chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered
Clinical narrative: This spontaneous report as received from an immunization health educator refers to a child patient of an unknown age and gender. The information regarding medical history, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was inadvertently given only the sterile diluent (dose, route and site of administration, lot number and expiration date were not reported), not (manufacturer unknown) reported as HiB vaccine.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site discharge, Injection site pain
Clinical narrative: This spontaneous report has been received from the patient's father referring to a 16 year old male patient. The patient did not have pertinent medical history, drug reactions or allergies. Concomitant therapies included PROZAC. On 02-MAR-2018, the patient was vaccinated with the third dose of GARDASIL 9 (strength, anatomical location, route, lot number and expiration date were not provided) for "prevention of HPV". It was reported that immediately after vaccination, the patient was complaining of soreness at the injection site, additionally, some of the vaccine was draining from the injection site and the patient's coat was wet. Although the patient sought medical attention, none treatment was given and none laboratory studies were performed. The outcome of injection site pain was reported not resolved. The outcome of injection site discharge was unknown. The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a currently 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with improperly stored doses GARDASIL 9 injection, lot # N007931, expiration date 17-NOV-2019, for prophylaxis (frequency, route and anatomical location were not provided). The vaccine was left under 6°F for 2 hours, below 32°F. There were no previous temperature excursions. No adverse effects reported.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Anxiety, Generalised erythema, Insomnia, Pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a Nurse Practitioner via company representative and refers to a 65 year old female patient. The patient's concurrent conditions include asthma and no information was provided regarding the patient's medical history or concomitant medications. On 15-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis and with influenza virus vaccine (lot number U1840AC, expiration date was not reported). On approximately, 15-SEP-2017, reported as "within 24 hours of administration of both vaccines", the patient developed redness over her entire body (generalised erythema), felt anxious, couldn't sleep and had a fever and itchiness, therefore, the patient was placed under therapy treatment with BENADRYL and prednisone (manufacturer unknown) on an unspecified date. On an unknown date, the patient was referred to the hospital due to the reaction and underlying asthma. On 24-SEP-2017, the patient assisted to the hospital but was not admitted. On 25-SEP-2017, the patient visited the physician's clinic, it was stated that the patient still had some erythema, so she was referred to a dermatologist, which the patient visited on an unknown date. On an unspecified date in March 2018, reported as "last week ", the patient visited the physician's clinic and she had fully recovered from the aforementioned events on an unknown date. The reporter did not provided the causality assessment between the events and therapy with PNEUMOVAX 23.
Sex: U
Vaccine: MMR, TYP
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 01-MAR-2018, the patient was vaccinated with one dose of (wistar ra 27-3) M-M-R II (rHA) lot # N009799 with expiration date 24-MAR-2019, for prophylaxis (route of administration was not reported). Other suspect therapies included TYPHIM VI lot # M15722M with expiration date 24-OCT-2018 and sterile diluent(STERILE DILUENT) lot # reported as M030846 with expiration date 26-APR-2020. On 06-MAR-2018, the patient was vaccinated with another dose of (wistar ra 27-3) M-M-R II (rHA) lot # N009799 with expiration date 24-MAR-2019, TYPHIM VI lot # M15722M with expiration date 24-OCT-2018 and sterile diluent(STERILE DILUENT) lot # reported as M030846 with expiration date 26-APR-2020. Lot number M030846 is an invalid lot number for sterile diluent.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a 12 year old male patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 15-FEB-2018, the patient was vaccinated with the first dose of GARDASIL 9, intramuscular, for prevention of human papillomavirus, (dose, frequency, lot number and expiration date were not provided). On 26-FEB-2018, the patient returned back to the office complaining about pain (arm pain) and weakness in the extremity. Nevertheless, it was also reported that no treatment was prescribed for the events and that no product quality complaint (PQC) was involved. Finally, it was also reported that the patient would not receive the other GARDASIL 9 doses. At the time of reporting, the outcome of pain in extremity and muscular weakness was unknown. The causal relationship between GARDASIL 9 and the reported events was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This one of 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003817: US-009507513-1803USA003814: US-009507513-1803USA003816: US-009507513-1803USA003813.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003816: US-009507513-1803USA003817: US-009507513-1803USA003594: US-009507513-1803USA003814.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003816: US-009507513-1803USA003817: US-009507513-1803USA003813: US-009507513-1803USA003594.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report was received from a consumer and refers to her daughter a 11 year old female patient. The patient's concurrent conditions include attention problem and her concomitant medications include STRATTERA. It was reported that the patient did not have any drug reactions or allergies. On 01-MAR-2018, the patient was vaccinated with GARDASIL 9 injection in the right arm (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in March 2018, the patient developed a dime-sized knot with redness which was not hot at the touch at injection site on the right upper arm, also, it was stated that the patient was afebrile. It was reported that the patient did not seek for medical attention, no treatment was provided for the event and no clinical analysis were performed. The outcome of the events injection site nodule and injection site erythema was not recovered and the reporter did not provided the causality assessment between the aforementioned events and therapy with GARDASIL 9.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2016, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a health care center as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated (by an unspecified healthcare professional) at a physicians' practice for a persistent and severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and unknown gender. Medical history, concurrent conditions, and concomitant medications were not provided. During 2012, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated (by an unspecified healthcare professional) at a medical office for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-FEB-2016, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-APR-2016, she was treated (by an unspecified healthcare professional) at a hospital emergency department (ED) for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles.   As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, 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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2015, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a pharmacy, recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, she was treated (by an unspecified healthcare professional) at a facility for urgent care for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, 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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2008, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a family practice office, recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, she was treated (by an unspecified healthcare professional) at the family practice office for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-APR-2016, the patient was treated at a hospital, for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 22-JUN-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-APR-2016, the patient was treated at a medical center for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As 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: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2010, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2014, the patient was treated at physician office for blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed gabapentin and VALTREX for management of her painful symptoms As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-MAR-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2016, the patient was treated at physician office for blistering vesicular outbreak and decreased immune symptoms, which was diagnosed as herpes zoster, or shingles. She was prescribed PERCOCET, gabapentin, and acyclovir for management of her painful symptoms. On or about 10-MAY-2016, she sought subsequent treatment and was diagnosed with post herpetic neuralgia, a condition of chronic pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-MAR-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2016, the patient was treated at physician office for blistering vesicular outbreak and decreased immune symptoms, which was diagnosed as herpes zoster, or shingles. She was prescribed PERCOCET, gabapentin, and acyclovir for management of her painful symptoms. On or about 10-MAY-2016, she sought subsequent treatment and was diagnosed with post herpetic neuralgia, a condition of chronic pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2011, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy 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. During 2016, she was treated (by an unspecified healthcare professional) at a healthcare facility for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 09-FEB-2015, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy 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. During 2016, she was treated (by an unspecified healthcare professional) at a clinic for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. 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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2016, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy 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. During 2016, she was treated (by an unspecified healthcare professional) at an medical office facility for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. 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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2013, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy 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. During 2016, he was treated (by an unspecified healthcare professional) at an urgent care facility for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2012, the patient was inoculated (by an unspecified person) with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-APR-2016, he was treated (by an unspecified healthcare professional) at an immediate medical care facility for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. The patient has been prescribed FAMVIR for management of his painful symptoms. 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. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-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. During 2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-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. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, 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. During 2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's concurrent condition included asthma. The patient's medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (MRK INJ) which was used for the reconstitution of VARIVAX. On an unknown date the patient was vaccinated with one dose of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N020013 and expiration date: 17-JUL-2019) at a temperature from 6 Fahrenheit (F) to 14 F for 45 minutes. There was no previous excursion for the VARIVAX. No adverse effects reported. Data logger was involved. No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Information has been received from a consumer regarding a case for ZOSTAVAX (MARRS #1409USA001454) concerning people (demographics unknown) who were vaccinated with ZOSTAVAX (dates of vaccination, lot numbers, dosages, and routes of administration not provided). The consumer reported that she has "now seen how many people have gotten Bell's palsy right after the shingle shot." The outcome of the Bell's palsy is unknown. Additional information has been requested.; Sender's Comments: US-009507513-1409USA001454:
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 4-month-old patient. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. On 12-MAR-2018 the patient was vaccinated subcutaneously with VARIVAX (dose, units and frequency were unknown) (lot # N022995, expiration date 23-AUG-2019) which was reconstituted with sterile diluent (MRK INJ) (lot # N013283 and expiration date 03-OCT-2019) (drug administered to patient of inappropriate age). No adverse effects reported. There was no product quality compliant reported. No additional information provided.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Child woke up at 6:30 am 03/13/2018 with fever of 102 and complaining of pain in his right arm. Mother states that his arm was red and swollen. Child ran fever off and on most of the day with highest temp at 102 degrees. MOTRIN did reduce fever. Child is present in clinic on 03/14/2018 with right deltoid that is red and swollen. Area is hot to touch. Child has no fever at present time. Child does complain of pain in area. Child states that it hurts his arm to move it.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Child woke up at 6:30 am 03/13/2018 with fever of 102 and complaining of pain in his right arm. Mother states that his arm was red and swollen. Child ran fever off and on most of the day with highest temp at 102 degrees. MOTRIN did reduce fever. Child is present in clinic on 03/14/2018 with right deltoid that is red and swollen. Area is hot to touch. Child has no fever at present time. Child does complain of pain in area. Child states that it hurts his arm to move it.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus, Skin lesion
Clinical narrative: Patient came in 2 days after vaccine with red swollen injection site reaction on the right arm. Rph consulted package insert to which this was a normal expected adverse event, and informed patient to let us know if not improved within 1 week. Patient came in 3/14/18 (1 week after vaccination) and said the arm reaction was gone, but had large red itchy lesions on her forehead and scalp. Informed patient to seek medical care from her doctor.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, X-ray limb normal
Clinical narrative: Patient has reported longstanding pain in the left arm since injection. She was treated with 2 rounds of steroids and methocarbamol with little to no improvement. She was then referred to an orthopedic doctor for further evaluation and treatment.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Patient woke up the next morning extremely fatigued with moderate-to-severe soreness at the injection site. A large red rash developed near the injection site and was warm and itchy. The rash is still present 5 days post-injection. Patient took 800 mg of ibuprofen to reduce pain and inflammation.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient woke up the next morning extremely fatigued with moderate-to-severe soreness at the injection site. A large red rash developed near the injection site and was warm and itchy. The rash is still present 5 days post-injection. Patient took 800 mg of ibuprofen to reduce pain and inflammation.
Age: 19.0
Sex: F
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: Unknown.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a female patient of unknown age. The patient's concurrent condition and medical history were not reported. Concomitant therapy included sterile diluent. On 23-FEB-2018, the patient was inadvertently vaccinated with VARIVAX (lot # N012132, expiration date 17-APR-2019) and PROQUAD (lot # N023966, expiration date 28-FEB-2019, therapy type rHA), as prophylaxis (route not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies were not reported. On 05-MAR-2018 (reported as today), a patient was vaccinated with an improperly stored dose (reported as one shot) of VARIVAX injection (strength, dose and route of administration were not reported) (lot # N024568, expiry date: 07-SEP-2019) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # N013282, expiry date: 28-AUG-2019). The administered VARIVAX had undergone a temperature excursion of 15 degrees Fahrenheit (F) to 46 F (28.1 F) for 4 hour and 44 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. On 05-MAR-2018, the patient was also vaccinated with properly stored dose (reported as one shot) of M-M-R II (lot # N013868, expiry date: 04-MAY-2019, therapy type: RHA). No adverse effects were reported. There was no product quality complaint (PQC) reported. No further adverse event information was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003594: US-009507513-1803USA003816: US-009507513-1803USA003817: US-009507513-1803USA003813: US-009507513-1803USA003814.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 28-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis. The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003816: US-009507513-1803USA003594: US-009507513-1803USA003813: US-009507513-1803USA003814.
Sex: F
Vaccine: PPV
Symptoms: Injection site infection, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse regarding a 67-year-old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-FEB-2018, the patient received a dose of PNEUMOVAX 23 lot# N025384 with expiry date of 19-APR-2019, intramuscularly for medicare annual wellness visit (prophylaxis). The patient returned to the physician's office visit on 28-FEB-2018, complaining of left upper arm pain. The nurse reported that it was unspecified how long after the injection when the pain originated. On 28-FEB-2018, the patient was admitted to the medical center with diagnosis of injection site infection. Patient received treatment of unspecified dose and duration of vancomycin. The patient was fully recovered and was discharged from the medical center on 05-MAR-2018. Causality of the event was not reported. No product quality complaint was present. The event was considered to be serious due to hospitalization.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a identifiable patient. On 11-JAN-2018 the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # L048848 expiry date 09-AUG-2018 for prophylaxis. Temperature and time frame was reported as 47 degrees Fahrenheit to 77 degrees Fahrenheit (47 degrees Fahrenheit) 2 Hours and 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 5 Hours. There was no previous temperature excursion involved. The call was because of a data logger. No adverse effects reported. No PQC involved. No further details provided.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Dizziness, Headache, X-ray normal
Clinical narrative: Parent reports ongoing, intermittent headaches and dizziness since child received HPV 9 (8-30-2017).
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMR, PNC13, VARCEL
Symptoms: Tic
Clinical narrative: Severe facial tics.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This is one of the 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003594: US-009507513-1803USA003817: US-009507513-1803USA003813: US-009507513-1803USA003814.