chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did not prevent covid or transmission of covid; did not prevent covid or transmission of covid; 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 "did not prevent covid or transmission of covid". Clinical course: Covid shot did not prevent covid or transmission of covid.  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, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 45-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 and 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) all with onset 11Aug2025, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2025) Positive.  Additional Information: During an inbound call for financial assistance, the patient stated, she actually tested positive today for COVID, her doctor sent in a prescription for Paxlovid for her because she had a lot of other medical conditions and she just got out the hospital for one of them. Her insurance wasn't approving Paxlovid. She guesses that's stopped or something How do she could get help getting the antibodies, the Paxlovid, because she means, she had been vaccinated. She got the Pfizer vaccines. She was getting sick" Additionally she stated, "she's antigen...she has got two dogs that she need to make sure survive, so she guessed she should probably survive too." Toward the end of the call, she stated, This is the first time she had ever gotten COVID, and she didn't even leave her house.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  An 87-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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500162422 Same reporter/product/event, different patient;
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Accidentally gave subcutaneously instead of intramuscular, but has no known adverse event
Age: 62.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt complaining of hot spot, redness, swelling, and heat around injection site. Advised pt to take Tylenol and use ice. Advised pt to monitor over next few days and if it seems to be getting worse, contact her provider.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blood creatine phosphokinase increased, Blood potassium decreased, Carbon dioxide decreased, Chest X-ray normal, Chest pain
Clinical narrative: During afternoon workout pt developed chest pain and shortness of breath which persisted for 6-7 hours and resulted in ER visit.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram thorax normal, Dyspnoea, Electrocardiogram normal, Full blood count normal
Clinical narrative: During afternoon workout pt developed chest pain and shortness of breath which persisted for 6-7 hours and resulted in ER visit.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Throat tightness
Clinical narrative: Patient returned to the pharmacy after some shopping complaining of dizziness, feeling weak, and that her throat felt restricted.  I offered to use an epipen and call 911, but she declined and said she would call her daughter to pick her up.  She accepted 1 tablet of Benadryl 25mg.  She was wearing a continuous glucose monitor and her sugar level was at 105.  She wanted to check her blood pressure and it was 92/72 which she was was normal for her.  We monitored her until her daughter picked her up.  I recommended that she went to the emergency room for monitoring and to follow up with her doctor.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Brain fog, Dyspnoea, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: the day after the covid vaccine injection, the next day I was extremely sick with the total time being 29 days. 7 of the first days was extremely hard to breathe, fever between 99-104 for the 7 days, hot and cold sweats all day long, little to no sleep, the first 3 days zero food consumption and little to no water, everything kept being thrown up, extreme brain flogged. from day 7-29 extremely sick still but fever was more on and off could hold down food. Extreme amount of bone pain, within knuckles and joints for the whole duration.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: the day after the covid vaccine injection, the next day I was extremely sick with the total time being 29 days. 7 of the first days was extremely hard to breathe, fever between 99-104 for the 7 days, hot and cold sweats all day long, little to no sleep, the first 3 days zero food consumption and little to no water, everything kept being thrown up, extreme brain flogged. from day 7-29 extremely sick still but fever was more on and off could hold down food. Extreme amount of bone pain, within knuckles and joints for the whole duration.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cold sweat, Hot flush, Malaise
Clinical narrative: Was extremely sick from the prior vaccine that I've made a previous report on that lasted the entire time. I then had to receive this vaccine, which made my fever go back to 99-104 for 5 days, during the first 3 days of this Second round of vaccine I could not hold down any food and barely any water, Extreme cold sweats and hot flashes very little sleep. then for the following 16 days I was very sick with extreme joint pain that still was persisting from the prior vaccine into this vaccine, as well as just overall health feeling sick nauseous, very low and reduced energy. Basically, after getting this vaccine, I got extremely sick, as well as the first round of vaccine making me extremely sick as well.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sleep disorder, Vomiting
Clinical narrative: Was extremely sick from the prior vaccine that I've made a previous report on that lasted the entire time. I then had to receive this vaccine, which made my fever go back to 99-104 for 5 days, during the first 3 days of this Second round of vaccine I could not hold down any food and barely any water, Extreme cold sweats and hot flashes very little sleep. then for the following 16 days I was very sick with extreme joint pain that still was persisting from the prior vaccine into this vaccine, as well as just overall health feeling sick nauseous, very low and reduced energy. Basically, after getting this vaccine, I got extremely sick, as well as the first round of vaccine making me extremely sick as well.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test positive, Deep vein thrombosis, Depression, Hypercoagulation, Post-traumatic stress disorder
Clinical narrative: Multiple severe DVTs, consecutive bilateral PEs, enrichment taken from life, debt and depression. PTSD from painful blood thinning injections.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Multiple severe DVTs, consecutive bilateral PEs, enrichment taken from life, debt and depression. PTSD from painful blood thinning injections.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac ventricular thrombosis, Catheterisation cardiac abnormal, Cough, Myocardial infarction
Clinical narrative: STARTED with cough then weakness across my whole body 5-25-22 - Heart attack with 3 Blood Clots found.
Age: 20.0
Sex: F
Vaccine: COVID19, HPV9, TTOX
Symptoms: Photophobia, Rash, Raynaud's phenomenon
Clinical narrative: She now has MCAS - Mast Cell Activation Syndrome by an allergy clinic,; Shell of herself; headaches; high blood pressure; sensitivity to light; rashes; patient was diagnosed with Raynaud's Disease/Some days are better than others, but no comparison to how she was prior to receiving the three  shots; fatigue; This spontaneous report was received from a consumer referring her daughter as a 20-year-old female patient.   The patient's medical history was not reported. Her concurrent conditions included Raynaud's disease which was diagnosed on 2 different times, once in middle school and once in high school. Concomitant therapies were unknown. She had not known allergies.  On 13-May-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, 1 dosage form (dosage regimen, anatomical location, route of administration, batch/lot # and expiration date were not reported) administered as prophylaxis; with elasomeran (COVID-19 VACCINE MODERNA) (reported as "Covid shot [Moderna]") 1 dosage form (dosage regimen, anatomical location, route of administration, indication, expiration date, and lot # were not reported); and with tetanus vaccine (reported as "Tetanus shot"), 1 dosage form (dosage regimen, anatomical location, route of administration, indication, expiration date, and lot # were not reported.)   Since 13-May-2024 (reported as "ever since receiving the shots"), she had been a shell of herself (emotional disorder). On unspecified date (s) in May-2024, she experienced high blood pressure (hypertension), rashes (rash), fatigue, sensitivity to light (photophobia), and headaches (headache). The patient was in bed from 15-May-2024 through all last summer. She went to her senior year of college in the fall of 2024. During the year, the patient missed a lot of classes and needed a lot of rest. It was also reported regarding her Raynaud's disease that patient's fingers were painful and had difficulty opening bottles, with some days better than others, but no comparison to how she was prior to receiving the three vaccines (reported as "shots") (Raynaud's phenomenon) She had been to numerous doctors while in college. She also went to the other facility. The patient underwent bloodwork, Ziopatch for heart monitoring, Gold Standard Potts Diagnosis, but the tests results were not provided. On unspecified date, she had Mast Cell Activation Syndrome (MCAS) by an allergy clinic.  At the reporting time, the patient had not recovered from the events and was on unspecified medications.  The causal relationship between the events and the suspect vaccines was unknown, and the reporter wanted to know if it was safe to administer the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) along with the "Covid and Tetanus shots", and how to know for sure which vaccine was causing the issues.   Upon internal review, the event mast cell activation syndrome was considered to be medically significant.  Batch/lot # is being requested and will be submitted if received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Drug-resistant insomnia
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Redness at the injection site; Warm and tenderness at the injection site; Warm and tenderness at the injection site; Chilled fever; Itchiness at at the injection site; This is a spontaneous report received from a Nurse.  A 56-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Aug2025 at 12:09 as dose number unknown, 0.5ml single (Lot number: LN4932, Expiration Date: 30Aug2026) at the age of 56 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness at the injection site"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Warm and tenderness at the injection site"; PYREXIA (non-serious), outcome "unknown", described as "Chilled fever"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itchiness at at the injection site". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pain, vaccination site warmth, pyrexia, vaccination site pruritus.  Causality for "redness at the injection site", "warm and tenderness at the injection site", "chilled fever" and "itchiness at at the injection site" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: Doctor prescribed Doxycycline, Prednisone, Triamcinolone Cream and Pepcid. NDC number of Prevnar 20: 0005200001; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500157347 Same reporter and suspect product different patient/AE;US-PFIZER INC-202500157363 Same reporter and suspect product different patient/AE;
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel very ill; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Immunization. The following information was reported: MALAISE (non-serious), 5 days after the suspect product(s) administration, outcome "unknown", described as "feel very ill".  Additional information: Patient reported that just got 4th booster and after 5 days felt very ill. No Hospitalization Prolonged.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID last night/ on like day three of symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "underlying health issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 vaccination; Bnt162b2 (Dose 2, single), for COVID-19 vaccination. The following information was reported: COVID-19 (non-serious) with onset Aug2025, outcome "unknown", described as "tested positive for COVID last night/ on like day three of symptoms". The event "tested positive for covid last night/ on like day three of symptoms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did three of the boosters in a row, but the last one was in Oct2022. The patient was on like day three of symptoms, and tested positive for COVID last night (12Aug2025). The patient's wife got a tele visit with doctor this morning (13Aug2025).   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500098451 same reporter, same drug/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I did test positive for it; I did test positive for it; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 67-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) and in Jan2021 as dose 2, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 07Aug2025, outcome "unknown" and all described as "I did test positive for it". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2025) positive. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  Clinical Course :Additional Information: The Patient stated last Thursday (07Aug2025), he went to the doctor, and they tested for COVID, and he had strep throat also, double, so it wasn't good. When asked for clarification if he had picked up the medication on Thursday, the patient stated," After he went to a friend's house to borrow the money, he did. He was scared as he never had COVID or the Corona virus or whatever he never had before. The patient got a terrible headache and a cough, and he didn't want to play around with this. The patient stated "for the record, back in Jan2021 he did get the Pfizer Vaccine. Two separate trips to the Hospital down. And he hasn't had any Covid symptoms or signs of anything since then until last week. He must have come in contact with it somehow, because he did test positive for it.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have COVID; have COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 66-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "have COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  The reason that she was calling is because she  have COVID and they prescribed the Paxlovid. Later, she stated, Don't mind me, I'm like delirious with this COVID." Pfizer is the one that gave her the shot. After confirming if the shot was for COVID, stated, "Yes. I took two. Number one and number two. Yeah, with Pfizer." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Biopsy skin, Cellulitis, Full blood count, Herpes zoster, Macule
Clinical narrative: December 28, 2024 Left arm and forearm itchy rash, diffuse red macules, cellulitis, herpetic neuralgia and zoster, redness, swelling, moderate pain, Peau d'orange skin changes, neuralgia C5-C6 dermatome
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Neuralgia, Pain, Peau d'orange, Rash, Rash pruritic
Clinical narrative: December 28, 2024 Left arm and forearm itchy rash, diffuse red macules, cellulitis, herpetic neuralgia and zoster, redness, swelling, moderate pain, Peau d'orange skin changes, neuralgia C5-C6 dermatome
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Multiple sclerosis, Myocardial infarction, Myocarditis
Clinical narrative: I had at myocardial infarct the day after I got my booster. I now have Multiple Sclerosis since 2024
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Hypoaesthesia, Pain, Palpitations
Clinical narrative: Soreness and headache, heart palpitations when lying down to go to sleep.  Came down with COVID and then developed Long COVID with numbness in right hand and arm, which then developed with a hand tremor, then developed an internal vibration throughout the whole right arm,  The pulsing vibration,  will wake me up at night.   So I am prescribed Ambien in order to sleep through the night.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 antibody test positive, Sensory disturbance, Sleep disorder, Tremor
Clinical narrative: Soreness and headache, heart palpitations when lying down to go to sleep.  Came down with COVID and then developed Long COVID with numbness in right hand and arm, which then developed with a hand tremor, then developed an internal vibration throughout the whole right arm,  The pulsing vibration,  will wake me up at night.   So I am prescribed Ambien in order to sleep through the night.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: I had both the flu and pneumonia shot that day. They were both injected into my upper left arm?.i dont know the exact name of the   Vaccines?..they warned of some possible injection sight pain, but said it would go away?.it was painful the next day, and now 10 months later my arm is very painful?I can?t sleep on that side?any arm movement causes pain..
Age: 62.0
Sex: F
Vaccine: FLU3, PNC20, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: erythema at site edema pruritis, has been getting worse over past few days
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood glucose increased, Brain fog, Dyspnoea, Executive dysfunction
Clinical narrative: Palpitations, High BP, Shortness of Breath, Higher than normal Glucose levels, Brain Fog, Loss of Executive Function, Loss of Balance Treated symptoms, alternative functional treatment (supplements, frequencies, etc.) Improvement after 8 months. However in April of 2025 many of the same symptoms have recurred and are not yet resolved.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: Palpitations, High BP, Shortness of Breath, Higher than normal Glucose levels, Brain Fog, Loss of Executive Function, Loss of Balance Treated symptoms, alternative functional treatment (supplements, frequencies, etc.) Improvement after 8 months. However in April of 2025 many of the same symptoms have recurred and are not yet resolved.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fumbling, Memory impairment
Clinical narrative: Neurological. Patient first noticed minor fumbling with their fingers at their laptop the morning after the vax.  Patient is a neuroscientist and musician. On the evening after the vax, patient attempted a practice session at the piano and could not remember long passages from pieces previously well-established in memory, including pieces played fluently the night before the vax. Impairment still ongoing today, two days after vax. No other evidence of amnesia or cognitive impairment, brain fog, confusion, etc. Impairment at the piano was/is profound. Patient's speculation as a neuroscientist is that it reflects cerebellar inflammation/neuropathy affecting muscle memory stored in cerebellum.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Brain fog, Cognitive disorder, Fatigue
Clinical narrative: Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine  two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (12+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, General physical health deterioration, Imaging procedure abnormal, Inflammatory marker increased, Laboratory test abnormal
Clinical narrative: Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine  two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (12+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Myositis, Neuralgia, Pyrexia
Clinical narrative: Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine  two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (12+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Undifferentiated connective tissue disease
Clinical narrative: Patient: Female, midlife (menopausal transition), history of mild autoimmune-like symptoms prior to vaccination. Vaccine: Pfizer COVID-19 vaccine  two doses plus booster. Timeline: o After first and second doses: mild, manageable symptoms. o After booster: rapid and severe health decline leading to hospitalization. Post-booster symptoms included (not a complete list): o Autoimmune-like flare, later diagnosed as Undifferentiated Connective Tissue Disease o Extremely elevated inflammation markers o Gastrointestinal issues o Muscle inflammation affecting mobility o Recurrent fevers (12+ times per month for over a year) o Severe fatigue o Cognitive impairment (brain fog) o Joint pain o Nerve pain o Prolonged recover with persistent mobility limitations and reduced daily function o Ongoing symptoms; unlikely to fully recover Notes: I believe the combination of menopausal hormone changes and underlying autoimmune vulnerability contributed to a severe adverse immune response after receiving the vaccine. Symptoms worsened significantly after the booster, culminating in an autoimmune crisis. I attempted to report this earlier but was unable to complete the process due to illness and cognitive issues. Submitting now to ensure this case is documented. The event was debilitating and recovery is still incomplete..
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Pain, Vomiting
Clinical narrative: Body aches, diarrhea, vomiting
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID last night/ on like day three of symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "underlying health issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious) with onset Aug2025, outcome "unknown", described as "tested positive for COVID last night/ on like day three of symptoms". The event "tested positive for covid last night/ on like day three of symptoms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did three of the boosters in a row, but the last one was in Oct2022. The patient was on like day three of symptoms and tested positive for COVID last night (12Aug2025). The patient got a tele visit with doctor this morning (13Aug2025).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500163075 same reporter, same drug/event, different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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) all with onset 2024, outcome "unknown" and all described as "got Covid". Caller mentioned he has been getting the Pfizer Covid-19 Vaccine believed since 2019 or 2020 but then skipped a year and behold last winter him and his wife both got Covid and it was horrible.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Blood test, Burning sensation, Chest X-ray
Clinical narrative: Muscle loss, WORMS throughout body, weakness, memory loss, burning throughout body, pain all through her body, Had NEVER been sick BEFORE these shots in ALL her life. She has tried all vitamins and herbs to try to combat all she was feeling. We have gone many, many, many times to 3 hospitals. They ran many tests all these times and thy tell her that all of this is "in her head" never gave much relief. She feels like she is dying, and she LOOKS like she is dying.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Helminthic infection, Muscle atrophy, Pain, Urine analysis
Clinical narrative: Muscle loss, WORMS throughout body, weakness, memory loss, burning throughout body, pain all through her body, Had NEVER been sick BEFORE these shots in ALL her life. She has tried all vitamins and herbs to try to combat all she was feeling. We have gone many, many, many times to 3 hospitals. They ran many tests all these times and thy tell her that all of this is "in her head" never gave much relief. She feels like she is dying, and she LOOKS like she is dying.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Anxiety, Coeliac disease, Defaecation urgency, Diarrhoea
Clinical narrative: Patient has been health and is a teenager. She has had 3 MRNA Covid vaccines since 2021. She has now been diagnosed with anxiety and new celiac disease in 2025.  She has had new GI issues consisting of diarrhea and occasional fecal incontinence due to urgency. Patient also started developing severe headaches in Jan 2022 and had to follow with neurology.  They were waking her up at night and she would have several during the week lasting all day. In october 2022 she started to experience frequent dizziness and frequent fainting having once fainted twice in 1 day
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Magnetic resonance imaging head normal, Sleep disorder, Syncope
Clinical narrative: Patient has been health and is a teenager. She has had 3 MRNA Covid vaccines since 2021. She has now been diagnosed with anxiety and new celiac disease in 2025.  She has had new GI issues consisting of diarrhea and occasional fecal incontinence due to urgency. Patient also started developing severe headaches in Jan 2022 and had to follow with neurology.  They were waking her up at night and she would have several during the week lasting all day. In october 2022 she started to experience frequent dizziness and frequent fainting having once fainted twice in 1 day
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was accidentally administered the FluAd instead of Flucelvax which is not the recommended dosing for the patient's age.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Patient called the pharmacy on 08/15/2025 at around 10am.  She stated she received a Flu shot on 8/14/25, and about 20 minutes later, started to experience dizziness, shortness of breath, and increased heartrate.  She was not hospitalized and did not see a doctor.  I asked her how she was feeling now, and she said fine, but wanted to inform us of what had happened.  She asked me which flu vaccine did she receive in the past because she has never experienced any of these symptoms before.  Her profile showed that she had Afluria the past 2 years.  This was her first time receiving Flucelvax.  I annotated this reaction in her profile, and that she may only tolerate Afluria.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms
Clinical narrative: Within 4 to 5 hours patient complained of severe chills that progressed into muscle spasms. Patient also stated that there pretty continuous for the next 2 days. Patient was advised to follow up with doctor.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Local reaction. Redness, pain and swelling. Diameter of reaction 4-4.5 inches.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Injection site mass
Clinical narrative: knot on her arm where  got the IMZ, not hot or anything, about the size of a nickel to a quarter
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness neurosensory, Deafness unilateral
Clinical narrative: hearing loss in left ear determined to be neurological
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypertension
Clinical narrative: High blood pressure
Age: 78.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Erythema, Induration, Limb mass, Pruritus
Clinical narrative: The patient states that she had a knot on her arm that was very hard for about a day or so, then that progressed to significant redness around the area along with itchiness that lasted for about 3-4 days. After the 5th day, the patient states that she was fine.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Neurodermatitis, Rash
Clinical narrative: Vaccine Details  Dose 1: 01-04-2022, Pharmacy  Dose 2: 02-08-2022, Pharmacy  Timeline of Injury & Medical Negligence Date Event Medical/Legal Significance Apr 8, 2022 First rash appears (within 60 days of vaccination) Direct temporal link to vaccine per *article* 2022-2024 Dermatologist ignored vaccine link; prescribed: Malpractice: - Avoided guideline-backed UV therapy - Reckless steroids with MDD/history - Potent topical steroids (Clobetasol 0.05%, Fluocinonide)  - Intralesional triamcinolone injections (high-risk areas: forehead)  Aug 22, 2024 Diagnostic biopsy performed Proof of delayed diagnosis: - 28-month delay in biopsy = standard-of-care violation
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Migraine
Clinical narrative: Severe migraine lasting several hours and headache lasting two days
Age: 61.0
Sex: M
Vaccine: FLU3, PNC21
Symptoms: Headache, Malaise, Myalgia, Pain
Clinical narrative: Patient started to experience headache, malaise, and body/muscle pain at about 9:00AM on 8/17/25. He tried to treat his symptoms with over the counter Tylenol. The symptoms did not fully resolve so he called the pharmacy at about 1:00PM. We talked to the patient and suggested he tried switching to ibuprofen instead of the Tylenol to aid with the muscle pain/aches. We followed up with the patient at 3:00PM and the patient reports feeling a little better than before. The patient states that he does not believe he needs any additional medical attention.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Headache, Injected limb mobility decreased
Clinical narrative: After five days I still have the following symptoms: headache, chest tightness, shortness of breath, lump almost 10 cm in diameter in the right arm, itching in the right arm, back and chest, the lump in the right arm is very hot, burning, painful and difficult to move; I have trouble sleeping and when I sleep I have nightmares or strange sensations
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Limb mass, Nightmare, Pain, Pruritus
Clinical narrative: After five days I still have the following symptoms: headache, chest tightness, shortness of breath, lump almost 10 cm in diameter in the right arm, itching in the right arm, back and chest, the lump in the right arm is very hot, burning, painful and difficult to move; I have trouble sleeping and when I sleep I have nightmares or strange sensations
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory disturbance, Skin warm
Clinical narrative: After five days I still have the following symptoms: headache, chest tightness, shortness of breath, lump almost 10 cm in diameter in the right arm, itching in the right arm, back and chest, the lump in the right arm is very hot, burning, painful and difficult to move; I have trouble sleeping and when I sleep I have nightmares or strange sensations
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Joint injury, Loss of consciousness, Syncope
Clinical narrative: Flu vaccine administered. Pt then experienced syncopal event approximately 30 seconds after vaccine administered while provider was turned towards the cabinets to complete documentation on the vaccine consent, pt fell from a seated position on the exam table onto the floor hitting her head and knee.  Pt regained consciousness within 10 seconds, appeared pale and stated she was okay.  EMS was called by the PCT, pt was slowly transitioned to a seated position, bp taken.  Pt remained alert and oriented until EMS arrived approximately 5 minutes later and took over evaluation of the pt.  Vital signs were stable, pt was advised by EMS that she could be taken by ambulance to the ER for further evaluation but it was not required, pt declined and called her boyfriend to come pick her up and take her to the ER.  Pt stated she is in nursing school and notified a friend currently working at ER that she would be driving there with her boyfriend to be evaluated and was told the charge nurse was informed of this. Approximately 10 minutes later, pts boyfriend arrived in the clinic and pt ambulated independently out of the clinic accompanied by her boyfriend.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Adverse Event(s):     ?    On July 31, 2025, developed chest pain, shortness of breath, and elevated heart rate within 1?2 days after receiving the COVID-19 vaccine.     ?    Diagnosed with pericarditis on August 1, 2025.     ?    Symptoms included chest discomfort, fatigue, lightheadedness, and elevated heart rate reaching the 120s?130s with light activity (walking, climbing stairs).     ?    Blood pressure has occasionally been low   Treatment:     ?    Initially prescribed ibuprofen 800 mg three times daily for 10 days.     ?    Due to persistent inflammation, started on colchicine as ongoing treatment, as well as continued ibuprofen for three additional weeks.     ?    Advised to avoid strenuous activity, monitor heart rate, and rest.     ?    Scheduled for a follow-up with cardiology on August 25, 2025.  Outcome (as of submission):     ?    Symptoms are gradually improving but not fully resolved.     ?    Still experiencing elevated heart rate with exertion and occasional fatigue.     ?    Continuing colchicine therapy and activity modification per physician guidance.     ?    Concern for possible recurrence or chronic pericarditis remains.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ST-T change, Fatigue, Heart rate increased, Inflammatory marker increased, Pericarditis
Clinical narrative: Adverse Event(s):     ?    On July 31, 2025, developed chest pain, shortness of breath, and elevated heart rate within 1?2 days after receiving the COVID-19 vaccine.     ?    Diagnosed with pericarditis on August 1, 2025.     ?    Symptoms included chest discomfort, fatigue, lightheadedness, and elevated heart rate reaching the 120s?130s with light activity (walking, climbing stairs).     ?    Blood pressure has occasionally been low   Treatment:     ?    Initially prescribed ibuprofen 800 mg three times daily for 10 days.     ?    Due to persistent inflammation, started on colchicine as ongoing treatment, as well as continued ibuprofen for three additional weeks.     ?    Advised to avoid strenuous activity, monitor heart rate, and rest.     ?    Scheduled for a follow-up with cardiology on August 25, 2025.  Outcome (as of submission):     ?    Symptoms are gradually improving but not fully resolved.     ?    Still experiencing elevated heart rate with exertion and occasional fatigue.     ?    Continuing colchicine therapy and activity modification per physician guidance.     ?    Concern for possible recurrence or chronic pericarditis remains.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: red, slightly inflamed rectangular area around the injection site about 3 inches across. pt reports that it is warm and sore and reported to pharmacy day after injection
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Colectomy total, Colitis ulcerative, Colon dysplasia, Condition aggravated, Hernia repair
Clinical narrative: Sever inflammation in all areas of body with in a day of second injection. Inflammation ultimately defeated medication providing remission of UC resulting in total Colectomy (Dysplasia Found), Protectomy and Hernia surgeries
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Proctectomy
Clinical narrative: Sever inflammation in all areas of body with in a day of second injection. Inflammation ultimately defeated medication providing remission of UC resulting in total Colectomy (Dysplasia Found), Protectomy and Hernia surgeries
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: warm just below the injection site; had a red reaction just below the injection site; small, puffy, swollen just below the injection site; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional).  This case involves an unknown age female patient who had a red reaction, small, puffy, swollen and warm just below the injection site after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone hd].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Aug-2025, the patient received an unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine, Suspension for injection in pre-filled syringe (lot U8764BB and expiry date: 30-Jun-2026) (strength not reported) via unknown route in unknown administration sit for influenza.  On an unknown date in Aug-2025, the patient had a red reaction, small, puffy, swollen, warm just belowthe injection site (vaccination site erythema) (vaccination site swelling) (vaccination site warmth) (latency: Few days approximately).   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 Unknown for all the events.