chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Severe skin rash; itching on both arms and upper thigh; This is a spontaneous report from a contactable consumer. A 72-Years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in Arm Left, on 12Jan2021, 10:00 AM (age at the time of vaccination 72-Years-old) as a single dose for COVID-19 immunisation. Patient medical history included Hypothyroidism but it was under control and had allergic to dust. Patient did not receive other vaccine in four weeks of vaccination. Patient concomitant medication included levothyroxine sodium (SYNTHROID) 25 mgs, PO daily in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had experienced severe skin rash and itching on both arms and upper thigh areas on 13Jan2021, 08:00 PM and it required medical treatment and patient took other medications as Prednisone 10 mgs PO, Famotidine 20mgs PO, Banophen 25 mgs PO for the events. Outcome of the events were reported as recovered on an unknown date in 2021.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: bad reaction; concern the vaccines were given too soon; This spontaneous report was received from a female patient of unknown age reporting on herself. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies.  On an unknown date, the patient was vaccinated with the third dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, frequency, route of administration, lot number, expiration date, vaccination scheme and anatomical location were not reported), as prophylaxis.        On an unknown date, the patient experienced a bad reaction. She further stated, she was worried that they gave it too soon (inappropriate schedule of product administration).  At the time of the report, she recovered from the adverse reaction, as she mentioned she was fine.  Causality assessment was not provided by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Chills, Peripheral swelling, Poor quality product administered, Pyrexia, Tremor
Clinical narrative: chills, shakes, was increasingly sore, and a fever of 103.5 degrees; chills, shakes, was increasingly sore, and a fever of 103.5 degrees; chills, shakes, was increasingly sore, and a fever of 103.5 degrees; They believed it was a bad batch of PENUMOVAX; They believed it was a bad batch of PENUMOVAX; temperature up to 103 degrees/fever of 103.5 degrees.; severe swelling in her arm; This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On 05-MAY-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  On an unspecified date in May 2017, the patient had a bad reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23): experienced temperature up to 103 degrees (scale not provided) (body temperature increased) and severe swelling in the arm (peripheral swelling). On 08-MAY-2017, she was seen by the health care professional (HCP), with chills, shakes (tremor), was increasingly sore (pain) and a fever of 103.5 degrees (scale not provided). She was treated at that time with acetaminophen (TYLENOL). The physician stated they believed it was a bad batch of  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23), because he had other patients experience unspecified reactions as well, and normally you don't saw that kind of reactions from Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The outcome of body temperature increased, pain, tremor, chills and peripheral swelling was unknown. The reporter considered body temperature increased, pain, tremor, chills and peripheral swelling to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2104USA001602:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse event; exposure during pregnancy; This spontaneous prospective pregnancy report was received from a nurse, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 02-APR-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (ml) once as prophylaxis (vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported), while being 28 weeks pregnant (exposure during pregnancy). No additional adverse events were reported in the patient. The date of last menstrual period (LMP) was 21-SEP-2020, and the estimated date of delivery (EDD) would be 28-JUN-2021. Neither the pregnancy outcome nor the fetal outcome were known at the time of the report. No prenatal tests or results were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product packaging issue
Clinical narrative: No adverse event; 2 vials of VAQTA taken from a damaged carton were administered to 2 patients; Medical assistant reports 7 of 15 boxes received were partially opened on the sides of the carton. The opened boxes looks like the cartons had moisture on them; Medical assistant reports 7 of 15 boxes received were partially opened on the sides of the carton. The opened boxes looks like the cartons had moisture on them; This spontaneous report as received from a medical assistant and a physician concerning to 2 patients of unknown age ang gender.  No information regarding the patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies was reported.  It was reported that on 31-MAR-2021 the product of hepatitis A vaccine, inactivated (VAQTA) were received. Then, as reported by the medical assistant, on 08-APR-2021, 7 of 15 boxes (multi-unit packaging, 10 vials per box) of hepatitis A vaccine, inactivated (VAQTA) strength: 25U/0.5 mL (lot number reported as # T036813 with expiration confirmed as 11-DEC-2021) received were partially opened on the sides of the cartons, nonetheless, the safety seals were not affected (product quality issue, product packaging issue). The opened boxes looked like the cartons had moisture on them. It was also reported that the cartons looked like the shipping freezer bags moistened the cartons and the 7 cartons affected were partially opened.   Additionally, two vials of hepatitis A vaccine, inactivated (VAQTA) strength: 25U/0.5 mL (lot number reported as # T036813 with expiration confirmed as 11-DEC-2021) were administered at a dose of 0.5 mL (route of administration, and dosage regimen was not reported) as prophylaxis to 2 patients (poor quality vaccine administered). The two (2) vials of hepatitis A vaccine, inactivated (VAQTA) were taken from a damaged carton. No additional adverse events (AEs) were reported (no adverse event).  No further information was provided.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster related injurues; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 91-year-old patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 01-NOV-2007, the pt was administered the zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and location of administration, lot # and expiration date were not specified) at the pharmacy by a pharmacist, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the pt was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injures. The outcome of the events was unknown. The reporter considered all the events as related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported; VAQTA was inadvertently administered on 13 APR202 l after a temperature excursion occurred/Temperature 9.0C; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-APR-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) pre-filled syringe, lot # T033304, expiration date reported as 23-JUN-2022, but upon internal validation process, it was established as 02-APR-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of 9 degrees Celsius for 10 hours and 56 minutes.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA003667: US-009507513-2104USA003782: US-009507513-2104USA003622: US-009507513-2104USA003606:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Nurse reported at temperature excursion on GARDASIL 9 was administered; This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions,  pertinent medical history, drug reactions, allergies, and concomitant therapies were not provided.   On 03-APR-2021 (conflicting information also reported as "03-APR-2022"), the patient was vaccinated with a temperature excursion of (product storage error) HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 time dose, lot number 1621929, expiration date: 06-DEC-2021 for prophylaxis (route of administration, and vaccination scheme was not provided). No signs or symptoms reported. Administered dose of vaccine experienced the temperature excursion of above 9 degrees Celsius for (°C ) (10.63 °C ) and below2 °C  (0.0 °C ) for 4 hours, 20 minutes and 0 seconds. There was no data logger involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Injury
Clinical narrative: Ramsay Hunt Syndrome; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 30-OCT-2014, the patient was administered the zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): Ramsay Hunt Syndrome and other zoster related injuries. The outcome of the events was unknown. The causality assessment was considered as related by the lawyer.  Upon internal review, Ramsay Hunt Syndrome was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: one dose of administration after a temperature excursion; No additional AE/NO PQC reported.; This spontaneous report as received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 04-MAR-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T025946 was confirmed to be valid, expiry date 30-JUL-2022 (dose, route of administration, vaccination site were not specified) for prophylaxis. The administered dose underwent a temperature excursion between -7.3 degrees Celsius (C) for 55 minutes. There were previous temperature excursions (6.9 degrees Fahrenheit (F) for 9 minutes). Digital data logger was involved. No additional adverse effect was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No further AEs reported; patient was administered an expired dose ofMMR II on 19-APR-2021, (expiry date 09-DEC-2020).; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) 1 injection, lot # R035700, expiration date: 09-DEC-2020 for prophylaxis. No further adverse event was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected Vaccination failure / Two light flare-ups of shingles spring 2020 / Severe ongoing shingles from nov 28, 2020 to present; Two light flare-ups of shingles spring 2020 / Severe ongoing shingles from nov 28, 2020 to present; This case was reported by a physician and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In 2019, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In 2020, less than a year after receiving Shingrix and Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age group was captured as adult as per vaccine indication. Age at vaccination was not reported. After taking both shingrix doses in late 2019, then the patient had two light flare ups of shingles in spring 2020, then severe ongoing shingles from 28th November 2020 to 31st March, 2021.  The patient also wonder if the patient could get the high cost of the two shingrix doses refund by the company. The patient have had to take high doses of valacyclovir to treat this severe during this time period also received two covid vaccines.  The patient asked would there be an interference in the effective of the covid vaccine by valacyclovir. 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: FLUX
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: Also had flu like symptoms; And / kicked his butt; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2019-2020 season and an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms and feels awful. On an unknown date, the outcome of the influenza-like symptoms and feels awful were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feels awful to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. In November 2019, the patient received 1st dose of Shingrix prior to the pandemic and was sore at the injection site refer case: US2021079438. He mentioned that he had received the flu short for over 65 patients within 3 to 4 weeks of the Shingrix vaccine, however, he couldn't' confirm which vaccine he received first. The patient also had flu like symptoms with the flu vaccine and both kicked his butt.  It was reported that the patient received COVID-19 vaccine recently.  The patient refused to provide any private information and did not consent to follow up. Note: As it was unclear which vaccine was received first, so as per description chronology Shingrix 1st dose was conservatively considered as concomitant products.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021079438:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 15 people / experienced shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was 1 of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088499:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I took both Shringrex shots and I'm still getting them/ suspected vaccination failure; I took both Shringrex shots and I'm still getting them.; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The patient received both the doses of Shingrix shot and still got the shingles. This case was considered as suspected vaccination failure as details regarding the laboratory test confiding shingles and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shingle shots and later I got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The patient received Shingles shots and later got shingles. The reporter stated that, the vaccine was not preventable. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and also have had two cases of shingles/ suspected vaccination failure; I had the shot and also have had two cases of shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient received a shot of Shingles vaccine and had two cases of shingles. This case was considered as suspected vaccination failure as details regarding the vaccination schedule, laboratory test confiding shingles and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got a shot for shingles and after a year / I got the shingles./ suspected Vaccination failure; I got a shot for shingles and after a year / I got the shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient got a shot for shingles and after a year or so experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shingles shot but I still got the shingles years later/Suspected vaccination failure; Shingles / horrible; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had the Shingles shot but still got the shingles years later, it was horrible very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have had vaccine and just recently broke out AGAIN; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was reported but captured as adult as per vaccine indication. The reporter stated that the vaccine did not work for everyone that they would not get them again. The patient had the Shingles vaccine broke out again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported. This case has been linked with case US2021AMR089522, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR089522:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shingles shot and later got shingles/suspected vaccination failure; I got the shingles shot and later got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient got the Shingles and later experienced shingles. The physician did not ask patient whether had chicken pox. The physician said the patient should not get the shot if he or she never had chicken pox. The patient was not happy to say the least. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Pharmacist gave it to me in my SC rather than deltoid area of my arm; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of intramuscular formulation administered by other route in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2021, the patient received Shingrix (subcutaneous). On 16th April 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The pharmacist administered the Shingrix vaccine subcutaneously(SC) rather than in the deltoid area of arm, which led to intramuscular formulation administration by other route. The patient wanted to know if another dose was needed because it was not absorbed as well in subcutaneous route(SC). The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've had them twice and have had the shot; Yes they are painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  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 vaccine indication. The patient received shingles vaccine and had shingles twice and they were painful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination scedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Dialysis, Herpes zoster, Hypersomnia, Vaccination failure
Clinical narrative: Sleep for 3 days /neice found her and put her in the hosp; Got the shot and still got the shingles; Had to have dialysis possibly for the rest of her life; Suspected vaccination failure; This case was reported and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), sleep excessive (serious criteria hospitalization), shingles and dialysis nos. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the sleep excessive was recovered/resolved and the outcome of the dialysis nos was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, sleep excessive, shingles and dialysis nos to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's sister. The age at vaccination was not reported. The patient got the shot and got shingles. The patient was given medicines which put her to sleep for 3 days. The patient's daughter found her and put her in the hospital and later was informed that the patient had to have dialysis possibly for the rest of her life. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Illness, Malaise
Clinical narrative: got violently ill couldn't even keep water down for at least 36 hours; still not well; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness and feeling unwell. On an unknown date, the outcome of the illness and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the illness and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. Reporter stated that her husband had the shingles vaccination 2 1/2 weeks after his second Covid-19 shot. He got violently ill couldn't even keep water down for at least 36 hours. He was still not well after 3 days. The reporter suggested not get the shingles vaccine to close to the Covid vaccination. No further information was reported. It was unknown if the reporter considered the illness and feeling unwell to be related to Covid-19 vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shot, then about two weeks ago I got a small case of them again / horrible thing; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (very painful took a month for them to leave).   On an unknown date, the patient received Shingles vaccine. In April 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got the shingles before vaccination and took a month for them to leave. The patient got the shot and then about two weeks before the time of reporting, got a small case of shingles again. The reporter hoped that they were done with that horrible thing of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingles from the shingles shot/ Suspected vaccination failure; Got the shingles from the shingles shot.....; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated he/she got the shingles from the shingles shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shingle shot and 6 months later I got shingles/Suspected vaccination failure; I got the shingle shot and 6 months later I got shingles; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected  vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination which was very painful. The patient used lacaine patches which help a lot to the patient. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Vaccination failure
Clinical narrative: received the Shingles after the shot/Suspected vaccination failure; received the Shingles after the shot on the face; left with nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated he/she experienced the shingles after the shot on the face and was left with nerve damage. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Within a day or two / pain; restricted the range of motion in left arm; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and joint range of motion decreased. On an unknown date, the outcome of the pain in arm and joint range of motion decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm and joint range of motion decreased 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 captured adult as per vaccine indication. The patient received the first Shingrix vaccination and within a day or two the pain restricted the range of motion in left arm by about 90 percent. This lasted for approximately 4 months. The patient asked if this could have been an allergic reaction.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Insomnia, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; had my last shot on March 18 / Shingles / my back / only one blister; Started hurting on April 17.; my daughter look at my back / sees only one blister; have not been to sleep for the pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th March 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On 17th April 2021, 30 days after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, blister and difficulty sleeping. On an unknown date, the outcome of the vaccination failure, shingles, pain, blister and difficulty sleeping were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister and difficulty sleeping to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  On 18th March 2021, the patient received the last dose of shingles vaccine and on 17th April 2021 started hurting. The patient stated that shingles did not cross his/her mind untill the morning of day of reporting, till the patient's daughter looked at back of patient and she saw only one blister. It was reported that patient was not able to sleep for the pain. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had a reaction / Internal shingles; Had a reaction / Nerve damage / Nerve injury; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) for product used for unknown indication.   On an unknown date, the patient received Shingrix and Dupixent 300 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. The action taken with Dupixent was unknown. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received the dose of Shingrix and dupilumab (Dupixent) and patient experienced nerve damage and internal shingles. No lab data was provided. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Incorrect dose administered, Product dispensing error, Product preparation issue
Clinical narrative: reconstituted the Menveo product with Menactra; reconstituted the Menveo product with Menactra and administered the 0.5 mL to the patient; Menveo, was dispensed from pharmacy with a vial of Menactra; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On an unknown date, the patient received Menveo .5 ml and MENACTRA. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and product dispensing error. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and product dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported the patient who was ordered to receive Menveo, was dispensed from pharmacy with a vial of Menactra which led to product dispensing error and the registered nurse reconstituted the Menveo product with Menactra and administered the 0.5 mL to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist inquired for recommendations from GlaxoSmithKline about whether this dose of Menveo needed to be repeated or made up or would the efficacy of the Menveo be expected to be the same if it was reconstituted with anything other than the supplied diluent.