chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Mast cell activation syndrome, Weight
Clinical narrative: Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea acc; This spontaneous case was reported by a consumer and describes the occurrence of MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea acc) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea acc) (seriousness criterion medically significant). At the time of the report, MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea acc) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: she used to be 196 lbs and is currently down to 140 lbs..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  In 2020 or 2021, when the first vaccine came out, she took it. She took another one a year later. She had since been sick all the time. She got flare-ups in the forms of hives and rashes. She felt pain in her body and limbs, and they always felt weak. She added that her joints hurt. She went to a dermatologist, but he was not able to diagnose her. She also had ongoing vomiting and diarrhea accompanied by abdominal pain. When she went to the ER, they were not able to tell her what the problem was. She added that she used to be 196 lbs and was currently down to 140 lbs. She was finally diagnosed to have Mast Cell Syndrome. She added that she had mast cells in her stomach.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medications were reported.   This case was linked to MOD-2025-788259 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative, Off label use
Clinical narrative: Antibody levels checked 2 weeks after receiving the half dose are undetectable; She has had only one half-dose; This non-serious initial spontaneous safety report was reported by a Physician via contact center (MI No. NOV25-00332) and concerns a 44-year-old Female who experienced "ANTIBODY LEVELS CHECKED 2 WEEKS AFTER RECEIVING THE HALF DOSE ARE UNDETECTABLE" and "SHE HAS HAD ONLY ONE HALF-DOSE" on unknown dates after receiving Nuvaxovid on an unknown date.  At the time of the report, the outcome of the Antibody test negative was Unknown and Off label use was Recovered/Resolved.; Sender's Comments: This 44-year-old Female experienced Antibody test negative and Off label use after vaccination with Nuvaxovid.  The events Antibody test negative and Off label use were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Nuvaxovid and Antibody test negative and Off label use is considered Possible.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Weight decreased
Clinical narrative: Loss of taste for a few months/Eventually partially return; Attributes 15lb weight loss to this; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 (BNT162B2 NOS), in Aug2022 as dose number unknown, 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: AGEUSIA (non-serious), outcome "recovering", described as "Loss of taste for a few months/Eventually partially return"; WEIGHT DECREASED (non-serious), outcome "recovering", described as "Attributes 15lb weight loss to this". It was unknown if therapeutic measures were taken as a result of ageusia, weight decreased. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  Clinical course: The caller inquired about a prescription medicine for COVID-19 they saw advertised. The agent explained that Pfizer offers a prescription medication for COVID-19. The caller expressed dissatisfaction with the COVID-19 vaccine's effectiveness and mentioned past experiences with COVID-19. The agent suggested consulting a doctor for more detailed information. Submitted AE as the caller mentioned that patient had Covid and got Pfizer Covid 19 but it does no good to him.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: Covid After Pfizer Covid Immunizations; Covid After Pfizer Covid Immunizations; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stress" (unspecified if ongoing); "blood pressure went up" (unspecified if ongoing); "in and out of the hospital" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number unknown, single), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid After Pfizer Covid Immunizations". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: went up. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient reported she was not feeling good. She was at the pharmacy and didn't have insurance for Paxlovid for COVID. Patient stated she haven't been teaching for over a year. She left teaching over a year ago. It was just too stressful then her blood pressure went up. Patient was in and out of the hospital. Patient was provided with her voucher information.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 39.0
Vaccine: TDAP
Symptoms: No adverse event, Off label use
Clinical narrative: with off label diagnosis s61.012A; Initial information received on 22-Jul-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 39 years old with unknown gender patient who had off label diagnosis s61.012A (with no reported 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 had an intentional off label prescription by hcp as Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (with  an unknown lot number, expiry date and strength) (frequency once; dose 0.5ml) via intramuscular route in unknown administration site was prescribed with off label diagnosis s61.012A Laceration without foreign body of left thumb without damage to nail, initial encounter (Skin laceration) (with no reported adverse event) had off label diagnosis s61.012A (Off label vaccine use) (latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  No follow up possible since reporter denied to respond to Sanofi PV.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Hypersensitivity, Immediate post-injection reaction, Vision blurred
Clinical narrative: immediate bad cough; blurred vision; Allergic reaction; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who had immediate bad cough, blurred vision and allergic reaction after receiving influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone].  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 influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).   On an unknown date the patient developed immediate bad cough (cough), blurred vision (vision blurred) and allergic reaction (hypersensitivity) (unknown latency).  Reportedly, patient developed an immediate bad cough, and blurred vision after receiving fluzone - which went away after about two weeks.   Information on the batch number was requested corresponding to the one at time of event occurrence.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.   At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events.
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired adacel vaccine was given with no reported adverse event; Initial information received on 24-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown demographics whom expired diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was given with no reported 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 expired suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (expired product administered) (latency: on same day).  Action taken was not applicable.  Information regarding batch number and expiry date corresponding to the one at time of event occurrence is requested.  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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Cyanosis, Oxygen saturation decreased
Clinical narrative: Resident observed choking, lips blue in color, oxygen saturation decreased to <80% on 5 liters oxygen
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea
Clinical narrative: My period stopped entirely for 13 months
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: severe headache, body aches, high fever, extreme fatigue that last 3 days
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Abnormal behaviour, Blood test, Crying, Dysstasia, Eating disorder
Clinical narrative: About a 20 minute drive from Dr office to home. He was limping when we arrived. Laying up most of the day, when he wakes in the morning he is crying and hit the flood not trying to put pressure on his right leg. Brought him back to clinic she says it was an adverse reaction told me to give it a week it should go away. I have been back and forth to hospitals diagnosed with a seroma due to injury.. got a second opinion. Set up for orthopedic and therapy. I can't get any answers. Everyone I talk to gives me the run around and treats it like it's normal! His behavior, eating, and sleeping habits have changed. He is fatigued and still has problems with his right leg
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Fatigue, Gait disturbance, Seroma, Sleep disorder, Ultrasound scan abnormal
Clinical narrative: About a 20 minute drive from Dr office to home. He was limping when we arrived. Laying up most of the day, when he wakes in the morning he is crying and hit the flood not trying to put pressure on his right leg. Brought him back to clinic she says it was an adverse reaction told me to give it a week it should go away. I have been back and forth to hospitals diagnosed with a seroma due to injury.. got a second opinion. Set up for orthopedic and therapy. I can't get any answers. Everyone I talk to gives me the run around and treats it like it's normal! His behavior, eating, and sleeping habits have changed. He is fatigued and still has problems with his right leg
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Cardiac monitoring, Chest pain, Inflammation, Injection site swelling, Swelling
Clinical narrative: CHEST PAIN; INFLAMMATION OF THE CHEST; INJECTION SITE SWELLING; SWELLING OF THE CHEST; This spontaneous report was received from a Physician and refers to a 52-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and.  The patient's concomitant medication included hydroxyzine 25mg, metoprolol tart 25mg, atorvastatin 10mg. The patient's concurrent conditions included high cholesterol, high blood pressure (HBP) and allergy to penicillin - hives. On 11-Apr-2025, the patient was vaccinated with the first dose of pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) lot number Y011819 and expiration date of 01-Oct-2025, intramuscularly in left arm and the first dose of Varicella zoster vaccine rgE (CHO) (SHINGRIX) intramuscularly in right arm, lot number 9L944 (expiration date was not reported) both for prophylaxis.    On 12-Apr-2025, the patient experienced swelling/inflammation of the chest, severe chest pain, swelling of the left arm around injection site, currently wearing a heart monitor was prescribed famotidine recently. On that date, the patient was hospitalized for 3 days. The patient was order echography, magnetic resonance image (MRI), echocardiogram (EKG) and electrocardiogram. On 14-APR-2025, the patient was prescribed aspirin, ibuprofen and colchicine.  The outcome of the events and the causal relationship between the events and the suspect vaccines were not provided.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-07-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2840364 , Central date : 2025-07-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist realized patient received expired vaccine after patient  left the store.   Pharmacist called  the patient and explained .Patient said  she will call to let us know when she will want to come in for revaccination.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist realized patient received expired vaccine after patient left . Pharmacist called the patient and explained. Patient said he will call  before coming in for revaccination.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Gynaecomastia
Clinical narrative: Covid vacation at fair ground
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Thrombocytopenia, Tinnitus
Clinical narrative: Thrombocytopenia and Tinnitus
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Ophthalmological examination abnormal, Visual field defect, Visual impairment
Clinical narrative: I started noticing visual impairments approximately 05/2024. That consisted of not being able to see road signs in my peripheral vision which then made me notice I couldn't see anything in my peripheral without turning my head. I then went to my eye doctor 5/20/24.  Who then advised me to see a specialist for diagnoses. I was able to see my first specialist 7/15/2024, who was not able to help me and recommended a different specialist. I don't recall the exact date but it was before the end of 2024. I still was unable to get diagnosed from that specialist as well. After receiving testing, it was noted that my left eye is considered blind. With a significant loss of vision. They then questioned if I should be driving, I told them I made a personal adjustment and put in a panoramic rear view mirror to help guide me, and I don't drive at night time EVER because of my lack of vision.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: 73 yr old male   I've had all of the Covid vaccines whenever reccommended by CDC (maybe 6 in all?)  Mon 7.8 25 Moderna 2024-2025 booster  Thurs 7.17.25  symptoms started   through Sat 7.19.25   felt terrible overall including: large  leg rash on shin and calf (at site of injury 2 years earlier)  myalgia,   nausea   headache   chills   mild arm soreness   fever Fever 103.9degrees F  peak     Sat 9 am 7.18.25        headache began 1-2 days later  Sun  7.20.25  somewhat better overall   headache worse, terrible  Thurs 7.24 .25  headache better  Sat.   7.26.25 feeling almost normal  still rash, but much improved
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: 73 yr old male   I've had all of the Covid vaccines whenever reccommended by CDC (maybe 6 in all?)  Mon 7.8 25 Moderna 2024-2025 booster  Thurs 7.17.25  symptoms started   through Sat 7.19.25   felt terrible overall including: large  leg rash on shin and calf (at site of injury 2 years earlier)  myalgia,   nausea   headache   chills   mild arm soreness   fever Fever 103.9degrees F  peak     Sat 9 am 7.18.25        headache began 1-2 days later  Sun  7.20.25  somewhat better overall   headache worse, terrible  Thurs 7.24 .25  headache better  Sat.   7.26.25 feeling almost normal  still rash, but much improved
Age: 73.0
Sex: M
Vaccine: PNC20
Symptoms: Laboratory test, Pneumonia
Clinical narrative: I  received the "new" pneumonia  vaccine, 20 valent pcv20 on April 18,  In July I was hospitialzied for pneumonia.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test negative, Aphonia, Dermatitis contact, Eczema, Hepatic enzyme increased
Clinical narrative: (1)Eczema type break out/swelling of the face (suspected photosensitive) suspectedly caused by cat. 3 Medrol dose packs from July 2022-August 2022, (2)March 2023 another eczema type breakout and loss of voice possibly caused by tree pollen treated with Medrol dose packs and Tacrolimus cream. (3)May 2024 another eczema type breakout along with severe itching caused by poison ivy. Treated with 2 rounds of Medrol dose packs. (4) Severe raised liver enzymes (total 2600)
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photosensitivity reaction, Pruritus, Swelling face
Clinical narrative: (1)Eczema type break out/swelling of the face (suspected photosensitive) suspectedly caused by cat. 3 Medrol dose packs from July 2022-August 2022, (2)March 2023 another eczema type breakout and loss of voice possibly caused by tree pollen treated with Medrol dose packs and Tacrolimus cream. (3)May 2024 another eczema type breakout along with severe itching caused by poison ivy. Treated with 2 rounds of Medrol dose packs. (4) Severe raised liver enzymes (total 2600)
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Computerised tomogram, Electrocardiogram, Full blood count, Ischaemic stroke, Magnetic resonance imaging head abnormal
Clinical narrative: Patient suffered an ischemic stroke and was transported by EMS to Hospital, CT scan, tPA therapy, thrombectomy. Patient 4 days post is in Telemetry unit, positive MRI, speech deficits minor, right hand deficit significant, able to ambulate.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Musculoskeletal disorder, Speech disorder, Thrombectomy, Ultrasound scan
Clinical narrative: Patient suffered an ischemic stroke and was transported by EMS to Hospital, CT scan, tPA therapy, thrombectomy. Patient 4 days post is in Telemetry unit, positive MRI, speech deficits minor, right hand deficit significant, able to ambulate.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Alanine aminotransferase normal, Analgesic drug level therapeutic, Aspartate aminotransferase increased, Bacterial test negative
Clinical narrative: Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status  in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase increased, Blood culture negative, Blood lactic acid increased, Borrelia test negative, C-reactive protein increased
Clinical narrative: Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status  in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF glucose increased, CSF lymphocyte count normal, CSF monocyte count negative, CSF neutrophil count increased, CSF protein increased
Clinical narrative: Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status  in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF red blood cell count positive, CSF virus no organisms observed, Computerised tomogram, Computerised tomogram head normal, Computerised tomogram normal
Clinical narrative: Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status  in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Discomfort, Drug screen negative, Electroencephalogram abnormal, Endotracheal intubation
Clinical narrative: Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status  in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fungal test negative, Glycosylated haemoglobin normal, HIV test negative, Hepatitis A antibody negative, Hepatitis C antibody negative
Clinical narrative: Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status  in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphocyte count increased, Magnetic resonance imaging head normal, Mental status changes, Monocyte count increased, Red blood cell sedimentation rate increased
Clinical narrative: Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status  in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan with contrast normal, Troponin increased, Urinary casts, White blood cell count increased
Clinical narrative: Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status  in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; a 10-month-old male patient was accidentally given a Gardasil 9 vaccination in their right leg on 15Jul2025 by mistake; This spontaneous report was received from a nurse referring to a 10-month-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On 15-Jul-2025, the patient was accidentally vaccinated by mistake with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y008640 has been verified to be a valid lot # for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date not reported but upon internal validation established as 24-May-2026), administered in right leg as prophylaxis (product administered to patient of inappropriate age). No other adverse events or unwanted effects have been reported at this time (no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First dose In May 2023, and the 2nd Dose July 2023, and Another Dose June 10, 2025; Initial report received on 10-Jul-2025.  A pharmacy intern in the reported that a 27-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in May-2023, the second dose in Jul-2023, and a third dose on 10-Jun-2025.  No medical history or concomitant medications were reported.  In May-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available).  In Jul-2023, the patient received dose 2 of HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available).  On 10-Jun-2025, after receiving the second dose of HEPLISAV-B, the patient received dose 3 of a HEPLISAV-B (lot number 945665, expiration date 31-Jan-2027, NDC number 43528-003-05) intramuscularly in the left arm. Previous doses were received at a different pharmacy than the third dose.  No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo; 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 Men B NVS (Bexsero) (batch number 55N34, expiry date 30-SEP-2027) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 17-JUL-2025, the patient received Bexsero. The patient did not receive Menveo. On 17-JUL-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo). The outcome of the wrong vaccine administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-JUL-2025 The reporter stated that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo, which led to wrong vaccine administered.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix expired dose administration;  This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HA9CH, expiry date 13-JUL-2025) for prophylaxis.   On 21-JUL-2025, the patient received Boostrix. On 21-JUL-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix expired dose administration). The outcome of the expired vaccine used 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 had wanted to receive information regarding the administration of a Boostrix dose that had expired less than 30 days prior, which led to Expired vaccine used. He then inquired about the risk of administering another shot that day, so the call had been transferred to the second line
Age: 29.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to received ADACEL but received DAPTACEL instead with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 29 years old male patient who was supposed to received diphtheria-2/tetanus/5 Ac pertussis vaccine [Adacel] but instead received diphtheria-15/tetanus/5 Ac pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. No other vaccine.  On 22-Jul-2025 at 08:55 AM, the patient supposed to received diphtheria-2/tetanus/5 Ac pertussis vaccine but instead  received 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection of standard strength, frequency once with lot 3CA11C1 and expiry date 31-Dec-2025 via intramuscular route in the left deltoid for immunization with no reported adverse event (wrong product administered) (Latency same day)  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.
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient who is due to receive their second dose today, on day 7 of the series, but they may not be able to come into the pharmacy with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was due to receive their second dose rabies (HDC) vaccine [Imovax rabies] today, on day 7 of the series, but they may not be able to come into the pharmacy with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient who was due to receive their second dose of rabies (HDC) vaccine Powder and solvent for suspension for injection (Unknown strength, lot and expiry date) for Immunization on day 7 of the series, but they may not be able to come into the pharmacy with no reported adverse event (routine immunisation schedule not administered)  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: 5.0
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired dose of VAQTA was administered to a patient.; This spontaneous report was received from a consumer (HBP) refers to a 5-year-old patient of unknown gender.   The patient's medical history, current conditions and concomitant therapies was not reported.   On 11-JUL-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) as a prefilled syringe, at a dose of 0.5 ml (lot #X025485 who had been verified to be a valid lot number, expiration date reported and validated as 13-MAY-2025) (anatomical route of administration was not reported) as prophylaxis (Expired product administered).    No additional adverse events reported.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: She received first dose of September 13 2024, and has not had the second dose; Initial report received on 15-Jul-2025.   A pharmacist reported that a 55-year-old female (race, ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 13-Sep-2024 and had not yet received the second dose.  No medical history or concomitant medications were reported.   On 13-Sep-2024, the patient received dose 1 of a hepatitis B vaccine ([HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). At the time of reporting, the patient had not received the second dose yet.    No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initial report received on 15-Jul-2025.  A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had a temperature excursion for a total of 6 days.  No medical history or concomitant medications were reported.  On 20-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 947931, expiration date 15-May-2027, and NDC number 43528-003-01) intramuscularly. The reporter noted a temperature excursion for a total of 6 days prior to the vaccination. No adverse reactions were reported.  No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initial report received on 15-Jul-2025.  A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had experienced a temperature excursion for a total of 6 days.  No medical history or concomitant medications were reported.  On 23-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 947931, expiration date 15-May-2027, and NDC number 43528-003-01) intramuscularly. The reporter noted a temperature excursion for a total of 6 days prior to the vaccination. No adverse reactions were reported.  No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Herpes zoster, Pain, Pruritus
Clinical narrative: Suspected vaccination failure; Shingles on my upper thigh; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In JUL-2025, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on my upper thigh). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUL-2025 This case was reported by a patient via interactive digital media. Patient had the Shingrix vaccine but still got shingles on his/her upper thigh.  It was not fun at all.  He/she was taking Valtrex, and it had been a week since the blisters appeared.  Some had broken and were drying, while others still needed to break.  Ice packs helped. It was painful, itchy, and annoying. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles on my upper thigh; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In JUL-2025, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on my upper thigh). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUL-2025 This case was reported by a patient via interactive digital media. Patient had the Shingrix vaccine but still got shingles on his/her upper thigh.  It was not fun at all.  He/she was taking Valtrex, and it had been a week since the blisters appeared.  Some had broken and were drying, while others still needed to break.  Ice packs helped. It was painful, itchy, and annoying. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix
Vaccine: PNC21
Symptoms: Blister, Rash macular
Clinical narrative: one patient experienced a red patch with big blisters after vaccination with CAPVAXIVE; one patient experienced a red patch with big blisters after vaccination with CAPVAXIVE; This spontaneous report was received from a consumer or other non-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 patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).   On an unknown date, reported as after vaccination, the patient experienced red patch (Erythema) with big blisters (Blister). At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and the suspect vaccine was not reported.
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initial report received on 15-Jul-2025.  A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had experienced a temperature excursion for a total of 6 days.  No medical history or concomitant medications were reported.  On 23-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 947931, expiration date 15-May-2027, and NDC number 43528-003-01) intramuscularly. The reporter noted a temperature excursion for a total of 6 days prior to vaccination. No adverse reactions were reported.  No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.