chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: pain during the administration; the needle "probably" wento into the deltoid muscle; the needle "probably" wento into the deltoid muscle; This spontaneous report was received from a 32 year old non-pregnant female patient referring to herself. The patient's concurrent conditions included allergy to ondansetron (ZOFRAN). The patient had no pertinent medical history.  On 28-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (lot #, expiration date, dose were not reported) for prophylaxis (reported as rubella). The patient stated that the needle probably went into the deltoid muscle. Concomitant therapies included ethinylestradiol (+) etonogestrel (NUVARING) and minerals nos (+) vitamins nos (PRENATAL). On the same day, during the administration, the patient experienced pain at the injection site.  The patient did not seek medical attention. No laboratory diagnostics were performed.  The outcome of vaccination site pain was reported as recovered/resolved on 28-MAY-2021. Causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called in to report a temperature excursion on ROTATEQ; No AE/ PQC reported at this time.; This spontaneous report was received from a other health professional concerning to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of vaccination and indication were not provided) (lot # 1741376 and expiration date since it makes match with the autopopulated expiration date 06-MAR-2022).        It was reported, that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine was stored at temperature excursion. The temperature excursion was between 36 and 48.2 degrees Fahrenheit for a time frame of cero hours and 15 minutes, as recorded by a data logger. There was 46.2 degrees Fahrenheit as previous temperature excursion. No further details available. No additional adverse event reported.   This is one of several cases reported from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: ROTATEQ was improperly stored and administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 01-JUN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number 1707408, has been verified to be a valid lot number, expiration date reported and validated as 07-JAN-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature of 13.5 degrees Celsius (C) for 1 hour and 50 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient in her 50s received a dose of GARDASIL; no adverse event; This spontaneous report was received from a physician assistant referring to a female patient of exact age unknown. The patient's medical history included human papilloma virus test positive for 2 strains of HPV.   No other information was provided regarding the patient's concurrent conditions, past drug history or concomitant medications.   On an unspecified date, within the past 6 months to 1 year, the patient was vaccinated with 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) while in her 50s (product administered to patient of inappropriate age). No adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Ill-defined disorder
Clinical narrative: children who were administered GARDASIL 9 were listed as 'compromised'; This spontaneous report as received from a health care business professional refers to a child patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown date, 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 # S020255, expiration date: 09-DEC-2021 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  It was reported that the child was listed as 'compromised' (Ill-defined disorder) within registry, on an unknown date; Immunization registry entry was entered incorrectly as confirmed by Healthcare Business Professional at call time. Healthcare Business Professional was not able to further clarify the meaning of 'compromised' (Ill-defined disorder) on unsuccessful clarification attempt at call time. The healthcare business professional had extremely limited information.Health care business professional requested a  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) expiry check. No additional adverse event. The outcome of ill-defined disorder was unknown.  The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Pharmacist called to report that a dose of MMRlI that expired on 05/23/2021 was administered on 05/26/2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 26-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number S015962, expiration date 23-MAY-2021 (route of administration was not reported) for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion with VAQTA which was administered to a patient; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, drug reactions, concurrent conditions and concomitant therapies were not provided.  On 01-JUN-2021, the patient was vaccinated with an incorrect stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T020109, expiration date reported as 26-JAN-2022, dose reported as 0.5 milliliter, for prophylaxis (strength, route, frequency were not reported)..  The temperature excursion was of 47.1 Fahrenheit degrees (°F) during 15 minutes. A previous temperature excursion was not reported. A digital data logger was not involved. No adverse effects 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: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events; improperly stored dose of VAQTA was administered to a patient; This spontaneous report was received from a medical assistant referring to a specific patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-MAY-2021, the patient was vaccinated with an improperly stored dose of  hepatitis a vaccine, inactivated (VAQTA), pre-filled syringe, lot # T008697, expiring on 04-JUN-2021, 0.5 milliliter, for prophylaxis (route and site of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 46.9F for 84 hours and 30 minutes. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008697; 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; Sender's Comments:  US-009507513-2106USA001537:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events; temperature excursion with Rotateq which was administered to a patient; This spontaneous report was received from a medical assistance and refers to a patient of unknown age an gender. The patient's pertinent medical history, drug reaction, allergies and concomitant medications were not reported.  On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml, orally, lot # 1707408, expiration date 07-JAN-2022 for prophylaxis. The temperature excursion was 47.1 degrees Fahrenheit (F) for 15 minutes. There were no previous excursions reported. The digital data logger was non involved. No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: no additional adverse event reported; Varivax was administered by the intramuscular route instead of the subcutaneous route; This spontaneous report was received from an office manager and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 02-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S030223, expiration date 26-SEP-2021, at a dose of 0.5 milliliter, intramuscularly instead of subcutaneous route for prophylaxis (strength and anatomical location were not provided).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported.; Rotateq Improperly Stored, administered; This spontaneous report was received from a medical assistant who refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 18-MAY-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S040076, expiry date 15-JUN-2021, 2 milliliter orally, for prophylaxis (formulation, concentration, dose number, frequency were not reported).  Digital data logger was not involved. The vaccine underwent the temperature excursion above 47 degrees of Fahrenheit (F) (46.9 F) for 84 hours 30 minutes. It was not provided if there was a previous temperature excursion. No additional adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001381:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Proquad and Varivax were administered at the same time; This spontaneous report was received from a medical assistant and refers to a 12-month-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 02-JUN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) at the same time, for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration). The reporter requested information on potential side effects when these vaccines are given concomitantly. The outcome, action taken and causality assessment were not provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: A medical assitant reported PROQUAD was improperly stored and administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was not provided.  On 19-MAY-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) with lot number T008281 and expiration date 05-SEP-2021 (both verified as valid) for prophylaxis (dose, vaccination scheme, route and anatomical location of administration were not reported).  On an unspecified date, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was improperly stored at a temperature of -14 degrees Celsius for a time frame of 35 hours and 43 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001739: US-009507513-2106USA001761: US-009507513-2106USA001914: US-009507513-2106USA001941: US-009507513-2106USA001959:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 24-MAY-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHa)) (PROQUAD) for prophylaxis (strength, dose, route of administration, and anatomical location were not reported; lot number T008281 had been verified to be a valid number; expiration date 05-SEP-2021 (conflicted information also reported 25-JUN-2022)). The  temperature  excursion was at -14 degree Celsius (C), for a time frame of 35 hours and 43 minutes, No had the previous temperature excursion. It was reported that the call was due to data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001746:
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; RECOMBIVAX HB had been inadvertently administered after its labeled expiry date; This spontaneous report was received from a physician who refers to a 14-year-old female patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and her pertinent medical history was not provided. On 02-JUN-2021, the patient was inadvertently vaccinated with expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vial, lot # R021372, expiry date 25-MAY-2021, for prophylaxis (concentration, dose, dose number, route of administration, frequency, were not reported). The physician inquired if the vaccine was still viable and if the patient would need to be revaccinated. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: allergy to Pneumovax23; This spontaneous report was received from a other health professional and refers to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot#, expiration date, strength, frequency and route of administration were not provided) for prophylaxis. On an unspecified date, the patient experienced allergy to vaccine. The outcome was unknown.  The relationship between the event and the vaccine was determined to be related.; Sender's Comments:  US-009507513-2105USA001067:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored and administered Proquad; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and cocomitant therapies were not provided.  On 27-MAY-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # U002535, expiration date 24-JUL-2020 (dose and route of administration were not provided) for prophylaxis. The vaccine was improperly stored in temperature excursion of -14 degress Celsius for 35 hours and 43 minutes. There was no previous temperature excursion. Data logger was involved.   The report is linked to 2106USA001746, received from the same reporter.; Sender's Comments:  US-009507513-2106USA001746:
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Patient who was previously administered a GARDASIL 9 dose in 'June and August' experienced an interrupted; NO additional AE; This spontaneous report was received from a pharmacist and refers to a currently 37-year-old male patient (also reported as a 36-year-old). No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in June 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in August 2020, he was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. By the time of this raport, the patient did not receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of drug administration). No additional adverse effect was reported.
Sex: U
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: No other AEs reported; Patient received a MMRII vaccine that was mixed with the diluent from a Shingrix vaccine; This spontaneous report was received from a caller concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 27-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter, intramuscularly, for prophylaxis (lot # S039310 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. expiration date reported and establish as 04-DEC-2021) (strength and anatomical location were not provided), that was mixed with the diluent from a shringix vaccine, 0.5 milliliter, intramuscularly, lot number 5XP9M, expiration date 15-OCT-2022 (anatomical location was not provided) (product preparation error).  No adverse event reported.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: No additional AEs; RECOMBIVAX HB 0.5ml was administered to a 22 year old patient instead of 1ml.; Information has been received from a medical assistant reporting on a 22-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 16-NOV-2020, the patient was vaccinated for the first time with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) lot# reported as 4G2TT, expiration date 20-FEB-2021 for prophylaxis, with a dose of 0.5 mL instead of 1 mL. No additional adverse events reported.  Lot number 4G2TT is an invalid lot number for hepatitis B vaccine (recombinant) (RECOMBIVAX HB). Lot number 4G2TT does not match any Company product as confirmed by Lot Verification team.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no other Advers ee event; 20 year old patient who received their first dose of GARDASIL 9/The customer said they administered the second dose of GARDASIL 9 a couple of days ago; This spontaneous report as received from a pharmacist refers to an adult  patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  It was reported that the patient had 20 year patient  when received their first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) "a year ago or longer" , date unspecified for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   The reporter said they administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) a couple of days ago, approximately in June 2021 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No further information was provided by the customer.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Cerebrovascular accident, Diplopia, Paraesthesia
Clinical narrative: bell's palsy; stroke; diplopia; parethesias; Information has been received from a lawyer regarding a case in litigation and refers to a currently 60-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-APR-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) by a medical assitant for the long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequently), the patient was treated by providers for diplopia, paresthesia, Bell's palsy, and stroke. The patient claimed damages as a result of injuries to themselves, loss of consortium, loss of services, and economic losses. At the time of this report, the outcome of the events was unknown. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, stroke and Bell's palsy were considered medically significant events.
Sex: F
Vaccine: HPV4
Symptoms: Angioedema, Hypersensitivity, Incomplete course of vaccination
Clinical narrative: allergic reaction to Gardasil- giant hives; This spontaneous report as received from a patient herself via Pfizer (manufacturer control # 2021330267) refers to a 18-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On an unknown date in May 2009, 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) for prophylaxis.         On an unknown date, when the patient was in high school, right before she was supposed to go to prom, she experienced an allergic reaction to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). No one knew or figured out what the active ingredient she was allergic to in the first place. The patient was rushed to the hospital at the time and had giant hives everywhere. The patient did not know if the reaction was from an active ingredient or what, as this happened to her when she was 18 years old and she did not have records of this event. Since she was in high school, her parents took care of it. She did not get the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The outcome of the event was unknown. The reporter considered the event to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of giant hives was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site mass, Pruritus
Clinical narrative: arm was on fire; She started to itch and got this big baseball size, a baseball or softball, whichever is the bigger ball, under her arm where the pharmacist gave her the injection.; She started to itch and got this big baseball size, a baseball or softball, whichever is the bigger ball, under her arm where the pharmacist gave her the injection.; This spontaneous report was received from a 74 year old  female patient via Pfizer with bronchiectasis and atypical mycobacterial infection.      On an unknown date, the patient was vaccinated with zoster vaccine live(manufacturer unknown) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.    On an unknown date, the patient experienced her arm was on fire (feeling hot). She started to itch and got this big baseball size, a baseball or softball, whichever was the bigger ball, under her arm where the pharmacist gave her the injection (vaccination site mass and vaccination site pruritus). She went back to the pharmacy showed her arm and the pharmacist said that was not normal.  At the time of the report, the outcome of feeling hot, vaccination site mass and vaccination site pruritus was unknown.        The patient did not mention the causality assessment between the events and zoster vaccine live(manufacturer unknown) vacciantion.
Sex: F
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 female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, 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). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster. 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 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 not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered as disability.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No other AE reported; The product was stored outside of the recommended storage range and administered to patients; PROQUAD administered to an adult patient over the age of 13 years; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 18-MAY-2021, the patient (reported as adult and over the age of 13 years) was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (dose and route of administration not reported, lot # T028139, expiry date reported as 15-APR-2022 but upon internal validation established as 15-FEB-2022) for prophylaxis (inappropriate age at vaccine administration). The administered dose of vaccine was stored outside of the recommended storage range, in temperature of 43 degree Fahrenheit (F), for 21 days (product storage error). Digital data logger was not involved. The vaccine did not experience any previous temperature excursions. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003760: US-009507513-2106USA003761: US-009507513-2106USA001912:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; The product was stored outside of the recommended storage range and administered to patients; PROQUAD administered to an adult patient over the age of 13 years; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 19-MAY-2021, the patient (reported as adult and over the age of 13 years) was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (dose and route of administration not reported, lot # T028139, expiry date reported as 15-APR-2022 but upon internal validation established as 15-FEB-2022) for prophylaxis (inappropriate age at vaccine administration). The administered dose of vaccine was stored outside of the recommended storage range, in temperature of 43 degree Fahrenheit (F), for 21 days (product storage error). Digital data logger was not involved. The vaccine did not experience any previous temperature excursions. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003759: US-009507513-2106USA001912: US-009507513-2106USA003761:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No other AE reported; The product was stored outside of the recommended storage range and administered to patients; PROQUAD administered to an adult patient over the age of 13 years; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 02-JUN-2021, the patient (reported as adult and over the age of 13 years)  was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA) (dose and route of administration not reported, lot # T028139, expiry date reported as 15-APR-2022 but upon internal validation established as 15-FEB-2022) for prophylaxis(inappropriate age at vaccine administration). The administered dose of vaccine was stored outside of the recommended storage range, in temperature of 43 degree Fahrenheit (F), for 21 days (product storage error). Digital data logger was not involved. The vaccine did not experience any previous temperature excursions. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003759: US-009507513-2106USA003760: US-009507513-2106USA001912:
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: first dose of GARDASIL 9 on l 7NOV2020 and has not received his second dose yet.; No additional AE; This spontaneous report was received from a pharmacist and refers to a 30-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-NOV-2020, the patient was vaccinated with a first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dose, lot # R030456, expiration date 23-JUL-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The patient did not yet receive his second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at the time or reporting (inappropriate schedule of vaccine administered). 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: R030456; 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
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; ROTATEQ, M-M-R II and VAQTA that underwent a temperature excursion were administered.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 25-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1707591, expiration date reported as 10-MAR-2022, but upon internal validation established as 11-MAR-2022) (exact dose not provided) for prophylaxis. The administered dose was stored in temperature above 46 Fahrenheit degrees (F) (46.8 F) for 30 minutes. No previous temperature excursion occurred. Digital data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006607: US-009507513-2106USA003900: US-009507513-2106USA003901:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; ROTATEQ, M-M-R II and VAQTA that underwent a temperature excursion were administered.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 25-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1707591, expiration date reported as 10-MAR-2022, but upon internal validation established as 11-MAR-2022) (exact dose not provided) for prophylaxis. The administered dose was stored in temperature above 46 Fahrenheit degrees (F) (46.8 F) for 30 minutes. No previous temperature excursion occurred. Digital data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006607: US-009507513-2106USA003899: US-009507513-2106USA003901:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; ROTATEQ, M-M-R II and VAQTA that underwent a temperature excursion were administered.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 25-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1707591, expiration date reported as 10-MAR-2022, but upon internal validation established as 11-MAR-2022) (exact dose not provided) for prophylaxis. The administered dose was stored in temperature above 46 Fahrenheit degrees (F) (46.8 F) for 30 minutes. No previous temperature excursion occurred. Digital data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006607: US-009507513-2106USA003900: US-009507513-2106USA003899:
Sex: U
Vaccine: HPV9
Symptoms: Ill-defined disorder
Clinical narrative: 2x unknown children who were administered GARDASIL 9 were listed as 'compromised'; This spontaneous report as received from a health care business professional refers to a child patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown date, 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 # S020255, expiration date: 09-DEC-2021 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  It was reported that the child was listed as 'compromised' (Ill-defined disorder) within registry, on an unknown date; Immunization registry entry was entered incorrectly as confirmed by Healthcare Business Professional at call time. Healthcare Business Professional was not able to further clarify the meaning of 'compromised' (Ill-defined disorder) on unsuccessful clarification attempt at call time. The healthcare business professional had extremely limited information.Health care business professional requested a  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) expiry check.  No additional adverse event. The outcome of ill-defined disorder was unknown.  The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-0095075132106USA001252:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion on ROT ATEQ and product administered; This spontaneous report was received from a medical assistant concerning a 4-months-old patient of unknown gender.   The patient's concurrent conditions, past drug reactions, allergies, medical history, and concomitant therapies were not provided.   On 07-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # T033812 with expiration date of 29-DEC-2021), single dose  orally for prophylaxis (dose was not reported). The administered dose of the vaccine was exposed to a temperature excursion of 47 Fahrenheit degrees for 1 hour. No digital data logger was reported. The vaccine had not had any previous temperature excursions.  There were no adverse events or product quality complaint (PQC) reported.   This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003944: US-009507513-2106USA004087: US-009507513-2106USA004039: US-009507513-2106USA004106:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no further adverse event; her first dose was give January 14,2021. Then the second dose was given on February 12, 2021. The consumer explained she was due for her third dose today June 14, 2021; This spontaneous report was received from a 39-year-old female consumer referring to herself.  Information about the patient's pertinent medical history, concomitant medication and drug reactions or allergies was not provided.  On 14-JAN-2021, 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) and on 12-FEB-2021, she was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) both of them for prophylaxis (route and anatomical location of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration). She also reported that she was due to her third dose on 14-JUN-2021 (reported as today).  The patient was inquiring about the dosing schedule for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) since she considered her doses seem to be too close together. No adverse events were reported.
Sex: U
Vaccine: TYP
Symptoms: Abdominal discomfort, Inappropriate schedule of product administration
Clinical narrative: Patient took all four doses of Vivotif at once; Stomach upset; Mild symptoms; A spontaneous report was received on 02JUN2021 from a physician.  The physician reported that a patient (gender/age) took all four doses of Vivotif (Typhoid vaccine live oral Ty21A) at once (PT: Inappropriate schedule of product administration). The physician stated that he does not know if the patient experienced any adverse events after taking all the four doses at once. Additionally he has not reached out to the patient yet.   On 09JUN2021, follow up was received from the physician:  Patient demographics, concomitant medications, date of administration and additional adverse events were reported.  It was reported that a 70 year old patient took all four doses of Vivotif on an unknown date in 2018OCT. The patient experienced mild symptoms (PT: Adverse event following immunization) including stomach upset (PT: Abdominal discomfort) which was temporary. At the time of this report, the outcome for the events mild symptoms including stomach upset were reported as resolved. Concomitant medications included Nasonex (mometasone furoate) and aspirin.   No additional information was available at the time of report.   Company Comment: A physician reported that a 70 year old patient (unspecified gender) took all four doses of Vivotif at once on an unknown date in 2018OCT. The patient experienced mild symptoms (PT: Adverse event following immunization) including stomach upset (PT: Abdominal discomfort) which was temporary. At the time of this report, the outcome for the events mild symptoms including stomach upset were reported as resolved. Concomitant medications included Nasonex (mometasone furoate) and aspirin. The reported events of stomach upset and mild symptoms is plausible with Vivotif, however, they are unlisted, these events might have occurred as a result of comorbid conditions (unknown medical history) and/or aspirin intake.  The case is considered non-serious as per medical assessment and case information. There is no change to risk-benefit profile of Vivotif.; Sender's Comments: Company Comment: A physician reported that a 70 year old patient (unspecified gender) took all four doses of Vivotif at once on an unknown date in 2018OCT. The patient experienced mild symptoms (PT: Adverse event following immunization) including stomach upset (PT: Abdominal discomfort) which was temporary. At the time of this report, the outcome for the events mild symptoms including stomach upset were reported as resolved. Concomitant medications included Nasonex (mometasone furoate) and aspirin. The reported events of stomach upset and mild symptoms is plausible with Vivotif, however, they are unlisted, these events might have occurred as a result of comorbid conditions (unknown medical history) and/or aspirin intake.  The case is considered non-serious as per medical assessment and case information. There is no change to risk-benefit profile of Vivotif.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Head discomfort, Headache, Pyrexia
Clinical narrative: temperature is now 99.1 / down this morning but back up presently; shivering; head discomfort; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine and allergy. Concomitant products included Herpes zoster (Shingrix).   On 26th January 2021, the patient received the 2nd dose of Shingrix 50 mcg/mg. In January 2021, 12 hrs after receiving Shingrix, the patient experienced fever, shivering and head discomfort. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering and head discomfort were unknown.   It was unknown if the reporter considered the fever, shivering and head discomfort to be related to Shingrix.  Additional details were reported as follows: The patient had head discomfort, shivering and fever 99.1 degree F 12 hours after vaccination. The patient also developed headache. The patient was asked whether, to take acetaminophen to reduce temperature or develop a headache. The Fever was down on reporting morning but back up at time of reporting. For tolerance with 2nd dose refer case US2021AMR019585. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR019585:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported for reporter's mother. The age at vaccination was not reported. The patient received the vaccine and few days later came down with shingles, now few years later she has shingles again. The reporter did not trust this vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.