chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Vaccine was given inadverantly at 6 month well child care check No adverse reactons at time of discharge Provider was informed within 3 minutes Mother of the child was informed within 10 minutes Review of potential adverse reactions reviewed with mother of child prior to giving vaccine and again upon calling mother to inform her of error.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Incorrect product formulation administered, No adverse event
Clinical narrative: Individual was administered Pfizer Bivalent vaccine on March 30, 2023, then on May 12, 2023, she was administered Moderna Bivalent. COVID Vaccine. Individual was administered vaccine weeks prior to 4 months recommended interval.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure via skin contact, Needle issue, No adverse event, Underdose
Clinical narrative: The needle had a split at the base where it connects to the syringe.  When I went to administer it, the liquid rolled out of the needle and down her arm.  She and I assessed the flaw in the needle and agreed we didn't feel she received her dose.  She asked for me to readminister it so she could get her full dose.  The were no adverse reactions to the shot at the time of administration or by the time she left.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiac failure congestive, Cardiomyopathy
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/25/2022 NONISCHEMIC CARDIOMYOPATHY  ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/25/2022 CHF, STAGE C, UNSPECIFIED
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder cancer, Cerebrovascular accident, Hypotension, Pelvic fracture, Urinary tract infection
Clinical narrative: I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 11/28/2022 BLADDER CANCER, UNSPECIFIED SITE I95.9 HYPOTENSION 12/12/2022 BLADDER CANCER, UNSPECIFIED SITE I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 11/28/2022 UTI (URINARY TRACT INFECTION) I95.9 HYPOTENSION 12/12/2022 UTI (URINARY TRACT INFECTION) I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 11/28/2022 BLADDER CANCER, INVASIVE, UNSPECIFIED SITE I95.9 HYPOTENSION 12/12/2022 BLADDER CANCER, INVASIVE, UNSPECIFIED SITE I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 11/28/2022 PELVIC FX, INIT I95.9 HYPOTENSION 12/12/2022 PELVIC FX, INIT
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 12/14/2022 COVID-19 DISEASE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Diplopia, Dizziness, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: In February 2021,I  noticed I was getting dizzy. I went to my doctor's and he said my blood pressure was low and told me to stop taking my blood pressure  medication, and eventually took me off . I started getting dizzy, having double vision, tired and on the weekends, I did not get off the couch.  My blood pressure did not raise. It just kept getting lower. He referred me to a cardiologist to make sure it did not have to do with my heart. The doctor also found a heart murmur.  I went to see my cardiologist, on 01/2023. And then I had an echocardiogram and sonic gram on 2/17/2023. The echocardiogram, the sonic gram, and an EKG looked normal. They told me I might have had a little leakage, but it was not anything to worry about. The doctor put me on blood pressure medication on 02/2023, but it was not effective. I was still getting dizzy. I am now on low blood pressure medication, Midodrine to try to raise my blood pressure. I was fine all through my years, and after my 2nd vaccine, my blood pressure has now been low. My blood pressure stays low all the time. I even try to eat salt to help my blood pressure stay up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypotension, Ultrasound scan normal
Clinical narrative: In February 2021,I  noticed I was getting dizzy. I went to my doctor's and he said my blood pressure was low and told me to stop taking my blood pressure  medication, and eventually took me off . I started getting dizzy, having double vision, tired and on the weekends, I did not get off the couch.  My blood pressure did not raise. It just kept getting lower. He referred me to a cardiologist to make sure it did not have to do with my heart. The doctor also found a heart murmur.  I went to see my cardiologist, on 01/2023. And then I had an echocardiogram and sonic gram on 2/17/2023. The echocardiogram, the sonic gram, and an EKG looked normal. They told me I might have had a little leakage, but it was not anything to worry about. The doctor put me on blood pressure medication on 02/2023, but it was not effective. I was still getting dizzy. I am now on low blood pressure medication, Midodrine to try to raise my blood pressure. I was fine all through my years, and after my 2nd vaccine, my blood pressure has now been low. My blood pressure stays low all the time. I even try to eat salt to help my blood pressure stay up.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess limb, Hypokalaemia, Hypotension, Mental status changes, Organ failure
Clinical narrative: ACUTE PULMONARY EMBOLISM 9/6/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  HYPOTENSION 9/6/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  ACUTE PULMONARY EMBOLISM 9/6/2022 LEFT HAND ABSCESS  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 LEFT HAND ABSCESS  HYPOTENSION 9/6/2022 LEFT HAND ABSCESS  ACUTE PULMONARY EMBOLISM 9/6/2022 HYPOKALEMIA  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 HYPOKALEMIA  HYPOTENSION 9/6/2022 HYPOKALEMIA  ACUTE PULMONARY EMBOLISM 9/6/2022 ALTERED MENTAL STATUS, UNSPECIFIED  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 ALTERED MENTAL STATUS, UNSPECIFIED  HYPOTENSION 9/6/2022 ALTERED MENTAL STATUS, UNSPECIFIED
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Reversible ischaemic neurological deficit, Sepsis
Clinical narrative: ACUTE PULMONARY EMBOLISM 9/6/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  HYPOTENSION 9/6/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  ACUTE PULMONARY EMBOLISM 9/6/2022 LEFT HAND ABSCESS  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 LEFT HAND ABSCESS  HYPOTENSION 9/6/2022 LEFT HAND ABSCESS  ACUTE PULMONARY EMBOLISM 9/6/2022 HYPOKALEMIA  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 HYPOKALEMIA  HYPOTENSION 9/6/2022 HYPOKALEMIA  ACUTE PULMONARY EMBOLISM 9/6/2022 ALTERED MENTAL STATUS, UNSPECIFIED  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 ALTERED MENTAL STATUS, UNSPECIFIED  HYPOTENSION 9/6/2022 ALTERED MENTAL STATUS, UNSPECIFIED
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Feeling abnormal, Headache, Pyrexia
Clinical narrative: I had a low-grade fever, runny nose, a really bad headache, I used a home COVID-19 test that came back positive. I called my doctor to consult with her about my positive test and symptoms, she prescribed the PAXLOVID. I started taking the medication, I was feeling better within the five days of taking the course of the medication. Three days after finishing the medication I started feeling bad again, I started having a croupy cough. I stayed in quarantine; I wore a mask when no one was home walked to the front door to go outside walked around the neighborhood to get my lungs to take the deep breaths. In total I was in quarantine for a total of 21 days. My strength is returning, and I feel I have recovered fully.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a low-grade fever, runny nose, a really bad headache, I used a home COVID-19 test that came back positive. I called my doctor to consult with her about my positive test and symptoms, she prescribed the PAXLOVID. I started taking the medication, I was feeling better within the five days of taking the course of the medication. Three days after finishing the medication I started feeling bad again, I started having a croupy cough. I stayed in quarantine; I wore a mask when no one was home walked to the front door to go outside walked around the neighborhood to get my lungs to take the deep breaths. In total I was in quarantine for a total of 21 days. My strength is returning, and I feel I have recovered fully.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphagia, Gait disturbance, Orthosis user, Pain in extremity, Tendon disorder
Clinical narrative: 12/26/22 My feet became very sensitive and started hurting.  I am used to that, but generally recover quickly. While I was on a trip, I had issues with walking. Eventually, I could not stand.  I treated it as if it was plantar fasciitis. I continued self-treating. I went to my PCP who sent me to a podiatrist. The podiatrist said it was my Achilles tendon.  I have been wearing a boot for over a month. I was prescribed a lidocaine, meloxicam and baclofen cream.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: X-ray limb abnormal
Clinical narrative: 12/26/22 My feet became very sensitive and started hurting.  I am used to that, but generally recover quickly. While I was on a trip, I had issues with walking. Eventually, I could not stand.  I treated it as if it was plantar fasciitis. I continued self-treating. I went to my PCP who sent me to a podiatrist. The podiatrist said it was my Achilles tendon.  I have been wearing a boot for over a month. I was prescribed a lidocaine, meloxicam and baclofen cream.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood test abnormal, Pain, Pain in extremity, Red blood cell count increased
Clinical narrative: The red blood count is high and it could have a stroke, I have a burning pain in my leg. I went to the doctor and they did the blood test showed the blood cells were very high. I took some vitamins and hot and cold patches to help with the knee pain.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 5/15/2023; expired date of 5/11/2023
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 9/30/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Sex: M
Vaccine: VARZOS
Symptoms: Blood cholesterol increased, Blood glucose increased, Blood immunoglobulin E increased
Clinical narrative: Glucose blood increased; This non-serious case was reported by a consumer and described the occurrence of blood glucose increased in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included cetirizine hydrochloride (Zyrtec), lamotrigine and simvastatin.   On 03-MAY-2023, the patient received Shingrix. On 04-MAY-2023, 1 days after receiving Shingrix, the patient experienced blood glucose increased (Verbatim: Glucose blood increased). The outcome of the blood glucose increased was not resolved.   It was unknown if the reporter considered the blood glucose increased to be related to Shingrix.     It was unknown if the company considered the blood glucose increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAY-2023 This report was submitted by patient via the online direct entry reporting system.  The patient suffered from Glucose blood increased the day after receiving Shingrix vaccine. The patient had high IgE level, high cholesterol bad cholesterol level. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: Interchange of vaccine products, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Denies side effects or symptoms / no additional AE; 1st dose with MMR II and Varivax and 2nd dose with Proquad; PROQUAD second dose prior to age of 4-6 years of age.; This spontaneous report was received from a nurse and refers to a 15-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-OCT-2022 (at 12 months old), the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (M-M-R II) injection, lot #U006489, expiration date reported and confirmed upon internal validation as 26-FEB-2023 (exact dose, frequency, route and site of administration were not reported), and on the same day, she was vaccinated individually with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot #U039722, expiration date reported and confirmed upon internal validation as 15-DEC-2023 (exact dose, route and site of administration were not reported), both for prophylaxis. On 23-JAN-2023 (at 15 months old), the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin) (PROQUAD) injection, lot #W028564, expiration date reported and confirmed upon internal validation as 06-MAR-2024 (exact dose, frequency, route and site of administration were not reported) as second dose, also for prophylaxis (interchange of vaccine products, product administered to patient of inappropriate age). Side effects or symptoms were denied (no adverse event).
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; Nurse reported adult patient was accidently administered a pediatric dose of VAQTA; This spontaneous report was received from a nurse, referring to 19-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 05-MAY-2023, the patient was accidentaly vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (0.5 mL, lot #1966105 which has been verified to be a not valid lot number, expiration date was reported as 06-FEB-2024, route of administration and anatomical location were not provided) for prophylaxis (Adult use of a child product). No further information provided. No additional adverse event reported (No adverse event). No product quality complaint (PQC) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Caller confirmed that no symptomatic side effects were reported; Nurse calling to report administration of PROQUAD to an adult patient.; This spontaneous report has been received from a nurse, concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 08-MAY-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection at a dose of 0.5 milliliters (ml) as prophylaxis (product administered to patient of inappropriate age) (strength, route of administration, anatomical location, lot number, and expiration date were not provided). No symptomatic side effects were reported. No additional adverse events were reported
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE; HCP called to inform patient received expired dose of GARDASIL 9. HCP refused to provide patients first name. MIR on 02386787. No Additional AE/PQC.; This spontaneous report was received from an other health professional and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions/allergies were not reported.  On 09-MAY-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 mL, once (X1), administered intramuscularly (lot# T030749, expiration date and internal validation established as 16-MAR-2023) (strength was not provided) for prophylaxis (expired product administered). No additional adverse event (AE) or product quality complaints (PQCs) were reported.
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was recived from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 18-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excurson total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until aftre the first fact due to employee errror of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occured in the point of storage in clinical practice.  This is one of several reports recived from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No issue. No adverse event on patient.; Temeprature excurseion total time 25 min, 3 excursion. Escursion were not noted until after the fact due to employee error of cleanning data logger more than once a day; This spontaneous report has been received from a office manager, regarding a 13-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-SEP-2022, the patient was vaccinated with one improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, as prophylaxis (lot number and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (Strength, dose, scheme, route and anatomical location of administration were not reported).  Temperature excursion total time was of 25 minutes, divided in 3 temperature excursions, one on 09-SEP-2022 for 8 minutes, one on 16-SEP-2022 for 5 minutes and another one on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines were purchased with public, and privet founds and were given in private doctor's office/ hospital. The medication error occurred in the point of storage in clinical practice. No additional adverse event was reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot and got shingles / suspected vaccination failure; Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included autologous hematopoietic stem cell transplant (in August 2020). Concurrent medical conditions included blood cholesterol increased. Concomitant products included acetylsalicylic acid (Aspirin), atorvastatin and acyclovir.   In JUL-2022, the patient received Shingles vaccine. On 17-APR-2023, between 8 and 10 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot and got shingles / suspected vaccination failure) (serious criteria hospitalization and GSK medically significant) and shingles (Verbatim: Shingles) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 08-MAY-2023 The patient self-reporter this case. The patient got shingles vaccine as part of protocol. Took Acyclovir after treatment until January 2023. The patient was in hospital for Shingles after receiving Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a other health professional and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-MAY-2023 The patient experienced Shingles after receiving Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter was consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and got internal shingles/ suspected vaccination failure; Got internal shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and got internal shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got internal shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The patient got the shot and also got internal shingles.  They come and go frequently. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine, have shingles on hand/ suspected vaccination failure; Shingles on hand; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the vaccine, have shingles on hand/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on hand). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The patient had the vaccine and had shingles on his/her hand. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Had both shots, still got shingles/Suspected vaccination failure; Still got shingles, it's awful; Ribs feel like they're broke; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shots, still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Still got shingles, it's awful) and feeling abnormal (Verbatim: Ribs feel like they're broke). The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling abnormal were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 The case was received from the patient via interactive digital media. The consumer reported he or she took both the vaccine shots. He or she still got the shingles which were awful. His or her ribs felt like they were broken. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My Mom took it and still got it/Suspected vaccination failure; Got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My Mom took it and still got it/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's children via interactive digital media. The patient took shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles a year after we got the vaccine/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 (Verbatim: Got shingles a year after we got the vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and after one year he or she experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available. This case had been linked with US2023AMR066798 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR066798:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shots gave me shingles, suspected vaccination failure; shingles; This serious case was reported by a nurse via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of herpes zoster (Hepatitis B shots in 90s gave the shingles to patient, refer case US2023AMR067343).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shots gave me shingles, suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR067343   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient reported that Shingles vaccine shots gave him or her shingles. The patient said did not do shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR067343, reported by same reporter for different vaccine for same patient.; Sender's Comments:  US-GSK-US2023AMR067343:Same patient, same report, different vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Had the shots, get a mild form of shingles every year; Shingles mild case every year; Shooting pain; Entire body is itchy; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got mild form of shingles every year around February).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shots, get a mild form of shingles every year) (serious criteria GSK medically significant), shingles (Verbatim: Shingles mild case every year), shooting pain (Verbatim: Shooting pain) and pruritus (Verbatim: Entire body is itchy). The outcome of the vaccination failure was unknown and the outcome of the shingles, shooting pain and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, shooting pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, shooting pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient got a mild form of shingles every year around February first comes like clockwork. The patient had the shots did not prevent it.  It was horrible he/she got shooting pain his/her entire body was itchy. 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. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: i went into violent convulsions; This serious case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On 01-SEP-2022, the patient received Shingles vaccine. On 02-SEP-2022, 1 days after receiving Shingles vaccine, the patient experienced convulsion (Verbatim: i went into violent convulsions) (serious criteria GSK medically significant).  The outcome of the convulsion was not reported.  It was unknown if the reporter considered the convulsion to be related to Shingles vaccine.  It was unknown if the company considered the convulsion to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that, he/she took the shingles vaccine. On September 2, exactly 24 hour later, he/she went into violent convulsions. The reporter had stated that, he/she would never again would take any kind of vaccine. The follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Had shingles; shingles; Itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient had shingles after getting the shot, only itching and loved being in the summer heat.  MD put him/her on medicine, and they helped. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The reporter said that shingles shot gave her husband Bell's palsy.  These shots were worse than the actual disease. The reporter said do not do it. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shots; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shots) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient had the shots and still got 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. The follow-up would not possible as no contact details were available.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Intussusception
Clinical narrative: Intussusception; This serious case was reported by a physician via sales rep and described the occurrence of intussusception in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX).   On 17-APR-2023, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 26-APR-2023, 9 days after receiving Rotarix lyophilized formulation, the patient experienced intussusception (Verbatim: Intussusception) (serious criteria GSK medically significant). The outcome of the intussusception was resolving.   It was unknown if the reporter considered the intussusception to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the intussusception to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2023. The reporter reported that Rotarix first dose given orally on 15 February 2023 with no issues Rotarix 2nd dose given orally on 17 April 2023 and baby developed intussusception on 26 April 2023.  Baby's condition improved after treatment.  The doctor did not sure if related to product.  Either doctor or nurse could be contacted for more information. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles after getting the vaccine; I got shingles after getting the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got shingles after getting the vaccine) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles after getting the vaccine). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient got shingles after getting the vaccine. The reporter said you could get them do not believe everything you were reading. 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. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pain, Vaccination failure
Clinical narrative: My reaction to the shingles vaccine was shingles; My reaction to the shingles vaccine was shingles; I am in terrible pain; meds to treat it make me extremely tired; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My reaction to the shingles vaccine was shingles) (serious criteria GSK medically significant), shingles (Verbatim: My reaction to the shingles vaccine was shingles) (serious criteria GSK medically significant), pain (Verbatim: I am in terrible pain) and tiredness (Verbatim: meds to treat it make me extremely tired). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and tiredness were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient's reaction to the shingles vaccine was shingles.  The patient was in terrible pain and the medicine to treat it make him/her extremely tired. 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. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Influenza, Vaccination failure
Clinical narrative: shingles fired up this week; Not happy was sick; like flu with both vaccination; shingles fired up this week; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In SEP-2022, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles fired up this week). On an unknown date, the patient experienced vaccination failure (Verbatim: shingles fired up this week) (serious criteria GSK medically significant), sickness (Verbatim: Not happy was sick) and influenza (Verbatim: like flu with both vaccination). The outcome of the vaccination failure was unknown and the outcome of the shingles, sickness and influenza were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, sickness and influenza to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, sickness and influenza to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient had vaccination and booster; shingles fired up this week.  Not happy, was sick, like flu with both vaccinations. 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. The follow-up would not possible as no contact details were available.