chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: U
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: No additional AE reported.; administered to an adult; This spontaneous report was received from a medical assistant and refers to a 26-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 30-JUN-2021, the adult patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # T029104 has been verified to be a valid lot number, expiration date 23-FEB-2022, albumin status rHA (formulation, strength, frequency and route of administration were not reported) for prophylaxis. No other adverse event was reported.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles and other zoster-related conditions; shingles and other zoster-related conditions; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a patient (pt) of unknown age or gender. No information was provided regarding concomitant medications, concurrent conditions, or medical history. On or about 01-MAR-2014 (at 59 years old), the pt was administered zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route of administration, lot number and expiration date were not provided) by a healthcare provided (HCP) at a healthcare facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by an HCP for the following injuries resulting from the pt zoster vaccine live (ZOSTAVAX) use: shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). Outcome of the event was not provided. Causal relationship of the events was reported as related to zoster vaccine live (ZOSTAVAX).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no additional AE details are available; inadvertently gave a dose of Proquad to a 14 year old patient; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 01-JUL-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) lot # T034823, expiration date 11-APR-2022, at a dose of 0.5 milliliter for prophylaxis (dose #, route and anatomical location were not reported).
Sex: U
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: Vision Loss; other zoster-related conditions; other zoster-related conditions; This spontaneous report was received from a lawyer regarding a case in litigation and refers refers to a currently 76-year-old patient (pt) of unknown gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not provided) in a pharmacy by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: vision loss and other zoster-related conditions. The outcome of the events was unknown. The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the event of vision loss was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's reported; VARlVAX was administered to (1) patient shortly after the excursion; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 06-JUL-2021 at 09:39, shortly after the excursion, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose) lot number T029533 with expiration date on 01-SEP-2022 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis.   The administered dose of the vaccine experienced a temperature excursion of -12.7°C for 32 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. The patient was asymptomatic and no additional AE's or product quality complaint were reported.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Ill-defined disorder
Clinical narrative: hearing loss; other zoster-related conditions; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a patient (pt) of unknown age or gender. No information was provided regarding concomitant medications, concurrent conditions, or medical history. On or about 11-JUN-2014 (at 62 years old), the pt was administered zoster vaccine live (ZOSTAVAX) by a healthcare provided (HCP) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by an HCP for the following injuries resulting from the pt zoster vaccine live (ZOSTAVAX) use: hearing loss (deafness) and other zoster-related conditions (ill-defined disorder). Outcome of the event was not provided. Causal relationship of deafness was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, deafness was determined to be medically significant event.
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Exposure during pregnancy
Clinical narrative: bruising; she discovered after getting the vaccine that she was pregnant.; This spontaneous report has been received from a 29 years old female consumer referring to herself. The patient's medical history, concomitant medication and drug reactions or allergies were not provided. The patient's history of previous pregnancy and live births were not provided.  On an unknown date (reported as few years ago), the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength, route, lot# and expiration date unknown) for prophylaxis. The patient did not have any of the paperwork. The patient became pregnant with last menstrual period (LMP) of 30-APR-2021 and estimated date of delivery (EDD) of 04-FEB-2022. On 24-MAY-2021, the patient was vaccinated with the second dose in a 2 part series of varicella virus vaccine live (Oka/Merck) (VARIVAX) (injectable; dose, strength, lot# and expiration date unknown) for prophylaxis in the outer portion of the left arm (Exposure during pregnancy). After vaccination, the patient discovered she was pregnant. On the same day, the patient experienced bruising. The patient has not used any treatments for the pregnancy or the bruising. Until the reporting date (reported as so far), the patient was everything ok with the pregnant. The patient still had some bruising.  The causality between the event of bruising and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No PQC or additional AEs reported.; Caller reports expired dose of MMR II administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 02-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) 0.5 ml, intramuscularly, lot # S020161 was confirmed to be valid, expiration date 30-JUN-2021 (anatomical location was not reported) for prophylaxis. No additional adverse events were reported.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; administered on 11/2/2018 ( ...) Patient receive second dose on 4/22/2021, and the third dose on 6/23/2021.; This spontaneous report was received from a pharmacist and refers to a 19-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 02-NOV-2018, at the age of seventeen (conflicting information, also reported as at the age of sixteen), 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) injection, 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 22-APR-2021 and on 23-JUN-2021, the patient received respectively the second and the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported). The patients health care provider was requesting the patient to get a fourth dose, due to the patient being poor historian and moving from a different state without medical records. The pharmacist wanted to call to inquire if the interrupted schedule needed to be restarted. No additional adverse event was reported.
Age: 22.0
Sex: U
Vaccine: HEPA, HEPAB
Symptoms: Extra dose administered
Clinical narrative: No other information was available at the time of this call; VAQTA on 6/7/2021, and another VAQT A on 7/7/2021; Patient received one dose of TWINRIX and two doses of VAQTA; Patient received one dose of TWINRIX and two doses of VAQTA; Medical assistant calls and reports a patient inadvertently received a third dose of; This spontaneous report as received from a Medical assistant concerning a 23-year-old patient, gender unspecifed. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 21-FEB-2020, the patient was vaccinated with a dose of hepatitis a vaccine inact, hepatitis b vaccine rhbsag (yeast)(TWINRIX) (dose, dose number, route, Lot #, anatomical location and expiration date were not reported).   On 07-JUN-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (dose, dose number, route, Lot #, anatomical location and expiration date were not reported). The Medical assistant mentioned that the patient received a "third dose " (conflicting information was the secon dose of hepatitis a  vaccine, inactivated(VAQTA) reported ) of hepatitis a  vaccine, inactivated(VAQTA) lot # T040581, expiration date: 28-MAR-2022, reported as recently, on 07-JUL-2021 (dose, route, and  anatomical location were not reported).  No other information was available at the time of this call. No PQC reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T040581; expirationdate: 28-MAR-2022; 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: HEP, HEP
Symptoms: Underdose
Clinical narrative: pediatric dose of RECOMVIBAX HB was administered to an adult patient; pediatric dose of RECOMVIBAX HB was administered to an adult patient; This spontaneous report was received from a nurse referring to a 63-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-JUL-2021, the patient was accidentally vaccinated with a pediatric dose of thimerosal free hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # S022584, expiration date 31-OCT-2021) 0.5 mL, intramuscularly (IM) (frequency and anatomical location not reported) for prophylaxis (incorrect dose administered, product administered to patient of inappropriate age). combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-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
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: he has had no side effects or problems from the vaccine; expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a pharmacist referring to a 65-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 23-JUN-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S028601, expiration date S028601) 0.5 mL intramuscularly (IM) (frequency and anatomical location not reported) for prophylaxis. It was reported that the patient had no side effects or problem from the vaccine and that the vaccine had no temperature excursions and was always stored within the recommended temperature range.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No PQC or additional AEs reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 07-JUL-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T039322, expiration date 09-SEP-2022) 0.5 mL, intramuscularly (IM) for prophylaxis. The vaccine was stored at a temperature of -1 degrees Celsius (C) for 3 hours and 3 minutes. No previous temperature excursions were reported, and a digital data logger was involved. The patient did not experience any adverse event (AE) with the vaccine. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T039322; expirationdate: 09-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient is scheduled to receive the second dose of GARDASIL 9 approximately 4 years after receiving the first dose; No additional AE reported; This spontaneous report was received from a pharmacist and refers to an 18-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2017 (reported as approximately 4 years ago, at the age of 14 years old), 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) (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  At the reporting time, the patient did not finished vaccination schedule with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and was sheduled to receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). All three doses would not be given within a 1-year period (inappropriate schedule of product administration). No additional adverse event (AE) reported.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: received her first GARDASIL 9 vaccine at 36 years old, wants to complete the vaccination series; No PQC or additional AEs reported; This spontaneous report was received from a nurse referring to a female patient of unknown age and gender.      The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in 2018, when the patient was 36 years old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, frequency, lot # and expiration date not reported) for prophylaxis. At the time of the report, the patient wanted to complete the vaccination series. No adverse events were reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE reported; temperature excursion occurred on 6/3-4/2021/ improperly stored temperature excursion/ GARDASIL 9 lot BELOW 2C (-51.0C) for 14 hours; This spontaneous report was received from a physician referring to an 18-year-old patient whose gender was not specified. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, drug reactions, or allergies.  Between 03-JUN-2021 and 04-JUN-2021 (reported as "6/3-4/2021"), a temperature excursion involving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number 1659422, verified as valid for syringe formulation, with an expiration date reported and validated as 04-SEP-2022) occurred. The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was improperly stored at a temperature below 2 degrees Celsius (-51 degrees Celsius) for 14 hours. There was no previous temperature excursion, and a data logger was not involved. On 09-JUN-2019, the improperly stored vaccine was administered to the patient for prophylaxis (administered dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA008011: US-009507513-2107USA002641: US-009507513-2107USA002967: US-009507513-2107USA003379:
Sex: F
Vaccine: VARCEL
Symptoms: Heart transplant, Vaccination failure
Clinical narrative: Patient 1: found to be non-immune to VZV, despite receiving immunization at 11 years of age; none of the patients developed symptoms of vaccine related viral illness; This literature marketed report has been received from the authors of the published article, titled as stated below referring  a 11 year old female patient. The patient's concurrent conditions included dilated cardiomyopathy and heart failure. Information regarding the patient's pertinent medical history and concomitant medications was not provided by the authors.  On an unspecified date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (strength, dose, route of administration, frequency, lot number and expiration date were not provided).  On an unspecified date, at the age of 12 years the patient was going to underwent on an orthotopic heart transplantation (OTH) for her dilated cardiomyopathy and heart failure. Her pre-transplant infectious diseases evaluation was unremarkable except as that she was found to be immune to measles mumps and rubella but was not immune to varicella zoster virus (VZV) despite being vaccinated previously (vaccination failure). She was therefore given a second dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown), and eight days later she underwent the OTH surgery. It was reported that the patient did not develop any symptoms of vaccine related viral illness.   At the time of reporting, the outcome of vaccination failure was unknown.   The causal relationship between the vaccination with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) and vaccination failure was considered to be related.   This is one of three reports received from the same literature (2107USA005480, 2107USA005481 and 2107USA002514) Sender's Comments:  US-009507513-2107USA005480: US-009507513-2107USA005481:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles, included any and all of its sequelae; shingles, included any and all of its sequelae; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a 58-year-old female patient (pt). No information was provided regarding concomitant medications, concurrent conditions, or medical history. On or about 10-MAY-2017 (at 56 years old), the pt was administered zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route of administration, lot number and expiration date were not provided) by a healthcare provided (HCP) at a pharmacy as prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 11-JUL-2018, the pt was caused to suffer shingles (herpes zoster), including any and all of its sequelae (ill-defined disorder); the pt suffered severe personal injuries, pain, suffering, and emotional distress, and incurred substantial economic damages; which were all permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The pt required and/or would require more health care and services and incurred medical, health, incidental and related expenses. The pt was informed and believed and further alleges that she would in the future be required to obtain further medical and/or hospital care, attention, and services. Outcome of the events was not recovered. Causal relationship of the events reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster and ill-defined disorder to be disabling event.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: any and all of its sequelae; Shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 78 year old male patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 17-JUL-2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) as prophylaxis.  As a result of his receipt of zoster vaccine live (ZOSTAVAX), in August 2015 the patient was caused to suffer shingles including any and all of it's sequelae.  As a result of his receipt of zoster vaccine live (ZOSTAVAX), Plaintiff, has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages.  Defendants failed to exercise ordinary care in the designing, researching, manufacturing, marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control, and/or distribution of zoster vaccine live (ZOSTAVAX),  into interstate commerce in that Defendants knew or should have known that using zoster vaccine live (ZOSTAVAX), created a high risk of unreasonable, dangerous side effects, including Shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation for the lawyer, concerning a 67-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies were not provided. On 25-JUL-2017, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX), (lot number, expiration date, dosage information were not provided) at pharmacy. As a result of her receipt of Zoster Vaccine Live (ZOSTAVAX), on 28-JUL-2017, the patient was caused to suffer shingles including any and all of its sequelae, it has been caused to suffer dangerous side effects, including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physician pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the time of the report, the patient's outcome was not recovered, and the reporter considered the event of shingles to be related to suspect therapy. The event of shingles was considered as disabling by the reporter, since it caused permanent injuries.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Arthralgia, Hypermobility syndrome
Clinical narrative: loose joint; joint pain; This spontaneous report has been received from an unspecified reporter from healthcare office reported to her daughter of unknown age (reported as in college now). The patient's medical history, concomitant medication and drug reactions or allergies were not provided.   On an unknown date in 2017 (reported as possibly 4 years ago, when the patient was in high school), the patient was vaccinated Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiration date not provided) for prophylaxis. On an unknown date in 2017, around the same time, the patient was diagnosed with loose joint, joint pain. The patient had done every kind of therapy for years. The outcome for the events was unknown.  The causality between the events and the suspect vaccine was not provided.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided. No AE/ PQC reported at this time; improperly stored temperature excursion; This spontaneous report was received from a physician referring to a 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  From 03-JUN-2021 to 04-JUN-2021, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1659422 has been verified to be valid, expiration date not reported, but upon internal validation established as 04-SEP-2022) was under temperature excursion.   The storage temperature of the vaccine was below 2 degree Celsius (-51.0 C) for a time frame of 14 hours 0 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No data logger was involved. On 25-JUN-2021, the patient was vaccinated with the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose detail and route were not reported) for prophylaxis.  No adverse event or product quality complaint 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: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA002504: US-009507513-2106USA008011: US-009507513-2107USA003379: US-009507513-2107USA002967:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: no other adverse events; nurse called to report a temperature excursion on Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 16-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) 1 time dose, lot # T035408, expiration date 14-APR-2022 for prophylaxis (exact dose, dose #, route and anatomical location were not provided). The temperature excursion was 8.258 degrees Fahrenheit (F) for 15 minutes. There were no previous excursions reported. The digital data logger was involved. No signs or symptoms were reported. No other adverse events reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2106USA005098:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE reported at this time; temperature excursion occured; This spontaneous report was received from a physician referring to a 12-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 18-JUN-2021 (also reported as between 03-JUN-2021 and 04-JUN-2021), the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1659422, expiration date 04-SEP-2022), underwent a temperature excursion below 2 degrees Celsius (C), at -51.0 C) for 14 hours. No adverse event (AE) was experienced. No previous temperature excursions were reported, and a digital data logger was not involved.  This is one of several report provided by the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA002504: US-009507513-2107USA003379: US-009507513-2107USA002641:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE reported; Improperly stored and administered; This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 25-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number: T007230, expiration date: 27-FEB-2022; dose and route of administration not provided). The vaccine was stored in temperature below -50 degrees Celsius (-51 degrees Celsius) (also reported as below 2 degrees Celsius (-51 degrees Celsius)) for 14 hours. There was no previous temperature excursion. Digital data lodger was not involved.  No adverse event was reported.
Age: 35.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event
Clinical narrative: No additional AE reported; her first dose of GARDASIL 9 on 24JUN2021 and was given second dose pf GARDASIL 9 today, 08JUL2021; This spontaneous report as received from a registered nurse refers to a 35-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 24-JUN-2021, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  for prophylaxis (dose, dose number, route, Lot #, anatomical location and expiration date were not reported).On 08-JUL-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, lot #: T038529, (expiration date :11-MAR-2023). No additional adverse event reported. No product quality complaint 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: T038529; expirationdate: 11-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: U
Vaccine: VARZOS
Symptoms: Cardiac failure
Clinical narrative: heart failure; zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 78 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 15-SEP-2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, Plaintiff was treated by a doctor in nursing practice for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: heart failure and other zoster-related conditions. The outcome of the events was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, heart failure was determined to be a medically significant event.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/PQC reported at this time; improper storage of product in use; This spontaneous report was received from a physician referring to an 18-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in June 2021 (reported as between 03-JUN-2021 and 04-JUN-2021), the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1659422, expiration date 04-SEP-2022), underwent a temperature excursion below 2 degrees Celsius (C), at -51.0 C) for 14 hours. On 09-JUN-2021, the patient was vaccinated with the improperly stored vaccine (dose, frequency, route and anatomical location not reported) for prophylaxis. No adverse event (AE) was experienced. No previous temperature excursions were reported, and a digital data logger was not involved.  This is one of several report provided by the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA002504: US-009507513-2106USA008011: US-009507513-2107USA002641: US-009507513-2107USA002967:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her 1st two GARDASIL 9 vaccinations but will be out of the country when the 3rd dose is due and will not be returning until December; No additional AEs reported; This spontaneous report has been received from an unspecified reporter referring to a female patient of unknown age. The patient's medical history, concomitant medication and drug reactions or allergies were not provided.   On unknown dates, the patient received her first two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date unknown) for prophylaxis. The patient would be out of country when the third dose was due and would not be returned until December (Inappropriate schedule of product administration). No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; Varivax was administered on 09JUL2021 that expired on 21MAR2021; This spontaneous report was received from a pharmacist 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 09-JUL-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number S008692, expiration date 21-MAR-2021 (route of administration was not reported) for prophylaxis. No adverse event was reported. The vaccine had not had any temperature excursion.
Sex: M
Vaccine: MMR
Symptoms: Seroconversion test negative
Clinical narrative: received two doses of MMR II one year apart and when they tested him, he is not positive; This spontaneous report was received from a nurse referring to a 57-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with 2 doses measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dosage regimen, route of administration, lot number and expiration date were not reported) for prophylaxis, 1 year apart. When tested him, the patient remained negative (seroconversion test negative).      The outcome of seroconversion test negative was reported as not recovered. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the events was not reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported.; Vaccine administered after temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's historical drugs, historical conditions, and concomitant medications were not reported.  On 12-JUL-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number U007860 and expiration date 14-JAN-2022 were verified as valid) 2 milliliters (ml) taken orally for prophylaxis.   The vaccine was exposed to a temperature excursion; it was stored at 9.6 Centigrade degrees for 11 minutes, which was detected by digital data logger; with no previous temperature excursion
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: loss of vision; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently 81 or 82-year-old patient (pt.) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 11-MAR-2015, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles (herpes zoster). On an unspecified date, the pt. was subsequently treated by healthcare providers (HCP) for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX) herpes zoster and loss of vision (blindness). The pt. claimed damages as a result of injury to itself and economic losses. The outcome of the events was not reported. The reporter considered the events to be related to vaccination with zoster vaccine live (ZOSTAVAX).  Upon internal review, the event blindness was considered to be medically significant.
Age: 49.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; a 49 year old male patient received his second dose of GARDASIL 9 on 12JUL2021; This spontaneous report was received from a pharmacist, via company representative, referring to a 49-year-old male patient.  The patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies were not reported.  On 12-JUL-2021, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, vaccination scheme, lot number and expiration date were unknown by the reporter; route of administration and anatomical location of administration were not reported) as prophylaxis (product administered to patient of inappropriate age). The date of administration of the first dose was unknown. No additional adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure
Clinical narrative: Patient 2: was non-immune to VZV, despite receiving 2 doses previously as per the  recommended vaccine schedule at 1 and 4 years of age; none of the patients developed symptoms of vaccine related viral illness; This literature marketed report has been received from the authors of the published article, titled as stated below referring  a 16 year old female patient. The patient's concurrent conditions included 22q11.2 deletion, cardiomyopathy and chronic heart failure. Information regarding the patient's pertinent medical history and concomitant medications was not provided by the authors.  On an unspecified date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (strength, dose, route of administration, frequency, lot number and expiration date were not provided).  On an unspecified date, the patient was going to underwent on an orthotopic heart transplantation (OTH) for her cardiomyopathy and heart failure. Her pre-transplant infectious diseases evaluation was unremarkable, however her serology testing revealed that she was immune to measles but not immune for varicella zoster virus (VZV) despite being vaccinated previously (vaccination failure) as per the recommended vaccine schedule at 1 and 4 years of age. She therefore received a third dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) and seven days later she underwent to her OTH surgery. It was reported that the patient did not develop any symptoms of vaccine related viral illness.   At the time of reporting, the outcome of vaccination failure was unknown.   The causal relationship between the vaccination with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) and vaccination failure was considered to be related.   This is one of three reports received from the same literature (2107USA005480, 2107USA005481 and 2107USA002514); Sender's Comments:  US-009507513-2107USA002514:
Sex: F
Vaccine: FLUN4
Symptoms: Overdose
Clinical narrative: OVERDOSE; A spontaneous report has been received from a health professional. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced not applicable overdose (preferred term: Overdose).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Sex: F
Vaccine: FLUN4
Symptoms: Gastroenteritis
Clinical narrative: ACUTE GASTROENTERITIS; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced acute gastroenteritis (preferred term: Gastroenteritis).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Hyperhidrosis, Loss of consciousness
Clinical narrative: Loss of consciousness; Dizziness; Hyperhidrosis; This case was received via FDA VAERS (Reference number: 1321990) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery bypass graft (X4 vessels). Concurrent medical conditions included Coronary artery disease, Hypertension and Hyperkeratosis lenticularis perstans. Concomitant products included LISINOPRIL, METOPROLOL, ATORVASTATIN and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 16-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness) and HYPERHIDROSIS (Hyperhidrosis). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness) and HYPERHIDROSIS (Hyperhidrosis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 102/70 (Inconclusive) 102/70. On an unknown date, Heart rate: 54 (Inconclusive) 54. On an unknown date, Oxygen saturation: 95 percent (Inconclusive) 95 percent room air.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that he left site in no acute distress, awake alert oriented to person, place time and situation.  No treatment information was given.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.