chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 the ZOSTAVAX vaccine at a medical office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-OCT-2016, the patient was treated at a medical office 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. 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 2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the  prevention of shingles (dose, route, and lot number 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 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 vaccine 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 01-NOV-2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number 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 01-AUG-2016, the patient was treated 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 vaccine 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 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2016, the patient was treated 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 vaccine 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 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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 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. On or about 22-AUG-2016, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. Later in 2016, the patient sought subsequent treatment for the onset of a severe vesicular rash accompanied, which was diagnosed as herpes zoster or shingles. In 2017, the patient sought additional treatment for the onset of a severe vesicular rash accompanied, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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 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 2010, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2012, the patient was treated 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 vaccine 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
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 27-MAR-2009, the patient was inoculated with ZOSTAVAX 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 shingles, or severe herpes zoster. On or about 31-OCT-2014, the patient was treated by the same physician for the onset of rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Fatigue, Herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about late 2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient developed blisters on her chin, a rash on her left ear and scalp, both of which were accompanied by pain, weakness and fatigue. In response to these complaints, the patient presented to her primary physician and was diagnosed as suffering from herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, a diminished quality of life and diminished ability to work. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the herpes zoster to be related to ZOSTAVAX. The outcome of herpes zoster was unknown. The event of herpes zoster was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about late 2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient developed blisters on her chin, a rash on her left ear and scalp, both of which were accompanied by pain, weakness and fatigue. In response to these complaints, the patient presented to her primary physician and was diagnosed as suffering from herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, a diminished quality of life and diminished ability to work. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the herpes zoster to be related to ZOSTAVAX. The outcome of herpes zoster was unknown. The event of herpes zoster was considered to be disabling. Additional information has been requested.
Sex: U
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 ZOSTAVAX by a pharmacist 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. Later in 2015, 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 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 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number 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 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 vaccine 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, Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 21-JUL-2014 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and 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 24-MAY-2016 the patient was treated at urgent care for a blistering vesicular outbreak, and decreased immune system which was diagnosed as severe shingles. The patient was prescribed acyclovir for management of her pain symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. 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 13-FEB-2014, the patient was inoculated with the ZOSTAVAX vaccine at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2014, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2013 the patient was inoculated with ZOSTAVAX vaccine at a medical clinic for routine adult health maintenance and 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 2014 the patient was treated by a physician at internal medicine clinic for a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2015 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 02-JUL-2015 the patient was treated at a hospital for onset of severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2012 the patient was inoculated with ZOSTAVAX vaccine at a VA health center for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015 the patient was treated at a hospital for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 07-AUG-2013 the patient was inoculated with ZOSTAVAX vaccine at a hospital for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 21-OCT-2015 the patient was treated by a physician at a medical clinic for onset of a vesicular rash, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir and TYLENOL for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2013 the patient was inoculated with ZOSTAVAX vaccine by a physician for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016 the patient was treated by a physician at a medical clinic for onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2014 the patient was inoculated with ZOSTAVAX vaccine by a physician for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014 the patient was treated by a physician at a medical clinic for onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2013 the patient was inoculated with ZOSTAVAX vaccine at a public health department for routine adult health maintenance and the prevention of shingles.  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014 the patient was treated by a physician for onset of a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Pyrexia, Viral infection
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative, referring to a 66 year old female patient. The patient had no medical history, concurrent conditions, drug and allergy history to be reported. On 09-OCT-2018, the patient was vaccinated with PNEUMOVAX 23, intramuscularly (strength, dose, frequency, lot # and expiration date were not provided) for vaccination. Concomitant therapies included FLUAD. The reporter stated that on 12-OCT-2018, the patient contacted pharmacy to explain that she had experienced fever and chills on 09-OCT-2018 (also reported as almost immediately after receiving PNEUMOVAX 23. Furthermore, it was reported that on an unspecified date after receiving PNEUMOVAX 23, the patient was examined by an unspecified physician, who explained that the patient had a virus. The patient had treated herself with TYLENOL and MOTRIN. The outcome of viral infection was reported as not recovered. At the time of the reporting time, the causality between the aforementioned event and PNEUMOVAX 23 was not reported.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Immunosuppression
Clinical narrative: This spontaneous report was received from a male patient of unknown age, reporting on himself. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On an unknown date ("a few years ago"), the patient was vaccinated VARIVAX for prophylaxis (dosage information, lot number, route and anatomical site of vaccination were not informed). Other suspect therapies included Merck sterile diluent. On an unknown date ("recently"), the patient had "titers done" and was informed that "he was negative for varicella. Subsequently, In July (unknown year) the patient received another dose of VARIVAX for prophylaxis (dosage information, lot number, route and anatomical site of vaccination were not informed). Then, on an unspecified date, the patient completed a 2nd titer. And the titer was also negative. The patient also stated that he was immunosuppressed, however, he did not confirmed if he was immunosuppressed at the time of receiving either vaccine. At the time of report, the outcome of antibody test negative and immunosuppression was reported as not recovered. The causality assessment between antibody test negative and immunosuppression and VARIVAX was not provided. Upon internal review the event immunosuppression was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Papilloma excision, Skin papilloma
Clinical narrative: This spontaneous report was received from the patient's mother referring to a 17 year old female patient. The patient's pertinent medical history included ear tube insertion (reported as "tubes in ears"). Her concurrent conditions included Sulfa based medications allergy. The patient had not concomitant medications. In November 2017, the patient was vaccinated with the first dose of GARDASIL 9 "1 x 0.5-mL dose at 0, 2 and 6 months", intramuscularly, for prophylaxis (lot # and expiration date were not reported). On an unspecified date in 2017 (reported as "about two weeks after receiving her first dose"), the patient experienced warts on her fingers (skin papilloma). An unspecified treatment was given to the patient. On an unknown date, the patient's dermatologist removed one wart to analyzed it (papilloma excision). At the time of reporting, the outcome of the events was reported as recovered on an unspecified date. The causality assessment between the events and GARDASIL 9 was not provided. This one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA006350.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On 12-OCT-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R009408 (expiration date: 07-MAR-2020), lot # R002084 (expiration date: 26-OCT-2019) or lot # R016640 (expiration date: 28-JAN-2020) for prophylaxis (strength, dose, frequency and route of administration were not reported). The nurse was unsure which lot number was administered to the patient, so all lot numbers in stock were provided. Temperature excursion was 32°F up to 35°F ° and time frame was 38 minutes as recorded by a data logger. No adverse effects were reported.
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 number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated 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 vaccine 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 2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated, 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 vaccine 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 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: FLUA3, PPV, FLUA3, PPV
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning an elderly male patient with unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#: N032092, expiration date: 12-SEP-2019) one dose, once, for pneumonia prevention and FLUAD (strength, dose, route, frequency, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced redness and swelling at the injection site that went from shoulder to elbow, the skin at the injection site was painful to touch, had trouble lifting the injected arm and was feeling under the weather with flu-like symptoms that persisted for 3-4 days. At the reporting time, the outcome of injection site pain, flu-like symptoms, injected limb mobility decreased, injection site erythema and injection site swelling were reported as recovered on an unknown date. The causality between PNEUMOVAX 23 and FLUAD and injection site pain, injected limb mobility decreased, flu-like symptoms, injection site erythema and injection site swelling were not assessed. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA004434: US-009507513-1810USA004364.
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were reported as follows: The patient's wife contacted GSK (GlaxoSmithKline) employee to report that her husband received a dose of SHINGRIX and experienced an allergic reaction (unknown symptoms). The age at vaccination was not reported. The GSK employee reported that the patient's wife stated that she had to go, and disconnected. The writer attempted to contact the caller from the phone number provided, as indicated and left a voicemail to call back GSK including the phone number and the SR Number.
Sex: U
Vaccine: PNC13
Symptoms: Haemolytic uraemic syndrome, Pneumococcal infection, Vaccination failure
Clinical narrative: This is spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age and gender received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pneumococcal infection and hemolytic uremic syndrome on an unspecified date with outcome of unknown. The information on the lot number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Linked Report(s): US-PFIZER INC-2018410904 Same reporter/drug/event, different patient. (2 of 4).
Sex: U
Vaccine: PNC13
Symptoms: Haemolytic uraemic syndrome, Pneumococcal infection, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable physician who reported similar events for 4 patients. This is 4th of 4 reports. A patient of unspecified age and gender received PREVNAR 13, on an unspecified date, at single dose for immunisation. The patient's medical history and concomitant medications were not reported. A failure of efficacy of pneumococcal 13-val conj vaccine occurred on an unknown date; the patient had a condition in association with his/her pneumococcal infection and then had hemolytic uremic syndrome. The outcome of the events was unknown. The information on the lot number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : US-PFIZER INC-2018410904 Same reporter/drug/event, different patient.
Age: 64.0
Sex: M
Vaccine: FLUR4, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279740, 2018SA279743 and 2018SA277209 (same reporter). This case involves a 64 years old male patient was vaccinated with a 0.5 ml dose of FLUBLOK QIV lot QFAA1829; expiry date; 30-Jun-2019 via intramuscular route in the left deltoid on 02 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received HEPATITIS A as concomitant. It was a case of actual medication error due to incorrect product storage. It was reported that the patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279748, 2018SA279744, 2018SA279747, 2018SA279742, 2018SA279746, 2018SA279740, 2018SA279743 and 2018SA277209 (same reporter). This case involves a patient of an unknown demographics who was vaccinated with a dose of FLUBLOK QIV lot QFAA1829; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 in the united states regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279742, 2018SA279747, 2018SA279740, 2018SA279743 and 2018SA277209 (same reporter). This case involves a 55 years old male patient was vaccinated with a 0.5 ml dose of FLUBLOK QIV lot QFAA1829; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Age: 59.0
Sex: M
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279748, 2018SA279744, 2018SA279745, 2018SA279742, 2018SA279746, 2018SA279740, 2018SA279743 and 2018SA277209 (same reporter). This case involves a 59-years-old male patient who was vaccinated with a 0.5 mL dose of FLUBLOK QIV lot QFAA1829; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not provided any information confirming whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid serious case received from a other health professional. This case is linked to case 2018SA280098 (same reporter). This case involves Elderly female patient (age not reported), who developed band like around lateral side of her arm 1-2 inches below the injection site and diagnosed with cellulitis, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 03-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot: UJ004AB and expiry date: 30-Mar-2019) via intramuscular route in the left deltoid. On an unspecified date, the patient developed a serious band like around lateral side of her arm 1-2 inches below the injection site and diagnosed with cellulitis (cellulitis) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. It was reported that patient was seen by the nurse practitioner on 05-Oct-2018. No Lab data was reported. Final diagnosis was developed band like around lateral side of her arm 1-2 inches below the injection site and diagnosed with cellulitis. The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN) on an unknown date. The patient outcome is reported as Unknown for developed band like around lateral side of her arm 1-2 inches below the injection site and diagnosed with cellulitis. Documents held by the sender: none.; Sender's Comments: This case involves an elderly patient who presented with cellulitis after vaccination. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.