chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids; ischemia in the lateral wall of the heart; other acute cardiovascular events; severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids; The pt was vaccinated with Zostavax on or around 14-MAY-2013 and 30-SEP-2013; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On or around 14-MAY-2013 and 30-SEP-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe and debilitating shingles, including painful abscesses across her scalp and blisters on the inside of her eyelids. She also developed ischemia in lateral wall of the heart, as well as other acute cardiovascular events, as a result of zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, injury and extensive medical treatment. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered all events to be disabling. Upon internal review, the events of severe and debilitating shingles including blisters on the inside of her eyelids and ischemia in lateral wall of the heart were determined to be medically significant.
Age: 8.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patients were administered improperly stored PROQUAD; This spontaneous report was received from a vaccine coordinator, referring to two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, or medical history was provided. The concomitant therapy included sterile diluent.  Since 24-APR-2019, the patients were vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rha)) (PROQUAD), lot # R030801 and expiration date 22-APR-2020, for prophylaxis (dose and route of administration were not reported) which was reconstituted with properly stored sterile diluent.  The administered doses of the vaccine experienced a temperature excursion of -14 to -10 degrees Celsius (C) for 1 hour and 12 minutes and of -9 degree C to 8 degree C (-0.04 degree C) for 6 hours and 50 minutes, as recorded by a data logger. The vaccine had had previous temperature excursions of -14 degree C to -10 degree C (-11.6 degree C) for 28 minutes and of -14 degree C to -10 degree C (-13.12 degree C) for 25 minutes. There was no adverse effect reported. No product quality complaint was involved.  This case is non-valid due to lack of patient identifiers.  Follow-up information was received from the vaccine coordinator on 20-APR-2020. The reporter was ready to provide the requested information like administration dates and patient identifiers but, would have to search for the information. The reporter would call back to provide the information.  Follow-up information was received from the vaccine coordinator on  30-APR-2020. The individual patient identifiers and details were reported and the case has become valid. This case was regarding a 8 year old male patient who was vaccinated  with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rha)) (PROQUAD) on 06-AUG-2019 (previously reported as since 24-APR-2019).  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1910USA010836:
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Emphysema, Pneumonia
Clinical narrative: Pneumonia; Emphysema; This initial spontaneous report was received from a lawyer on 30-APR-2020, regarding a case in litigation and refers to a male patient of unknown age. His medical history, concurrent conditions or concomitant medications were not reported. On or around 23-NOV-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after receiving" zoster vaccine live (ZOSTAVAX)), the patient suffered chest pains and breathing problems resulting in a diagnosis of emphysema and pneumonia. It was mentioned that these injuries were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination, he experienced mental and emotional distress due to resulting physical limitations and seriousness of his conditions. The patient sustained severe and permanent personal injuries. Further, as a tragic consequence of vaccination, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of pneumonia and emphysema was not recovered. The reporter considered this case as serious due to disabling. Upon internal review, pneumonia was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Lichen planus, Onychomadesis, Rash, Scar, Skin lesion
Clinical narrative: Lichen planus; Information has been received from a lawyer concerning a case in litigation and refers to a male patient of unknown age. The patient's medical history, historical drugs and concomitant therapies were not reported.  On or about 05-NOV-2014, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered painful rashes, scarring and lesions on the soles of this feet, his ankles, his lower back and around his eyes. He also lost his fingernails and toenails, and was diagnosed with lichen planus.   The symptoms had resulted in physical limitations, mental and emotional distress. The patient sustained severe and permanent personal injuries. He suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event was not recovered.  The causal relationship between the event and Zoster Vaccine Live (ZOSTAVAX) was related.   The event was considered to be a disabling event.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additiona AE information provided; the patient was administered an improperly stored dose of PNEUMOVAX; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 13-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection as prophylaxis (dosage regimen, route of administration, and anatomical location were not reported; lot number S004548, which has been verified to be valid, expiration date reported and validated as 12-AUG-2020) (product storage error). No additional adverse event information provided.  The temperature excursion was of 47.3 degrees Fahrenheit, for 20 minutes. No previous temperature excursion reported. A data logger was used.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000310: US-009507513-2005USA000317: US-009507513-2005USA000352: US-009507513-2005USA000356: US-009507513-2005USA000357: US-009507513-2005USA000359: US-009507513-2005USA000389: US-009507513-2005USA000401: US-009507513-2005USA000413: US-009507513-2005USA000415: US-009507513-2005USA000425: US-009507513-2005USA000431: US-009507513-2005USA000465: US-009507513-2005USA000488: US-009507513-2005USA000493: US-009507513-2005USA000495: US-009507513-2005USA000498: US-009507513-2005USA000505: US-009507513-2005USA000510: US-009507513-2005USA000512: US-009507513-2005USA000624:
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 23-OCT-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe injection as prophylaxis (strength, dosage regimen, route of administration, and anatomical location were not reported; lot number S004548, which has been verified to be valid, expiration date reported and validated as 12-AUG-2020) (product storage error). No additional adverse event information provided.  The temperature excursion was of 47.3 degrees Fahrenheit, for 20 minutes. No previous temperature excursion reported. A data logger was used.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient inadvertently received an expired dose of PROQUAD; This spontaneous report was received from a registered nurse referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug allergies and reactions were not reported.  On 01-MAY-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R026722 with expiration date on 17-MAR-2020 (strength, dose, anatomical location, and route of administration were not reported) for prophylaxis, which was reconstituted with sterile diluent (MERCK STERILE DILUENT).  The nurse also reported that the patient's twin brother was also received an expirated dose of vaccine (MARRS#2005USA000636).   No adverse effects were reported. This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000636:
Sex: F
Vaccine: HPV9
Symptoms: Cerebral haemorrhage, Fatigue, Food intolerance, Headache, Immune system disorder
Clinical narrative: transient ischemic attack (TIA) mini-stroke; has had a hemorrhage in brain/ fatigue/ in bed with headaches all the time; is allergic to everything; immune system is on overload; food is not agreeing with her; sick all the time; This spontaneous report was received from a consumer, concerning a 20-year-old female patient who was also the girlfriend of the reporter's son. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, it was reported that the patient was sick all the time (malaise); had a hemorrhage in brain, was in bed with headaches all the time, had fatigue (cerebral haemorrhage); a transient ischemic attack (TIA) mini-stroke, the patient was allergic to everything (multiple allergies), immune system was on overload (immune system disorder), and food was not agreeing with her (food intolerance).  At the time of the report, the outcome of the events was unknown (also reported as the patient could be getting better or getting worse). The causal relationship between the suspect vaccine and the aforementioned events was not reported.    Upon internal review, the event transient ischaemic attack and cerebral haemorrhage were determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA000534:
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Multiple allergies, Transient ischaemic attack
Clinical narrative: transient ischemic attack (TIA) mini-stroke; has had a hemorrhage in brain/ fatigue/ in bed with headaches all the time; is allergic to everything; immune system is on overload; food is not agreeing with her; sick all the time; This spontaneous report was received from a consumer, concerning a 20-year-old female patient who was also the girlfriend of the reporter's son. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, it was reported that the patient was sick all the time (malaise); had a hemorrhage in brain, was in bed with headaches all the time, had fatigue (cerebral haemorrhage); a transient ischemic attack (TIA) mini-stroke, the patient was allergic to everything (multiple allergies), immune system was on overload (immune system disorder), and food was not agreeing with her (food intolerance).  At the time of the report, the outcome of the events was unknown (also reported as the patient could be getting better or getting worse). The causal relationship between the suspect vaccine and the aforementioned events was not reported.    Upon internal review, the event transient ischaemic attack and cerebral haemorrhage were determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA000534:
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additonal AE information provided; The patient was administered an improperly stored dose of PNEUMOVAX23; Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug/reactions allergies.  On 18-NOV-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004548 and expiration date of 12-AUG-2020 (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 47.3 Fahrenheit degrees for 20 minutes. No previous temperature excursion was reported. No additional adverse event information provided.   Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 06-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number S004548  with expiration date 12-AUG-2020 (dose, route, anatomical location were not reported) for prophylaxis. The pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was exposed at 47.3 degrees Farenthold during 20 minutes. There was no previous temperature excursion. Data digital logger was filled.  This is one of several reports from the same source.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302: US-009507513-2005USA000310: US-009507513-2005USA000317: US-009507513-2005USA000352: US-009507513-2005USA000357: US-009507513-2005USA000359: US-009507513-2005USA000389: US-009507513-2005USA000401: US-009507513-2005USA000413: US-009507513-2005USA000415: US-009507513-2005USA000431: US-009507513-2005USA000465: US-009507513-2005USA000488: US-009507513-2005USA000493: US-009507513-2005USA000495: US-009507513-2005USA000498: US-009507513-2005USA000505: US-009507513-2005USA000510: US-009507513-2005USA000512: US-009507513-2005USA000614: US-009507513-2005USA000624: US-009507513-2005USA000735:
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 17-OCT-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S004548, and expiration date 12-AUG-202 for prophylaxis.  The administered dose of vaccine experienced the temperature excursion of 47.3 F degrees Fahrenheit for 20 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:  manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S004548; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PNEUMOVAX 23; the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a Licensed Practical Nurse referring to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 24-FEB-2020, the patient was vaccinated with an improperly stored dose of  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S004548, expiring on 12-AUG-2020, for prophylaxis (dose, route and site of administration, were not reported).   The administered dose of the vaccine experienced a temperature excursion of 47.3F degrees for 20 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. Information on pertinent medical history, concomitant medications and drug reactions/allergies was not reported.   On 09-OCT-2019 the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S004548, expiration date 12-AUG-2020 for prophylaxis (dose, dose number, route of administration and anatomical location were not reported).   The vaccine was exposed to a temperature of 47.3 degrees Fahrenheit (F) for a time frame of 20 minutes as recorded by a digital data logger. There were no previous temperature excursions. No additional adverse event information was provided.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; Patient was administered an dose of improperly stored PNEUMOVAX 23; Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug/reactions allergies.  On 18-SEP-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004548 and expiration date of 12-AUG-2020 (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 47.3 Fahrenheit degrees for 20 minutes. No previous temperature excursion was reported. No additional adverse event information provided.   Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; Patient was administered an improperly stored dose of PNEUMOVAX 23; Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug/reactions allergies.  On 27-NOV-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004548 and expiration date of 12-AUG-2020 (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 47.3 Fahrenheit degrees for 20 minutes. No previous temperature excursion was reported. No additional adverse event information provided.   Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was administered an improperly stored dose; No adverse event; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 30-AUG-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S004548 with expiration date of 12-AUG-2020 (indication, strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis. No adverse event reported. The vaccine was exposed to a temperature of 47.3 °F during a time frame of 20 minutes and called by a data logger.  This is one of multiple cases from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302: US-009507513-2005USA000310: US-009507513-2005USA000317: US-009507513-2005USA000352: US-009507513-2005USA000356: US-009507513-2005USA000357: US-009507513-2005USA000359: US-009507513-2005USA000389: US-009507513-2005USA000401: US-009507513-2005USA000413: US-009507513-2005USA000431: US-009507513-2005USA000465: US-009507513-2005USA000488: US-009507513-2005USA000493: US-009507513-2005USA000495: US-009507513-2005USA000498: US-009507513-2005USA000505: US-009507513-2005USA000510: US-009507513-2005USA000512: US-009507513-2005USA000614: US-009507513-2005USA000624: US-009507513-2005USA000735:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; incorrect product storage; Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug/reactions allergies.  On 22-AUG-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004548 and expiration date of 12-AUG-2020 (route of administration and anatomical location were not reported), for prophylaxis, which was stored in the range of 47.3 Fahrenheit degrees for 20 minutes. No previous temperature excursion was reported. No additional adverse event information provided.   Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: back in 2013, patient was vaccinated with a first dose of GARDASIL but he never completed the series then on 11-JUL-2019, patient got his 1st dose of GARDASIL 9; back in 2013, patient was vaccinated with a first dose of GARDASIL but he never completed the series then on 11-JUL-2019, patient got his 1st dose of GARDASIL 9; No adverse reaction reported; This spontaneous report was received from a currently 27 year old male patient concerning himself. Patient's concurrent conditions, medical history and concomitant therapies were not reported.     Sometime back in 2013, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis but he never completed the series. Then on 11-JUL-2019, patient got his 1st dose of the newer HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) for prophylaxis in an unknown "clinic" and he said he was told by the clinic that he should come back to the clinic in approximately 6 monlhs to receive his 2nd dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) series, which he had not done yet.   Patient said he was getting mixed information from the clinic who told him to get vaccinated wifh his 2nd dose 6 months from the 1st dose (administered on 11-JUL-2019) and then he would still need to get his 3rd dose, however, his unknown physician told him he would only need one more dose of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) to complete the series. No adverse reaction reported. No PQC involved. No additional AE information was given.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 21-OCT-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S004548, and expiration date 12-AUG-2020 for prophylaxis.  The administered dose of vaccine experienced the temperature excursion of 47.3 F degrees Fahrenheit for 20 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided; The patient was administered an improperly stored dose of PNEUMOVAX23 on 10/31/2019; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 31-OCT-2019, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number S004548 with expiration date in 12-AUG-2020 (route of administration, strength and anatomical location not reported).  The pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 47.3 degrees Fahrenheit (°F) for the time frame of 20 minutes. There was no previous temperature excursion and the call was because of a data logger.   No additional adverse effects reported.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:  manufacturerstate: ; manufacturercountry: ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA000302:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of PNEUMOVAX 23 on 10/17/2019; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-OCT-2019, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number S004548 with expiration date in 12-AUG-2020 (route of administration, strength and anatomical location not reported).  The pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 47.3 degrees Fahrenheit (°F) for the time frame of 20 minutes. There was no previous temperature excursion and the call was because of a data logger.   No additional adverse effects reported.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA000302:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; The patient was administered an improperly stored dose of PNEUMOVAX23 on 9/3/2019; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 03-SEP-2019, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number S004548 with expiration date in 12-AUG-2020 (route of administration, strength and anatomical location not reported).  The pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 47.3 degrees Fahrenheit (°F) for the time frame of 20 minutes. There was no previous temperature excursion and the call was because of a data logger.   No additional adverse effects reported.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA000302:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 12-DEC-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S004548, and expiration date 12-AUG-202 for prophylaxis.  The administered dose of vaccine experienced the temperature excursion of 47.3 F degrees Fahrenheit for 20 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; The patient received an imporperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not provided.   On 22-APR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dose for prophylaxis (strength, dose volume, frequency, route, lot # and expiration date were not provided). The vaccine underwent a temperature excursion at a temperature of 35°F during 8 hours as recorded by a data logger. There was no previous temperature excursions.
Sex: F
Vaccine: HPV9
Symptoms: Encephalitis, Fatigue, Headache
Clinical narrative: the patient had encephalitis, was on stomach steroids for 2 years and had fatigue so bad she could not get out of bed/ headache; This spontaneous report was received from a consumer, concerning a 20-year-old female patient who was also a daughter of a friend. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient developed encephalitis, had fatigue so bad she could not get out of bed, and also experienced headache (encephalitis). The patient was on "stomach" steroids for 2 years.   At the time of the report, the outcome of the event was unknown (also reported as the patient could be getting better or getting worse). The causal relationship between the suspect vaccine and the encephalitis was not reported.  Upon internal review, the event encephalitis was determined to be medically significant. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA000331:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a nurse referring to an unknown age patient. Information about concurrent condition, concomitant medication and medical history was not provided.     On 26-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dosage form, lot # S004548, expiration date 12-AUG-2020, therapy type: digital data logger; strength and route were unknown) for prophylaxis. The temperature was 47.3 Fahrenheit and time frame 20 minutes. There was no previous temperature excursion. The call was because of a data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PNEUMOVAX 23; This initial spontaneous report as received from a licensed practical nurse (LPN) referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 31-JUL-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S004548 with expiration date 12-AUG-2020, dose detail and route were not reported) for prophylaxis. The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)). The vaccine experienced improperly stored and was stored at 47.3 Fahrenheit degrees for 20 minutes. There was no previous temperature excursion. The call was because of a data logger involved. For pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)), the lot number was reported as S004548 and the serial number was not available. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; patient inadvertently received an expired dose of proquad; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not reported. The patient's and concomitant medication included sterile diluent ( MERCK STERILE DILUENT). On 01-MAY-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: rHA) (PROQUAD) lot # R026722, expiration date reported as 17-MAR-2020 for prophylaxis (strength, dose, frequency, route, were not reported) (expired product administered). The patient experienced no adverse event.The outcome of expired product administered and no adverse event was unknown.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000315:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received improperly stored dose of rotateq; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 29-APR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (therapy type: Digital Data Logger) (ROTATEQ) one dose for prophylaxis (strength, dose, route, lot/ batch number and expiry date were not reported (product storage error). The administered dose of the vaccine experienced a temperature excursion of 35 Fahrenheit for a time frame of 8 hours as recorded by a data logger. The vaccines had no previous temperature excursion. The patient experienced no adverse event. No product quality complaint was reported.  The outcome of product storage error and no adverse event was unknown.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000681: