chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse prescriber referring to an unknown number of patients. Information regarding the patients' current conditions, medical history, concomitant therapies and drug reactions or allergies was not provided. It was reported that on 15-MAY-2017, an unknown number of patients were vaccinated with improperly stored doses of ROTATEQ orally, lot number M040267 and expiration date of 14-MAY-2018 (dose was not provided). The ROTATEQ doses were exposured to a temperature ranges between 32° (f) fahrenheit and 35 °f, during a time frame of 2 hours, which were called by a data logger. Then returned back in range, with no previous temperature excursions. No adverse events were reported. This is one of several cases from  the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008456: US-009507513-1705USA009812: US-009507513-1705USA009810:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse prescriber referring to an unknown number of patients. Information regarding the patients' current conditions, medical history, concomitant therapies and drug reactions or allergies was not provided. It was reported that on 15-MAY-2017, an unknown number of patients were vaccinated with improperly stored doses of VAQTA with a lot number N005274 and an expiration date: 03-APR-2018 (dose, anatomical location and route were not provided). The VAQTA doses were exposured to a temperature ranges between 32° (f) fahrenheit and 35 °f, during a time frame of 2 hours which were called by a the data logger. Then returned back in range. There were not previous temperature excursions. No adverse events were reported. This is one of several cases from  the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009811: US-009507513-1705USA008456: US-009507513-1705USA009810:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Induration, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 73 year female patient. The patients concurrent conditions included allergy to: paraphenylenediamine, ciprofloxacin (CIPRO), meperidine hydrochloride (DEMEROL) and nonsteroidal anti-inflammatory drug (unspecified). There was no information provided about the patient's medical history, concomitant medications, drug reactions or allergies. On 24-MAY-2017, the patient received an injectable dose of PNEUMOVAX23 intramuscularly for routine vaccine (lot # N005096 with expiration date on 22-OCT-2018) (strength, dose, frequency and anatomical location were not reported). The patient said to the reporter that, on 24-MAY-2017 (also reported as "immediately after receiving the PNEUMOVAX23"), her arm began to get "red and swollen". The reporter stated that, on 25-MAY-2017 (also reported as "at the time of the follow up visit"), the patient's arm was "hot, swollen, itchy, indurated and red, from her elbow to her deltoid" (feeling hot, pruritus, and induration). On an unspecified date in 2017, the patient was placed on diphenhydramine hydrochloride (BENADRYL) as treatment for the events. At the time of reporting, the patient had not recovered from the events of erythema, peripheral swelling, feeling hot, pruritus, and induration. The relationhip between the vaccination with PNEUMOVAX23 and the events of erythema, peripheral swelling, feeling hot, pruritus, and induration was not provided. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 73 year female patient. The patients concurrent conditions included allergy to: paraphenylenediamine, ciprofloxacin (CIPRO), meperidine hydrochloride (DEMEROL) and nonsteroidal anti-inflammatory drug (unspecified). There was no information provided about the patient's medical history, concomitant medications, drug reactions or allergies. On 24-MAY-2017, the patient received an injectable dose of PNEUMOVAX23 intramuscularly for routine vaccine (lot # N005096 with expiration date on 22-OCT-2018) (strength, dose, frequency and anatomical location were not reported). The patient said to the reporter that, on 24-MAY-2017 (also reported as "immediately after receiving the PNEUMOVAX23"), her arm began to get "red and swollen". The reporter stated that, on 25-MAY-2017 (also reported as "at the time of the follow up visit"), the patient's arm was "hot, swollen, itchy, indurated and red, from her elbow to her deltoid" (feeling hot, pruritus, and induration). On an unspecified date in 2017, the patient was placed on diphenhydramine hydrochloride (BENADRYL) as treatment for the events. At the time of reporting, the patient had not recovered from the events of erythema, peripheral swelling, feeling hot, pruritus, and induration. The relationhip between the vaccination with PNEUMOVAX23 and the events of erythema, peripheral swelling, feeling hot, pruritus, and induration was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 from a lawyer regarding a female patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) in 2012, at a pharmacy, as recommended for routine adult health maintenance 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 07-JUL-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe 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: 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 regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 02-JUL-2013, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-APR-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed acyclovir 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Ophthalmic herpes zoster, Rash vesicular, Thrombocytopenia
Clinical narrative: Information has been received on 26-MAY-2017 regarding a case in litigation from a lawyer and a consumer regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 09-SEP-2009 at a pharmacy, as recommended for routine adult health maintenance 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 23-SEP-2014, the patient was treated by a physician at a health clinic for a vesicular outbreak that was diagnosed as severe shingles with neuralgia. On or about 12-APR-2016, the patient was treated by a physician for a Mooren's ulcer related to keratoconjunctivitis secondary to herpes. The patient has further been diagnosed with thrombocytopenia since being inoculated with ZOSTAVAX. Thrombocytopenia is a serious disorder involving depleted platelets, and is commonly found among adults with shingles, especially in patients like the patient who experience repeat outbreaks of shingles. The patient was prescribed famciclovir and hydrocodone-acetaminophen 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. Upon internal review, Mooren's ulcer and thrombocytopenia were considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Ulcerative keratitis
Clinical narrative: Information has been received on 26-MAY-2017 regarding a case in litigation from a lawyer and a consumer regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 09-SEP-2009 at a pharmacy, as recommended for routine adult health maintenance 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 23-SEP-2014, the patient was treated by a physician at a health clinic for a vesicular outbreak that was diagnosed as severe shingles with neuralgia. On or about 12-APR-2016, the patient was treated by a physician for a Mooren's ulcer related to keratoconjunctivitis secondary to herpes. The patient has further been diagnosed with thrombocytopenia since being inoculated with ZOSTAVAX. Thrombocytopenia is a serious disorder involving depleted platelets, and is commonly found among adults with shingles, especially in patients like the patient who experience repeat outbreaks of shingles. The patient was prescribed famciclovir and hydrocodone-acetaminophen 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. Upon internal review, Mooren's ulcer and thrombocytopenia were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 regarding a case in litigation concerning a female (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 21-NOV-2007 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance 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 07-JAN-2008  the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. On or about 01-NOV-2010 the patient was treated for ongoing and worsening shingles that had persisted for several weeks. The patient was treated again on or about 11-NOV-2010 for chronic nerve pain from shingles outbreaks, which was diagnosed as post herpetic neuralgia. She was prescribed "lipoderm" patches 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Joint range of motion decreased, Muscle twitching, Musculoskeletal stiffness, Neuralgia
Clinical narrative: Information has been received on 26-MAY-2017 regarding a case in litigation from a lawyer and a consumer regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 28-MAY-2015 by a physician for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to experience severe side effects and to contract a persistent strain of herpes zoster. On or about 30-MAY-2015, the patient experienced neck stiffness, nerve twitches, and pain that resulting from the shot that limited her range of motion in her neck and arm. This reaction continued for one week. Throughout June of 2015, the patient was treated at her state University Hospital system for a vesicular outbreak that was diagnosed as severe shingles. The patient continues to endure chronic nerve pain in the site of her shingles outbreaks. The patient was prescribed Gabapentin 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: Pain, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 regarding a case in litigation from a lawyer and a consumer regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 28-MAY-2015 by a physician for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to experience severe side effects and to contract a persistent strain of herpes zoster. On or about 30-MAY-2015, the patient experienced neck stiffness, nerve twitches, and pain that resulting from the shot that limited her range of motion in her neck and arm. This reaction continued for one week. Throughout June of 2015, the patient was treated at her state University Hospital system for a vesicular outbreak that was diagnosed as severe shingles. The patient continues to endure chronic nerve pain in the site of her shingles outbreaks. The patient was prescribed Gabapentin 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a patient (age and gender unknown) was inoculated with ZOSTAVAX on or about 01-OCT-2012, at a clinic, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JAN-2015, patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. On or about 03-SEP-2015, patient was treated for ongoing and worsening symptoms which was diagnosed by physician as post herpetic neuralgia, a chronic condition on nerve pain and residual to shingles. Patient was prescribed pregabalin (LYRICA) for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 24-AUG-2013 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance 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 22-APR-2016 the patient was seen by a physician and was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed famciclovir (FAMIR) and hydrocodone 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information was received on 26-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 05-DEC-2014, at a  Public Health clinic as recommended for routine adult health maintenance 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 27-SEP-2013 (date conflicts with later vaccination date), the patient was treated by a physician at a health center for a vesicular outbreak that was diagnosed as severe shingles with ophthalmic involvement. (shingles in the eye).  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. Upon internal review, ophthalmic herpes was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 04-OCT-2017 (Date is conflicting information.) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, 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 10-DEC-2013, the female patient was treated at a family practice facility for a vesicular outbreak that was diagnosed as severe shingles.  The female patient was prescribed gabapentin for management of her painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, 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: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 22-NOV-2014, the patient was vaccinated with ZOSTAVAX at a hospital  as recommended for routine adult health maintenance for the prevention of shingles (route and lot # 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 09-FEB-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles.  She was prescribed  acyclovir  and oxycodone/paracetamol  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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuritis, Pain, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX in 2014, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-MAY-2016, patient was treated by a physician for a vesicular outbreak that was diagnosed as shingles with acute neuritis. Patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Hypotonic-hyporesponsive episode, Irritability
Clinical narrative: Hypotonic/Hyporesponsive episode on day of vaccine, followed by irritability. Family (Mom) can provide specifies about vaccine clinic.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose from 24-APR-2017 to 09-MAY-2017 of GARDASIL 9 with Lot # M037770 with an expiration date of 01-JUN-2019 and lot # M043731 with an expiration date of 22-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 47 Fahrenheit degrees (°F) to 77 °F range for a time frame of 28 minutes. The temperature excursion was recorded by a data logger and it had previous temperature excursions on 19-APR-2017 of 32 °F to 35 °F by 29 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009720: US-009507513-1705USA009720.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Blister, Diarrhoea, Headache, Nausea, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient with no current illnesses and medical history. On 05-JAN-2017, the patient was vaccinated intramuscularly in the left arm with the first dose of GARDASIL 9 (lot # L040054), subcutaneously in the left arm with the second dose of M-M-R II (lot # M004305, expiry date 25-JAN-2018), intramuscularly in the left arm with the 4th dose of IPOL (lot # N1A451M), subcutaneously in the right arm with the 2nd dose of VARIVAX (lot # M000756, expiry date 06-JAN-2018), intramuscularly in the right arm with the 5th dose of BOOSTRIX (lot # E735A), intramuscularly in the left arm with the first dose of MENACTRA (lot # U5415AA), intramuscularly in the right arm with the first dose of HAVRIX (lot # E735A) and in the right arm with the first dose of FLUZONE Quadrivalent (lot # U1709AA). On 17-JAN-2017, the patient experienced headache. On 18-JAN-2017, he noticed some red bumps on stomach before school, when he came home had more blisters on head and face. The rash cleared up 23-JAN-2017. On 25-JAN-2017, he experienced nausea, vomiting and diarrhoea. The outcome of blister, vomiting, nausea, headache, diarrhoea was reported as recovered on an unknown date in 2017. The relatedness between the events and GARDASIL 9, M-M-R II and VARIVAX was not reported. Additional information is not expected as no follow up could be obtained from Agency.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Rash erythematous, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient with no current illnesses and medical history. On 05-JAN-2017, the patient was vaccinated intramuscularly in the left arm with the first dose of GARDASIL 9 (lot # L040054), subcutaneously in the left arm with the second dose of M-M-R II (lot # M004305, expiry date 25-JAN-2018), intramuscularly in the left arm with the 4th dose of IPOL (lot # N1A451M), subcutaneously in the right arm with the 2nd dose of VARIVAX (lot # M000756, expiry date 06-JAN-2018), intramuscularly in the right arm with the 5th dose of BOOSTRIX (lot # E735A), intramuscularly in the left arm with the first dose of MENACTRA (lot # U5415AA), intramuscularly in the right arm with the first dose of HAVRIX (lot # E735A) and in the right arm with the first dose of FLUZONE Quadrivalent (lot # U1709AA). On 17-JAN-2017, the patient experienced headache. On 18-JAN-2017, he noticed some red bumps on stomach before school, when he came home had more blisters on head and face. The rash cleared up 23-JAN-2017. On 25-JAN-2017, he experienced nausea, vomiting and diarrhoea. The outcome of blister, vomiting, nausea, headache, diarrhoea was reported as recovered on an unknown date in 2017. The relatedness between the events and GARDASIL 9, M-M-R II and VARIVAX was not reported. Additional information is not expected as no follow up could be obtained from Agency.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug and allergy history was not reported. On an unspecified day in August of 2015, the patient was vaccinated with an unspecified dose of GARDASIL (strength, dose, route of administration, lot # and expiration date were not provided) for prophylaxis. Then, on an unspecified day in July of 2016, the patient was vaccinated with an injection of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided) for prophylaxis. It was reported that both vaccines were administered prior to the patient's 15th birthday. Adverse events were not reported. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 16-MAY-2017, the patient was vaccinated with ZOSTAVAX, lot number M037016, expiration date: 22-NOV-2017 (dose was not reported) subcutaneously "in the back of the arm" for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (lot number and expiration date were not provided). The pharmacist reported that the patient may have received a second dose of ZOSTAVAX. After the pharmacist administered the ZOSTAVAX to the patient on 16-MAY-2017, the patient said, "I think I may have received ZOSTAVAX previously because of where you administered that dose." The pharmacist stated that the patient may have received the first dose "at least a year ago ." The patient has not reported any adverse effects. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Product dosage form confusion
Clinical narrative: This spontaneous report has been received from a registered nurse, referring to a vaccine RECOMBIVAX HB used for prophylaxis (there are not specific lot numbers, expiration dates and patients involved), who reported that the sections of :"dosage and administration" and "dosage forms and strengths" of the prescribing information for the vaccine are confusing, because the "dosage and administration" section does not clearly state the amount of vaccine contained in the 0.5 ml and 1 ml dosages, additionally the reporter stated that " it is difficult to differentiate between the 1 ml dialysis dosage and the 1 ml adult dosage, because there are two distinctly different doses and both contained in 1ml ". Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown gender and age. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On unknown dates in 2017, from 24-APR-2017 to 09-MAY-2017, the patients were vaccinated with improperly stored doses of ROTATEQ with lot # M040267 and expiration date of 14-MAY-2018 (orally; strength and dose were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 47 Fahrenheit degrees to 77 Fahrenheit degrees range for a time frame of 28 minutes. The temperature excursion was recorded by a data logger and it had previous temperature excursions on 19-APR-2017 of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 29 minutes. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009720: US-009507513-1705USA005357:
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 3 months old non pregnant female patient. The patient had non medical, drug and allergy history. On 15-JAN-1996 the patient was vaccinated with the first dose of RECOMBIVAX HB Injection (strength, dose, frequency, route, lot number and expiration date were not provided) to prevent hepatitis B, on 18-MAR-1996 the patient received the second dose of the vaccine and on 21-MAY-1996 The patient was vaccinated with the third dose. The patient had non concomitant medications.   On an unspecified date, in May of 2017 (reported as "last week") the patient was performed a Hepatitis B antibodies titer and the result was negative. The patient did not receive any treatment. The outcome of the patient was unknown and the causality assessment between RECOMBIVAX HB and negative Hepatitis B antibodies titer was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Musculoskeletal stiffness, Seizure, Staring, Vomiting
Clinical narrative: This spontaneous report was received from a physician referring to an 11 year old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date in May 2017 (reported as "last week"), the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not provided). Other suspect vaccine administered on the same date included diphtheria toxoid(+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid (TDAP) (dose, route of administration, lot number and expiration date were not provided), also for prophylaxis. On an unknown date in May 2017, the patient had complaints of dizziness after receiving the vaccines and then she had a seizure that lasted for 30 seconds. In addition, her face went blank and her legs and arms were stiff. The physician also reported that the patient's vital signs were stable, so they kept her for two hours for observation, at which time she vomited (vomiting). The outcome of the events was unknown at the time of this report. Causality relationship between the events seizure and vomiting with and GARDASIL 9 and diphtheria toxoid(+) pertussis acellular vaccine (unspecified)(+) tetanus toxoid (TDAP) was not reported. Upon internal review, the event seizure was determined to be medically significant. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 23-MAY-2017 (also reported as "05/23/2018"), the patient received an expired injectable dose of VARIVAX (lot # L017145 with expiration date on 13-MAY-2017) for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 09-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#,  expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661:  US-009507513-1704USA000587: US-009507513-1704USA001660:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 04-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date: 31-MAR-2018, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M040267 with expiration date on 14-MAY-2018; and lot # M025563 with expiration date on 06-NOV-2017) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015171: US-009507513-1705USA015170: US-009507513-1705USA015169: US-009507513-1705USA015168:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was 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. The patient was inoculated with ZOSTAVAX on or about November 2015, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was subsequently treated at an urgent care center for a vesicular outbreak that was diagnosed as severe shingles (onset not provided). 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: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 16-DEC-2013, the patient was vaccinated with ZOSTAVAX at a hospital as recommended for routine health maintenance for the prevention of shingles (route and lot # 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 03-NOV-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. She was prescribed  acyclovir, gabapentin (NEURONTIN), prednisone and oxycodone/paracetamol (PERCOCET) 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, pain and suffering, and other damages. The outcome of shingles was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was 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. The patient was inoculated with ZOSTAVAX on or about 23-DEC-2008, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JAN-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed acyclovir 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX on or about 21-NOV-2012 at a physician's office, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-JUL-2016, patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. Patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, 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: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 regarding a case in litigation concerning a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 16-SEP-2013 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance 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 31-MAR-2016 the patient was treated for a vesicular outbreak that was diagnosed as herpes zoster (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, pain and suffering, and other damages.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 25-FEB-2008, at a pharmacy as recommended for routine adult health maintenance 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 23-APR-2014, the patient was treated by a physician at a physician office for a vesicular outbreak that was diagnosed as severe shingles. On or about 01-DEC-2014, the patient was treated again for ongoing and worsening symptoms by a physician who affirmed the diagnosis of shingles.  The patient was prescribed valacyclovir (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.