chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-DEC-2010, the patient was inoculated with ZOSTAVAX at a family physician's office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician at the same family physician's office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 09-JUL-2011, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-JUN-2016, the patient was treated by a physician at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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. In November 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-NOV-2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir and gabapentin for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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. On or about 03-AUG-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2014, the patient was treated at a clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR and hydrocodone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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. On or about 19-NOV-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-FEB-2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed ZOVIRAX and NORCO for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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. On or about 10-JUN-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed valacyclovir, prednisone, and tramadol for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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. On or about 20-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-NOV-2013, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir, tramadol and LYRICA for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: HEP, HPVX, MNQ
Symptoms: Exposure during pregnancy, Knee operation, No adverse event
Clinical narrative: Initial unsolicited pregnancy report received from a Nurse on 29-May-2018. This case involves a 15-year-old female patient, who was vaccinated with 0.5ml once injection of MENACTRA (Batch number: U5765AC; expiry date and dose in series were not reported) in her right arm on 23-May-2018 while she was pregnant. Pregnancy information including estimated delivery date and patient was in her third trimester during vaccine exposure. Last menstrual period  Oct-2017, patient was 35-37 weeks pregnant. Patient's medical history and concomitant medications were not reported. It was also reported that patient was having knee surgery. No adverse event symptoms were reported. Pregnancy outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to tetanus toxoid; Initial unsolicited report received from physician (rheumatology) on 23-May-2018. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had allergy to tetanus toxoid. Lab data and corrective treatment were not reported. The outcome of events was not reported.  List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from physician via Pfizer on 23-May-2018. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had allergy (unspecified). Lab data and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 0.67
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial unsolicited report received from physician on 24 May 2018. This case involves eight-month-old patient (gender not reported) who was vaccinated with a dose of PENTACEL and ACTHIB (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from an office person medical assistant on 30-May-2018. This case involves 12 months old patient (gender was not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiration date, dose, dose in series, route and site of administration were not reported) instead of ACT-HIB (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient was previously vaccinated with a dose of DAPTACEL. It was a case of an actual medication error due to wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial unsolicited report received from a nurse on 31 May 2018. This case involves a patient (age and gender not reported) who was vaccinated with two doses of IPOL (batch number, expiry date, dose, dose in series, site and route of administration were not reported for both doses) on unspecified dates. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to extra dose administered as patient was vaccinated with second dose just nine days apart from first dose. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Muscle aches severe, chills and lasted through the night.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema, Headache, Herpes zoster
Clinical narrative: Painful headache in left side of head and prickly skin on 6/8/18, proceeded to get worse. On 6/9/18 in the evening started to get red blisters on left eyelid and left eyebrow. On 6/10/18, woke up to fire red blisters on left eyelid, left eyebrow, left forehead and left scalp. I got shingles from the vaccine
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmological examination, Paraesthesia
Clinical narrative: Painful headache in left side of head and prickly skin on 6/8/18, proceeded to get worse. On 6/9/18 in the evening started to get red blisters on left eyelid and left eyebrow. On 6/10/18, woke up to fire red blisters on left eyelid, left eyebrow, left forehead and left scalp. I got shingles from the vaccine
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Headache, Herpes zoster, Paraesthesia, Rash
Clinical narrative: Painful headache in left side of head and prickly skin on 6/8/18, proceeded to get worse. On 6/9/18 in the evening started to get red blisters on left eyelid and left eyebrow. On 6/10/18, woke up to fire red blisters on left eyelid, left eyebrow, left forehead and left scalp. I got shingles from the vaccine
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Painful headache in left side of head and prickly skin on 6/8/18, proceeded to get worse. On 6/9/18 in the evening started to get red blisters on left eyelid and left eyebrow. On 6/10/18, woke up to fire red blisters on left eyelid, left eyebrow, left forehead and left scalp. I got shingles from the vaccine
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Eyelid oedema, Headache, Herpes zoster, Injection site pain
Clinical narrative: Painful headache in left side of head and prickly skin on 6/8/18, proceeded to get worse. On 6/9/18 in the evening started to get red blisters on left eyelid and left eyebrow. On 6/10/18, woke up to fire red blisters on left eyelid, left eyebrow, left forehead and left scalp. I got shingles from the vaccine
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: Painful headache in left side of head and prickly skin on 6/8/18, proceeded to get worse. On 6/9/18 in the evening started to get red blisters on left eyelid and left eyebrow. On 6/10/18, woke up to fire red blisters on left eyelid, left eyebrow, left forehead and left scalp. I got shingles from the vaccine
Age: 1.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Provider ordered KINRIX and MA gave as ordered. No adverse event.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness
Clinical narrative: On 1st and 2nd dose...flu like symptoms. Painful joints. Headache. Appeared 6 hours after injection. Took ADVIL and rested!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia, Rash generalised
Clinical narrative: Per the doctor's office, the patient had swelling and redness at the injection site, rashes throughout her body, fever and aches. The Dr. office prescribed a taper of prednisone and told the patient to take over the counter ZYRTEC. Patient has not started therapy yet.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness approx. 3 in in diameter over deltoid are right arm. Denies fever, itching.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Mom reports red hard bump at injection site accompanied with small red bumps/rash around the site.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue
Clinical narrative: Client received a Hepatitis B vaccine on 6/6/18. Client called on 6/8/18 to report that she had dizziness and fatigue that evening following the vaccine. She has had some fatigue since then, and dizziness in the am's. No other symptoms or complaints. Has not fainted. Has not contacted or been to an MD.  Dizziness and fatigue have not interfered with her usual daily activities. Instructed patient to contact her MD or seek medical assistance if symptoms persisted or worsened, or if she was concerned.  Instructed that malaise and fatigue are side effects that are documented that can occur in less than 10% of clients who are vaccinated with Hepatitis B. She verbalized her understanding.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Shortly after the vaccination I felt lightheaded and was unable to focus on simple computer tasks and felt very tired and weak. Laid down could not focus on reading or viewing TV slept for several hours. The following day I tried to work after a breakfast of toast and coffee, but the symptoms of the previous day continued so I returned to bed and slept for the next 8 hours. When I woke-up I had what I would describe as flu-like symptoms body aches and chills. This lasted until early evening on the third day when I started to feel better. By the fourth day I felt well again.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersomnia, Influenza like illness, Pain
Clinical narrative: Shortly after the vaccination I felt lightheaded and was unable to focus on simple computer tasks and felt very tired and weak. Laid down could not focus on reading or viewing TV slept for several hours. The following day I tried to work after a breakfast of toast and coffee, but the symptoms of the previous day continued so I returned to bed and slept for the next 8 hours. When I woke-up I had what I would describe as flu-like symptoms body aches and chills. This lasted until early evening on the third day when I started to feel better. By the fourth day I felt well again.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture, C-reactive protein, Chest X-ray abnormal, Full blood count, Pneumonia
Clinical narrative: on 5/31/18 she woke up with a fever, was given tylenol and went back to bed. The morning of 6/1/18 she woke up and continued to fever and had a rash. Went to the pediatrician's office, confirmed it was a vaccine reaction. Asked to give tylenol to keep the fever down and it would subside in about 24-48 hours. From 6/1-6/4 she spiked fevers every 4 hours that would range from 104.5-105.1. Called the nurse line on 6/2 and we were told to continue tylenol. She went back to the pediatrician on 6/4 due to high fevers still and was diagnosed with pneumonia via chest x-ray. Given Rocephin shot, then prescribed oral amoxicillin for 10 days.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Red blood cell morphology, Vaccination complication, White blood cell count
Clinical narrative: on 5/31/18 she woke up with a fever, was given tylenol and went back to bed. The morning of 6/1/18 she woke up and continued to fever and had a rash. Went to the pediatrician's office, confirmed it was a vaccine reaction. Asked to give tylenol to keep the fever down and it would subside in about 24-48 hours. From 6/1-6/4 she spiked fevers every 4 hours that would range from 104.5-105.1. Called the nurse line on 6/2 and we were told to continue tylenol. She went back to the pediatrician on 6/4 due to high fevers still and was diagnosed with pneumonia via chest x-ray. Given Rocephin shot, then prescribed oral amoxicillin for 10 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Mobility decreased, Night sweats, Pain, Swelling
Clinical narrative: I could not move my arm. It was FROZEN. My shoulder SWELLED UP INCREDIBLY BAD,........  I had the shot on 05-22-2018 and tried my best to overcome the PAIN AND SWELLING, sweating at night, shakes, temperature, loss of appetite, inability to move my shoulder. It was "TOTALLY LOCKED" and I could not take the pain anymore so I went to Urgent Care for help with the pain. I got a shot of TORADOL in my right hip and then a shot of steroids in my left hip. I got Rx a bottle of TORADOL pain pills (30) and a MEDROL DOSE PACK. All this was done on 05-31-2018 around 5 p.m. Side effects started on 5-22-2018 and I could not take the pain and finally gave up and went to the Urgent Care Clinic on 5-31-2018,........and my side effects finally resided on 6-10-2018.  My side effects lasted from 5-22-2018 to 6-10-2018.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: I could not move my arm. It was FROZEN. My shoulder SWELLED UP INCREDIBLY BAD,........  I had the shot on 05-22-2018 and tried my best to overcome the PAIN AND SWELLING, sweating at night, shakes, temperature, loss of appetite, inability to move my shoulder. It was "TOTALLY LOCKED" and I could not take the pain anymore so I went to Urgent Care for help with the pain. I got a shot of TORADOL in my right hip and then a shot of steroids in my left hip. I got Rx a bottle of TORADOL pain pills (30) and a MEDROL DOSE PACK. All this was done on 05-31-2018 around 5 p.m. Side effects started on 5-22-2018 and I could not take the pain and finally gave up and went to the Urgent Care Clinic on 5-31-2018,........and my side effects finally resided on 6-10-2018.  My side effects lasted from 5-22-2018 to 6-10-2018.
Age: 1.5
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal stiffness, Myalgia
Clinical narrative: Pt reports severe muscle aches and stiffness for the last 3 weeks since the vaccine was administered.  This has been interfering with her daily activities and range of motion.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: 3 May 2018 at 08:16 From note: Her hands and feet are red and swollen, started last night, also reports achy joints. Very brief period of SOB last night. On exam: HEENT unremarkable. Heart: RRR w/o murmur; Lungs: CTA bilat; Skin: warm and dry without lesions or rash. Palms of both hands and soles of both feet are fiery red with some swelling. No pain to touch; Ext: no edema BLE; Psych: A&Ox4; Neuro: CNII-XII grossly intact. Assessment: T50.B95A. Plan: Prednisone 20mg tab; Sig: Take 2 tablets once daily for four days. Disp#8 NR. Recommend she take OTC ZYRTEC BID; RTC if sxs do not resolve. Call 911 if difficulty breathing develops.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Dizziness, Malaise, Pyrexia, Vomiting
Clinical narrative: I was told it was PREVNAR 13 but not sure as on this visit summary say I did not received any immunizations documented. Don't know-I was not given any info. of this shot no paperwork recorded. No info! Became dizzy walking out of clinic. Had dizzy spell for a second 1/2 hour walking up stairs at brothers house-did not understand why? Let it go. Came home did not feel well 3 HRs later became sick vomiting - 6:30 P.M. felt week dizzy had to lay down. Equilibrium was out of whack. Felt like I had a fever did not want to move just wanted to lady still in bed. Hospital said they could not give help on phone. I don't think my Doctor did anything wrong! But the Clinic should keep better records of what they do! No info of the shot I was given and Records say I did not receive a immunization shot PREVNAR 13 that day? Why?
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Trigeminal neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-DEC-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician's assistant at an office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. On or about 08-NOV-2016, she sought subsequent treatment at the same office for ongoing and worsening zoster complications, which was diagnosed as trigeminal neuralgia, which is a secondary diagnosis of chronic herpes zoster rash. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 19-MAY-2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-JUN-2016, the patient was treated at a medical office facility by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
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. On or about 15-APR-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-DEC-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. On or about 28-DEC-2015, the patient sought subsequent treatment by a physician for a persistent and severe vesicular rash, which was diagnosed as ocular herpes zoster and post-herpetic neuralgia. The patient has been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Upon internal review, ocular herpes zoster was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2015, the patient was treated by a physician, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-NOV-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-SEP-2014, the patient was treated at a medical facility for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. In February 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), administered by a physician at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-FEB-2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. On or about 15-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-MAY-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. In September 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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. In 2006, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient has been prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
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. On or about 03-SEP-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-FEB-2017, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles with complications. The patient has been prescribed valacyclovir (VALTREX) and acetaminophen and hydrocodone (NORCO) for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. In May 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in June 2015, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.