chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; twice in the eye; I have had shingles 3 times once on the body; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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: twice in the eye) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingles 3 times once on the body). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUL-2025 This case was reported by a wife of the patient via interactive digital media. She had received the shot a while ago and she had shingles three times once on her body and twice in her eye. This year was the third time. The episodes in her eyes were worse than the one on her body. It felt like someone was sticking a screwdriver in her eye. The reporter tried to get ointment this year, but it was over dollar 500 and her insurance did not cover it. She eventually got eye drops, which shea had to use four to six times a day. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding ophthalmic herpes zoster and shingles were unknown at the time of reporting. This case was linked with US2025AMR094239 reported by same reporter.; Sender's Comments: A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine, in a female patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR094239:same reporter
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: Vitaligo, I have it on my hands legs arms face and lips. I went to get treatment from a dermatologist she said it was probably dormant and the shot made it activate. I tried creams and light therapy they didn't worm.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident expired
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given Hep A instead of HPV9. Patient tolerated vaccine well with no adverse reaction noted.  I  have called and spoke to mother to check on the child and his well being. She states he is doing well and will return to clinic for the correct vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: No adverse event
Clinical narrative: No symptoms of adverse event reported by patient.
Age: 64.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Balance disorder, Computerised tomogram head, Deafness unilateral, Ear discomfort, Electrocardiogram
Clinical narrative: 1 week after injection awoke with hearing loss right ear, balance issues so severe that I need a cane to help keep me from falling over.  Loud ringing in right ear.  Low grade fever of 100.  I still can't even hear a smoke alarm going off.  A feeling of pressure in ear
Age: 64.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Full blood count, Metabolic function test, Tinnitus, Walking aid user
Clinical narrative: 1 week after injection awoke with hearing loss right ear, balance issues so severe that I need a cane to help keep me from falling over.  Loud ringing in right ear.  Low grade fever of 100.  I still can't even hear a smoke alarm going off.  A feeling of pressure in ear
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient had syncope episode after receiving the vaccines. She was laid down on the table and was coherent after 20 seconds. Legs were bent at the knees. Nurse was brought into the room and did vitals. Patient was given juice and crackers. Vitals were monitored while the doctor was brought into the room.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inbound call from pharmacist who states she has a patient who initiated GARDASIL-9 at age 45 years old but received their second dose at age 46 years old on 7-MAR-2025.  Caller states patient is now requesting their 3rd dose to complete the series bu; Information has been received from Business Partner/CRO on 08-Jul-2025.  This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), dose number 1, (indication, expiration date, and lot # were not reported). On 07-Mar-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #Y013469, expiration date: 10-Oct-2026), dose number 2, for an unknown indication (Inappropriate schedule of vaccine administered).
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: HCP calling to report a PQC for GARDASIL 9.  Caller states "the syringe broke" following the administration of a GARDASIL 9 dose to a patient.  Caller states the "glass part" near the plunger broke for one of the syringes of GARDASIL 9.; Syringe broken; No adverse event; This spontaneous report was received from Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, "the syringe broke" following the administration of a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #Z005469, expiration date: 27-Feb-2026 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis to the patient.  The primary reporter stated that the "glass part near the plunger" near the plunger broke for one of the syringes of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The break was noticed after the administration and the needle was removed from the patient's arm. Caller states the break occurred prior to placing the needle cover. Even with the break, the HCP administering the vaccine was able to cover the needle with the safety cover. The patient received the full dose. Other doses from the box have been administered with no issues. No adverse event reported.; Reporter's Comments
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the first two doses of twinrix but the third dose was only the Hep B vaccine (not the A and B); This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a patient who did not receive HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 2 doses on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. The patient had incomplete course of vaccination (Verbatim: the first two doses of twinrix but the third dose was only the Hep B vaccine (not the A and B)). The outcome of the incomplete course of vaccination 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: 21-JUL-2025 The pharmacist reported that the patient was given the first two doses of Twinrix but the third dose was only the Hepatitis B vaccine (not the A and B). The Hepatitis B vaccine that was administered was Dynavax and the drug name the Heplisav. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix vaccine (Hepatis A antigen), which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I was told that I have shingles.; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JUL-2018, the patient received the 2nd dose of Shingrix. In APR-2018, 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: I was told that I have shingles.). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   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: 23-JUL-2025 The patient got two shots of Shingrix in April and July 2018 then on the day of reporting the patient was told that he/she had shingles.  Reporter questioned that should he/she had gotten an extra show since he/she was 77 years old. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix); Maladministration of DTAP (Infanrix); This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 5KR3R, expiry date 06-FEB-2027) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16-JUL-2025, the patient received Infanrix. The patient did not receive Boostrix. On 16-JUL-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix)) and inappropriate age at vaccine administration (Verbatim: Maladministration of DTAP (Infanrix)). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-JUL-2025 Registered nurse called to report that the maladministration of the wrong vaccine diphtheria, tetanus, and pertussis (Infanrix) instead of tetanus, diphtheria, and pertussis vaccine (Boostrix) to twin brothers, which led to wrong vaccine administered.  The patient received Infanrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter wants guidance on this situation.   Vaccination date, vaccine detail and patient demographics were obtained in this call.  No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. This is 2 of 2 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2025092569:case for twin brother
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: so her arm would be pretty sore; she'd have muscle aches, particularly around her thumbs, the wrist muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (so her arm would be pretty sore) and MYALGIA (she'd have muscle aches, particularly around her thumbs, the wrist muscles) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (so her arm would be pretty sore) and MYALGIA (she'd have muscle aches, particularly around her thumbs, the wrist muscles). At the time of the report, PAIN IN EXTREMITY (so her arm would be pretty sore) and MYALGIA (she'd have muscle aches, particularly around her thumbs, the wrist muscles) had resolved.     Concomitant medication was not reported.  The caller described that with previous vaccinations, after about 48 hours or so her arm would be pretty sore, and she had muscle aches, particularly around her thumbs, the wrist muscles, but she did not have that now. All her vaccines have been Moderna so far. Started in 2021 and has had a total of 9 vaccines including the dose on 22-Jul-2025.   It was unknown if the patient experienced any additional symptoms/events.   Treatment medication was not reported.   This case was linked to MOD-2025-788313 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: arm would be pretty sore; muscle aches, particularly around thumbs, the wrist muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm would be pretty sore) and MYALGIA (muscle aches, particularly around thumbs, the wrist muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm would be pretty sore) and MYALGIA (muscle aches, particularly around thumbs, the wrist muscles). At the time of the report, PAIN IN EXTREMITY (arm would be pretty sore) and MYALGIA (muscle aches, particularly around thumbs, the wrist muscles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  With the previous vaccinations, after about 48 hours or so arm would be pretty sore, and had muscle aches, particularly around thumbs, the wrist muscles, but not had that now. All the vaccines have been Moderna so far. Started in 2021 and has had a total of 9 vaccines including the dose on 22-Jul-2025.   It was unknown if the patient experienced any additional symptoms/events.   Treatment medication was not reported.   This case was linked to MOD-2025-788315 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Influenza like illness
Clinical narrative: had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year; had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year; This is a spontaneous report received from an Other HCP from a sales representative.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), in 2025 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), FATIGUE (non-serious) all with onset 2025, outcome "recovered" (2025) and all described as "had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year". Therapeutic measures were not taken as a result of influenza like illness, fatigue.  Additional information: Person mentioned that she had fatigue and mild flu-like symptoms the day after getting the Covid vaccine earlier this year. Person did not know which Covid vaccine she received and received a flu vaccine the same day.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Blindness, Blood cholesterol, Blood cholesterol increased, Blood pressure measurement, Diabetes mellitus
Clinical narrative: My eye went blind; It raised up diabetes; high blood pressure, cholesterol; high blood pressure, cholesterol; This is a spontaneous report received from a Consumer or other non HCP.  An adult 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "My eye went blind"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "It raised up diabetes"; HYPERTENSION (non-serious), BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown" and all described as "high blood pressure, cholesterol". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Blood pressure measurement: high; Diabetes mellitus: raised up.  Clinical course: Consumer stated, "I would like to talk to someone about the COVID shot (Pfizer COVID-19 Vaccine). I have had 5 of them and they have done me in. I am not myself. They (COVID-19 Vaccine) have created a lot of heath issue for me now and I just came out from the hospital last night. I am tired of going in the hospital because of the COVID shot. I am trying to get back to my son in, from (withheld) to (withheld) and try to get in, my eye went blind. It raised up diabetes, high blood pressure, cholesterol. I have never experienced these things in my entire life and I have been trying to get the help and I cannot get any form of help because nobody, some people just only got two shots, some did not take any but most of the people that I have talked to, had bad reactions and mine seems to be getting worse. Now, I need Pfizer to come up with something to help me. I have no money. I have spent all the money I have had on trying to get myself well in another naturopathic stuff. I am a naturopathic person".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: My eye went blind; It raised up diabetes; high blood pressure, cholesterol; high blood pressure, cholesterol; This is a spontaneous report received from a Consumer or other non HCP.  An adult 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "My eye went blind"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "It raised up diabetes"; HYPERTENSION (non-serious), BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown" and all described as "high blood pressure, cholesterol". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; Blood pressure measurement: high; Diabetes mellitus: raised up.  Clinical course: Consumer stated, "I would like to talk to someone about the COVID shot (Pfizer COVID-19 Vaccine). I have had 5 of them and they have done me in. I am not myself. They (COVID-19 Vaccine) have created a lot of heath issue for me now and I just came out from the hospital last night. I am tired of going in the hospital because of the COVID shot. I am trying to get back to my son in, from (withheld) to (withheld) and try to get in, my eye went blind. It raised up diabetes, high blood pressure, cholesterol. I have never experienced these things in my entire life and I have been trying to get the help and I cannot get any form of help because nobody, some people just only got two shots, some did not take any but most of the people that I have talked to, had bad reactions and mine seems to be getting worse. Now, I need Pfizer to come up with something to help me. I have no money. I have spent all the money I have had on trying to get myself well in another naturopathic stuff. I am a naturopathic person".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pruritus
Clinical narrative: Sore arms; Chills, especially at night; Muscle aches; Headache; Some itching on top of her head; This is a spontaneous report received from a Consumer or other non HCP from License Party.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MODAFINIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRAZODONE HCL; CLONAZEPAM; PROZAC; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; CALCIUM. The following information was reported: CHILLS (non-serious) with onset 16Dec2024, described as "Chills, especially at night"; HEADACHE (non-serious) with onset 16Dec2024; MYALGIA (non-serious) with onset 16Dec2024, described as "Muscle aches"; PRURITUS (non-serious) with onset 16Dec2024, described as "Some itching on top of her head"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2024, described as "Sore arms".  Amendment: This follow-up report is being submitted to amend previous information: adding case identifiers, classification (At Risk) deleted.
Sex: F
Vaccine: COVID19
Symptoms: Autonomic failure syndrome, Encephalitis autoimmune, Headache, Orthostatic hypotension
Clinical narrative: Pure Autonomic Failure; Autoimmune Encephalitis; orthostatic hypotension; head pain; This is a spontaneous report received from a Consumer or other non HCP.  A 20-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster) 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 completed, Unknown manufacturer), for Covid-19 immunization. The following information was reported: AUTONOMIC FAILURE SYNDROME (disability, medically significant), outcome "not recovered", described as "Pure Autonomic Failure"; ENCEPHALITIS AUTOIMMUNE (disability, medically significant), outcome "not recovered", described as "Autoimmune Encephalitis"; ORTHOSTATIC HYPOTENSION (disability), outcome "not recovered"; HEADACHE (disability), outcome "not recovered", described as "head pain". Event information: It was reported that the patient has been diagnosed with Pure Autonomic Failure and Autoimmune Encephalitis. She has chronic, daily head pain, orthostatic hypotension also a list of other symptoms.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Injected limb mobility decreased
Clinical narrative: Left Arm loss of motion
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: Office did report the HCP involved did have a slight cut on a finger due to this break; occupational exposure; Syringe broken; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the healthcare who was involved in administration of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #Z005469, expiration date: 27-Feb-2026 (strength, dose, dose number, route and anatomical location were not provided) with a syringe broke for prophylaxis had a slight cut on a finger due to this break (Limb injury and occupational exposure). At the reporting time, the outcome limb injury of was not provided.  The causal relationship between the event of limb injury and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.   This is one of two reports from the same reporter. This case was considered invalid due to lack of patients' identifiers.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Speech disorder, Syncope
Clinical narrative: Reported Symptoms: 10001488:AGGRESSION; 10001497:AGITATION; 10041469:SPEECH IMPAIRMENT NOS; 10042772:SYNCOPE; Narrative: Patient has PMH of having a stroke, suspected seizure (on seizure med because of it), stenosis of carotids (yearly ultrasound), and per CT large area of encephalomalacia is seen in the left frontal lobe. The symptoms listed here were patient was admitted to hospital around April 9, 2021 are being attributed to March 15, 2021 covid-19 injection (2nd shot, both by pfizer). This is farther out than normal adr of syncope is listed in the literature for this vaccine. Other Relevant HX: Other: SPEECH IMPAIRMENT; SYNCOPE; PHYSICAL AGGRESSION
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Lung disorder, Oropharyngeal pain, Pleurisy
Clinical narrative: Reported Symptoms: 10035618: PLEURISY; 1004137: SORE THROAT; 10051054: LUNG DISEASE; Narrative: Other Relevant HX: Other: Sorethroat followed by pleurisy with lung damage over the next few months
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Reported Symptoms: 10019211:HEADACHE; Narrative: Other Relevant HX: Other: HEADACHE
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844: Rash; Narrative: Other Relevant HX: Other: RASH
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Other Relevant HX: Other: TACHYCARDIA
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: Reported Symptoms: 10013963:DDYSPNEA; Narrative: Other Relevant HX: Other: DYSPNEA.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Reported Symptoms: 10016797: FLU-LIKE SYMPTOMS; Narrative: Other Relevant HX: other: INFLUENZA-LIKE ILLNESS
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Reported Symptoms: 10007882:CELLULITIS; Narrative: Other Relevant HX: Other: CELLULITIS
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery disease, Depression, Haematocrit decreased, Haemoglobin decreased, Hyperlipidaemia
Clinical narrative: Reported Symptoms: 10016558:FEVER; Narrative: Patient was a 73 y/o with hx of follicular lymphoma undergoing R-CHOP who was admitted and given COVID-19 vaccine. Patient experienced fevers (which occurred prior to vaccination) that continued with chemotherapy. Since fevers lasted several weeks, provider entered as adverse reaction. Other Relevant HX: Patient also received R-CHOP chemotherapy on 3/5/2021. Patient was admitted to the hospital 3/5/2021 until 3/21/2021. At time of admission, patient presented with subacute onset fevers and night sweats (and actually received vaccine following admission, so additional factors likely contributed to noted ADR of fevers). The following was indicated on patient's discharge summary: SECONDARY DISCHARGE DIAGNOSES: - Right groin abscess s/p I&D (02/25/2021) with wound vac (removed 3/22/21) - Type 2 diabetes mellitus compounded by steroid-induced hyperglycemia - Hypertension - Hyperlipidemia - Coronary artery disease - Depression - Fever, unspecified Other: FEVER
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Platelet count normal, Pyrexia, Type 2 diabetes mellitus, White blood cell count increased
Clinical narrative: Reported Symptoms: 10016558:FEVER; Narrative: Patient was a 73 y/o with hx of follicular lymphoma undergoing R-CHOP who was admitted and given COVID-19 vaccine. Patient experienced fevers (which occurred prior to vaccination) that continued with chemotherapy. Since fevers lasted several weeks, provider entered as adverse reaction. Other Relevant HX: Patient also received R-CHOP chemotherapy on 3/5/2021. Patient was admitted to the hospital 3/5/2021 until 3/21/2021. At time of admission, patient presented with subacute onset fevers and night sweats (and actually received vaccine following admission, so additional factors likely contributed to noted ADR of fevers). The following was indicated on patient's discharge summary: SECONDARY DISCHARGE DIAGNOSES: - Right groin abscess s/p I&D (02/25/2021) with wound vac (removed 3/22/21) - Type 2 diabetes mellitus compounded by steroid-induced hyperglycemia - Hypertension - Hyperlipidemia - Coronary artery disease - Depression - Fever, unspecified Other: FEVER
Sex: M
Vaccine: COVID19
Symptoms: Wound closure
Clinical narrative: Reported Symptoms: 10016558:FEVER; Narrative: Patient was a 73 y/o with hx of follicular lymphoma undergoing R-CHOP who was admitted and given COVID-19 vaccine. Patient experienced fevers (which occurred prior to vaccination) that continued with chemotherapy. Since fevers lasted several weeks, provider entered as adverse reaction. Other Relevant HX: Patient also received R-CHOP chemotherapy on 3/5/2021. Patient was admitted to the hospital 3/5/2021 until 3/21/2021. At time of admission, patient presented with subacute onset fevers and night sweats (and actually received vaccine following admission, so additional factors likely contributed to noted ADR of fevers). The following was indicated on patient's discharge summary: SECONDARY DISCHARGE DIAGNOSES: - Right groin abscess s/p I&D (02/25/2021) with wound vac (removed 3/22/21) - Type 2 diabetes mellitus compounded by steroid-induced hyperglycemia - Hypertension - Hyperlipidemia - Coronary artery disease - Depression - Fever, unspecified Other: FEVER
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC; experienced two temperature excursions; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, current conditions and concomitant therapies was not reported.   On an unspecified date in 2025, the patient was vaccinated with an improper storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) as prefilled syringe formulation, at a dose of 0.5ml (lot #Y015179 who had been verified to be a valid lot number, expiration date reported and validated as 28-JAN-2027). The vaccine was administered as prophylaxis.  On 14-JUL-2025, the vaccine experienced two temperature excursions. Temperature reported 47.3F with a time frame of 0 hours 50 minutes and 24 seconds, there was a previous temperature excursion of 47.5F for 0 hours 36 minutes and 51 seconds (Product storage error).   No additional adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Blisters; This serious case was reported by a physician via sales rep and described the occurrence of blister in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15-MAY-2025, the patient received Shingles vaccine (left deltoid). On 15-MAY-2025, less than a day after receiving Shingles vaccine, the patient experienced blister (Verbatim: Blisters) (serious criteria other: serious as per reporter). The outcome of the blister was not resolved.   The reporter considered the blister to be related to Shingles vaccine.     The company considered the blister to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2025 The patient had blisters after received a subsequent dose of Shingles vaccine. It persisted and tended to spread to additional areas. No other products were received by the patient.; Sender's Comments: A case of Blister, less than a day after receiving Shingles vaccine, in a female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident expired
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Tendon rupture, X-ray
Clinical narrative: Quad rupture
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Electrocardiogram, Pain in jaw
Clinical narrative: pt contacted pharmacy to let them know she went to the ER because she had pressure on her chest. She had jaw pain and could not her jaw.  She was given EKG. BP 102/69, heart rate and temp was in normal range. She was discharged to home to follow up PCP.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: vasovagal response, loss of consciousness, laid patient flat on floor, patient returned to consciousness after laying flat, patient evaluated, slowly raised to sitting position, waited an additional 10 minutes prior to standing position, patient left accompanied by mother
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Atrial flutter, Endotracheal intubation, Laboratory test, Laryngeal dyskinesia
Clinical narrative: After the first vaccine in 10/2021 within weeks I started to have aflutter in my heart and passing out at work. I had to be admitted to the hospital. I filled a workmans comp claim and was denied. I was forced to get the second vaccine as well and within a month I started to have raynauds syndrome in my hands and feet, heart arrythmias , seizures, adult onset laryngomalacia and paradoxical vocal fold motion disorder. I was hospitalized several times, told I was lying and drug seeking. I was intubated over 6 times and had to have multiple surgeries to open my airway. Due to the delayed care and medical malpractice I ended up with a tracheostomy for 9 months. I have had a couple surgeries since I got the trach out in 2023. The last surgery I had to dilate my airway was may 16th 2025. I still use oxygen at night and am fighting for social security.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laryngomalacia, Loss of consciousness, Raynaud's phenomenon, Seizure, Tracheal dilation procedure
Clinical narrative: After the first vaccine in 10/2021 within weeks I started to have aflutter in my heart and passing out at work. I had to be admitted to the hospital. I filled a workmans comp claim and was denied. I was forced to get the second vaccine as well and within a month I started to have raynauds syndrome in my hands and feet, heart arrythmias , seizures, adult onset laryngomalacia and paradoxical vocal fold motion disorder. I was hospitalized several times, told I was lying and drug seeking. I was intubated over 6 times and had to have multiple surgeries to open my airway. Due to the delayed care and medical malpractice I ended up with a tracheostomy for 9 months. I have had a couple surgeries since I got the trach out in 2023. The last surgery I had to dilate my airway was may 16th 2025. I still use oxygen at night and am fighting for social security.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tracheostomy
Clinical narrative: After the first vaccine in 10/2021 within weeks I started to have aflutter in my heart and passing out at work. I had to be admitted to the hospital. I filled a workmans comp claim and was denied. I was forced to get the second vaccine as well and within a month I started to have raynauds syndrome in my hands and feet, heart arrythmias , seizures, adult onset laryngomalacia and paradoxical vocal fold motion disorder. I was hospitalized several times, told I was lying and drug seeking. I was intubated over 6 times and had to have multiple surgeries to open my airway. Due to the delayed care and medical malpractice I ended up with a tracheostomy for 9 months. I have had a couple surgeries since I got the trach out in 2023. The last surgery I had to dilate my airway was may 16th 2025. I still use oxygen at night and am fighting for social security.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Deafness unilateral, Dizziness, Dysstasia
Clinical narrative: By November 2022, I was in my 5th month of pregnancy and suddenly began experiencing severe vomiting and debilitating dizziness that made it difficult to stand. They always associated it with my pregnancy and low blood pressure during this time. By April 2023, I realized I could not hear from my right ear. An auditory test showed a sudden hearing loss and as a result, tinnitus. Throughout 2024 and 2025, I experienced multiple flu episodes along with dizziness, vomiting, loss of balance, and light sensitivity. The diagnosis was sinusitis. In less than 6 months, I have undergone 3 treatments with antibiotics, and I continue to have relapses from viruses in the respiratory tract.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure during pregnancy, Glycosylated haemoglobin, Hypotension, Influenza, Magnetic resonance imaging
Clinical narrative: By November 2022, I was in my 5th month of pregnancy and suddenly began experiencing severe vomiting and debilitating dizziness that made it difficult to stand. They always associated it with my pregnancy and low blood pressure during this time. By April 2023, I realized I could not hear from my right ear. An auditory test showed a sudden hearing loss and as a result, tinnitus. Throughout 2024 and 2025, I experienced multiple flu episodes along with dizziness, vomiting, loss of balance, and light sensitivity. The diagnosis was sinusitis. In less than 6 months, I have undergone 3 treatments with antibiotics, and I continue to have relapses from viruses in the respiratory tract.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Photophobia, Respiratory tract infection viral, Sinusitis, Sudden hearing loss, Tinnitus
Clinical narrative: By November 2022, I was in my 5th month of pregnancy and suddenly began experiencing severe vomiting and debilitating dizziness that made it difficult to stand. They always associated it with my pregnancy and low blood pressure during this time. By April 2023, I realized I could not hear from my right ear. An auditory test showed a sudden hearing loss and as a result, tinnitus. Throughout 2024 and 2025, I experienced multiple flu episodes along with dizziness, vomiting, loss of balance, and light sensitivity. The diagnosis was sinusitis. In less than 6 months, I have undergone 3 treatments with antibiotics, and I continue to have relapses from viruses in the respiratory tract.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: By November 2022, I was in my 5th month of pregnancy and suddenly began experiencing severe vomiting and debilitating dizziness that made it difficult to stand. They always associated it with my pregnancy and low blood pressure during this time. By April 2023, I realized I could not hear from my right ear. An auditory test showed a sudden hearing loss and as a result, tinnitus. Throughout 2024 and 2025, I experienced multiple flu episodes along with dizziness, vomiting, loss of balance, and light sensitivity. The diagnosis was sinusitis. In less than 6 months, I have undergone 3 treatments with antibiotics, and I continue to have relapses from viruses in the respiratory tract.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy normal, Dyspnoea, Endoscopy normal, Fatigue, Haemoglobin decreased
Clinical narrative: Excessive tiredness, could not walk more than 50 ft without having to stop and catch my breath. Sleepiness all the time.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Excessive tiredness, could not walk more than 50 ft without having to stop and catch my breath. Sleepiness all the time.
Vaccine: MENB
Symptoms: Pain, Pain in extremity
Clinical narrative: throbbing pain/pinching pain; arm hurts during the day/burning pain in arm; This non-serious case was reported by a consumer and described the occurrence of throbbing pain in a patient who received Men B NVS (Bexsero) (batch number 7MN4C, expiry date 29-FEB-2028) for prophylaxis.   In JUL-2025, the patient received Bexsero. In JUL-2025, an unknown time after receiving Bexsero, the patient experienced throbbing pain (Verbatim: throbbing pain/pinching pain) and pain in arm (Verbatim: arm hurts during the day/burning pain in arm). The outcome of the throbbing pain and pain in arm were not resolved.   It was unknown if the reporter considered the throbbing pain and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the throbbing pain and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 21-JUL-2025 The patient's mother reported that case. Two weeks post vaccination of Bexsero vaccine the mom reported that the patient was still experiencing throbbing pain when sleeping, arm hurts during the day and when she lifts it.  The patient was seen in office for examination and four days later mom called to report that the arm was still experiencing a pinching or burning pain
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given Kinrix to a 7-month-old; 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 7-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 11-JUL-2025, the patient received Kinrix. On 11-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: given Kinrix to a 7-month-old). The outcome of the inappropriate age at vaccine administration 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: 14-JUL-2025 Physician reported that he/she had given a Kinrix to a 7-month-old, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: administered as IM instead of Subcutaneous; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received MMR (Priorix) (batch number 32YB4, expiry date 01-DEC-2026) for prophylaxis.   On 15-JUL-2025, the patient received Priorix (intramuscular). On 15-JUL-2025, an unknown time after receiving Priorix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered as IM instead of Subcutaneous). The outcome of the intramuscular 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: 16-JUL-2025 Other HCP reported regarding to the immunization Priorix, the MMR vaccine. Reporter just wanted to get information in regard because, they administered as IM instead of Subcutaneous and reporter wanted to know if there was going to be any complications for the patient or anything that should the patient know about it. The patient was administered with Priorix vaccine Intramuscularly, which led to Intramuscular formulation administered by other route.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient that inadvertently received the pediatric dose; adult patient that inadvertently received the pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 24-year-old male patient who received HBV (Engerix B pediatric) (batch number 3N2ND, expiry date 16-JAN-2027) for prophylaxis.   On 16-JUL-2025, the patient received Engerix B pediatric. On 16-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patient that inadvertently received the pediatric dose) and accidental underdose (Verbatim: adult patient that inadvertently received the pediatric dose). The outcome of the adult use of a child product and accidental underdose 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 Pharmacist wanted to know if she could give a second pediatric dose to complete a full dose of Engerix-B in an adult patient that inadvertently received the pediatric dose. Adult patient received pediatric of dose of Engerix B, which led to adult use of a child product and accidental underdose.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: accidental administration of a pediatric dose of Engerix-B to a 49 year old; accidental administration of a pediatric dose of Engerix-B to a 49 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 49-year-old male patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis.   On 19-JUL-2025, the patient received the 1st dose of Engerix B pediatric. On 19-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: accidental administration of a pediatric dose of Engerix-B to a 49 year old) and accidental underdose (Verbatim: accidental administration of a pediatric dose of Engerix-B to a 49 year old). The outcome of the adult use of a child product and accidental underdose 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: 23-JUL-2025 The nurse reported that the accidental administration of a pediatric dose of Engerix B to the adult patient, with the 10 mcg dose administered, which led to adult use of a child product and accidental underdose. The vaccine administration facility was the same as primary reporter.