chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Expired vaccine got administered to a patient; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-NOV-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # S009759, expiration date: 27-SEP-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no AE; ROTATEQ administered during temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-SEP-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1684163, expiration date was reported as 20-JUN-2021 but upon internal verification it was established as 26-JUN-2021 (exact dose was not provided) for prophylaxis.   On an unknown date, the administered dose had experienced a temperature excursion. No adverse events (AE) were reported.
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Injection site mass, Injection site pain
Clinical narrative: lump appeared near the injection site; extreme fatigue; it is sore at the injection site; This spontaneous report was received from a male patient, age reported as 55 (units not provided), reporting on himself. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not reported.    On 15-OCT-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), intramuscular, for prophylaxis (strength, dose, lot number, and expiration date were not reported).   On an unknown date in 2020, the patient experienced injection site pain and extreme fatigue. The patient reported that on approximately 05-NOV-2020 (reported as 3 weeks after the injection), a lump appeared near the injection site (injection site mass).   At the time of reporting, the outcome of injection site pain, fatigue and injection site mass was unknown.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This spontaneous report has been received from a nurse, regarding on a patient of unspecified age and gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history. On 10-NOV-2020, the patient was vaccinated with RECOMBIVAX HB as prophylaxis. The expiration date of the vaccine was reported as 06-NOV-2020 (expired product administered) (strength, dosage, route of administration, anatomical site of vaccination, vaccination scheme frequency, and lot number were not reported). Follow-up information has been received from a nurse on 16-NOV-2020. The patient's name and the patient's physician's name was provided. A valid lot number for RECOMBIVAX HB was provided as R004185 with expiration dated given and upon internal validation confirmed as 06-NOV-2020. It was noted that the product had no prior temperature excursions. No product quality complaint. This case was previously considered to be non-valid but upon receipt of follow-up information that included patient identifiers it was updated to be valid.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: 2 patient's received expired vaccines; This spontaneous report as received from a nurse referring to two patients of unknown age and gender. Information regarding patients concurrent  conditions, concomitant medications, drug allergies or reactions was not provided.     On 10-NOV-2020, the patients were vaccinated with a expired hepatitis a vaccine, inactivated(VAQTA) for prophylaxis, lot # S032056 which has been verified to be valid for hepatitis a vaccine, inactivated and expiration date 09-NOV-2020 (strength, dose, frequency, and administration route were not provided). The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 11.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient administered MMR II and PROQUAD concurrently; This spontaneous report was received from a Nurse and refers to a 11 years old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 10-NOV-2020,  the patient was vaccinated concurrently  with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter for prophylaxis and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter for prophylaxis  (route of administration, lot number and expiration date were not reported for any suspect therapy).
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: a dose of PEDVAXHIB had been administered after undergoing a temperature excursion; This spontaneous report has been received from a nurse, referring to a male patient of unknown age. The patient's current condition, historical condition and concomitant medication were not provided.  On 11-NOV-2020 the patient was vaccinated with an improperly stored dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T000885 with expiration date: 29-MAY-2022; 0.5 ml one time, strength and route were unknown) for prophylaxis (product storage error).   The vaccine was stored above 47 Fahrenheit (F) (50.0F) for 1 hour 21 minutes and 0 seconds. The vaccine was stored below 36F (33.8F) for 0 hours 23 minutes and 0 seconds. The previous temperature excursion included hours: 0; minutes: 21; seconds: 0; temp: 47.8F; hours: 0; minutes: 26; seconds: 0; temp: 49.5F; hours: 0; minutes: 9; seconds: 0; temp: 35F; hours: 0; minutes: 6; seconds: 0; temp: 35.2F; hours: 0; minutes: 8; seconds: 0; temp: 35F; hours: 0; minutes: 10; seconds: 0; temp: 35.2F. The digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA008842:
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other issues or adverse effects reported; Expired vaccine being administered; This spontaneous report was received from a licensed practical nurse and refers to a 65-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S030588, expiration date 20-OCT-2020 (dose, frequency, route of administration were not reported). No other issues or adverse effects were reported.
Age: 45.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no AE; the vaccine was given in error; This spontaneous report was received from a licensed practical nurse and refers to a 45-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 09-NOV-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) lot # T021485 and expiration date: 15-MAR-2022 (exact dose, frequency and route of administration were not reported) for prophylaxis. The nurse stated that the vaccine was given "in error". No adverse events (AE) were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no AE; temperature excursion 47 F to 77 F (54.9F); This spontaneous report as received from a licensed vocational nurse (LVN) and refers to a 4-year-old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-NOV-2020, the patient was vaccinated wit an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T015599, expiration date: 02-NOV-2021, 0.5 milliliter one time (injection site and route of administration were not provided) for prophylaxis.  The administered dose experienced the temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees F (54.9 F) for 1 hour and 25 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No other adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA008842: US-009507513-2011USA008619:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: vaccine was administered to a patient after temperature excursion occurred; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drugs reactions or allergies, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # 1660704, expiration date reported and validated as 20-MAR-2021) for prophylaxis. The vaccines were exposed to the following temperature excursion: 55 degrees Fahrenheit for 35 minutes as recorded by a data logger. There were no previous temperature excursions.   This case has been considered non-valid due to the lack of patient's identifiers.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no additional AE; proquad and varivax injection on the same day; This spontaneous report was received from a nurse and refers to a 1-year-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 12-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T016991 was verified to be valid, expiration date: 11-NOV-2021, albumin status: rHa) and on the same day he received varicella virus vaccine live (oka/merck) (VARIVAX) (lot#T003707 was verified to be valid, expiration date: 30-JAN-2022) both for prophylaxis (exact doses, dose number, routes of administration and anatomical location of aforementioned vaccines were not reported). Inappropriate dose of vaccine was administered. No additional adverse events were reported. The outcome of the events was unknown.
Sex: F
Vaccine: PPV
Symptoms: Total lung capacity decreased
Clinical narrative: lung capacity decreased to 30%; This spontaneous report was received from a pharmacist, concerning a currently 45-year-old female patient. The patient's concurrent conditions included amyotrophic lateral sclerosis (ALS). No information was provided regarding the patient's medical history, concomitant medications or previous drug allergies.  On an unspecified date in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (vaccination scheme, dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient's lung capacity was decreased to 30% (total lung capacity decreased).   At the time of the report, the patient had not recovered from total lung capacity decreased. The causal relationship between the event and the suspect therapy was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: The customer reported a patient received an MMRII vaccine that was reconstituted with expired STERILE DILUENT.; The customer reported a patient received an MMRII vaccine that was reconstituted with expired STERILE DILUENT.; No other AE reported.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 12-NOV-2020, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), as prophylaxis (formulation, strength, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), which was reconstituted (medication dilution) with 1 dose of an expired sterile diluent (MERCK STERILE DILUENT) (product preparation issue) (formulation, strength, frequency and route of administration were not reported; lot number S018816, which has been verified to be valid, expiration date reported and validated as 14-SEP-2020). The reporter stated that, the product had not had any temperature excursions. No additional adverse events were reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered; This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T012551, expiration date: 10-APR-2022; route of administration was not provided) 0.5 mL. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (1.7 degrees Celsius) for 1 hour and 11 minutes. There was no previous temperature excursion. Digital data lodger was involved.
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Occupational exposure to product, Syringe issue
Clinical narrative: skin burns a little.; The needle and hub separated after being drawn; the medication sprayed back in her face; the medication sprayed back in her face; This spontaneous report was received from a patient (nurse prescriber) of unknown age referring to herself. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.   On 16-NOV-2020, the patient had drawn up the medication measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot# and expiration date were not provided) to administer. The needle and hub separated after being drawn (needle issue) and the medication sprayed back in her face (exposure via skin contact and occupational exposure to product). She rinsed her eyes and washed her face. Her skin was burned a little (skin burning sensation). The outcome of skin burning sensation was reported as not recovered. The outcome of needle issue, exposure via skin contact and occupational exposure to product was unknown.    The causality assessment between the event of skin burning sensation and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: a patient received V ARIV AX via Intramuscular route instead of subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient concomitant medication, pertinent medical history and drug reactions or allergies were not provided.    On 16-NOV-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength was not provided; 1 dosage form, lot number T006345 and expiration date was 20-FEB-2022) intramuscularly for prophylaxis (incorrect route of product administration).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection
Clinical narrative: tested positive for a HPV strain not covered by the vaccine; This spontaneous report was received from a consumer and refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies 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) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (she was unsure which vaccine was given).  On an unknown date, at a later point in time, the patient was tested positive for a HPV strain not covered by the vaccine. The outcome of human papilloma virus test positive was unknown. There was no causality assessment provided by the reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE reported; PROQUAD was improperly stored and administered to a patient; This spontaneous report as received from a customer and refers to patient of an unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 16-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status RHA, lot # T023917 was confirmed to be valid, expiration date 01-JUL-2021 (however lot # was also reported as S023917, confilciting infomartion) (dose, route of administration, vaccination site were not specified) for prophylaxis. The administered dose underwent a temperature excursion of - 5.1 degrees Celsius for 63 hours and 15 minutes. There were no previous temperature excursions. Digital data logger was involved. No additional adverse effect was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE reported; PROQUAD was improperly stored and administered to a patient; This spontaneous report was received from a customer and refers to a patient of unknown age and gender. No information regarding the patient concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 16-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 1 dose, lot # T023917 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date: 09-JAN-2022 (route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 63 hours and 15 minutes in the temperature -5.1 degrees Celsius (C) on unknown date prior to administration. There was no previous temperature excursion. Digital Data Logger was involved.  There was no other adverse event reported. The outcome of medication error was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Improperly stored product administered; This spontaneous report was received from a physician  and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 17-NOV-2020,  the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) Lot # T025506, expiration date 23-JAN-2022, 0.5 milliliter for prophylaxis (route of administration not reported).     The improperly stored dose of the suspect vaccine experienced a temperature excursion of 22.8 degree fahrenheit (°F) for 13 hours and 25 minutes with a previous temperature excursion of 17.4 °F for 31 minutes and 30 seconds. The call was made due to a digital data logger. No adverse symptoms were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; PROQUAD was improperly stored then administered; 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 17-NOV-2020, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5ml with lot number T025506 with expiration date on 23-JAN-2020 for prophylaxis (route of administration was not reported). The administered dose of the vaccine experienced a temperature excursion 22.8 degrees F for 13 hours and 25 minutes.   There was no adverse effect reported.  This call was because of a data logger.   No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; improperly stored product administered; This spontaneous report was received from a physician  and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 17-NOV-2020,  the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) Lot # T010651, expiration date 22-SEP-2021, 0.5 milliliter for prophylaxis (route of administration not reported).     The improperly stored dose of the suspect vaccine experienced a temperature excursion of 22.8 degree fahrenheit (°F) for 13 hours and 25 minutes with a previous temperature excursion of 17.4 °F for 31 minutes and 30 seconds.  The call was made due to a digital data logger. No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; Improperly stored 68 F / administered vaccine; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T006347 was confirmed to be valid, expiration date 20-FEB-2022 (exact dose, route and site of administration were not provided) for prophylaxis. On 08-NOV-2020, the administered dose of vaccine was exposed to the temperature of 68 degrees Fahrenheit for 20 hours. There was no previous temperature excursion. The call was because of a digital data logger. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: F
Vaccine: HPV9
Symptoms: Device defective, Syringe issue, Underdose
Clinical narrative: She felt the "plunger was sticking". The plunger required the use of more force that usual to prime.; She felt the "plunger was sticking". The plunger required the use of more force that usual to prime.; The plunger required the use of more force that usual to prime and the product became "unstuck" after applying pressure which forced "most of the medication" to empty from the syringe.; The plunger required the use of more force that usual to prime and the product became "unstuck" after applying pressure which forced "most of the medication" to empty from the syringe.; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age who was also a nurse. Information regarding the patient's medical history,concurrent conditions and concomitant medications was not provided. IIt was reported that nurse removed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T007024 with expiration date 23-APR-2022, pre-filled syringe from refrigerator to prepare to administer to a patient, but felt the "plunger was sticking". Caller states the nurse reported the plunger required the use of more force that usual to prime and the product became "unstuck" after applying pressure which forced "most of the medication" to empty from the syringe. Caller also informed Agent that she spoke with nurse and she informed that she was not sure but she does believe that the product was dispensed on her because the product shot everywhere. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.42
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT; expired vaccine used; This spontaneous report was received from a nurse referring to a 17-month-old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 17-NOV-2020, the patient was vaccinated with  a dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) that had a labeled expiration of 01-NOV-2020, lot # R031628, 0.5 milliliter for prophylaxis (strength, vaccination scheme frequency and route of administration were not reported). The reporter stated the administered vaccine did not experience any temperature excursions. The reporter followed up with the patient's parent on 18-NOV-2020, and no additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Post herpetic neuralgia
Clinical narrative: vision loss; post-herpetic neuralgia; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for post-herpetic neuralgia and vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 will continue to suffer such losses, and damages in the future. The outcome of the event post-herpetic neuralgia and vision loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, vision loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration unknown) for the long-term prevention of shingles and/or zoster-related conditions at the medical office. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2010, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a physician for vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was determined to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: the vaccine was extremely painful; she became nauseous; felt like she was going to pass out; This spontaneous report was received from a nurse and refers to a not-pregnant female patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 03-NOV-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 milliliter, intramuscular (IM) (lot # and expiration date were not reported) for routine vaccination. She stated, that on that day, the vaccine was extremely painful, she became nauseous and felt like she was going to pass out. She did not seek medical attention an no treatment was given. On an unknown date in November 2020, the patient recovered from the events.   The causality between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the events of nauseous and felt like she was going to pass out was not provided. The causality between the suspect therapy and the vaccine was extremely painful was considered to be related.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse experiences; Administration of improperly stored vaccine; Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported.   On 03-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml (route of administration not reported) (Lot number T014309, expiration date: 24-APR-2022), as prophylaxis. The patient did not report any additional adverse experiences as a result of receiving the improperly stored vaccine.  The reporter stated that the vaccines were supposed to arrive on 27-OCT-2020 but it arrived on 29-OCT-2020. The caller stated that when she first received the vaccines, for some reason thought the current date of receipt was 27-OCT-2020 and not 29-OCT-2020 and that the product was received on time. The reporter immediately placed the product into the freezer. The product was received 2 days late.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA013581: US-009507513-2011USA013379: US-009507513-2011USA013163: US-009507513-2011USA013620: US-009507513-2011USA013293:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of Rotateq/expired 10 days ago; Did not experienced any adverse event; Information has been received from a consumer via a company representative concerning to a 2 month old patient. No medical history, concurrent condtions nor concomitant medications were reported. On an unknown date, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, route of administration, lot number and expiration date not reported) for prophylaxis. Even lot number and expiration date was not unknown, it was reported that had expired "10 days ago"). No adverse event was experienced.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients reported any additional adverse experiences as a result of receiving the improperly stored vaccine; Since the receipt of the late shipment, the vaccine has been administered to 6 patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 03-NOV-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T014309, expiration date: 24-APR-2022), as prophylaxis (product storage error). The patient did not report any additional adverse experiences as a result of receiving the improperly stored vaccine (no adverse event).  The reporter stated that they ordered the vaccines and they were supposed to come on 27-OCT-2020 but the product arrived on 29-OCT-2020. The caller stated that when she first received the vaccines, for some reason thought the current date of receipt was 27-OCT-2020 and not 29-OCT-2020 and that the product was received on time. The reporter immediately placed the product into the freezer. The product was received 2 days late.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA013851: US-009507513-2011USA013379: US-009507513-2011USA013163: US-009507513-2011USA013620: US-009507513-2011USA013200:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported.; patient received expired MMRII; This spontaneous report was received from a pharmacy technician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 12-OCT-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (strength, dose, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number R028382, expiration date reported as 03-OCT-2020, but upon internal validation it was established as 10-MAR-2020), as prophylaxis (expired product administered). No additional adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a patient received improperly stored vaccine; This spontaneous report was received from the administrator from the doctor's office, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 10-NOV-2020, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S027467, which have been verified to be valid, expiration date reported and validated as 02-MAR-2021) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 17.2 degrees Fahrenheit (F) for 1 hour and 30 minutes, as recorded by a data logger. The previous temperature excursion reported was 12.2 degrees F for 1 hour.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2011USA013420: US-009507513-2011USA013458: US-009507513-2011USA013844:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a patient received improperly stored vaccine; This spontaneous report was received from the administrator from the doctor's office, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 30-OCT-2020, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S027467, which have been verified to be valid, expiration date reported and validated as 02-MAR-2021) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 17.2 degrees Fahrenheit (F) for 1 hour and 30 minutes, as recorded by a data logger. The previous temperature excursion reported was 12.2 degrees F for 1 hour.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA013430: US-009507513-2011USA013420: US-009507513-2011USA013844:
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Skin rash; This spontaneous report was received from a physician via medical records and refers to a currently 74-year-old female patient. Information about the patient's concurrent conditions, medical history, concomitant medications were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) for prophylaxis (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported).  On an unknown date, the patient experienced an allergy reaction reported as skin rash (rash). The patient subsequently experienced herpes zoster, postherpetic neuralgia and other events while on therapy with zoster vaccine live (ZOSTAVAX) (case # 1904USA006786, case was part of a litigation process).  The outcome of rash was unknown.     The reporter considered rash to be related to varicella virus vaccine live (manufacturer unknown).     All available medical records will be provided upon request.; Sender's Comments:  US-009507513-1904USA006786:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Expired ROT ATEQ administered to patient.; This spontaneous report was received from an other health professional referring to a 2 month old male patient. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.     Between 10AM to 11AM on 20-NOV-2020, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent(ROTATEQ)  (dose, strength, and anatomical site of vaccination were not reported, lot # S006159, expiration date reported and validated as 10-NOV-2020) orally for prophylaxis (expired product administered). The outcome of expired product administered was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: she may of received an expired dose of MMR II; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, lot #, and expiration date were not reported) for prophylaxis.         The pharmacist inquired how far past the expiration date of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), was the dose still valid and if the patient would need another vaccination.