chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; an expired VAQTA was administered to a patient; This spontaneous report was received from a certified medical assistant (CMA) referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies was provided.  On 26-JUL-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) (0.5 milliliter (mL); lot # T014836 has been verified to be a valid lot number, expiration date reported and established as 17-JUL-2021; route and site of administration were not reported) for prophylaxis. The vaccine had no prior temperature excursions. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Patient was administered improperly stored PNEUMOVAX23 Prefilled Syringe on 07/27/2021; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies was provided.  On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (lot number T039322 has been verified to be a valid lot number, expiration date reported and established as 09-SEP-2022) (dose, route and anatomical location of administration were not reported) for prophylaxis (product storage error).   The involved vaccine was exposed to a temperature excursion of 65 grades Fahrenheit (F) for 8 hours, as recorded by a data logger. There was not a previous temperature excursion. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T039322; expirationdate: 09-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 1.92
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no known side effects; an improperly stored (supported) dose of PROQUAD was administered today; This spontaneous report was received from a medical assistant and refers to a 1-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T037956, expiration date 09-MAY-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly for the time frame of 1 hour and 15 minutes in the temperature of -12.4 degrees Celsius (C) and for 1 hour and 30 minutes in the temperature of -3.2 C. The previous temperature excursion was reported as time frame of 1 hour and 40 minutes in the temperature -8.6 C. Digital Data Logger was involved.  There were no known side effects.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/ PQC reported at this time; HCP called in to report a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 26-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T030944, expiration date 09-MAR-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 14 degrees Fahrenheit (F) and 46 degrees Fahrenheit (26.6 F) for the time frame of 3 hours and 20 minutes. There was no previous temperature excursion. Digital Data Logger was not involved.  No adverse event was reported.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no other AEs reported; Doses were administered via the intramuscular route versus subcutaneously; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. Information regarding patient's medical history, concomitant medications, drug allergies or reactions was not provided.   On 21-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T029534,has been verified to be valid, expiration date 01-SEP-2022, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # T016197 has been verified to be valid, expiration date 11-MAY-2022, both 1 injection (dosage form) intramuscularly for prophylaxis (strength, and dose  number were not provided) instead of subcutaneously (incorrect route of product administration). No adverse events were reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE or PQC reported at time of call; was inadvertently administered PROQUAD and MMRlI concomitantly; Information has been received from a physician referring to a 4-year-old patient of unknown gender. The patient's concomitant drug, pertinent medical history, drug reactions or allergies were not reported.  On 29-JUL-2021, the patient was inadvertently administered measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (0.5 ml, lot number: T030481, expiration date: 07-MAR-2022; strength and route were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 ml, lot number: T006166, expiration date: 19-FEB-2022; strength and route were not provided) concomitantly for prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse event was reported. The outcome of the event was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/PQCs reported; Incorrect product Storage; This spontaneous report was received from an office manager 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 19-JUL-2021, varicella virus vaccine live (oka/merck)(VARIVAX) lot number T041685, expiration date 10-DEC-2022 suffered a temperature excursion (product storage error) and the patient was vaccinated with one dose of it on 29-JUL-2021 (route of administration was not provided) for prophylaxis. No adverse events were reported.  The temperature excursion was of -11.4 degrees Celsius for 8 hours and 40 minutes. No other previous temperature excursions were detected. The call was due to digital data logger.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Incorrect product storage; This spontaneous report was received from an office manager referring to a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 28-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T013541, expiration date 17-OCT-2021 (dose and route of administration were not provided) for prophylaxis. No adverse events were reported.         The vaccine underwent a temperature excursion beteween -14 degrees Celsius (°C) and -10°C with an average of -13.6°C for 1 hour. There were no previous temeprature excursions. The call was due to digital data logger.  On 06-AUG-2021 a telephone call was received from the reported who stated that all the information concerning the case was given, thus no further information was available.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Injection site pain, Injection site rash, Pyrexia, Rash vesicular
Clinical narrative: Rashes that look like streaks, fever and soreness in her shoulder where he received the vaccine.; Caller stated that he is experiencing rashes that look like streaks/caller stated that the rashes have become bigger and "more filled in; Rashes that look like streaks, fever and soreness in her shoulder where he received the vaccine.; Rashes that look like streaks, fever and soreness in her shoulder where he received the vaccine.; 20 Mcg/5 ML; Sinus Issues; This spontaneous report has been received from a consumer referring on himself, a 20-years-old male patient. His concomitant medications included haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (reported as" hameophylis B") (manufacturer unknown) and a tetanus booster (manufacturer unknown). It was reported that he did not had any pertinent medical history, past drug reactions or allergies.  On approximately 01-AUG-2021 (reported as "3 days ago"), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 20 microgram per 0.5 milliliter (reported as "20 Mcg/.5 ML") (product use issue) at a route of administration reported as injection (dose number, vaccination scheme frequency, exact route and anatomical site of administration, lot number and expiration date were not provided) for sinus issues (product use in unapproved indication).  On 03-AUG-2021, the patient experienced rashes that looked like streaks (vaccination site streaking), fever (pyrexia), and soreness in his shoulder where he received the vaccine (vaccination site pain). It was stated that the rashes had become bigger and more filled in (rash vesicular).  It was reported that the patient had a blood work done but no information or details were provided. He sought for medical attention and had been in contact with his physician.  The outcome of the events was reported as not recovered at the time of this report. The causality assessment between the suspect therapy with all the events was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a dose of Proquad involved in a temperature excursion was administered to a patient today; This spontaneous report has been received from a nurse practitioner concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.  On 05-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) as prophylaxis (dose, route of administration, vaccine scheme and anatomical site of vaccination were not provided; lot number T03410 is an invalid lot number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD). Lot number T03410 does not match any Company product as confirmed by Lot Verification team, expiration date reported as 14-APR-2022).   The administered dose of the vaccine experienced a temperature excursion of 13 degrees Fahrenheit during a time frame of 45 minutes, which was detected by a data logger. The vaccine did not have any previous temperature excursion.  There was no additional adverse event (AE) reported.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccines administered; Information has been received from an administrator referring to a male patient (reported as baby boy). Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 22-JUL-2021,  the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, dose, frequency and route were unknown, lot # T022566, expiration date: 03-NOV-2022) that was improperly stored for prophylaxis (incorrect product storage).         The stored temperature was -1.4 degree Celsius.  The time frame was 1 hours There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2108USA001990: US-009507513-2108USA001815:
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccines administered.; This spontaneous report was received from an administrator referring to a male patient of unknown age (reported as baby boy). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-JUL-2021, the patient was vaccinated with improperly stored first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # T022566 was confirmed to be valid, expiration date: 03-NOV-2022; exact dose, route of administration, anatomical location were not reported) for prophylaxis.    The administered dose underwent a temperature excursion of -1.4 degree Celsius (C) for 1 hour and -26.4 C for 4 hours. There were no previous excursions reported. The digital data logger was involved.   This is one of several cases received from the same reporter; Sender's Comments:  US-009507513-2108USA001905: US-009507513-2108USA001815:
Sex: U
Vaccine: VARZOS
Symptoms: Myocardial infarction
Clinical narrative: heart attack; Initial information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a heart attack. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered/not resolved. The reporter considered the event related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of myocardial infarction was determined to be medically significant. The reporter considered the event of myocardial infarction to be disabling.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; a dose of expired MMRlI was administered to a patient; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 05-AUG-2021, the patient was vaccinated with an expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliters (ml) as prophylaxis (lot number S022753 which has been verified to be valid, expiration date reported and validated as 22-JUL-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Suffered multiple outbreaks of herpes zoster and postherpetic neuralgia; Suffered multiple outbreaks of herpes zoster and postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. It was also specified that the pt 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 herpes zoster and postherpetic neuralgia was not recovered. The reporter considered herpes zoster and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX). The events were cosnidered to be  disabling by the reporter.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received vaccine after improper storage; No other AE; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   It was reported the following vaccines were improperly stored and administered to multiple patients (dates of administration were unknown): varicella virus vaccine live (Oka/Merck) (VARIVAX); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (all strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The reporter did not know which vaccines the patient received. The reporter also was not sure about the previous temperature excursion details for the vaccines. No other adverse event was reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003205: US-009507513-2108USA003206: US-009507513-2108USA003207:
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received vaccine after improper storage; No other AE; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   It was reported the following vaccines were improperly stored and administered to multiple patients (dates of administration were unknown): varicella virus vaccine live (Oka/Merck) (VARIVAX); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (all strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The reporter did not know which vaccines the patient received. The reporter also was not sure about the previous temperature excursion details for the vaccines. No other adverse event was reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003202: US-009507513-2108USA003206: US-009507513-2108USA003207:
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received vaccine after improper storage; No other AE; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   It was reported the following vaccines were improperly stored and administered to multiple patients (dates of administration were unknown): varicella virus vaccine live (Oka/Merck) (VARIVAX); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (all strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The reporter did not know which vaccines the patient received. The reporter also was not sure about the previous temperature excursion details for the vaccines. No other adverse event was reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003202: US-009507513-2108USA003205: US-009507513-2108USA003207:
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received vaccine after improper storage; No other AE; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   It was reported the following vaccines were improperly stored and administered to multiple patients (dates of administration were unknown): varicella virus vaccine live (Oka/Merck) (VARIVAX); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (all strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The reporter did not know which vaccines the patient received. The reporter also was not sure about the previous temperature excursion details for the vaccines. No other adverse event was reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003202: US-009507513-2108USA003205: US-009507513-2108USA003206:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; The patient was accidently administered MMR II via the intramuscular route not the subcutaneous route; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter (strength, lot number and expiration date were not reported) accidently via the intramuscular route not the subcutaneous route for prophylaxis (incorrect route of product administration). No additional adverse event was reported. The outcome of the event was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. There were no previous excursions reported. No additional adverse effect was reported.   This is one of several cases received from the same reporter; Sender's Comments:  US-009507513-2108USA003333: US-009507513-2108USA003334: US-009507513-2108USA003335: US-009507513-2108USA003332: US-009507513-2108USA003331:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No side effects to report; Per nurse a patient was given an expired VAQTA on 8/9/2021.; This spontaneous repot was received from a certified medical assistant (also reported as a nurse) and refers to a patient of unknown age and gender. No information regarding the patent's medical history, concurrent conditions or concomitant medications was provided.  On 09-AUG-2021, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # T014836 was confirmed to be valid, expiration date 17-JUL-2021, (dose, route and site of administration were not reported) for prophylaxis. No side effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A dose of GARDASIL 9 that experienced a temperature excursion was administered to a patient on 9 AUG 2021.; This spontaneous repot was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patent's medical history, concurrent conditions or concomitant medications was provided.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T029522 was confirmed to be valid, expiration date 13-MAR-2023, (route and site of administration were not reported) for prophylaxis.  The administered dose was exposed to the temperature of -4.8 degrees Celsius for 20 minutes. It was reported that there was no previous temperature excursion. No additional adverse event was reported. 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: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: HPV9
Symptoms: Breast mass
Clinical narrative: On 28APR2021, the patient's mother noticed a lump on her son's breast; This spontaneous repot was received from a licensed practical nurse via a company representative and refers to a 11-year-old male patient. No information regarding the patent's medical history, concurrent conditions or concomitant medications was provided.  On 15-MAR-2021, 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) for prophylaxis (dose, lot #, expiration date, route and site of administration were not reported).  On 28-APR-2021, the patient's mother noticed a lump on her son's breast. On an unspecified date in 2021, an ultrasound was completed, and the results were unremarkable. Action taken with the suspect vaccine was withdrawn, reported as the patient will not be receiving the second dose. The outcome of the event was unknown.  The causality assessment between the aforementioned event and the suspect vaccine was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003248: US-009507513-2108USA003333: US-009507513-2108USA003334: US-009507513-2108USA003335: US-009507513-2108USA003332:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003331: US-009507513-2108USA003248: US-009507513-2108USA003333: US-009507513-2108USA003334: US-009507513-2108USA003335:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003248: US-009507513-2108USA003331: US-009507513-2108USA003332: US-009507513-2108USA003334: US-009507513-2108USA003335:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003333: US-009507513-2108USA003248: US-009507513-2108USA003331: US-009507513-2108USA003332: US-009507513-2108USA003335:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003334: US-009507513-2108USA003248: US-009507513-2108USA003331: US-009507513-2108USA003332: US-009507513-2108USA003333:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Expired ROTATEQ was administered; no additional AE; This initial spontaneous report was from a medical assistant regarding a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1691140, 2 milliliter, oral, for prophylaxis (strength was not reported). The product had no prior temperature excursions. No additional events reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events; child should have received second dose of PROQUAD; This spontaneous report was received from am office manager, referring to a 15 month old patient.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On 18-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S0239311, expiration date 04-DEC-2021, for prophylaxis (strength, route and dosage schedule not reported). On 04-AUG-2021, the patient was vaccinated with another dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHa) lot # T028297, expiration date 16-FEB-2020, for prophylaxis.    No additional adverse events reported.  Lot number S0239311 has been determined to be an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE/PQC reported; PROQUAD was inadvertently given to an 18 year old patient; This spontaneous report was received from a medical assistant referring to an 18-year-old patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 11-AUG-2021, the patient was inadvertently vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # T032145 with an expiration date on 20-MAR-2022) for prophylaxis  (strength, dose, frequency, route of administration, lot #, and expiration date were not reported) at the age of 18 years old (product administered to patient of inappropriate age).  No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Herpes zoster, Immune system disorder, Nervous system disorder, Pneumonia
Clinical narrative: bruising; other serious neurological problems; issues with immune system; pneumonia; herpes zoster/ rashes; Information has been received regarding a case in litigation from a lawyer and referred to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster, rashes, bruising, other serious neurological problems, issues with immune system and pneumonia. 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 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 the patient's condition. As a result of the manufacturer, 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 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 herpes zoster/rashes, bruising, other serious neurological problems, issues with immune system and pneumonia was considered as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.   The lawyer considered all the events herpes zoster, bruising, other serious neurological problems, issues with immune system and pneumonia to be disability. Other serious neurological problems was considered to be medically significant by the lawyer. Upon internal review, pneumonia was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: bruising; other serious neurological problems; issues with immune system; pneumonia; herpes zoster/ rashes; Information has been received regarding a case in litigation from a lawyer and referred to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster, rashes, bruising, other serious neurological problems, issues with immune system and pneumonia. 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 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 the patient's condition. As a result of the manufacturer, 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 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 herpes zoster/rashes, bruising, other serious neurological problems, issues with immune system and pneumonia was considered as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.   The lawyer considered all the events herpes zoster, bruising, other serious neurological problems, issues with immune system and pneumonia to be disability. Other serious neurological problems was considered to be medically significant by the lawyer. Upon internal review, pneumonia was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; MMR II was improperly stored and administered.; This spontaneous report has been received from a nurse practitioner (also reported as nurse prescriber) referring to a patient of unknown age and unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 23-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) for prophylaxis (lot # S037497, expiration date 20-NOV-2021; strength, dose, and route were not reported). The product was stored at 55 Fahrenheit (F) from 08-JUN-2021 to 03-AUG-2021, the reporter was unable to provide total time out of range (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; MMR II was improperly stored and administered; This spontaneous report has been received from a nurse practitioner (also reported as nurse prescriber) referring to a patient of unknown age and unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 26-JUL-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) for prophylaxis (lot # T006166, expiration date 19-FEB-2022; strength, dose, and route were not reported). The product was stored at 55 Fahrenheit (F) from 08-JUN-2021 to 03-AUG-2021, the reporter was unable to provide total time out of range (product storage error). There was no previous temperature excursion. No additional adverse event was reported.