chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a county health facility for routine adult health maintenance and for the long-term 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 26-SEP-2016, the patient was treated at a clinic 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 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-JUL-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended. On or about 26-SEP-2016, the patient was treated by a physician at a family medicine for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir 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: 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 27-JUL-2010, the patient was inoculated with ZOSTAVAX at a clinic 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 28-SEP-2016, the patient was treated at a clinic by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed "Valacyclovir" for management of her painful symptoms and chronic pain. 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: 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 by a physician at a clinic 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 or shingles. In 2016, the patient was treated at a medical clinic 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: Blister, Death, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: Information regarding a case in litigation has been received from a lawyer and the spouse of a deceased male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain condition of herpes zoster. On or about 15-AUG-2016, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the vaccination failure and herpes zoster/shingles was unknown. As a direct and proximate result of using the ZOSTAVAX vaccine, and/or despite using ZOSTAVAX for the sole purpose of preventing shingles of preventing shingles, the patient suffered from shingles and/or other painful herpes zoster-related injuries and required extensive medical and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. On 29-APR-2018, the patient passed away. The cause of the patient's death was not reported. It is unknown if an autopsy was performed. Upon internal review, death was determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: Death.
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 01-APR-2013, the patient was inoculated with the ZOSTAVAX vaccine at a county health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAY-2013, the patient was treated at a healthcare facility 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 2013, the patient was inoculated with the ZOSTAVAX vaccine at an army hospital as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016 the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (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. On or about 08-JUN-2012, 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 condition of herpes zoster. On or about 17-DEC-2013, the patient was treated the same 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: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-JUL-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a drug store, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 30-SEP-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 the long-term prevention of shingles, the pt 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a medical center 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. 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 2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a medical facility 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-MAR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 30-SEP-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: 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 12-MAY-2011, 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, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-OCT-2012, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) from a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-OCT-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: 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 05-MAR-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: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 29-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and bacitracin for her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Metabolic encephalopathy, Septic encephalopathy
Clinical narrative: Information has been received from a pharmacist referring to a 76 year old female patient. Information about concomitant medications, and medical history and drug reactions was not provided. On 04-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N020502 and expiration date 08-FEB-2019; route was unknown) on unspecified arm for prophylaxis. On an unknown date in October 2018 after the administration of PNEUMOVAX 23, the patient was admitted to an unspecified hospital for "cellulitis with metabolic septic encephalopathy"(cellulitis, septic encephalopathy and metabolic encephalopathy). The patient was later discharged from the hospital on an unspecified day and at the reporting time the patient was recovering. The causality was not provided. Upon internal review, cellulitis, septic encephalopathy and metabolic encephalopathy were determined to be medically significant.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Condition aggravated, Confusional state, Essential hypertension, Mental status changes
Clinical narrative: Information has been received from a pharmacist referring to a 76 year old female patient. Information about concomitant medications, and medical history and drug reactions was not provided. On 04-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N020502 and expiration date 08-FEB-2019; route was unknown) on unspecified arm for prophylaxis. On an unknown date in October 2018 after the administration of PNEUMOVAX 23, the patient was admitted to an unspecified hospital for "cellulitis with metabolic septic encephalopathy"(cellulitis, septic encephalopathy and metabolic encephalopathy). The patient was later discharged from the hospital on an unspecified day and at the reporting time the patient was recovering. The causality was not provided. Upon internal review, cellulitis, septic encephalopathy and metabolic encephalopathy were determined to be medically significant.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Metabolic encephalopathy, Restlessness
Clinical narrative: Information has been received from a pharmacist referring to a 76 year old female patient. Information about concomitant medications, and medical history and drug reactions was not provided. On 04-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N020502 and expiration date 08-FEB-2019; route was unknown) on unspecified arm for prophylaxis. On an unknown date in October 2018 after the administration of PNEUMOVAX 23, the patient was admitted to an unspecified hospital for "cellulitis with metabolic septic encephalopathy"(cellulitis, septic encephalopathy and metabolic encephalopathy). The patient was later discharged from the hospital on an unspecified day and at the reporting time the patient was recovering. The causality was not provided. Upon internal review, cellulitis, septic encephalopathy and metabolic encephalopathy were determined to be medically significant.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Metabolic encephalopathy, Septic encephalopathy
Clinical narrative: On the afternoon of 10/4/18, a neighbor noticed she was wandering in her yard confused. She was taken to the ER for altered mental status and admitted with metabolic encephalopathy due to right upper extremity cellulitis. Discharge Diagnosis: Acute metabolic encephalopathy; cellulitis; essential hypertension.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Condition aggravated, Confusional state, Essential hypertension, Mental status changes
Clinical narrative: On the afternoon of 10/4/18, a neighbor noticed she was wandering in her yard confused. She was taken to the ER for altered mental status and admitted with metabolic encephalopathy due to right upper extremity cellulitis. Discharge Diagnosis: Acute metabolic encephalopathy; cellulitis; essential hypertension.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Metabolic encephalopathy, Restlessness
Clinical narrative: On the afternoon of 10/4/18, a neighbor noticed she was wandering in her yard confused. She was taken to the ER for altered mental status and admitted with metabolic encephalopathy due to right upper extremity cellulitis. Discharge Diagnosis: Acute metabolic encephalopathy; cellulitis; essential hypertension.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Arrhythmia, Autoimmune disorder, Dizziness, Fatigue, Headache
Clinical narrative: This spontaneous report was received from a physician via social media refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. Other suspect therapies included GARDASIL 9 (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. On an unknown date, the patient experienced auto immune disease (autoimmune disorder), side effect (adverse event), inflammation, neck pain, nausea, neck pain, rheumatoid arthritis, infection, injury, paralysis, tiredness (fatigue), rash, dizziness, arrhythmia, headache, fainting (syncope), numbness (hypoesthesia), and sinus congestion. The patient died on an unknown date.The outcome of arrhythmia, syncope, headache, dizziness, nausea, fatigue, inflammation, neck pain, adverse event, infection, injury, rash, hypoesthesia, sinus congestion, paralysis and rheumatoid arthritis was unknown. The causality of all the events were not reported. Upon internal review the events death, arrhythmia, autoimmune disorder, paralysis, and rheumatoid arthritis were considered to be medically significant.; Sender's Comments: US-009507513-1810USA005156:
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Hypoaesthesia, Infection, Inflammation, Injury, Nausea
Clinical narrative: This spontaneous report was received from a physician via social media refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. Other suspect therapies included GARDASIL 9 (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. On an unknown date, the patient experienced auto immune disease (autoimmune disorder), side effect (adverse event), inflammation, neck pain, nausea, neck pain, rheumatoid arthritis, infection, injury, paralysis, tiredness (fatigue), rash, dizziness, arrhythmia, headache, fainting (syncope), numbness (hypoesthesia), and sinus congestion. The patient died on an unknown date.The outcome of arrhythmia, syncope, headache, dizziness, nausea, fatigue, inflammation, neck pain, adverse event, infection, injury, rash, hypoesthesia, sinus congestion, paralysis and rheumatoid arthritis was unknown. The causality of all the events were not reported. Upon internal review the events death, arrhythmia, autoimmune disorder, paralysis, and rheumatoid arthritis were considered to be medically significant.; Sender's Comments: US-009507513-1810USA005156:
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Neck pain, Paralysis, Rash, Rheumatoid arthritis, Sinus congestion
Clinical narrative: This spontaneous report was received from a physician via social media refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. Other suspect therapies included GARDASIL 9 (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. On an unknown date, the patient experienced auto immune disease (autoimmune disorder), side effect (adverse event), inflammation, neck pain, nausea, neck pain, rheumatoid arthritis, infection, injury, paralysis, tiredness (fatigue), rash, dizziness, arrhythmia, headache, fainting (syncope), numbness (hypoesthesia), and sinus congestion. The patient died on an unknown date.The outcome of arrhythmia, syncope, headache, dizziness, nausea, fatigue, inflammation, neck pain, adverse event, infection, injury, rash, hypoesthesia, sinus congestion, paralysis and rheumatoid arthritis was unknown. The causality of all the events were not reported. Upon internal review the events death, arrhythmia, autoimmune disorder, paralysis, and rheumatoid arthritis were considered to be medically significant.; Sender's Comments: US-009507513-1810USA005156:
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via social media refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. Other suspect therapies included GARDASIL 9 (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. On an unknown date, the patient experienced auto immune disease (autoimmune disorder), side effect (adverse event), inflammation, neck pain, nausea, neck pain, rheumatoid arthritis, infection, injury, paralysis, tiredness (fatigue), rash, dizziness, arrhythmia, headache, fainting (syncope), numbness (hypoesthesia), and sinus congestion. The patient died on an unknown date.The outcome of arrhythmia, syncope, headache, dizziness, nausea, fatigue, inflammation, neck pain, adverse event, infection, injury, rash, hypoesthesia, sinus congestion, paralysis and rheumatoid arthritis was unknown. The causality of all the events were not reported. Upon internal review the events death, arrhythmia, autoimmune disorder, paralysis, and rheumatoid arthritis were considered to be medically significant.; Sender's Comments: US-009507513-1810USA005156:
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, drug reactions/allergies and concomitant medication. On 09-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported), following this on 11-OCT-2018, the patient received another dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects have been reported in the patient.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281687, 2018SA281638, 2018SA281635, 2018SA281637, 2018SA281634, 2018SA281636, 2018SA279979, 2018SA281632, 2018SA281692 (Same reporter). This case involves a two-months old male patient who was vaccinated with 0.5 mL dose of PENTACEL (lot number: C5507AA and expiry date: 05-Sep-2019) (dose in series and route was not reported) in the left thigh on 11-Sep-2018 which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277418 and 2018SA282124. (Same Reporter) This case involves a 73-year-old female patient who received a partial dose of vaccine FLUZONE QUADRIVALENT which was leaked out from hub of syringe. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. Reported as no other vaccines given. On 04-Oct-2018, the patient received a 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6301NA expiry date: 30-Jun-2019 via unknown route. It was reported that do not know the site of the vaccination was given. It was a case of actual medication error due to vaccine under dose. It was reported that vaccine leaked out from hub of syringe during administration to patient, reported partial dose was given to patient. It was also a case of syringe issue. It was not reported that if any adverse event was experienced or not. 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 Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277418 and 2018SA282120. (Same Reporter). This case involves a 91 years old male patient who received a partial dose of vaccine FLUZONE QUADRIVALENT which was leaked out from hub of syringe. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. Reported as no other vaccines given. On 04-Oct-2018, the patient received a 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6301NA expiry date: 30-Jun-2019 via intramuscular route. It was reported that do not know the site of the vaccination was given. It was a case of actual medication error due to vaccine under dose. It was reported that vaccine leaked out from hub of syringe during administration to patient, reported partial dose was given to patient. It was also a case of syringe issue. It was not reported that if any adverse event was experienced or not. 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 Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Incorrect route of product administration, Local reaction
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 years old female patient who experienced local reaction, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR for Immunisation. On 15-Jun-2015, the patient received (fourth dose in series) a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via subcutaneous route in the thigh (expiry date not reported). On an unknown date, patient developed a non-serious local reaction following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was also case of actual medication error due to Inappropriate route of vaccination. Dose was accidentally given subcutaneously instead of intramuscular to a four-year-old child. Relevant tests were not reported. Final diagnosis was local reaction. It was not reported if the patient received a corrective treatment. On an unknown date, patient was recovered from local reaction. 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. Additional information was received from physician on 09-Oct-2018. Patient demographic, Concomitant medication and dose of suspect added. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Pain in arm, difficulty moving arm, especially abduction, tenderness beyond injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal stiffness, Pruritus
Clinical narrative: Severe redness, stiffness, itching.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED DTAP AND POLIO ONLY. PATIENT DID NOT RECEIVE HIB PORTION.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Hypertension, Sensation of foreign body
Clinical narrative: Increase heart rate, hypertensive, throat feels full like there is "a tube in my throat".
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Erythema
Clinical narrative: Development of bilateral lower extremity erythema. Per parent report, lower extremities also seemed to turn blue briefly. Returned to clinic from parking lot. By time of return, no cyanosis. Erythema of LE noted, no respiratory distress. Given BENADRYL.
Sex: F
Vaccine: PPV
Symptoms: Chronic disease
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 70 year old female patient. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history and concomitant medication. On an unknown date in approximately 2013 (reporter as "5 years ago"), the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed a chronic condition. It was unknown if the chronic condition occurred before or after administration of PNEUMOVAX 23. Furthermore, was unknown by the reporter if any treatment was given for the adverse event or if any laboratories diagnostics or studies were performed. The outcome of chronic disease was reported as not recovered. The causal relationship between chronic disease and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: DTAP
Symptoms: Contusion, Seizure
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid serious case received from a non-health professional (other company: Mylan). This case involves female patient who experienced seizure and bruising, while she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious seizure following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a non serious bruising following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was bruising and seizure. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. Documents held by sender: none. Sender's Comments: This case involves a patient of unknown age who experienced seizure post vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer. Time to onset is unknown. Additional information regarding patient's medical history, history of similar episode, condition at the time of vaccination, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on available information the role of vaccine cannot be assessed.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Abdominal pain upper, Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: Mother called Health Department October 12th, 2018 at 9:30 AM explaining that her daughter woke up at 6:30 AM that morning not feeling well. Had a fever of 103.7 and vomited 4 times that morning. Mother stated that her daughter was saying that her stomach hurt and just ached all over. Mother stated that they had been given patient TYLENOL which brought the temperature down to 100.2. Daughter not showing any other signs and symptoms. Alert and oriented and responding appropriately, no difficulty breathing. Nurse stated to mother if symptoms continue and fever does not come down with TYLENOL to call their healthcare provider. Nurse made a follow up phone call on 10/15/18 at 9:00 AM, mother of patient stated that her daughter is feeling better and is back to her baseline. Mother stated that symptoms lasted until 10/13/18 around noon time. Patient's fever continued until Saturday at noon but that TYLENOL helped keep the fever down.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: General muscle and joint soreness, severe headache, fatigue, diarrhea, nausea, SHINGRIX injection site sore, hot and red more than 72 hours. Some symptoms lasting more than 48 hours. Tried ibuprofen after 24 hours with no relief of symptoms.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Injection site warmth, Myalgia, Nausea
Clinical narrative: General muscle and joint soreness, severe headache, fatigue, diarrhea, nausea, SHINGRIX injection site sore, hot and red more than 72 hours. Some symptoms lasting more than 48 hours. Tried ibuprofen after 24 hours with no relief of symptoms.