chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.    On 09-JUL-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dosage regimen was not provided) lot number S032355, expiration date 14-OCT-2021, administered subcutaneously, for prophylaxis; which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) lot number S032591, and expiration date 16-AUG-2022.     The improperly store dose experienced a temperature of 6 degrees Fahrenheit (°F) to 14°F (average temperature was 13.6°F) for 12 hours on multiple excursions; and 15°F to 46°F (average temperature was 16.0°F) for 30 minutes, with no previous temperature excursions. The call was performed due to digital data logger.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001233:
Age: 1.58
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, referring to a 19-months-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 30-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously (strength, dose, vaccination scheme frequency and anatomical location were not reported; lot number S032355, which have been verified to be valid, expiration date reported and validated as 14-OCT-2021) as routine vaccination (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number S032591, which have been verified to be valid, expiration date reported and validated as 16-AUG-2022).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (13.6 degrees F) for 12 hours (multiple excursions); 15 degrees F to 46 degrees F (16.0 degrees F) for 30 minutes, as recorded by a data logger. There was no previous temperature excursion reported.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001233:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report was received from a Licensed practical nurse and  refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided. Concomitant therapies included sterile diluent.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella  (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) lot # S031881, expiration date 07-APR-2021, 0.5 milliliter for prophylaxis (strength, frequency and route of administration were not reported).    The improperly stored suspect vaccine experienced a temperature of -9 degree Celsius (°C) to 8°C with an average of -2.8 °C  for 5 hours and  2 minutes. There was no previous temperature excursion.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA001249: US-009507513-2009USA001227:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 4-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies or concomitant medications was provided.    On 17-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not provided) lot # S032355 expiration date 14-OCT-2021, administered subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (Lot number: S032591, Expiration date: 16-AUG-2022).  The improperly stored dose experienced multiple excursions, the first in a temperature of 6 degree Fahrenheit (°F) to 14°F (average temperature was 13.6°F) for 12 hours, and then a temperature of 15°F to 46°F (average temperature was 16.0°F) for 30 min. There was no previous temperature excursions. The call was because a digital data logger.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001233:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD administered post temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 21-AUG-2020, the patient was administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S031881, expiration date 07-APR-2021) as prophylaxis, post temperature excursion (product storage error).  The vaccine underwent a temperature excursion between minus 9 degrees Celsius (C) to 8C (-2.8C) for 5 hours and 2 minutes, as recorded by a data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001249: US-009507513-2009USA001227:
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician, referring to a 3-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 13-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneous (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (dosage, vaccination scheme, frequency, anatomical site of injection were not reported), as routine vaccination (prophylaxis), reconstituted with a properly stored sterile diluent. The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (13.66 F), during a time frame of 12 hours (multiple excursion) and at a temperature of 15 F to 46 F (16.0 F) for 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from the authors of the published literature article concerning to an 18-day-old patient (gender not reported) who was exposed to measles when taken by the police to authors ED after being abandoned. On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (strength, route of administration, lot number and expiration date not reported) for prophylaxis. A large debate ensued about whether appropriate isolation could occur in a group or foster care setting. The neonate was ultimately sent to a home with an immune family, shortly before the index patient was determined to ultimately have the vaccine-induced rash. The patient's outcome was not reported.   This report is linked to case US-009507513-2008USA013592 from the same literature article.  A copy of published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2008USA013592:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addition adverse event; An expired dose of V AQTA was given; This spontaneous report was received from a medical assistant and refers to a 1 year old patient (gender not reported). The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.     On 02-SEP-2020 (also reported as "today"), the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated (VAQTA) lot # S019435, expiration date 23-AUG-2020, 0.5 milliliter for prophylaxis (route was  not reported). So, medical assistant called inquiring about stability data and confirmed no addition adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 4 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 12-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032355, expiration date 14-OCT-2021, subcutaneous (dose and frequency were not provided), for prophylaxis reconstituted with properly stored sterile diluent.  Temperature/Time frame: 6°F to 14°F (l3.6F) 12 hours (multiple excursions); 15°F to 46°F (16.0F) 30 minutes Previous temperature excursion? no Was call because ofa "data logger''? yes
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pneumococcal vaccine and pneumovax vaccine, date of vaccination: 2016; This spontaneous report was received from a 68-year-old female patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unknown date in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "Pneumococcal") and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2004USA000752:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: three children received a dose of the V ARlV AX that was stored out of recommended temperature range; This spontaneous report was received from the office manager and refers to an infant patient of an unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On 31-AUG-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, lot # R035226 and expiration date of 04-DEC-2020 (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 57.9 Fahrenheit (F) for 49 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2009USA001387: US-009507513-2009USA001758:
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 15-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355, expiration date 14-OCT-2021 subcutaneously (dose and route of administration were not provided) for routine vaccination. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit (F) for 12 hours and between 15 to 46F for 30 minutes. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001233: US-009507513-2009USA001256:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355, expiration date 14-OCT-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot # S032591, expiration date 16-AUG-2022).  Administered dose of vaccine was exposed to the temperature excursion of 13.6 degrees Fahrenheit for 12 hours (reported as multiple excursions) and 16 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.; Sender's Comments:  US-009507513-2009USA001256:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; PROQUAD administered post temperature excursion; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.  On 27-AUG-2020,  the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) 0.5 ml, lot # S031706, expiration date 06-APR-2021 (route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion from -9 Celsius degrees to 8 Celsius degrees (-2.8 Celsius degrees) for 5 hours and 2 minutes. No previous temperature excursion was reported. Digital data logger was used. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Varivax administered post temperature excursion; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not provided.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml once, lot# S032355, expiration date 14-OCT-2021 (route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion from 9 Celsius degrees to 8 Celsius degrees (-2.8 Celsius degrees) for 5 hours and 2 minutes. No previous temperature excursion was reported. Digital data logger was used.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355, expiration date 14-OCT-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot # S032591, expiration date 16-AUG-2022).  Administered dose of vaccine was exposed to the temperature excursion of 13.6 degrees Fahrenheit for 12 hours (reported as multiple excursions) and 16 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 24-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355, expiration date 14-OCT-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot # S032591, expiration date 16-AUG-2022).  Administered dose of vaccine was exposed to the temperature excursion of 13.6 degrees Fahrenheit for 12 hours (reported as multiple excursions) and 16 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), injection, lot # S032355, expiration date: 14-OCT-2021, subcutaneously (exact dose and injection site were not provided) as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (MERCK) lot # S032591, expiration date: 16-AUG-2022. The administered dose of vaccine experienced temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (13.6 degrees Fahrenheit) for 12 hours (multiple excursions) and 15 degrees Fahrenheit to 46 degrees Fahrenheit (16.0 degrees Fahrenheit) for 30 minutes. The digital data logger was involved regarding the temperature excursion details. No previous temperature excursion had occurred.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: The patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, vaccine scheme and anatomical location were not provided; lot number R024025 has been verified to be a valid lot number, expiration date was on 02-SEP-2020); as prophylaxis.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse reported PROQUAD was given to a 50 year old patient/ pediatric dose administered to adult patient; No adverse event; This spontaneous report has been received from a registered nurse concerning a 50 year-old-patient of unknown gender. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   The reporter stated that a pediatric dose was administered to an adult patient, as on an unspecified date, a dose of measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was given to the 50-year-old patient (batch/lot No, expiration date; dose and route of administration were not reported) (product administered to patient of inappropriate age) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided.      On 03-SEP-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019583, expiration date on 25-JUN-2021, for prophylaxis; reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). Vaccine was improperly stored at a temperature of 21.9°F, during a time frame of 108 minutes, There was no previous temperature excursions and the call was not because of a data logger.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The reporter wanted to know how long will a fever from the Shingrix shot last. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Laboratory test, Pyrexia
Clinical narrative: fever to 101; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient experienced fever. The patient's body temperature was 101 degree Fahrenheit. The reporter wanted to know was it better to take Tylenol for fever to 101 after Shingrix or not to medicate.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: chills; fever; achy joints; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced chills, fever, joint pain and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, fever, joint pain and muscle pain were unknown.   It was unknown if the reporter considered the chills, fever, joint pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had chills, fever, achy joints, muscle pain. The patient took 500 mg Tylenol at 3 hrs ago.  The reporter asked what else he could did.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Vaccination failure
Clinical narrative: we got flu shots and after my shit I got the flu/ suspected vaccination failure; flu; got the Asian flu was so sick and it was terrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 81-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   The reporter considered the vaccination failure, influenza and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported but patient could be 80 or 81 years old. The patient stated that he/she never got flu shots years ago when just out of high school. The patient  got the Asian flu shot and was so sick and told that it was terrible. The patient was working in the hospital and got flu shots and after the shot he/she got the flu. The patient stated that they told it was not from the shot but he/she knew it was because of vaccine. The patient received the flu shots every year at age 81 and thought it was a good idea. The patient stated that If you do get the flu it would not be as bad he/she was hoping. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: softball sized rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The reporter was a patient's wife. The age at vaccination was not reported. The patient received shot last saturday from the time of reporting and experienced softball sized rash. The reporter wanted to know was this normal. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: was in bed / got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingles and was in bed for almost two days.  The reporter asked was it too soon and said to wait a year.  The reporter asked was that why got so sick and should get the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Fever; Body aches; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever and general body pain. On an unknown date, the outcome of the pain in arm, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had arm pain, fever and body aches that lasted several days. The reporter did not agree to follow up from GSK.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Vaccination failure
Clinical narrative: got the flu/ suspected vaccination failure; got the flu; never so sick in my life; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza and sickness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were reported as follows: The patient's demographics were not reported. The patient never had the flu for 40 years. The patient got first flu shot this year and had flu. The patient stated that he/she was never so sick in life and still recuperating since 5 months. The patient stated that he/she would never get the flu shot again. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Dry skin, Erythema, Headache, Swelling
Clinical narrative: Patient reports that 2-3 days after vaccination he developed a 2" diameter red circle with some swelling and dry skin. Patient states Dial soap and cold shower water helped to provided relief.  Patients reports a few headaches too.  Patient states he will see his PCP.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received the first dose of Shingrix a week ago before reporting, did not say exact date, and experienced diarrhea, the patient had not recovered. The reporter did not consent to follow up. No patient or vaccine data. Health care professional said had no time to answer.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: more warm to the touch; left arm was sore,; red / that the arm was more red / are of  redness is approximately 6 inches; This case was reported by a pharmacist via call center representative and described the occurrence of skin warm in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3F3FP, expiry date 30th April 2022) for prophylaxis.   On 25th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 27th August 2020, 2 days after receiving Shingrix, the patient experienced skin warm, pain in arm and erythema of extremities. On an unknown date, the outcome of the skin warm, pain in arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the skin warm, pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and noticed the left arm was sore, red, and warm to the touch.  The patient stated the changes were that the arm was more red and more warm to the touch.  The pharmacist described the area of redness was approximately 6 inches and this was on day 3 after the injection. No HCP information was obtained.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of personal independence in daily activities, Movement disorder, Nausea, Paraesthesia
Clinical narrative: developed nausea; had difficulty brushing her hair; tingling sensation all over her body / like pins and needles; This case was reported by a nurse via call center representative and described the occurrence of tingling sensation in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   The patient's past medical history included suicide attempt. Previously administered products included iodine. Concurrent medical conditions included attention deficit hyperactivity disorder, depression and anxiety. Concomitant products included lithium, citalopram, guanfacine, hydroxyzine hydrochloride (Hydroxyzine), methylphenidate hydrochloride (Methylphenidate) and ethinyloestradiol + levonorgestrel (Levonorgestrel 0.15, Ethinyloestradiol 0.03).   On 27th August 2020, the patient received Menveo .5 ml. On 27th August 2020, 1 hr 30 min after receiving Menveo, the patient experienced tingling sensation. On 28th August 2020, the patient experienced nausea and movement disorder. On an unknown date, the outcome of the tingling sensation, nausea and movement disorder were unknown.   It was unknown if the reporter considered the tingling sensation, nausea and movement disorder to be related to Menveo.  Additional details were provided as follows: The patient received Menveo vaccine and an hour 1/2 later developed tingling sensation all over her body, like pins and needles. The patient developed nausea and had difficulty brushing her hair. The patient had a history of to food, nut and iodine, shellfish and suicide attempts. The reporter consented to follow up.  The Nurse stated that Safety might reach out for additional information.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: severe back pain; This case was reported by a physician via call center representative and described the occurrence of back pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included neurological disorder nos (had pre-existing neurological condition).   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details were provided as follows: The reporter was a field representative reporting an adverse event for Shingrix that was reported to her by the administering physician.  The patient received Shingrix in the left arm last week and shortly after the dose was given the patient experienced severe back pain. The reporter did not consent to follow up. The reporter did not had lot number or expiration date information to provide and had limited information to provide about the patient. The reporter did not get consent to follow up with HCP.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: red raised area; This case was reported by a nurse via call center representative and described the occurrence of red rash in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   The patient's past medical history included shingles (shingles during pregnancy years ago). Previously administered products included zostavax injection.   On 26th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a raised red area after injection. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Erythema, Fatigue, Illness
Clinical narrative: She coudnt get out of her bed; every joint in her body hurts; my arm blew up; rheumatoid arthritis flare; Fatigue; Pain; Redness / one inch below the demarcation point, there is a  a four inch by two and one half inch red mark; Swelling; very sick for three days; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis flare up in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hemochromatosis.   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), fatigue, pain, erythema, swelling, sickness, joint pain and pain in arm. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with prednisone. On an unknown date, the outcome of the rheumatoid arthritis flare up, fatigue, pain, erythema, swelling, joint pain, pain in arm and activities of daily living impaired were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis flare up, fatigue, pain, erythema, swelling, sickness, joint pain, pain in arm and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The patient experienced swelling, redness, pain, and fatigue that started after receiving injection. The patient stated that she became very sick for three days, her arm blew up , and one inch below the demarcation point, there was a four inch by two and one half inch red mark that was becoming larger every day. The patient couldn't get out of bed because every joint in her body hurt from a rheumatoid arthritis flare. She stated that her reaction was severe. She took Prednisone on August 29, 2020, and she felt better by August 30, 2020. She was not planning to speak with her physician regarding the reaction because they did not know anything. All information was not available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: She coudnt get out of her bed; every joint in her body hurts; my arm blew up; rheumatoid arthritis flare; Fatigue; Pain; Redness / one inch below the demarcation point, there is a  a four inch by two and one half inch red mark; Swelling; very sick for three days; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis flare up in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hemochromatosis.   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), fatigue, pain, erythema, swelling, sickness, joint pain and pain in arm. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with prednisone. On an unknown date, the outcome of the rheumatoid arthritis flare up, fatigue, pain, erythema, swelling, joint pain, pain in arm and activities of daily living impaired were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis flare up, fatigue, pain, erythema, swelling, sickness, joint pain, pain in arm and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The patient experienced swelling, redness, pain, and fatigue that started after receiving injection. The patient stated that she became very sick for three days, her arm blew up , and one inch below the demarcation point, there was a four inch by two and one half inch red mark that was becoming larger every day. The patient couldn't get out of bed because every joint in her body hurt from a rheumatoid arthritis flare. She stated that her reaction was severe. She took Prednisone on August 29, 2020, and she felt better by August 30, 2020. She was not planning to speak with her physician regarding the reaction because they did not know anything. All information was not available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis, Swelling
Clinical narrative: She coudnt get out of her bed; every joint in her body hurts; my arm blew up; rheumatoid arthritis flare; Fatigue; Pain; Redness / one inch below the demarcation point, there is a  a four inch by two and one half inch red mark; Swelling; very sick for three days; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis flare up in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hemochromatosis.   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), fatigue, pain, erythema, swelling, sickness, joint pain and pain in arm. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with prednisone. On an unknown date, the outcome of the rheumatoid arthritis flare up, fatigue, pain, erythema, swelling, joint pain, pain in arm and activities of daily living impaired were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the rheumatoid arthritis flare up, fatigue, pain, erythema, swelling, sickness, joint pain, pain in arm and activities of daily living impaired to be related to Shingrix.  Additional information was provided as follows: The patient experienced swelling, redness, pain, and fatigue that started after receiving injection. The patient stated that she became very sick for three days, her arm blew up , and one inch below the demarcation point, there was a four inch by two and one half inch red mark that was becoming larger every day. The patient couldn't get out of bed because every joint in her body hurt from a rheumatoid arthritis flare. She stated that her reaction was severe. She took Prednisone on August 29, 2020, and she felt better by August 30, 2020. She was not planning to speak with her physician regarding the reaction because they did not know anything. All information was not available.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Ultrasound scan normal
Clinical narrative: swelling of the supraclavicular lymph; Redness and swelling around the injection site; swelling around the injection site; This case was reported by a physician via call center representative and described the occurrence of enlargement of lymph nodes in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA92AZ, expiry date 28th February 2022) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Bexsero. In August 2020, 1 week after receiving Bexsero, the patient experienced enlargement of lymph nodes (serious criteria clinically significant/intervention required), injection site erythema (serious criteria clinically significant/intervention required) and injection site swelling (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved and the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, injection site erythema and injection site swelling to be related to Bexsero.  Additional details were provided as follows: The patient received the first dose of 1 Bexsero. About a week later, the patient developed swelling of the supraclavicular lymph node onthe left side, which was on the injected side. Redness and swelling around the injection site were also reported.  The physician saw the patient last 12th August 2020, but it was reported the symptoms were improving (lymph node) and the arm was back to normal. An ultrasound was performed for the lymph node showed it was benign and reactive in nature. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Inappropriate schedule of product administration, Neoplasm malignant
Clinical narrative: did not receive the second dose on time because the patient started chemotherapy.; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix on time because the patient started chemotherapy.  The patient wanted to have the 2nd dose on the day of reporting.