chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site bruising, Injection site erythema, Pyrexia, Somnolence
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date February 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose). On 13th July 2018, the patient received the 2nd dose of SHINGRIX. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration. On an unknown date, the outcome of the injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that the patient came into the pharmacy on the day of reporting to ask about the side effects she was having from the vaccine. The patient showed the pharmacist the area around the injection site and the skin around the injection site was red and warm to the touch which the patient was told was as expected after getting vaccine injections. The patient continued to show her arm to the pharmacist. The pharmacist said that inner bicep of the patient's arm was black and blue like a bruise. The patient said that the area was painful and warm to touch. The bruised area was as big as the palm of hand and located on the side of the injection site the pharmacist said. There were no problems or side effects with the first dose of the vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site erythema, Injection site warmth, Pain, Skin discolouration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date February 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose). On 13th July 2018, the patient received the 2nd dose of SHINGRIX. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration. On an unknown date, the outcome of the injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that the patient came into the pharmacy on the day of reporting to ask about the side effects she was having from the vaccine. The patient showed the pharmacist the area around the injection site and the skin around the injection site was red and warm to the touch which the patient was told was as expected after getting vaccine injections. The patient continued to show her arm to the pharmacist. The pharmacist said that inner bicep of the patient's arm was black and blue like a bruise. The patient said that the area was painful and warm to touch. The bruised area was as big as the palm of hand and located on the side of the injection site the pharmacist said. There were no problems or side effects with the first dose of the vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date February 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose). On 13th July 2018, the patient received the 2nd dose of SHINGRIX. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration. On an unknown date, the outcome of the injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, contusion, pain localized, skin warm and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that the patient came into the pharmacy on the day of reporting to ask about the side effects she was having from the vaccine. The patient showed the pharmacist the area around the injection site and the skin around the injection site was red and warm to the touch which the patient was told was as expected after getting vaccine injections. The patient continued to show her arm to the pharmacist. The pharmacist said that inner bicep of the patient's arm was black and blue like a bruise. The patient said that the area was painful and warm to touch. The bruised area was as big as the palm of hand and located on the side of the injection site the pharmacist said. There were no problems or side effects with the first dose of the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever 101.3, pain in site, headache, swelling and redness in site, shivering.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 101.3, pain in site, headache, swelling and redness in site, shivering.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Differential white blood cell count, Full blood count, Lymphadenitis, Mononucleosis heterophile test, Mumps antibody test
Clinical narrative: Information has been received from a registered nurse, concerning a 22 year old female patient with psoriasis, anxiety, myopia, sebaceous cyst and "bumps on skin", as concurrent conditions since unknown dates; no previously drug reactions and no allergies reported. The patient's concomitant medications included tacrolimus, fluocinolone, clindamycin, citalopram, benzoyl peroxide, DIFFERIN and albuterol. On 15-JUN-2018, the patient was vaccinated with M-M-R II one dose subcutaneously, lot number N024696 with expiration date on 07-APR-2019 (albumin status, strength and anatomical location were not provided), for prophylaxis. On the next day, the patient developed lymphadenitis; the patient sought medical attention and was saw by a physician at an urgent care clinic. The following laboratories were performed without results provided: sedimentation rate, complete blood count with differential, mumps immunoglobulin (IGM test) and mono test. Patient received an unspecified treatment for the adverse event. The reporting nurse stated that the patient was "doing better" at the time of the report and considered lymphadenitis to be related to M-M-R II, since it could had been caused by the mumps component of the M-M-R II.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Information has been received from a registered nurse, concerning a 22 year old female patient with psoriasis, anxiety, myopia, sebaceous cyst and "bumps on skin", as concurrent conditions since unknown dates; no previously drug reactions and no allergies reported. The patient's concomitant medications included tacrolimus, fluocinolone, clindamycin, citalopram, benzoyl peroxide, DIFFERIN and albuterol. On 15-JUN-2018, the patient was vaccinated with M-M-R II one dose subcutaneously, lot number N024696 with expiration date on 07-APR-2019 (albumin status, strength and anatomical location were not provided), for prophylaxis. On the next day, the patient developed lymphadenitis; the patient sought medical attention and was saw by a physician at an urgent care clinic. The following laboratories were performed without results provided: sedimentation rate, complete blood count with differential, mumps immunoglobulin (IGM test) and mono test. Patient received an unspecified treatment for the adverse event. The reporting nurse stated that the patient was "doing better" at the time of the report and considered lymphadenitis to be related to M-M-R II, since it could had been caused by the mumps component of the M-M-R II.
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported. The Medical Assistant reported that on 06-JUL-2018, the patient was vaccinated with a dose of MENACTRA (dose, route and anatomical location were not reported, lot number U5984AB, expiration date 14-AUG-2019) instead of intended M-M-R II (lot number and expiration date not reporte) both for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 20-JUL-2017, the patient was vaccinated with a dose of VAQTA injection, intramuscularly, for prophylaxis (exact dose, lot# and expiration date were not reported). On 09-MAR-2018, the patient was vaccinated with a dose of VAQTA injection, intramuscularly, for prophylaxis (exact dose, lot# and expiration date were not reported). On 09-JUL-2018, the patient was vaccinated with a dose of VAQTA injection, intramuscularly, for prophylaxis (exact dose, lot# and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-JUL-2018, the patient received one dose of M-M-R II, lot # N023150 and expiration date on 24-AUG-2019, for prophylaxis, via the intramuscular route rather than the recommended subcutaneous route (anatomical location was not reported). No adverse effects were reported.
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. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose 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, the very virus that ZOSTAVAX is intended to prevent. In 2013, 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. 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2014, the patient was treated by the same 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 outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. In 2014, the patient was inoculated with the ZOSTAVAX vaccine by a physician 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 18-MAY-2015, the patient was treated for a severe vesicular outbreak, which was diagnosed as  shingles. The patient was prescribed acyclovir and gabapentin for management of his painful symptom 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. This is an amended report, primary reporter was added.
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-DEC-2015, the patient was inoculated with ZOSTAVAX at a county health department 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. In 2016, the patient was treated at a medical center for a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2010, the patient was inoculated with ZOSTAVAX by a physician 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 09-JUL-2016, the patient was treated by a physician for the onset of severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2007, the patient was inoculated with ZOSTAVAX 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. In 2015, the patient was treated by a physician for the onset of a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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
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 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). On or about 26-JUL-2016, the patient was treated by a physician for the onset of a 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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 03-JUL-2014, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance and for the long-term 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 26-OCT-2015, the patient was treated by a physician at an urgent care center for a persistent and severe vesicular rash, which was diagnosed as shingles. He was prescribed acyclovir 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to currently about 90-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date (reported as years ago), the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, strength, frequency, route of administration, lot # and expiration date were not provided) as prevention of pneumococcal disease. On an unknown date (reported as years ago) after taking PNEUMOVAX 23, the patient experienced seizure. The outcome of seizure was recovered on an unknown date. The relatedness between seizure and PNEUMOVAX 23 was not reported. Upon internal review, seizure was considered to be medically significant.
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 2015, the patient was inoculated with the ZOSTAVAX vaccine at a hospital 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. In-2016, the patient was treated at a hospital for a vesicular outbreak, 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
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 2013, the patient was inoculated with the ZOSTAVAX vaccine 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. In 2015, the patient was treated for a vesicular outbreak, 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: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 18-DEC-2012, 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-JUL-2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and prednisone 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: Blister, Herpes zoster, Pain, 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. On or about 28-AUG-2014, 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 20-JUN-2015, the patient was treated by a nurse practitioner for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. The patient was prescribed acetaminophen and FAMVIR for management of her painful symptoms and excruciating 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: M
Vaccine: VARZOS
Symptoms: Blister, 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. In 2010, 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. In-2014, the patient was treated by a physician assistant for a blistering vesicular outbreak, 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: Blister, 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 2016, 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. Later in-2016, the patient was treated by a physician for a blistering vesicular outbreak, 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: Blister, Herpes zoster, Infection, Neuropathy peripheral, 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 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at a medical facility for an infection caused by the blistering vesicular outbreak of herpes zoster or shingles, which was diagnosed as peripheral neuropathy. 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. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review peripheral neuropathy was considered a medically significant event. 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-JAN-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 of herpes zoster. On or about 22-JAN-2015, the patient was treated by a physician for a blistering 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: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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. On or about 26-MAR-2009, the patient was inoculated with ZOSTAVAX 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 condition of herpes zoster. On or about 14-SEP-2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster. She was prescribed VALTREX and tramadol 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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. On or about 16-SEP-2015, the patient was inoculated with ZOSTAVAX 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 condition of herpes zoster. On or about 24-SEP-2015, the patient was treated at a medical clinic for a blistering vesicular outbreak which was then diagnosed as shingles. She was prescribed prednisone 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. On or about 17-JUL-2014, the patient was inoculated with ZOSTAVAX 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 condition of herpes zoster. In 2016, the patient was treated by a physician at a community health center for a blistering vesicular outbreak which was then diagnosed as 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 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: 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. In 2012, the patient was inoculated with ZOSTAVAX at the health department as recommended for routine adult health maintenance for the prevention of shingles (route, dose, and lot # not provided). 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 for a blistering 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 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: 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. In 2015, the patient was inoculated with ZOSTAVAX 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 condition of herpes zoster. Later in 2015, the patient was treated by a physician for a blistering 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 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: 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 26-JAN-2015, the patient was inoculated with ZOSTAVAX 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 condition of herpes zoster. On or about 30-JAN-2016, the patient was treated at a hospital (not specified whether admitted; therefore, considered Emergency Room visit until follow-up is received) for a blistering vesicular outbreak which was diagnosed as severe 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. On or about 11-JUN-2007, the patient was inoculated with ZOSTAVAX at a medical center-primary care 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 condition of herpes zoster. On or about 15-DEC-2015, the patient was treated by a physician at a medical center-ophthalmology for a blistering 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 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 18-JUL-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. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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 condition of herpes zoster. Later in 2015, the patient was treated 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 the 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 on 18-JUL-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 14-MAY-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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 condition of herpes zoster. In 2016, the patient was treated at a care 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 the 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, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 18-JUL-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 18-FEB-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office 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 condition of herpes zoster. On or about 18-FEB-2014, the patient was treated by a physician's assistant at a physician's office for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. On or about 24-JUN-2015, the patient sought subsequent treatment from a nurse practitioner for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed hydrocodone-acetaminophen for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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, Pain, Rash vesicular
Clinical narrative: Information has been received on 18-JUL-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 26-JUL-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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 condition of herpes zoster. On or about 05-APR-2017, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir, CALADRYL lotion and GARAMYCIN ointment for management of his painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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.