chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient is off schedule from her first dose of GARDASIL 9 due to becoming pregnant after her first dose; patient is off schedule from her first dose of GARDASIL 9 due to becoming pregnant after her first dose; No additional AE/PQC reported; This spontaneous report was received from a nurse, concerning a female patient of unknown age. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  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) as prophylaxis (dose, frequency, strength, route of administration, anatomical injection site, lot number and expiration date were not provided). It was reported that the patient was off schedule from her first dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) due to she become pregnant after her first dose (inappropriate schedule of product administration and maternal exposure before pregnancy). The last menstrual period (LMP) and estimate day of delivery (EDD) were not provided. The pregnancy outcome was pending. It was reported that the adverse event was not a cancer event. Additionally, it was stated that the patient did not received the vaccine from the provider's office that reported it. The reporter did not want to provide any patient demographic information or any other information pertaining to case. No additional adverse event (AE)/ product quality complaint (PQC) reported. No further details provided.  The outcome of maternal exposure before pregnancy, no adverse event and inappropriate schedule of product administration was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Gastrointestinal pain, Headache, Loss of consciousness, Vomiting
Clinical narrative: 2 of the 5 patients immediately passed out; headache; upper GI pain; vomiting; This spontaneous report has been received from a nurse referring to a pediatric 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 an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T007024 with expiration date of 23-APR-2022 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis.    On an unknown date, the patient experienced headache, vomiting, gastrointestinal pain and passed out (loss of consciousness). The outcome of headache, vomiting, gastrointestinal pain and loss of consciousness was unknown. The reporter considered headache, vomiting and gastrointestinal pain to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  Upon internal review, loss of consciousness was determined to be medically significant.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA014407: US-009507513-2011USA014406: US-009507513-2011USA014408: US-009507513-2011USA014405:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; Information was received from a lawyer regarding a case in litigation involving a male patient of unknown age. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the vaccine the patient was suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of receiving zoster vaccine live (ZOSTAVAX) the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition. As a result of zoster vaccine live (ZOSTAVAX) the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had 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 causality of the events was considered to be related to zoster vaccine live (ZOSTAVAX). The events of herpes zoster and postherpetic neuralgia were considered as disabling.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported.; Nurse called to report a child received a dose of expired PROQUAD.; This spontaneous report was received from a registered nurse, referring to a child patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 23-OCT-2020, the patient received an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), for prophylaxis (formulation, strength, vaccination scheme and anatomical site of vaccination were not reported, lot number S012532, which has been verified to be valid, expiration date reported and validated as 20-OCT-2020) (expired product administered). As concomitant therapy, a sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were reported as unknown) was used to reconstitute the vaccine. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported.; Nurse reported adose of PROQUAD was administered to a patient on 11/18/2020 that had been involved in a temperature excursion that was not reported. Temperature: Unknown at this time, alarm went off but nurse is unable to read the data logger.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.      On 18-NOV-2020, the nurse reported a patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number T015261, which has been verified to be valid, the expiration date was reported and validated as 31-OCT-2021), at a dose of 0.5 milliliters (ml) as prophylaxis (dose number, vaccination scheme, and route of administration were not provided). Concomitant therapies included sterile diluent (lot number was not provided).  The vaccine had been involved in a temperature excursion that was not reported. Nurse had not finished the temperature excursion information at this time and will have to email it in at a later time, outcome was unknown if supported or not. Temperature was unknown at this time, alarm went off but nurse was unable to read the data logger at this time (product storage error). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued suffer ongoing injuries including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses as medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no additional AE reported; the patient did not come back until now to get her 2nd dose; This spontaneous report was received from a pharmacy tech and refers to a 21-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 28-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  The patient did not come back unit 24-NOV-2020 (reported as now) to got her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No additional adverse events reported.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; both MMR II and VARIVAX that had undergone temperature excursion were both administered to one patient; This spontaneous report was received from a nurse referring to a 1 year old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 17-NOV-2020, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form, both for prophylaxis. Route of administration, lot number and expiration date were not provided for either of the vaccines. No additional adverse events were reported.  The vaccines had a temperature excursion from 9 Celsius degrees (°C) to 25°C, with an average of 15°C for 6 hours. The vaccines had had previous temperature excursions. The call was due to digital data logger.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; a dose of PROQUAD was administered to a patient on 18-NOV-2020 that had been involved in a temperature excursion that was not reported; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, and previous drug reactions or allergies was not provided.   On 18-NOV-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 5 milliliter (strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T015261, which have been verified to be valid, expiration date reported and validated as 31-OCT-2021) as prophylaxis (product storage error). It was reported the use of sterile diluent to reconstitute the vaccine (dose, lot number and expiration date were not provided).  The temperature excursion was not reported, as the nurse had not finished the temperature excursion information and was unable to read the data logger at the reporting time. There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HCP reported an improperly stored administered ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 23-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dosage form, orally, lot number 1684163, expiration date 26-JUN-2021 for prophylaxis.  The vaccine had a temperature excursion from 0.92 Celsius degrees (°C) to 13.3°C for 43 hours and 45 minutes. There were no previous temperature excursions.
Sex: U
Vaccine: MMRV
Symptoms: Product preparation error
Clinical narrative: No additional AE; Caller reported that PROQUAD was administered after being reconstituted with a non Merck diluent; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 16-NOV-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 dosage form,  lot number T015599, expiration date 02-NOV-2021 (route of administration not provided) for prophylaxis was reconstituted with sterile water, lot number W56778, expiration date 01-FEB-2021, and was administered to the patient. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider at a medical office for shingles (herpes zoster). On an unknown date, the pt was admitted to the hospital due to the event. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster was unknown. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 67.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient vaccinated PNEUMOVAX23 on 01-JAN-2014 and with pneumococcal (PCV13) ON 11-DEC-2015; This spontaneous report was received from a 67 year-old male patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.   On 01-JAN-2013 the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). Therefore, it was reported that on 11-DEC-2015 another dose of pneumococcal 13v conj vaccine (manufacturer unknown) was administered to the patient (inappropriate schedule of product administration). No adverse event was reported.   This is one of two reports received from the same patient.; Sender's Comments:  1903USA006160:
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 61 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 23-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  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: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2010USA011251: US-009507513-2011USA015358:
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from an administrator via a field representative referring to a 44 years old male patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 23-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  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: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2011USA015357: US-009507513-2010USA011251:
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 83 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 26-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  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: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2010USA011251: US-009507513-2011USA015363: US-009507513-2011USA015358: US-009507513-2011USA015357:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Product distribution issue, Product storage error
Clinical narrative: Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 66 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 26-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  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: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2010USA011251: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2011USA015357: US-009507513-2011USA015358:
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Product distribution issue, Product storage error
Clinical narrative: Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 65 years old male patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 27-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  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: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2010USA011251: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2011USA015357: US-009507513-2011USA015358:
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Product distribution issue, Product storage error
Clinical narrative: Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 80 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 27-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  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: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2010USA011251: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2011USA015357: US-009507513-2011USA015358:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Product distribution issue, Product storage error
Clinical narrative: Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 66 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 27-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  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: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2010USA011251: US-009507513-2011USA015357: US-009507513-2011USA015358:
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: An MMR II vaccine was administered today after it had expired; This spontaneous report was received from a registered medical assistant and refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 24-NOV-2020, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031636, expiration date 01-NOV-2020 (exact dose, vaccination site and route of administration were not provided) for prophylaxis.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 23-NOV-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, for prophylaxis (lot number 1684163 was verified to be valid, expiration date reported and established as 26-JUN-2021), (dose, strength and frequency were not provided).  The administered dose of vaccine previously experienced a temperature excursion of 0.92 and 13.36 Celsius degrees for the time frame of 43 hours and 45 minutes. There was no previous temperature excursion. Digital Data Logger was not involved.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: administered: 04-FEB-2005, 30-OCT-2009; This spontaneous report was received from a physician and refers to a 65-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and other events were described in main case (US-009507513-1904USA006765).  On 04-FEB-2005, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient received another dose on 30-OCT-2009.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1904USA006765:
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Discomfort
Clinical narrative: I got diarrhea / diarrhea / had diarrhea ever since; am stll having discomfort; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix. In November 2020, 1 day after receiving Shingrix, the patient experienced diarrhea and discomfort. On an unknown date, the outcome of the diarrhea and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the diarrhea and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix over a week before the date of reporting (on Thursday) and on Friday experienced diarrhea. Less than 2 weeks after vaccination, the patient experienced discomfort. The reporter asked if it was common for it to last this long.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: fever; Nausea; injection site was sore / normal pain; mass at the injection site is smaller but still present / the mass / began to ache; not feeling well for 2-3 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site mass (1st dose received on 13th September 2020. please refer the case US2020226609).   On 12th November 2020, the patient received the 2nd dose of Shingrix. On 12th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site mass, feeling unwell and nausea. On 16th November 2020, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site mass, fever and nausea were unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site mass, feeling unwell, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was not feeling well for 2 to 3 days following the 2nd shot. The injection site was sore but not as bad as the first time. She described it as the normal pain associated with a vaccine administration. She also reported that the mass on her left began to ache after she received the 2nd vaccine in her right arm. The reporter consented to follow up. This case has been linked with case US2020226609, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   The reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had an allergic reaction to the first Shingrix shot. The patient asked if they should have the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had severe allergic reaction after the first shoot of Shingrix vaccine. The patient asked what was the percentage of coverage after just one shot.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Discomfort
Clinical narrative: got diarrhea; still having discomfort; This case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, 1 days after receiving Shingrix, the patient experienced diarrhea. In November 2020, the patient experienced discomfort. On an unknown date, the outcome of the diarrhea and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the diarrhea and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had diarrhea and discomfort. The reporter asked it common for it to last this long.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingrix about 3 months ago and experience a little bit of arm soreness.  The reporter did not want to provide the contact information for the pharmacy and did not want to answer any further questions.  The reporter did not want to provide personal address.  The reporter provided limited information.  For tolerances of 2nd dose, refer case US2020227529, reported by same reporter for same patient.   Sender's Comments: US-GLAXOSMITHKLINE-US2020227529: same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: R sided painful blistered rash; Blistered rash; This case was reported by a other health professional via interactive digital media and described the occurrence of painful rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced painful rash and blistery rash. On an unknown date, the outcome of the painful rash and blistery rash were unknown.   It was unknown if the reporter considered the painful rash and blistery rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. A week before the date of reporting, the patient received Shingrix. The patient called to the reporter and told that the patient had right sided painful blistered rash. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: developed a 10 cm area of redness on their arm.; This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient developed 10 cm area of redness on the arm, after receiving the 1st dose of Shingrix. The patient visited the emergency room. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: fever; severe shaking; This case was reported by a consumer via call center representative and described the occurrence of fever in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and tremor. On an unknown date, the outcome of the fever and tremor were unknown.   It was unknown if the reporter considered the fever and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had severe bad reaction of fever and tremor. The reporter asked if she should get the second dose of Shingrix and if she would experience the adverse events again.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Diarrhoea, Hyperhidrosis, Hypersomnia
Clinical narrative: so sick; can't move my arm after 3 days; vomiting; worst body ache; sweat / sweated; Arm is so painful; heart was racing; had diarrhea; shaking, shivering; every bone in her body aches; there's a big hard lump; lymph nodes are swollen; and slept from 12 PM until 8 AM Sunday; got 1 shot of adjuvant only then immediately; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 50-year-old patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date unknown) and (batch number 9G44C, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, the 2nd dose was an unknown dose. On an unknown date, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication. On an unknown date, the outcome of the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes and hypersomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 1st dose of shingrix on 11 September 2020 and second dose on 13th November 2020. Patient received only adjuvent of second dose which because HCP did not mixed it well and given without adjuvent which led inappropriate preparation of medication. It was reported that after that patient immediately got the second shot with adjuvent and antigen ( replacement dose). It was stated that patient experienced some event like patient was sick and after 3 days patient not able to move arm. Patient also experienced vomiting,worst body ache,sweat and very painful arm. Patient also reported that heart was racing at tha moment. On friday 13th November 2020 in night by 9 PM patient went for dinner and experienced vomiting and had diarrhea. On Saturday AM from 7 AM to 12 PM then lay down with shaking, shivering, sweated through her pajamas and slept from 12 PM until 8 AM Sunday. It was also reported that it was worse than the flu every bone in her body aches (getting slightly better now) also At injection site there was big hard lump and her lymph nodes are swollen. The reporter consented to follow up. The case was considered as medication error with harm.