chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: PNC21
Symptoms: Diarrhoea, Diplegia, Dizziness, Dysarthria, Heart rate increased
Clinical narrative: Heart rate ranging from 170-180s, pain in chest, dizziness. Paralysis of hand, arms and legs, slurring/aphasia. EMS call with two doses of IV Adenosine  administered without success en route to hospital. Defibrillator pads administered, unused. IV administration of Magnesium and Potassium in emergency room upon arrival. Spiked fever and was treated for sepsis with Vancomycin and Azteronam. Heart rate lowered to 150s once admitted to the hospital but required further medication to lower resting HR. Anti clot injections administered. Vomiting and diarrhea treated with Zofran and fluids. SVT as a result of elevated heart rate.
Age: 38.0
Sex: F
Vaccine: PNC21
Symptoms: Laboratory test, Pyrexia, Sepsis, Supraventricular tachycardia, Vomiting
Clinical narrative: Heart rate ranging from 170-180s, pain in chest, dizziness. Paralysis of hand, arms and legs, slurring/aphasia. EMS call with two doses of IV Adenosine  administered without success en route to hospital. Defibrillator pads administered, unused. IV administration of Magnesium and Potassium in emergency room upon arrival. Spiked fever and was treated for sepsis with Vancomycin and Azteronam. Heart rate lowered to 150s once admitted to the hospital but required further medication to lower resting HR. Anti clot injections administered. Vomiting and diarrhea treated with Zofran and fluids. SVT as a result of elevated heart rate.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident, Transient ischaemic attack
Clinical narrative: Two regular vaccines then 2 boosters First, TIAs then full CVA (stroke)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Road traffic accident, Ventricular fibrillation
Clinical narrative: Was diagnosed with v fib, moo was riot symptoms of anything at all prior to taking vaccine es.  No family history .
Age: 65.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: The patient has not received a second dose of Twinrix; received first dose of Havrix on 29Jan2019/first dose of Twinrix on 10Apr2025/Inappropriate schedule of vaccine administered; 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 65-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Havrix (patient received the first dose of Havrix on 29-JAN-2019 Batch no: D94MK Exp date :05-JUL-2021).   On 10-APR-2025, the patient received the 1st dose of Twinrix. The patient did not receive the 2nd dose of Twinrix. On 10-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Havrix on 29Jan2019/first dose of Twinrix on 10Apr2025/Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: The patient has not received a second dose of Twinrix). The outcome of the drug dose administration interval too long and incomplete course of vaccination 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: 17-JUL-2025 A patient received the first dose of Havrix and Twinrix has not receive a second dose. The patient received a dose of Havrix and then received a dose of Twinrix as a booster of Havrix (Hepatitis A) later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Asphyxia, Autopsy, Bed sharing, Death, Laboratory test
Clinical narrative: I do not believe that the vaccination was a cause of adverse event, but given severity of event, I would like to report to VAERS out of due diligence as as encourage by VAERS instructions. The patient passed away ~6/21, died from sudden unexpected infant death (SUID) versus asphyxiation due to accidental cause, sleeping in an adult bed.   PLEASE NOTE,  The official  medical examiners office autopsy puts the cause as accidental asphyxiation because the pathologist "does not believe in SUID/SIDS as is my understanding. T
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Sudden infant death syndrome
Clinical narrative: I do not believe that the vaccination was a cause of adverse event, but given severity of event, I would like to report to VAERS out of due diligence as as encourage by VAERS instructions. The patient passed away ~6/21, died from sudden unexpected infant death (SUID) versus asphyxiation due to accidental cause, sleeping in an adult bed.   PLEASE NOTE,  The official  medical examiners office autopsy puts the cause as accidental asphyxiation because the pathologist "does not believe in SUID/SIDS as is my understanding. T
Age: 18.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Loss of consciousness, Pallor, Retching
Clinical narrative: The order of vaccines I administered was Flucelvax, Gardasil, then Menquadfi. After the third vaccine the patient's face went white, and she asked her mother to get her water. As the mother was out of the room the patient passed out for approximately 30 seconds while seated. When she came back up there was shaking and she felt the need to throw up (the patient dry heaved for approximately 30 seconds). She was able to recall who she was and where she was. The  patient drank water, and ate something before leaving.
Age: 48.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 48 year old patient that got 2 doses of Bexsaro; 48 year old patient that got 2 doses of Bexsaro; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Men B NVS (Bexsero) (batch number G334J, expiry date 31-OCT-2027) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number Z39XM, expiry date 31-OCT-2026) for prophylaxis.   On 06-JUN-2025, the patient received the 2nd dose of Bexsero. On 01-MAY-2025, the patient received the 1st dose of Bexsero. On 01-MAY-2025, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 48 year old patient that got 2 doses of Bexsaro). On 06-JUN-2025, the patient experienced inappropriate age at vaccine administration (Verbatim: 48 year old patient that got 2 doses of Bexsaro). The outcome of the inappropriate age at vaccine administration 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: 28-JUL-2025 Reporter stated that a 48 year old patient that got 2 doses of Bexsaro which is not approved for over 25 years of age, which led to Inappropriate age at vaccine administration. Also stated that he is not immunocompromised and he was going to nursing school so they assume that is why.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient has 1st dose in Dec 2024, 2nd dose May 2025; 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 female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in December 2024).   In MAY-2025, the patient received the 2nd dose of Twinrix. In MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Patient has 1st dose in Dec 2024, 2nd dose May 2025). 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: 29-JUL-2025 and 30-JUL-2025  The reporter reported that a patient was late for her second dose due to being out of the country. The HCP who originally called regarding medical information question in (withheld) case was different from Pharmacist who provided additional AE information upon callback from (withheld). This pharmacist's details who provided more information regarding AE are in AE form. The original HCP did not provide details regarding there being 2 patients.  At this time, it was unknown if both patients had their doses on the same dates. Upon call back HCP who originally contacted (withheld) she states that both patients (husband and wife) got their 1st dose in Dec 2024, 2nd dose in May 2025. 3rd dose had not yet been administered. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case had been linked with US2025097730, reported by the same reporter; Sender's Comments:  US-GSK-US2025097730:Same reporter/Diffrent patient
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a other health professional via call center representative 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 25-NOV-2019, the patient received the 2nd dose of Shingrix. On 07-AUG-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and 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 was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 30-JUL-2025 The nurse reported that they all experience a case of shingles after getting Shingrix. The nurse reported that 2 other patients, had a case of shingles after getting Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule 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 Shingrix  (1st dose)and Shingrix(2nd dose) US-GSK-US2025098394:same reporter, Different patient
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a nurse via sales rep 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 09-JUL-2020, the patient received the 2nd dose of Shingrix. On 09-JAN-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and 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 was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 30-JUL-2025 The reporter stated that the patient experienced case of shingles after getting Shingrix. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is one of the three linked cases reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). US-GSK-US2025098302:same reporter, Different patient US-GSK-US2025098299:same reporter, Different patient
Age: 73.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Intramuscular administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 73-year-old male patient who received MMR (Priorix) (batch number 7975C, expiry date 01-MAR-2027) for prophylaxis.   On 01-AUG-2025, the patient received Priorix (intramuscular). On 01-AUG-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular administration). The outcome of the subcutaneous injection formulation administered by other route 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: 01-AUG-2025 The registered nurse reported that an adult received a Priorix intramuscularly today (date of reporting), which led to Subcutaneous injection formulation administered by other route.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she finally caught COVID; she finally caught COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 84-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Nov2024 as dose 1, single (Lot number: LN0589) at the age of 83 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (ongoing); "next-door neighbor had covid" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] intramuscular taken for immunisation, on 01Nov2024 as dose number unknown, single; RSV VACCINE intramuscular taken for immunisation, in Nov2024 as dose number unknown, single; OMEPRAZOLE taken for gastrooesophageal reflux disease; VITAMINS NOS. Vaccination history included: Covid-19 vaccine (took all of her shots and everything was fine), for covid-19 immunisation.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jul2025, outcome "unknown" and all described as "she finally caught COVID". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown Results, notes: The lab work for COVID, I had a blood test done; (unspecified date) Unknown Results, notes: The lab work for COVID, I had a blood test done; SARS-CoV-2 test: (16Jul2025) Positive, notes: It was about 16Jul, 17Jul and the results were that I had COVID, SARS COVID-19, it was positive; (17Jul2025) Positive, notes: It was about 16Jul, 17Jul and the results were that I had COVID, SARS COVID-19, it was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took all of her shots and everything was fine. Her last shot was in Nov of last year (2024). It slipped her mind to take another one in the next 4, 5, or 6 months, so she was almost 7 or 8 months without having a shot, forgot the latest shot. After 3 years of being successful, the caller's incredible next-door neighbor asked her for a ride, so she gave him a ride, and he was sick. It turned out he had COVID, so for the first time in three or four years, she finally caught COVID.Her doctor gave her Tamiflu, and COVID really knocked her down hard. After the last 30 days of having it, she now needs to know because her flu shot is set for the end of Aug, and she had already planned to get a COVID shot. However, her doctor advised her not to get it because she now has antibodies, but she told them that she's going to get the shot anyway. People who just relied on their antibodies have had COVID two or three times. She took her Pfizer shots and never got it.
Vaccine: PNC20
Symptoms: Erythema, Feeling hot, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: I am worried about cellulites in the arm; this arm, I could barely lift up; The whole thing hurts very bad.; It is so red and it feels like there is bubble under the skin and it is very hot.; It is so red and it feels like there is bubble under the skin and it is very hot.; some kind of allergy; my arm is completely swollen and red; my arm is completely swollen and red; This is a spontaneous report received from a Nurse.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: Oct2024, for COVID-19 Immunization, reaction(s): "Drug allergy", "Erythema of extremities", "Extremities hot feeling of", "Swollen arm". The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "I am worried about cellulites in the arm"; INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "unknown", described as "this arm, I could barely lift up"; PAIN (non-serious), outcome "unknown", described as "The whole thing hurts very bad."; FEELING HOT (non-serious), SKIN DISORDER (non-serious), outcome "unknown" and all described as "It is so red and it feels like there is bubble under the skin and it is very hot."; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "some kind of allergy"; ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "my arm is completely swollen and red".  Additional Information: Reporter received Prevnar 20 and now reporter arm was completely swollen and red. Reporter received last fall, the Pfizer COVID vaccine Comirnaty, that one and reporter had a reaction in the other arm. Reporter arm was completely swollen, red and very hot. Reporter need to know what if, ingredients are the same in those vaccines, anything was there Because reporter definitely had some kind of allergy. When paraphrased the concern, consumer stated, Anything that was similar. Reporter looked it up on AI and it does not says if there anything similar between these two. Consumer stated, Okay, yes, well, in the meantime, reporter was going to go to the clinic to get checked about this because this was now two vaccines. The COVID reporter got last fall, October and now, this arm, reporter could barely lift. The whole thing hurts very bad. Reporter was worried about cellulites in the arm. It was so red and it felt like there was bubble under the skin and it was very hot.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: PNC20
Symptoms: Product container issue
Clinical narrative: one of the vial was broke; This is a spontaneous report received from an Other HCP from product quality group.  This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LP4948, Expiration Date: 31Aug2026) for immunisation, Device Lot Number: LP4948, Device Expiration Date: 31Aug2026. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "one of the vial was broke".  Additional information: A nurse practitioneris calling in regards to Prevnar 20 stated that they open a box of 10 yesterday(on 29Jul2025) and one of the vial is broke. When probed if there was any patient involvement, reporter stated, no, that was not administer. She had actually got the vial here in her office, in her possession. Prevnar 20 in tin, one of the vials arrived broken. Reporter was informed not to discard the product as the report will be forwarded for review by our Quality department.? Reporter stated okay. Reporter stated, a sample of the product available to be returned, she had got it right in front of her and she would not discard it. She will keep it. Reporter stated, packaging sealed and intact. When they opened the box, then they discovered that one because it was brand new tin vial box and so that was the only one that was broken. Reporter stated, no additional lot numbers, this is the only one.  Sample not requested due to sharps risk. Product strength and count size dispensed: Reporter stated, "It is the Prevnar 20. It says 1 dose 0.5 ML.". Product NDC# 0005-2000-01.  Causality for "one of the vial was broke" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Inflammation, Pain in extremity, Pruritus, Skin warm
Clinical narrative: arm pain; redness to upper arm spreading to lower arm; itchy; Inflammation to the upper arm spreading through the lower arm; Hot to touch; Swelling; This is a spontaneous report received from a Nurse.  An 82-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Jul2025 as dose 1, single (Lot number: LN4930, Expiration Date: 31Jul2026) at the age of 82 years, in left arm for immunisation. The patient's relevant medical history included: "Sulfa Antibiotics: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset 2025, outcome "unknown", described as "Hot to touch"; INFLAMMATION (non-serious) with onset 2025, outcome "unknown", described as "Inflammation to the upper arm spreading through the lower arm"; SWELLING (non-serious) with onset 2025, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset 2025, outcome "recovering", described as "arm pain"; PRURITUS (non-serious) with onset 2025, outcome "recovering", described as "itchy"; ERYTHEMA (non-serious) with onset 2025, outcome "recovering", described as "redness to upper arm spreading to lower arm". Therapeutic measures were taken as a result of pain in extremity, erythema, pruritus, inflammation, feeling hot, swelling.  Additional information: The vaccine was administered at a doctor's office or urgent care facility. The patient did not receive any other vaccines on the same date as the Prevnar 20 vaccine. The patient did not receive any other vaccines within four weeks prior to receiving the Prevnar 20 vaccine. The patient experienced arm pain and redness in the upper arm, which spread to the lower arm and was occasionally itchy. Treatment orders was placed to shut down inflammation process - Doxycycline, Prednisone, Triamcinolone, Zyrtec. Inflammation to the upper arm spreading through the lower arm, redness, hot to touch, itchiness and swelling. The primary care is already treating the patient.
Vaccine: RSV
Symptoms: Injection site rash
Clinical narrative: rash in injection site area; This is a spontaneous report received from a Physician from medical information team.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "rash in injection site area".  Additional information: The reporter questioned if Abrysvo had shown to cause a rash in injection site area during studies. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid; got Covid; This is a spontaneous report and received from Consumer or other non HCPs.  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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". The event "got covid" required physician office visit. Clinical course: reporter was calling on behalf of wife (patient) and stated that patient got COVID. There was no medicine at the pharmacy that the patient was prescribed (still has not arrived). Reporter wanted to know how much it costs. The patient was sick and laying down.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: RSV
Symptoms: Neurological symptom
Clinical narrative: Neurological reaction to the RSV vaccine (Abrysvo Vaccine); This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (hospitalization), outcome "unknown", described as "Neurological reaction to the RSV vaccine (Abrysvo Vaccine)".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis after vaccine and has not resolved; This is a spontaneous report received from a Nurse from a sales representative.  An adult 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 and concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis after vaccine and has not resolved". It was unknown if therapeutic measures were taken as a result of psoriasis.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: immune system gotten worse; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "reaction to steroid" (unspecified if ongoing); "allergic to latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "immune system gotten worse".  Additional information: The reporter informed that she has been receiving from Pfizer and the last email she received was from 29July2025. The email said Pfizer wanted to know more about her situation. She informed that she didn't want any more shots because she's done with it and it could've been fatal for her.  She informed that she already reported it through (redacted) back in 2021. She was just letting them know she has already recorded this to the (redacted). So she's not sending additional information.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: reported that patient experienced: body ache; reported that patient experienced: fever; Initial information received on 01-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult female patient who had body ache and fever after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history included Insomnia, Kidney stone and Bladder disorder.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Intervertebral disc disorder, Multiple sclerosis and Nephrolithiasis.   On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient developed body ache (pain) and fever (pyrexia)  (latency unknown) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product prescribing error, Wrong technique in product usage process
Clinical narrative: this situation is pre-assessed as an off-label use as per local labelling due to product not administered immediately after reconstitution with no adverse event; the vaccine should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who was prescribed with Rabies (HDC) vaccine [Imovax Rabies] that should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14 and the product was not administered immediately after reconstitution with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection (expiry date, lot number and strength-unknown) via unknown route in unknown administration site for Immunization was not administered immediately after reconstitution (wrong technique in product usage process) and the vaccine should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14 with no adverse event (product prescribing error).  Reportedly- The vaccine must be administered immediately after reconstitution but on their day 7, their vaccine was already reconstituted on the desk.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Dizziness, Exercise tolerance decreased, Fatigue, Gait disturbance
Clinical narrative: After several weeks, extreme fatigue, spikes in heart rate, dizziness, difficulty walking, exercise intolerance. These symptoms have worsened over time. Heat exposure, stress, and overdoing are major triggers.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: After several weeks, extreme fatigue, spikes in heart rate, dizziness, difficulty walking, exercise intolerance. These symptoms have worsened over time. Heat exposure, stress, and overdoing are major triggers.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Ascites, Blood albumin decreased, Blood immunoglobulin G decreased, Blood sodium decreased, Dehydration
Clinical narrative: Admitted to pediatric ICU early August 2025 with hyponatremic dehydration. MRI with concern for multiple associated short segment enteroenteric intussusceptions. Subsequent US without intussusception. Also severe hypoalbuminemia, hypogammaglobulinemia. Change in stool started prior to rotavirus vaccine.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Enterocolitis, Gastrointestinal wall thickening, Hypoalbuminaemia, Hypogammaglobulinaemia, Hyponatraemia
Clinical narrative: Admitted to pediatric ICU early August 2025 with hyponatremic dehydration. MRI with concern for multiple associated short segment enteroenteric intussusceptions. Subsequent US without intussusception. Also severe hypoalbuminemia, hypogammaglobulinemia. Change in stool started prior to rotavirus vaccine.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Intensive care, Intussusception, Laboratory test normal, Magnetic resonance imaging abdominal abnormal, Magnetic resonance imaging pelvic
Clinical narrative: Admitted to pediatric ICU early August 2025 with hyponatremic dehydration. MRI with concern for multiple associated short segment enteroenteric intussusceptions. Subsequent US without intussusception. Also severe hypoalbuminemia, hypogammaglobulinemia. Change in stool started prior to rotavirus vaccine.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Magnetic resonance imaging thoracic abnormal, Pleural effusion, Rotavirus test negative, Ultrasound abdomen normal
Clinical narrative: Admitted to pediatric ICU early August 2025 with hyponatremic dehydration. MRI with concern for multiple associated short segment enteroenteric intussusceptions. Subsequent US without intussusception. Also severe hypoalbuminemia, hypogammaglobulinemia. Change in stool started prior to rotavirus vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Coordination abnormal, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: unable to live my life since this reaction started; now I can barely navigate stairs; despair; can not sleep; neuropathy hands and feet; Pain; Fever; Tachycardia; progressive weakness; This serious case was reported by a consumer and described the occurrence of peripheral neuropathy in a 41-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included acute myeloid leukemia, stem cell transplant and chronic graft versus host disease. Concomitant products included belumosudil mesylate (Rezurock).   On 21-MAY-2025, the patient received Shingles vaccine. On 25-MAY-2025, 4 days after receiving Shingles vaccine, the patient experienced peripheral neuropathy (Verbatim: neuropathy hands and feet) (serious criteria GSK medically significant), pain (Verbatim: Pain), fever (Verbatim: Fever), tachycardia (Verbatim: Tachycardia) and weakness (Verbatim: progressive weakness). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: unable to live my life since this reaction started), mobility decreased (Verbatim: now I can barely navigate stairs), feeling of despair (Verbatim: despair) and insomnia (Verbatim: can not sleep). The outcome of the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired and mobility decreased were not resolved and the outcome of the feeling of despair and insomnia were not reported.   It was unknown if the reporter considered the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine.     The company considered the peripheral neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUL-2025 The patient received Shingles vaccine and experienced fever, tachycardia, progressive weakness, pain and neuropathy hands and feet. Each step has been harder than the last, full of challenges that the patient suffered through.  The patient was so excited to finally receive vaccinations and absolutely devastated that she has been in agonizing pain and unable to live life since this reaction started.  The patient was an athletic youngish 40 and at the time of reporting she can barely navigate stairs, cannot sleep because of the pain. The patient literally hobble. The patient wants her life back.  The patient felt maimed by this event, and it was causing despair.; Sender's Comments: A case of Neuropathy peripheral, 4 days after receiving Shingles vaccine. in a 41-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor (acute myeloid leukemia).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myalgia, Neuropathy peripheral, Pyrexia
Clinical narrative: unable to live my life since this reaction started; now I can barely navigate stairs; despair; can not sleep; neuropathy hands and feet; Pain; Fever; Tachycardia; progressive weakness; This serious case was reported by a consumer and described the occurrence of peripheral neuropathy in a 41-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included acute myeloid leukemia, stem cell transplant and chronic graft versus host disease. Concomitant products included belumosudil mesylate (Rezurock).   On 21-MAY-2025, the patient received Shingles vaccine. On 25-MAY-2025, 4 days after receiving Shingles vaccine, the patient experienced peripheral neuropathy (Verbatim: neuropathy hands and feet) (serious criteria GSK medically significant), pain (Verbatim: Pain), fever (Verbatim: Fever), tachycardia (Verbatim: Tachycardia) and weakness (Verbatim: progressive weakness). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: unable to live my life since this reaction started), mobility decreased (Verbatim: now I can barely navigate stairs), feeling of despair (Verbatim: despair) and insomnia (Verbatim: can not sleep). The outcome of the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired and mobility decreased were not resolved and the outcome of the feeling of despair and insomnia were not reported.   It was unknown if the reporter considered the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine.     The company considered the peripheral neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUL-2025 The patient received Shingles vaccine and experienced fever, tachycardia, progressive weakness, pain and neuropathy hands and feet. Each step has been harder than the last, full of challenges that the patient suffered through.  The patient was so excited to finally receive vaccinations and absolutely devastated that she has been in agonizing pain and unable to live life since this reaction started.  The patient was an athletic youngish 40 and at the time of reporting she can barely navigate stairs, cannot sleep because of the pain. The patient literally hobble. The patient wants her life back.  The patient felt maimed by this event, and it was causing despair.; Sender's Comments: A case of Neuropathy peripheral, 4 days after receiving Shingles vaccine. in a 41-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor (acute myeloid leukemia).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tachycardia, Vaccination site pain
Clinical narrative: unable to live my life since this reaction started; now I can barely navigate stairs; despair; can not sleep; neuropathy hands and feet; Pain; Fever; Tachycardia; progressive weakness; This serious case was reported by a consumer and described the occurrence of peripheral neuropathy in a 41-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included acute myeloid leukemia, stem cell transplant and chronic graft versus host disease. Concomitant products included belumosudil mesylate (Rezurock).   On 21-MAY-2025, the patient received Shingles vaccine. On 25-MAY-2025, 4 days after receiving Shingles vaccine, the patient experienced peripheral neuropathy (Verbatim: neuropathy hands and feet) (serious criteria GSK medically significant), pain (Verbatim: Pain), fever (Verbatim: Fever), tachycardia (Verbatim: Tachycardia) and weakness (Verbatim: progressive weakness). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: unable to live my life since this reaction started), mobility decreased (Verbatim: now I can barely navigate stairs), feeling of despair (Verbatim: despair) and insomnia (Verbatim: can not sleep). The outcome of the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired and mobility decreased were not resolved and the outcome of the feeling of despair and insomnia were not reported.   It was unknown if the reporter considered the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine.     The company considered the peripheral neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUL-2025 The patient received Shingles vaccine and experienced fever, tachycardia, progressive weakness, pain and neuropathy hands and feet. Each step has been harder than the last, full of challenges that the patient suffered through.  The patient was so excited to finally receive vaccinations and absolutely devastated that she has been in agonizing pain and unable to live life since this reaction started.  The patient was an athletic youngish 40 and at the time of reporting she can barely navigate stairs, cannot sleep because of the pain. The patient literally hobble. The patient wants her life back.  The patient felt maimed by this event, and it was causing despair.; Sender's Comments: A case of Neuropathy peripheral, 4 days after receiving Shingles vaccine. in a 41-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor (acute myeloid leukemia).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuropathy peripheral, Pain, Pyrexia, Tachycardia
Clinical narrative: unable to live my life since this reaction started; now I can barely navigate stairs; despair; can not sleep; neuropathy hands and feet; Pain; Fever; Tachycardia; progressive weakness; This serious case was reported by a consumer and described the occurrence of peripheral neuropathy in a 41-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included acute myeloid leukemia, stem cell transplant and chronic graft versus host disease. Concomitant products included belumosudil mesylate (Rezurock).   On 21-MAY-2025, the patient received Shingles vaccine. On 25-MAY-2025, 4 days after receiving Shingles vaccine, the patient experienced peripheral neuropathy (Verbatim: neuropathy hands and feet) (serious criteria GSK medically significant), pain (Verbatim: Pain), fever (Verbatim: Fever), tachycardia (Verbatim: Tachycardia) and weakness (Verbatim: progressive weakness). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: unable to live my life since this reaction started), mobility decreased (Verbatim: now I can barely navigate stairs), feeling of despair (Verbatim: despair) and insomnia (Verbatim: can not sleep). The outcome of the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired and mobility decreased were not resolved and the outcome of the feeling of despair and insomnia were not reported.   It was unknown if the reporter considered the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine.     The company considered the peripheral neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUL-2025 The patient received Shingles vaccine and experienced fever, tachycardia, progressive weakness, pain and neuropathy hands and feet. Each step has been harder than the last, full of challenges that the patient suffered through.  The patient was so excited to finally receive vaccinations and absolutely devastated that she has been in agonizing pain and unable to live life since this reaction started.  The patient was an athletic youngish 40 and at the time of reporting she can barely navigate stairs, cannot sleep because of the pain. The patient literally hobble. The patient wants her life back.  The patient felt maimed by this event, and it was causing despair.; Sender's Comments: A case of Neuropathy peripheral, 4 days after receiving Shingles vaccine. in a 41-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor (acute myeloid leukemia).