chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC20
Symptoms: Arthritis, Mouth swelling, Pain in extremity, Pain in jaw, Peripheral swelling
Clinical narrative: Her arm was very/really sore  for many days and swollen at the the same time; It's on the right side of mouth where she is having issues, it was swollen; Her jaw hurts a lot.; TMJ joint is inflamed; TMJ joint is inflamed; Her arm was very/really sore  for many days and swollen at the the same time; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Feb2025 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Feb2025, outcome "recovered" (26Feb2025), PERIPHERAL SWELLING (non-serious), outcome "recovered" (26Feb2025) and all described as "Her arm was very/really sore  for many days and swollen at the the same time"; PAIN IN JAW (non-serious) with onset 23Feb2025, outcome "not recovered", described as "Her jaw hurts a lot."; TEMPOROMANDIBULAR PAIN AND DYSFUNCTION SYNDROME (non-serious), ARTHRITIS (non-serious) all with onset 23Feb2025, outcome "not recovered" and all described as "TMJ joint is inflamed"; MOUTH SWELLING (non-serious), outcome "unknown", described as "It's on the right side of mouth where she is having issues, it was swollen". Therapeutic measures were taken as a result of pain in jaw, temporomandibular pain and dysfunction syndrome, arthritis. Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling. Additional information: TMJ joint is inflamed: She further explained it hurts when drink hot and cold. She cannot pin point a tooth whole, whole side is sore. Patient took Ibuprofen once or twice a day for TMJ joint is inflamed. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: first time ever getting Covid; first time ever getting Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as does 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 (Primary series complete.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "first time ever getting Covid". The event "first time ever getting covid" required emergency room visit. Clinical details: the patient stated that out of all the times, this was her first time ever getting Covid, she never had it. She got all her Covid shots.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lichenoid keratosis
Clinical narrative: lichenoid dermatitis; long term fatigue; This is a spontaneous report received from a Consumer or other non HCP.  A 73-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 included: "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "Chronic fatigue/long hauler covid" (unspecified if ongoing); "Chronic fatigue/long hauler covid" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "L ventricular regurgitation/coronary artery disease" (unspecified if ongoing); "L ventricular regurgitation/coronary artery disease" (unspecified if ongoing); "mild copd" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; WELLBUTRIN taken for depression; TRINTELLIX taken for depression; ADDERALL taken for fatigue, post-acute covid-19 syndrome; CLONAZEPAN taken for insomnia; ASA taken for coronary artery disease, mitral valve incompetence. Past drug history included: Codeine for Drug allergy; Talwin for Drug allergy; Augmentin for Drug allergy; Zpak for Drug allergy; Erythromycin for Drug allergy; Lunesta for Drug allergy; Seroquel for Drug allergy. The following information was reported: LICHENOID KERATOSIS (non-serious), outcome "unknown", described as "lichenoid dermatitis"; FATIGUE (non-serious), outcome "unknown", described as "long term fatigue".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500007634 same patient, product, event; different dose;
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis, Gait disturbance, Guillain-Barre syndrome, Paraesthesia, Presyncope
Clinical narrative: Guillain-Barre Syndrome; Facial paralysis is still pretty significant.; Patient still can't walk without walker; Syncope; Presyncope; Paresthesia; This spontaneous case, initially received on 20-Feb-2025, was reported by a health professional and concerns an adult male patient.  Concomitant medication were reported as unknown and patient has no medical history. There was no allergy information reported.  There was no product complaint associated with this case.  Administration of company suspect drug: On 01-Jan-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: 946583.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 14-Feb-2025, the patient experienced Guillain-Barre Syndrome (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved), Facial paralysis is still pretty significant (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved), Patient still can't walk without walker (Hospitalized, outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Syncope (Medically Significant, outcome: Not Reported), presyncope (outcome: Not Reported), paresthesia (outcome: Not Reported).  The following additional adverse events had been identified during post-approval use of FLUCELVAX or FLUCELVAX QUADRIVALENT. Because these events were reported voluntarily from a population of uncertain size, it was not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Nervous systems disorders: Syncope, presyncope, paresthesia, Guillain-Barré syndrome." Patient received Flucelvax and experienced Guillain-Barré Syndrome. Patient still could not walk without walker and facial paralysis was still pretty significant. Patient never experienced an adverse reaction to the vaccine. It was prescribed to patient 5 days of hemoglobulin therapy infusion.  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Hemoglobin  Reporter's assessment: The reporter assessed the events Guillain-Barre Syndrome, Facial paralysis is still pretty significant, and Patient still can't walk without walker as serious (Hospitalization) and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the rest of the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related.(onset latency/temporality, medical history, concomitant drugs,diagnostic reports). Brighton collaboration criteria assessed as Level 4 (insufficient information to meet any level of certainty) for Guillain Barre Syndrome and facial paralysis .
Sex: M
Vaccine: FLU3
Symptoms: Syncope, Walking aid user
Clinical narrative: Guillain-Barre Syndrome; Facial paralysis is still pretty significant.; Patient still can't walk without walker; Syncope; Presyncope; Paresthesia; This spontaneous case, initially received on 20-Feb-2025, was reported by a health professional and concerns an adult male patient.  Concomitant medication were reported as unknown and patient has no medical history. There was no allergy information reported.  There was no product complaint associated with this case.  Administration of company suspect drug: On 01-Jan-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: 946583.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 14-Feb-2025, the patient experienced Guillain-Barre Syndrome (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved), Facial paralysis is still pretty significant (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved), Patient still can't walk without walker (Hospitalized, outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Syncope (Medically Significant, outcome: Not Reported), presyncope (outcome: Not Reported), paresthesia (outcome: Not Reported).  The following additional adverse events had been identified during post-approval use of FLUCELVAX or FLUCELVAX QUADRIVALENT. Because these events were reported voluntarily from a population of uncertain size, it was not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Nervous systems disorders: Syncope, presyncope, paresthesia, Guillain-Barré syndrome." Patient received Flucelvax and experienced Guillain-Barré Syndrome. Patient still could not walk without walker and facial paralysis was still pretty significant. Patient never experienced an adverse reaction to the vaccine. It was prescribed to patient 5 days of hemoglobulin therapy infusion.  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Hemoglobin  Reporter's assessment: The reporter assessed the events Guillain-Barre Syndrome, Facial paralysis is still pretty significant, and Patient still can't walk without walker as serious (Hospitalization) and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the rest of the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related.(onset latency/temporality, medical history, concomitant drugs,diagnostic reports). Brighton collaboration criteria assessed as Level 4 (insufficient information to meet any level of certainty) for Guillain Barre Syndrome and facial paralysis .
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial infarction, Ventricular fibrillation
Clinical narrative: Vfib heart attack; Vfib heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: VENTRICULAR FIBRILLATION (death), MYOCARDIAL INFARCTION (death) all with onset Jan2022, outcome "fatal" and all described as "Vfib heart attack". The patient date of death was Jan2022. Reported cause of death: "Vfib heart attack", "heart attack". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202500024499 Same patient and suspect product different dose/AE;; Reported Cause(s) of Death: Vfib heart attack; heart attack
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Vfib heart attack; Vfib heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: VENTRICULAR FIBRILLATION (death), MYOCARDIAL INFARCTION (death) all with onset Jan2022, outcome "fatal" and all described as "Vfib heart attack". The patient date of death was Jan2022. Reported cause of death: "Vfib heart attack", "heart attack". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202500024499 Same patient and suspect product different dose/AE;; Reported Cause(s) of Death: Vfib heart attack; heart attack
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: The nurse told her she was losing her hair as well; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "The nurse told her she was losing her hair as well".  Additional information: Reporter stated she was talking to a lady in the store, and they were comparing Pfizer covid vaccine things. She was a nurse and stated that 15,000 people had same reaction as she did with Pfizer Covid vaccine. The nurse told her she was losing her hair as well after the Pfizer Covid vaccine. The lady said she had the same and at least 15,000 had the same reaction she did.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: PNC20
Symptoms: Device breakage
Clinical narrative: one of the 10 vials in the box was cracked; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown., single (Lot number: LK6655, Expiration Date: 30Jun2026) for immunisation, Device Lot Number: LK6655, Device Expiration Date: 30Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "one of the 10 vials in the box was cracked".  The reporter considered "one of the 10 vials in the box was cracked" not related to pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein). Causality for "one of the 10 vials in the box was cracked" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: CSF test, Headache, Imaging procedure, Laboratory test, Neurodegenerative disorder
Clinical narrative: Vaccine given on 11/1/24. Headache lasting 5 days that started on 11/4/24. On 11/15 started with neurologic findings that would lead to diagnosis of autoimmune cerebellar degeneration.
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect 3rd dose of twinrix gives less than 6 months from first (shot given 2/26/25 instead of 3/13/2025)
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red localized swelling at administration site
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Patient stated she experience 100 degree fever.
Age: 57.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site rash
Clinical narrative: LITTLE RASH AT THE INJECTION SITE WITH NO SWOLLEN
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Cough, Immediate post-injection reaction, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Immune Thrombocytopenia requiring hospitalization and IVIG infusion
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Immune Thrombocytopenia requiring hospitalization and IVIG infusion
Age: 65.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms, patient was notified, provider was notified
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Skin reaction
Clinical narrative: local cutaneous reaction, fever.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Chemotherapy, Colorectal cancer stage IV, Death, Hair growth abnormal
Clinical narrative: Online report of premature death for a health care worker, a mid-50's female. Victim was diagnosed with stage 4 colon cancer in late May 2022, exact date unknown. DOSE1 date 12/23/20 LOT# EJ1685, DOSE2 date UNK, LOT# UNK, DOSE3 date 10/03/2021. LOT# UNK. Online report states victim died at home surrounded by family. Online photos imply victim was injected at work, a facility. Victim went through cycles of hair loss and growth. By 09/22 she had undergone her 8th chemo administered by Dr. . Victim wore masks in occupational and non-occupational settings for 3+ years. Victim likely received medical care or had any hospital stay at Hospital
Age: 79.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Started with red circle around inj. site, itchy, redness and slight swelling on upper arm. After 24 hours, lasted 72 hours. Relieved with BENADRYL, resolved.
Age: 1.0
Sex: M
Vaccine: MMR, PNC20, VARCEL
Symptoms: Injection site discolouration, Injection site induration
Clinical narrative: ~ 1 1/2" x 3" pink area on deltoid, slight firmness right around injection site. No tenderness, no swelling or induration.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood creatinine normal, Musculoskeletal stiffness
Clinical narrative: onset of progressively severe muscle pain - mainly bilateral thighs while hiking up mountain on 10/8/24. Diffuse stiffness that resolved over the next 4 days, Did not seek medical attention until 10/10 with labs ordered for 10/11/24
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: onset of progressively severe muscle pain - mainly bilateral thighs while hiking up mountain on 10/8/24. Diffuse stiffness that resolved over the next 4 days, Did not seek medical attention until 10/10 with labs ordered for 10/11/24
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; An office manager called to report an AE where a dose of GARDASIL 9 was administered to a patient after it's expiration date. No additional information provided to further clarify the details. No additional adverse effects reported. No additional AE; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On 25-FEB-2025, the patient was vaccinated with an expired dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) administered as prophylaxis (Lot No. W031448 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant suspension for injection], expiration date reported and upon internal validation established as 12-FEB-2025) (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (expired product administered). No additional adverse event was reported (no adverse event).
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2024, the patient received Shingrix. In DEC-2024, less than 2 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 19-FEB-2025 The patient had been dealing with shingles since middle of December 2024 and still had unbelievable itching ,pain constantly. The patient had tried everything and nothing has helped. The patient asked for suggestions that can help and this was after the vaccine in October. The patient was wondering how this help seemed not to have helped. This case was considered as suspected vaccination failure since the details regarding completion of primary  vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Vaccine: RVX
Symptoms: Cough, Fatigue, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Respiratory syncytial virus infection; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 84-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection) (serious criteria hospitalization and GSK medically significant). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 20-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV vaccine and a few months later was in the hospital with the RSV infection. The patient was 84 years old, and it was horrible. After going home 8 days later stayed in room for a month, exhausted and coughing all time. The patient would definitely get the shot. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine.
Vaccine: RSV
Symptoms: Death
Clinical narrative: The two people that died from an RSV vaccine; This serious case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: The two people that died from an RSV vaccine) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Arexvy.     The company considered the unknown cause of death to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter reported that two people that have died from an RSV vaccine.  The reporter would like to receive data on the circumstances surrounding their deaths.  No further details provided.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Arexvy.; Reported Cause(s) of Death: Unknown cause of death
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Severe chills
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antiphospholipid syndrome, Blood test abnormal, Dizziness, Feeling abnormal, Hypoaesthesia
Clinical narrative: Patient was feeling dizzy and heart felt like it was racing within 12 hours of being administered.  Heart normalized but the dizziness continued. Patient kept feeling bad and on 10/25/2021 she went to the doctor. At the beginning of the year her fingers began feeling numb and turning color until eventually they were a purple color. Patient was misdiagnosed to have Raynaud's but then later it was discovered that she had a blood clot in her arm restricting blood flow to her fingers.   After issue with the clot was resolved she was referred to a Hematologist for testing and was diagnosed with Antiphospholipid syndrome.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Skin discolouration, Thrombosis
Clinical narrative: Patient was feeling dizzy and heart felt like it was racing within 12 hours of being administered.  Heart normalized but the dizziness continued. Patient kept feeling bad and on 10/25/2021 she went to the doctor. At the beginning of the year her fingers began feeling numb and turning color until eventually they were a purple color. Patient was misdiagnosed to have Raynaud's but then later it was discovered that she had a blood clot in her arm restricting blood flow to her fingers.   After issue with the clot was resolved she was referred to a Hematologist for testing and was diagnosed with Antiphospholipid syndrome.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Headache, Joint stiffness, Mast cell activation syndrome
Clinical narrative: Bodyaches, headache, fever, joint stiffness and pain, muscle weakness, nausea.  Vaccine resulted in UCTD and MCAS.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Pain, Pyrexia, Undifferentiated connective tissue disease
Clinical narrative: Bodyaches, headache, fever, joint stiffness and pain, muscle weakness, nausea.  Vaccine resulted in UCTD and MCAS.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Whole body scan
Clinical narrative: Bodyaches, headache, fever, joint stiffness and pain, muscle weakness, nausea.  Vaccine resulted in UCTD and MCAS.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram, Electrocardiogram ambulatory, Electrocardiogram normal, Palpitations
Clinical narrative: Since I have gotten the shot my palpations have gotten worse I would only get them on occasion now when I get them they last for days or weeks with no end nothing makes them calm down and I have ended up in the er many times due to this ongoing issue where I have had them now for a month and have to get a halter monitor put on
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Scan myocardial perfusion, X-ray
Clinical narrative: Since I have gotten the shot my palpations have gotten worse I would only get them on occasion now when I get them they last for days or weeks with no end nothing makes them calm down and I have ended up in the er many times due to this ongoing issue where I have had them now for a month and have to get a halter monitor put on
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Headache, Induration, Pruritus, Skin warm
Clinical narrative: Arm became red, hard, warm to the touch, tender, and itchy. Patient also c/o mild headache.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Tenderness
Clinical narrative: Arm became red, hard, warm to the touch, tender, and itchy. Patient also c/o mild headache.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient fainted the morning after receiving the SHINGRIX shot. She reported feeling lightheaded and dizzy shortly before fainting, but mentioned she had a full breakfast and wasn't dehydrated in any way. Luckily, someone had caught her before she had passed out on the ground. She received medical attention promptly from an ambulance.
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain in extremity, Rash, Urticaria
Clinical narrative: Patient came to the pharmacy and showed the spot on her arm, it was red, and the skin was raised indicative or hives. Patient reported soreness in the arm still 2 days after vaccine. Patient was able to raise her arm and move it without discomfort other then general soreness.  The rash itself was still painful to the touch.  Instructed patient to take Benadryl to help with the histamine response, and to contact provider asap.  Also instructed patient to monitor the site to make sure it doesn't get any bigger.  If it continues expanding or any signs of anaphylaxis to seek immediate medical attention
Age: 80.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second prevnar 20 shot. one in 2022 and one now in 2025. no adverse events were reported at this time
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling, Viral infection
Clinical narrative: Patient states she had swelling, and a viral episode breakout of the mouth  that started 48 hours after vaccine
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Ulcerative keratitis
Clinical narrative: Sunday, february 16 I had Multiple fever blisters on bottom lip. Worst outbreak I ever had in 60 years. Saturday, March 1st I had corneal ulcer diagnosed by doctor.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Musculoskeletal chest pain, Pain, Periarthritis
Clinical narrative: Evening after vaccine, left arm was extremely painful at injection site. Following week I experienced sharp jabbing intermittent pain at left ribcage. Following weeks left arm a shoulder became extremely painful when trying to move frozen arm. Saw Dr 2 months after vaccines due to extremely painful and frozen shoulder. Dr diagnosed adhesive capsulitis. I was prescribed steroid pack, which I am taking for 6 days. Physical therapy was prescribed also, along with follow up if there are no improvements.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 1st dose was given 9/25/2023 and then a 2nd dose was given 2/28/2025 (not recommended by cdc)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Severe flu-like symptoms including high fever, chills, aches, fatigue, headache
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe flu-like symptoms including high fever, chills, aches, fatigue, headache
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: PATIENT STATED PRESENTED RED AREAS AROUND ADMINISTRATION AREA THAT LOOKED LIKE A MAP THEY WERE DISPERSE AROUND ADMINISTRATION AREA SHE REPORTED INFLAMATION ON AREA AND FEELING OF WARM ON THE SKIN. NO RASH OR ITCH OR FEVER OR OTHER SYMPTOM REPORTED . PATIENT STATED SHE USED COLD COMPRESSES ON AREA AND SYMPTOMS IMPROVE WITHIN DAYS AND SINCE SHE ALSO TAKES MELOXICAM INFLAMMATION IMPROVED . PATIENT WAS ORIENTED TO TALK TO PRIMARY CARE PHYSICIAN SINCE SHE IS WORRIED ABOUT ADMINISTERING THE VACCINE SECOND DOSE
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: patient said: dizzy, light headed, nausea and sore arm
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Abdominal rigidity, Blood test, Computerised tomogram abdomen, Dehydration, Diarrhoea
Clinical narrative: 3/14 -3/15became dehydrated vomiting and diarrhea (hospital visit)  tested positive for rotavirus  3/29 admitted to hospital for continued symptoms and suspected Intussusception, hospital notes to back that up and noted his symptoms as guarding, inconsolable and fever also blood in stools discharged at the end of the day 3/30/2022 IV fluids received on all hospital visits. Doctors also noted hyperactive bowel sounds
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Emotional distress, Food allergy, Gastrointestinal pathogen panel, Gastrointestinal sounds abnormal, Haematochezia
Clinical narrative: 3/14 -3/15became dehydrated vomiting and diarrhea (hospital visit)  tested positive for rotavirus  3/29 admitted to hospital for continued symptoms and suspected Intussusception, hospital notes to back that up and noted his symptoms as guarding, inconsolable and fever also blood in stools discharged at the end of the day 3/30/2022 IV fluids received on all hospital visits. Doctors also noted hyperactive bowel sounds
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Pyrexia, Rotavirus test positive, Ultrasound scan, Vomiting
Clinical narrative: 3/14 -3/15became dehydrated vomiting and diarrhea (hospital visit)  tested positive for rotavirus  3/29 admitted to hospital for continued symptoms and suspected Intussusception, hospital notes to back that up and noted his symptoms as guarding, inconsolable and fever also blood in stools discharged at the end of the day 3/30/2022 IV fluids received on all hospital visits. Doctors also noted hyperactive bowel sounds
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: Patient states that since the evening of injection she has developed a red red 1/2 the width of her arm.  It is painful and has bouts of itching.  The skin is swollen she states and has been advancing from injection site to elbow
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Brain oedema, Cerebral haemorrhage, Concussion, Dizziness, Head injury
Clinical narrative: Less than 24 hours after vaccination, the patient experienced extreme dizziness and collapsed. He hit his head, causing a concussion, brain swelling, and bleeding in the brain. The patient was rushed to Hospital emergency room and transferred to Hospital trauma unit.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Less than 24 hours after vaccination, the patient experienced extreme dizziness and collapsed. He hit his head, causing a concussion, brain swelling, and bleeding in the brain. The patient was rushed to Hospital emergency room and transferred to Hospital trauma unit.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin cancer
Clinical narrative: Skin cancer on left side of face 8/21 and skin cancer left shoulder in 2021 as well
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Injury, Limb injury, Loss of consciousness
Clinical narrative: Patient states he fell on boat the next day and he passed out once he got home.  Patient states fall and passing out resulted in minor injuries and a hurt toe.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Tachycardia
Clinical narrative: Tachycardia Heart rate 140-160 24hrs a day x 2 years, shortness of breathe x 2 years
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Duplicate dose. 1st given 7/24 & 2nd 2/25
Age: 71.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Dizziness, Headache, Injection site pain
Clinical narrative: Pain at injection sites, headache, dizziness
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient's arm started swelling and getting red, the spot has only gotten bigger and traveling down her arm since 2/24 and is still red on 3/2
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient presented to hospital emergency room on Friday, February 14, 2025 and was diagnosed with GuiGuillain Barre Syndrome secondary to the FLu vaccine he had received on January 1, 2025.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Chemotherapy, Morphoea
Clinical narrative: En Coupe de Sabre - looking through pictures, it began in February after the first covid 19 vaccine was received in January.  It got progressively worse, though we didn't notice it nor make the connection to the vaccine until later.  He had a second covid 19 vaccine in June.  The disease progressed exponentially after that point.  Sadly, he was only diagnosed in late 2024, undergoing intensive steroid and chemotherapy treatment (at the age of 10).  Despite treatment, the disease continues though there has been improvement. However, there is permanent damage to his face, with a deep gouge vertically through his forehead.  Given that En Coup de Sabre is an autoimmune disease (a  form of scleroderma), the doctors assume this was triggered by the covid 19 vaccine which has triggered many autoimmune responses.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient states he developed a rash on his ankle.
Age: 52.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: wrong vaccine given, should have been MMR
Age: 54.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt's mother called with concern regarding redness,tenderness at injection site on right arm. pt got flu and pneumonia vaccine in same arm on the same day.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional dose of vaccine as she had already received a dose on 11/8/23 and did not require an additional dose as per cdc recommendations.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Supraventricular tachycardia
Clinical narrative: SVT
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Deltoid Muscle myalgia -- began after exercise, thought just sore muscle but felt just like post injection site pain. continued from November to present. Aches, muscle feels strained when used and achy.
Age: 64.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Patient reported reaction starting 2/27/25. That day she took her bandaid off from the vaccines and started having a fever, redness and itchiness in her hair and on her arm. Patient reported to the pharmacy today where there is a visible red rash on her left arm that is swollen and hot to touch. she said the itching in her hair has gotten better, but no visible rash seen. she reports her arm is still painful as well. recommended that patient take some benadryl to help with the itchiness and reaction, tylenol for pain and fever and to ice her arm. i told her if after a few days if it didnt get better or got worse to seek care from her provider.
Age: 64.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Patient reported reaction starting 2/27/25. That day she took her bandaid off from the vaccines and started having a fever, redness and itchiness in her hair and on her arm. Patient reported to the pharmacy today where there is a visible red rash on her left arm that is swollen and hot to touch. she said the itching in her hair has gotten better, but no visible rash seen. she reports her arm is still painful as well. recommended that patient take some benadryl to help with the itchiness and reaction, tylenol for pain and fever and to ice her arm. i told her if after a few days if it didnt get better or got worse to seek care from her provider.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Menopause
Clinical narrative: 4 months after vaccine I stopped getting a period. My doctor ran blood work after 8 months of no period and I was in full menopause. Prior to the vaccine I was getting periods and ovulating normally.
Age: 72.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a duplicate dose of the vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Central nervous system lesion, Demyelination, Magnetic resonance imaging head abnormal
Clinical narrative: Diagnosed with demyelinating disease on the left side of my Brain from the COVID vaccine shot. I have a lesion on the left side of my Brain which is causing me, health scare.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Urinary incontinence
Clinical narrative: extreme burning and urinary incontinence for 12 hours
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: wrong vaccine administered. should have been MMR
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient passed out after vaccine and was unconscious for about 15-20 seconds. Patient experienced light headedness prior to that.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carpal tunnel syndrome, Condition aggravated
Clinical narrative: Patient received a flu and COVID vaccine 1/30/2025.  She reported to the pharmacy 2/28/2025 that the COVID vaccine (right arm) may have caused her carpal tunnel to flair up the following day requiring two hospitalizations, a visit to her primary care physician, and a neurology referral.  Her provider could not confirm if this incident was related to her vaccination.  No issues were experienced in the other arm with her flu vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dysgraphia, Feeding disorder, Impaired driving ability, Impaired work ability
Clinical narrative: Patient received a flu and COVID vaccine 1/30/2025.  She reported to the pharmacy 2/28/2025 that the COVID vaccine (right arm) may have caused her carpal tunnel to flair up the following day requiring two hospitalizations, a visit to her primary care physician, and a neurology referral.  Her provider could not confirm if this incident was related to her vaccination.  No issues were experienced in the other arm with her flu vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Patient received a flu and COVID vaccine 1/30/2025.  She reported to the pharmacy 2/28/2025 that the COVID vaccine (right arm) may have caused her carpal tunnel to flair up the following day requiring two hospitalizations, a visit to her primary care physician, and a neurology referral.  Her provider could not confirm if this incident was related to her vaccination.  No issues were experienced in the other arm with her flu vaccination.
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Underarm area of arm where vaccine was administered is sore/swollen. No bruising at admin site, patient noticed the soreness 4 days after administration and has continued for more than 24 hours.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Vasovagal syncope
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Dysphagia, Enlarged uvula, Pruritus
Clinical narrative: SWOLLEN EPIGLOTTIS (UVULA) SOMEWHAT DIFFICULTY TALKING AND SWALLOWING. DEEP NERVE ITCHING ON HANDS AND FEETS
Age: 67.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Unevaluable event
Clinical narrative: advise patient to take otc Tylenol and check with her primary care dr and let us know if anything else happen
Age: 1.42
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin E increased, Urticaria
Clinical narrative: Immunoglobulin E (IgE) levels is high which suggests a higher potential for allergic reaction. Pt gets hives and breaks out all over his body
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Hyperhidrosis, Hypoaesthesia, Hypotonia
Clinical narrative: 10 days after first dose I ended up waking up in the middle of the night extremely sweaty and thirsty, when i went to the kitchen, I went limp on the floor in a paralyzed state as if I had a mini stroke covered in sweat and unable to move for several minutes. Once i came to i was able to crawl to my husband who rushed me to hospital ER. December 2023- MRI shows signs ICP. March 2024- woke up and have lost feeling in lower limbs bilaterally. Sent to ER. After follow up with Neuro and many test, diagnosed with Transverse Myelitis. New studies linking Covid vaccine to TM, ICP, mini strokes.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal, Myelitis transverse, Paralysis
Clinical narrative: 10 days after first dose I ended up waking up in the middle of the night extremely sweaty and thirsty, when i went to the kitchen, I went limp on the floor in a paralyzed state as if I had a mini stroke covered in sweat and unable to move for several minutes. Once i came to i was able to crawl to my husband who rushed me to hospital ER. December 2023- MRI shows signs ICP. March 2024- woke up and have lost feeling in lower limbs bilaterally. Sent to ER. After follow up with Neuro and many test, diagnosed with Transverse Myelitis. New studies linking Covid vaccine to TM, ICP, mini strokes.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Sleep disorder, Thirst
Clinical narrative: 10 days after first dose I ended up waking up in the middle of the night extremely sweaty and thirsty, when i went to the kitchen, I went limp on the floor in a paralyzed state as if I had a mini stroke covered in sweat and unable to move for several minutes. Once i came to i was able to crawl to my husband who rushed me to hospital ER. December 2023- MRI shows signs ICP. March 2024- woke up and have lost feeling in lower limbs bilaterally. Sent to ER. After follow up with Neuro and many test, diagnosed with Transverse Myelitis. New studies linking Covid vaccine to TM, ICP, mini strokes.