chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue, Single component of a two-component product administered
Clinical narrative: a dose of PENTACEL was administered without reconstituting with the HIB portion of the vaccine, reporting only the DTAP/IPV portion was administered with no reported adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old male patient who had a dose of pentacel was administered without reconstituting with the hib portion of the vaccine, reporting only the dtap/ipv portion was administered with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); and rotavirus vaccine (Rotavirus vaccine).  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine lot UJ551AAA via intramuscular route, expiry date- 05-Aug-2022 in unknown administration site.  On 28-Mar-2022 the patient had a dose of pentacel was administered without reconstituting with the hib portion of the vaccine, reporting only the dtap/ipv portion was administered with no reported adverse event (single component of a two-component product administered) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Rash
Clinical narrative: a rash all over the child's body; Initial information received on 28-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who experienced a rash all over the  body while receiving vaccines HEPATITIS B VACCINE and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  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 suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UJ696AA in unknown administration site as immunization.  On an unknown date, the patient received a  dose of 0.25 ml of suspect HEPATITIS B VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported in unknown administration site as immunization.  The patient used the vaccines for the first time.  On 25-SEP-2021 the patient developed a non-serious event a rash all over the child's body (rash) (unknown latency) following the administration of all suspect vaccines.  Action taken  was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash.  At time of reporting, the outcome was Recovering / Resolving for the event.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: FEVER; OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a consumer via a company representative concerned a 5 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced fever, off label use, and inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: total relief of pre-existing vertigo since receiving the 3rd full dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (total relief of pre-existing vertigo since receiving the 3rd full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (total relief of pre-existing vertigo since receiving the 3rd full dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (total relief of pre-existing vertigo since receiving the 3rd full dose) had resolved.            Concomitant medications were not reported Treatment information was not reported
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer a expiry vaccine to herself; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer a expiry vaccine to herself) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 019F21A and 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer a expiry vaccine to herself). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer a expiry vaccine to herself) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: determined to be immunocompromised after half dose booster; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (determined to be immunocompromised after half dose booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (determined to be immunocompromised after half dose booster) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (determined to be immunocompromised after half dose booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.  Company comment: This is a spontaneous case concerning a male patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of immunodeficiency after a booster dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Reported stated that the patient was determined to be immunocompromised after receiving half dose of booster. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of immunodeficiency after a booster dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Reported stated that the patient was determined to be immunocompromised after receiving half dose of booster. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: gave 4th dose of the Moderna Covid-19 vaccine of 0.5mL instead of 0.25mL dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (gave 4th dose of the Moderna Covid-19 vaccine of 0.5mL instead of 0.25mL dose.) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (gave 4th dose of the Moderna Covid-19 vaccine of 0.5mL instead of 0.25mL dose.). At the time of the report, ACCIDENTAL OVERDOSE (gave 4th dose of the Moderna Covid-19 vaccine of 0.5mL instead of 0.25mL dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient is immunocompromised and did not received a third dose but a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient is immunocompromise and did not received a third dose but a booster dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a, 006m20a and 038k20a) for COVID-19 vaccination.     The patient's past medical history included Cancer and Chemotherapy. Concurrent medical conditions included Immunocompromised.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient is immunocompromise and did not received a third dose but a booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient is immunocompromise and did not received a third dose but a booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue
Clinical narrative: A little tired; Given a third full dose instead of a booster (half) dose.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little tired) and ACCIDENTAL OVERDOSE (Given a third full dose instead of a booster (half) dose.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced FATIGUE (A little tired) and ACCIDENTAL OVERDOSE (Given a third full dose instead of a booster (half) dose.). At the time of the report, FATIGUE (A little tired) and ACCIDENTAL OVERDOSE (Given a third full dose instead of a booster (half) dose.) outcome was unknown.  It was reported that the patient was not immunocompromised. No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product was stored in refrigerator after expiration; they administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients) and PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients) and PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Date the vial was initially stored in the refrigerator on 28 Mar 2022. The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2022-528254 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Patient not immunocompromised  received a full dose instead the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Patient not immunocompromised  received a full dose instead the booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 OVERDOSE (Patient not immunocompromised  received a full dose instead the booster dose). At the time of the report, OVERDOSE (Patient not immunocompromised  received a full dose instead the booster dose) outcome was unknown.            Patient is not immunocompromised, she was advised to receive the full dose by her pharmacist. No concomitant medications were reported. No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: pt states she had a bad reaction a few hours later (difficulty breathing and swallow) - she took 3 benadryls which relieved her symptoms
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Administered expired product.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Parosmia.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Diarrhoea, Fatigue, Lethargy
Clinical narrative: Systemic: Diarrhea-Medium, Systemic: Exhaustion/Lethargy-Medium. Additional Details: Patient  recieved the Pfizer COVID-19 vaccine-2nd dose on 3/21/2022. Later that day, she started feeling fatigue and diarrhea. Adverse reactions are still going on 3/28/2022. Seemed like longer than usual for side effects from a vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Systemic: Headache-Medium, Additional Details: Patient reported still having a headache 6 days after recieving the Shingrix vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (temp/location).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Malaise
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: possibly drop in heart rate but bp was normal at 110/70. measured twice-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: blood pressure and heart rate was measured. Pt described as "not feeling well" and possibly feel weak and dizzy. symptoms resolved afte rabout 30 minutes.; ambulance was called and bloodpressure and heart rate was also checked again by emt. pt was found to be normal and did not need to go to er.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Anticoagulant therapy, Blood electrolytes, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient is fully vaccinated and boosted x2  . COVID positive on admission. 77y.o. male with history of lymphoma, pulmonary embolism (June 2021), unintentional weight loss, CAD and glaucoma who presents with hypoxic [SPO2 80%] and tachypneic with conversational dyspnea while performing a 6-minute walk test.  Positive for cough, sputum production, fatigue and weight loss.EKG was negative for acute ischemic changes with negative troponin. D dimer, 1,255.  No significant electrolyte abnormality. A CTA PE study was was obtained and it showed no signs of pulmonary embolism. PET CT, Multiple foci of ground glass opacity with increased metabolic activity in bilateral lungs likely due to infectious or inflammatory process. Malignancy is less likely.  DX: COVID pneumonia. Treatment: oxygen, lovenox, decadron. Patient currently remains hospitalized at this report
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Electrocardiogram normal, Fatigue, Fibrin D dimer increased, Hypoxia
Clinical narrative: Patient is fully vaccinated and boosted x2  . COVID positive on admission. 77y.o. male with history of lymphoma, pulmonary embolism (June 2021), unintentional weight loss, CAD and glaucoma who presents with hypoxic [SPO2 80%] and tachypneic with conversational dyspnea while performing a 6-minute walk test.  Positive for cough, sputum production, fatigue and weight loss.EKG was negative for acute ischemic changes with negative troponin. D dimer, 1,255.  No significant electrolyte abnormality. A CTA PE study was was obtained and it showed no signs of pulmonary embolism. PET CT, Multiple foci of ground glass opacity with increased metabolic activity in bilateral lungs likely due to infectious or inflammatory process. Malignancy is less likely.  DX: COVID pneumonia. Treatment: oxygen, lovenox, decadron. Patient currently remains hospitalized at this report
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Positron emission tomogram, Productive cough, SARS-CoV-2 test positive, Tachypnoea
Clinical narrative: Patient is fully vaccinated and boosted x2  . COVID positive on admission. 77y.o. male with history of lymphoma, pulmonary embolism (June 2021), unintentional weight loss, CAD and glaucoma who presents with hypoxic [SPO2 80%] and tachypneic with conversational dyspnea while performing a 6-minute walk test.  Positive for cough, sputum production, fatigue and weight loss.EKG was negative for acute ischemic changes with negative troponin. D dimer, 1,255.  No significant electrolyte abnormality. A CTA PE study was was obtained and it showed no signs of pulmonary embolism. PET CT, Multiple foci of ground glass opacity with increased metabolic activity in bilateral lungs likely due to infectious or inflammatory process. Malignancy is less likely.  DX: COVID pneumonia. Treatment: oxygen, lovenox, decadron. Patient currently remains hospitalized at this report
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin normal, Weight decreased
Clinical narrative: Patient is fully vaccinated and boosted x2  . COVID positive on admission. 77y.o. male with history of lymphoma, pulmonary embolism (June 2021), unintentional weight loss, CAD and glaucoma who presents with hypoxic [SPO2 80%] and tachypneic with conversational dyspnea while performing a 6-minute walk test.  Positive for cough, sputum production, fatigue and weight loss.EKG was negative for acute ischemic changes with negative troponin. D dimer, 1,255.  No significant electrolyte abnormality. A CTA PE study was was obtained and it showed no signs of pulmonary embolism. PET CT, Multiple foci of ground glass opacity with increased metabolic activity in bilateral lungs likely due to infectious or inflammatory process. Malignancy is less likely.  DX: COVID pneumonia. Treatment: oxygen, lovenox, decadron. Patient currently remains hospitalized at this report
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: I have CN VII palsy left-side. Mouth involvement. Sudden onset.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Lacrimation increased, Pruritus
Clinical narrative: I have CN VII palsy left-side. Mouth involvement. Sudden onset.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Rectal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: Patient presented to the ER due to rectal bleeding. He was incidentally found COVID-19 positive. He remained asymptomatic during his hospital stay.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, VARZOS, VARZOS
Symptoms: Axillary pain, Blood test normal, Chills, Computerised tomogram thorax, Discomfort
Clinical narrative: Headaches random areas of head. Pain/pressure behind both eyes. Extreme fatigue. Hard to get out of  bed for 2 days. Even resting feels like it's work and I can't get comfortable. Poor sleep. Night  sweats-then chillls. Pain deep In both armpits. Nausea. Body starts to shake when I don't rest. Taking a  shower wears me out. Neck hurts and my head feels heavy to hold up. Feels like a migraine and noises  really bother me. Brain Fog is off the charts ll
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, VARZOS, VARZOS
Symptoms: Eye pain, Fatigue, Feeling abnormal, Head discomfort, Headache
Clinical narrative: Headaches random areas of head. Pain/pressure behind both eyes. Extreme fatigue. Hard to get out of  bed for 2 days. Even resting feels like it's work and I can't get comfortable. Poor sleep. Night  sweats-then chillls. Pain deep In both armpits. Nausea. Body starts to shake when I don't rest. Taking a  shower wears me out. Neck hurts and my head feels heavy to hold up. Feels like a migraine and noises  really bother me. Brain Fog is off the charts ll
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, VARZOS, VARZOS
Symptoms: Migraine, Mobility decreased, Nausea, Neck pain, Night sweats
Clinical narrative: Headaches random areas of head. Pain/pressure behind both eyes. Extreme fatigue. Hard to get out of  bed for 2 days. Even resting feels like it's work and I can't get comfortable. Poor sleep. Night  sweats-then chillls. Pain deep In both armpits. Nausea. Body starts to shake when I don't rest. Taking a  shower wears me out. Neck hurts and my head feels heavy to hold up. Feels like a migraine and noises  really bother me. Brain Fog is off the charts ll
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, VARZOS, VARZOS
Symptoms: Ocular discomfort, Poor quality sleep, Tinnitus, Tremor
Clinical narrative: Headaches random areas of head. Pain/pressure behind both eyes. Extreme fatigue. Hard to get out of  bed for 2 days. Even resting feels like it's work and I can't get comfortable. Poor sleep. Night  sweats-then chillls. Pain deep In both armpits. Nausea. Body starts to shake when I don't rest. Taking a  shower wears me out. Neck hurts and my head feels heavy to hold up. Feels like a migraine and noises  really bother me. Brain Fog is off the charts ll
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Angiotensin converting enzyme, Antinuclear antibody, Eye pain, Full blood count, Lysozyme
Clinical narrative: 3-19-22 - Pain + redness to Left eye - Augmentin, tobrex 3-24-22 - dx c periorbital cellulitis 3-28. 22 - refer to ophtho              - ED Uveitis of left eye - steroids & atropine drops
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Ocular hyperaemia, Periorbital cellulitis, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: 3-19-22 - Pain + redness to Left eye - Augmentin, tobrex 3-24-22 - dx c periorbital cellulitis 3-28. 22 - refer to ophtho              - ED Uveitis of left eye - steroids & atropine drops
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Treponema test, Urine analysis, Uveitis
Clinical narrative: 3-19-22 - Pain + redness to Left eye - Augmentin, tobrex 3-24-22 - dx c periorbital cellulitis 3-28. 22 - refer to ophtho              - ED Uveitis of left eye - steroids & atropine drops
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills, headache, body aches,
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test positive
Clinical narrative: Develop Covid illness 1/11/2022 at 3:00 a.m. Testing positive for Covid on 1/13/2022. Very ill for 48 hours. Then gradually recovered over another week.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health, per guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: During pre-employment screening, associate received the Varicella vaccine and subsequently developed a reaction to the site that has gotten worse. Including a painful, itchy, red lump that is warm to the touch, along with a headache.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: During pre-employment screening, associate received the Varicella vaccine and subsequently developed a reaction to the site that has gotten worse. Including a painful, itchy, red lump that is warm to the touch, along with a headache.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Moderna 1/1/20, 3/25/21, 4/21/21. Positive on 3/31/22
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: rash all over, swollen lip
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Lethargy, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: From March 4 through March 6th extreme lethargy and significant cold symptoms. Positive home Covid test. From March 7 through Marhc 9, less severe lethargy and less significant cold symptoms.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health, per guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Public Health, per guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Headache, Hypertension
Clinical narrative: The next day after the vaccine, I woke up with extreme headaches and checked my BP that was 170/120. I have never had a blood pressure reading that high and my blood pressure has always been normal. I went to my doctor and was prescribed a medication. It did not work so called my doctor again and was put on another medication. After the 4th or 5th attempt at contacting my doctor and changing meds, I finally have a medication that works and controlled my blood pressure. To this day, I am still on blood pressure medications.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram QT prolonged, Full blood count, Headache, Metabolic function test
Clinical narrative: Dizziness 1 hr after Vaccine. 1 day after vaccine nausea, tachycardia, dizziness, headache. Saw MD on 3/17/22 for continued symptoms with no improvement, EKG showed Long QT
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tachycardia, Urine analysis
Clinical narrative: Dizziness 1 hr after Vaccine. 1 day after vaccine nausea, tachycardia, dizziness, headache. Saw MD on 3/17/22 for continued symptoms with no improvement, EKG showed Long QT
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atelectasis, Blood lactate dehydrogenase increased, Blood lactic acid, COVID-19
Clinical narrative: Patient was admitted on 1/7/2022 because of fatigue.  She does have a history of breast cancer on chemotherapy and COVID-19.  Patient was a diagnosis COVID-19 pneumonia on 01/05/2021 with symptom onset on 01/03/2021.  She was discharged on doxycycline.  She had been at progressively weaker and developed nausea and fatigue.  On arrival in the emergency room she was satting 89% on room air and uses 2 L nasal cannula at home.  She has received COVID-19 vaccination and booster.  She is currently undergoing chemotherapy for breast cancer.  On arrival in the emergency room D-dimer was 1368 LDH 296 lactic acid 1.4.  Chest x-ray revealed mild scattered opacities the lung base primarily likely due to atelectasis versus evolving infiltrates which appears slightly more prominent compared to prior studies.  She does complain of dysphagia and feels like things get stuck.  She was started on IV Decadron and Remdesivir was discussed with her.  She is currently on nasal cannula oxygen at 4 L. She is due to have another course of chemotherapy next week in she was told that she this will likely need to be postponed.  Her oncologist is Dr. "PRIVATE".     Her oxygen was able to be weaned down to 3 L nasal cannula.  She is normally on 2 L at home.  She felt that she was stable for discharge home on 1/10.  She was treated with dexamethasone and azithromycin.  Remdesivir will be discontinued and she will be sent home with the Covid care kit.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chemotherapy, Chest X-ray abnormal, Dysphagia, Fatigue
Clinical narrative: Patient was admitted on 1/7/2022 because of fatigue.  She does have a history of breast cancer on chemotherapy and COVID-19.  Patient was a diagnosis COVID-19 pneumonia on 01/05/2021 with symptom onset on 01/03/2021.  She was discharged on doxycycline.  She had been at progressively weaker and developed nausea and fatigue.  On arrival in the emergency room she was satting 89% on room air and uses 2 L nasal cannula at home.  She has received COVID-19 vaccination and booster.  She is currently undergoing chemotherapy for breast cancer.  On arrival in the emergency room D-dimer was 1368 LDH 296 lactic acid 1.4.  Chest x-ray revealed mild scattered opacities the lung base primarily likely due to atelectasis versus evolving infiltrates which appears slightly more prominent compared to prior studies.  She does complain of dysphagia and feels like things get stuck.  She was started on IV Decadron and Remdesivir was discussed with her.  She is currently on nasal cannula oxygen at 4 L. She is due to have another course of chemotherapy next week in she was told that she this will likely need to be postponed.  Her oncologist is Dr. "PRIVATE".     Her oxygen was able to be weaned down to 3 L nasal cannula.  She is normally on 2 L at home.  She felt that she was stable for discharge home on 1/10.  She was treated with dexamethasone and azithromycin.  Remdesivir will be discontinued and she will be sent home with the Covid care kit.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Lung infiltration, Lung opacity, Nausea, Oropharyngeal discomfort
Clinical narrative: Patient was admitted on 1/7/2022 because of fatigue.  She does have a history of breast cancer on chemotherapy and COVID-19.  Patient was a diagnosis COVID-19 pneumonia on 01/05/2021 with symptom onset on 01/03/2021.  She was discharged on doxycycline.  She had been at progressively weaker and developed nausea and fatigue.  On arrival in the emergency room she was satting 89% on room air and uses 2 L nasal cannula at home.  She has received COVID-19 vaccination and booster.  She is currently undergoing chemotherapy for breast cancer.  On arrival in the emergency room D-dimer was 1368 LDH 296 lactic acid 1.4.  Chest x-ray revealed mild scattered opacities the lung base primarily likely due to atelectasis versus evolving infiltrates which appears slightly more prominent compared to prior studies.  She does complain of dysphagia and feels like things get stuck.  She was started on IV Decadron and Remdesivir was discussed with her.  She is currently on nasal cannula oxygen at 4 L. She is due to have another course of chemotherapy next week in she was told that she this will likely need to be postponed.  Her oncologist is Dr. "PRIVATE".     Her oxygen was able to be weaned down to 3 L nasal cannula.  She is normally on 2 L at home.  She felt that she was stable for discharge home on 1/10.  She was treated with dexamethasone and azithromycin.  Remdesivir will be discontinued and she will be sent home with the Covid care kit.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient was admitted on 1/7/2022 because of fatigue.  She does have a history of breast cancer on chemotherapy and COVID-19.  Patient was a diagnosis COVID-19 pneumonia on 01/05/2021 with symptom onset on 01/03/2021.  She was discharged on doxycycline.  She had been at progressively weaker and developed nausea and fatigue.  On arrival in the emergency room she was satting 89% on room air and uses 2 L nasal cannula at home.  She has received COVID-19 vaccination and booster.  She is currently undergoing chemotherapy for breast cancer.  On arrival in the emergency room D-dimer was 1368 LDH 296 lactic acid 1.4.  Chest x-ray revealed mild scattered opacities the lung base primarily likely due to atelectasis versus evolving infiltrates which appears slightly more prominent compared to prior studies.  She does complain of dysphagia and feels like things get stuck.  She was started on IV Decadron and Remdesivir was discussed with her.  She is currently on nasal cannula oxygen at 4 L. She is due to have another course of chemotherapy next week in she was told that she this will likely need to be postponed.  Her oncologist is Dr. "PRIVATE".     Her oxygen was able to be weaned down to 3 L nasal cannula.  She is normally on 2 L at home.  She felt that she was stable for discharge home on 1/10.  She was treated with dexamethasone and azithromycin.  Remdesivir will be discontinued and she will be sent home with the Covid care kit.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Clostridium difficile colitis, Nausea, Retching
Clinical narrative: C. difficile colitis - She was given 2 liters of IV normal saline and her blood pressures improved. She was given 4 mg IV Zofran, which resolved her nausea and dry heaving.  She was admitted to inpatient for C. difficile colitis. She was started on IV metronidazole 500 mg 200 mL/hr Q8H, IV famotidine, and oral vancomycin 500 mg. She will be discharged on 125 mg oral vancomycin QID and 4 mg oral Zofran PRN, and was encouraged to push fluids. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Dizziness, Dyspepsia, Dysstasia
Clinical narrative: 04/17/2021 Because I have some risks factors, I had to wait full 30 min after vaccine. Once that was over, I got in my car to drive home, 45 min drive, I was on the phone with my mom and she started getting worried about me during the drive because I was telling her I was feeling lightheaded and brain foggy. I started feeling dyspeptic. It also happened after the first vaccine. Felt I would just be a little unwell for a day or so. When I got home, I was feeling pretty unwell, cold and could not warm up. At some point, 2 hours later, evening that day, I made a bowl of soup for myself. After I ate the bowl of soup, things began to develop rapidly in a bad direction. By that night, I was in more pain than I had been in my entire life and incredibly nauseated. The pain was in all the muscles and joints in my body. It felt like a really bad cramp in every muscle. This continued until the next morning. Vomited many times, perhaps 6 times or more. It was so bad, I was calling out to God to take me. I could not bear it or take it. My husband, at the time, was going through cancer treatment and I had to call him for help, I could not stand or sit up. I don't know how many days it took me to feel normal. It took at least 2 weeks to recover. Did not go to ER that night because my husband could not drive me and I was too incapacitated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Immobile, Malaise, Muscle spasms
Clinical narrative: 04/17/2021 Because I have some risks factors, I had to wait full 30 min after vaccine. Once that was over, I got in my car to drive home, 45 min drive, I was on the phone with my mom and she started getting worried about me during the drive because I was telling her I was feeling lightheaded and brain foggy. I started feeling dyspeptic. It also happened after the first vaccine. Felt I would just be a little unwell for a day or so. When I got home, I was feeling pretty unwell, cold and could not warm up. At some point, 2 hours later, evening that day, I made a bowl of soup for myself. After I ate the bowl of soup, things began to develop rapidly in a bad direction. By that night, I was in more pain than I had been in my entire life and incredibly nauseated. The pain was in all the muscles and joints in my body. It felt like a really bad cramp in every muscle. This continued until the next morning. Vomited many times, perhaps 6 times or more. It was so bad, I was calling out to God to take me. I could not bear it or take it. My husband, at the time, was going through cancer treatment and I had to call him for help, I could not stand or sit up. I don't know how many days it took me to feel normal. It took at least 2 weeks to recover. Did not go to ER that night because my husband could not drive me and I was too incapacitated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Sitting disability, Vomiting
Clinical narrative: 04/17/2021 Because I have some risks factors, I had to wait full 30 min after vaccine. Once that was over, I got in my car to drive home, 45 min drive, I was on the phone with my mom and she started getting worried about me during the drive because I was telling her I was feeling lightheaded and brain foggy. I started feeling dyspeptic. It also happened after the first vaccine. Felt I would just be a little unwell for a day or so. When I got home, I was feeling pretty unwell, cold and could not warm up. At some point, 2 hours later, evening that day, I made a bowl of soup for myself. After I ate the bowl of soup, things began to develop rapidly in a bad direction. By that night, I was in more pain than I had been in my entire life and incredibly nauseated. The pain was in all the muscles and joints in my body. It felt like a really bad cramp in every muscle. This continued until the next morning. Vomited many times, perhaps 6 times or more. It was so bad, I was calling out to God to take me. I could not bear it or take it. My husband, at the time, was going through cancer treatment and I had to call him for help, I could not stand or sit up. I don't know how many days it took me to feel normal. It took at least 2 weeks to recover. Did not go to ER that night because my husband could not drive me and I was too incapacitated.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Hepatic enzyme increased, Hypertransaminasaemia, Inflammatory marker increased
Clinical narrative: Patient was admitted on 1/25/2022 because of symptomatic COVID-19 infection as well as transaminitis .  Patient presented emergency department with a complaint of generalized body ache fever as well as headache.  Patient was found to have elevated liver enzymes as well as inflammatory markers.  Testing for COVID-19 infection eventually came back positive.  Patient was not hypoxic and therefore did not qualify for any specific treatment.  Patient was started on IV fluid hydration as well as symptomatic treatment.  Patient continued to improve with almost complete resolution of his symptoms.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted on 1/25/2022 because of symptomatic COVID-19 infection as well as transaminitis .  Patient presented emergency department with a complaint of generalized body ache fever as well as headache.  Patient was found to have elevated liver enzymes as well as inflammatory markers.  Testing for COVID-19 infection eventually came back positive.  Patient was not hypoxic and therefore did not qualify for any specific treatment.  Patient was started on IV fluid hydration as well as symptomatic treatment.  Patient continued to improve with almost complete resolution of his symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Central venous catheterisation, Debridement, Device occlusion, Medical device removal, Wound treatment
Clinical narrative: Patient admitted for Procedure(s): Right - EXCISIONAL DEBRIDEMENT AND IRRIGATION RIGHT ANKLE WITH HARDWARE REMOVAL. The hospitalization was necessary for pain control, therapy, medical care and discharge placement. Ultimately, the patient was discharged to home under satisfactory medical and post-operative condition. ED visit 4 days later for occlusion of peripherally inserted central catheter. Treated and released. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pain, Eye pruritus, Periorbital swelling, Scleritis
Clinical narrative: Starting 2 weeks after receiving the vaccine, I woke up with an itching sensation and slight burning in my left eye. 2 days later, it continued to get red and puffy. So, I went to the optometrist and they gave me an antibiotic eye drop. 2 days later, it got worse and my face started swelling and my eye was very painful. I went back to the optometrist and they sent me to an eye specialist. Doctor's associate saw me and started me on another antibiotic eye drop. She had me see the other doctor a few days to a week later. Then I started seeing him every 2 weeks until recently. He ended up putting me on oral prednisone and prednisolone eye drops. He diagnosed it as scleritis.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Starting 2 weeks after receiving the vaccine, I woke up with an itching sensation and slight burning in my left eye. 2 days later, it continued to get red and puffy. So, I went to the optometrist and they gave me an antibiotic eye drop. 2 days later, it got worse and my face started swelling and my eye was very painful. I went back to the optometrist and they sent me to an eye specialist. Doctor's associate saw me and started me on another antibiotic eye drop. She had me see the other doctor a few days to a week later. Then I started seeing him every 2 weeks until recently. He ended up putting me on oral prednisone and prednisolone eye drops. He diagnosed it as scleritis.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Intensive care, Visual field defect
Clinical narrative: CVA - exam by ED/telestroke providers with L sided field cut concerning for R occipital stroke. He received TNK . Admitted to Facility post TNK. Today the patient reports that visual field deficits have resolved and he feels back at baseline. Discharged home and will follow up outpatient. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Colectomy, Colon cancer
Clinical narrative: Malignant neoplasm of splenic flexure; Procedures: Laparoscopic assisted transverse colectomy. Recovered in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid test in fully vaccinated and boostered patient
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery bypass
Clinical narrative: Patient hospitalized for Coronary artery bypass grafting x4 - left internal mammary artery grafted to LAD and reverse saphenous vein grafts placed to diagonal, obtuse marginal and right posterior descending coronary arteries on cardiopulmonary bypass. this was within 6 weeks of receiving covid vaccination.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ED/Hospitalization within 6 weeks of COVID vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Blood test
Clinical narrative: I had a miscarriage at 6 weeks.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hyperpyrexia
Clinical narrative: I went to the Pharmacy to get Covid Shot. I waited 20 minutes and went home. I was doing ok and in the evening, I started getting sweaty and I started running a high Fever. I kept going to sleep and waking up in sweat. I was like that for about 3 days. I took medication during this time. After about 32 hours I started to feel better.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Psychotic disorder
Clinical narrative: psychotic reaction
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks of COVID vaccination.