chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity, Restlessness, Skin warm, Throat tightness
Clinical narrative: Symptoms started about 5pm day of vaccines with redness, swelling at site. Hives started on arm in am 12/30/16 pain in arm, neck, and head that continues. It continues to be hot to touch. No respiratory distress but felt like her throat was thickening all night. She did not rest well. She had abdominal pain with diarrhea all the next day, but better now.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Symptoms started about 5pm day of vaccines with redness, swelling at site. Hives started on arm in am 12/30/16 pain in arm, neck, and head that continues. It continues to be hot to touch. No respiratory distress but felt like her throat was thickening all night. She did not rest well. She had abdominal pain with diarrhea all the next day, but better now.
Age: 23.0
Sex: F
Vaccine: HPVX
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Small hard nodule appeared where vaccine was administered. Nodule slowly grew in size over time, appearing with redness and warmth. The nodule raised the skin at the site and was very painful to touch. Gynecology consult was sought 12/12/2016, and was told it could be some necrosis due to vaccine spill/vaccine technique with removal of needle. Site continued to worsen and became more painful. PCP consult was sought on 12/23/2016 for a second opinion. PCP determined the site was abscessed, but did not warrant antibiotic therapy yet as PCP believes this is a potential reaction to a preservative in the vaccine or a reaction in general. Site continued to worsen over the weekend and redness grew a few inches in diameter. Consult #2 with PCP on 12/28/2016, where an antibiotic was initiated. Site has not improved significantly since then and PCP follow-up #3 is scheduled for week of Jan 1, 2016.
Age: 23.0
Sex: F
Vaccine: HPVX
Symptoms: Injection site warmth
Clinical narrative: Small hard nodule appeared where vaccine was administered. Nodule slowly grew in size over time, appearing with redness and warmth. The nodule raised the skin at the site and was very painful to touch. Gynecology consult was sought 12/12/2016, and was told it could be some necrosis due to vaccine spill/vaccine technique with removal of needle. Site continued to worsen and became more painful. PCP consult was sought on 12/23/2016 for a second opinion. PCP determined the site was abscessed, but did not warrant antibiotic therapy yet as PCP believes this is a potential reaction to a preservative in the vaccine or a reaction in general. Site continued to worsen over the weekend and redness grew a few inches in diameter. Consult #2 with PCP on 12/28/2016, where an antibiotic was initiated. Site has not improved significantly since then and PCP follow-up #3 is scheduled for week of Jan 1, 2016.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Cardiac function test, Condition aggravated, Echocardiogram, Electrocardiogram
Clinical narrative: 10 minute syncopal episode, Herpes lesions in left eye, esophageal dysmotility MS flair up.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes ophthalmic, Multiple sclerosis relapse, Oesophageal motility disorder, Oesophagogastroduodenoscopy, Ophthalmological examination
Clinical narrative: 10 minute syncopal episode, Herpes lesions in left eye, esophageal dysmotility MS flair up.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: 10 minute syncopal episode, Herpes lesions in left eye, esophageal dysmotility MS flair up.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Sleep disorder
Clinical narrative: Ache and pain at site. For the past 2 months pain radiated down to elbow and up to shoulder into scapula. Pain limits range of motion. Loss of sleep due to excruciating pain.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Eczema, Hypersomnia, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: After being injected child instantly fell asleep, slept for 24 hours straight. Redness around injection site and tender. By the next morning his skin broke out in a red itchy rash. He now has eczema. Break outs include itching non stop even when skin is broken open and bleeding.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Rash erythematous, Rash pruritic, Skin haemorrhage
Clinical narrative: After being injected child instantly fell asleep, slept for 24 hours straight. Redness around injection site and tender. By the next morning his skin broke out in a red itchy rash. He now has eczema. Break outs include itching non stop even when skin is broken open and bleeding.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Red, hard, swollen area around injection site.  Area continued to increase in size over 48 hours.  patient seeked medical attention due to worsening symptoms.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: SKIN RASH ON ARM THAT PATIENT RECEIVED IMMUNIZATION.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: ARM STARTED OUT SORE, AS THE NIGHT AND NEXT DAY WENT ON IT BECAME MORE SORE AND STARTED SPREADING.  THERE WAS ALSO REDNESS AND SWELLING AROUND THE SITE AND MOVING DOWN HER ARM.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: Sudden intense light-headedness and nausea.  Felt very much like I was going to faint. Extremely weak.  Returned to bed and symptoms greatly diminished.  Felt very fatigued over next four days.
Age: 1.33
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Glossodynia, Irritability, Pain in extremity, Pyrexia
Clinical narrative: Three projectile vomiting within 20 minutes of receipt of injection. Showing signs on hand pain, irritability, signs tongue hurt. Fever for 24 hours- 102.5. Drank little water and did not want to eat.
Age: 1.33
Sex: F
Vaccine: PNC13
Symptoms: Vomiting projectile
Clinical narrative: Three projectile vomiting within 20 minutes of receipt of injection. Showing signs on hand pain, irritability, signs tongue hurt. Fever for 24 hours- 102.5. Drank little water and did not want to eat.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Blood test, Eye movement disorder, Febrile convulsion, Malaise, Mobility decreased
Clinical narrative: Patient woke up about 8 AM and was unresponsive. His arms and his legs were not moving and his eyes were rolling back. Patient's father then rushed him to the hospital where they were visiting. Where the doctors wanted to initially fly patient to Hospital two hours away. He was kept overnight. The doctors later determined patient had a febroid seizure.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient woke up about 8 AM and was unresponsive. His arms and his legs were not moving and his eyes were rolling back. Patient's father then rushed him to the hospital where they were visiting. Where the doctors wanted to initially fly patient to Hospital two hours away. He was kept overnight. The doctors later determined patient had a febroid seizure.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Adnexa uteri pain, Dysmenorrhoea, Hormone level abnormal, Infertility female
Clinical narrative: While attempting to donate my Eggs, a fertility specialist told me I have low ovarian reserve which means I may never be able to have children. She took blood and discovered my hormone levels were extremely low for my age (20 years old). She even gave me fertility drugs to see if my eggs would still be able to be donated and they were completely unresponsive and she was giving me the highest dose possible (the amount a completely infertile woman should be taking) and still nothing. We even took these tests over the course of a couple months to see if i was just having a bad month but it was the same. She told me I have the eggs that she would normally see in a 35 year old woman. After I had my vaccine, I did begin having slight cramps in my ovaries once a month (along with my menstrual cramps, they would not occur at the time of my period.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient received high dose flu shot in left arm on 12-3-16. Afterwards, patient reported a sore shoulder but no signs of swelling, redness or tenderness but the sore arm has lasted for a few weeks. I notified her doctor and he told her to use ice and move arm around and to call back if it gets worse.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test, Dizziness, Headache, Nausea, Pain
Clinical narrative: She started having a headache about 2 hrs after vaccine. Then she was nauseated and had body aches for two days and was lightheaded for up to a week after the vaccine administration.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt complains of muscle pain/soreness in area of left deltoid pt has not see dr-treating with OTC Ibuprofen- (some help)
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Abasia, Arthritis infective, Aspiration joint, Bacterial infection, Bacterial test positive
Clinical narrative: After getting Hep A vaccination on 12/20, went home and son took a nap, he woke up and would not walk.  After 48 hours of him not walking at all and then I noticed swelling in his left knee (same leg as vaccine) went back to Dr's office, Dr took blood work and x-rays.  Dr spoke to Ortho Nurse Practitioner and they advised to give Motrin thru the holiday weekend.  My son began to walk, with a bad limp on Fri 12/23.  On Tues 12/27, went to see the Ortho Nurse Practitioner (b/c Dr was on vac), she did more blood work.  On Wed received a call from my Ped. & she advised me to go to hospital.  They did more blood work, ultrasound, and x-rays.  Then drew fluid from knee.  After that test came back they admitted us due to a bacterial infection in the knee.  My son had surgery the next day to flush out the knee.  Son is doing much better, still walking with a limp.  They were unable to determine what kind of bacteria caused the problem.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Blood test, C-reactive protein, Gait disturbance, Injection site swelling, Red blood cell sedimentation rate
Clinical narrative: After getting Hep A vaccination on 12/20, went home and son took a nap, he woke up and would not walk.  After 48 hours of him not walking at all and then I noticed swelling in his left knee (same leg as vaccine) went back to Dr's office, Dr took blood work and x-rays.  Dr spoke to Ortho Nurse Practitioner and they advised to give Motrin thru the holiday weekend.  My son began to walk, with a bad limp on Fri 12/23.  On Tues 12/27, went to see the Ortho Nurse Practitioner (b/c Dr was on vac), she did more blood work.  On Wed received a call from my Ped. & she advised me to go to hospital.  They did more blood work, ultrasound, and x-rays.  Then drew fluid from knee.  After that test came back they admitted us due to a bacterial infection in the knee.  My son had surgery the next day to flush out the knee.  Son is doing much better, still walking with a limp.  They were unable to determine what kind of bacteria caused the problem.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Surgery, Ultrasound scan, X-ray
Clinical narrative: After getting Hep A vaccination on 12/20, went home and son took a nap, he woke up and would not walk.  After 48 hours of him not walking at all and then I noticed swelling in his left knee (same leg as vaccine) went back to Dr's office, Dr took blood work and x-rays.  Dr spoke to Ortho Nurse Practitioner and they advised to give Motrin thru the holiday weekend.  My son began to walk, with a bad limp on Fri 12/23.  On Tues 12/27, went to see the Ortho Nurse Practitioner (b/c Dr was on vac), she did more blood work.  On Wed received a call from my Ped. & she advised me to go to hospital.  They did more blood work, ultrasound, and x-rays.  Then drew fluid from knee.  After that test came back they admitted us due to a bacterial infection in the knee.  My son had surgery the next day to flush out the knee.  Son is doing much better, still walking with a limp.  They were unable to determine what kind of bacteria caused the problem.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain, Tenderness
Clinical narrative: EDEMA ERYTHEMA PAIN TENDERNESS.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TDAP, VARZOS
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: Patient stated she had "normal" stiffness in left deltoid muscle day after vaccine, but on 12/31 (3 full weeks after the vaccine), stated still having tightness in arm and throbbing when she lays down, intermittently.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Rash and pain in vaccinated arm only. Continuing pain even until today.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash generalised
Clinical narrative: SEVERE ITCHING (WITH NO RASH) ALL OVER BODY.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Tingling in feet.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Cellulitis, Chills, Flushing, Pyrexia
Clinical narrative: (I am the patient's husband). My wife had an office visit at the Hospital and Clinic facility on 28 December 2016. During that visit she was given a vaccine called Pneumococcal Conj Vaccine 13 Valent IM. Later, around 4PM, (28 December) she experienced chills and feverish feeling, and pain at the vaccine location (left arm). Later, we noticed her face was flushed. Around 10PM on 28 December, we noticed a rash developing on the front of her thighs. At this time we went to the Emergency Department. The diagnosis included vaccination reaction and cellulitis. She was prescribed Clindamycin for the cellulitis. We noticed the rash getting worse on 31 Dec, and went to the Urgent Care at the same facility. She was prescribed prednisone and instructed to report to the emergency room if conditions worsened. We are currently watching her rash condition.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Urine analysis, Vaccination complication, Vaccination site pain
Clinical narrative: (I am the patient's husband). My wife had an office visit at the Hospital and Clinic facility on 28 December 2016. During that visit she was given a vaccine called Pneumococcal Conj Vaccine 13 Valent IM. Later, around 4PM, (28 December) she experienced chills and feverish feeling, and pain at the vaccine location (left arm). Later, we noticed her face was flushed. Around 10PM on 28 December, we noticed a rash developing on the front of her thighs. At this time we went to the Emergency Department. The diagnosis included vaccination reaction and cellulitis. She was prescribed Clindamycin for the cellulitis. We noticed the rash getting worse on 31 Dec, and went to the Urgent Care at the same facility. She was prescribed prednisone and instructed to report to the emergency room if conditions worsened. We are currently watching her rash condition.
Age: 1.58
Sex: F
Vaccine: HEPA, MMR
Symptoms: Blood test, Bronchial hyperreactivity, Bronchoscopy, Cardiac failure, Computerised tomogram
Clinical narrative: Brought her to Dr's office for respiratory illness, given albuterol nebs, cough & breathing worsened throughout the day, brought to ED, admitted to PICU with 50% oxygen & not responding to albuterol, had respiratory & cardiac failure 4/25 in the PICU, was administered CPR, breathing & feeding tubes, and put into medically induced coma for a week, stayed in PICU for 3 weeks, all tests for viruses returned negative, medical staff uncertain what caused this reaction, diagnosed with Reactive Airway Disease.
Age: 1.58
Sex: F
Vaccine: HEPA, MMR
Symptoms: Cough, Endotracheal intubation, Gastrointestinal tube insertion, Intensive care, Medical induction of coma
Clinical narrative: Brought her to Dr's office for respiratory illness, given albuterol nebs, cough & breathing worsened throughout the day, brought to ED, admitted to PICU with 50% oxygen & not responding to albuterol, had respiratory & cardiac failure 4/25 in the PICU, was administered CPR, breathing & feeding tubes, and put into medically induced coma for a week, stayed in PICU for 3 weeks, all tests for viruses returned negative, medical staff uncertain what caused this reaction, diagnosed with Reactive Airway Disease.
Age: 1.58
Sex: F
Vaccine: HEPA, MMR
Symptoms: Nuclear magnetic resonance imaging, Respiration abnormal, Respiratory disorder, Respiratory failure, Resuscitation
Clinical narrative: Brought her to Dr's office for respiratory illness, given albuterol nebs, cough & breathing worsened throughout the day, brought to ED, admitted to PICU with 50% oxygen & not responding to albuterol, had respiratory & cardiac failure 4/25 in the PICU, was administered CPR, breathing & feeding tubes, and put into medically induced coma for a week, stayed in PICU for 3 weeks, all tests for viruses returned negative, medical staff uncertain what caused this reaction, diagnosed with Reactive Airway Disease.
Age: 1.58
Sex: F
Vaccine: HEPA, MMR
Symptoms: Viral test negative
Clinical narrative: Brought her to Dr's office for respiratory illness, given albuterol nebs, cough & breathing worsened throughout the day, brought to ED, admitted to PICU with 50% oxygen & not responding to albuterol, had respiratory & cardiac failure 4/25 in the PICU, was administered CPR, breathing & feeding tubes, and put into medically induced coma for a week, stayed in PICU for 3 weeks, all tests for viruses returned negative, medical staff uncertain what caused this reaction, diagnosed with Reactive Airway Disease.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Complex partial seizures, Decreased eye contact, Developmental delay, Dyskinesia, Failure to thrive
Clinical narrative: Arms flinging out, no more smiles no more eye contact not thriving anymore.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypotonia, Infantile spasms, Partial seizures, Seizure
Clinical narrative: Arms flinging out, no more smiles no more eye contact not thriving anymore.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Fever, redness of arm, swelling (patient applied cool compress and started taking tylenol and benadryl).
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Extreme pain at site of injection radiating to neck and shoulders. Loss of ROM and loss of strength. My dominate hand.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Fatigue, Flushing, Gait disturbance, Nausea
Clinical narrative: Abdominal Pain, walking slow due to pain in stomach, lump on neck, flushing of cheeks, nausea, fatigue.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Neck mass
Clinical narrative: Abdominal Pain, walking slow due to pain in stomach, lump on neck, flushing of cheeks, nausea, fatigue.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Dull ache area of shot.  Severe pain when muscle is stretch as in raising are up. Increasing more pain all day. Took 2 Aleve with minimal relief.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Dull ache area of shot.  Severe pain when muscle is stretch as in raising are up. Increasing more pain all day. Took 2 Aleve with minimal relief.
Sex: F
Vaccine: HPV4
Symptoms: Arrhythmia, Autopsy, Cardiomyopathy, Condition aggravated, Contusion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 15-FEB-2010, a 19 year old female patient with autism and history of atraumatic generalized seizure disorder with abnormal EEG and acute right otitis media (illness at time of vaccination) received a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 19-FEB-2010, she had a grand mal seizure. She had her second shot (reported as lot# "0640Z", not valid for HPV rL1 6 11 16 18 VLP vaccine (yeast) in left arm via intramuscular on 06-AUG-2010. She died on 19-AUG-2010. Medical examiner listed cause of death as sudden unexpected death associated with seizure disorder. Received autopsy report which stated cause of death as: sudden unexpected death associated with generalized seizure disorder. Manner of death: natural. Autopsy findings included patient's history, pulmonary congestion and oedema, and minor scalp contusion. No further information is  available. The listing indicated that one or more of the events resulted in death. The original reporting source was not provided. The VAERS ID # is 406289. This report was also received from the FDA through the Freedom of Information Act. There is no additional information. Follow-up information was received on 28-DEC-2016 from a consumer via social media. The consumer stated that this was a murder and should be stopped. The consumer also added that the patient had been already injured by the vaccine and had no business receiving the GARDASIL. The consumer attached a VAERS form of the patient's case where the following events, experienced by the patient on an unknown date in 2010 (according to the first vaccination with GARDASIL and the patient's death date) were listed: torsade de pointes, QT prolongation, systemic lupus erythematous, arrhythmia, convulsions/generalised convulsive seizures following immunisation, non infectious encephalitis, non infectious encephalopathy/delirium, non infectious meningitis and cardiomyopathy. The outcome of these events was unknown and were considered to be medically significant. Additional information is not expected as there is no contact information. Reported Cause(s) of Death: grand mal seizure; Sudden unexpected death.
Sex: F
Vaccine: HPV4
Symptoms: Death, Delirium, Electrocardiogram QT prolonged, Encephalitis, Encephalopathy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 15-FEB-2010, a 19 year old female patient with autism and history of atraumatic generalized seizure disorder with abnormal EEG and acute right otitis media (illness at time of vaccination) received a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 19-FEB-2010, she had a grand mal seizure. She had her second shot (reported as lot# "0640Z", not valid for HPV rL1 6 11 16 18 VLP vaccine (yeast) in left arm via intramuscular on 06-AUG-2010. She died on 19-AUG-2010. Medical examiner listed cause of death as sudden unexpected death associated with seizure disorder. Received autopsy report which stated cause of death as: sudden unexpected death associated with generalized seizure disorder. Manner of death: natural. Autopsy findings included patient's history, pulmonary congestion and oedema, and minor scalp contusion. No further information is  available. The listing indicated that one or more of the events resulted in death. The original reporting source was not provided. The VAERS ID # is 406289. This report was also received from the FDA through the Freedom of Information Act. There is no additional information. Follow-up information was received on 28-DEC-2016 from a consumer via social media. The consumer stated that this was a murder and should be stopped. The consumer also added that the patient had been already injured by the vaccine and had no business receiving the GARDASIL. The consumer attached a VAERS form of the patient's case where the following events, experienced by the patient on an unknown date in 2010 (according to the first vaccination with GARDASIL and the patient's death date) were listed: torsade de pointes, QT prolongation, systemic lupus erythematous, arrhythmia, convulsions/generalised convulsive seizures following immunisation, non infectious encephalitis, non infectious encephalopathy/delirium, non infectious meningitis and cardiomyopathy. The outcome of these events was unknown and were considered to be medically significant. Additional information is not expected as there is no contact information. Reported Cause(s) of Death: grand mal seizure; Sudden unexpected death.
Sex: F
Vaccine: HPV4
Symptoms: Encephalopathy, Generalised tonic-clonic seizure, Generalised tonic-clonic seizure, Meningitis, Meningitis noninfective
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 15-FEB-2010, a 19 year old female patient with autism and history of atraumatic generalized seizure disorder with abnormal EEG and acute right otitis media (illness at time of vaccination) received a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 19-FEB-2010, she had a grand mal seizure. She had her second shot (reported as lot# "0640Z", not valid for HPV rL1 6 11 16 18 VLP vaccine (yeast) in left arm via intramuscular on 06-AUG-2010. She died on 19-AUG-2010. Medical examiner listed cause of death as sudden unexpected death associated with seizure disorder. Received autopsy report which stated cause of death as: sudden unexpected death associated with generalized seizure disorder. Manner of death: natural. Autopsy findings included patient's history, pulmonary congestion and oedema, and minor scalp contusion. No further information is  available. The listing indicated that one or more of the events resulted in death. The original reporting source was not provided. The VAERS ID # is 406289. This report was also received from the FDA through the Freedom of Information Act. There is no additional information. Follow-up information was received on 28-DEC-2016 from a consumer via social media. The consumer stated that this was a murder and should be stopped. The consumer also added that the patient had been already injured by the vaccine and had no business receiving the GARDASIL. The consumer attached a VAERS form of the patient's case where the following events, experienced by the patient on an unknown date in 2010 (according to the first vaccination with GARDASIL and the patient's death date) were listed: torsade de pointes, QT prolongation, systemic lupus erythematous, arrhythmia, convulsions/generalised convulsive seizures following immunisation, non infectious encephalitis, non infectious encephalopathy/delirium, non infectious meningitis and cardiomyopathy. The outcome of these events was unknown and were considered to be medically significant. Additional information is not expected as there is no contact information. Reported Cause(s) of Death: grand mal seizure; Sudden unexpected death.
Sex: F
Vaccine: HPV4
Symptoms: Noninfective encephalitis, Pulmonary congestion, Pulmonary oedema, Seizure, Sudden death
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 15-FEB-2010, a 19 year old female patient with autism and history of atraumatic generalized seizure disorder with abnormal EEG and acute right otitis media (illness at time of vaccination) received a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 19-FEB-2010, she had a grand mal seizure. She had her second shot (reported as lot# "0640Z", not valid for HPV rL1 6 11 16 18 VLP vaccine (yeast) in left arm via intramuscular on 06-AUG-2010. She died on 19-AUG-2010. Medical examiner listed cause of death as sudden unexpected death associated with seizure disorder. Received autopsy report which stated cause of death as: sudden unexpected death associated with generalized seizure disorder. Manner of death: natural. Autopsy findings included patient's history, pulmonary congestion and oedema, and minor scalp contusion. No further information is  available. The listing indicated that one or more of the events resulted in death. The original reporting source was not provided. The VAERS ID # is 406289. This report was also received from the FDA through the Freedom of Information Act. There is no additional information. Follow-up information was received on 28-DEC-2016 from a consumer via social media. The consumer stated that this was a murder and should be stopped. The consumer also added that the patient had been already injured by the vaccine and had no business receiving the GARDASIL. The consumer attached a VAERS form of the patient's case where the following events, experienced by the patient on an unknown date in 2010 (according to the first vaccination with GARDASIL and the patient's death date) were listed: torsade de pointes, QT prolongation, systemic lupus erythematous, arrhythmia, convulsions/generalised convulsive seizures following immunisation, non infectious encephalitis, non infectious encephalopathy/delirium, non infectious meningitis and cardiomyopathy. The outcome of these events was unknown and were considered to be medically significant. Additional information is not expected as there is no contact information. Reported Cause(s) of Death: grand mal seizure; Sudden unexpected death.
Sex: F
Vaccine: HPV4
Symptoms: Systemic lupus erythematosus, Torsade de pointes
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 15-FEB-2010, a 19 year old female patient with autism and history of atraumatic generalized seizure disorder with abnormal EEG and acute right otitis media (illness at time of vaccination) received a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 19-FEB-2010, she had a grand mal seizure. She had her second shot (reported as lot# "0640Z", not valid for HPV rL1 6 11 16 18 VLP vaccine (yeast) in left arm via intramuscular on 06-AUG-2010. She died on 19-AUG-2010. Medical examiner listed cause of death as sudden unexpected death associated with seizure disorder. Received autopsy report which stated cause of death as: sudden unexpected death associated with generalized seizure disorder. Manner of death: natural. Autopsy findings included patient's history, pulmonary congestion and oedema, and minor scalp contusion. No further information is  available. The listing indicated that one or more of the events resulted in death. The original reporting source was not provided. The VAERS ID # is 406289. This report was also received from the FDA through the Freedom of Information Act. There is no additional information. Follow-up information was received on 28-DEC-2016 from a consumer via social media. The consumer stated that this was a murder and should be stopped. The consumer also added that the patient had been already injured by the vaccine and had no business receiving the GARDASIL. The consumer attached a VAERS form of the patient's case where the following events, experienced by the patient on an unknown date in 2010 (according to the first vaccination with GARDASIL and the patient's death date) were listed: torsade de pointes, QT prolongation, systemic lupus erythematous, arrhythmia, convulsions/generalised convulsive seizures following immunisation, non infectious encephalitis, non infectious encephalopathy/delirium, non infectious meningitis and cardiomyopathy. The outcome of these events was unknown and were considered to be medically significant. Additional information is not expected as there is no contact information. Reported Cause(s) of Death: grand mal seizure; Sudden unexpected death.
Age: 84.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Monoplegia, Oxygen saturation decreased, Pain
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) via other company, Pfizer (Reference number- 2016576708) on 23 December 2016. This case involves a 84-years-old female patient who was vaccinated with a dose of Influenza Vaccine and with one dose of PREVNAR 13 (lot number, expiration date, route of administration and dose in series were not reported for both vaccines) in the upper left arm on 10 October 2016 (reported as the patient was vaccinated while she was admitted in intensive care unit (ICU)). The medical history was reported as pneumonia in her right lung for which the patient was admitted in hospital for four days. The concomitant medications were not reported. The patient was previously vaccinated with flu shot in every year for the last four or five years. On 10 October 2016, same day following the vaccination, the patients developed left arm paralysis. On 10 October 2016, 30 minutes following the vaccination, the patients developed pain/sharp pain. On an unknown day of October 2016, unspecified timeframe following vaccination, the patient developed oxygen deficiency for that the patient was hospitalized for 10 days on 11 October 2016. The patient needed ER/doctor visit (Orthopedic doctor) on an unknown day. The laboratory test and the corrective treatment were not reported. The outcome of the event as arm paralysis and pain was reported as persisting, the outcome of the event as oxygen deficiency was reported as unknown. The patient was discharged on 21 October 2016. Upon internal review the company decided to consider the event serious because of important medical event as left arm paralysis. List of the documents held by sender: none. Sender's Comments: Patient was vaccinated with influenza vaccine and PREVNAR 13 vaccines while discharge from the hospital for pneumonia, patient had arm paralysis, pain and oxygen deficiency. Time to onset is compatible, as patient had oxygen deficiency and was admitted for that again next day, it might be due to recovering from the pneumonia and patient was on oxygen in the hospital. Detail history regarding patient medical history, similar previous episodes, stroke history, past vaccination history are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Heart rate increased, White blood cell count increased
Clinical narrative: This spontaneous report was received from an approximately 70 year old female patient regarding herself. It was reported that the patient did not have any pertinent medical history and drug reactions or allergies. On 19-DEC-2016, the patient was vaccinated with PNEUMOVAX23 (strength, frequency, dose, batch/lot number and expiry date unknown) intramuscularly for prevention of pneumonia.  The concomitant therapies included ATORVASTATIN 20 mg, OXYBUTYNIN 2.5 mg and DICLOFENAC SODIUM 75 mg.  On 20-DEC-2016 (also reported as on the following day of therapy), the patient experienced chills, white blood cell count increased and heart rate increased. The patient sought medical attention and went to the emergency room where the patient received an antibiotic (details unspecified) and was sent home the following day. The events of chills, white blood cell count increased and heart rate increased was considered to be serious due to hospitalization. The therapy with PNEUMOVAX23 was continued. The outcome of chills, white blood cell count increased and heart rate increased was reported as recovered. The causality assessment was not provided. There was no product quality complaint reported. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report was received from a 80 year old male patient reporting on himself. The patient was not taking any concomitant medication, had no pertinent medical history, known drug reactions or allergies. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) injection (dose, route of administration, lot # and expiry date were not reported) for prevention from shingles. On the following day (02-DEC-2016), the patient began to experience flu-like symptoms that were getting worse as of the date of this report. The patient did not seek medical attention. No lab diagnostics studies were performed. The patient did not receive any treatment for this event. Product quality complaint (PQC) was not involved. At the reporting time, the patient still had the flu like symptoms. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 14 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date in August 2016, the patient was vaccinated with a dose of PROQUAD (dose, route, lot# and expiry date were not reported). On an unknown date in October 2016, the patient was revaccinated with a second dose of PROQUAD (dose, route, lot# and expiry date were not reported). The revaccination occurred at the request of the patient's oncologist. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 22-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose, route of administration were not reported; lot # M026306, expiry date: 30-APR-2018) for prophylaxis. The dose was exposed to the temperature of 32 degrees Fahrenheit (F) for a time frame of 26 days (from 05-NOV-2016 to 30-NOV-2016). There were no prior temperature excursions. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA011310.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report received from a consumer referred to a 28 year old female patient. The patient's current condition included allergy to many unspecified antibiotics. Medical history and concomitant medications were not reported. The patient received the VARIVAX on 14-NOV-2016 and the patient found out on 14-DEC-2016, that she was pregnant. Because the product information for VARIVAX states that pregnancy should be avoided for 3 months a full AE is being reported. The Last Menstrual period (LMP) date is 01-DEC-2016 and the due date is 07-SEP-2017. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that occasionally her physician office practice will administer a properly stored dose of GARDASIL (lot number and expiration date unknown by reporter) to an unspecified patient over the recommended maximum age of 26, up to 30 years of age, if prescribed by physician and specifically requested by patient.A No adverse effects reported. dditional information is not possible as consent to contact was not available.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered GARDASIL 9 (lot: M009326; expiry: 13-JUN-2018 and lot: M007764; 30-JAN-2018) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA010325:same reporter.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 13-DEC-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB (dosing details were not reported) (lot # K014190, expiry date: 24-OCT-2016) for prophylaxis (expired vaccine administered). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical histories, concomitant medications and drug histories are all unknown. On an unknown dates in 2016, an unknown number of patients received PNEUMOVAX 23 (lot: L038522, expiry: 11-AUG-2017) after a temperature excursion that occurred on 21-NOV-2016. The reporting nurse stated that none of the patients involved had reported adverse events or symptoms after receiving their vaccination. The patients' laboratory data was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical histories, concomitant medications and drug histories are all unknown. On an unknown dates in 2016, an unknown number of patients received GARDASIL 9 (lot: M023169, expiry: 13-JUN-2018) after a temperature excursion that occurred on 21-NOV-2016. The reporting nurse stated that none of the patients involved had reported adverse events or symptoms after receiving their vaccination. The patients' laboratory data was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 injection at a temperature excursion of above 46F below 50F for 383 hours and 18 minutes (strength and dosage not reported), lot # M011840 (expiry date: 01-FEB-2018) for prophylaxis. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA000029.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB at a temperature excursion of above 46F below 50F for 383 hours and 18 minutes (strength and dosage not reported), lot # M001578 (expiry date: 21-NOV-2018) for prophylaxis. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA000002:
Sex: U
Vaccine: MEN
Symptoms: Migraine
Clinical narrative: This is a spontaneous report obtained from a contactable physician. A patient of an unspecified age, race and gender received meningococcal group B Rlp2086, single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced an intense migraine that recovered after 15 days.
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Bone pain, Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This 52-year-old male patient of other race received on 29Nov2016 a single dose of PREVNAR 13 intramuscular in the left arm for routine vaccination. The patient was diabetic (from 1993). Concomitant medications were not reported. On 29Nov2016 the patient had soreness at the injection site with outcome of not recovered. Additionally it was reported that on an unspecified date in 2016 the patient had soreness in the whole left arm and back, numbness in the arm and no good way to sleep, all with outcome of unknown. Course of the events was as follows: the patient had vaccination on 29Nov2016 and started experiencing soreness at the injection site since that day and was still having soreness 5 weeks later. This event required a visit to physician office. He stated that the soreness was actually the whole left arm and back, explaining that when he sit down in the chair the arm will start going numb and stay numb. Because of that he had no good way to sleep. He had been experiencing numbness and soreness in the arm since an unspecified date in 2016. The arm hurted all the time and he could barely use it. He said a physician tried to take his BP and that the cuff made his arm go numb and feel ice cold, it wouldn't get warm even wrapped in a comforter. He felt like the pain was in the bone, like it was deeper than the muscle. Treatment for pain was provided and included gabapentin 100mg three times at bedtime started on 26Dec2016, but it did not help.
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral coldness, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This 52-year-old male patient of other race received on 29Nov2016 a single dose of PREVNAR 13 intramuscular in the left arm for routine vaccination. The patient was diabetic (from 1993). Concomitant medications were not reported. On 29Nov2016 the patient had soreness at the injection site with outcome of not recovered. Additionally it was reported that on an unspecified date in 2016 the patient had soreness in the whole left arm and back, numbness in the arm and no good way to sleep, all with outcome of unknown. Course of the events was as follows: the patient had vaccination on 29Nov2016 and started experiencing soreness at the injection site since that day and was still having soreness 5 weeks later. This event required a visit to physician office. He stated that the soreness was actually the whole left arm and back, explaining that when he sit down in the chair the arm will start going numb and stay numb. Because of that he had no good way to sleep. He had been experiencing numbness and soreness in the arm since an unspecified date in 2016. The arm hurted all the time and he could barely use it. He said a physician tried to take his BP and that the cuff made his arm go numb and feel ice cold, it wouldn't get warm even wrapped in a comforter. He felt like the pain was in the bone, like it was deeper than the muscle. Treatment for pain was provided and included gabapentin 100mg three times at bedtime started on 26Dec2016, but it did not help.