chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported), for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit degrees (°F) to 77 Fahrenheit degrees (°F) for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates the patients were vaccinated with unspecified doses of PNEUMOVAX 23 (lot # N001007, expiration date 19-SEP-2018; lot # N011491, expiration date 04-NOV-2018; lot # M047519, expiration date 04-AUG-2018; dose, route, site of administration unknown) for prophylaxis. On unknown dates the patients experienced one or more of the following adverse effects: redness, swelling of full arm, pain in full arm that radiated to the shoulder neck, or hand, rash at the injection site, and numbness in fingers. The patients sought medical attention by calling the physician office. Treatments were given for the events. The nurse reported that all patients were instructed to take an unspecified over the counter pain reliever and to apply a warm compress to the effected upper extremity. The patients who reported a rash were told to take BENADRYL (dose unspecified). The nurse was unsure which patient received which lot number. The nurse requested a lot check for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # M047519, expiration date 04-AUG-2018 and lot # N011491, expiration date 04-NOV-2018. The outcome of the events was unknown. Causality assessment was not provided. It was reported that no product quality complaint (PQC) was involved. This report is one of four reports received from the same reporter. The lot check request also appears in the linked reports.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date (reported as when the patient was a baby) the patient was vaccinated with a dose of VARIVAX, for prophylaxis. On an unknown date (reported as when the patient was a first-grader) the patient developed chickenpox. The outcome of chickenpox is unknown. The causality assessment was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent condition or medical history was unknown. On an unknown date the patient was inadvertently vaccinated with a dose of improperly stored reconstituted M-M-R II (lot # M008589 with expiration date 16-FEB-2018 or lot # reported as M042846 with expiration date 21-OCT-2018, dose and route unknown) and diluent (lot # M013638 with expiration date 19-NOV-2018, lot # L039101 with expiration date 09-MAY-2018, lot # M045716 with expiration date 26-MAY-2019 or lot # M029027 with expiration date 14-MAR-2019) for prophylaxis. No adverse event was reported. The vaccine and diluent were stored under 62.4 degree Fahrenheit  for 5 hours and 30 minutes and 50.5 degree Fahrenheit  for 15 minutes. No data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # M042324, expiration date 10-JUN-2018, dose and route not reported) for prophylaxis. The vaccine was improperly stored at -5.2 degrees Celsius for 7 hours (6 cycles). There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Information has been received from a pharmacy technician referring to a patient of unknown age and gender. There was no information about medical history, concomitant medication or concurrent condition. On 17-JUL-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose and route unknown, lot# N009167, expiration date 02-FEB-2018) for prophylaxis. Properly stored sterile diluent (dose and route unknown, lot# N008378, expiration date 08-JUN-2018) was used to reconstitute ZOSTAVAX. The vaccine was exposure to 6 Fahrenheit degree (F) to 14F for 7 days, 15F to 46F for 3 days. No previous temperature excursion was involved. No data logger was involved. This is one of the reports received from the same reporter (MARRS# 1707USA010616). Sender's Comments: US-009507513-1707USA010616.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with RECOMBIVAX HB dose 3 for prophylaxis. On 21-JUL-2017, 3 months 16 days after onset of therapy the patient experienced inappropriate schedule of drug administration. No adverse event reported. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to RECOMBIVAX HB. This report is linked to case #1707USA010213, due to same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1707USA010213.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a multiple unspecified patient of unknown age with prophylaxis. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX for prophylaxis. The ZOSTAVAX was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported with any patients. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA007049:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with RECOMBIVAX HB dose 3 for prophylaxis. On 21-JUL-2017, 3 months 16 days after onset of therapy the patient experienced inappropriate schedule of drug administration. No adverse event reported. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to RECOMBIVAX HB. This report is linked to the case# 1707USA010084, due to same reporter source.  Additional information has been requested.; Sender's Comments: US-009507513-1707USA010084:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Erythema, Folliculitis, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. The patient's medical history included hypertension. On 02-JUN-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On unknown date in June 2017, reported as 12 hours after vaccination, the patient experienced headache, folliculitis (for which the anonymous physician prescribed an unspecified antibiotic), erythema (reported as "red pimples down her legs"), rash, malaise (reported as"felt under the weather"), asthenia, dizziness and nausea. The outcome of dizziness, headache, nausea, rash, asthenia, erythema, malaise and folliculitis was reported as not recovered/not resolved. The causality assessment between the events and with ZOSTAVAX was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. The patient's medical history included hypertension. On 02-JUN-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On unknown date in June 2017, reported as 12 hours after vaccination, the patient experienced headache, folliculitis (for which the anonymous physician prescribed an unspecified antibiotic), erythema (reported as "red pimples down her legs"), rash, malaise (reported as"felt under the weather"), asthenia, dizziness and nausea. The outcome of dizziness, headache, nausea, rash, asthenia, erythema, malaise and folliculitis was reported as not recovered/not resolved. The causality assessment between the events and with ZOSTAVAX was not provided. Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a 23 year old female patient (also a pharmacy intern) concerning on herself. The patient's medical history and concurrent conditions were not reported. On an unspecified dates, the patient was vaccinated with M-M-R II injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. The patient's concomitant medications included NUVARING. In May 2017, the pharmacy intern "failed a titer" for Measles, Mumps and Rubella (MMR). On 10-MAY-2017, the pharmacy intern received a dose of M-M-R II injection, lot # M045390, expiration date: 14-NOV-2018 (strength and dose were not reported) for prophylaxis. It was also reported that the patient had a "2 step TB test" performed. The first step was performed on "last Monday" and the second step was performed on 25-JUL-2017 ant it would be read on Friday on an unknown date. At the time of the report, the outcome of the event was unknown. The causality assessment between the event and the M-M-R II was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 8 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 25-JUL-2017, the patient was vaccinated with a first dose of GARDASIL 9 lot # M040412, expiration date 30-JUN-2019, (route and dose were not reported) for prophylaxis. Information regarding concomitant therapies was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 2002 the patient was vaccinated with M-M-R II for prophylaxis. On 19-JUL-2017 the patient experienced rubella antibody negative. The outcome of rubella antibody negative is unknown.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored dose of M-M-R II for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II.; Sender's Comments: US-009507513-1707USA010527: US-009507513-1707USA010532: US-009507513-1707USA010529: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010526: US-009507513-1707USA010528:
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 regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 22-OCT-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated by a physician for a  painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) and topical shingles cream for management of her painful condition. 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: 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 regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 09-JAN-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JUN-2016, the patient was treated by a physician for a painful and 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, 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 (lot number, dosage, and route of administration not provided) on or about 21-MAY-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about "26-JUN-2015," the patient was treated by a dermatologist for a  painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about "16-JUN-2015," the patient "was treated again" by a physician for continued and worsening symptoms that were diagnosed as post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to shingles. On or about "23-JUN-2015," the patient "was treated again" by pain management specialist for treatment of worsening post-herpetic neuralgia. The patient was prescribed gabapentin (NEURONTIN), and acyclovir, tramadol, acetaminophen, and gabapentin (manufacturers unknown). 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: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-JAN-2014,the patient was inoculated at 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 vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUN-2016, the patient was treated by a nurse practitioner for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed famciclovir(FAMVIR) for management of his painful condition. 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: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-AUG-2011, 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 vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAY-2015, the patient was treated physician for a painful and 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, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 24-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 21-SEP-2012 at a medical center, as recommended for routine adult health maintenance and 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 28-JUL-2016, the patient was treated by a physician at a medical center (different from the one where the patient was inoculated with ZOSTAVAX on or about 21-SEP-2012) for a painful and blistering vesicular outbreak, which was diagnosed as Herpes Zoster, or shingles.   The patient has been prescribed "valcyclovir" 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Discomfort, Emotional distress, Herpes zoster
Clinical narrative: Information had been received on 24-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated (by an unspecified person) with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 08-AUG-2015 at a pharmacy, as recommended for routine adult health maintenance and 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 and chronic strain of Herpes Zoster. On or about 21-FEB-2016, the patient was treated at an urgent care center, for a blistering vesicular outbreak accompanied by weakened immune symptoms and severe discomfort and distress, which was diagnosed as Herpes Zoster, or shingles.  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, pain and suffering and other damages.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information had been received on 24-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated (by an unspecified person) with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 08-AUG-2015 at a pharmacy, as recommended for routine adult health maintenance and 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 and chronic strain of Herpes Zoster. On or about 21-FEB-2016, the patient was treated at an urgent care center, for a blistering vesicular outbreak accompanied by weakened immune symptoms and severe discomfort and distress, which was diagnosed as Herpes Zoster, or shingles.  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, 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 had been received on 24-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated (by an unspecified person) with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 03-MAR-2013 at a pharmacy, as recommended for routine adult health maintenance and 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 patient to contract a persistent strain of Herpes Zoster. On or about 04-SEP-2015, the female patient was treated at a dermatology and skin surgery center (It was not specified who treated the female patient), for a painful and blistering vesicular outbreak, which was diagnosed as Herpes Zoster, or shingles.  The patient was prescribed Triamcinolone 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, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information had been received on 24-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a patient of unknown age and gender was inoculated (by an unspecified person) with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 16-AUG-2011, at a family medicine facility, as recommended for routine adult health maintenance and 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 29-MAY-2012, the patient was treated at the same family medicine facility, for a blistering vesicular outbreak, which was diagnosed as Herpes Zoster, or shingles. 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, 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 as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored VARIVAX (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with GARDASIL 9 (lot # reported as M036059, expiry date: 03-JUN-2019), (route: oral) (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F at a time frame of 15 hours. No adverse effects reported. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA010855.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition or medical history was unknown. On 25-JUL-2017 the patient was vaccinated with an expired dose of PROQUAD (lot # M001151 with expiration date 05-JUL-2017, dose and route unknown) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Information has been received from a pharmacy technician referring to a patient of unknown age and gender. There was no information about medical history, concomitant medication or concurrent condition. On 18-JUL-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose and route unknown, lot# N009167, expiration date 02-FEB-2018) for prophylaxis. Properly stored sterile diluent (STERILE DILUENT) (dose and route unknown, lot# N008378, expiration date 08-JUN-2018) was used to reconstitute ZOSTAVAX. The vaccine was exposure to 6 Fahrenheit degree (F) to 14F for 7 days, 15F to 46F for 3 days. No previous temperature excursion involved. No data logger involved. This is one of the reports received from the same reporter (MARRS# 1707USA009982).; Sender's Comments: US-009507513-1707USA009982:
Age: 29.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 29 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (LOT #: N012615 EXP: 16-MAR-2018), subcutaneous for prophylaxis. On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding the concurrent condition or medical history was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # M000442 with expiration date 31-MAR-2018, lot # M034894 with expiration date 11-NOV-2018, lot # M035487 with expiration date 23-FEB-2019, lot # N002914 with expiration date 04-NOV-2019, lot # reported as N006321 with expiration date 08-NOV-2019) (dose and route unknown) for prophylaxis. No adverse events were reported. The vaccines were stored under 0-1 degrees Celsius for 3 hours and 43 minutes and 9-25 degrees Celsius for 3 hours and 4 minutes.   Data logger was involved. This is one of several report received from the same reporter. Sender's Comments: US-009507513-1707USA010873: US-009507513-1707USA010872.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 year old male adolescent patient. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. In August 2016, the patient was vaccinated with GARDASIL injection, (dose, frequency not reported) for prophylaxis when the patient was 12 years old. The patient did not receive any additional doses of GARDASIL injection. The patient did not return to the office until 07-JUL-2017 (when he was 13 years old) and on that date, the patient was given a dose of GARDASIL 9 injection, (dose, frequency were not reported) for prophylaxis. Outcome of events was unknown. No symptoms were reported. There was no product quality compliant involved. No further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 4 year old patient. On an unknown date the patient was vaccinated with improperly stored VARIVAX (1 dose, lot# reported as N014366, expiration date 09-MAY-2019, route unknown) for prophylaxis. The sterile diluent (1 dose, lot# reported as N015631, expiration date 18-MAR-2019) did not undergo any temperature excursions. No adverse effects reported. Temperature and time frame was 15 Fahrenheit degree (F) to 46 F for 8 hours with previous temperature excursion of 15 F to 46 F for 4 hours. The call was because of a data logger.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician via company representative refers to unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with ROTATEQ (lot # M019707, expiry date: 25-OCT-2017), (route: oral) (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F at a time frame of 15 hours. No adverse effects reported. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA010598.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored GARDASIL 9 (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored ROTATEQ (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored M-M-R II (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored PROQUAD (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding the concurrent condition or medical history was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored ROTATEQ (lot # M038209 with expiration date 23-APR-2018, lot # M044399 with expiration date 25-JUN-2018, lot # reported as N003392 with expiration date 11-OCT-2018) (dose unknown) orally for prophylaxis. No adverse events were reported. The vaccines were stored under 0-1 degrees Celsius for 3 hours and 43 minutes and 9-25 degrees Celsius for 3 hours and 4 minutes. Data logger was involved. This is one of several report received from the same reporter. Sender's Comments: US-009507513-1707USA010619: US-009507513-1707USA010872.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding the concurrent condition or medical history was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored VAQTA (lot # reported as N005796 with expiration date 26-MAY-2018, lot # reported as N012324 with expiration date 05-APR-2018) (dose and route unknown) for prophylaxis. No adverse events were reported. The vaccines were stored under 0-1 degrees Celsius for 3 hours and 43 minutes and 9-25 degrees Celsius for 3 hours and 4 minutes. Data logger was involved. This is one of several report received from the same reporter. Sender's Comments: US-009507513-1707USA010619: US-009507513-1707USA010872.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L044707, lot # M032649, lot# M036153 or lot # L0447707 for prophylaxis. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007005: US-009507513-1707USA011013: US-009507513-1707USA011014: US-009507513-1707USA011015.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with GARDASIL 9 lot # M037770, lot # M042853 or lot # M017983, for prophylaxis. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007005: US-009507513-1707USA011012: US-009507513-1707USA011014: US-009507513-1707USA011015.
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Malaise, Pyrexia, Tremor
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for her son. A 19-year-old male patient of an unspecified ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 11Aug2016 at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced awful fever, chills, fatigue, shaky and sick as a dog on an unspecified date with outcome of unknown. Now it's been almost a year and the patient did not receive the second dose yet. No follow-up attempts are possible. No further information is expected. Follow-up (21Jul2017): additional information received from the contactable consumer includes age of the patient and date of vaccination. Sender's Comments: Linked Report(s): 2016395485 Legacy paper report number.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Pain
Clinical narrative: This is a spontaneous report from a contactable physician reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, body aches, diarrhea and fatigue all on an unspecified date with outcome of unknown. She had a dose of BONIVA one day after receiving pneumococcal 13-val conj vac.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: This is a spontaneous report from a contactable medical assistant calling on behalf of a physician. A 74-year-old male patient received PREVNAR 13 (lot: R75238, expiry date: May2018, NDC number: 0005197101) on 18Jul2017, at 0.5 ml single, intramuscular, in left arm, for immunization. Medical history and concomitant medications were none. On 22Jul2017 the patient experienced fever (102 degrees Fahrenheit), was tired, headache, joint and muscle pain and stiff neck. The patient did not have any coughing, respiratory or GI issues to report. The doctor prescribed TYLENOL 500 mg QID to the patient who had not yet recovered at the time of report.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable medical assistant calling on behalf of a physician. A 74-year-old male patient received PREVNAR 13 (lot: R75238, expiry date: May2018, NDC number: 0005197101) on 18Jul2017, at 0.5 ml single, intramuscular, in left arm, for immunization. Medical history and concomitant medications were none. On 22Jul2017 the patient experienced fever (102 degrees Fahrenheit), was tired, headache, joint and muscle pain and stiff neck. The patient did not have any coughing, respiratory or GI issues to report. The doctor prescribed TYLENOL 500 mg QID to the patient who had not yet recovered at the time of report.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given Dtap/IPV at his 11 yo check up instead of Tdap BOOSTRIX.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given KINRIX Dtap/IPV at 11 yr old Check up instead of Tdap BOOSTRIX.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Oropharyngeal pain, Seizure
Clinical narrative: Son had seizure the evening after the day of vaccine. He then had another seizure the morning after the first seizure. He also had a terrible sore throat starting three days after vaccine.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blister, Erythema, Induration, Peripheral swelling
Clinical narrative: Mom reports that patient received Tdap on Thursday, started having swelling and redness to right arm on Friday, blisters noted to area on Saturday by Sunday the blisters were gone but redness and swelling remained, On Monday area remains hard to touch, no swelling area continued to improve daily. Child had no fever, sickness or difficulty breathing. Child complained of just throbbing to area. Mom gave child ibuprofen and ice to area. Mom contacted Dr and he advised her to call the Health Department..
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Reaction at injection site. Large hive, 6 inches by 3 inches. Hot, stinging, burning, itching, swelling.
Age: 1.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, HPV9, PNC13
Symptoms: Drug administered to patient of inappropriate age, Injection site pain, Irritability
Clinical narrative: Vaccine inadvertently given to 22 mo. old infant, outside of indication of age 9 y and up. Also given with other vaccines at the same time- PEDIARIX, Hib, PCV13 - baby had some mild fussiness overnight, slight tenderness at imm. site as per mom.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PPV
Symptoms: Feeling abnormal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Baby passed out as the shots where giving, she couldn't cry or grasp air, her limps looked very relaxed and her eyes were closing, ones she woke up she looked spaced out.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray normal, Cough, Culture throat negative, Culture urine negative, Decreased appetite
Clinical narrative: Patient had a fever of 105.0 rectally, as well as coughing, sneezing and decreased appetite.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count normal, Pyrexia, Sneezing, Streptococcus test negative, Urine analysis normal
Clinical narrative: Patient had a fever of 105.0 rectally, as well as coughing, sneezing and decreased appetite.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Patient says she has been having shooting pains in her body since she received a Tdap shot. Tdap shot was given over a year ago. She denies any other reactions after the vaccine. Says she doesn't even remember having any discomfort at the injection site.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. Other suspect therapies included PEDVAXHIB. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered no adverse event to be not related to GARDASIL 9 and PEDVAXHIB. The reporter considered incorrect product storage to be not related to PEDVAXHIB and GARDASIL 9.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On 13-JUL-2017, the patient was vaccinated with M-M-R II lot # L024265 for prophylaxis. Concomitant therapies included sterile diluent. On 13-JUL-2017, the patient experienced expired product administered. The patient experienced no adverse event.