitalized. The patient started to experience symptoms on 20-NOV-2012. The patient saw his primary care physician initially. He was also referred to an ENT (Ear, Nose and Throat) specialist on 07-DEC-2012. CT scan, lab work and spinal tab were performed without any results. However his symptoms exacerbated and he was hospitalized on 12-DEC-2012 and spent 3 to 4 days in the hospital. The patient was still experiencing deafness in one ear, trouble swallowing and partial paralysis of his throat. He was still recuperating at home. He was prescribed acyclovir for his condition. The patient had a history of cancer however he was in remission for the past year and had not received any therapy related to cancer in the past year. At the time of reporting, the outcome was reported as recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Faint after receiving shot.