chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding a currently 18-month-old patient of unknown gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were not reported. On an unknown date the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # R005116 and expiration date: 20-NOV-2020) (dose and route were unknown) for prophylaxis following a temperature excursion and no adverse effects (no adverse event) were reported. The temperature and timeframe were at or above 32 degree Fahrenheit to 35 degree Fahrenheit (0 degree Celsius to 1 degree Celsius) (34.6 Fahrenheit) (multiple excursions) for 34.5 hours and previously also had temperature excursions at 47 degree Fahrenheit to 77 degree Fahrenheit (9 degree Celsius to 25 degree Celsius) (49.2 Fahrenheit) for 320 minutes. The call was because of a data logger. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1812USA000178:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In approximately November 2016, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 15-NOV-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about September 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In approximately 2008, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about October 2008, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-NOV-2009, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In 2014, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Very red and swollen around sight of injection and warm to touch. Barely move arm. Told to see Dr.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: 2 days after vaccine had supraclavicular swelling - persistant. Evaluation pending.
Age: 12.0
Sex: F
Vaccine: DTAP, FLU4, HPV9, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to be given a Tdap and was given a Dtap by mistake.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: WARM, RED, PAINFUL CIRCULAR AREA AROUND INJECTION SITE.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling abnormal, Gaze palsy, Hyperhidrosis, Loss of consciousness, Muscle rigidity
Clinical narrative: Patient became rigid, eyes rolled back in head, spaced out, appeared like a seizure, sweating profusely. Good Samaritan in line identified herself as a nurse and helped pharmacist keep patient's head still and taking pulse. Pharmacist got tech to call the clinic nurse who came over and took blood pressure and heart rate. Cold water bottles were placed behind patient's head and neck and nurses and pharmacist helped patient to the floor to get blood to his head. Tech called 911 and EMS reported to scene. EMS began to check patient's vitals and stood patient up only for patient to act like he was going to vomit and passed out again. EMS put patient on stretcher and took patient to a medical facility.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Seizure like phenomena
Clinical narrative: Patient became rigid, eyes rolled back in head, spaced out, appeared like a seizure, sweating profusely. Good Samaritan in line identified herself as a nurse and helped pharmacist keep patient's head still and taking pulse. Pharmacist got tech to call the clinic nurse who came over and took blood pressure and heart rate. Cold water bottles were placed behind patient's head and neck and nurses and pharmacist helped patient to the floor to get blood to his head. Tech called 911 and EMS reported to scene. EMS began to check patient's vitals and stood patient up only for patient to act like he was going to vomit and passed out again. EMS put patient on stretcher and took patient to a medical facility.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Angiogram, Balance disorder, Chest X-ray, Dizziness
Clinical narrative: Sudden Hearing Loss Syndrome resulting in vertigo so severe I was in hospital 3 days and rehab 6 more days. While huge improvements have been made, dizziness and balance issues remain unresolved. While hospitalized, an MRI of the brain showed a TIA that appeared to have happened about the same time as the FLUZONE was administered. Saw PCP's PA on 10-01-18. Saw ENT on 10-16-18. Saw PCP on 10-26-18. Saw Audiologist and ENT on 11-14-18 for full hearing and balance testing.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram, Electrocardiogram, Nuclear magnetic resonance imaging brain abnormal, Sudden hearing loss, Transient ischaemic attack
Clinical narrative: Sudden Hearing Loss Syndrome resulting in vertigo so severe I was in hospital 3 days and rehab 6 more days. While huge improvements have been made, dizziness and balance issues remain unresolved. While hospitalized, an MRI of the brain showed a TIA that appeared to have happened about the same time as the FLUZONE was administered. Saw PCP's PA on 10-01-18. Saw ENT on 10-16-18. Saw PCP on 10-26-18. Saw Audiologist and ENT on 11-14-18 for full hearing and balance testing.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound Doppler, Vertigo
Clinical narrative: Sudden Hearing Loss Syndrome resulting in vertigo so severe I was in hospital 3 days and rehab 6 more days. While huge improvements have been made, dizziness and balance issues remain unresolved. While hospitalized, an MRI of the brain showed a TIA that appeared to have happened about the same time as the FLUZONE was administered. Saw PCP's PA on 10-01-18. Saw ENT on 10-16-18. Saw PCP on 10-26-18. Saw Audiologist and ENT on 11-14-18 for full hearing and balance testing.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dyspepsia, Fatigue, Injection site pain, Myalgia
Clinical narrative: By night-time Wednesday (after the shot Wednesday morning), I had a low-grade fever; it got as high as 101 and was up and down between mid 99 and mid-100 for about 24 hours (my norm is approximately 97.7) - Also had low energy, muscle aches and gastric distress (as well as the tenderness around the shot area). Symptoms had mostly subsided by Friday morning, but I stayed home from work Thursday and Friday to make sure there wasn't something else going on. 5 days later tired and some sinus drainage.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: By night-time Wednesday (after the shot Wednesday morning), I had a low-grade fever; it got as high as 101 and was up and down between mid 99 and mid-100 for about 24 hours (my norm is approximately 97.7) - Also had low energy, muscle aches and gastric distress (as well as the tenderness around the shot area). Symptoms had mostly subsided by Friday morning, but I stayed home from work Thursday and Friday to make sure there wasn't something else going on. 5 days later tired and some sinus drainage.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthma, Condition aggravated, Gait disturbance, Guillain-Barre syndrome, Joint hyperextension
Clinical narrative: Day after receiving flu shot, tip of my nose itched and I started breaking out in welt hives on my face. Four days later, I had an asthma attack (first in several months), and then on the following Monday 11/26, I started feeling muscle weakness and tingling in my arms and legs on both sides.  That continued through the week worsening until Friday evening 11/30, I could not walk right. My knees would hyperextend and lock. Saturday morning I woke up, still unable to walk properly, went to the ER. There they diagnosed me with a mild case of an immune reaction to my nerves, called Guillain-Barre Syndrome.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint lock, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Day after receiving flu shot, tip of my nose itched and I started breaking out in welt hives on my face. Four days later, I had an asthma attack (first in several months), and then on the following Monday 11/26, I started feeling muscle weakness and tingling in my arms and legs on both sides.  That continued through the week worsening until Friday evening 11/30, I could not walk right. My knees would hyperextend and lock. Saturday morning I woke up, still unable to walk properly, went to the ER. There they diagnosed me with a mild case of an immune reaction to my nerves, called Guillain-Barre Syndrome.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Day after receiving flu shot, tip of my nose itched and I started breaking out in welt hives on my face. Four days later, I had an asthma attack (first in several months), and then on the following Monday 11/26, I started feeling muscle weakness and tingling in my arms and legs on both sides.  That continued through the week worsening until Friday evening 11/30, I could not walk right. My knees would hyperextend and lock. Saturday morning I woke up, still unable to walk properly, went to the ER. There they diagnosed me with a mild case of an immune reaction to my nerves, called Guillain-Barre Syndrome.
Age: 45.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal pain, Neck pain
Clinical narrative: Severe (extreme) pain in right shoulder, right side of neck, right shoulder blade, and from injection site all the way down to right wrist. Very limited mobility of right arm, loss of sleep due to pain.
Age: 45.0
Sex: F
Vaccine: PPV, TD
Symptoms: Pain in extremity
Clinical narrative: Severe (extreme) pain in right shoulder, right side of neck, right shoulder blade, and from injection site all the way down to right wrist. Very limited mobility of right arm, loss of sleep due to pain.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Condition aggravated, Tic
Clinical narrative: Tics started around the 4th day after vaccine. Patient has a similar reaction around 6 yrs old. We worked to build her immunity up with supplements and followed a strict diet. As of the past 2 years patient had been free from tics. After this meningitis vaccine, the tics started up again.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle and joint aching, chills and fever. Chills occurred again at 11:30 when ibuprofen wore off. Temperature 99 by morning.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Auditory disorder, Bed rest, Electrocardiogram normal, Electromyogram normal, Fatigue
Clinical narrative: FRI 9/14- FATIGUED, NOT QUITE RIGHT. SAT 9/15- SLIGHT HEADACHE, TIRED. SUN 9/16- VOMITING, HEADACHE, STAYED IN BED ALL DAY-UNKNOWN IF I HAD A FEVER. MONDAY 3AM 9/17 - SEIZURE, STIFF BODY-SHAKING- AUDITORY DISTURBANCE -INABILTY TO WILLFULLY MOVE MY BODY. TUES 6:00AM, SHORT SLIGHT EVENT JUST INVOLUNTARY SHAKING, NO AUDITORY DISTURBANCE.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Muscle rigidity, Nuclear magnetic resonance imaging normal, Seizure, Tremor
Clinical narrative: FRI 9/14- FATIGUED, NOT QUITE RIGHT. SAT 9/15- SLIGHT HEADACHE, TIRED. SUN 9/16- VOMITING, HEADACHE, STAYED IN BED ALL DAY-UNKNOWN IF I HAD A FEVER. MONDAY 3AM 9/17 - SEIZURE, STIFF BODY-SHAKING- AUDITORY DISTURBANCE -INABILTY TO WILLFULLY MOVE MY BODY. TUES 6:00AM, SHORT SLIGHT EVENT JUST INVOLUNTARY SHAKING, NO AUDITORY DISTURBANCE.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: FRI 9/14- FATIGUED, NOT QUITE RIGHT. SAT 9/15- SLIGHT HEADACHE, TIRED. SUN 9/16- VOMITING, HEADACHE, STAYED IN BED ALL DAY-UNKNOWN IF I HAD A FEVER. MONDAY 3AM 9/17 - SEIZURE, STIFF BODY-SHAKING- AUDITORY DISTURBANCE -INABILTY TO WILLFULLY MOVE MY BODY. TUES 6:00AM, SHORT SLIGHT EVENT JUST INVOLUNTARY SHAKING, NO AUDITORY DISTURBANCE.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Depression, Headache, Pain, Pyrexia
Clinical narrative: Acute onset of Depression, Fever (100.8 F), Chills, Headache, Body aches. Duration was 48 hours.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports that the site of her vaccine injection is red, swollen, tender and itchy.
Age: 20.0
Sex: M
Vaccine: FLUN4, MENB
Symptoms: Cold sweat, Dizziness, Posture abnormal
Clinical narrative: Within seconds of receiving the vaccine, patient said he felt woozy, slumped forward, Skin cool and clammy. Episode lasted approximately 15 seconds, then patient opened his eyes, asked if he rec'd the shot. Pulse was 60 and faint, kept supine for 15 mins, alert and oriented. Sat on side of exam table, drank 2 small glasses of water, skin warm and dry. Patient did state that he had only a protein bar all morning, and was not drinking much today.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever over 102F beginning about 15 hours after vaccine administration, chills, muscle aches. Symptoms lasted over 8 hours.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Lymphadenopathy, Neck pain, Night sweats
Clinical narrative: Injection was placed below the deltoid, hitting tendon/nerve, resulting in immediate and lasting pain.  Pain continued up through shoulder, neck and jaw (swollen lymph nodes) over the course of 2 days, which continued until I consulted a massage therapist who worked it out. Had continuous night sweats for 12 days, followed by post-nasal drip, for which I obtained medication.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in jaw, Product administered at inappropriate site, Upper-airway cough syndrome
Clinical narrative: Injection was placed below the deltoid, hitting tendon/nerve, resulting in immediate and lasting pain.  Pain continued up through shoulder, neck and jaw (swollen lymph nodes) over the course of 2 days, which continued until I consulted a massage therapist who worked it out. Had continuous night sweats for 12 days, followed by post-nasal drip, for which I obtained medication.
Age: 0.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Baby was given a dose of baby flu (0.25) in our pediatric office instead of a Hep B. Dr spoke with mother and baby is doing well, eating and a febrile.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: Rash on my lower arms and lower legs, my throat was swelling up and my tongue, couldn't really breathe well, and I forgot to mention I had bad diarrhea. I took Benadryl and I used albuteral inhaler from when I had bronchitis a couple years back. The rash went away the next morning and the swelling in my throat and tongue went away to. My throat was still red and itchy the next day didn't take anything for it. I also had a little bit of diarrhea the next day but it got better through the day. On the third day everything went away except me feeling tired and run down.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Swollen tongue, Throat irritation
Clinical narrative: Rash on my lower arms and lower legs, my throat was swelling up and my tongue, couldn't really breathe well, and I forgot to mention I had bad diarrhea. I took Benadryl and I used albuteral inhaler from when I had bronchitis a couple years back. The rash went away the next morning and the swelling in my throat and tongue went away to. My throat was still red and itchy the next day didn't take anything for it. I also had a little bit of diarrhea the next day but it got better through the day. On the third day everything went away except me feeling tired and run down.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: At injection site, soreness and redness that spread.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site mass, Injection site pain
Clinical narrative: Pt described the vaccine as painful at the time of injection as if a nerve had been hit. She developed a small lump and discomfort rapidly. She reported soreness and difficulty using her arm for the two months following the injection.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Started as a small rash on back, and progressed to cover whole back.
Age: 60.0
Sex: M
Vaccine: HEPA
Symptoms: Culture wound negative, Nodule
Clinical narrative: Pt received Hep A and flu vaccine while at work in October, a few weeks later he developed a knot on the right arm. We evaluated the area, obtained a culture which was negative, and treated with mupirocin ointment.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient's arm has been sore ever since he received the vaccination.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test, Injection site haemorrhage
Clinical narrative: I was unable to stop bleeding at site; went to ER for help; hemorrhage at injection site; gelfoam applied with bandages; 11/29/2018.  Bleeding continued through the night; went back to ER on 11/30/2018 for additional help.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site haemorrhage
Clinical narrative: I was unable to stop bleeding at site; went to ER for help; hemorrhage at injection site; gelfoam applied with bandages; 11/29/2018.  Bleeding continued through the night; went back to ER on 11/30/2018 for additional help.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Muscle twitching
Clinical narrative: LOC for 15 seconds post IM. Patient was in chair and didn't fall to ground or have injury related to LOC. Twitching S/S during LOC. Gave juice and observed patient in clinic for 20 minutes. Changed positions slowly. S/S resolved before client left the clinic.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Confusional state, Rash, Tremor
Clinical narrative: Per patient's daughter, her mother experienced shaking and chills and confusion about 3 hours after injection. The daughter described what she thought was cellulitis down her arm past her elbow. She also had a rash on her torso. She had no fever. No medical treatment was sought and symptoms resolved on their own.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Both my husband and I received shingles vaccines at pharmacy. The first one led to some arm pain and that was all. After the second shot we both experienced severe headache, nausea, and fever.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: After injection patient was experiencing limited upward movement of his arm, tingling and numbness in his fingers and pain. This started within a week after the injection. Patient has seen PCP and VOLTAREN gel was prescribed for treatment but is waiting for prior authorization. Physician is ordering further evaluation.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Areflexia, Balance disorder, Computerised tomogram, Dysstasia, Gait disturbance
Clinical narrative: On Tuesday 10/30/18 she woke up and she felt like her balance was off, had to hold on to furniture in order to walk. On Wednesday 10/31/18 it was worse when she woke up. I as the pharmacist advised her to call her doctor right away because she said she couldn't feel her legs and she couldn't stand. She had an appointment with her doctor that afternoon and was unable to walk and she could not feel from her knees down. The doctor immediately recognized the symptoms and sent her to the hospital right away. They directly admitted her. She spent 9 days in the hospital. They diagnosed her with Guillain-Barre Syndrome within 24 hours of being in the hospital. She had no reflexes from her knees down. She received 5 plasmapheresis treatments every other day while she was in the hospital. Her doctor said that the Guillain-Barre syndrome was from the flu shot not the Shingrix since it was a few days before. She still is doing PT two days per week and the bottoms of her feet are still numb.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Nuclear magnetic resonance imaging, Plasmapheresis
Clinical narrative: On Tuesday 10/30/18 she woke up and she felt like her balance was off, had to hold on to furniture in order to walk. On Wednesday 10/31/18 it was worse when she woke up. I as the pharmacist advised her to call her doctor right away because she said she couldn't feel her legs and she couldn't stand. She had an appointment with her doctor that afternoon and was unable to walk and she could not feel from her knees down. The doctor immediately recognized the symptoms and sent her to the hospital right away. They directly admitted her. She spent 9 days in the hospital. They diagnosed her with Guillain-Barre Syndrome within 24 hours of being in the hospital. She had no reflexes from her knees down. She received 5 plasmapheresis treatments every other day while she was in the hospital. Her doctor said that the Guillain-Barre syndrome was from the flu shot not the Shingrix since it was a few days before. She still is doing PT two days per week and the bottoms of her feet are still numb.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory disturbance
Clinical narrative: On Tuesday 10/30/18 she woke up and she felt like her balance was off, had to hold on to furniture in order to walk. On Wednesday 10/31/18 it was worse when she woke up. I as the pharmacist advised her to call her doctor right away because she said she couldn't feel her legs and she couldn't stand. She had an appointment with her doctor that afternoon and was unable to walk and she could not feel from her knees down. The doctor immediately recognized the symptoms and sent her to the hospital right away. They directly admitted her. She spent 9 days in the hospital. They diagnosed her with Guillain-Barre Syndrome within 24 hours of being in the hospital. She had no reflexes from her knees down. She received 5 plasmapheresis treatments every other day while she was in the hospital. Her doctor said that the Guillain-Barre syndrome was from the flu shot not the Shingrix since it was a few days before. She still is doing PT two days per week and the bottoms of her feet are still numb.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Brief convulsion.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient came to the pharmacy today 12/5 and said that he's having issues with his arm since his shot. He said he can not lift his right arm (flu shot arm) very well and has trouble scratching his back. It started a few days after he got the shot and he has seen the Dr since and started physical therapy for the arm. He thought that made he had some nerve damage from the vaccine. He did not know the exact date that his symptoms started.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a clinic. On or about 2015, the patient was treated at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-JAN-2014, the patient's healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 21-NOV-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-AUG-2013, the patient was administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided) at a pharmacy. On or about 23-JUL-2016, the patient was treated by a healthcare provider at a healthcare clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about September 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 08-JUN-2016, the patient was treated by a healthcare provider for zoster ocular disease. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, zoster ocular disease was determined to be medical significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 14-JUN-2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-JUN-2016, the patient was treated by a healthcare provider for Bell's Palsy. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Bell's Palsy was determined to be significant medical event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2006, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-DEC-2015 the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 17-FEB-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, on or about 02-NOV-2016, the patient was treated by a physician for shingles, as the patient was diagnosed with shingles or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.