chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Facial paralysis, Guillain-Barre syndrome, Hypoaesthesia, Speech disorder
Clinical narrative: face started drooping; numbness in toes on one foot, numbness spread to both feet then to hand; cannot speak clearly; Guillain-Barre' Syndrome; Initial information received on 28-Mar-2022 regarding an unsolicited valid serious case received from a patient.   This case involves an unknown demographic patient who experienced guillain-barre' syndrome, face started drooping, numbness in toes on one foot, numbness spread to both feet then to hand and cannot speak clearly after receiving vaccine influenza vaccine.  The patient's past medical history included Back disorder. The patient's past vaccination(s) included COVID-19 vaccination. The patient's past medical treatment(s) and family history were not provided.   On 28-Feb-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose, lot number and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On 14-Mar-2022, latency 14 days, the patient started having numbness in his/her toes on one foot. On Tuesday and Wednesday the numbness spread to both feet then to hands (hypoaesthesia). He/She made an appointment to see the doctor having previous back issues and was prescribed prednisone on Thursday of that week. On Sunday (Mar-2022) his/her face started drooping (facial paralysis) (latency few days) so he/she was taken by ambulance to the hospital. He/she was diagnosed with Guillain-Barre' Syndrome (onset date: Mar-2022, latency: few days). He/She cannot speak clearly (speech disorder) (onset date: Mar-2022, latency: few days) thus today was the first day he/she had access to his/her laptop to report this. He/She did receive the Covid vaccine from Johnson and Johnson last spring with no ill effects.   It was  unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  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 Not Recovered / Not Resolved for all the events.  Seriousness Criteria: Medically significant for Guillain-Barre' Syndrome and facial paralysis. Hospitalization for facial paralysis; Sender's Comments: Sanofi Company Comment on 31-Mar-2022:  This case involves an unknown demographic patient who experienced guillain-barre' syndrome, face started drooping, numbness in toes on one foot, numbness spread to both feet then to hand and cannot speak clearly after receiving vaccine influenza vaccine. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: adacel was administered the day of the excursion on 20-Mar-2022, lowest temperature was 29.2 degrees F with no reported adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from health care professional.  This case involves a 51-year-old female patient to whom adacel was administered the day of the excursion on 20-Mar-2022, lowest temperature was 29.2 degrees F with no reported adverse event after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Related case 2022SA098672   On 20-Mar-2022, the patient received a dose of 0.5 ml, Frequency: once, Strength = standard, of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (lot number: U6923JAA, expiry date:21-Jan-2023) via intramuscular route in the right deltoid for immunization.  On 20-Mar-2022, Adacel was administered and lowest temperature was 29.2 degrees F with no reported adverse event (product storage error) (Latency: same day).  Action taken was not applicable.  Outcome was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered, with no reported adverse event; Initial information received on 29-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who experienced expired vaccine administered, with no reported adverse event after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination; HPV VACCINE (HPV VACCINE) for Prophylactic vaccination; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination.  On 01-Mar-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6874AA  and expiry date 21-Feb-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  On 01-MAR-2022 the patient developed a non-serious event "expired vaccine administered, with no reported adverse event (expired product administered) (latency same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired vaccine administered, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired vaccine administered, with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Off label use
Clinical narrative: they gave a 5 month old QUADRACEL with no reported adverse event; Initial information received on 30-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 months old and unknown gender patient who was given Quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as Immunisation. The patient used the product for the first time.  On an unknown date the patient was given quadracel with no reported adverse event (off label use) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.
Age: 1.25
Sex: U
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered
Clinical narrative: The patient received an extra dose of Polio with no adverse event; Initial information received  on 31-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an 15 months old and unknown gender patient who received an extra dose of polio with no adverse event while receiving vaccines IPV (VERO) [IPOL] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot U6940BA, expiry date: 21-May-2022, dose, form, strength: not reported) and received suspect IPV (VERO) (lot U6940BA, expiry date, dose, form, strength: not reported) both via unknown route in unknown administration site for Immunisation.  On an unknown date the patient received an extra dose of polio with no adverse event (extra dose administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and (unknown latency) following the administration of IPV (VERO). It was reported that they gave a 15 month old the pentacel because he needed the DTap but he was not overdue for the Polio.  Action taken: not applicable.   Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chronic fatigue syndrome, Fibromyalgia, Immobile, Vision blurred
Clinical narrative: Vaccines exacerbated her Fibromyalgia,Vaccines caused her to relapse,Myalgia; Vaccines exacerbated her Fatigue syndrome,Vaccines caused her to relapse, Fatigue; Stomach was upset for weeks; Eyes were blurry; Patient was immobilized/Patient couldn't do anything; This spontaneous case was reported by a consumer and describes the occurrence of IMMOBILE (Patient was immobilized/Patient couldn't do anything), FIBROMYALGIA (Vaccines exacerbated her Fibromyalgia,Vaccines caused her to relapse,Myalgia), CHRONIC FATIGUE SYNDROME (Vaccines exacerbated her Fatigue syndrome,Vaccines caused her to relapse, Fatigue), ABDOMINAL DISCOMFORT (Stomach was upset for weeks) and VISION BLURRED (Eyes were blurry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Drug allergy (sensitive to medication), Chronic fatigue syndrome (Fatigue syndrome) and Fibromyalgia.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMOBILE (Patient was immobilized/Patient couldn't do anything), FIBROMYALGIA (Vaccines exacerbated her Fibromyalgia,Vaccines caused her to relapse,Myalgia), CHRONIC FATIGUE SYNDROME (Vaccines exacerbated her Fatigue syndrome,Vaccines caused her to relapse, Fatigue), ABDOMINAL DISCOMFORT (Stomach was upset for weeks) and VISION BLURRED (Eyes were blurry). At the time of the report, IMMOBILE (Patient was immobilized/Patient couldn't do anything), FIBROMYALGIA (Vaccines exacerbated her Fibromyalgia,Vaccines caused her to relapse,Myalgia), CHRONIC FATIGUE SYNDROME (Vaccines exacerbated her Fatigue syndrome,Vaccines caused her to relapse, Fatigue), ABDOMINAL DISCOMFORT (Stomach was upset for weeks) and VISION BLURRED (Eyes were blurry) had resolved.            Patient medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was Fatigue syndrome and Fibromyalgia which got started  before vaccines.  Concomitant medications were not provided.  Patient never had COVID + test or diagnosis.  Treatment medication was not provided.  Patient reported that patient had side effects from the full doses of the moderna COVID-19 vaccines that lasted 3 months and that with the 1st booster (half dose) the side effects only lasted 3 weeks.   This case was linked to MOD-2022-528382 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2022: Live follow-up-Snapshot added
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Generalized myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Generalized myasthenia gravis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ocular myasthenia (Prior getting Moderna COVID-19 vaccine, just about finishing treatment for Ocular Myasthenia.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MYASTHENIA GRAVIS (Generalized myasthenia gravis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYASTHENIA GRAVIS (Generalized myasthenia gravis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient had got monthly infusion treatment of IVIG.  The patient doctor said they did not had an idea if her symptoms were related to the vaccine. The patient symptoms had worsened. Patient had not ever tested COVID positive test or had COVID-19 diagnosis. No other vaccination were given within 1 month prior to Moderna COVID-19 vaccine.  Company Comment: This is a Spontaneous case concerning a 74-year-old female patient, with medical history of ocular myasthenia, who experienced the unexpected, serious (hospitalization and medically significant), and AESI of Myasthenia gravis. The event started approximately 3 weeks after the first dose of mRNA-1273 vaccine, and was exacerbated after second and third dose. She gets monthly infusion of immunoglobulin IV. Medical history of ocular myasthenia remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-529242 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 74-year-old female patient, with medical history of ocular myasthenia, who experienced the unexpected, serious (hospitalization and medically significant), and AESI of Myasthenia gravis. The event started approximately 3 weeks after the first dose of mRNA-1273 vaccine, and was exacerbated after second and third dose. She gets monthly infusion of immunoglobulin IV. Medical history of ocular myasthenia remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient given expired vaccine; First dose on 31-Aug-21 and second dose on 25-Mar-22; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31-Aug-21 and second dose on 25-Mar-22) in a 79-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 25-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31-Aug-21 and second dose on 25-Mar-22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31-Aug-21 and second dose on 25-Mar-22) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient did not have immediate allergic reaction to any vaccine, injection or shot or to any component of COVID-19 vaccine or a severe allergic reaction to anything. Patient did not had history of cancer, leukemia, HIV/AIDS or any other condition that weakens the immune system. In the last 10 days, patient did not have COVID-19 test because of symptoms or isolated or quarantine at home due to COVID-10 infection or exposure. She was not treated with antibody therapy or convalescent plasma for COVID-19 in the past 90 days. Patient was not taking any medications that affect immune system such as cortisone, prednisone or other steroids, anticancer drugs or had radiation treatments. Patient did not have bleeding disorder, a history of blood clots or taking any blood thinner. Patient did not have history of myocarditis or pericarditis.Patient was not feeling sick on the day of vaccination.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-530285 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Report type changed from invalid to spontaneous. Added patient demographics, vaccine details and new event .
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: After receiving this first dose she experienced a tingling sensation and after receiving the second dose this sensation continued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After receiving this first dose she experienced a tingling sensation and after receiving the second dose this sensation continued) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PARAESTHESIA (After receiving this first dose she experienced a tingling sensation and after receiving the second dose this sensation continued). At the time of the report, PARAESTHESIA (After receiving this first dose she experienced a tingling sensation and after receiving the second dose this sensation continued) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-531656 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Dose administered past the expiration date of a  Moderna Covid-19 vaccine as a Booster dose; Received 0.5 ml as a booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration date of a  Moderna Covid-19 vaccine as a Booster dose) and ACCIDENTAL OVERDOSE (Received 0.5 ml as a booster dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033h21A and 035C21A) for COVID-19 vaccination.     Concomitant products included ESTROGENS CONJUGATED (PREMARIN), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration date of a  Moderna Covid-19 vaccine as a Booster dose) and ACCIDENTAL OVERDOSE (Received 0.5 ml as a booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration date of a  Moderna Covid-19 vaccine as a Booster dose) and ACCIDENTAL OVERDOSE (Received 0.5 ml as a booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient concomitant medication included Hydra 500 mg The reporter confirmed that patient received third and booster dose on her deltoid muscles. Reporter did not know if the patient had experiencing any symptoms. Date the vial initially stored in refrigerator: 7-Mar-2022 The vial did not under go any temperature excursions. No treatment information provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-531858, MOD-2022-531860, MOD-2022-531856.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability
Clinical narrative: wife was tired; did not feel like getting up and doing things; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (wife was tired) and IMPAIRED WORK ABILITY (did not feel like getting up and doing things) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (wife was tired) and IMPAIRED WORK ABILITY (did not feel like getting up and doing things). At the time of the report, FATIGUE (wife was tired) and IMPAIRED WORK ABILITY (did not feel like getting up and doing things) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-531854, MOD-2022-531858, MOD-2022-531860, MOD-2022-531849, MOD-2022-531857 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Since 2 February she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 21 January, 12 days prior to onset of her symptoms. She has used oral antihistamines and oral corticosteroids with benefit. She denies constitutional symptoms. UCT score today is 11 (0, 1, 0, 3, 0, 3, 2, 2). No history of adverse reactions to prior vaccines.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Urticaria
Clinical narrative: Since 2 February she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 21 January, 12 days prior to onset of her symptoms. She has used oral antihistamines and oral corticosteroids with benefit. She denies constitutional symptoms. UCT score today is 11 (0, 1, 0, 3, 0, 3, 2, 2). No history of adverse reactions to prior vaccines.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Shingles outbreak with bad nerve pain that lingered for months.  Needed several prescriptions plus nerve pain meds  Lasted months
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Neuralgia, Pain of skin
Clinical narrative: Shingles outbreak with bad nerve pain that lingered for months.  Needed several prescriptions plus nerve pain meds  Lasted months
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Injection site pain, Lethargy
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Seizure-Severe, Additional Details: had multiple seizures throughout the night lasting more than 15minutes
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Seizure
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Seizure-Severe, Additional Details: had multiple seizures throughout the night lasting more than 15minutes
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: DERMATOLOGIST OKAYED GIVING THE SECOND DOSE
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: patient hospitalized
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram normal, Magnetic resonance imaging normal, Tinnitus
Clinical narrative: I noticed ringing in my ears in 2021 during times when I was studying for school in a quiet room. I scheduled an appointment with my PCP and was referred to an ENT office. They ordered an MRI with and without contrast to rule out any visible causes of the ringing. MRI was normal.  Also did an audiogram but hearing was normal. I have reduced caffeine intake and now manage high cholesterol, but ringing persists.   The ringing in my ears is constant, and sometimes manifests as a pulsatile tinnitus.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Cardiovascular disorder, Chest discomfort, Chest pain, Dry mouth
Clinical narrative: Experience slight chest tightness/pain and reduced cardiovascular performance for approximately four weeks after second injection. Left untreated and resolved. // Experienced anal thrombosis approximately one month after second injection. Treated with anal suppositories and topical ointment. Resolved after three weeks. // Experienced eye infection (possible stye) approximately two months after second injection. Treated with antibiotics on two separate occasions after first treatment ineffective. // Experienced auto-immune disorder symptoms approximately four months after second injection. Symptoms include dry mouth, oral ulcers, bleeding gums, tooth sensitivity, gum erosion, white web-like appearance in oral cavity (similar to oral lichen planus). Treated with Prednisone on two occasions. Symptoms reduced but not resolved. Ongoing issue at time of VAERS submission.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye infection, Gingival bleeding, Gingival erosion, Haemorrhoids thrombosed, Hyperaesthesia teeth
Clinical narrative: Experience slight chest tightness/pain and reduced cardiovascular performance for approximately four weeks after second injection. Left untreated and resolved. // Experienced anal thrombosis approximately one month after second injection. Treated with anal suppositories and topical ointment. Resolved after three weeks. // Experienced eye infection (possible stye) approximately two months after second injection. Treated with antibiotics on two separate occasions after first treatment ineffective. // Experienced auto-immune disorder symptoms approximately four months after second injection. Symptoms include dry mouth, oral ulcers, bleeding gums, tooth sensitivity, gum erosion, white web-like appearance in oral cavity (similar to oral lichen planus). Treated with Prednisone on two occasions. Symptoms reduced but not resolved. Ongoing issue at time of VAERS submission.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mouth ulceration, Oral disorder, Vitamin D
Clinical narrative: Experience slight chest tightness/pain and reduced cardiovascular performance for approximately four weeks after second injection. Left untreated and resolved. // Experienced anal thrombosis approximately one month after second injection. Treated with anal suppositories and topical ointment. Resolved after three weeks. // Experienced eye infection (possible stye) approximately two months after second injection. Treated with antibiotics on two separate occasions after first treatment ineffective. // Experienced auto-immune disorder symptoms approximately four months after second injection. Symptoms include dry mouth, oral ulcers, bleeding gums, tooth sensitivity, gum erosion, white web-like appearance in oral cavity (similar to oral lichen planus). Treated with Prednisone on two occasions. Symptoms reduced but not resolved. Ongoing issue at time of VAERS submission.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse outcome. Administration error only. FK9896 administered after beyond use date of 4/1/22. Error reported to manufacturer to advise on stability of the vaccine and further treatment/revaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Migraines with nausea.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Angiogram, Computerised tomogram, Magnetic resonance imaging, Tinnitus
Clinical narrative: Pulsating tinnitus
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol use, Dyspnoea, Pruritus, Throat irritation, Urticaria
Clinical narrative: 12/28/2021 I did not feel nothing bad, but when I drink a beer, I started feeling itchy and all my body broke out in hives. My throat was itching, and I started having trouble breathing. I took Benadryl and everything went away.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Fibrosis
Clinical narrative: Fibrosis and Abscess forming 1 month after injection.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Anaphylactic reaction
Clinical narrative: Anaphalaxis occurred within minutes of the injection.  Expired epipen was used which alleviated the immediate symptoms, but it persisted in a mild form for 3 days.  Upon returning home, I was seen in office by my Immunologist, Dr., who administered a prednisone injection, which alleviated the symptoms.   Followed up with testing provided by CDC.  More detail is possible, but this form does not work properly and won't allow me to continue to additional information.  Ironic.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Blood pressure increased, Blood test normal
Clinical narrative: I have always had very low blood pressure. As soon as I took my 2nd dose, my blood pressure changed. It spiked and had never had that before. I ended up in the ER. I went through many tests. Blood work, Even my doctor said he had been keeping records of those who took the Pfizer and other patients had also experienced high blood pressure. I have been hesitant to get the booster. I really think it was an adverse reaction. I am still taking blood pressure medication.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cluster headache, Conjunctivitis, Endoscopy, Fatigue
Clinical narrative: After the second dose, I experienced unexplained conjunctivitis, which was ultimately followed by intermittent cluster headaches.  It was ultimately diagnosed as trigeminal neuralgia, likely caused by an autoimmune response to the COVID vaccination regimen.  I was prescribed Indomethacin to alleviate symptoms, which seemed to help with the symptoms, but did not cure the condition.  I was advised by all my doctors not to get the booster, which I did not.  Ultimately, I contracted the Covid omicron variant and tested positive on 12/31/21.  After a mild case, the neuralgia seems to have resolved itself along with other symptoms I encountered previously including chronic fatigue and diminishment of taste and smell.  More info available but the additional info form below is not working
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hypogeusia, Hyposmia, Trigeminal neuralgia
Clinical narrative: After the second dose, I experienced unexplained conjunctivitis, which was ultimately followed by intermittent cluster headaches.  It was ultimately diagnosed as trigeminal neuralgia, likely caused by an autoimmune response to the COVID vaccination regimen.  I was prescribed Indomethacin to alleviate symptoms, which seemed to help with the symptoms, but did not cure the condition.  I was advised by all my doctors not to get the booster, which I did not.  Ultimately, I contracted the Covid omicron variant and tested positive on 12/31/21.  After a mild case, the neuralgia seems to have resolved itself along with other symptoms I encountered previously including chronic fatigue and diminishment of taste and smell.  More info available but the additional info form below is not working
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Cardiac disorder, Cardiac function test, Feeling abnormal, Nausea
Clinical narrative: Heart disease, high Fever, convulsions,  paralysis, blurred vision, body aches, nausea, brain fog, memory loss
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paralysis, Pyrexia, Seizure, Vision blurred
Clinical narrative: Heart disease, high Fever, convulsions,  paralysis, blurred vision, body aches, nausea, brain fog, memory loss
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Cardiac monitoring, Feeling abnormal, Heart rate irregular, Tinnitus
Clinical narrative: tinnitus evaluated by EENT (no treatment), brain fog (no treatment - blood tests normal), heart rate irregularity now being evaluated by heart rate monitor
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Positron emission tomogram, Swelling
Clinical narrative: The last week in January I noticed a swelling in my left clavicle. I called my oncologist and made an appointment just because of my past breast cancer diagnosis in my right breast. The oncologist ordered a PET scan. On my way home from where I had the pet scan done asking which arm I had my COVID vaccination in. When I got the report, the report stated the swelling in my clavicle was "most likely due to COVID  19 vaccine". Since then I have developed an ache in my left shoulder. The ache is still there.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization with covid; fully vaccinated
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: For unknown reason (not documented in chart) patient received the first Pfizer COVID-19 Vaccine dose on 07/14/21, the  second dose of Pfizer COVID-19 Vaccine on 08/04/21 and the third/booster dose on 12/20/2021 which is earlier than the required 5 months and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Required hospitalization after receiving vaccinex2.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted.   COVID breakthrough infection
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis of right anterior lower leg - She was initially treated with IV ancef with excellent clinical and lab response. Decision was made to transition to oral antibiotics and discharge home with plans for close outpatient follow up. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein normal, Chest discomfort, Dyspnoea, Dyspnoea exertional, Echocardiogram normal
Clinical narrative: Patient received his Pfizer COVID-19 vaccination on Saturday, 3/5/2022 for the first time.  Notes that that evening he began to have nausea and vomiting along with some dyspnea on exertion.  Played a hockey game on Sunday and had severe shortness of breath and dyspnea on exertion.  Since then is also struggled to maintain his breath and occasionally feels some chest discomfort.  No palpitations or rapid heartbeat that he has noticed.  He has had COVID-19 twice previously that was test confirmed.  He denies any history of underlying cardiac issues and no history of asthma or other lung diseases.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Nausea, Vomiting
Clinical narrative: Patient received his Pfizer COVID-19 vaccination on Saturday, 3/5/2022 for the first time.  Notes that that evening he began to have nausea and vomiting along with some dyspnea on exertion.  Played a hockey game on Sunday and had severe shortness of breath and dyspnea on exertion.  Since then is also struggled to maintain his breath and occasionally feels some chest discomfort.  No palpitations or rapid heartbeat that he has noticed.  He has had COVID-19 twice previously that was test confirmed.  He denies any history of underlying cardiac issues and no history of asthma or other lung diseases.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Mobility decreased
Clinical narrative: Patient came into the store the day after his vaccination stating that he could not move his arm. Upon further evaluation, I could see that the technician that administered the vaccination gave it too high on his shoulder. He said he would follow up with his physician.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Drug use disorder, Schizoaffective disorder, Treatment noncompliance
Clinical narrative: Patient admitted for decompensated schizoaffective disorder; Patient was using methamphetamine and medication noncompliant. Behavioral health admission and treatment. Hospital admission within 6 weeks of receiving the COVID vaccine,
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: or unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 08/03/21, the  second dose of Moderna COVID-19 Vaccine on 08/31/21 and the third/booster dose on 12/16/2022 which is earlier than the required 5 months and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Bipolar disorder, Depression, Suicidal ideation
Clinical narrative: ED visit for depression with suicidal ideation.  Hospital admission for bipolar disorder. Behavioral health admission and treatment. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Staff  in to room with mom and staff reviewed vaccines to be given  mom in agreement with vaccines being given. vaccines explained and given per staff. when staff went to complete orders in chart  noted that. vaccines had changed  in review, Notified doctor of  incident, child was  still to get the vaccines that were  given on a  different catch up schedule, so orders were changed again to the  match the vaccine administered today.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Swelling face
Clinical narrative: Swelling of lower face and difficulty swallowing
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dysuria, Malaise, Sepsis, Urinary tract infection
Clinical narrative: I started feeling sick on the 3rd Of March. By the 6th I was having burning when going to the bathroom. I had to go to the hospital which I stayed for a week. UTI that went Septic and I had an blood infection.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site reaction, Pain in extremity, Rash papular
Clinical narrative: Has had pain in the arm since the injection. The pain has decreased some over time. But still have pain if any pressure on the arm. Noticed recently in the area of the injection that she has bumps on her are that are raised a little but just under a dime size.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Functional gastrointestinal disorder, Gastrointestinal decompression, Gastrointestinal tube insertion, Gastrointestinal tube removal, Ileus
Clinical narrative: Ileus - He was managed with NGT for decompression, IVF and symptom management. He responded well to this management, he began having bowel function, NGT removed, he was started on liquid diet and advanced to regular diet on 1/4. He has tolerated the diet, is having bowel function and now requesting to discharge home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chest tube insertion, Epidural injection, Lung lobectomy, Lung neoplasm malignant
Clinical narrative: Patient underwent right lower lobectomy and thoracic lymphadenectomy for lung cancer.  Postoperation with her standard surgical floor where she had chest tubes to suction.  She had some borderline blood pressures with her thoracic epidural, which did respond to fluid resuscitation.  Once her chest tube outputs dropped and her airleak stopped her chest tubes were sequentially removed.  On the day of discharge she was breathing easy. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenectomy
Clinical narrative: Patient underwent right lower lobectomy and thoracic lymphadenectomy for lung cancer.  Postoperation with her standard surgical floor where she had chest tubes to suction.  She had some borderline blood pressures with her thoracic epidural, which did respond to fluid resuscitation.  Once her chest tube outputs dropped and her airleak stopped her chest tubes were sequentially removed.  On the day of discharge she was breathing easy. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis, Laparoscopic surgery
Clinical narrative: Acute appendicitis - patient that was admitted to the hospital and taken to the operating room and underwent a(n) Laparoscopic Appendectomy.  The patient tolerated the procedure(s) well and was transferred to the ward post operatively.  Post operative course was unremarkable.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: chronic fatigue lasting 4 weeks
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills, headache, fatigue
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Joint injection, Joint range of motion decreased, Limb mass, Muscle swelling
Clinical narrative: Soon after the injections I developed soreness and within a month I hardly could move my should without pain. By late December my should was in pain and had limited ROM. I went to doctor and upon examination after xrays they diagnosed Frozen Should early January 2022.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain, Periarthritis, Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: Soon after the injections I developed soreness and within a month I hardly could move my should without pain. By late December my should was in pain and had limited ROM. I went to doctor and upon examination after xrays they diagnosed Frozen Should early January 2022.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, MMR, PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Five year old male patient received Hib Vaccine outside of Protocol recommendations. Contributing factors: 1.  The child was starting over with vaccines at health department visit with no proof of prior vaccinations. 2.  The nurse who ordered the vaccines was not the nurse who performed the well child exam. 3.  Staff did not utilize the protocol manual to verify the age limit for administering a Hib vaccine. Via in house interpreter spoke with Father, by phone and he denies the child having any adverse reaction to vaccines.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: generalized abdominal pain, nausea, vomiting,
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diagnostic aspiration, Follicular lymphoma, Lymphadenectomy, Lymphadenopathy, Neck mass
Clinical narrative: Follicular Lymphoma... started with a lump in my neck in July.  I watched it, not knowing what it was.  When it didn't change or go away, I had it examined the first part of 2022
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: Follicular Lymphoma... started with a lump in my neck in July.  I watched it, not knowing what it was.  When it didn't change or go away, I had it examined the first part of 2022