chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized with dyspnea COPD exacerbation, hypercapneic and hypoxic resp failure. COVID.
Headache started 2-3-2021 at 9pm. I am still having headaches today (over 48 hours after vaccine). I was not sure if I needed to report it after it stops.   I have not seek treatment for this.
Information has been received from a physician concerning a 4 year old patient (gender not reported) who on 22-JAN-2007 was vaccinated with ProQuad (upgrade process) (lot#655752/1122F). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. On 22-JAN-2007 (within the hour of receiving vaccine) the patient experienced severe anaphylactic reaction. Allergy testing was obtained (no results provided). Subsequently, the patient recovered from severe anaphylactic reaction. The patient sought unspecified medical attention. There was no product quality complaint. Severe Anaphylactic reaction was considered to be an other important medical event and immediately life-threatening by the reporter. Additional information has been requested.
patient developed a vermilion border lower lip ulcer; This non-serious case was reported by a nurse via call center representative and described the occurrence of lip ulcer in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 2739M, expiry date 06-OCT-2024) for prophylaxis.   Concurrent medical conditions included hiv infection (The patient does have HIV, but with long-term suppression.). Additional patient notes included The patient had no prior history of oral herpes simplex or herpes zoster..   On 21-JUN-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced lip ulcer (Verbatim: patient developed a vermilion border lower lip ulcer). The outcome of the lip ulcer was not resolved.   It was unknown if the reporter considered the lip ulcer to be related to Shingrix.     It was unknown if the company considered the lip ulcer to be related to Shingrix.   Additional Information: GSK Receipt date: 05-JUL-2023 Nurse Practitioner reported that over this past weekend the patient developed a vermilion border lower lip ulcer.  The patient had no prior history of oral herpes simplex or herpes zoster.  The patient does have HIV, but with long-term suppression. The Vaccine Administration Facility is the same as Primary Reporter. The Nurse Practitioner plans to prescribe Valtrex, but this has not yet been initiated. The reporter consented to follow up.
This spontaneous report was received from a Nurse Practitioner and refers to a 17 year old (currently an 18 year old) male patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. On 18-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Pain and tenderness in arm (wakes me up at night when I roll over) Fatigue, mild headache, achy all over, chills, joint pain, some nausea
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. Initial information was processed with the additional information received on 16-JUL-2021. The patient's height, and weight were not reported. The patient's past medical history included organ transplant.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient did not show antibodies (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) No antibody found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186131.; Sender's Comments: V0: 20210733429-covid-19 vaccine ad26.cov2.s -Suspected immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fever 99.8; Cold; Stiff muscles; Dizzy; Weak; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Feb2022 (Lot number: unknown) at the age of 29 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 10Feb2022, outcome "unknown", described as "Fever 99.8"; NASOPHARYNGITIS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Cold"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Stiff muscles"; DIZZINESS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Dizzy"; ASTHENIA (non-serious) with onset 10Feb2022, outcome "unknown", described as "Weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
flu like symptoms; feels terrible; whole body aches; Fever of 101 degree F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feels terrible), PAIN (whole body aches) and PYREXIA (Fever of 101 degree F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feels terrible), PAIN (whole body aches) and PYREXIA (Fever of 101 degree F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feels terrible), PAIN (whole body aches) and PYREXIA (Fever of 101 degree F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Pyrexia: 101 (High) Fever of 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.
This spontaneous report was received from a pharmacist regarding a 71 year old male patient. There was no information about concurrent condition and historical medication. On 10-SEP-2015, the patient was vaccinated with PNEUMOVAX23 lot # K009105, expiration date- 21-JAN-2016, intramuscular. No concomitant medication was reported. On an unknown date in September 2015, as reported within 2-3 hours of receiving the PNEUMOVAX23 the patient experienced injection site warmth and injection site swelling about 4 inches by 4 inches. The patient cold compresses on it. No product quality complaint (PQC) was involved. No laboratory diagnostics were performed. The outcome of injection site warmth and injection site swelling was unknown. Causality between injection site warmth and injection site swelling and PNEUMOVAX23 was unknown. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-DEC-2008, a physician at a medical clinic administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 20-NOV-2016 and 12-JAN-2017, the patient was treated by physicians at a hospital and medical clinic for shingles and post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
feeling being under the weather; allergy-ish in the eyes; sinuses; with a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 09Mar2021, outcome "unknown", described as "feeling being under the weather"; EYE ALLERGY (non-serious) with onset 09Mar2021, outcome "unknown", described as "allergy-ish in the eyes"; SINUSITIS (non-serious) with onset 09Mar2021, outcome "unknown", described as "sinuses"; NASOPHARYNGITIS (non-serious) with onset 09Mar2021, outcome "unknown", described as "with a cold". Therapeutic measures were not taken as a result of nasopharyngitis.  Additional information: Also today is supposed to be her schedule for the second dose. She expressed the. Possibility that she might not make it today in the facility. She is then asking how to reschedule and whether there an allowable time to extend beyond 21 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Onset of left upper extremity erythema, warmth and tenderness on 09 MAR. Presented to the Hospital Emergency Department due to progression of symptoms with associated chills and body aches. Given 1g of Ceftriaxone with continued progression of erythema and admitted for treatment of presumed cellulitis for IV vancomycin. Symptoms improved and discharged on oral Doxycycline and Amoxicillin.
Severe arm soreness x 5 days following shot. Went away for 3-4 days. Area effected was from elbow to shoulder. After that 3-4 days it came back and never went away. Still severely limited mobility in shoulder.
Mother reports daughter has only the following symptoms of an unknown rash located on face, hands and legs and low grade fever on 7-27-05. Denies SOB, changes in child's appetite & activity. Past history of skin irritation since she was 7 months old. The week of 7-24-06, she has had mutiple exposures, food(crab), chemical (carpet cleaner) and environmental (grass/park).
Patient reports a rash that covers her torso up to her scalp. Patient states that it is itchy, and she taking Zyrtec to treat symptoms. The rash appeared the day after vaccination. As of two days after vaccination, the rash has not yet resolved.
muscle aches-started at 16 hours post shot and lasted 48 hours chills-started at 18 hours post shot and lasted 8 hours fever-started at 24 hours post shot and lasted 48 hours-took Tylenol every 4-5 hours nausea-started at 20 hours post shot and lasted 2 hours-took medication headache-started at 28 hours post shot and lasted 48 hours.  pressure in head-started at 28 hours and lasted 72 hours large red circle around injection site-started 16 hours post shot and continued to get worse for 72 hours, after 72 hours the circle went down and was completely gone within 1 week.
pt recv vax 10:30 28MAR97 & whiny & clingy @ 11:30;fever 101 & 130PM lethargic, unresponsive, pale;CBC WNL x WBC 12-7% bands;
PRESENTED IN OFFICE >50 LESIONS VARICELLA SIBLING HAD SHINGLES X 2 WEEKS PRIOR CHILDREN BATHED TOGETHER X 2 WEEKS AGO.
true reaction to eye medication; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves an Adult patient who experienced true reaction to eye medication (drug hypersensitivity), while the patient received INFLUENZA VACCINE [INFLUENZA VACCINE].  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, after started vaccine, the patient had a true reaction to eye medication (drug hypersensitivity) as well as flu vaccine.  No laboratory data was provided.  Final diagnosis was illness.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for flu.
Diarrhea, NauseaVomiting, Injection site swelling and redness Narrative:
I got COVID; started off experiencing a cold, severe Asthma (used Inhaler several times a day). I contacted my doctor and was prescribed Steroid. The Asthma lasted for about three months, continued to use my inhaler which is abnormal. As of present which is now nine months later I'm still using my inhaler multiple times a week.
Flu like symptoms, nausea, diarrhea, headache, body aches, fatigue. Today is the fourth day of these reactions.
VACCINE WAS GIVIG 1 WEEK BEFORE DUE DATE. CLINICAL STAFF DIDNT VERIFY ORDER WITH THE PROVIDER .
pt recvd vax & on 1DEC92 w/in seconds felt bad, exp a h/a & devel elevated BP; was sent to ER; 8 days later again presented to ER w/h/a; dx cerebral aneurysm requiring surgery;
Patient developed lower extremity swelling less then two weeks after the injection that was diagnosed as a DVT
Joint pain in lower back, lower extremities; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in lower back, lower extremities) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ARTHRALGIA (Joint pain in lower back, lower extremities). At the time of the report, ARTHRALGIA (Joint pain in lower back, lower extremities) outcome was unknown.            Concomitant medications and treatment information were not provided.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-083560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083560:Case for Plumbers cousin
Small bumps around circumference of upper left arm around where the site of injection (Hep A) was; member had similar response following H1N1 Injection in same arm in Jan 2010.
Reaction to vaccine. Ended up in hospital with pneumonia. Hospitalization lasted 5 days.
tested positive for Covid 19 virus; tested positive for Covid 19 virus; feeling under the weather/feel bad; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 as single dose, second dose via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient had received both doses of his Covid 19 vaccine, first dose was 30Mar2021, second dose was about one week ago on 20Apr2021. He was feeling a little under the weather when he received the second vaccine on 20Apr2021 but he had seasonal allergies so he thought that was what he was experiencing. His temperature was taken at the Covid 19 vaccine clinic and he was able to receive his second vaccine. He continued to feel bad and was tested for the Covid 19 virus. He got the results back today, 27Apr2021, and was positive for the Covid 19 virus. That means he had the Covid 19 virus when he received his second Covid 19 vaccine. He was asking what happens if he's already infected with the Covid 19 virus when he receives his Covid 19 vaccine? Is there a reason if he's asymptomatic with the Covid 19 virus and gets the Covid 19 vaccine, does it matter or does he have to get another Covid 19 vaccine? He started having side effects then decided to take a covid test on Sunday (25Apr2021) and positive. He wanted to know if he will have to take another covid vaccine since he tested positive after receiving his second covid vaccine. The outcome of the events was unknown.
Fever, ~100F; Chills; Body aches; Shortness of breath; Cough; Headache; Injection arm painful to lift; Pain in muscles of back; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8936) via an unspecified route of administration in the left arm on 21Apr2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 08:00, the patient experienced fever, about 100 Fahrenheit, chills, body aches, shortness of breath, cough, headache, injection arm painful to lift, and pain in muscles of back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, about 100 Fahrenheit, chills, body aches, shortness of breath, cough, headache, injection arm painful to lift and pain in muscles of back was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Given 10 mcg of Moderna Bivalent instead of recommended 25 mcg
Severe Flu symptoms, body aches by 5-21-2021 (Day 3). Went to ER on 5-21-2021 (day 6) with severe acute chest pain from the heart area
DOSE GIVEN TOO EARLY.  NO FURTHER ACTION REQUIRED. PATIENT/PARENT WAS SATISFIED WITH THIS EVENT.
Abnormal menstrual cycle; came 10 days early. This does not happen to me.
the patient also received a PNEUMOVAX23 (3.5 years ago).; This spontaneous report was received from a pharmacist referring to a 48-year-old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.  In April 2017 (reported as 3.5 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On 16-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (l dose, lot # T027110, expiration date 23-MAR-2022) (inappropriate schedule of product administration). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027110; expirationdate: 23-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
10/2 took shot, head started itching, pains in top head & ear.  10/25 broken out on head & ear pain-sharp, blisters.  12/5 still broken out on head & face.
PT was scheduled to receive the 2nd COVID vaccine at 1230 PM. Client presented to vaccination station and sat down with the vaccinator. Client disclosed to the vaccinator that after her first dose Pfizer vaccine (administered on 04/01/2021), she developed a localized rash on her forehead/ above her eyebrow. The vaccinator then called Nurse over for a consult. The client reported that the rash developed about 6 hours status post vaccine and lasted about 5 days. Rash was ?dry, patchy, itchy, and felt like dry skin, but was not raised.? Client has no known drug allergies or any other types of allergies and has no pertinent medical history. Client reported she has only had a gallbladder surgery back in 2014. Client also explained that she started a new face cream, ?Function of Body,? about 2 days prior to her first vaccination. She has continued to use it every other day and has had no problems or reactions since. Client did not consult with her primary care provider regarding the rash. After collecting all pertinent information, Nurse elevated the situation and consulted with the medical team. The medical team gave the okay to proceed with the second dose. At 1340, the second dose Pfizer vaccine was administered to the client (Pfizer, Lot #: EW0172, and expiration date: 08/2021) and Nurse educated the client that if a rash or additional symptoms developed, client should contact their primary care provider and report the effects on v- safe.