chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-JUN-2021, the patient was vaccinated with one of following incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported) for prophylaxis: lot # T024283 has been verified to be a valid lot number, expiration date reported as 14-JUL-2022, but upon internal validation established as 15-JUL-2022; lot # T032930 has been verified to be a valid lot number, expiration date reported as 27-SEP-2022, but upon internal validation established as 28-SEP-2022 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 09-JUN-2021, the patient was vaccinated with one of following incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported) for prophylaxis: lot # T024283 has been verified to be a valid lot number, expiration date reported as 14-JUL-2022, but upon internal validation established as 15-JUL-2022; lot # T032930 has been verified to be a valid lot number, expiration date reported as 27-SEP-2022, but upon internal validation established as 28-SEP-2022 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 11-JUN-2021, the patient was vaccinated with one of following incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported) for prophylaxis: lot # T024283 has been verified to be a valid lot number, expiration date reported as 14-JUL-2022, but upon internal validation established as 15-JUL-2022; lot # T032930 has been verified to be a valid lot number, expiration date reported as 27-SEP-2022, but upon internal validation established as 28-SEP-2022 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 7.3 Fahrenheit (F) (6 F to 14 F) for 10 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: numbness over 60%; Information has been received from a other health professional, referring to a currently 29 years old female patient. The patient's medical history included asthma, depression, high cholesterol, liver disease, paraesthesia and fatigue. The current condition included multiple sclerosis. Information of concomitant therapy was not provided.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.         On an unknown date, the patient experienced numbness over 60%. The outcome of the event was unknown. The relationship between suspect therapy and the event was not reported.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No other AE.; GARDASIL on 9/19/2012 at the age of 12. The patient received the second dose of GARDASIL on 5/13/14 at the age of 13; This spontaneous report was received from a pharmacist and refers to a 13-year-old patient of unknown gender.There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-SEP-2012, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). On 13-MAY-2014, the patient received second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). Both doses were administered for prophylaxis. The reporter stated that the patient only received 2 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). No additional adverse event was reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional AEs reported; reconstituted with expired diluent; This spontaneous report was received from a pharmacist and 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 16-JUN-2021, the patient was vaccinated with dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#S029534, an invalid lot number, expiration date: 20-SEP-2022 (formulation, strength, dose, frequency, route of administration were not reported) reconstituted in expired sterile diluent, 0.5 ml (lot # N026989, expiration date: 13-JUL-2018) (formulation, strength, frequency, route of administration were not reported), both for prophylaxis (expired product administered). No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product temperature excursion issue
Clinical narrative: no other adverse events; nurse called to report a temperature excursion on Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 16-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) 1 time dose, lot # T035408, expiration date 14-APR-2022 for prophylaxis (exact dose, dose #, route and anatomical location were not provided). The temperature excursion was 8.258 degrees Fahrenheit (F) for 15 minutes. There were no previous excursions reported. The digital data logger was involved. No signs or symptoms were reported. No other adverse events reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2107USA002799:
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Nurse reports the administration of expired PNEUMOVAX 23.; This spontaneous report has been received from a nurse, referring to an unknown age and gender patient, Information about the patient's pertinent medical history, previous drug reactions or allergies and concomitant medication were unknown.  On 18-JUNE-2021 an expired Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) at a dose of 0.5 milliliter (route of administration, vaccination scheme and anatomical location were not provided; lot number S029542 has been verified to be a valid lot number, expiration date reported and established as 10-JUN-2021), as prophylaxis. No additional adverse event was reported).  No Additional adverse event was reported.  This case was considered as non-valid case due to lack of patient's identifiers. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; Varivax intramuscular instead of subcutaneous route today; This spontaneous report was received from a pharmacist referring to a 24 years old female patient. The patient's pertinent medical history, concomitant drugs and drug allergies were reported unknown.  On 18-JUN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength, lot number and expiration date were not reported) intramuscularly instead of subcutaneously for prophylaxis (subcutaneous injection formulation administered by other route). No additional adverse event was reported. Medical attention was not sought, and there was no intervention performed at this time. Permission was given to follow-up with the reporter if necessary.
Age: 1.17
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; temperature excursion where vaccine administeres to patient; This spontaneous report was received from a medical assistant, via Pfizer, referring to an unspecified patient of unknown age and gender. Relevant medical history, drug reactions or allergies and concomitant medication for the patients involved were not reported.  On 15-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number: S02A919 (expiration date: 16-SEP-2021) 0.5 milliliter, subcutaneous in the right thigh, for prophylaxis.  This is a non-valid case due to the lack of a patient identifier.  Follow-up information has been received from the medical assistant on 13-JUL-2021. The patient was 14 months old at the time of the vaccination. The lot number of varicella virus vaccine live (Oka/Merck) (VARIVAX) has been updated and verified as S028919, expiration date 16-SEP-2021.  On 08-JUN-2021, at 10 a.m., the products varicella virus vaccine live (Oka/Merck) (VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), and hepatitis A vaccine were exposed to -2.2 degrees Fahrenheit. On the same day, at 4 p.m., the temperature was found to be 60 degrees Fahrenheit. The reporter stated that their office was closed on 09-JUN-2021 (reported as "on Wednesdays"), however, on 10-JUN-2021 (reported as "Thursday morning"), the temperature was found to be 3.2 degrees Fahrenheit.  On 15-JUN-2021, the patient was also vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (vaccine scheme, dose, route of administration, anatomical site of vaccination were not provided; lot number S032825 has been verified as valid, expiration date 16-OCT-2021) as prophylaxis. Other suspect vaccine included hepatitis A vaccine (dose, indication, route of administration, anatomical site of vaccination, lot number vaccine scheme and expiration date were not provided).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion that occurred on MMR II which underwent temperature excursion was administered to multiple patients; This spontaneous report was received from a physician and an healthcare business professional, concerning a patient of unknown age and gender. No information was provided regarding the patients' pertinent medical history, current conditions, concomitant medications and previous drug reactions or allergies.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) lot number S039313, expiration date 04-DEC-2021, as prophylaxis (dose, vaccination scheme frequency, route and anatomical location of administration were not reported).  The administered vaccine experienced two temperature excursion of 9.5 grades Celsius (C) during a time frame of 0 hour, 40 minutes and 0 seconds, as recorded by data logger(product storage error). There was not a previous temperature excursion. No additional adverse events were reported.   This is one of 3 reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Product temperature excursion issue
Clinical narrative: No additional AE's; temperature excursion that occurred on MMR II which underwent temperature excursion was administered to multiple patients; This spontaneous report was received from a physician and an healthcare business professional, concerning a patient of unknown age and gender. No information was provided regarding the patients' pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies.  On 17-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) lot number S039313, expiration date 04-DEC-2021, as prophylaxis (dose, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).  The administered vaccine experienced two temperature excursion of 9.5 grades Celsius (C) during a time frame of 0 hour, 40 minutes and 0 seconds, as recorded by data logger. There was not a previous temperature excursion. No additional adverse events were reported.   This is one of 3 reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: A patient received an expired MMR II; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender.   The patient pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S015962, expiration date: 23-MAY-2021) 1 dose for prophylaxis.
Sex: M
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No other AE  reported; Administration of an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age (reported as 7 (units not provided)). The patient pertinent medical history, concurrent conditions and concomitant therapies were not reported.    On 21-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # T018275, expiration date: 23-NOV-2021) 0.5 ml dose, one time for prophylaxis. No other adverse event was reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported.         The albumin status for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) has been verified to be rHA (recombinant human albumin).
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: no additional adverse event reported; pnuemovax 23 following a temerature excursion; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 20-JUN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S034299, expiration date 01-JUL-2021 for prophylaxis (dose #, exact dose, route and anatomical location were not reported). The temperature excursion was above 48 degrees Fahrenheit for 24 hours and 27.9 F degrees Fahrenheit for 24 hours. There were no previous excursions reported. The digital data logger was not involved. No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse; dose was administered via intramuscular route instead of subcutaneous route; This spontaneous report was received from a pharmacist who was reporting on 26-year-old female patient. There was no information about the patients concurrent conditions, medical history and drug reactions or allergies provided. Concomitant therapies included spironolactone, levocetirizine, ethinylestradiol, norgestimate (TRI-PREVIFEM), bupropion hydrochloride (BUPROPION XL) and montelukast sodium (SINGULAIR). On the vaccination day the patient also received hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (upon internal validation Lot# LG5RN was not valid for company product., expiration date was reported20-AUG-2022).  On 11-JUN-2021, the patient was vaccinated with dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II), 0.5 milliliter in the left arm, (lot number S035355 was confirmed to be valid; expiration date 05-NOV-2021; strength, was not provided) for prophylaxis. The vaccine was administered via intramuscular route instead of subcutaneous route (misuse).  No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: No additional adverse experiences have been reported; a patient was given PROQUAD and VARlVAX on the same day by accident yesterday; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 22-JUN-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, 0,5 milliliter, lot # T021640, expiration date: 21-DEC-2021 (route of administration and anatomical location were not reported) for prophylaxis. On the same day, the patient was given by an accident the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0,5 milliliter, lot # T033166 (lot No. T033166 has been verified to be a valid lot number for varicella virus vaccine live, expiration date reported and established as 29-SEP-2022) for prophylaxis (route of administration and anatomical location were not reported). The error was discovered on 23-JUN-2021, reported as today, with vaccine reconciliation.  At the time of the report, no additional adverse experiences were reported by the family of the patient and the family was not notified of the error. The reporter was wondering if Company had any information on the co-administration of the products prior to contacting the patient family. The nurse was inquiring if there are any special things they should be looking out for.
Age: 81.0
Sex: U
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no other AE reported; patient who received Prevnar 13 on 15-OCT-2018 was scheduled to receive Pneumovax 23 on 21-JUN-2021, but was inadvertently administered another injection of Prevnar 13; This spontaneous report was received from a pharmacist and refers to a 81-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 15-OCT-2018, patient received a dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (lot #, expiration date, exact dose, dose #, route and anatomical locatio were not reported). The patient was scheduled to receive pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on 21-JUN-2021, but was inadvertently administered another injection of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) 1 injection, lot # DX8302, expiration date 28-FEB-2021, at that time. No other adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Varivax that underwent a temperature excursion was administered; This spontaneous report as received from a physician 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 22-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T028307 that expires on 20-AUG-2022 for prophylaxis (dose, route of administration and administration site were not reported).  The administered dose of the vaccine experienced a temperature excursion of -50 degrees Celsius to  -15 degrees Celsius (-12.8 degrees Celsius) for 40 minutes and at 12.7 degrees Celsius for 1 hour as recorded by a data logger. There was no adverse effect reported.  No product quality complaint was involved.
Sex: U
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; MMR II, Varivax, Vaqta and prevnar 13 intended for a 12 months pediatric visit were inadvertenly administered to a 6 month old; This spontaneous report was received from a registered nurse referring to a 6-month-old patient (gender unknown). No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On 22-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) one injection, lot # T000890 that expires on 01-JAN-2022, for prophylaxis (dose, route of administration, lot number and expiration date were not reported), varicella virus vaccine live (oka/merck)(VARIVAX) one injection, lot # T028309 that expires on 20-AUG-2022 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) , hepatitis a vaccine, inactivated(VAQTA) one injection, lot # T023913  expiration date reported as 20-AUG-2022, but upon internal validation established as 31-MAR-2022.)(dose, route of administration, lot number and expiration date were not reported) and pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) one injection, for prophylaxis (dose, route of administration, lot number and expiration date were not reported) intended for a 12 month pediatric visit but was inadvertently administered to the 6 month old patient.  It reported that the patient was not exhibiting any adverse symptoms at the time of the call.  No additional adverse event was reported. No product quality complain. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023913; expirationdate: 31-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 criteria for reportability
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; RECOMBIVAX HB was administered after the expiration date; This spontaneous report as received from an administrator refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 25-JUN-202,1 the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # r028529, expiration date: 09-JUN-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine did not experience a temperature excursion prior to administration. No adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Product dose omission in error
Clinical narrative: No additional AEs reported or PQC reported; she got her first and second dose of GARDASIL on 2013, and never received her third dose because she forgot. She wants to know if she can get the GARDASIL 9; This spontaneous report was received from a consumer referring to herself, a female patient of unknown age. No information was provided regarding patient's medical history, concurrent conditions or previous drug reactions or allergies  On an unspecified dates on 2013, the patient was vaccinated with the first and second dose of quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis (doses, route of administration, frequency vaccination scheme,  anatomical locations of administration, lot numbers and expiration dates were not reported). The patient never received her third dose of the vaccine because she forgot (product dose omission in error), and now she inquired if she could get HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No additional adverse events (AEs) reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; The MMR-11 expired; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.  On 28-JJUN-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with albumin status rHA (recombinant Human albumin) 0.5 ml, once (strength, route of administration and anatomical site of vaccination were not reported, lot # S018592, expiration date reported and validated as 17-JUN-2021) for prophylaxis (expired product administered). No additional adverse events reported.
Sex: F
Vaccine: VARZOS
Symptoms: Product dose omission issue
Clinical narrative: she is one month overdue to receive her second shingles vaccine; she is one month overdue to receive her second shingles vaccine; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient concomitant therapies included pembrolizumab (KEYTRUDA). No information was provided regarding the patient's medical history, concurrent conditions and drug reactions or allergies.  On an unknown date, the patient was vaccinated with zoster vaccine live (MANUFACTURER UNKNOWN) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). The patient stated that she was one month overdue to receive her second zoster vaccine live (MANUFACTURER UNKNOWN) dose (circumstance or information capable of leading to medication error  and  extra dose administered).
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: over a year late getting his last dose; no additional adverse events; This spontaneous report as received from a pharmacist, referring to her 16 years old son. The patient's historical condition, concurrent condition and concomitant medication were not reported.   On an unknown date, the patient was over a year late got his last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, dose number, route of administration, anatomical location, lot# and expiration date were not provided) but had finally completed the series (inappropriate schedule of product administration). No additional adverse events reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No AE/PQC reported; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 10-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) for prophylaxis (lot # T027112 was verified to be valid, expiration date reported and established as 07-FEB-2022), (dose, frequency, route and site of administration were not provided).  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (F) (10 F) for 7 hours. There was also a previous temperature excursion of 6 F to 14 F (6.10 F) for 1 hour and 30 minutes. It was reported that the excursion occurred on 01-JUN-2021. The Digital Data Logger was not involved. The outcome, action taken and the causality assessment were not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA000296: US-009507513-2106USA008058: US-009507513-2106USA008067: US-009507513-2107USA000174:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARlVAX was improperly stored and administered; This spontaneous report was received from a pharmacist referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 25-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T028306, expiration date 20-AUG-2022) at a dose of 0.5 milliliter once for prophylaxis (route of administration and anatomical site of vaccination were not reported).  The vaccine was stored in a temperature of 41 degree Fahrenheit (°F) for 24 hours. This was not recorded in a data logger. There was no previous temperature excursion reported.; Sender's Comments:  US-009507513-2107USA000237:01957053
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around November 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered neuropathy. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered/not resolved. The event was related to zoster vaccine live (ZOSTAVAX).   Upon internal review, neuropathy was considered to be medically significant. The lawyer considered neuropathy to be disability.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, Product storage error
Clinical narrative: the dose that was administered had expired on 06/23/2021 and has had a previous temperature excursion; No additional adverse events reported; an expired dose of GARDASIL 9 was administered today, 06/30/2021, to a patient; This spontaneous report has been received from a registered nurse and refers to an 11-years old patient of unspecified gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 30-JUN-2021, the patient was vaccinated with a 0.5 milliliters (mL) expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (lot number R027577, was verified to be valid for syringe formulation, expiration date reported and verified as 23-JUN-2021) (dose number, vaccination scheme frequency, route, and anatomical site of administration were not provided) (expired product administered). Additionally, the expired administered vaccine had experienced a previous temperature excursion on an unspecified date (product storage error).  No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027577; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; GARDASIL 9 that underwent temperature excursions was administered; This spontaneous report was received from a nurse referring to male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-JUN-2021, the patient was vaccinated with an improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # T026323, expiring on 22-FEB-2023, for prophylaxis (dose, route and site of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of -13.5°Celsius for 1 hours and 16 minutes, and of 1.8°Celsius for 7 hours and 30 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. 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: T026323; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 1.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: Needle issue, Underdose
Clinical narrative: The patient is doing fine as far as we know/ No additional AEs; patient received less than the recommended dose; Some of the product got on the patient's skin and on the bed; the needle was not screwed on appropriately; This spontaneous report as received from a Medical Assistant refers to a 1 year old male patient. The patient's medical history included premature at 36 weeks.  Concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and pneumococcal vaccine conj 7v (crm197)(PREVNAR).    On 29-JUN-2021 the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated(VAQTA) (lot # T035721 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 15-APR-2022), via intramuscular route for prophylaxis (anatomical location was not reported). When giving the vaccine, the needle was not screwed on appropriately (device connection issue) and some of the vaccinated with hepatitis a vaccine, inactivated(VAQTA) got on the patients skin (exposure via skin contact) and on the bed, therefore the patient received less than the recommended dose (incorrect dose administered by product). No additional Adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035721; expirationdate: 15-APR-2022; deviceage and unit: 0 ; serialnumber: 100880435798; 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: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Precocious puberty
Clinical narrative: onset of early menses (growth of public hair); This spontaneous report was received from a consumer via a company representative referring to a 9 year old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On an unspecified date in 2020, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).          On an unknown date, the patient experienced growth of pubic hair and onset of early menses (precocious puberty).  The patient sought unspecified medical attention.  No treatment was given for the event.  The outcome of the event and the causal relationship between the event and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) were not provided.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported.; patient received the first dose of GARDASIL 9 over a year ago; This spontaneous report as received from a pharmacist refers to a 17-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On an unknown date in 2020 (also reported as when 16 years old, over a year ago) 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) (dose, strength, route and lot# were not provided) for prophylaxis. On 30-JUN-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose: 0.5 ml, strength, route and lot# were not provided) for prophylaxis (inappropriate schedule of product administration).  No additional AE reported.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; received 3 doses of GARDASIL 9 at intervals not consistent with the recommended dosing schedule; This spontaneous report was received from a physician concerning an 11-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.    On 11-JUL-2016, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # L043213, expiration date: 28-AUG-2017, route unknown) for prophylaxis. Then, on 12-SEP-2016, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # L043213, expiration date: 28-AUG-2017, route unknown). Finally, on 05-DEC-2016, the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # L037554, expiration date: 25-DEC-2017, route unknown) which is an interval not consistent with the recommended dosing schedule. No other adverse event (AE) occurred.
Sex: U
Vaccine: RV5
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: 17 out of 50 doses are not sealed. 18 out of 50 have already been administered; No additional AEs; Caller states foil is not sealed on ODT's from two boxes; This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age or gender.  The patients' pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies were not provided.  On unknown dates, the patients were vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) whose foil was not sealed, at a dose of 2 milliliter via oral route (lot number 1707486 has been verified to be valid, expiration date reported and validated as 20-MAR-2022; vaccination scheme was not reported) as prophylaxis (poor quality product administered).  On 29-JUN-2021, the reporter identified that the foil was not sealed on ODT's from two boxes of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) with same lot number, and 17 out of 50 doses were not sealed (product container seal issue). It was also reported that 18 out of 50 doses had already been administered and 15 left out did not appear to be affected. No additional adverse event were reported.  This is a non-valid case due to the lack of patients' identifiers.  Follow up was received from medical assistant on 06-JUL-2021. Medical assistant found another doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) which were not sealed. This time the reported found 12 out of 25 pieces of vaccine ware not sealed. On an unknown dates, 3 out 25 doses were administered. Ten doses are still intact and will be returned, as all affected doses did not fit in one mailer, second mailer would be send.. All vaccines found had the same lot number 1707486. The reporter was inquiring if the not sealed vaccines ware able to be used.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; inadvertent administration of expired V AQT A to a patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 01-JUL-2021, the patient was inadvertent administration of expired hepatitis a vaccine, inactivated (VAQTA) (0.5 ml, lot # T008698, expiration date 04-JUN-2021; strength and route of administration were not reported) for prophylaxis (expired product administered). The administered hepatitis a vaccine, inactivated (VAQTA) had no previous temperature excursions and was supported by the post expiry memo. No additional adverse events (no adverse event). No product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; on 30-JUN-2021 a patient was adminis MMRlI that expired on l 7-JUN-2021; Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided. Concomitant therapies included sterile diluent (manufacturer unknown).  On 30-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin(rHA)) (M-M-R II) (0.5 ml, lot # S018594, expiration date 17-JUN-2021;  route and anatomical location were not provided) for prophylaxis(Expired vaccine used). The vaccine had not had any temperature excursions. No further adverse event (AE) was reported by the physician. The physician was provided with the expired supported disclaimer. No additional AEs were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 18-MAR-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered to be not recovered. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered disabling.