chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Acute kidney injury, Blood creatinine increased, Chromaturia, Haematuria, Headache
Clinical narrative: ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium.  On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis.  18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit.  On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02.  At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present.   The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Injection site pain, Pain, Protein urine present, Pyrexia, Pyuria
Clinical narrative: ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium.  On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis.  18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit.  On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02.  At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present.   The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Urine abnormality, White blood cells urine positive
Clinical narrative: ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium.  On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis.  18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit.  On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02.  At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present.   The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Acute kidney injury, Back pain, Bacterial test positive, Blood creatinine normal, Blood urine present
Clinical narrative: ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium.  On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis.  18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit.  On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02.  At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present.   The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chromaturia, Condition aggravated, Haematuria, Headache, Injection site pain
Clinical narrative: ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium.  On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis.  18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit.  On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02.  At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present.   The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Pain, Protein urine present, Pyrexia, Pyuria, Urinary squamous epithelial cells increased
Clinical narrative: ACUTE KIDNEY INJURY; PAIN; PYURIA; HAEMATURIA; WHITE BLOOD CELLS URINE POSITIVE; BLOOD CREATININE INCREASED; INJECTION SITE PAIN; PYREXIA; CHROMATURIA; URINE ABNORMALITY; HEADACHE; PROTEIN URINE PRESENT; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency #2846718-1) on 20-Aug-2025. This spontaneous report refers to a 69-year-old female patient. The patient's medical history was not reported. As concurrent conditions were reported acute on chronic lumbar back pain, Hypertension, prediabetes, high cholesterol, Seafood allergy (hives) and Lisinopril allergy (cough). Concomitant medications included Naproxen sodium, Hydrochlorothiazide (VALSARTAN), Nifedipine A , Vitamin b12 (Cobamamide), Vitamin D3 Ol (Colecalciferol) and Atorvastatin calcium.  On 17-Jun-2025, the patient was vaccinated with the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # 2004301 is an invalid batch/lot number for [Pneumococcal 21-valent Conjugate Vaccine], dose number 2,, administered by Intramuscular route in the Left Arm (LA) (expiration date was not reported) administered as prophylaxis.  18-Jun-2025, the patient experienced acute kidney injury, pain, pyuria, hematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present. It was reported that the patient vi cited the emergency room/office visit.  On an unspecified date in June 2025, an urianalysis (UA) results were UA was cloudy, red in color, with 100 protein, large blood, and 21-50 WBCs; positive for squamous cells and rare bacteria and Creatinine showed increased from 0.7 to1.02.  At the reporting time, the patient had not recovered from acute kidney injury, pain, pyuria, haematuria, white blood cells urine positive, blood creatinine increased, injection site pain, pyrexia, chromaturia, urine abnormality, headache and protein urine present.   The causal relationship between all the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of acute kidney injury was determined to be medically significant.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :  , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2846718 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Arrhythmia, Injected limb mobility decreased, Injection site oedema, Pain in extremity
Clinical narrative: patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; patient was evaluated at an urgent care clinic on 06/05/2025 with arrythmia, edema at the injection site, and arm soreness to the point the patient could not lift their arm.; This spontaneous report was received from an Office manager and refers to a 27-year-old female patient.   The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were reported as none.  On 03-Jun-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) SYRINGE 0.5 mL administered by Intramuscular route, lot # Y016291 has been verified to be valid, expiration date reported as 31-DEC-2026 but upon internal validation established as 06-DEC-2026, given for Low IG level  vaccination [Immunoglobulins decreased (Considered as concurrent condition)].   On 05-Jun-2025, the patient was evaluated at an urgent care clinic on with arrythmia, edema at the injection site (Vaccination site edema), and arm soreness (Vaccination site pain) to the point the patient could not lift their arm (Injected limb mobility decreased). Unspecified treatment was given for the adverse events and on an unspecified date in 2025, the patient recovered from all the events.  The causal relationship between all the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) SYRINGE was not reported.  Upon internal review, the event of arrythmia was considered medically significant.  This is one of four reports from the same reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Electromyogram, Laboratory test, Nerve conduction studies, Postural orthostatic tachycardia syndrome
Clinical narrative: Severe Dysautonomia, Postural Orthostatic Tachycardia, Neurally Mediated Syncope
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Severe Dysautonomia, Postural Orthostatic Tachycardia, Neurally Mediated Syncope
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hyperacusis, Tinnitus
Clinical narrative: My tinnitus definitely got worse and my ears more sensitive--an increase in hyperacusis. I'm still feeling it 8 months later.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Documented hypersensitivity to administered product, Hypoaesthesia, Malaise
Clinical narrative: Patient was allergic to dtap  per documentation patient was feeling body numbness and feeling sick medical assistant administered TDAP before provider order. Patient not feeling well patient was send to emergency room per provider per provider direction.
Age: 79.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Death, Nausea, Unresponsive to stimuli, Vomiting
Clinical narrative: Resident developed nausea and vomiting on 08/23/2025  at 1500, resident vomited x2  Ordered zofran from MD PRN. Resident still monitored every shift with no episodes noted for the ff shift.  Resident still eating her meals for dinner and breakfast. Around shower time the next day resident noted to be non responsive while up on the shower chair. Transferred to bed, no vitals obtained. Resident is DNR.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Loss of employment, Malaise
Clinical narrative: I got dizzy and then i got brain fog, and i have a list of the symptoms, I am better but some do linger. I was hoping it would go away and i got to see my new doctor 3 weeks after the vaccine, and it took him by surprise. I went to facility twice. I lost my job over this and i have been sick ever since, I had over 35 symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Mild inflammation on his knee after having the Novavax vaccine; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via contact center (No. NOV25-00632) and concerns an elderly Male who experienced "MILD INFLAMMATION ON HIS KNEE AFTER HAVING THE NOVAVAX VACCINE" after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on 23-Oct-2023.  At the time of the report, the outcome of the event Arthritis was Recovered/Resolved.  A few discrepancies were identified in the source document. Patient's age group was reported as "Adult" but was captured as "Elderly" according to the reported date of birth. The Novavax vaccination information reported for the 'Body Site Location' of the product administration was provided as "Left". Left arm was conservatively selected and will be confirmed with the query sent to the consumer.; Sender's Comments: This Male of an unspecified age experienced Arthritis after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The event Arthritis was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Arthritis is considered Possible.
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: could not hear the sound; This serious case was reported by a consumer via interactive digital media and described the occurrence of deafness in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced deafness (Verbatim: could not hear the sound) (serious criteria GSK medically significant). The outcome of the deafness was not reported.   It was unknown if the reporter considered the deafness to be related to Herpes Zoster vaccine.     The company considered the deafness to be unrelated to Herpes Zoster vaccine.   Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. Patient could not hearth the sound.; Sender's Comments: A case of Deafness, on an unknown time after receiving Herpes Zoster vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles in my right eye 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles on scalp) and ophthalmic herpes zoster (had shingles in right eye, eyelid was affected).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: shingles in my right eye again) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. The patient said that his/her physician told him/her once you have had shingles it was in your system, and the shot would not help. The patient had shingles on his/her scalp and in right eye, finally recovered after a few months but his/her eyelid was affected, got the 2 Shingles shots and 2 years later, in his/her right eye again. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of ophthalmic herpes zoster 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 Shingles vaccine (dose 1) and Shingles vaccine (dose 2). A case of Ophthalmic herpes zoster, 2 years after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Zoster sine herpete
Clinical narrative: Suspected vaccination failure; had it on my eye and 30 days from that, internal, and then on my head; Internal shingles; Shingles on head;  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), ophthalmic herpes zoster (Verbatim: had it on my eye and 30 days from that, internal, and then on my head) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: Internal shingles) and shingles (Verbatim: Shingles on head). The outcome of the vaccination failure, ophthalmic herpes zoster, zoster sine herpete and shingles were not reported.   The reporter considered the vaccination failure, ophthalmic herpes zoster, zoster sine herpete and shingles to be possibly related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. The company considered the zoster sine herpete and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that same had it on eye and 30 days from that, internal, and then on head. The reporter was also mentioned that the vaccination be triggered it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; 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. A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine in a patient.  Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before; really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 58-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete), for COVID-19 immunization; Bnt162b2 (dose number unknown (booster)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient stated, "(inaudible) really hurting too. There's this like stabbing in my throat feeling and I've had it before, I've used Paxlovid before. I've gotten the booster every year." Later while searching for the patients account she added, "I have my Pfizer booster every year I wasn't due for it yet, I had it in at the end of Sep of last year (2024) so obviously (inaudible)."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: came down with the COVID/still picked up this variant; came down with the COVID/still picked up this variant; This is a spontaneous report and received from Consumer or other non HCPs, Program ID:.  An 84-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "came down with the COVID/still picked up this variant". Clinical course: During an inbound call for financial assistance, the patient, (name withheld), stated, "I wish I had applied for my Part D at the start, but I'm 84, I'm not sure I can get it." When (name withheld) was asked if he had any further questions, an unknown person, who joined the call, stated, "I have a question. When I came down, I came down with the COVID first, and (name withheld) came down a day later. But I applied and I got-I got the pills for free, especially when you're sick and your brain doesn't work right anymore." After explaining the differences between the different programs offered, (name withheld) stated, "I think that-that you've helped us as much as you can, and it looks like we have to go through the government first and then go from there. But by that time, hopefully I will be over COVID." After explaining to (name withheld) that he is not eligible for the program initially, (name withheld) asked, "So, I do, or I don't?" The unknown person then answered, "You don't, but you're retired, so I don't know what they're going by because you just retired this year." Later in the call, the unknown person stated, "It's bad enough having COVID without being penalized, you know. And I must tell you that we have always kept our Pfizer vaccines up. We had our last one in Jun, but we still picked up this variant, whatever it is, and, anyway, they've always-the vaccines have always been very successful. My mother's 99, and she was living with us until a few months ago, so we were careful, but she's not with us now." At the end of the call, the unknown person stated, "Okay, I'm going to give this information to a neighbor since we have COVID and we're quarantined. So a neighbor be able to pick this up for us, I guess."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alzheimer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Premarin, reaction(s): "Stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: there is a chance that I could have had covid, I had a kind of fluish period of time; there is a chance that I could have had covid, I had a kind of fluish period of time; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "there is a chance that I could have had covid, I had a kind of fluish period of time". Clinical course: per caller she was thinking that she need another booster, and that they could give her a titer blood test to see if she still had immunity against a covid virus.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Metastasis
Clinical narrative: metastasis of prostate cancer.; This is a spontaneous report received from a Physician from a sales representative.  An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Metastatic Prostate Cancer" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE; manufacturer unknown), for Covid-19 immunisation. The following information was reported: METASTASIS (life threatening, medically significant), 1 month after the suspect product(s) administration, outcome "recovering", described as "metastasis of prostate cancer.". Therapeutic measures were taken as a result of metastasis. Clinical course: Dr. reported about a month after he received his 3rd Pfizer Covid vaccine, he had metastasis of prostate cancer. Dr. considered the event resulted in life threatening illness (immediate risk of death from the event).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event metastasis and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I came down with the COVID; I came down with the COVID; This is a spontaneous report and received from Consumer or other non HCPs, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "I came down with the COVID". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Rheumatoid factor negative
Clinical narrative: Joint pain in hands that never fully went away. Within 1-2 weeks of the vaccine my hands suddenly felt like I was 80 years old, it gradually got better but it never went away. The same thing happened after boosters. It's been 4 1/2 years and hands still hurt.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dysstasia, Fatigue, Hypoaesthesia
Clinical narrative: pt says she on 2/26/21 she was feeling very fatigue and she didn't have any leg strength. She was very weak. At work she had a sharp pain that went from her hip and  went down her right leg. She immediately sat down. She had to called the ambulance because she couldn't stand up. She was taken to Hospital ER. She couldn't feel it when they lifted her right leg. She was admitted and was there for over 2 weeks. She was diagnosed with Transverse myelitis that affected both legs and lower part of her body. She is currently wheelchair bound and disabled. Had to go to (withheld name) rehab after being discharged. She is currently being treated by a neurologist Dr. at the MS clinic.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Muscular weakness, Myelitis transverse, Pain in extremity
Clinical narrative: pt says she on 2/26/21 she was feeling very fatigue and she didn't have any leg strength. She was very weak. At work she had a sharp pain that went from her hip and  went down her right leg. She immediately sat down. She had to called the ambulance because she couldn't stand up. She was taken to Hospital ER. She couldn't feel it when they lifted her right leg. She was admitted and was there for over 2 weeks. She was diagnosed with Transverse myelitis that affected both legs and lower part of her body. She is currently wheelchair bound and disabled. Had to go to (withheld name) rehab after being discharged. She is currently being treated by a neurologist Dr. at the MS clinic.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Plasmapheresis, Wheelchair user
Clinical narrative: pt says she on 2/26/21 she was feeling very fatigue and she didn't have any leg strength. She was very weak. At work she had a sharp pain that went from her hip and  went down her right leg. She immediately sat down. She had to called the ambulance because she couldn't stand up. She was taken to Hospital ER. She couldn't feel it when they lifted her right leg. She was admitted and was there for over 2 weeks. She was diagnosed with Transverse myelitis that affected both legs and lower part of her body. She is currently wheelchair bound and disabled. Had to go to (withheld name) rehab after being discharged. She is currently being treated by a neurologist Dr. at the MS clinic.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Feeling cold, Muscular weakness, Pyrexia
Clinical narrative: I got the injection around noon, and i came home and i sat down with my dog and a cup of coffee and then all of the sudden i was freezing and i couldn't get warm. Then i got tired, fever, throwing up, dizzy. My legs are very weak.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: I got the injection around noon, and i came home and i sat down with my dog and a cup of coffee and then all of the sudden i was freezing and i couldn't get warm. Then i got tired, fever, throwing up, dizzy. My legs are very weak.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Biopsy peripheral nerve, Blood pressure fluctuation, Borrelia test negative, Brain fog
Clinical narrative: Arm, wrist, leg swelling that comes and goes and has persisted to this day.  Brain fog, very sensitive to noise. very fatigued.  Occasional tremors.  Fluctation in blood pressure, POTS
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Fatigue, Hyperacusis, Joint swelling
Clinical narrative: Arm, wrist, leg swelling that comes and goes and has persisted to this day.  Brain fog, very sensitive to noise. very fatigued.  Occasional tremors.  Fluctation in blood pressure, POTS
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Postural orthostatic tachycardia syndrome, SARS-CoV-2 antibody test positive, Tremor
Clinical narrative: Arm, wrist, leg swelling that comes and goes and has persisted to this day.  Brain fog, very sensitive to noise. very fatigued.  Occasional tremors.  Fluctation in blood pressure, POTS