chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 82 years old. No information was provided about the pt's medical history, concurrent conditions or concomitant medications. On an unknown date (reported as "on or about 41358"), 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 pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider at a clinic walk-in, 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).
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: No additional AE; healthcare provider prescribed but she has never had any lung problems and does not believe she is in the high risk group; This spontaneous report as received from a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On an unspecified dates, the patient  was vaccinated with  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and pneumococcal vaccine conj 7v (CRM197). Then on 17-MAR-2021, her healthcare provided prescribed again vaccine, polyvalent (23-valent)(PNEUMOVAX23) (route, lot number and expiration date not reported) for prophylaxis. The patient stated that she had never had any lung problems and did not believe she was in the high risk group for pneumococcal infection. The caller reported she was confused as to why the healthcare provider prescribed her a second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The pharmacist did not give her the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). No additional adverse event was provided.
Age: 1.25
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gardasil 9 was inadvertently given to a 15 month old child; No other AE reported; This spontaneous report was received from a medical assistant, referring to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (product administered to patient of inappropriate age) (dose, frequency, and route of administration were not provided; lot number T027789, expiration date 27-FEB-2023). No other adverse events were reported. The outcome of product administered to patient of inappropriate age was unknown. 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: devicelotnumber: T027789; expirationdate: 27-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: chills; low grade fever; This spontaneous report was received from a physician, referring to a 57 year old male patient. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included pantoprazole.     On 09-AUG-2021 (also reported as "seven days ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route of administration, anatomical location of vaccination, lot number and expiration date were not reported) as prophylaxis.   Since that same day, he had been experiencing periodic low-grade fevers (pyrexia), with body temperature between 99.2 - 99.4 degrees fahrenheit (F), mostly in the evenings. The physician stated the patient's baseline temperature was 97.6 - 97.8 F, so while the fevers were low-grade the patient was very aware of them. The patient had also stated he experienced chills, but the physician did not think they had been rigors. On an unspecified day in August 2021, the patient went to an urgent care where he received negative coronavirus disease 2019 (COVlD-19) and streptococcus (reported as "strep") tests. The patient sought medical attention and only received acetaminphen (TYLENOL) as treatment for the events. The outcome of both events was reported as not recovered by the physician.   The reporting physician did not provide a causality assessment between the vaccine and the events; however, it was reported that when the patient went to the urgent care he was told (by an unreported contact) the symptoms were likely a reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Incomplete course of vaccination, Papilloma viral infection
Clinical narrative: High risk of HPV 18 or 16; This spontaneous report was received from a nurse via a company representative referring to her daughter a 27 year old female patient. No information regarding the patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were provided.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via intramuscular route to prevent human papilloma viral (HPV), dose reported as 1 time dose (anatomical site of vaccination, lot number and expiration date were not provided).  In 2018 (reported as 3 years ago), the patient was diagnosed with high risk HPV 16 or 18 (papilloma viral infection).   At the reporting time, the outcome of papilloma viral infection was unknown.        The reporter did not assess the causal relationship between the event and the suspect vaccines.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 29-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequently, the patient was treated for the following injuries resulted from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of shingles and ill-defined disorder were not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a n elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about September 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequently, the patient was treated for the following injuries resulted from zoster vaccine live (ZOSTAVAX) use: shingles and zoster related injuries. The outcome of shingles and ill-defined disorder were not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Facial paralysis, Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: Herpes Zoster ophthalmicus; right Bell's Palsy; facial paralysis; shingles; other zoster related injuries; varicella type rash; Information has been received regarding a case in litigation regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On or about 15-APR-2008, the patient was administered zoster vaccine live (ZOSTAVAX) by a healthcare provider in a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient was treated by a healthcare provider the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles, Herpes Zoster ophthalmicus, varicella type rash, facial paralysis, right Bell's Palsy, and other zoster related injuries. The outcome of the events was not provided.  Upon internal review, the events Herpes zoster ophthalmicus, right Bell's Palsy, and facial paralysis were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Ill-defined disorder
Clinical narrative: Bell's Palsy; Ill-defined disorder; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 72 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 24-AUG-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, Plaintiff was treated by physicians in a healthcare facility for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: Bell's Palsy and other zoster-related injuries. The outcome of the events was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Bell's Palsy was determined to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; other zoster related injuries; Information has been received from a lawyer regarding a case in litigation regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On or about 01-APR-2014, the patient was administered zoster vaccine live (ZOSTAVAX) by a healthcare provider in a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported)..  On an unknown date, the patient was treated by a healthcare provider the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles, postherpetic neuralgia, and other zoster related injuries. The outcome of the events was not provided.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster related injuries; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 73 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 08-JAN-2010, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, Plaintiff was treated by healthcare provider in a healthcare facility for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related injuries. The outcome of the events was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injuries; shingles; vaccinated at 56-years-old; Information was received from a lawyer regarding a case in litigation concerning a 56-year-old patient of unspecified gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On or about 01-DEC-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX), administered by a healthcare provider at a pharmacy, for the long-term prevention of shingles and 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 patient's zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a physician and other healthcare providers, at a family practice for shingles and other zoster-related conditions (Ill-defined disorder). The outcome of events was not provided. Causality was related.
Sex: U
Vaccine: MMRV
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 measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T030945 has been verified to be a valid lot number, expiration date reported and established as 09-MAR-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-009507513-2108USA003330: US-009507513-2108USA004581: US-009507513-2108USA004582:
Sex: U
Vaccine: VARCEL
Symptoms: 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: US-009507513-2108USA003330: US-009507513-2108USA004582:
Sex: U
Vaccine: MMRV
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 measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T030945 has been verified to be a valid lot number, expiration date reported and established as 09-MAR-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: US-009507513-2108USA004581: US-009507513-2108USA003330:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: it is unclear if 18 year old received PROQUAD.; it is unclear if 18 year old received PROQUAD.; No additional AE details; This spontaneous report was received from a consumer referring to an 18 years old patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    It was unclear if the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error). No additional AE details were reported.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional information available.; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant concerning a 68-year-old patient of unknown gender. No concurrent condition, medical history, or concomitant therapy was reported.     On 16-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, and route were unknown; lot # T040202 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 11-SEP-2022) for prophylaxis following a temperature excursion (product storage error). Temperature were 12.7 degrees celsius (C) and 1.6 C. The time frame was reported as 2 hours and 20 minutes, and 21 hours. There was no previous temperature excursion. No additional information was available. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T040202; expirationdate: 11-SEP-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: RV5
Symptoms: Ill-defined disorder
Clinical narrative: just had some issues; This spontaneous report was received from a consumer (friend of patient's mother) and refers to an infant patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally (dose, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced some unspecified issues (ill-defined disorder). It was unknown by the reporter if the patient received any treatment for the event. The outcome of the event was not provided.  The causality assessment was unknown. It was reported that they were trying to figure out if the event was due to the vaccine, but it had not been confirmed that it was the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) that caused the issues.
Age: 74.0
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 of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 74 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 20-JUL-2017, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a healthcare provider at a grocery store for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider at an urgent care, 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).
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; 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 72 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 13-JUL-2012, 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 healthcare facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by physicians at a healthcare facility, and by other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles, postherpetic neuralgia, 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: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Bronchitis, Herpes zoster, Injury, Pneumonia, Varicella
Clinical narrative: pneumonia; bronchitis; other zoster related injuries; shingles; chickenpox; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 70 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about an unknown date in September 2015, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a physician and a healthcare provider at an emergency room (ER), and at a healthcare facility, by other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles, chickenpox, pneumonia, bronchitis 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).  Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's reported/no symptoms were reported; Proquad administered since the excursion occured on 22-JUL-2021; This spontaneous report was received from a nurse 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 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T037955, expiration date 09-MAY-2022, dose 1 (unit not provided) (injection site and route of administration were not provided) for prophylaxis.   On 22-JUL-2021, the administered dose experienced a temperature excursion of 13.02 degrees Fahrenheit for 1 hours and 30 minutes The digital data logger was involved in recording the temperature excursion details. Previously the dose experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 6 hours, 14 degrees Fahrenheit to 46 degrees Fahrenheit (46 degrees Fahrenheit) for 14 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.9 degrees Fahrenheit) for 30 minutes. The vaccine was given a new expiry date of unknown date in September 2021. No additional adverse events were reported.   This is one of 5 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000958: US-009507513-2108USA000973:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's reported/no symptoms were reported; Proquad administered since the excursion occured on 22-JUL-2021; This spontaneous report was received from a nurse 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 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T037955, expiration date 09-MAY-2022, dose 1 (unit not provided) (injection site and route of administration were not provided) for prophylaxis.   On 22-JUL-2021, the administered dose experienced a temperature excursion of 13.02 degrees Fahrenheit for 1 hours and 30 minutes The digital data logger was involved in recording the temperature excursion details. Previously the dose experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 6 hours, 14 degrees Fahrenheit to 46 degrees Fahrenheit (46 degrees Fahrenheit) for 14 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.9 degrees Fahrenheit) for 30 minutes. The vaccine was given a new expiry date of unknown date in September 2021. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000958: US-009507513-2108USA000973:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's reported/no symptoms were reported; Proquad administered since the excursion occured on 22-JUL-2021; This spontaneous report was received from a nurse 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 30-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T037955, expiration date 09-MAY-2022, dose 1 (unit not provided) (injection site and route of administration were not provided) for prophylaxis.   On 22-JUL-2021, the administered dose experienced a temperature excursion of 13.02 degrees Fahrenheit for 1 hours and 30 minutes The digital data logger was involved in recording the temperature excursion details. Previously the dose experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 6 hours, 14 degrees Fahrenheit to 46 degrees Fahrenheit (46 degrees Fahrenheit) for 14 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.9 degrees Fahrenheit) for 30 minutes. The vaccine was given a new expiry date of unknown date in September 2021. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000958: US-009507513-2108USA000973:
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Ill-defined disorder, Rash
Clinical narrative: hearing loss; other zoster related injuries; body rash; Information was received from a lawyer regarding a case in litigation concerning a patient of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unknown date (Reported as "On or about 41404"), the patient was inoculated with zoster vaccine live (ZOSTAVAX), administered by a healthcare provider at a pharmacy, for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (Reported as "subsequently"), the patient was treated, by unspecified healthcare providers, for hearing loss (Deafness), body rash, and other zoster related injuries (Ill-defined disorder). The outcome of the events was not provided. Causality was related.  Upon internal review, the patient's deafness was determined to be a medically significant event.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder, Post herpetic neuralgia
Clinical narrative: other zoster related injuries; postherpetic neuralgia; shingles; Information was received from a lawyer regarding a case in litigation concerning an elderly patient of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On or about 25-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX), administered by a healthcare provider at a pharmacy, for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (Reported as "subsequently"), the patient was treated, by a nurse practitioner (NP) and a physician, for shingles, postherpetic neuralgia, and other zoster related injuries (Ill-defined disorder). Loss of consortium was also alleged. The outcome of the events was not provided. Causality was related.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: RECOMBIVAX HB expired on 08-JUN-2021 and was administered 16-AUG-2021; No additional AE reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 16-AUG-2021, the patient was vaccinated with expired hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R028384 with expiration date 08-JUN-2021, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was stated that the vaccinated did not undergo any temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, on or about 2017, the patient's pharmacist relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated in emergency department for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles and ill-defined disorder were not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 17-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about 02-SEP-2014, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for long-term prevention of shingles and zoster related conditions. Alternatively, on the same date, the patient's healthcare provider at the office relied on the warning label affixed to the Zoster Vaccine Live (ZOSTAVAX) vaccine and believed that it was effective in prevention shingles on a long-term or permanent basis, and that it did not carry any significant risks of adverse effects. Subsequent, the patient was treated by a physician for shingles and sought further treatment with other physician for other-zoster related conditions. Then, on an unknown date, the patient was hospitalized due to the event. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries including but not limited to cost for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. At the reporting time, the outcome of the events was not provided. The reporters considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster related injuries; Information has been received from a lawyer regarding a case in litigation reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was administered zoster vaccine live (ZOSTAVAX) by a healthcare provider in a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient was treated by a healthcare provider the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 01-MAR-2021 and 12-APR-2021, first and second doses of GARDASIL 9; Information has been received from a 28-year-old female patient reporting on herself.  The patient's concurrent conditions and medical history were not reported. Historical therapies included Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  on 01-MAR-2021 and 12-APR-2021, the patient received the first and second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose, frequency, route, lot number and expiration date were not reported) as prophylaxis (inapropriate schedule of vaccine administration)  The patient  wanted to know the dosing schedule as she needed the last dose but had not receive it yet.  This is one of two cases from the same patient.; Sender's Comments:  US-009507513-2108USA003871:
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: other zoster related injuries; herpes zoster; varicella type rash; 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 59 years old. No information was reported about the pt's medical history, concurrent conditions or concomitant medications. On or about 18-APR-2014, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a physician for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by physicians and other healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: herpes zoster, varicella type rash, 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: 74.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PREVNAR 13 and pneumococcal PPSV23 both vaccinated on 12-MAY-2016; This spontaneous report has been received from a physician, via a Plaintiff IR/MR from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2104USA001323), concerning a 74-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 12-MAY-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, site, lot# and expiration date were unknown; route was intramuscular) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (syringe, lot# 100005045157, left upper arm, route was intramuscular; dose and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).   This is one of two cases regarding the same patient.; Sender's Comments:  US-009507513-2104USA001323:
Sex: F
Vaccine: FLUN4
Symptoms: Overdose
Clinical narrative: OVERDOSE; A spontaneous report has been received from a health professional. The report concerns a female patient of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number UNKNOWN), via nasal route, for influenza vaccine on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced overdose (preferred term: Overdose).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Aversion, Migraine, Nasal congestion
Clinical narrative: Migraine; Abdominal discomfort; aversion; nasal congestion; pain; parosmia; photopsia; arthralgia; pyrexia; This case was received via VAERS (Reference number: 1093397) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion) and PAIN (pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included UTI (UTI 4 days before.). Concomitant products included CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion), PAIN (pain), PAROSMIA (parosmia), PHOTOPSIA (photopsia), ARTHRALGIA (arthralgia) and PYREXIA (pyrexia). At the time of the report, MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion), PAIN (pain), PAROSMIA (parosmia), PHOTOPSIA (photopsia), ARTHRALGIA (arthralgia) and PYREXIA (pyrexia) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-155904 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Parosmia, Photopsia, Pyrexia
Clinical narrative: Migraine; Abdominal discomfort; aversion; nasal congestion; pain; parosmia; photopsia; arthralgia; pyrexia; This case was received via VAERS (Reference number: 1093397) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion) and PAIN (pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included UTI (UTI 4 days before.). Concomitant products included CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion), PAIN (pain), PAROSMIA (parosmia), PHOTOPSIA (photopsia), ARTHRALGIA (arthralgia) and PYREXIA (pyrexia). At the time of the report, MIGRAINE (Migraine), ABDOMINAL DISCOMFORT (Abdominal discomfort), AVERSION (aversion), NASAL CONGESTION (nasal congestion), PAIN (pain), PAROSMIA (parosmia), PHOTOPSIA (photopsia), ARTHRALGIA (arthralgia) and PYREXIA (pyrexia) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-155904 (Patient Link).
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Pyrexia, Social problem
Clinical narrative: 1st dose received just before Covid/not able to get the second yet / had the second last Tuesday; painful side effect with pain; low grade fever; feeling like a wet noodle; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (very mild case around left eye years ago) and shingles (Family History) (great granddaughter had it when she was 19, mother in law had every year and so did sister in law). Previously administered products included Shingles vaccine (as original shingles vaccination, received on an unknown date) and Shingles vaccine (1st dose of new vaccine received in last year, just before COVID).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient had the original shingles vaccination when it (unspecified) came out. Till the time of reporting, the patient was not able to get the 2nd of the new vaccine. The follow-up would not possible as no contact details were available.   Follow-up information received from consumer on 16th August 2021: The patient had 1st dose of new Shingles vaccine just before Covid hit. The patient received the 2nd dose of new Shingles vaccine on last Tuesday before reporting date due to Covid hit. One day after the vaccination with 2nd dose, the patient had painful side effect with pain, low grade fever and felt like a wet noodle. The patient was fine on 2nd day of vaccination.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given just a menveo solution not the powder; given just a menveo solution not the powder; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received just a Menveo solution not the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked what to do with it. The reporter consented to follow up. This case has been linked with case US2021AMR170497, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170497:Same reporter