chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Large red rashes below injection sites, specifically large below the left arm with both shots. Itchy, inflamed, sore.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient is complaining or sore arm with limited range of motion for more than one year after injection. She claims she has had treatment from her physician with no improvement.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Large red spot, slightly less than the size of a dollar bill. Received vaccine on Monday, was given prednisone from dr and by Friday the reaction had resolved.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Patient has/had about 9 quarter size red spots on arm between elbow and shoulder. No itching, a little swelling at spots, was checking to see if she had a fever and said would call back. Never got a return call.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Seizure like phenomena
Clinical narrative: Both my wife and daughter have been to the ER for symptoms that I have also now developed.  I have very low energy and seizure like spasms.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pain in extremity
Clinical narrative: ptx experinced very severe pain both arms, extreme headache, alsmost went to hospital
Age: 80.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: pt's daughter said that her mom was experiencing  excruciating pain after getting the pneumovax on her left arm. The injection site was red and swollen. The pain was sharp and she couldn't move her arm. The daughter had already given her Tylenol 1gm  twice and icepack when she called. I then instructed her to  also give ibuprofen 200x3 too. I called back next day. The situation was about the same. I then called back on day #3. The situation had gotten slightly better but her arm still couldn't move.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: October 2nd (Days after administration date 9/26/2020) patient woke up with welps on right arm along with redness and itching.  October 3rd. Welps are gone but large red circle with circumference of 2 and 1/2 inches + itching.  October 4th. Still red but feels better as time goes on.
Age: 33.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Pain
Clinical narrative: Fever, chills, aches, loss of appetite, severe pain and redness on right arm.  Symptoms of fever, chills and loss of appetite lasted from date of vaccine until 10/3/2020. Fatigue and aches is still present. Hives and swelling showed up on my right arm on 10/2/2020. Hives presented as stripes and by 10/3/2020 had combine into one large hive/rash on arm. Swelling and red rash still present on right arm. Rash starts on the outside of my arm and goes to the inside of arm.
Age: 33.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Fever, chills, aches, loss of appetite, severe pain and redness on right arm.  Symptoms of fever, chills and loss of appetite lasted from date of vaccine until 10/3/2020. Fatigue and aches is still present. Hives and swelling showed up on my right arm on 10/2/2020. Hives presented as stripes and by 10/3/2020 had combine into one large hive/rash on arm. Swelling and red rash still present on right arm. Rash starts on the outside of my arm and goes to the inside of arm.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Crying, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: A week or so after the vaccination, patient started with a rash on the top of his feet, it quickly spread to his forehead. Then about each day thereafter it spread like wildfire and into red raised bumps. His soft skin turned into what felt like a heavy grain sandpaper. He was crying all of the time, couldn't sleep, itched like crazy and seemed to be in pain. He also developed a fever for multiple days. The rash covered his entire body, even his groin area. This very adverse reaction looked exactly like measles and lasted three and a half weeks. It was absolutely horrid for a baby and parents to go through.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Rash papular, Skin disorder, Sleep disorder
Clinical narrative: A week or so after the vaccination, patient started with a rash on the top of his feet, it quickly spread to his forehead. Then about each day thereafter it spread like wildfire and into red raised bumps. His soft skin turned into what felt like a heavy grain sandpaper. He was crying all of the time, couldn't sleep, itched like crazy and seemed to be in pain. He also developed a fever for multiple days. The rash covered his entire body, even his groin area. This very adverse reaction looked exactly like measles and lasted three and a half weeks. It was absolutely horrid for a baby and parents to go through.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Rash, Vomiting
Clinical narrative: Vomit, swollen lips, rash
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Pallor, Syncope, Tremor
Clinical narrative: fainted w/some shaking pale and nauseous for a few minutes after  EMS was called but they chose not to go to ER
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: patient called 2 weeks after getting vaccine to say his arm continued to be extremely itchy. Advised patient to contact PCP, use topical and oral anti histamines.
Age: 10.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Headache, Heart rate increased, Pyrexia
Clinical narrative: Rapid hearth rate; fever; headache; Information has been received on 18-AUG-2020.  This spontaneous report was received from a nurse concerning a 10 year old male patient. The patient's medical history was not provided. The patient's concurrent conditions included allergy to cefalexin (KEFLEX). The patient's concomitant therapies included vitamins (unspecified)(FLINTSTONES MULTIVITAMIN).  On 15-OCT-2018 at 16:36, 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) lot # R011631 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 12-DEC-2020, intramuscular in the right deltoid for prophylaxis.  On the same day, the patient was also vaccinated with influenza virus split virion 3v vaccine inactivated(FLUZONE) lot # 46293DA, intramuscular in the left deltoid  for an unknown indication (expiration date was not provided). Three to four hours after immunization was given, the patient had fever (pyrexia), headache and rapid heart rate (heart rate increased). No medical tests were performed. The reporter stated that the events lasted between 12 to 24 hours. At the reporting time, the patient recovered from the adverse events.  The causality assessment between the occurrence of the events and the vaccines administration was not reported.  As of 24-SEP-2020, the nurse was unable to provide documentation without a name or date of birth. 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: R011631; expirationdate: 12-DEC-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 suggest a causal association with the device or device constituent
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Seizure
Clinical narrative: laid back on exam chair and upper body convulsions for about 10 seconds; felt dizzy; This spontaneous report was received from a consumer concerning an 18 year old non-pregnant female patient. At the time of vaccination, the patient was on ethinyl estradiol, ferrous fumarate, norethindrone acetate(BLISOVI FE) oral contraceptives. There was no information about the patient's concurrent conditions or pertinent medical history.    On 11-SEP-2019 at 11:40, 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) in the left arm (dose, frequency, route of administration, lot number and expiration date were not provided). On 11-SEP-2019 at 11:45, the patient felt dizzy (dizziness), laid back on exam chair and had upper body convulsions for about 10 seconds (seizure). The outcome of seizure and dizziness was reported as resolved.  The reporter did not provide any causality assessment.  As of 24-SEP-2020, no further information was available. 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.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 1.0
Sex: M
Vaccine: MMRV, DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13
Symptoms: Irritability, Pruritus, Rash, Rash erythematous, Rash vesicular
Clinical narrative: developed scattered erythematous papular rash on chest 10/1, no fever or other symptoms. rash worsened 10/2, spread to scalp, face, trunk, extremities, groin.   seen again in office 10/5, still with erythem papular rash with macular patches on trunk, extremities, groin, no longer has rash on face/scalp. slightly pruritic. still no other symptoms (fever, malaise, decreased appetite, etc)
Age: 1.0
Sex: M
Vaccine: MMRV, DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13
Symptoms: Scratch, Urticaria, Varicella post vaccine
Clinical narrative: developed scattered erythematous papular rash on chest 10/1, no fever or other symptoms. rash worsened 10/2, spread to scalp, face, trunk, extremities, groin.   seen again in office 10/5, still with erythem papular rash with macular patches on trunk, extremities, groin, no longer has rash on face/scalp. slightly pruritic. still no other symptoms (fever, malaise, decreased appetite, etc)
Age: 1.0
Sex: M
Vaccine: MMRV, DTAPIPVHIB, FLU4, HEPA, MMRV, PNC13
Symptoms: Rash macular, Rash papular, Rash pruritic
Clinical narrative: developed scattered erythematous papular rash on chest 10/1, no fever or other symptoms. rash worsened 10/2, spread to scalp, face, trunk, extremities, groin.   seen again in office 10/5, still with erythem papular rash with macular patches on trunk, extremities, groin, no longer has rash on face/scalp. slightly pruritic. still no other symptoms (fever, malaise, decreased appetite, etc)
Age: 63.0
Sex: M
Vaccine: FLU4, PPV, UNK
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: PATIENT CALLED THE PHARMACY AND SAID THAT HIS ARM  AT THE INJECTION SITE GOT SWOLLEN AND WAS SENSITIVE TO THE TOUCH
Age: 63.0
Sex: M
Vaccine: FLU4, PPV, UNK
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PATIENT CALLED THE PHARMACY AND SAID THAT HIS ARM  AT THE INJECTION SITE GOT SWOLLEN AND WAS SENSITIVE TO THE TOUCH
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive
Clinical narrative: cervical dysplasia; positive for HPV; Information has been received from a nurse practitioner via company representative concerning a female patient of unknown age. The patient's concurrent conditions, medical history, historical drugs, and concomitant medications were unknown.  On an unspecified date (reported as when the patient was 12), the patient was vaccinated with the three-dose series of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), administered intramuscularly, to prevent human papillomavirus (dose, anatomical location of administration, lot number and expiration date were not reported).  The nurse practitioner stated that a female patient came into the office on an unknown date and this patient tested positive for human papillomavirus and cervical dysplasia. The outcome for Human papillomavirus test positive and cervical dysplasia was unknown. The patient did not have an overdose.  The reporter did not provide the causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb vaccine (GARDASIL) administration and, Human papillomavirus test positive event and cervical dysplasia.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: positive for HPV; Information has been received from a nurse practitioner via a company representative concerning a female patient of unknown age. The patient's concurrent conditions, medical history, historical drugs, and concomitant medications were unknown.  On an unspecified date (reported as years ago), the patient was vaccinated with the three-dose series of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), administered intramuscularly, to prevent human papillomavirus (dose, anatomical location of administration, lot number, and expiration date were not reported).  The nurse practitioner stated that a female patient tested positive for human papillomavirus on an unspecified date. The outcome for the Human papillomavirus test positive event was unknown. The patient did not have an overdose.  The reporter did not provide the causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb vaccine (GARDASIL) administration and the Human papillomavirus test positive event.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administration; This spontaneous report was received from an unspecified reporter and refers to a currently 4-year old patient of an unknown gender. Information concerning the patient's past medical history, concurrent conditions, concomitant medications and historical drugs/allergies was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 milliliter, lot # T005406, expiration date 12-AUG-2021 (frequency and route of administration were not reported) as prophylaxis  . The improperly stored suspect vaccine experienced a temperature excursion of - 9.5 Celsius degrees (C) for 8 hours and 53 minutes, and -10.1 C for 6 hours and 40 minutes as recorded by a digital data logger. No previous temperature excursion was reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2009USA008533: US-009507513-2009USA008520: US-009507513-2009USA008398: US-009507513-2009USA008449: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008553: US-009507513-2009USA008555: US-009507513-2009USA008557: US-0095075132009USA008761:
Age: 0.83
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; PNEUMOVAX 23 instead of the intended PREVNAR 13 was administered to 10 month old child; 10 months old patient was administered Pneumovax 23; This spontaneous report was received from a practice manager on behalf of physician and refers to a 10-month-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 25-SEP-2020 at 16:45, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T010779, expiry date 30-JAN-2022 (dose, route of administration, anatomical location were not provided) for prophylaxis, instead of intended pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T010779; expirationdate: 30-JAN-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: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient should have been given MMR; A 46-year-old patient was vaccinated with PROQUAD; This spontaneous report has been received from a nurse, concerning to a 46 years-old female patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 23-SEP-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml subcutaneously (lot#: T015599, expiration date: 02-NOV-2021) for prophylaxis (product administered to patient of inappropriate age). It was reported that the patient should have been given Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) instead of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (wrong vaccine administered). No further information was provided.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Pharmacist is reporting that a patient received VARIVAX Intramuscular route instead of subcutaneous route.; This spontaneous report was received from a pharmacist, referring to a 29-year-old female patient. The patient's pertinent medical history, previous drug reactions, allergies and concomitant medications were not reported.   On 28-SEP-2020, at the age of 29-year-old the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX), by intramuscular route instead of subcutaneous route (incorrect route of product administration) (formulation, strength, vaccination scheme and anatomical site of vaccination were not reported; lot number T012551, which has been verified to be valid, expiration date reported and validated as 10-APR-2022) as prophylaxis.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: 1621931; expirationdate: 26-JAN-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1621931; expirationdate: 26-JAN-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the right upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1621931; expirationdate: 26-JAN-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 12-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1621931; expirationdate: 26-JAN-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1621931; expirationdate: 26-JAN-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the right upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: 1621931; expirationdate: 26-JAN-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 13-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)0.5 ml  in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S023475; expirationdate: 26-MAR-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp devicelotnumber: S023475; expirationdate: 26-MAR-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 01-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: S023475; expirationdate: 26-MAR-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-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; Sender's Comments:  US-009507513-2009USA006106:
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 10-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml in the left upper arm for prophylaxis (lot # S023475, expiration date on 26-MAR-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: S023475; expirationdate: 26-MAR-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; Sender's Comments:  US-009507513-2009USA006106: