chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal
Clinical narrative: 3/20/22  I have a history of PVC?s.  I felt like I had a cold and had started taking Zicam about three days before . The PVC?s got really bad where I was short of breath, and I was exhausted. They would last 8-10 hours without letting up. I saw a doctor who ordered tests, nothing showed up. Two days later, I went to the Emergency Room. I was diagnosed with PVC?s and was put on Metoprolol and said to follow up with my doctor and my cardiologist. I had an Echocardiogram the next week which showed no abnormalities in my heart. I have continued the Metoprolol and waiting to see a Cardiologist.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Full blood count normal, Nasopharyngitis, Red blood cell count normal, Tachycardia
Clinical narrative: 3/20/22  I have a history of PVC?s.  I felt like I had a cold and had started taking Zicam about three days before . The PVC?s got really bad where I was short of breath, and I was exhausted. They would last 8-10 hours without letting up. I saw a doctor who ordered tests, nothing showed up. Two days later, I went to the Emergency Room. I was diagnosed with PVC?s and was put on Metoprolol and said to follow up with my doctor and my cardiologist. I had an Echocardiogram the next week which showed no abnormalities in my heart. I have continued the Metoprolol and waiting to see a Cardiologist.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ventricular extrasystoles
Clinical narrative: 3/20/22  I have a history of PVC?s.  I felt like I had a cold and had started taking Zicam about three days before . The PVC?s got really bad where I was short of breath, and I was exhausted. They would last 8-10 hours without letting up. I saw a doctor who ordered tests, nothing showed up. Two days later, I went to the Emergency Room. I was diagnosed with PVC?s and was put on Metoprolol and said to follow up with my doctor and my cardiologist. I had an Echocardiogram the next week which showed no abnormalities in my heart. I have continued the Metoprolol and waiting to see a Cardiologist.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: storage and Handling Incident
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysphagia, Fatigue, Insomnia, Productive cough
Clinical narrative: I had a lot of phlegm, cough but no fever and felt very fatigue. The phlegm was hard to swallow and had trouble sleeping.  My symptoms lasted for over a month. I took a COVID-19 Test on 01/18/2023 and it was positive. I was prescribed Azithromycin and I also had a Promethazine DM cough medicine I took.  I have recovered from my symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a lot of phlegm, cough but no fever and felt very fatigue. The phlegm was hard to swallow and had trouble sleeping.  My symptoms lasted for over a month. I took a COVID-19 Test on 01/18/2023 and it was positive. I was prescribed Azithromycin and I also had a Promethazine DM cough medicine I took.  I have recovered from my symptoms.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine increased, Blood test abnormal, Dyspepsia, Gastrooesophageal reflux disease, Pain
Clinical narrative: It started as indigestion that got more and more painful.  In September 2021, I went to the emergency, and they told me I had acid reflux. I was given Omeprazole. After some time, the pain continued. In March 2022, I went to a GI doctor, and I was given a different medication, Pantoprazole and I continue taking that today.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: No adverse events happen. Spoke with parent patient tolerated it well.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic arteriosclerosis, Chronic respiratory failure, Obstructive sleep apnoea syndrome, Respiratory failure
Clinical narrative: G47.30 SLEEP APNEA 9/13/2021 ATHEROSCLEROSIS OF AORTA G47.33 OBSTRUCTIVE SLEEP APNEA 10/7/2021 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 10/7/2021 ATHEROSCLEROSIS OF AORTA J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 10/11/2021 ATHEROSCLEROSIS OF AORTA J96.10 CHRONIC RESPIRATORY FAILURE 9/13/2021 ATHEROSCLEROSIS OF AORTA G47.30 SLEEP APNEA 9/13/2021 ATHEROSCLEROSIS OF AORTA G47.33 OBSTRUCTIVE SLEEP APNEA 10/7/2021 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 10/7/2021 ATHEROSCLEROSIS OF AORTA J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 10/11/2021 ATHEROSCLEROSIS OF AORTA J96.10 CHRONIC RESPIRATORY FAILURE 9/13/2021 ATHEROSCLEROSIS OF AORTA
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome
Clinical narrative: G47.30 SLEEP APNEA 9/13/2021 ATHEROSCLEROSIS OF AORTA G47.33 OBSTRUCTIVE SLEEP APNEA 10/7/2021 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 10/7/2021 ATHEROSCLEROSIS OF AORTA J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 10/11/2021 ATHEROSCLEROSIS OF AORTA J96.10 CHRONIC RESPIRATORY FAILURE 9/13/2021 ATHEROSCLEROSIS OF AORTA G47.30 SLEEP APNEA 9/13/2021 ATHEROSCLEROSIS OF AORTA G47.33 OBSTRUCTIVE SLEEP APNEA 10/7/2021 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 10/7/2021 ATHEROSCLEROSIS OF AORTA J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 10/11/2021 ATHEROSCLEROSIS OF AORTA J96.10 CHRONIC RESPIRATORY FAILURE 9/13/2021 ATHEROSCLEROSIS OF AORTA
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Rash
Clinical narrative: tired, lethargy, rash which has spread to neck and arm area (started 48 hours post vaccination)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray abnormal, Chills, Dizziness
Clinical narrative: This started with chills. I started to get a little lightheaded and my oxygen level was low. I went to see the doctor who asked for chest x rays that revealed pneumonia. Tested positive on a PCR COVID-19 test. The next day I felt much better with my energy returned. Symptoms pretty much cleared up within a week.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: This started with chills. I started to get a little lightheaded and my oxygen level was low. I went to see the doctor who asked for chest x rays that revealed pneumonia. Tested positive on a PCR COVID-19 test. The next day I felt much better with my energy returned. Symptoms pretty much cleared up within a week.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: pt received vaccine that was stored improperly,, store in fridge past use by date of 1/29/23
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received vaccine that was improperly stored. it should have been disposed of on the use by date of 1/27/23
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Eye contusion
Clinical narrative: Patient developed bruising around left eye with no pain or tenderness.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Gastrointestinal disorder
Clinical narrative: About a month after being vaccinated, I noticed something wasn't right with my stomach. I went out of town and when I came back, I still had abdominal pain and went to the doctor. They scheduled appointment for a Gastroenterologist. This has been going on for about a year.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Storage and Handling Incident.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adrenal disorder, Biopsy thyroid gland, Blood creatinine increased, Blood pressure increased, Blood test abnormal
Clinical narrative: I saw my PCP on 1/5/2023. On that day, my blood pressure was slightly elevated, and that was the first time I had noticed that I had possibly had blood pressure issues. After that, I began monitoring my blood pressure more carefully. During that visit, my PCP was trying to pinpoint a possible cause for the elevated blood pressure. A blood test was done, and there were indications of irregularities of the thyroid gland. He then referred me to an endocrinologist. I went to the endocrinologist on 1/10/2023. She scheduled me to undergo a thyroid ultrasound on 1/19/2023. She also put me on a thyroid medication, methimazole. On 1/19/2023, I underwent the ultrasound. The results indicated that I had nodules on my thyroid, two of which were suspicious. The endocrinologist then scheduled me to undergo a biopsy, which I did on 4/27/2023. I am currently awaiting the results of the biopsy. I saw my PCP on 4/25/2023. He did a general review of all of my blood tests and checked my blood pressure, which was perfect that day. This occurred after I had my dosages of blood pressure medications incrementally increased. The increases took place on 1/26/2023, 2/12/2023, 2/14/2023, 3/13/2023, and 3/25/2023. I was also prescribed a new medication, olmesartan medoxomil, on 3/13/2023. My PCP has scheduled me for a nuclear coronary stress test on 5/17/2023. He has also scheduled me to undergo a conservation urine test, in which I keep samples of all of my urine during a 24-hour period and then submit them for testing. This procedure is being done, because I had slightly abnormal readings for my adrenal function. Also, on 1/25/2023, I was switched over from Genvoya to Biktarvy.  On4/7/2023, I underwent another blood test, which indicated that I had abnormal adrenal function and kidney function. The doctor was not concerned about my kidney function, though, as my kidney function has been slightly abnormal for some time. Also, the elevated creatinine levels may have been the result of the HIV medication I was taking. He had mentioned that the medication was tough on kidneys, but mine were holding up pretty well.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram heart abnormal, Coronary artery stenosis, Renal impairment, Therapy change, Thyroid disorder
Clinical narrative: I saw my PCP on 1/5/2023. On that day, my blood pressure was slightly elevated, and that was the first time I had noticed that I had possibly had blood pressure issues. After that, I began monitoring my blood pressure more carefully. During that visit, my PCP was trying to pinpoint a possible cause for the elevated blood pressure. A blood test was done, and there were indications of irregularities of the thyroid gland. He then referred me to an endocrinologist. I went to the endocrinologist on 1/10/2023. She scheduled me to undergo a thyroid ultrasound on 1/19/2023. She also put me on a thyroid medication, methimazole. On 1/19/2023, I underwent the ultrasound. The results indicated that I had nodules on my thyroid, two of which were suspicious. The endocrinologist then scheduled me to undergo a biopsy, which I did on 4/27/2023. I am currently awaiting the results of the biopsy. I saw my PCP on 4/25/2023. He did a general review of all of my blood tests and checked my blood pressure, which was perfect that day. This occurred after I had my dosages of blood pressure medications incrementally increased. The increases took place on 1/26/2023, 2/12/2023, 2/14/2023, 3/13/2023, and 3/25/2023. I was also prescribed a new medication, olmesartan medoxomil, on 3/13/2023. My PCP has scheduled me for a nuclear coronary stress test on 5/17/2023. He has also scheduled me to undergo a conservation urine test, in which I keep samples of all of my urine during a 24-hour period and then submit them for testing. This procedure is being done, because I had slightly abnormal readings for my adrenal function. Also, on 1/25/2023, I was switched over from Genvoya to Biktarvy.  On4/7/2023, I underwent another blood test, which indicated that I had abnormal adrenal function and kidney function. The doctor was not concerned about my kidney function, though, as my kidney function has been slightly abnormal for some time. Also, the elevated creatinine levels may have been the result of the HIV medication I was taking. He had mentioned that the medication was tough on kidneys, but mine were holding up pretty well.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Thyroid mass, Ultrasound kidney normal, Ultrasound thyroid abnormal
Clinical narrative: I saw my PCP on 1/5/2023. On that day, my blood pressure was slightly elevated, and that was the first time I had noticed that I had possibly had blood pressure issues. After that, I began monitoring my blood pressure more carefully. During that visit, my PCP was trying to pinpoint a possible cause for the elevated blood pressure. A blood test was done, and there were indications of irregularities of the thyroid gland. He then referred me to an endocrinologist. I went to the endocrinologist on 1/10/2023. She scheduled me to undergo a thyroid ultrasound on 1/19/2023. She also put me on a thyroid medication, methimazole. On 1/19/2023, I underwent the ultrasound. The results indicated that I had nodules on my thyroid, two of which were suspicious. The endocrinologist then scheduled me to undergo a biopsy, which I did on 4/27/2023. I am currently awaiting the results of the biopsy. I saw my PCP on 4/25/2023. He did a general review of all of my blood tests and checked my blood pressure, which was perfect that day. This occurred after I had my dosages of blood pressure medications incrementally increased. The increases took place on 1/26/2023, 2/12/2023, 2/14/2023, 3/13/2023, and 3/25/2023. I was also prescribed a new medication, olmesartan medoxomil, on 3/13/2023. My PCP has scheduled me for a nuclear coronary stress test on 5/17/2023. He has also scheduled me to undergo a conservation urine test, in which I keep samples of all of my urine during a 24-hour period and then submit them for testing. This procedure is being done, because I had slightly abnormal readings for my adrenal function. Also, on 1/25/2023, I was switched over from Genvoya to Biktarvy.  On4/7/2023, I underwent another blood test, which indicated that I had abnormal adrenal function and kidney function. The doctor was not concerned about my kidney function, though, as my kidney function has been slightly abnormal for some time. Also, the elevated creatinine levels may have been the result of the HIV medication I was taking. He had mentioned that the medication was tough on kidneys, but mine were holding up pretty well.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: What happened was the MA, drew up Proquad, Proquad diluent, and Varivax (all on one syringe) and it was administered to the patient. A double check was done by MA, but not until they were already drawn up. At that point it was labeled MMRV so MA thought it was Proquad. I contact agency and spoke with staff @ 1413. I told her the situation and she said that the patient got an extra dose of varicella. She advised we call the parents and discuss the following: There is an increased risk of febrile seizures with the additional dose of varicella. Watch for fevers and give acetaminophen and/or ibuprofen to reduce fevers as needed.  Staff will contact the patients parent and discuss.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, COVID-19, Cough, Pain in extremity, Pyrexia
Clinical narrative: The booster I had no reaction, other than my arm was a little sore. 04/26/2023, low grade fever and slight congestion and a slight cough. I probably would not have known that I had it, but my husband had it and he had it much worse than I had it. I took a COVID-19 nose test on 04/26/2023, there was a slight 2 lines, it was negative. The next morning, on 04/27/2023, I took another COVID-19 nose test and the result was a bright line, it was positive. Within an hour and a half, I went to see my doctor, and he prescribed Paxlovid. My symptoms were very mild prior to taking the Paxlovid and they never got any worse. My symptoms got better, and they started to improve. I am on my final day today, 05/01/2023, of taking the Paxlovid. My temperature is still a little bit high. It fluctuates from 98 - 99, which is unusual for me, otherwise I feel fine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: The booster I had no reaction, other than my arm was a little sore. 04/26/2023, low grade fever and slight congestion and a slight cough. I probably would not have known that I had it, but my husband had it and he had it much worse than I had it. I took a COVID-19 nose test on 04/26/2023, there was a slight 2 lines, it was negative. The next morning, on 04/27/2023, I took another COVID-19 nose test and the result was a bright line, it was positive. Within an hour and a half, I went to see my doctor, and he prescribed Paxlovid. My symptoms were very mild prior to taking the Paxlovid and they never got any worse. My symptoms got better, and they started to improve. I am on my final day today, 05/01/2023, of taking the Paxlovid. My temperature is still a little bit high. It fluctuates from 98 - 99, which is unusual for me, otherwise I feel fine.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, Bronchitis, Chest X-ray normal, Chest discomfort, Condition aggravated
Clinical narrative: 3/30/23  I woke up with tightness in my chest indicating an asthma episode. I took my inhalers and it subsided. The next day it was a tiny bit worse. I went to Urgent Care 4/1/23. I was diagnosed with Bronchitis.  I was prescribed Albuterol, Prednisone and an antibiotic.  I was pretty sick for about seven or eight days. I had to have a second round of  antibiotic and a small course of Prednisone. In about another week, things began to clear up.  I am on cough medicine. I have been off the nebulizer for about two weeks.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: 3/30/23  I woke up with tightness in my chest indicating an asthma episode. I took my inhalers and it subsided. The next day it was a tiny bit worse. I went to Urgent Care 4/1/23. I was diagnosed with Bronchitis.  I was prescribed Albuterol, Prednisone and an antibiotic.  I was pretty sick for about seven or eight days. I had to have a second round of  antibiotic and a small course of Prednisone. In about another week, things began to clear up.  I am on cough medicine. I have been off the nebulizer for about two weeks.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: What happened was the MA drew up Proquad, Proquad diluent, and Varivax (all on one syringe) and it was administered to the patient. A double check was done by another MA but not until they were already drawn up. At that point it was labeled MMRV so she thought it was Proquad. I contacted someone @ 1413. I told her the situation and she said that the patient got an extra dose of varicella. She advised we call the parents and discuss the following: There is an increased risk of febrile seizures with the additional dose of varicella. Watch for fevers and give acetaminophen and/or ibuprofen to reduce fevers as needed.  MA will contact the patients parent and discuss.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blindness unilateral, Echocardiogram, Electrocardiogram ambulatory, Retinal vascular occlusion, Ultrasound Doppler
Clinical narrative: I had my vaccination on 09/30/2022. In 03/2023 I started to have problems in my left eye for reading vision. I went to my optometrist and I could not see at all with my left eye. I was found to have a Branch Occlusion. I was referred to cardiologist and my tests were all shown that I am ok. The doctor gave me a injection to my left eye in 03/01/2023 and 04/05/2023. I am due for a 3rd injection on 05/05/2023.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Bexsero was given to patient instead of Menveo- no adverse reactions; no treatment needed
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Parent stated that no symptoms occurred
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Meningococcal was given/administered as a third dose. Vaccine was administered, 04/28/2023, extra as third dose when she had already received her second dose and was fully vaccinated for her age.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Cough, Dyspnoea, Fluid retention, Insomnia
Clinical narrative: I had shortness of breath, weight gain and soon after I was diagnosed with heart failure. I had a cough, I couldn't sleep laying down from fluid retention.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: I had shortness of breath, weight gain and soon after I was diagnosed with heart failure. I had a cough, I couldn't sleep laying down from fluid retention.
Age: 1.25
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient has had no adverse reactions or side effects; PROQUAD was given to a patient along with VARIVAX instead of MMR-II; 15 month old patient received an extra dose of Varicella; This spontaneous report was received from an operations manager for physician's office concerning to a 15-month-old male patient.  The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant medications included Merck sterile diluent.   On 21-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis along with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, 0.5 milliliter x 1dose, lot #W039843, expiration date: 12-JUN-2024, product  quantity: 1, administered subcutaneously as prophylaxis (anatomical location was not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). Therefore, the patient received an extra dose of varicella vaccine (extra dose administered).  Reporter also stated that the patient has had no adverse reactions or side effects (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Has had them 4 times/ 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Has had them 4 times/ 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: 25-MAR-2023 This case was reported by consumer cousin via interactive digital media. The reporter reported that his or her cousin received Singles vaccine still experienced shingles four times. The reporter stated that the vaccine does not help him or her. The reporter also stated that the shingles vaccine did not prevent you form getting shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and I've had shingles on my back/ suspected vaccination failure; Shingles on back; 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: I had the shot and I've had shingles on my back/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on back). 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: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles on his or her back for three times. 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: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: shot was terrible/shingles are worse/suspected vaccination failure; shot was terrible/shingles are worse; shot was terrible; 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: shot was terrible/shingles are worse/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shot was terrible/shingles are worse) and feels awful (Verbatim: shot was terrible). The outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-APR-2023 The case was received from the patient via interactive digital media. The patient stated that shot was terrible but shingles were worse. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: I still have pain/ still have stabbing pain; Had hand print size rash in the front under breast and the same on back right side; Had both shots. I got Shingles in August of 2021/ suspected vaccination failure; I got Shingles in August of 2021; 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. In AUG-2021, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shots. I got Shingles in August of 2021/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got Shingles in August of 2021). On an unknown date, the patient experienced pain (Verbatim: I still have pain/ still have stabbing pain) (serious criteria GSK medically significant) and rash (Verbatim: Had hand print size rash in the front under breast and the same on back right side). The outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2023 This case was reported by patient via interactive digital media. The patient had both shots and still had pain and had not been able to wear a bra since he/she got shingles.  The patient had a hand print size rash in the front under his/her breast and the same on his/her back right side.  The patient still had stabbing pain. 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. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had all vaccines and still break out/ suspected vaccination failure; Break out; 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 all vaccines and still break out/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Break out). 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 and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by patient via interactive digital media. The patient had all vaccines and still break out. 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. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and still got the shingles/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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and still got the 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.   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: 26-Mar-2023 The case was received form the patient via interactive digital media. The patient got the shot and still got the shingles. 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. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles even after got the shot/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 male 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 shingles even after got the shot/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: 26-MAR-2023 This case was reported by a patient's cousin via interactive digital media. The reporter stated that, the patient got shingles even after receiving shingles shot.  The reporter stated that getting the shingles shot did not actually make you immune unfortunately. 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. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shots & got shingles/suspected vaccination failure; shingles/ got shingles again and it was mild case; 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.   The patient's past medical history included shingles (had shingles).   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 shots & got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/ got shingles again and it was mild case). 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: 26-Mar-2023 The case was received form the patient via interactive digital media. The patient also had the shots and got the shingles again. The patient stated that it was a mild case. 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. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: I came down with Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy 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, 2 years after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: I came down with Bells Palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported.   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: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that please beware of shingles vaccine. The patient had shingles vaccine and came down with bell's palsy two years later. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR061465, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR061465:husband´s case
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; he came down with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: he came down with 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: 27-MAR-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that please beware of shingles vaccine. The patient had shingles vaccine, he came down with 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 case had been linked to US2023AMR061462, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR061462:reporter´s case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shot got shingles/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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot got 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.   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: 26-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was absolutely.  The patient had the shingles shot and two years later he/she got Shingles, the same week Covid lockdown started but no Covid vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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: Pain in extremity
Clinical narrative: quite painful, arm is still very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 24-MAR-2023, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: quite painful, arm is still very painful). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-MAR-2023 The case was received from the patient interactive digital media. The patient had shingles once long ago and did not remember it being that bad.  The patient got the shingles shot on the day of reporting and the shot itself was quite painful and now, 8 hours later, patient's arm was still very painful. The patient was not sure if he/she had got the shot and he/she knew the pain would be so bad. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Formication, Herpes zoster, Pain
Clinical narrative: Feel in my head as if snakes are walking on it; It gave me in my head, left side is just going to do a year; It's a terrible pain; Those painful blisters; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of crawling sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced crawling sensation (Verbatim: Feel in my head as if snakes are walking on it), shingles (Verbatim: It gave me in my head, left side is just going to do a year), pain (Verbatim: It's a terrible pain) and blister (Verbatim: Those painful blisters). The outcome of the crawling sensation was not resolved and the outcome of the shingles, pain and blister were resolved.   It was unknown if the reporter considered the crawling sensation, shingles, pain and blister to be related to Shingles vaccine.     It was unknown if the company considered the crawling sensation, shingles, pain and blister to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via  interactive digital media. The patient stated that it gave in his/her head, left side was just going to do a year and she/he still feel in her/his head as if snakes are walking on it.  That disease was horrible. The patient already got the first vaccine and he/she will get the second one.  The patient recommend, administered it on. it's a terrible pain and those painful blisters. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 Shingrix shots.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date the patient received 1st dose) and Shingrix (on an unknown date the patient received 2nd dose).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received 3 Shingrix shots.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The patient received three shots Shingrix. The patient wanted to know if there would be any adverse effects The reporter did not consent to follow up. The patient received 3rd shot shot of shingrix which led to extra dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: came down with Shingles; Excruciating Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: came down with Shingles) and pain (Verbatim: Excruciating Pain). The outcome of the shingles was not reported and the outcome of the pain was resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient's child via interactive digital media. The patient got the shingles shot and immediately came down with shingles and he had been laid up over a month excruciating pain. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Electric shock sensation, Pain
Clinical narrative: Had the symptoms, hurts a lot; Burning sensation, fire sensation; Burning sensation or electricity does not go away; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: Had the symptoms, hurts a lot), burning sensation (Verbatim: Burning sensation, fire sensation) and electric shock sensation (Verbatim: Burning sensation or electricity does not go away). The outcome of the pain, burning sensation and electric shock sensation were not resolved.   It was unknown if the reporter considered the pain, burning sensation and electric shock sensation to be related to Shingles vaccine.     It was unknown if the company considered the pain, burning sensation and electric shock sensation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient put on the shingles vaccine and got all the symptoms but got not blisters it's been 5 months and it still hurts a lot and that burning sensation or electricity does not go away patient don't know what to do. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.