chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Cardiac failure congestive, Cardiac stress test abnormal, Cardiomegaly, Chest X-ray abnormal
Clinical narrative: Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Chronic left ventricular failure, Death, Dilated cardiomyopathy
Clinical narrative: Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Genetic testing, Haematemesis, Headache
Clinical narrative: Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatomegaly, Hypoaesthesia, Myocardial oedema, Nausea, Night sweats
Clinical narrative: Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Orthopnoea, Oxygen saturation decreased, Palpitations, Peripheral swelling, Pulmonary infarction
Clinical narrative: Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory distress, Sepsis, Sinus tachycardia, Systemic lupus erythematosus, Tachypnoea
Clinical narrative: Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Vision blurred, Vitamin D decreased, Vomiting
Clinical narrative: Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body
Age: 14.0
Sex: M
Vaccine: HPV9, IPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age vaccine (subQ) given into Deltoid muscle on 3/12/2025 at 15:00. MD notified and MD notified patients mother. No current symptoms.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; HCP called to report a patient received an expired dose of VARIVAX. The expiration date was 03/12/2025 and the product was administered 03/14/2025. No side effects or symptoms reported. Caller verified no temperature excursions occurred. No Additiona; This spontaneous report was received from a registered nurse and refers to a 15-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 14-MAR-2025, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka-Merck) (VARIVAX) injection, 0.5 ml, lot #X007373, expiration date: 12-MAR-2025 (dose number, route of administration and anatomical location were not provided), for prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (route of administration, anatomical location, lot# and expiration date were not reported). No side effects or symptoms reported. The reporter verified no temperature excursions occurred and requested to review stability information. No additional adverse event was reported (No adverse event).
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; 65 year-old male received Gardasil 9 in the left arm; This spontaneous report was received from a nurse and refers to a 65-year-old male patient.   The patient's medical history, current conditions, and concomitant medications were not provided.  On 25-FEB-2025, the patient was vaccinated with a single dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection (lot #Y014510 who had been verified to be a valid lot number, expiration date was not provided but upon internal validation assessed as 01-NOV-2026) administered in left arm as prophylaxis (exact dose was not provided) (product administered to patient of inappropriate age).  No additional adverse event.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: patient died; got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced death (Verbatim: patient died) (serious criteria death and GSK medically significant) and shingles (Verbatim: got the shingles). The outcome of the shingles was not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the death and shingles to be related to Shingles vaccine.     The company considered the death to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her mother-in-law at age got the singles vaccination, then immediately got the shingles. Then a month or two after getting shingles she took the covid vaccination. The reporter begged her not to. She said if anything happens to her, she lived a great life. She took the jab and died a month later. It was unknown if the reporter considered the death and shingles to be related to COVID-19 vaccine.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: My mom died a week after the shingle vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included dementia.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: My mom died a week after the shingle vaccine) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     The company considered the unknown cause of death to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient's child via interactive digital media. The patient (mom) passed (died) away one week after that Shingles vaccine.  She had dementia but otherwise was very healthy on a couple of medications; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Unknown cause of death
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Incomplete course of vaccination
Clinical narrative: knuckles hurting; Incomplete course of vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in joint involving hand in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in joint involving hand (Verbatim: knuckles hurting) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the pain in joint involving hand was not resolved and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the pain in joint involving hand to be related to Shingrix.     It was unknown if the company considered the pain in joint involving hand to be related to Shingrix.   Additional Information: GSK receipt date: 09-MAR-2025 Patient stated that they wanted to know why his knuckles are still hurting after getting only 1 shingles shot which was they believed in October 2023, which was 1 year and 7 months ago. No more questions other than knuckles hurting. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got the 50 yr old single Shingles shot years ago.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got the 50 yr old single Shingles shot years ago.  ). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 12-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that this was exactly why afraid to get the shots.  The warnings on the commercials scare of that. The patient got the 50 years old single Shingles shot years ago.  Apparently that the patient had witness her boyfriend and father go through this.  She thought she only had measles when was younger and after her boyfriend got shingles, had a blood test to confirm indeed had chicken pox. As much as did not ever wish to experience shingles, the shot(s) side affects scare me and said sorry that had such a horrible experience. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; still goi it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: still goi it). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2025 and 14-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that she had a shot and still got it. This case was considered as suspected vaccination failure as details regarding time to onset for Respiratory syncytial virus infection and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I had the vaccine and still got shingles a milder case however/terrible itching/skin looks 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine and still got shingles a milder case however/terrible itching/skin looks terrible). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine and still got shingles it was milder case, however he/she was recovering from shingles but just terrible itching and his/her skin looks terrible. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had the shingles twice; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the shingles twice). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media The patient had the shingles twice, but had taken all the shots.  The reporter said stop sending these ads. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; nerve damage; 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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and nerve damage (Verbatim: nerve damage). The outcome of the vaccination failure, shingles and nerve damage were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and nerve damage to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media. Patient had the shingles vaccine but ended up getting shingles. It was the worst pain ever, and it caused nerve damage. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 18 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The patient got shingles 18 months after receiving the second shot. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(Dose 1 & 2)..
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles again; 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.   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: had shingles again). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had shingles, got the Shingles shot, and have had shingles again which was not fair. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got them; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles (Verbatim: I got them). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that he/she got them after first vaccine was deemed ineffective, and they asked if he/she got them from the new vaccine or without.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Then came down with shingles that lasted a year; Then he was given a double dose; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Then came down with shingles that lasted a year) and extra dose administered (Verbatim: Then he was given a double dose). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 13-MAR-2025  This case was reported by a patient via interactive digital media. The reporter reported that his/her brother-in-lawgot the shingles shot.  Then came down with shingles that lasted a year and then he was given a double dose, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; had the vaccine and still got 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: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine and still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2025 This case was reported by a patient via interactive digital media The patient had the Shingles vaccine and still got shingles This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Device connection issue, Underdose
Clinical narrative: glass little part that you screw in the needle tto, that little glass part is loose/syringe popped off; Product Complaint; needle stuck; not all the liquid not all the vaccine went in to the patient's leg"; This non-serious case was reported by a nurse via call center representative and described the occurrence of needle stick/puncture in a 8-month-old female patient who received Hib (Hiberix) (batch number 34L24) and (batch number 2R3BY, expiry date 15-JUL-2026) for prophylaxis. This case was associated with a product complaint.   On 04-MAR-2025, the patient received Hiberix. On 04-MAR-2025, an unknown time after receiving Hiberix, the patient experienced needle stick/puncture (Verbatim: needle stuck) and incomplete dose administered (Verbatim: not all the liquid not all the vaccine went in to the patient's leg"). On an unknown date, the patient experienced device connection loose (Verbatim: glass little part that you screw in the needle tto, that little glass part is loose/syringe popped off) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the needle stick/puncture was not reported and the outcome of the incomplete dose administered, device connection loose and pharmaceutical product complaint were not applicable.   It was unknown if the reporter considered the needle stick/puncture and device connection loose to be related to Hiberix.     It was unknown if the company considered the needle stick/puncture and device connection loose to be related to Hiberix.   Additional Information: GSK Receipt Date: 04-MAR-2025 The nurse reported that in the prefilled syringe in the glass little part that you screw in the needle too, that little glass part was loose.  So the nurse was assuming that when she put the pressure it went through and it popped-off in that part, she when she was injecting it with the pressure of the injection popped it off and not all the liquid not all the vaccine went in to the patient's leg. The nurse reported that once the Hiberix was mixed and the needle was placed in the patient's left leg the syringe popped off and the needle stuck in the babies left leg. The defect was discovered during administration. The product was only partially administered which led to incomplete dose adminstred. Syringe was involved in the complaint. There was no defect or damage on the syringe noticed. When removing the cap, it was screwed off.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: extra dose/Inappropriate schedule; 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 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B532G, expiry date 11-APR-2027) for prophylaxis.   Previously administered products included Pediarix (Patient received first dose on an unknown date), Pediarix (Patient received second dose on 09-OCT-2024) and Pediarix (patient received third dose on an unknown date).   On 02-FEB-2025, the patient received the 4th dose of Pediarix. On 02-FEB-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: extra dose/Inappropriate schedule). The outcome of the extra dose administered was not applicable.   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: 05-MAR-2025 Medical Assistant reported that a 6 month old patient completed Diphtheria, Tetanus, Pertussis Vaccine 2 doses on October ninth twenty twenty-four, they went to after that and the patient got vaccinated again for Diphtheria, Tetanus, Pertussis Vaccine there, the pharmacy was not aware of that.  So, on February second patient received the 3rd Diphtheria, Tetanus, Pertussis Vaccine dose as recommended by the profile.  Medical Assistant wanted to know as for the parent´s concern on the child´s health. Patient received fourth dose of Pediarix, which led to extra dose administered.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was given Infanrix instead of Tdap; given to an 11 year old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 73SX2, expiry date 24-MAR-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 03-MAR-2025, the patient received Infanrix. On an unknown date, the patient did not receive Tdap Vaccine. On 03-MAR-2025, an unknown time after receiving Infanrix and not applicable after receiving Tdap Vaccine, the patient experienced wrong vaccine administered (Verbatim: patient was given Infanrix instead of Tdap) and inappropriate age at vaccine administration (Verbatim: given to an 11 year old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   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: 13-MAR-2025 The staff member stated a patient was given Infanrix instead of Tdap which led to, wrong vaccine administered and inappropriate age at vaccine administration.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: lump on the injection site; pain in injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-JAN-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site lump (Verbatim: lump on the injection site) and injection site pain (Verbatim: pain in injection site). The outcome of the injection site lump and injection site pain were unknown.   It was unknown if the reporter considered the injection site lump and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site lump and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date : 13-MAR-2025  A patient had this vaccine last January twenty-twenty five, patient complained about a lump on the injection site and pain in injection site.  The reporter questioned how much was this gonna last.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Extra Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Extra Dose Administered). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 14-MAR-2025 The pharmacist reported that a patient who was unsure if they got the Arexvy vaccine twice, which led to extra dose administered. So, ask question was if they were vaccinated twice, whether, what should they do. The pharmacist did not have lot number of the vaccines and patient was not sure whether he received the Arexvy vaccine twice. Patient age was approximated by the health care professional between 75-76 years old.
Sex: F
Vaccine: COVID19
Symptoms: Death, Internal haemorrhage, Lung neoplasm malignant, Thrombosis
Clinical narrative: stage 4 lung cancer; internal bleeding; head to toe Blood clots; death; This spontaneous report received from a consumer concerned a female patient of unspecified age. received via JnJ managed social media.   The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced death. On an unspecified date, the patient experienced stage 4 lung cancer and was hospitalized on an unspecified date. On an unspecified date, the patient experienced internal bleeding and was hospitalized on an unspecified date. On an unspecified date, the patient experienced head to toe blood clots and was hospitalized on an unspecified date. (dose series 1) The patient had internal bleeding. One month in the hospital with no answers and then they said she developed head to toe blood clots and stage 4 lung cancer. It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable.    Reported cause of death was unknown cause of death.  The patient died on an unspecified date. The outcome of stage 4 lung cancer, internal bleeding and head to toe blood clots was not reported.  This report was serious (death and caused/prolonged hospitalization).; Sender's Comments: V0; Death, Lung neoplasm malignant, Internal haemorrhage and Thrombosis; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: unknown cause of death
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The adverse event was that the medication was expired at the time it was given.  No adverse reaction by patient.
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medication given pass the expiration date. No other adverse reactions noted or reported by pt parents.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medication given pass the expiration date. No other adverse reactions noted or reported by pt parents.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered Abrysvo outside of administration window. Administering medical assistant inadvertently grabbed Beyfortus as Abrysvo was no longer available at the site. Beyfortus was administered to the patient. Provider contacted patient and informed her of the inadvertent administration. Patient reported no adverse side effects.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Dysphonia, Lip erythema, Lip pruritus
Clinical narrative: Ball feeling in throat, having difficulty swallowing. fluid pooling in mouth . itchy right shoulder.  lips swollen, itchy, & red. lightheadness. voice going horse.  buring sensation down back of throat.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus, Sensation of foreign body, Throat irritation
Clinical narrative: Ball feeling in throat, having difficulty swallowing. fluid pooling in mouth . itchy right shoulder.  lips swollen, itchy, & red. lightheadness. voice going horse.  buring sensation down back of throat.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Deceased, anticipated and on hospice care.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FluBlok given instead of Fluzone; no adverse reactions
Age: 0.92
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was due for Dtap and polio according to the system. Medical assistant seen that we had a combination immunization in the VFC stock for children for the 2 immunizations due and administered the combination medication. After the combination immunization was administered and patient left the medical assistant was putting it into epic when it gave an alert that the child was not yet old enough for that particular immunization combination. After further investigation the immunization combination that was administered was found to be for children 4 to 6 years of age and the patient in question is 11 months old. The health department was contacted and notified of the adverse event and gave guidance on how to handle the situation and what all steps needed to be taken. The patients' parent was contacted and told about the adverse event and re-educated on the adverse reactions to look out for and when to contact our office if they do present or if the patient's parent has any further questions. The medical assistant was re-educated on immunization administration, additional learning was assigned, and new safeguards were put in place.