chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70-year-old female patient. The patient's pertinent medical history or concomitant therapies were not reported. The patient's drug reactions included allergy to sulfa. On 15-JUN-2018, the patient was vaccinated with a dose of PNEUMOVAX intramuscularly, lot # N014946, expiration date: 01-FEB-2019 (strength was not provided) to prevent pneumococcal pneumonia. On 16-JUN-2018, the patient developed cellulitis from the site of PNEUMOVAX injection down to the elbow. On 16-JUN-2018, the patient went to an emergency room and received a dose of ROCEPHIN, followed by a course of doxycycline and KEFLEX for the cellulitis. On 26-JUN-2018, the patient recovered from the event. The relatedness between cellulitis and PNEUMOAX was not reported. Upon internal review, cellulitis was considered to be medically significant.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70-year-old female patient. The patient's pertinent medical history or concomitant therapies were not reported. The patient's drug reactions included allergy to sulfa. On 15-JUN-2018, the patient was vaccinated with a dose of PNEUMOVAX intramuscularly, lot # N014946, expiration date: 01-FEB-2019 (strength was not provided) to prevent pneumococcal pneumonia. On 16-JUN-2018, the patient developed cellulitis from the site of PNEUMOVAX injection down to the elbow. On 16-JUN-2018, the patient went to an emergency room and received a dose of ROCEPHIN, followed by a course of doxycycline and KEFLEX for the cellulitis. On 26-JUN-2018, the patient recovered from the event. The relatedness between cellulitis and PNEUMOAX was not reported. Upon internal review, cellulitis was considered to be medically significant.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Axillary pain, Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: Patient began having reaction at approx. 12 PM on 6/30/18. The reaction started with pt. breaking out in hives and itching. On 7/1/18 he complained of bone and joint pain and continued to have hives. He was taken to the ER and prescribed steroids for Tx. On 7/5 mother reported reaction to health dept. and said that pt. was still having new hives come up. Pt. saw PCP on 7/6 and was Rx'd more steroids (ORAPRED).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Urticaria
Clinical narrative: Patient began having reaction at approx. 12 PM on 6/30/18. The reaction started with pt. breaking out in hives and itching. On 7/1/18 he complained of bone and joint pain and continued to have hives. He was taken to the ER and prescribed steroids for Tx. On 7/5 mother reported reaction to health dept. and said that pt. was still having new hives come up. Pt. saw PCP on 7/6 and was Rx'd more steroids (ORAPRED).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Arthralgia, Bone pain, Pruritus, Urticaria
Clinical narrative: Patient began having reaction at approx. 12 PM on 6/30/18. The reaction started with pt. breaking out in hives and itching. On 7/1/18 he complained of bone and joint pain and continued to have hives. He was taken to the ER and prescribed steroids for Tx. On 7/5 mother reported reaction to health dept. and said that pt. was still having new hives come up. Pt. saw PCP on 7/6 and was Rx'd more steroids (ORAPRED).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Arthralgia, Bone pain, Pruritus, Rash, Urticaria
Clinical narrative: Patient began having reaction at approx. 12 PM on 6/30/18. The reaction started with pt. breaking out in hives and itching. On 7/1/18 he complained of bone and joint pain and continued to have hives. He was taken to the ER and prescribed steroids for Tx. On 7/5 mother reported reaction to health dept. and said that pt. was still having new hives come up. Pt. saw PCP on 7/6 and was Rx'd more steroids (ORAPRED).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema at injection site about 3 inches wide and pain at injection site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Joint swelling
Clinical narrative: There is no way to know if my strong, (low grade fever for 24 hours, fatigue, all-over body ache, big soreness in injection arm & bad headache), but not serious (no trouble breathing) reaction to Shingrix evoked an auto-immune response.  Every year I receive the influenza vaccine and I like to stay up-to-date on any vaccines I think I should, i.e. Pertussis and Tetanus. Usually I have no reaction nor soreness; if I added the reactions to all of the vaccines that I have ever received, it would not be nearly as much as the reaction I had to Shingrix. I think I have RA genes that were going to get turned on sooner or later. I received the first dose of Shingrix on 03/16/18. It was almost 3 weeks later, on 04/05/18 between 7:00 P.M. and midnight when I went from never having had ANY joint pain to what I now know was the initial R.A. flare-up with most joints hurting and swollen, skin hot to the touch.  (Twenty four hours prior to that I did get a non-itchy prominent rash everywhere except my face, palms and soles of feet). My reaction to the second dose of Shingrix administered on June 20th was the same as what I experienced after the first dose. However, on June 21st I took Naproxen and it greatly relieved my symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Pain, Pyrexia, Rash generalised, Rheumatoid arthritis
Clinical narrative: There is no way to know if my strong, (low grade fever for 24 hours, fatigue, all-over body ache, big soreness in injection arm & bad headache), but not serious (no trouble breathing) reaction to Shingrix evoked an auto-immune response.  Every year I receive the influenza vaccine and I like to stay up-to-date on any vaccines I think I should, i.e. Pertussis and Tetanus. Usually I have no reaction nor soreness; if I added the reactions to all of the vaccines that I have ever received, it would not be nearly as much as the reaction I had to Shingrix. I think I have RA genes that were going to get turned on sooner or later. I received the first dose of Shingrix on 03/16/18. It was almost 3 weeks later, on 04/05/18 between 7:00 P.M. and midnight when I went from never having had ANY joint pain to what I now know was the initial R.A. flare-up with most joints hurting and swollen, skin hot to the touch.  (Twenty four hours prior to that I did get a non-itchy prominent rash everywhere except my face, palms and soles of feet). My reaction to the second dose of Shingrix administered on June 20th was the same as what I experienced after the first dose. However, on June 21st I took Naproxen and it greatly relieved my symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid factor increased, Skin warm
Clinical narrative: There is no way to know if my strong, (low grade fever for 24 hours, fatigue, all-over body ache, big soreness in injection arm & bad headache), but not serious (no trouble breathing) reaction to Shingrix evoked an auto-immune response.  Every year I receive the influenza vaccine and I like to stay up-to-date on any vaccines I think I should, i.e. Pertussis and Tetanus. Usually I have no reaction nor soreness; if I added the reactions to all of the vaccines that I have ever received, it would not be nearly as much as the reaction I had to Shingrix. I think I have RA genes that were going to get turned on sooner or later. I received the first dose of Shingrix on 03/16/18. It was almost 3 weeks later, on 04/05/18 between 7:00 P.M. and midnight when I went from never having had ANY joint pain to what I now know was the initial R.A. flare-up with most joints hurting and swollen, skin hot to the touch.  (Twenty four hours prior to that I did get a non-itchy prominent rash everywhere except my face, palms and soles of feet). My reaction to the second dose of Shingrix administered on June 20th was the same as what I experienced after the first dose. However, on June 21st I took Naproxen and it greatly relieved my symptoms.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Fatigue, Headache, Malaise, Nausea
Clinical narrative: I felt extreme fatigue afterwards and went home to sleep. Later I started feeling nauseous. Headaches started and have been feeling nauseous off and on for four days. Feeling malaise for 4 days. Sore throat started on 7/4/18. Waking up throughout night and early morning feeling stomach unsettled.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain
Clinical narrative: I felt extreme fatigue afterwards and went home to sleep. Later I started feeling nauseous. Headaches started and have been feeling nauseous off and on for four days. Feeling malaise for 4 days. Sore throat started on 7/4/18. Waking up throughout night and early morning feeling stomach unsettled.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass
Clinical narrative: Lymph node lump under right arm.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives within 2 hours.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Irritability, Muscle tightness
Clinical narrative: Pain in arm where I go the vaccination. Shivering and very cold all night. Muscle tense and sore throughout the night, aching this morning across upper body. Feel out of sorts.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Pain in arm where I go the vaccination. Shivering and very cold all night. Muscle tense and sore throughout the night, aching this morning across upper body. Feel out of sorts.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Patient received 1st dose of SHINGRIX vaccine in the pharmacy at 12:15. 10 minutes later, she reported tingling in her legs and light-headedness. Husband was present. EMS was called and took her to the hospital. ED Note: This is a 69-year-old female presents emergency department with altered mental status. She received a vaccination in the office and around noon she started to feel funny. She had a staring episode where she could not speak that lasted a period of time. She also admits to blurred vision that also resolved. She feels at her normal mental baseline currently and denies any complaints. She denies lightheadedness, dizziness, sense of spinning. She denies facial droop, numbness, focal weakness. She is feeling generally fatigued. She had similar symptoms last time she had a seizure. Her typical seizures are staring episodes which she feels similar today. She takes KEPPRA and is compliant with that medication. She did admit to a mild headache that resolved gradual onset similar to prior headaches. She denies any neck pain or back pain or fever.  She denies fall or injury. She denies syncope. Amp of D50 given. Plan to have patient orally eat after CT brain performed. She denies any chest pain or shortness of breath in the ED.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mental status changes, Paraesthesia, Speech disorder, Staring, Vision blurred
Clinical narrative: Patient received 1st dose of SHINGRIX vaccine in the pharmacy at 12:15. 10 minutes later, she reported tingling in her legs and light-headedness. Husband was present. EMS was called and took her to the hospital. ED Note: This is a 69-year-old female presents emergency department with altered mental status. She received a vaccination in the office and around noon she started to feel funny. She had a staring episode where she could not speak that lasted a period of time. She also admits to blurred vision that also resolved. She feels at her normal mental baseline currently and denies any complaints. She denies lightheadedness, dizziness, sense of spinning. She denies facial droop, numbness, focal weakness. She is feeling generally fatigued. She had similar symptoms last time she had a seizure. Her typical seizures are staring episodes which she feels similar today. She takes KEPPRA and is compliant with that medication. She did admit to a mild headache that resolved gradual onset similar to prior headaches. She denies any neck pain or back pain or fever.  She denies fall or injury. She denies syncope. Amp of D50 given. Plan to have patient orally eat after CT brain performed. She denies any chest pain or shortness of breath in the ED.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 30-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 17-FEB-2017, the patient was vaccinated with a 1st dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis and on 07-AUG-2017, with a 2nd dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. It was stated, that at the reporting time, the patient was in the pharmacy to receive the 3rd dose of GARDASIL 9 but had not received it yet. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 12-OCT-2017, the patient was vaccinated with PEDVAXHIB lot # M025194 (anatomical route was not reported) for prophylaxis. On an unknown date, the medical assistant reported, the patient received a dose of improperly stored vaccine, no adverse effects reported. Temperature time frame 28 Fahrenheit for 48 hours, no previous temperature excursion, the call was due to a data logger.
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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-NOV-2011, the patient was inoculated 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 19-APR-2013,  the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir  and hydrocodone for management of her 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. 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 24-DEC-2012, the patient was inoculated 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 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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 03-JUL-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by 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 09-JUL-2015, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for 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 15-JUL-2016, the patient was treated at an urgent care facility, (by an unspecified healthcare professional), for a 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. 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, Post herpetic neuralgia
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 27-MAR-2013, 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 (onset date unknown). On or about 11-FEB-2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as post herpetic neuralgia. 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 an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) 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 vesicular outbreak, 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, Pain, Rash vesicular
Clinical narrative: His 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 25-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance 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 29-MAY-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed valacyclovir, AUGMENTIN, and hydrocodone for management of his painful symptoms and chronic pain. 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, 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-OCT-2007, the patient was inoculated with ZOSTAVAX at a healthcare facility as recommended for routine adult health maintenance and for 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 01-JUL-2016, the patient was treated by a physician at the healthcare facility for a vesicular outbreak, which was diagnosed as subclinical shingles. The patient was prescribed VALTREX, and hydrocodone for management of her 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX, by a physician, as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a healthcare facility/nursing facility for a severe 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: Blister, Decreased immune responsiveness, 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 or about 29-JUN-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe 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: Blister, 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 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated by an urgent care for a blistering vesicular outbreak, which was then 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: Blister, 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 02-OCT-2012, 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 for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe 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: Blister, 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 or about 25-JUN-2013, 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 for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 26-FEB-2016, the patient was treated at the clinic for a blistering vesicular outbreak, 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: Blister, 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 or about 02-SEP-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2012, the patient was treated by a physician for a blistering vesicular outbreak, 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. On an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, 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 an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2013, the patient was treated by a physician for a blistering vesicular outbreak, 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. On or about 26-AUG-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-MAY-2012, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and lidocaine 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, 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 2014, 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 for the prevention of shingles. "The vaccine did function as intended," and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 27-OCT-2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir 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, 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 31-AUG-2012, 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 for the prevention of shingles. "The vaccine did function as intended," and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-MAR-2014, the patient was treated by a physician for a blistering vesicular outbreak, 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. On an unknown date in 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 by 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, 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 28-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 05-FEB-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX, gabapentin and a lidocaine patch 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.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Back pain, Balance disorder, Blood pressure increased, Feeling abnormal
Clinical narrative: This spontaneous report was received from a 73 year old Retired Registered Nurse (# US18-023886)referring to herself. The patient's medical conditions and drug history included she was generally in good health and had a "PNEUMOVAX 13" vaccine in 2017 (reported as last year). The patient's concomitant medications include Vitamin D3, magnesium, calcium, and probiotics. Prior to the vaccination patient's blood pressure and heart rate was normal (blood pressure105/68 and pulse was 70 units not reported). On 02-JUL-2018, the patient was vaccinated with PNEUMOVAX 23, in her left arm via intramuscular route for pneumococcal prevention(dosing details and lot/batch# not reported). On 02-JUL-2018 (also reported as 03-JUL-2018) she reported that, after receiving the vaccine "It's like the world went upside down" (feeling abnormal), her "blood pressure was 135/80 (heart rate increased) and her heart rate was 90 (heart rate increased) and she considered it as a severe reaction. She reported that she had sharp pains in the middle of her back just under her waist that lasted 5 minutes vertigo where she had difficulty keeping her balance but did not state she was nauseated. She reported that she sat down on a bench, because she would have passed out if she hadn't sat down. This feeling lasted about 10 minutes and stated that, she slowly felt better, pain and vertigo went away, she was able to eat and gave herself fluids. She later experienced bilateral aching, muscle aches that were "somewhat debilitating" along with an aching arm and headache. The reporter also stated that, she took TYLENOL, increased fluid intake and resting then later felt better. She reported that she just did not feel great. The outcome of heart rate increased, headache, pain in extremity, myalgia and blood pressure increased was reported as recovering/resolving. The outcome of back pain, vertigo and feeling abnormal was reported as recovered. The outcome of malaise was reported as not recovered. Causality assessment was not given by the reporter.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Heart rate increased, Malaise, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report was received from a 73 year old Retired Registered Nurse (# US18-023886)referring to herself. The patient's medical conditions and drug history included she was generally in good health and had a "PNEUMOVAX 13" vaccine in 2017 (reported as last year). The patient's concomitant medications include Vitamin D3, magnesium, calcium, and probiotics. Prior to the vaccination patient's blood pressure and heart rate was normal (blood pressure105/68 and pulse was 70 units not reported). On 02-JUL-2018, the patient was vaccinated with PNEUMOVAX 23, in her left arm via intramuscular route for pneumococcal prevention(dosing details and lot/batch# not reported). On 02-JUL-2018 (also reported as 03-JUL-2018) she reported that, after receiving the vaccine "It's like the world went upside down" (feeling abnormal), her "blood pressure was 135/80 (heart rate increased) and her heart rate was 90 (heart rate increased) and she considered it as a severe reaction. She reported that she had sharp pains in the middle of her back just under her waist that lasted 5 minutes vertigo where she had difficulty keeping her balance but did not state she was nauseated. She reported that she sat down on a bench, because she would have passed out if she hadn't sat down. This feeling lasted about 10 minutes and stated that, she slowly felt better, pain and vertigo went away, she was able to eat and gave herself fluids. She later experienced bilateral aching, muscle aches that were "somewhat debilitating" along with an aching arm and headache. The reporter also stated that, she took TYLENOL, increased fluid intake and resting then later felt better. She reported that she just did not feel great. The outcome of heart rate increased, headache, pain in extremity, myalgia and blood pressure increased was reported as recovering/resolving. The outcome of back pain, vertigo and feeling abnormal was reported as recovered. The outcome of malaise was reported as not recovered. Causality assessment was not given by the reporter.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Vertigo
Clinical narrative: This spontaneous report was received from a 73 year old Retired Registered Nurse (# US18-023886)referring to herself. The patient's medical conditions and drug history included she was generally in good health and had a "PNEUMOVAX 13" vaccine in 2017 (reported as last year). The patient's concomitant medications include Vitamin D3, magnesium, calcium, and probiotics. Prior to the vaccination patient's blood pressure and heart rate was normal (blood pressure105/68 and pulse was 70 units not reported). On 02-JUL-2018, the patient was vaccinated with PNEUMOVAX 23, in her left arm via intramuscular route for pneumococcal prevention(dosing details and lot/batch# not reported). On 02-JUL-2018 (also reported as 03-JUL-2018) she reported that, after receiving the vaccine "It's like the world went upside down" (feeling abnormal), her "blood pressure was 135/80 (heart rate increased) and her heart rate was 90 (heart rate increased) and she considered it as a severe reaction. She reported that she had sharp pains in the middle of her back just under her waist that lasted 5 minutes vertigo where she had difficulty keeping her balance but did not state she was nauseated. She reported that she sat down on a bench, because she would have passed out if she hadn't sat down. This feeling lasted about 10 minutes and stated that, she slowly felt better, pain and vertigo went away, she was able to eat and gave herself fluids. She later experienced bilateral aching, muscle aches that were "somewhat debilitating" along with an aching arm and headache. The reporter also stated that, she took TYLENOL, increased fluid intake and resting then later felt better. She reported that she just did not feel great. The outcome of heart rate increased, headache, pain in extremity, myalgia and blood pressure increased was reported as recovering/resolving. The outcome of back pain, vertigo and feeling abnormal was reported as recovered. The outcome of malaise was reported as not recovered. Causality assessment was not given by the reporter.