chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  It was reported that temperature excursion was intermittent beginning 28-AUG-2020, but not previously reported, involving Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD).   On 11-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S031882 with expiration date of 07-APR-2021, 0.5 milliliter, for   It was stated that the vaccines underwent a temperature excursion of -14 degrees Celsius (°C) to -10 °C (max -9.5°C) for a total of 38 hours and 30 minutes. No previous temperature excursion occurred. The call was because of a "data logger".  ; Sender's Comments:  US-009507513-2008USA014788:
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Patient received 2 doses of Varivax and immunity level is not achieved; This spontaneous report as received from a physician via company representative, referring to a female patient of unknown age. The patient had no pertinent medical history neither drug reactions or allergies. Information regarding the patient's concurrent conditions and concomitant therapies was not provided. It was reported that the patient did not have previous varicella vaccinations and a titer was checked and was low.  On 11-JUN-2019, the patient was vaccinated with an initial booster of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously (dose, route of administration, vaccination scheme frequency, anatomical site of vaccination, lot number and expiration date were not reported) as prevention of varicella. Subsequently, another titer was drawn and remained low. Therefore, on 30-MAY-2020, the patient was vaccinated with a second booster of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously (dose, route of administration, vaccination scheme frequency, and anatomical site of vaccination were not reported; lot number S030244 as been verified to be valid, expiration date reported and validated as 26-SEP-2021).  On 22-AUG-2020, subsequent serologic testiong-titers was drawn after second booster of varicella virus vaccine live (oka/merck) (VARIVAX) and still remained low (antibody test negative). Additionally, it was reported that no treatment was given for the adverse event and the patient did not seek medical attention.  The outcome of antibody test negative was reported as not recovered. The causal relationship between the event and the suspect vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion for vaccine that were administered to patient after excursion occurred; This spontaneous report was received from a nurse assistant referring to a patient of unknown age and gender. The patient´s pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 19-AUG-2020, after excursion occurred, patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # T002846, expiration date on 23-JAN-2022, for prophylaxis. The temperature was -10.2°C during a time frame of 1 hour and 53 minutes. There was no previous temperature excursions and the call was because of a data logger.        This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869:
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; 4 month old patient getting 1 dose of GARDASIL 9 in error; This spontaneous report was received from a licensed practical nurse concerning a 4-month-old patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 25-AUG-2020, the patient was vaccinated with by error with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S023476 was internally confirmed as valid for with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date 26-03-2022) 1 dosage form for prophylaxis (strength, route, anatomical site of administration and vaccination schedule were not reported). The patient did not experienced any adverse event. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S023476; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.
Age: 0.33
Sex: U
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no adverse reactions; the child was administered GARDASIL or GARDASIL 9.; the child was administered GARDASIL or GARDASIL 9.; This spontaneous report was received from a consumer referring via a company representative to a 4 months old patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 24-AUG-2020, the patient was accidentally 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) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration and wrong vaccine administered) (reported as it was unknown by the customer whether the child was administered 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)). The patient was asymptomatic at this point and no adverse reactions had been observed.
Sex: U
Vaccine: HPV9, HPV9, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received the second dose 6 days after the first dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.     On 19-AUG-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)(strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. On 25-AUG-2020, 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) (lot# 1637641, expiration date not reported, but upon internal validation established as 16-FEB-2022; strength, dose, frequency route were not reported) for prophylaxis (inappropriate schedule of vaccine administered). No other AE 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); devicelotnumber: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses; This spontaneous report as received from a registered nurse refers 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 11-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHa)) (PROQUAD) 0.5 ml, lot # T009929 was confirmed to be valid, expiration date 16-SEP-2021 (route of administration and anatomical location were not reported) for prophylaxis.   Since 28-JUL-2020, the administered dose of vaccine was stored in the temperature of -14 degrees Celsius (C) to -10 degrees C (max -9.5 degrees C for 38 hours and 30 minutes. There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported.
Sex: F
Vaccine: HPV9
Symptoms: Antibody test, H1N1 influenza, Herpes zoster, Immediate post-injection reaction, Infectious mononucleosis
Clinical narrative: Pituitary tumor; Diagnosed with Polycystic ovary syndrome; diagnosed with  non-determined viral infection; Mononucleosis; shingles; H1N1 immediately following the first dose of Gardasil 9; This spontaneous report as received from a 13 year old female patient referring to herself. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not provided. Concomitant therapies included cabergoline. It was reported that the patient had zero health issued up until the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.   On 31-AUG-2010, 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) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Immediately, after vaccination, the patient presented H1N1 with a fever that lasted for 34 days.  On 13-OCT-2010, 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) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Then, on 30-AUG-2011, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.  On an unspecified date in January 2013, the patent experienced shingles (herpes zoster). On an unspecified date in September 2013, the  patient developed mononucleosis (infectious mononucleosis) and was symptomatic for 6 months. On an unspecified date in September 2014, the patient was diagnosed with a non determined viral infection which lasted for 6 months. On an unspecified date in May 2020, the patient was diagnosed with polycistic ovary syndrome.  On an unspecified date in June 2020, the patient had a pituitary tumour and received cabergoline as treatment. Antibody tests were performed but results were not reported. The outcome of pituitary tumour, polycystic ovaries, infectious mononucleosis, herpes zoster and h1n1 influenza was reported as not resolved. The outcome of viral infection was reported as resolved. The reporter considered h1n1 influenza, pituitary tumour, polycystic ovaries, viral infection, infectious mononucleosis and herpes zoster to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).     Upon internal review, pituitary tumour was determined to be medically significant.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2009USA000340:
Sex: F
Vaccine: HPV9
Symptoms: Pituitary tumour, Polycystic ovaries, Pyrexia, Viral infection
Clinical narrative: Pituitary tumor; Diagnosed with Polycystic ovary syndrome; diagnosed with  non-determined viral infection; Mononucleosis; shingles; H1N1 immediately following the first dose of Gardasil 9; This spontaneous report as received from a 13 year old female patient referring to herself. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not provided. Concomitant therapies included cabergoline. It was reported that the patient had zero health issued up until the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.   On 31-AUG-2010, 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) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Immediately, after vaccination, the patient presented H1N1 with a fever that lasted for 34 days.  On 13-OCT-2010, 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) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Then, on 30-AUG-2011, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.  On an unspecified date in January 2013, the patent experienced shingles (herpes zoster). On an unspecified date in September 2013, the  patient developed mononucleosis (infectious mononucleosis) and was symptomatic for 6 months. On an unspecified date in September 2014, the patient was diagnosed with a non determined viral infection which lasted for 6 months. On an unspecified date in May 2020, the patient was diagnosed with polycistic ovary syndrome.  On an unspecified date in June 2020, the patient had a pituitary tumour and received cabergoline as treatment. Antibody tests were performed but results were not reported. The outcome of pituitary tumour, polycystic ovaries, infectious mononucleosis, herpes zoster and h1n1 influenza was reported as not resolved. The outcome of viral infection was reported as resolved. The reporter considered h1n1 influenza, pituitary tumour, polycystic ovaries, viral infection, infectious mononucleosis and herpes zoster to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).     Upon internal review, pituitary tumour was determined to be medically significant.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2009USA000340:
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: patient has not experienced any adverse reactions; Pharmacist stated an expired PNEUMOVAX 23 vaccine was accidentally given to a patient; This spontaneous report was received from a pharmacist referring to a male patient in his 50's. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On 28-AUG-2020, the patient was accidentally vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S004548, expiration date 12-AUG-2020; dose detail, strength and route were not provided) in the left arm for prophylaxis (expired product administered).  The patient had not experienced any adverse reactions related to the expired vaccine administered. The outcome of expired product administered was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Herpes zoster; Postherpetic Neuralgia.; Information has been received regarding a case in litigation regarding a male patient (pt) of unknown age. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  On or around 11-SEP-2017, the pt was vaccinated zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot number and expiration date were not reported).  Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not presented prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Joint swelling, Papule, Rash
Clinical narrative: herpes zoster; knee swelling; rash outbreak with raised papules; numbness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 08-JUN-2015 , the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for routine health maintenance and fot its intended purpose: the prevention of shingles(herpes zoster). Shortly on an unknown date, the patient suffered a rash across her lower back, waist and right leg and was diagnosed with herpes zoster. It was also reported that subsequently, the patient suffered another rash outbreak with raised papules, knee swelling and numbness. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), symptoms have resulted in physical limitations not present prior vaccination; serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, los of enjoyment of life, phycical impairment and injury. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disabling.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE information provided.; administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 10-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T002848 which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) (dosage and frequency were unknown by the reporter; vaccination scheme, route of administration and anatomical site of injection were not reported), as prophylaxis. The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (10.56 F), during a time frame of 50 minutes, as recorded by a digital data logger. There was a previous temperature excursion of 6 F to 14 F (8.47 F), during a time frame of 30 minutes. No further adverse event information was provided.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000699: US-009507513-2009USA000710: US-009507513-2009USA000736: US-009507513-2009USA000749: US-009507513-2009USA000757: US-009507513-2009USA000762:
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Herpes zoster
Clinical narrative: shingles blisters; severe pain on her back; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 15-DEC-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered shingles blisters (herpes zoster) and severe pain on her back (back pain). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. She sustained severe and permanent personal injuries. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, she has not recovered from herpes zoster and back pain. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster and back pain were considered disabling events by the reporter.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a Medical assistant and refers to a 15 year old male patient.   Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 27-AUG-2020,  the patient was vaccinated with an improperly stored  varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024364, expiration date 06-AUG-2021  for prophylaxis (strength, dose, frequency, and route of administration were not reported).    The improperly stored suspect vaccine experienced a temperature of -14 degree Celsius (°C) to - 10 °C with an average of -13.04 °C  for 45 minutes. There was no previous temperature excursion.  The suspect vaccine was reconstituted with a properly stored merck sterile diluent.  The call was made due to a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA000716: US-009507513-2009USA002063:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 4-year-old 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 31-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S021326, which has been verified to be valid, expiration date reported and validated as 05-JAN-2021) as prophylaxis (product storage error). No further adverse event (AE) information provided.  The vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F (10.56F) for 50 minutes. There was a previous temperature excursion between 6F to 14F (8.47F) for 30 minutes, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000762:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE information provided.; HCP notes with patient details on administration of improperly stored vaccines.; This spontaneous report was received from a medical assistant, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.     On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number S021326, which has been verified to be valid, expiration date reported and validated as 05-JAN-2021), as prophylaxis (product storage error) (dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). Concomitant therapies included the sterile diluent (lot number and expiration date were not provided).  Additionally, it was reported that the suspect vaccines was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F for a time frame of 50 minutes, as recorded by the digital data logger. There was a previous temperature excursion reported as between 6 degrees F to 14 degrees F (8.47 degrees F) for a time frame of 30 minutes. No further adverse event (AE) information provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000710: US-009507513-2009USA000736: US-009507513-2009USA000749: US-009507513-2009USA000747: US-009507513-2009USA000757: US-009507513-2009USA000762: US-009507513-2009USA000826: US-009507513-2009USA000894: US-009507513-2009USA000971: US-009507513-2009USA000976: US-009507513-2009USA001003: US-009507513-2009USA001123: US-009507513-2009USA001194:
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Eyelid rash, Facial pain, Herpes zoster, Pain
Clinical narrative: She suffered pain that started on her left ear and radiated to her cheek and brow and developed a rash on her left eyelid. She was diagnosed with herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 10-DEC-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered pain that started on her left ear and radiated to her cheek and brow and developed a rash on her left eyelid. She was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. She sustained severe and permanent personal injuries. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, she has not recovered from herpes zoster. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered a disabling event by the reporter.
Age: 3.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Extra dose administered, No adverse event
Clinical narrative: patient is not currently experiencing signs/symptoms of a reaction; pacient receiving a dose of VARIVAX and PROQUAD; This spontaneous report was received from a registered nurse referring to a 3-years-old patient of an unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not provided.  On 01-SEP-2020, the patient was vaccinated with the first doses of varicella virus vaccine live (VARIVAX), lot# S024367, expiration date on 06-AUG-2021, in the right thigh, and measles, mumps, rubella and varicella virus vaccine live (PROQUAD) (albumin status rha) in the left thigh lot# S031704, expiration date on 06-APR-2021, both administered intramuscularly (strength and frequency were not reported) for prophylaxis (accidental overdose).   It was reported that the medication error did not occur due to product confusion. The nurse stated, "That a new nurse pulled the medication to be given;" and the medication error was likely due to the other nurse's inexperience with pediatric vaccines. Additionally, it was reported that patient was not currently experiencing signs/symptoms of a reaction to her knowledge (no adverse event). No additional details were provided.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reaction/allergy was not provided.      On 27-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (lot # S030093, expiration date 24-MAR-2021; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Previous temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. Data logger was involved.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reaction/allergy was not provided.  On 31-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T002848, expiration date 23-JAN-2022; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Previous temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. No product quality complaint (PQC) was identified. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000747: US-009507513-2009USA000777: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000710:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S035125, expiration date 04-NOV-2021; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Previous temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. No product quality complaint (PQC) was identified. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000749:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reaction/allergy was not provided.      On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T002848, expiration date 23-JAN-2022; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Previous temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. No product quality complaint (PQC) was identified. Data logger was involved.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; patient received Pneumonia Booster in 2017 and 2018; This spontaneous report has been received from a lawyer via a Plaintiff Fact Sheet and refers to an approximately 75-year-old male patient. In 2017 and 2018 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown) (reported as Pneumonia Booster vaccine) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The lawyer reported that there was no adverse reaction or side effect experienced.  This is one split report from a case in litigation (case# US-009507513-1902USA008606)
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; administration of improperly stored vaccines; This spontaneous report as received from a certified medical assistant refers to a 5-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella virus vaccine live rHA (PROQUAD) (dose and route of administration were not reported, lot # S021326, expiration date 05-JAN-2021), for prophylaxis. The vaccine was reconstituted with a sterile diluent (STERILE DILUENT). Previously, the vaccine had experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes.  The current temperature excursion was from 4 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Digital data logger was used. No adverse event was reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further AE information provided; administration of improperly stored vaccines; This spontaneous report as received from a certified medical assistant refers to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route of administration were not reported, lot # T002848, expiration date 23-JAN-2022), for prophylaxis. The vaccine was reconstituted with a sterile diluent (STERILE DILUENT). Previously, the vaccine had experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes.  The current temperature excursion was from 4 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Digital data logger was used. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000749:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX administered post temperature excursion.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported  On 18-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) injection, 0.5 milliliter (ml) once (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (vaccination scheme, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error). The administered dose of the vaccine was stored at a temperature of -9 degrees Celsius (C) to 8 C (-2.8 C), during a time frame of 5 hours and 2 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000677: US-009507513-2009USA001249: US-009507513-2009USA001303: US-009507513-2009USA001333: US-009507513-2009USA001367: US-009507513-2009USA001381:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported  On 06-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, by intramuscular route (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported), as routine vaccination (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number: S032591; expiration date: 16-AUG-2022). The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (13.6 F), during a time frame of 12 hours (multiple excursions); 15 F to 46 F (16.0 F), during a time frame of 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001275: US-009507513-2009USA001278: US-009507513-2009USA001283: US-009507513-2009USA001312: US-009507513-2009USA001399: US-009507513-2009USA001677: US-009507513-2009USA001301:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported. On 24-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) injection, 0.5 milliliter (ml) once (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (vaccination scheme, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error). The administered dose of the vaccine was stored at a temperature of -9 degrees Celsius (C) to 8 C (-2.8 C), during a time frame of 5 hours and 2 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001227: US-009507513-2009USA000677: US-009507513-2009USA001303: US-009507513-2009USA001333: US-009507513-2009USA001367: US-009507513-2009USA001381:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported  On 23-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) injection, by subcutaneous route (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported), as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot number: S032591; expiration date: 16-AUG-2022). The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (13.6 F), during a time frame of 12 hours (multiple excursions); 15 F to 46 F (16.0 F), during a time frame of 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001233: US-009507513-2009USA001275: US-009507513-2009USA001278: US-009507513-2009USA001283: US-009507513-2009USA001312: US-009507513-2009USA001399: US-009507513-2009USA001677: US-009507513-2009USA001301: US-009507513-2009USA001685: US-009507513-2009USA001688:
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 14-month-old patient of unknown gender. There was no information about patient's concurrent conditions or pertinent medical history.  On 07-SEP-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (VARIVAX) subcutaneously, lot number S032355 with expiration date 14-OCT-2021 (dose and anatomical location were not reported) as routine vaccination. The varicella virus vaccine live (VARIVAX) was reconstituted with properly stored sterile diluent. The varicella virus vaccine live (VARIVAX) was exposed from 6 degrees Fahrenheit to 14 degrees Fahrenheit during 12 hours; and from 15 degrees Fahrenheit to 46 degrees Fahrenheit during 30 minutes; no previous temperature excursion was reported, digital data logger was filled.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, referring to a 4-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 04-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX), subcutaneously (strength, dose, vaccination scheme frequency and anatomical site of vaccination were not reported; lot number S032355, which have been verified to be valid, expiration date reported and validated as 14-OCT-2021) as routine vaccination (product storage error). It was reported that the Sterile Diluent used to reconstitute the vaccine was properly stored (lot number S032591, which have been verified to be valid, expiration date reported and validated as 16-AUG-2022).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (13.6 degrees F) for 12 hours (multiple excursions); 15 degrees F to 46 degrees F (16.0 degrees F) for 30 minutes, as recorded by a data logger. There was no previous temperature excursion reported.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001233:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 14-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032355, expiration date 14-OCT-2021 as prophylaxis (Product storage error); which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT), lot # S032591, expiration date 16-AUG-2022 (dose, frequency and route of administration were not reported) (Product storage error).  The improperly stored suspect vaccine experienced a temperature excursion of 6 Fahrenheit degrees (6°F) to 14°F (average 13.6°F) for 12 hours (multiple excursions); and 15°F to 46°F ( average 16.0°F )  for 30 minutes. No previous temperature excursion was reported. The call was made due to a digital data logger.