chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Gait inability, General physical health deterioration, Glucose tolerance impaired
Clinical narrative: Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and  knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers.  These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hypercholesterolaemia, Hypertension, Immunisation reaction
Clinical narrative: Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and  knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers.  These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired driving ability, Impaired quality of life, Joint swelling, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and  knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers.  These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menopausal symptoms, Mouth ulceration, Musculoskeletal disorder, Oral candidiasis, Pain
Clinical narrative: Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and  knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers.  These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell count decreased, Rheumatoid arthritis, Sick building syndrome, Soft tissue swelling, Stress
Clinical narrative: Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and  knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers.  These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12 deficiency, X-ray limb abnormal
Clinical narrative: Shortly after receiving the COVID-19 vaccination, I experienced intermittent vague fatigue and mild joint pains which I attributed to stress and aging (in 2021 and 2022). In April of 2023, I rapidly developed a constellation of persistent and debilitating symptoms that significantly impacted my health and quality of life. These included severe joint swelling and pain, inability to use my hands for simple routine tasks, profound fatigue, persistent extreme tiredness, and a chronic cough, despite evaluation and treatment by multiple physicians. My cough only began to improve after nearly 18 months, with the initiation of antifungal therapy. In April 2023 when I began experiencing severe, joint pain in my hands and  knees. The pain came and went in flares, but during episodes it was extremely intense and disabling with inability to walk or drive. This all prompted an extensive autoimmune workup, referral to a rheumatologist, and initiation of aggressive treatment with medications such as methotrexate, high-dose prednisone, and biologic agents. I developed hypertension and elevation in my blood sugars. Additionally, I developed severe mouth ulcers.  These treatments, while necessary to manage my inflammatory joint disease, have caused their own burdens. Methotrexate, a chemotherapeutic agent, comes with significant side effects, and prolonged prednisone use has contributed to abnormal glucose levels and hypertension. Both the stress of my illness and the side effects of treatment have further impacted my metabolic health. I now require care from a multidisciplinary team that includes a rheumatologist, endocrinologist, ENT, pulmonary specialist, lipid specialist, cardiologist, and my primary care physician. Several of these providers have expressed concern that my symptoms and disease course were most likely triggered by an adverse immune reaction to the COVID-19 vaccine. This ongoing experience has been physically, emotionally, and medically overwhelming, as I continue to manage both the disease and the complex side effects of its treatment.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema
Clinical narrative: pain redness injection site and dizziness day after...dizziness resolved 2nd day, still red
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: patient had severe s/e of chills, fatigue , sight of injection was warm at touch and redness was patchy it seemed like patient had an allergic reaction
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: There is redness extending outward from the injection site around to my armpit. It is approximately 2-3 inches wide and 3-4 inches wide circling the arm. It is not hot to the touch but is still very tender withing the border of the redness/irritation. It does not itch. The redness was noticed on 14 June 2025, two days after injection.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Autonomic nervous system imbalance, Cardiac stress test, Catheterisation cardiac, Chest pain
Clinical narrative: Development of dysautonomia.  I got my covid vaccine (one of several but I think this was my 1st Moderna) Feb 22, 2022. On April 14, 2022 I had my 1st episode of high HR and passed out (I had had plasma knee inj the day before). I then have another episode of syncope later in the summer when I was at the amusement park and started being more careful about hydration and heat. Fast forward to my move March 2023. By May I was noticing high heart rate but it was too fast to really count accurately then I got my Apple watch and it verified that my heart rate was high at times. I noticed SOB and pre syncope walking up the big hill and just activity intolerance overall. Then Aug was my daughter s wedding (stressful) and then 10d later we lost someone (my nephew that committed suicide). With all the stress of the move, the wedding, the death it all snowballed and by Oct to Dec is when I remember the profound fatigue starting. Fast forward to now and I suffer daily from debilitating symptoms- fatigue, SOB, CP, GI symptoms, dizziness, blurry vision, & temperature dysregulation.  I am no longer able to work FT.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram ambulatory abnormal, Exercise tolerance decreased, Fatigue
Clinical narrative: Development of dysautonomia.  I got my covid vaccine (one of several but I think this was my 1st Moderna) Feb 22, 2022. On April 14, 2022 I had my 1st episode of high HR and passed out (I had had plasma knee inj the day before). I then have another episode of syncope later in the summer when I was at the amusement park and started being more careful about hydration and heat. Fast forward to my move March 2023. By May I was noticing high heart rate but it was too fast to really count accurately then I got my Apple watch and it verified that my heart rate was high at times. I noticed SOB and pre syncope walking up the big hill and just activity intolerance overall. Then Aug was my daughter s wedding (stressful) and then 10d later we lost someone (my nephew that committed suicide). With all the stress of the move, the wedding, the death it all snowballed and by Oct to Dec is when I remember the profound fatigue starting. Fast forward to now and I suffer daily from debilitating symptoms- fatigue, SOB, CP, GI symptoms, dizziness, blurry vision, & temperature dysregulation.  I am no longer able to work FT.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Heart rate increased, Impaired work ability, Laboratory test, Loss of consciousness
Clinical narrative: Development of dysautonomia.  I got my covid vaccine (one of several but I think this was my 1st Moderna) Feb 22, 2022. On April 14, 2022 I had my 1st episode of high HR and passed out (I had had plasma knee inj the day before). I then have another episode of syncope later in the summer when I was at the amusement park and started being more careful about hydration and heat. Fast forward to my move March 2023. By May I was noticing high heart rate but it was too fast to really count accurately then I got my Apple watch and it verified that my heart rate was high at times. I noticed SOB and pre syncope walking up the big hill and just activity intolerance overall. Then Aug was my daughter s wedding (stressful) and then 10d later we lost someone (my nephew that committed suicide). With all the stress of the move, the wedding, the death it all snowballed and by Oct to Dec is when I remember the profound fatigue starting. Fast forward to now and I suffer daily from debilitating symptoms- fatigue, SOB, CP, GI symptoms, dizziness, blurry vision, & temperature dysregulation.  I am no longer able to work FT.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet rich plasma therapy, Presyncope, Scan, Stress, Syncope
Clinical narrative: Development of dysautonomia.  I got my covid vaccine (one of several but I think this was my 1st Moderna) Feb 22, 2022. On April 14, 2022 I had my 1st episode of high HR and passed out (I had had plasma knee inj the day before). I then have another episode of syncope later in the summer when I was at the amusement park and started being more careful about hydration and heat. Fast forward to my move March 2023. By May I was noticing high heart rate but it was too fast to really count accurately then I got my Apple watch and it verified that my heart rate was high at times. I noticed SOB and pre syncope walking up the big hill and just activity intolerance overall. Then Aug was my daughter s wedding (stressful) and then 10d later we lost someone (my nephew that committed suicide). With all the stress of the move, the wedding, the death it all snowballed and by Oct to Dec is when I remember the profound fatigue starting. Fast forward to now and I suffer daily from debilitating symptoms- fatigue, SOB, CP, GI symptoms, dizziness, blurry vision, & temperature dysregulation.  I am no longer able to work FT.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature regulation disorder, Vision blurred
Clinical narrative: Development of dysautonomia.  I got my covid vaccine (one of several but I think this was my 1st Moderna) Feb 22, 2022. On April 14, 2022 I had my 1st episode of high HR and passed out (I had had plasma knee inj the day before). I then have another episode of syncope later in the summer when I was at the amusement park and started being more careful about hydration and heat. Fast forward to my move March 2023. By May I was noticing high heart rate but it was too fast to really count accurately then I got my Apple watch and it verified that my heart rate was high at times. I noticed SOB and pre syncope walking up the big hill and just activity intolerance overall. Then Aug was my daughter s wedding (stressful) and then 10d later we lost someone (my nephew that committed suicide). With all the stress of the move, the wedding, the death it all snowballed and by Oct to Dec is when I remember the profound fatigue starting. Fast forward to now and I suffer daily from debilitating symptoms- fatigue, SOB, CP, GI symptoms, dizziness, blurry vision, & temperature dysregulation.  I am no longer able to work FT.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Melanocytic naevus, Mole excision
Clinical narrative: Two moles with mild and moderate atypia with positive margins that needed further removal.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Arthralgia, Brain fog, Computerised tomogram abdomen abnormal, Diarrhoea
Clinical narrative: Patient developed numbness and tingling in his extremities starting February 2022.  This progressed to arthralgias that were severe and associated with labored breathing, fatigue, generalized swelling including of the prostate, brain fog and moments of deep insight over the summer and fall of 2022.  He dealt with these symptoms for over 2 years.   He also had an episode of severe diarrhea and acute kidney injury March 2024.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Generalised oedema, Hypoaesthesia, Joint effusion
Clinical narrative: Patient developed numbness and tingling in his extremities starting February 2022.  This progressed to arthralgias that were severe and associated with labored breathing, fatigue, generalized swelling including of the prostate, brain fog and moments of deep insight over the summer and fall of 2022.  He dealt with these symptoms for over 2 years.   He also had an episode of severe diarrhea and acute kidney injury March 2024.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Tendon disorder, Tendon rupture
Clinical narrative: Patient developed numbness and tingling in his extremities starting February 2022.  This progressed to arthralgias that were severe and associated with labored breathing, fatigue, generalized swelling including of the prostate, brain fog and moments of deep insight over the summer and fall of 2022.  He dealt with these symptoms for over 2 years.   He also had an episode of severe diarrhea and acute kidney injury March 2024.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tenosynovitis, Vertebral foraminal stenosis
Clinical narrative: Patient developed numbness and tingling in his extremities starting February 2022.  This progressed to arthralgias that were severe and associated with labored breathing, fatigue, generalized swelling including of the prostate, brain fog and moments of deep insight over the summer and fall of 2022.  He dealt with these symptoms for over 2 years.   He also had an episode of severe diarrhea and acute kidney injury March 2024.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: After receiving vaccine patient became light headed. Laid patient down, applied cold pack and symptoms resolved. Patient appeared recovered after leaving pharmacy.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient had reported a rash/hives 2 days after  receiving vaccine. Patient called asking what OTC product they could use for itching and mentioned it may have been from the vaccine because the same rash occurred after the first dose. The rash was reported to be all over the body, including the trunk and legs, but not the face.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood test, Culture urine, Double stranded DNA antibody, Myocarditis
Clinical narrative: Myocarditis
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory viral panel, Urine analysis
Clinical narrative: Myocarditis
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Pt reports 3 episodes of nbnb vomiting within 6 hours of MCV vaccine given at pediatricians office yesterday 6/14/2025. Patient seen by myself at Urgent Care on 6/15/2025 for continued vomiting/abd pain. Pt threw up again today and has been complaining of abdominal pain since yesterday, 7/10 to umbilicus. No diarrhea or dizziness.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Diplopia, Magnetic resonance imaging spinal abnormal, Multiple sclerosis
Clinical narrative: Double vision, Bells Palsy
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Via phone on 6/14/25, patient reported that she had woken up with redness and puffiness in the area where her injections were given on 6/13/25.  Patient confirmed that area was hot to the touch when asked.  Patient was asked to go to urgent care to be seen.  Patient was seen at Urgent care on both 6/14/25 and 6/15/25. Via phone, PA stated that the patient appeared to have an injection site reaction.  Prescribed antibiotics for patient prophylactically and stated that patient was not ill appearing.  Patient will return to the urgent care for an additional follow up visit on 6/17/25.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Rash pruritic, Skin burning sensation
Clinical narrative: Burning and itching rash right wrist area
Vaccine: MMR, TDAP
Symptoms: Generalised oedema, Pain
Clinical narrative: Over all body swelling and pain
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster, Serology negative
Clinical narrative: recent serology  testing indicated that she does not have immunity against chickenpox; came down with Shingles after receiving the vaccine; This spontaneous report was received from a consumer and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with Varicella virus vaccine live (Oka-Merck) (VARIVAX) (strength, dose, lot #, expiration date, anatomical location, and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot #, and expiration date were not provided).    On an unspecified date in 1999, the patient experienced Shingles after receiving the vaccine (reported also as patient's pertinent medical history, conflicting information).  On an unknown date (also reported as recent), serology testing showed no immunity against chickenpox (Antibody test negative). The patient would like to get the chickenpox vaccine but concerned she would get shingles. At the reporting time, the outcome of the events was unknown.   The causal relationship between the events of antibody test negative and shingles and the suspect vaccine (Varicella virus vaccine live (Oka-Merck) (VARIVAX)), reconstituted suspect sterile diluent (MERCK STERILE DILUENT) was not reported.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Brain fog, Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Consumer called to report they received a PNEUMOVAX23 injection on 06/04/2025 and later that evening started experiencing painful burning and swelling at the injection site. The caller also reported having a fever, feeling fatigued, and experiencing; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; experiencing painful burning and swelling at the injection site; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; experiencing  painful burning and swelling at the injection site; This spontaneous report was received from a consumer and refers to a(n) 55-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Jun-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), formulation: injection, administered by intramuscular route (lot #, expiration date, exact dose and anatomical location were not provided).  On 04-Jun-2025, the patient experienced brain fog, fatigue, pyrexia, vaccination site pain (vaccination site burning), vaccination site pain and vaccination site swelling (reported as: later that evening started experiencing painful burning and swelling at the injection site. The caller also reported having a fever, feeling fatigued, and experiencing brain fog). At the reporting time, the reported events.   The causal relationship between the events of brain fog, fatigue, pyrexia, vaccination site pain (vaccination site burning), vaccination site pain and vaccination site swelling and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was unknown/not reported/not provided.
Age: 1.25
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Nurse calling with a report of an adverse event involving a 15 month old patient who was inadvertently administered PROQUAD and VARIVAX during the same vaccination appointment.  Nurse stated that the patient was inadvertently administered the vaccine; This spontaneous report was received from a nurse and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 09-JUN-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 mL (in two dose series), administered by intramuscular route for prophylaxis (anatomical location, lot # and expiration date were not reported); and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, 0.5 mL (in two dose series), administered by intramuscular route as Measles, Mumps, Rubella, Varicella vaccination (anatomical location, lot # and expiration date were not reported); both vaccines were given along with sterile diluents (Merck Sterile Diluent) solution for injection (no administration details), during the same vaccination appointment (Accidental overdose). No additional adverse events. At the reporting time, the outcome of the events was unknown. The action taken with the suspect products was not reported but established as not applicable.
Vaccine: HEP, HPV9
Symptoms: Wrong product administered
Clinical narrative: No additional AE; Caller confirmed that patient was not administered GARDASIL 9 same-day (missed dose); a patient who was inadvertently administered a pediatric dose of RECOMBIVAXHB instead of  GARDASIL 9; This spontaneous report has been received from an other health professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 10-JUN-2025, the patient who was inadvertently administered at a dose of Hepatitis B Vaccine (RECOMBIVAXHB) suspension for injection, at a dose of 0.5 milliliters (ml), lot number X027728,  instead which has been verified to be valid, expiration date reported and established as  16-OCT-2026) route of administration, and anatomical site of injection were not provided) instead  of Human Papillomavirus 9-valent (GARDASIL 9) (dose, route of administration, anatomical site of injection, lot number and expiration date were not reported), both vaccine administered as prophylaxis (Wrong product administered). Also, it was reported that the patient was not administered Human Papillomavirus 9-valent (GARDASIL 9) same-day (Product dose omission issue) and will come back a different day to continue vaccination with Human Papillomavirus 9-valent (GARDASIL 9). No additional adverse events were reported in the patient.
Sex: F
Vaccine: HEP, HEP, HPVX
Symptoms: Extra dose administered, Nodule
Clinical narrative: Nodule/ They developed a nodule in the arm; administered a double dose (2 separate administrations) of Engerix B; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of nodule on extremity in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   Concurrent medical conditions included hiv infection.   On an unknown date, the patient received Engerix B (right arm), Engerix B (right arm) and HPV vaccine. On an unknown date, an unknown time after receiving Engerix B, Engerix B and HPV vaccine, the patient experienced nodule on extremity (Verbatim: Nodule/ They developed a nodule in the arm) and overdose (Verbatim: administered a double dose (2 separate administrations) of Engerix B). The outcome of the nodule on extremity was resolved and the outcome of the overdose was not applicable.   The reporter considered the nodule on extremity to be related to Engerix B, Engerix B and HPV vaccine.     The company considered the nodule on extremity to be related to Engerix B, Engerix B and HPV vaccine.   Additional Information: GSK receipt date: 10-JUN-2025 The patient was administered a double dose (2 separate administrations) of Engerix B to an HIV patient in the same arm, which led to overdose. The patient developed a nodule in the arm at next visit, but it resolved spontaneously without any additional intervention.  A HPV vaccine was also given on the same day as the Engerix vaccines.
Sex: F
Vaccine: RVX
Symptoms: Condition aggravated, Headache, Migraine
Clinical narrative: gives me a headache and aggravates migraine and bothers dog; gives me a headache and aggravates migraine and bothers dog; This non-serious case was reported by a other health professional and described the occurrence of headache in a 74-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 12-JUN-2025, the patient received RSV vaccine. In JUN-2025, an unknown time after receiving RSV vaccine, the patient experienced headache (Verbatim: gives me a headache and aggravates migraine and bothers dog) and migraine aggravated (Verbatim: gives me a headache and aggravates migraine and bothers dog). The outcome of the headache and migraine aggravated were unknown.   It was unknown if the reporter considered the headache and migraine aggravated to be related to RSV vaccine.     It was unknown if the company considered the headache and migraine aggravated to be related to RSV vaccine.   Additional Information: GSK receipt date: 12-JUN-2025 It sounds very irritating and need to shut off as soon as it comes on the TV.  The patient not sure why it is necessary to include it in your RSV advertising. I finally decided to inform you of this. I am a retired MD.  It gives me a headache and aggravates migraine and bothers dog.
Vaccine: RVX
Symptoms: Malaise
Clinical narrative: I got the RSV shot and got super sick from it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness (Verbatim: I got the RSV shot and got super sick from it). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK receipt date: 11-JUN-2025 The case was received from the patient via interactive digital media. The patient got the RSV shot and got super sick from it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix dose 3 on 6/6/25; 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 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 93N4J) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11-FEB-2021 with batch number 3K743) and Shingrix (received 2nd dose on 18-AUG-2021 with batch number PG35Z).   On 06-JUN-2025, the patient received the 3rd dose of Shingrix. On 06-JUN-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix dose 3 on 6/6/25). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 09-JUN-2025 The health care professional reported that a female patient who was given 3rd vaccination of Shingrix and they did not need it, which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   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: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 09-JUN-2025 The reporter called to inform that a patient that had gotten only the 1st dose of Shingrix back in 2019 had not gotten their 2nd dose yet, and that it was programmed for later that same day. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: DTAPHEPBIP, HEP, HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 42B22, expiry date 07-MAR-2026), (batch number 79CX37, expiry date 12-DEC-2026), (batch number 47XP4, expiry date 16-JUL-2026), (batch number 39C29CD, expiry date 16-JAN-2027) and (batch number 42B22, expiry date 07-MAR-2022) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number J4K4X, expiry date 20-DEC-2026), (batch number 22GP3, expiry date 11-SEP-2026) and (batch number H39C97, expiry date 01-JAN-2027) for prophylaxis and DTPa-HBV-IPV (Pediarix) (batch number 4L544, expiry date 10-OCT-2027) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, the patient received Havrix. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Engerix B, Havrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug 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: 09-JUN-2025 The nurse reported that she had an excursion on the 26th of the last month for 84 minutes and reporter just want to see if these vaccinations that were administered are viable. The nurse did not know the patients information, she only knew that the vaccines went through a temperature excursion on May 26th, 2025 and were administered to different patients, which led to incorrect storage of drug. Excursion information duration of 84 min with temperature is 13.4 degree Celsius no prior excursions.
Age: 49.0
Sex: M
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Priorix Diluent administered to patient alone (without powder); Priorix Diluent administered to patient alone (without powder); Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 49-year-old male patient who received MMR (Priorix) (batch number 49M2F, expiry date 01-DEC-2026) for prophylaxis.   On 17-MAY-2025, the patient received Priorix. On 17-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Priorix Diluent administered to patient alone (without powder)), inappropriate dose of vaccine administered (Verbatim: Priorix Diluent administered to patient alone (without powder)) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate preparation of medication, inappropriate dose of 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: 09-JUN-2025 Pharmacist called to inquire when to re-administer Priorix if two patients (male and a female) received only the diluent part of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received a dose of Priorix at an inappropriate age, which led to inappropriate age at vaccine administration.  The vaccine administration facility was the same as primary reporter. Permission to storage personal information within medical information database was declined. The case was linked with case US2025071740, reported by the same reporter.; Sender's Comments:  US-GSK-US2025071740:same reporter
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: Priorix Diluent administered to patient alone (without powder); Priorix Diluent administered to patient alone (without powder); Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 45-year-old female patient who received MMR (Priorix) (batch number 49M2F, expiry date 01-DEC-2026) for prophylaxis.   On 17-MAY-2025, the patient received Priorix. On 17-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Priorix Diluent administered to patient alone (without powder)), inappropriate dose of vaccine administered (Verbatim: Priorix Diluent administered to patient alone (without powder)) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate preparation of medication, inappropriate dose of 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: 09-JUN-2025 Pharmacist called to inquire when to re-administer Priorix if two patients (male and a female) received only the diluent part of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received a dose of Priorix at an inappropriate age, which led to inappropriate age at vaccine administration.  The vaccine administration facility was the same as primary reporter. Permission to storage personal information within medical information database was declined. The case was linked with case US2025071738, reported by the same reporter.; Sender's Comments:  US-GSK-US2025071738:same reporter
Age: 75.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date). Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 06-JUN-2025, the patient received the 3rd dose of Twinrix. On 06-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Early dose administration). The outcome of the drug dose administration interval too short 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: 09-JUN-2025 The pharmacist reported that a patient had administration of an early schedule dose of Twinrix to a female patient on 6th June 2025, which led to drug dose administration interval too short. According to the health care provider, the second dose was administered on 4th April 2025, and the third dose was scheduled for September 2025. The vaccine administration facility was the same as primary reporter.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix early third dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 68-year-old female patient who received HAB (Twinrix) (batch number 2553X, expiry date 25-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (first dose taken on 27 Dec 2024) and Twinrix (second dose taken on 28 Jan 2025).   On 20-MAR-2025, the patient received the 3rd dose of Twinrix. On 20-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Twinrix early third dose). The outcome of the drug dose administration interval too short 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: 11-JUN-2025 The patient that received the third dose of Twinrix on 20 Mar 2025, 3 months earlier than recommended which led to Drug dose administration interval too short. First and second dose were given following the proper schedule on 27 Dec 2024 and 28 Jan 2025.
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose.). The outcome of the drug dose administration interval too long 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: 12-JUN-2025 A pharmacist called to ask a question about Twinrix, she asked If a patient missed the mark for the 2nd dose of Twinrix and get it 3 months later, when to administer the 3rd dose which led to drug dose interval too long. Pharmacist mentioned that this scenario has happened in the past at their facility.