chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Herpes simplex, Pyrexia, Vomiting
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; broke out with "herpes simplex" virus all over her face; fever; threw up; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series completed), for covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "diagnosed with COVID-19"; HERPES SIMPLEX (non-serious), outcome "unknown", described as "broke out with "herpes simplex" virus all over her face"; PYREXIA (non-serious), outcome "unknown", described as "fever"; VOMITING (non-serious), outcome "unknown", described as "threw up". Clinical course: Caller is a consumer, calling to report AE after receiving COVID-19 booster shots. After receiving booster shots she broke out with herpes simplex virus all over her face, had a fever, threw up and was diagnosed with COVID-19. Needs patient assistance for Paxlovid. Patients have government funded insurance.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Their Covid shot failed; Their Covid shot failed; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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 "Their Covid shot failed".  Clinical course: The reporter stated that Pfizer's Covid shot failed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer.  A 35-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. During an inbound call for financial assistance, the patient wanted to know what she has to do to try to lower the cost of COVID-19 medicine, because she currently has COVID. The patient got COVID and got to take a break from work. The patient remembers when this stuff was free. The patient had nirmatrelvir/ritonavir (PAXLOVID) before for COVID. Per patient, it didn't feel like this time. The patient was sicker than she was last time. But the patient had a couple shots and boosters, but then she hadn't had it in a long time. The patient had been in the patient assistance program before. The patient inquired if she could go take that COVID shot.
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Perhaps too effective because it made me feel horrible; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: MALAISE (non-serious), outcome "unknown", described as "Perhaps too effective because it made me feel horrible".  Additional information: Patient reported that yes, the covid shot was incredibly effective. Perhaps too effective because it made me feel horrible.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Nervous system disorder, Respiratory failure
Clinical narrative: respiratory failure; neurological distress; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY FAILURE (hospitalization, medically significant), 30 days after the suspect product(s) administration, outcome "unknown"; NERVOUS SYSTEM DISORDER (hospitalization), 30 days after the suspect product(s) administration, outcome "unknown", described as "neurological distress". No prior symptoms or diagnosis before the vaccine. Patient has been in the hospital/long term care (LTC) for over 100 days.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the following year, patient did get COVID and got pretty sick with it even though they did get vaccinated; the following year, patient did get COVID and got pretty sick with it even though they did get vaccinated; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old patient received BNT162b2 (COMIRNATY NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "the following year, patient did get COVID and got pretty sick with it even though they did get vaccinated". The clinical course was reported as follows: Patient was a teacher working in a fitness facility and they felt vulnerable. The patient didn't know if they should get another dose before school started or wait until the new version was available, but that might be after school started. The patient asked if they could get another dose every 6 months. Two years ago, the patient's superintendent urged them to get vaccinated before they came to school because of the likelihood of a surge with kids coming back into the classroom. The following year, patient did get COVID and got pretty sick with it even though they did get vaccinated.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Death, Pyrexia
Clinical narrative: Fever, 2 days later death occurred
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Dizziness, Fatigue, Heart rate decreased
Clinical narrative: Fell ill - high fever. Extremely body aches, dizziness, extremely fatigue, nausea, brain fog and extreme pain, ended up in the ER after a week from getting the vaccine. They claimed it was because I caught covid. O2 levels dropped to 86. Heart rate dropped to 38. Fever 104.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Oxygen saturation decreased, Pain, Pyrexia
Clinical narrative: Fell ill - high fever. Extremely body aches, dizziness, extremely fatigue, nausea, brain fog and extreme pain, ended up in the ER after a week from getting the vaccine. They claimed it was because I caught covid. O2 levels dropped to 86. Heart rate dropped to 38. Fever 104.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity
Clinical narrative: THe patient reported that she has been having pain in her arms since last October. She states she is unable to lift more than 15 pounds and that her arms fall asleep often.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, MMR
Symptoms: Menstruation delayed
Clinical narrative: Missed period 10+ days, no pregnancy. Unusual as it is always on time.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Pyrexia
Clinical narrative: Large red spot, taking up most of the upper arm. Fever and signs of high immune activity. Started the next day and continued for several days with the red injection site growing every day until it stopped. it is now beginning to go down and the flu like symptoms are resolving.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Myalgia, Pain
Clinical narrative: Swollen and sore at shot sight hour after shot I felt tired drowsy and sore
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Swollen and sore at shot sight hour after shot I felt tired drowsy and sore
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid infection, Fatigue, Feeling abnormal, Hordeolum, Immune system disorder
Clinical narrative: After vaccine was injected, very next morning I was extremely tired and almost cry due to feel so bad, Then My eyelid becomes Swallen and infected and few days later I had about 25000 stye under my upper eyelid, and I went to Employee Healths, they sent me home, my doctor had prescribed me antibiotics and a lot of other treatment. I was stayed out of work for about 2 weeks, until all inflammation and infections healed. And until they cleared me to back to work. All this record in my doctor's office chart and in hospital Employees health as well. I paid out of my packet for all medication, and for my sick days-its was took out of my vacation PTO time. And this medication was not by my choices-its was mandatory for hospital workers. My immune system never come back to Normal.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Inflammation, Swelling of eyelid
Clinical narrative: After vaccine was injected, very next morning I was extremely tired and almost cry due to feel so bad, Then My eyelid becomes Swallen and infected and few days later I had about 25000 stye under my upper eyelid, and I went to Employee Healths, they sent me home, my doctor had prescribed me antibiotics and a lot of other treatment. I was stayed out of work for about 2 weeks, until all inflammation and infections healed. And until they cleared me to back to work. All this record in my doctor's office chart and in hospital Employees health as well. I paid out of my packet for all medication, and for my sick days-its was took out of my vacation PTO time. And this medication was not by my choices-its was mandatory for hospital workers. My immune system never come back to Normal.
Age: 47.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: patient says that the next day after receiving the TWINRIX and FLUBLOK vaccine he started to experience numbness and tingling in his left arm and fingers
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Death, Deep vein thrombosis, Pulmonary embolism, Unresponsive to stimuli
Clinical narrative: On 8/13/2023 Police was called to do a wellness check on patient because she did not report to work or answer multiple phone calls which was very unusual. Upon entering patient's home, she was found unresponsive with no sign of life. EMS was dispatched to the home where they confirmed that she was deceased. She was transported to Coroner's office where an autopsy was performed to determine the exact cause of death. The report indicated that she had passed from multiple Pulmonary Embolism and multiple Deep Vein Thrombosis. We believe her death was directly related the Pfizer Covid-19 SARS injections since she was otherwise a very healthy person who worked in the health system.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Continuous glucose monitoring, Diarrhoea, Eczema, Feeding disorder, Insomnia
Clinical narrative: in September 2022, i ate a bag of M&Ms and started violently puking, diarrheaing, and passing out. because i had not received a diagnosis yet, i thought it was normal. in February 2024, i was diagnosed with type one diabetes. my pancreas is now dead and i have to take insulin shots and constantly monitor my sugar (i cant eat, i cant sleep, years are taken off my life). in addition to this, i have also developed eczema.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pancreatic disorder, Type 1 diabetes mellitus, Vomiting
Clinical narrative: in September 2022, i ate a bag of M&Ms and started violently puking, diarrheaing, and passing out. because i had not received a diagnosis yet, i thought it was normal. in February 2024, i was diagnosed with type one diabetes. my pancreas is now dead and i have to take insulin shots and constantly monitor my sugar (i cant eat, i cant sleep, years are taken off my life). in addition to this, i have also developed eczema.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Carotid endarterectomy, Cerebrovascular accident, Inflammation
Clinical narrative: Heart disease, stroke, carotid surgery, flammatory complications.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Chills, Condition aggravated, Continuous glucose monitoring, Headache
Clinical narrative: With the headache, muscle aches, and chills my blood sugar has been consistently higher than usual with extreme highs with food
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Type 2 diabetes mellitus
Clinical narrative: With the headache, muscle aches, and chills my blood sugar has been consistently higher than usual with extreme highs with food
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Chills, low headache, minor muscle ache, low temperature, general malaise
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Seizure
Clinical narrative: The immunizer stated that the patient started to have a seizure about 7-110 minutes after the flu shot was given. It last less than 1 minute. She stayed in the immunization room for about 20 minutes with the store manager. PT stated that she has a history of seizures and wasn't sure it was related to vaccine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: my husband and I have received all Moderna Covid Shots - we never got covid - the problem is we are both physically exhausted all the time started about a year ago and we wanted to know if this could be a long term side effect of all the shots
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillaine Barre Syndrome
Age: 89.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had previously received RSV (Arexvy)  on 9/28/23.  Per patient, she did not experience any adverse effects.
Age: 93.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had previously received RSV (Arexvy)  on 9/28/23.  Per patient, he did not experience any adverse effects.
Age: 66.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: THIS WAS THE VACCINE THAT CAUSED AN ADVERSE REACTION. WITH RED AND INFLAMED AREA.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Fatigue, Injection site rash, Injection site warmth, Malaise, Mobility decreased
Clinical narrative: THE PATIENT EXPERIENCED SEVERE MALAISE AND FATIGE. SHE COULD NOT GET OUT OF THE BED FOR 2 DAYS. SHE SLSO HAD A HUGE RASH ON HER LET ARM AT THE INJECTION SITE AND SURROUNDING AREA. IT WAS HOT TO THE TOUCH
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Anaphylactic reaction, Hypopnoea, Loss of consciousness, Urticaria
Clinical narrative: Patient was administered the above vaccinations and within a few minutes, patient developed anaphylactic reaction which includes shallow breathing, hives and unconscious. I administered Epipen to the right thigh and within a few seconds, patient breathing was better and consciousness returned.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Dizziness, Feeling hot
Clinical narrative: PATIENT SCHEDULED 4 VACCINATIONS. THE PATIENT WAS IMMUNIZED FIRST WITH FLUARIX AND THEN GARDASIL. AFTER GARDASIL SHE FELT LIGHTHEADED AND OVERHEATED. THE IMMUNIZING INTER CALLED ME (RPH) INTO THE ROOM AND THE PATIENT APPEARED TO BE ON THE VERGE OF SYNCOPE BUT STATED SHE WAS JUST VERY AFRAID OF NEEDLES. SHE WAS GIVEN WATER AND PAPER TOWELS TO WIPE HER FACE. PATIENT AND HER PARENTS DECLINED OFFER TO CALL EMS. RECOMMENDED  THE PATIENT NOT GET THE OTHER 2 VACCINATIONS (MENINGITIS AND TDAP) AT THIS TIME, BUT THE PATIENT STATED SHE FELT BETTER AFTER DRINKING WATER AND RESTING FOR 15 MINUTES AND PATIENT/PARENTS DECIDED TO CONTINUE WITH THE IMMUNIZATIONS. PATIENT REMAINED SEATED FOR 30 MINTUES WITH NO FURTHER ADVERSE EFFECTS.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Biopsy colon abnormal, Blood test abnormal, Colitis microscopic, Colonoscopy abnormal
Clinical narrative: 1. Severe recurring diarrhea, gas, bloating - diagnosed by Dr. 06/28/2022 via colonoscopy and biopsy; no previous history prior to COVID-19 vaccines; treated with budesonide, temporary relief only; condition worsened - treated with prednisone 10mg starting 12/2022 with some relief; recurring episodes of severe diarrhea treated with prednisione to current date. 2. Immune system no longer protective - CVID diagnosed 1/12/2024 by Dr.; no previous history prior to COVID-19 vaccines; currently treated with subcutaneous infusion of HyQvia.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence, Immunodeficiency common variable
Clinical narrative: 1. Severe recurring diarrhea, gas, bloating - diagnosed by Dr. 06/28/2022 via colonoscopy and biopsy; no previous history prior to COVID-19 vaccines; treated with budesonide, temporary relief only; condition worsened - treated with prednisone 10mg starting 12/2022 with some relief; recurring episodes of severe diarrhea treated with prednisione to current date. 2. Immune system no longer protective - CVID diagnosed 1/12/2024 by Dr.; no previous history prior to COVID-19 vaccines; currently treated with subcutaneous infusion of HyQvia.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac failure congestive, Cardioversion, Echocardiogram
Clinical narrative: patient was in hospital for new onset afib; Congestive heart failure; Pleural effusion; Fever; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included escitalopram oxalate (Lexapro).   On 23-AUG-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, less than a month after receiving Shingrix, the patient experienced atrial fibrillation (Verbatim: patient was in hospital for new onset afib) (serious criteria hospitalization and GSK medically significant), congestive heart failure (Verbatim: Congestive heart failure) (serious criteria hospitalization and GSK medically significant) and pleural effusion (Verbatim: Pleural effusion) (serious criteria hospitalization). On an unknown date, the patient experienced fever (Verbatim: Fever). The patient was treated with amiodarone, furosemide (Lasix), potassium and oxygen. The outcome of the atrial fibrillation, congestive heart failure and pleural effusion were not resolved and the outcome of the fever was resolved.   It was unknown if the reporter considered the atrial fibrillation, congestive heart failure, pleural effusion and fever to be related to Shingrix.     The company considered the atrial fibrillation, congestive heart failure and pleural effusion to be unrelated to Shingrix. It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JUL-2025 and 30-JUL-2025 The patient went to the emergency room on 9 September 2023 and was admitted for a week to 10 days and was diagnosed with new onset atrial fibrillation, pleural effusion, and congestive heart failure after receiving the Shingrix vaccine. She went home with 5 different medications on discharge which were Amiodarone, Lasix, a beta blocker, potassium and oxygen.  She also mentioned having a fever for a week or 2 weeks after hospitalization.  The patient had a cardioversion 4 weeks after her discharge. She had an ICD implant, ablation and an echocardiogram. Further the patient had difficult experience with the Shingrix vaccine which was still ongoing two years later The patient appreciated the support from the GlaxoSmithKline representative which made this difficult experience with the Shingrix vaccine much easier to talk about; Sender's Comments: A case of Atrial fibrillation, Cardiac failure congestive and Pleural effusion, less than a month after receiving Shingrix, in a 71-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained.  Further follow up information has been sought.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Implantable defibrillator insertion, Pleural effusion, Pyrexia
Clinical narrative: patient was in hospital for new onset afib; Congestive heart failure; Pleural effusion; Fever; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included escitalopram oxalate (Lexapro).   On 23-AUG-2023, the patient received the 2nd dose of Shingrix. In SEP-2023, less than a month after receiving Shingrix, the patient experienced atrial fibrillation (Verbatim: patient was in hospital for new onset afib) (serious criteria hospitalization and GSK medically significant), congestive heart failure (Verbatim: Congestive heart failure) (serious criteria hospitalization and GSK medically significant) and pleural effusion (Verbatim: Pleural effusion) (serious criteria hospitalization). On an unknown date, the patient experienced fever (Verbatim: Fever). The patient was treated with amiodarone, furosemide (Lasix), potassium and oxygen. The outcome of the atrial fibrillation, congestive heart failure and pleural effusion were not resolved and the outcome of the fever was resolved.   It was unknown if the reporter considered the atrial fibrillation, congestive heart failure, pleural effusion and fever to be related to Shingrix.     The company considered the atrial fibrillation, congestive heart failure and pleural effusion to be unrelated to Shingrix. It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JUL-2025 and 30-JUL-2025 The patient went to the emergency room on 9 September 2023 and was admitted for a week to 10 days and was diagnosed with new onset atrial fibrillation, pleural effusion, and congestive heart failure after receiving the Shingrix vaccine. She went home with 5 different medications on discharge which were Amiodarone, Lasix, a beta blocker, potassium and oxygen.  She also mentioned having a fever for a week or 2 weeks after hospitalization.  The patient had a cardioversion 4 weeks after her discharge. She had an ICD implant, ablation and an echocardiogram. Further the patient had difficult experience with the Shingrix vaccine which was still ongoing two years later The patient appreciated the support from the GlaxoSmithKline representative which made this difficult experience with the Shingrix vaccine much easier to talk about; Sender's Comments: A case of Atrial fibrillation, Cardiac failure congestive and Pleural effusion, less than a month after receiving Shingrix, in a 71-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained.  Further follow up information has been sought.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test, CSF white blood cell count increased, Clostridium difficile infection, Computerised tomogram normal, Confusional state
Clinical narrative: Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dizziness, Encephalitis, Feeding disorder, Hypersomnia, Insomnia
Clinical narrative: Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Magnetic resonance imaging normal, Malaise, Mental status changes, Mobility decreased
Clinical narrative: Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anxiety, Aphasia, CSF culture negative, Cerebral infarction, Clostridium test positive
Clinical narrative: Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypophagia, Klebsiella test positive, Magnetic resonance imaging head abnormal, Mental status changes
Clinical narrative: Patient s/p dog bite by family dog. Upon evaluation in the hospital, patient reported that dog was unknown canine who attacked patient and dog. Rabies vaccine was decided to be given by ED provider 7/25. RN administered vaccine and provided vaccine information sheet. Prior to vaccine, family reports that patient was in usual state of health. Following discharge from ED, patient's family reports that patient stopped eating and drinking, was feeling anxious and overwhelmed. Patient had trouble finishing sentences when brought back to the ED. Patient admitted with altered mental status.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, MMR
Symptoms: Menstruation delayed
Clinical narrative: Missed period, 10+ days late. No pregnancy. Unusual as it is ALWAYS on time +/- 2 days.; This is a spontaneous report received from an Other HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Jul2025 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in arm for covid-19 immunisation; measles vaccine, mumps vaccine, rubella vaccine (MMR), on 03Jul2025 as dose 2, single, in left arm for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Mmr (Dose 1, single), for Immunization. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 30Jul2025, outcome "unknown", described as "Missed period, 10+ days late. No pregnancy. Unusual as it is ALWAYS on time +/- 2 days.". Therapeutic measures were not taken as a result of menstruation delayed. Additional information: the patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) being reported.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: pregnant patient received Arexvy instead of Abrysvo; pregnant patient received Arexvy instead of Abrysvo within the health system; pregnant patient received Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On an unknown date, the patient received Arexvy. The patient did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Arexvy instead of Abrysvo), wrong vaccine administered (Verbatim: pregnant patient received Arexvy instead of Abrysvo within the health system) and product use in unapproved population (Verbatim: pregnant patient received Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and product use in unapproved population were not applicable.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 28-JUL-2025 The pregnant patient received Arexvy instead of Abrysvo within the health system which led to wrong vaccine administered, product use in unapproved population and vaccine exposure during pregnancy. No negative outcomes apparent at the time of reporting provided.
Sex: F
Vaccine: COVID19
Symptoms: Brain fog
Clinical narrative: brain fogging issues related to this specific vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN FOG (brain fogging issues related to this specific vaccine) 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 second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BRAIN FOG (brain fogging issues related to this specific vaccine). At the time of the report, BRAIN FOG (brain fogging issues related to this specific vaccine) had not resolved.            No concomitant medication was reported.  She was confused about if she had reactions upon getting the second vaccine and she had brain fogging issues related to this specific vaccine.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medication was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Angiotensin converting enzyme abnormal, Condition aggravated, Electromyogram, Epstein-Barr virus infection reactivation, Epstein-Barr virus test
Clinical narrative: Neuropathy,  Chronic pain, Reactivated EBV,  abnormal Angiotensin Converting Enzyme
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, SARS-CoV-2 antibody test
Clinical narrative: Neuropathy,  Chronic pain, Reactivated EBV,  abnormal Angiotensin Converting Enzyme
Sex: F
Vaccine: PNC21
Symptoms: Death, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: FBE calling on behalf of HCP to submit an AE for a patient who was given CAPVAXIVE. The experience happened "over the last month" where the patient was given CAPVAXIVE, then developed numbness "about a week later" and was diagnosed with severe Guilla; Death; Information has been received from Business Partner/CRO on 05-Aug-2025.  This spontaneous report was received from a physician and refers to a 61-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine 0.5 mL administered by Intramuscular route (lot # and expiration date were not reported). The patient started therapy with for the treatment of pneumonia prevention. The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine for the treatment of pneumonia prevention.  On an unknown date, the patient developed numbness and was diagnosed with severe Guillain-Barre. The patient was hospitalized due to those events. On unknown date, the patient died for unknown reason.   At the reporting time, the patient had not recovered from Guillain-Barre syndrome. On an unspecified date, the patient died because of the event of death. It was unknown whether an autopsy was performed.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable.   The causal relationship between all of the events and Pneumococcal 21-valent Conjugate Vaccine was not provided.   The reporter considered the event of Guillain-Barre to be life-threatening and disabling/incapacitating.
Age: 70.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Havrix 2nd dose one month early in series. First dose was given 03/11/25 and second dose was given 08/09/25 rather than 09/09/25
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vitiligo
Clinical narrative: I had 3 shots of Moderna over the course of 2021. It is hard to identify Vitiligo until summer and I start to tan The following summer 2022 I noticed the backside of my leg at the  bend was developing  what I know now was Vitiligo. It seemed to be getting larger as the summer went on. Summer of 2023 the area on the back of my leg was larger and a few more spots on the front of my leg and the inside of the right forearm. Summer of 2024. I went to the dermatologist and they identified it as Vitiligo. The summer of 2025 the area on my legs and right forearm are larger and now it is on the left forearm.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Pericardial drainage, Pericardial effusion
Clinical narrative: 2 months After vaccination started having chest pain and shortness of breath. In Oct 2021 went to Hospital and was misdiagnosed with heartburn and sent home due to excessive COVID 19 patients . Chest pain continued to progress so went to a different emergency room many months later, hospital ,and was admitted with 8 liters of fluid around heart and pericarditiis. Emergency surgery to remove fluid.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Pericarditis, Ultrasound scan
Clinical narrative: 2 months After vaccination started having chest pain and shortness of breath. In Oct 2021 went to Hospital and was misdiagnosed with heartburn and sent home due to excessive COVID 19 patients . Chest pain continued to progress so went to a different emergency room many months later, hospital ,and was admitted with 8 liters of fluid around heart and pericarditiis. Emergency surgery to remove fluid.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Catheterisation cardiac abnormal, Contrast echocardiogram, Dyspnoea, Ejection fraction decreased
Clinical narrative: very weaked heart & short of breath, especially outside in the heat
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Left ventricular enlargement
Clinical narrative: very weaked heart & short of breath, especially outside in the heat
Age: 65.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Nausea, Syncope
Clinical narrative: Fainting, nausea.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulation factor VIII level increased, Fatigue, Hypersomnia, Immune thrombocytopenia, Mobility decreased
Clinical narrative: in 2018 I resulted positive for ANA, dsDNA and being treatment for the possibility of Lupus (SLE). I received the COVID vaccine as a result of my medical conditions including that of asthma. However, after the second/third dose of the vaccination my autoimmune issues seemed to begin to worsen, and it has only been until now that I have been able to place to two together. After, I received the second/third dose of the vaccine I was unable to sit upright, I was extremely tired and slept for approximately two days and was unable to move from the bed. Ever since, it seems that my autoimmune issues have become more profound and recently I discovered I have a high Factor VIII/autoimmune thrombocytopenia.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis infective, Bacterial infection, Bone atrophy, Carpal tunnel syndrome, Computerised tomogram
Clinical narrative: pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly.  It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Dyspnoea, Electrocardiogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly.  It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle atrophy, Muscle injury, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly.  It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nerve injury, Pain, Protein total increased, Respiratory disorder, Retinal detachment
Clinical narrative: pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly.  It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rotator cuff repair, Scan brain, Trigger finger, Viral infection, Weight decreased
Clinical narrative: pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly.  It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly.  It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antiphospholipid syndrome, Beta-2 glycoprotein antibody positive, Blood test abnormal, Cardiac monitoring normal, Cardiolipin antibody positive
Clinical narrative: I am an active 65 year old man.  I bike 300 miles per month.  On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo.  I felt sick to my stomach.  The room was spinning.  I was nauseous.  I was at a restaurant with my wife at the time.  After about 15 minutes, it dissipated.  I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening.  2 days later on Sunday morning, February 3, I went for my bike ride.  After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me.  Once again, they dissipated about 15 minutes later.  My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out.  We discussed possible treatment for vertigo.  But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5.  The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER.  In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound.  Those tests both were negative.  My arteries in my neck and the back of my head were also checked through an ultrasound with dye.  Those tests showed my arteries were clear.  I was released from the hospital about 48 hours after admittance.  I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision.  The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB.  I visited my opthamologist re the double vision.  She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed.  She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes.  She thought over time the double vision would disappear.  As of today I still have permanent double vision.  I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily).  I am also required to take aspirin every day (81 mg).  And, I worry about a possible future stroke and so does my wife of 45 years.