chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; VAQTA experienced an excursion on 7/31/2021; which was not reported, and one today, 8/6/2021. Per caller, the product was administered to (1) patient today; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 106-AUG-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T033304, expiration date not reported, but upon internal validation established as 22-APR-2022 (administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported.   The vaccine had a temperature excursion of  9.5 Celsius (C), during 1 hour and 15 minutes.It was confirmed that the vaccine had a previous temperature excursion of 13.5 C during 9 hours and 5 minutes. The reported stated that the vaccine experienced an excursion on 31-JUL-2021; which was not reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T033304; expirationdate: 02-APR-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 suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMR, MMRV
Symptoms: Wrong product administered
Clinical narrative: child was inadvertently administered a dose of PROQUAD instead of the sheduled varicella vaccine; child was administered PROQUAD concomitantly with M-M-R II; This spontaneous report as received from a medical assistant refers to a child patient of unknown age and gender. On 06-AUG-2021, the patient was inadvertently vaccinated with a 0.5 mL dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (Lot # T034610 exp date 10-APR-2022) instead of the scheduled varicella virus vaccine live (oka/merck) (manufacturer unknown). The medical assistant also reported that the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route and lot # not reported) on the same date. Concomitant therapies included sterile diluent.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Infusion
Clinical narrative: Immune thrombocytopenic purpura; This spontaneous report as received from a consumer refers to his 1 year old son. On an unspecified date in 2007, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route and lot # not reported).         On an unspecified date in 2007, the patient experienced immune thrombocytopenic purpura after receiving the vaccine. The patient sought medical attention and was treated with anti-d immunoglobulin (WINRHO) infusion. At the time of the report, the patient had recovered.  The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  Upon internal review immune thrombocytopenic purpura was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AEs; syringes of GARDASIL 9 where the round portion of the plunger broke which occurred once when a nurse was giving the injection; syringes of GARDASIL 9 where the round portion of the plunger broke which occurred once when a nurse was giving the injection; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On 15-FEB-2021, while administering hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe (dose 0.5 milliliter, intramuscularly, lot # T008152, expiration date reported as 01-JUN-2022, but upon internal validation established as 21-JUN-2022) for prophylaxis, the round portion of the plunger broke.   No additional adverse events. No further information provided. It was reported that she was unable to obtain broken syringes/plunger as they had been placed in the sharps disposal. The plunger rod (only) did not fell out of syringe barrel during use or loose and the circular part of plunger broke during use. The broken area was of one piece broken off.  This is one of two reports received from the same reporter.  This case was considered non-valid due to the lack of patient identifiers.  Follow up information has been received on 04-AUG-2021 from Merck's Manufacturing Division (MMD). The case was reopened based on new information related to a potential harm associated with broken syringe during and after injection. The device problem codes and device evaluation codes have been updated. 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: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Yes; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: Yes; mdcpreprationale: Refer to QCC4 record for reportability rationale; evaluationvalue - Patient / Device: N/A / 2978; N/A / 1069 evaluationvalue - Method / Result / Conclusion: 4112 / 170 / 25; 3331 / 170 / 25; 4115 / 170 / 25; 11 / 170 / 25; Sender's Comments:  US-009507513-2102USA009030:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and postherpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events herpes zoster and postherpetic neuralgia to be disability.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Customer reports no other AE.; administration of an expired dose of GARDASIL 9 to a 24 year old female; This spontaneous report was received from a registered nurse, referring to a 24-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 10-AUG-2021, the patient was vaccinated with an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliters (ml) one time as prophylaxis (lot number R026716 which has been verified to be valid, expiration date reported and validated as 30-MAY-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). In addition, no other adverse events were reported in the patient.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; The patient received PROQUAD at age 3 instead of 4; This spontaneous report was received from a licensed vocational nurse referring to a 3-year-old patient whose gender was not specified.    No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, or drug reactions/allergies was provided. On 11-SEP-2018, the patient received varicella virus vaccine live (Oka/Merck) (VARIVAX) at the age of 13-months-old (historical vaccine).  On 19-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number S009759 verified as valid, expiration date reported and validated as 27-SEP-2020) for prophylaxis (administered dose, vaccination scheme, route and anatomical location of administration were not reported), at the age of 3 instead of age 4, as recommended in the prescribing information (product administered to patient of inappropriate age). No additional adverse event (AE) reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Viral titre decreased
Clinical narrative: no adverse event; adult patient received a dose of PROQUAD; This spontaneous report was received from an adult female consumer of unknown age reporting on herself. On an unspecified date in October 2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live( PROQUAD) (dose, route and lot # not reported) since her health care professional drew MMR titer levels and told her that she was not immune.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a dose of expired PROQUAD was administered.; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-AUG-2021, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, lot # T003835 has been verified to be a valid lot number, expiration date 01-AUG-2021 (formulation, strength, frequency and route of administration were not reported) for prophylaxis. lt was the second dose in the series. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; The Gardasil-9 expired on 5/30/2021 and was administered on 8/9/2021; This spontaneous report was received from a nurse and consumer and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-AUG-2021, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R024259, expiration date 30-MAY-2021 for prophylaxis (dose, route of administration and anatomical location were not reported). No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; the patients that were administered the vaccines involved in the temperature excursion; This spontaneous report has been received from a pediatric office clinical coordinator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported.   On 10-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T032930 has been verified to be a valid lot number, expiration date reported and established as 28-SEP-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 15.7 degrees Fahrenheit (F) during a time frame of 35 minutes; with no previous temperature excursion. No additional adverse events reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA004580:Original Case : 2108USA003330 US-009507513-2108USA004581:Original Case : 2108USA003330 US-009507513-2108USA004582:Original Case : 2108USA003330
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; MMR II was improperly stored and administered; This spontaneous report was received from a nurse practitioner 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 14-JUL-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 # T006166, expiration date 19-FEB-2022, for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse event reported.  The vaccine was stored in a temperature of 55 degree Fahrenheit (°F) for an unknown time frame from 08-JUN-2021 until 03-AUG-2021. There was no previous temperature excursion reported.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired quality of life
Clinical narrative: The patient stated that she vaccine made her "life into tailspin"; This spontaneous report has been received from a female consumer of unknown age referring to herself. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis.         The patient reported that she experienced unspecified adverse events after getting zoster vaccine live (ZOSTAVAX) in the past. It's reported that the vaccine made her "life into tailspin" and the patient did not explain what she meant by "life into tailspin". The outcome of the event was unknown.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; VARIVAX that underwent temperature excursions was administered; This spontaneous report has received from a reporter of unknown qualification (reported as other) concerning 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 07-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) underwent temperature excursions (lot# T024285 has been verified to be a valid lot number and expiration date was 15-JUL-2022; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). The administered dose experienced the following temperature excursions: -14 Celsius degree to -10 Celsius degree (-10.9 Celsius degree) for 34 minutes and -14 Celsius degree to -10 Celsius degree (-10.8 Celsius degree) for 49 minutes. The previous excursion was reported as -14 Celsius degree to -10 Celsius degree (-11.1 Celsius degree) for 1 hour 2 minutes. No additional adverse effect was reported.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: none adverse reaction or side effects experienced; patient vaccinated with 23-valent pneumococcal vaccines on 01-JUN-2012 and 06-OCT-2013; This initial spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (original legal case MARRS # 1901USA000773), concerning a 67-year-old male patient (pt), a non-smoker. On 01-JUN-2012, the pt was vaccinated at a pharmacy with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 06-OCT-2013, the pt was vaccinated at a pharmacy with another dose of polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of vaccine administered). Adverse reaction or side effects experienced with regard to the suspect vaccines' administration were reported as none.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1901USA000773:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaqta that underwent a temperature excursion was administered; This spontaneous report has been received from a physician concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 12-AUG-2021, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), Lot # T033304, expiration date on 02-APR-2022, (dosage information was not provided) that underwent a temperature excursion, for prophylaxis purposes.  The temperature excursion was described as above of 47 Fahrenheit degrees (46.5 F) for 0 hours, 5 minutes, and 0 seconds.  No additional adverse effects or product quality complaints were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T033304; expirationdate: 02-APR-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 criteria for reportability
Age: 34.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received Gardasil 9 on the left deltoid arm; This prospective pregnancy report was received from an office manager concerning a 34-year-old female patient. The patient has no pertinent medical history, concurrent conditions, nor drug reactions/allergies. Concomitant therapy included "multivitamins".  It was reported that the patient was pregnant. The last menstrual period (LMP) was estimated as 20-DEC-2020. On 12-AUG-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # T026324, 0.5 milliliter, intramuscularly (IM), in the left deltoid for prophylaxis while she was 33 weeks pregnant (vaccine exposure during pregnancy). The estimated delivery date (EDD) was reported as 11-SEP-2021. 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: T026324; expirationdate: 22-FEB-2023; 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 criteria for reportability
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No symptoms reported by any of the patients; temperature excursion; This spontaneous report was received from a registered nurse referring to a 7-year-old patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T037643 with an expiration date on 06-NOV-2022) for prophylaxis (strength, dose, frequency, and route of administration were not reported).  The dose of varicella virus vaccine live (oka/merck)(VARIVAX) were exposed on 11-AUG-2021 to a temperature excursion of 8 degrees Fahrenheit (°F) during a time frame of 2 hours and 15 minutes. There was no prior temperature excursion.  No symptoms were reported.
Age: 19.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No other issues or concerns noted; received expired MMR II and diluent; 19 years old patient vaccinated with M-M-R II; This spontaneous report was received from a pharmacist referring to a 19 years old patient of unknown gender.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 12-AUG-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 # S022753 with an expiration date on 22-JUL-2021), and sterile diluent(MERCK STERILE DILUENT) (lot# R032162 with an expiration date on 22-JUL-2021) for prophylaxis (expired product administered).  Strength, dose, frequency, and route of administration were not reported).   No other issues or concerns were noted.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T018892 with an expiration date on 02-JUN-2022) for prophylaxis  (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursión of above 9°C Celsius degrees (18.9°C) for  18 hours, 0 minutes and 0 seconds (product storage error).    No previous temperatura excursions were reported.  No additional adverse effect were reported.  This is one of five Reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003904:Original Case : 2108USA003819 US-009507513-2108USA003903:Original Case : 2108USA003819 US-009507513-2108USA003902:Original Case : 2108USA003819 US-009507513-2108USA003905:Original Case : 2108USA003819
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No symptoms reported by any of the patients; temperature excursion for frozen products; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 23-JUL-2021, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S037503 with an expiration date on 20-NOV-2021) for prophylaxis  (strength, dose, frequency, and route of administration were not reported).         The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) were exposed to a temperature excursion of 46.6 degrees Fahrenheit (°F) during a time frame of 1 hour. There was prior temperature excursion of 6°F for 5 minutes (47.3°F) for 6 minutes.   No symptoms were reported.  This is one of two reports received from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Vaccination failure
Clinical narrative: she got one of the strains of HPV that she was supposed to be protected from; only received two shots but not the third dose; Information has been received from a current 28-year-old female patient reporting on herself (age at the time of the first event was not reported).  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unspecified date, when the patient was younger, she was vaccinated with the first and second doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection (dose, frequency, route, lot number and expiration date were not reported) to prevent Human papillomavirus (HPV).  The patient stated that she received two shots but not a third dose.   On an unspecified date, reported as within last few years, the patient reported she got one of the strains of HPV that she was supposed to be protected from with the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccine. However, the patient did not specify which strain (vaccination failure).  The outcome of vaccination failure was not reported.  It was also reported that the patient started the series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on 01-MAR-2021 and 12-APR-2021, first and second doses respectively (reported in MARRS 2108USA004963), and she wanted to know the dosing schedule as she had not received the last dose yet.; Sender's Comments:  US-009507513-2108USA004963:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; PROQUAD underwent a temperature excursion and was administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live albumin status rHA (recombinant Human albumin) (PROQUAD) 0.5 ml, once, lot# U002538, expiration date 24-JUL-2022, for prophylaxis (strength and route were not reported). No additional adverse event reported.  The temperature excursion was of 5.7 Fahrenheit degrees (°F) during 10 minutes. A previous temperature excursion was not reported.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: innapropriate schedule of Hepatitis B vaccination; This spontaneous report was received from a medical assistant concerning a 9-weeks-old female patient. Information regarding the patient's current conditions, medical history and historical drug was not provided.   On 03-APR-2013, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) first dose. On 03-JUN-2013, the patient received the second dosis of the Hepatitis B Vaccine (Recombinant) (manufacturer unknown), and on 22-OCT-2013, the third dose was administered (dosages, routes of administration, lot numbers and expiration dates were not provided) all of them as prophylaxis.  There reporter did not provided the reason why the second dose was administered one month after the date it should be administered.  Vaccines administered concomitant with the second dose included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Manufacturer unknown) an Polio vaccine.; Sender's Comments:  US-009507513-1508USA008403: US-009507513-1508USA008403:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T018892 with an expiration date on 02-JUN-2022) for prophylaxis  (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursión of above 9°C Celsius degrees (18.9°C) for  18 hours, 0 minutes and 0 seconds (product storage error).    No previous temperatura excursions were reported.  No additional adverse effect were reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003904:Original Case : 2108USA003819 US-009507513-2108USA003903:Original Case : 2108USA003819 US-009507513-2108USA003905:Original Case : 2108USA003819 US-009507513-2108USA003819:Original Case : 2108USA003819
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# T035408 with an expiration date on 14-APR-2022) for prophylaxis  (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursion of -10°C to 8°C (6.2°C) for 16 hours 0 minutes and 0 seconds (product storage error).    No previous temperatura excursions were reported.  No additional adverse effect were reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003904:Original Case : 2108USA003819 US-009507513-2108USA003819:Original Case : 2108USA003819 US-009507513-2108USA003905:Original Case : 2108USA003819 US-009507513-2108USA003902:Original Case : 2108USA003819
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T018892 with an expiration date on 02-JUN-2022) for prophylaxis (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursión of above 9°C Celsius degrees (18.9°C) for  18 hours, 0 minutes and 0 seconds (product storage error).    No previous temperatura excursions were reported.  No additional adverse effect were reported.  This is one of the five reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003819:Original Case : 2108USA003819 US-009507513-2108USA003903:Original Case : 2108USA003819 US-009507513-2108USA003905:Original Case : 2108USA003819 US-009507513-2108USA003902:Original Case : 2108USA003819
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot# T035408 with an expiration date on 14-APR-2022) for prophylaxis  (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursion of -10°C to 8°C (6.2°C) for 16 hours 0 minutes and 0 seconds (product storage error).    No previous temperature excursions were reported.  No additional adverse effect were reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003904:Original Case : 2108USA003819 US-009507513-2108USA003903:Original Case : 2108USA003819 US-009507513-2108USA003819:Original Case : 2108USA003819 US-009507513-2108USA003902:Original Case : 2108USA003819
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported by any of the patients; temperature excursion for frozen products; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 29-JUL-2021, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S037503 with an expiration date on 20-NOV-2021) for prophylaxis  (strength, dose, frequency, and route of administration were not reported).         The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) were exposed to a temperature excursion of 46.6 degrees Fahrenheit (°F) during a time frame of 1 hour. There was prior temperature excursion of 6°F for 5 minutes (47.3°F) for 6 minutes.   No symptoms were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003837:
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms were reported by the patient/no additional AE was reported; a temperature excursion of VARIVAX had been administered to the patient; This spontaneous report has received from a registered nurse concerning a 7 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.     On 11-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), which occurred a temperature excursion (lot# T037643 has been verified to be a valid lot number and expiration date was 06-NOV-2022; dose reported as 1 (unit unknown); strength, frequency and route were not reported) for prophylaxis (product storage error). The administered dose experienced a temperature excursion of 8 degrees Fahrenheit for 2 hours and 15 minutes. There was no previous temperature excursion. No symptoms were reported by the patient. No additional adverse event was reported.     This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003810: US-009507513-2108USA004106:
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Multifocal motor neuropathy
Clinical narrative: multifocal motor neuropathy; Bell's palsy; Information has been received from a lawyer referring to an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 17-NOV-2009 (approximately 66 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a physician for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider (reported as provider) for the following injuries resulting from zoster vaccine live (ZOSTAVAX): multifocal motor neuropathy and Bell's Palsy. The outcome of the events was unknown.   Upon internal review, multifocal motor neuropathy and Bell's Palsy were determined to be medically significant.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 60 years old. No information was reported regarding the pt's medical history, concurrent conditions or concomitant medications. On or about 03-JUN-2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Coma, Nervous system disorder
Clinical narrative: congestive heart failure; Coma; serious neurological problems; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to an elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 09-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for the following injuries: serious neurological problems, congestive heart failure and coma. The outcome cardiac failure congestive, coma, and nervous system disorder were not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cardiac failure congestive, coma, and nervous system disorder were determined to be medically significant events.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE/PQC.; V AQT A was administered after it's expiration date; This spontaneous report as received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.         On 22-JUL-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (1 ml, strength, route of administration and anatomical site of vaccination were not reported, lot # T018670, expiration date reported as 11-JUL-2021) for prophylaxis (expired product administered). The outcome of expired product administered was unknown. The vaccine had no prior temperature excursions. No additional adverse events reported.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; a dose of PROQUAD was inadvertently administered to a 16 year old patient today; This spontaneous report was received from a nurse referring to a 16 years old patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reaction/allergies were not reported.  On 13-AUG-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (strength and route were not reported, lot # T030943, expiration date was 09-MAR-2022) 0.5 ml for prophylaxis; other suspect therapies included sterile diluent (start date: 13-AUG-2021, strength, frequency, indication and route were not reported; 0.5 ml, lot #  S022090, expiration date: 21-FEB-2022) ( product administered to patient of inappropriate age).      No additional information was provided. No additional adverse event was reported
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster related injuries; Initial information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not repoted. On or abotu 01-JUL-2017, the patient was vaccinated with za dose of oster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) by healthcare provider for the long-term prevention of shingles and zoster-related conditions. Subsequently patient  was treated by a healthcare provider and nurse practitioner for the following injuries resulting from the patient's dose of oster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not reported. The reporter considered shingles and other zoster related injuries to be related to dose of oster vaccine live (ZOSTAVAX).
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 65 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about an unknown date in January 2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider at a medical center for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a physician at the medical center, and other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: autism spectrum disorder; severe damages /unspecified damages caused by the MMR vaccine/damages are compounding with every passing day and week; This initial spontaneous report was received from a patient regarding a case in litigation referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was administered unspecified vaccines (dose, route of administration, indication, lot # and expiration date were not reported). Since 1988, the patient experienced severe damages done as a result of the immunisations. On an unspcified date, the patient experienced autism spectrum disorder. It was unknown if the patient received any treatment. The outcome of the events was not reported. The reporter considered the events to be related to suspected vaccines.  Upon internal review, the event of autism spectrum disorder was determined to be medically significant.  Follow-up information was received from the male patient via e-mail on 17-AUG-2021. On an unknown date, when the patient was a child, he was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). On an unspecified date (reported as since 1988 in the previous document), the vaccine caused unspecified damages to a patient. He reached a threshold in his life where his damages were compounding with every passing day and week.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender whose age at the time of report was 69 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date (reported as "on or about 41574"), the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a physician at a healthcare facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by the physician at the healthcare facility, and other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9, UNK
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; vaccine was administered after the expiration date; This spontaneous report was received from a registered nurse and refers to a child patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 29-JUL-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # R030453 was confirmed to be valid, expiration date 23-JUL-2021, for prophylaxis in a mobile clinic away from the office (route and site of administration were not reported). No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030453; expirationdate: 23-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
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 65 years old. No information was provided about the pt's medical history, concurrent conditions or concomitant medications. On or about 01-OCT-2013, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a physician at a clinic, and other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX): shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).