chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash-throat & chest; prickly sensation; slight wheeze cough; slight wheeze cough; Flu; fever; chills; diarrhea; weakness; dizzy; no appetite; tender beneath ears; tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6203, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 14:00 as dose number unknown, single for covid-19 immunisation at  Clinic. Medical history included asthma, allergies, high blood pressure, high cholesterol, overweight, migraines. Concomitant medications included hydrochlorothiazide, meloxicam, loratadine (lorat), metoprolol taken for an unspecified indication, start and stop date were not reported. The patient previously took valtrex, cortisone, prednisone, codeine, feldene, prilosec, femhrt, nasacort, statins, breo and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. On 11Mar2021 14:15, the patient experienced rash-throat & chest, prickly sensation, slight wheeze cough, flu, chills, diarrhea, weakness, dizzy, no appetite, tender beneath ears, fever, tiredness. All symptoms continued for 3 days. Afterwards, continued cough, low fever & tiredness. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab, rapid test): negative on 15Mar2021. The outcome for rash-throat & chest, prickly sensation, slight wheeze cough, flu, chills, diarrhea, weakness, dizzy, no appetite, tender beneath ears was recovering; for slight wheeze cough, fever, tiredness was not recovered.  No follow-up attempts are possible; No further information is expected.
Bilateral lymph node swelling and pain starting in armpit on 9/10/21 on vaccine side that continued to spread over the course of the week to breast; ribs; collar bone; neck; back/shoulder blades; ears; hips; groin; and extremities with calf pain/cramps; tinnitus in right ear; sore throat; and extreme fatigue. Above symptoms remained steady throughout the next week. At time of report- day 19- pain and/or swelling concentrated to opposite side groin; ears; throat; neck; and vaccine side arm, breast, armpit region. Fatigue continues.   Palliative care at home: tylenol, ibuprofen, Epsom salt baths, topical pain relief ointments, and compresses. Communication with PCP. Appointment scheduled at 2 weeks without relief.
A consumer report has been received. The report concerns a 15 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 22-Oct-2012. The patient experienced DRY COUGH which started on 22-Oct-2012. The outcome of the event of DRY COUGH is unknown. The report was considered to be non-serious.
17jul90 pt vax hepta B. 2-3 day aft vax pt devel malaise, fever (101 degF) and h/a.
PATIENT DESCRIBES ERYTHEMA TOPICAL REACTION MEASURING 3 X 4 INCHES, SWOLLEN, HOT, RED. PATIENT ALSO STATES SHE HAD DIZZINESS, HEADACHE, FATIGUE.
20 mins p/Td pt had syncope w/diaphoresis, BP 70/p; recovered p/DPH;
NO additional adverse etfect; was administered adose of expired VAQTA; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-MAR-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S001360, expiration date 06-MAR-2020, intramuscularly (dose was not reported) for prophylaxis. There was no adverse event reported.
Red and swollen arm.  Slight temp (99.7) and slept the following day ...unusual for me.
Dose administered after improper storage and handling (e.g., temperature excursion, more than allowed time after first vial puncture).
I mistaken pulled a vaccine from TWINRIX box, when should have pulled from KINRIX box. Vaccine administered to pt. No adverse reaction. Pt was given KINRIX before leaving clinic as mistake was discovered right after administration.
102 degree fever, heavy flu like symptoms.  4th covid vaccine, always followed by same, intense flu symptoms lasting 2 - 3 days.
Patient given vaccine, was 10 minutes into the waiting period, passed out of his chair, appeared to have a seizure.  Myself and the RN on duty giving vaccines provided first aid to make sure breathing, heartbeat, etc.   Kept airway open.   He came out of it in about 3-4 minutes and was coherent before the paramedics arrived (6-7 minutes) and was conversing with us and the paramedics.  They took him to the ambulance to be checked out.
Chills, unable to stop shaking, extreme headache, fatigue, mild nausea
This spontaneous report was received from a pharmacist and refers to a 15 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 29-FEB-2016, the patient who previously received two doss of MMR II, was inadvertently administered a third dose of MMR II (route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Severe puffy eyes, very dry red skin everywhere on face, followed by red dry patches on both arms near bend of elbow. Red rash on both arms. Then both legs very dry skin with red rash. Rash also appeared on chest and shoulders. First the rash started in the face and over time spread to limbs and chest. Very worried, so saw a dermatologist on the 15 of December. Doctor said she has treated many patients for these same symptoms post Covid vaccine.
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 19-NOV-2014, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-OCT-2015, the patient was treated by a health care provider for shingles. 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.
COVID-19; COVID-19; Horrible taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 at 16:15 as dose 4 (booster), single (Lot number: FM7553) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TASTE DISORDER (non-serious) with onset 12Jun2022 at 14:00, outcome "unknown", described as "Horrible taste in mouth"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other medication in 2 weeks. Patient had covid-19 treatment with Paxlovid with start date 11Jun2022 and stop date as 12Jun2022. Patient has horrible taste in mouth- it immediacy came back after brushing teeth, rinsing mouth or swallowing food.  Conclusion of Previously Completed Investigation: The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM7553. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
The customer , within 5-10 min post vaccination, felt light-headed, dizzy, and fell from the chair while was on a 15 minute waiting , seated on a chair post vaccination. A mild bruise seen on the forehead. As soon as, within few seconds,  pharmacist was notified. The customer immediately responded to pharmacist's questions. Did not call 911 due to his response and alertness. Epipen was ready but was not required.
Patient rec'd H1N1 vaccine approximately 10am on 11/14; developed itchy rash at 12-12:15pm same day. Pt. took 50 mg BENADRYL at 12:30pm. Pt. denied difficulty breathing or swallowing. Advised pt. to seek medical care if she developed worse symptoms. Hx of seasonal flu shot on 11/6/09 at grocery store given by a community vaccinator. Had splenectomy in 1955. 11/15/09 @ 2pm pt denies itchy rash, SOB or difficulty swallowing. Pt states she took 100mg of BENADRYL at hs on 11/14/09. Did not seek medical care.
3-22-16 PC from Pt: Pt began experiencing swelling and pain in (R) shoulder 3 days following TDaP vaccination.  Pain is not relieved with current pain medications. Instructed pt: to use cold compress and/or warm as comfort measure, check for fever and warmth at injection site, return to clinic for evaluations, report to PCP.
getting sick from covid19; diarrhea; body aches; chills; nausea; tiredness, fatigue; tested positive for COVID19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID19), DRUG INEFFECTIVE (lack of drug effect), ILLNESS (getting sick from covid19), DIARRHOEA (diarrhea) and MYALGIA (body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, the patient experienced COVID-19 (tested positive for COVID19) and DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced ILLNESS (getting sick from covid19), DIARRHOEA (diarrhea), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness, fatigue). The patient was treated with DEXAMETHASONE for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRATAB) for Adverse event, at an unspecified dose and frequency and BENZONATATE (TESSALON) for Cough, at an unspecified dose and frequency. On 16-Jan-2022, COVID-19 (tested positive for COVID19) had resolved. At the time of the report, DRUG INEFFECTIVE (lack of drug effect) and ILLNESS (getting sick from covid19) outcome was unknown and DIARRHOEA (diarrhea), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness, fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: positive (Positive) positive. On 16-Jan-2022, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medication was not provided.  Company Comment: This case concerns a 48-year-old female patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI), Drug ineffective, Illness, Diarrhea, Myalgia, Chills, Nausea and Fatigue. The events occurred approximately 7 months and 22 days after receiving the first dose of mRNA-1273 Vaccine.  The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a 48-year-old female patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI), Drug ineffective, Illness, Diarrhea, Myalgia, Chills, Nausea and Fatigue. The events occurred approximately 7 months and 22 days after receiving the first dose of mRNA-1273 Vaccine.  The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
terribly sick; fever; headache; body aches; could hardly move her limbs because it hurt so bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FK9495) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot number: ER8733), administration date: 29Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Rash", "metallic taste", "terribly sick", "Fever", "Headache", "body aches", "could hardly move her limbs because it hurt so bad"; BNT162b2 (Dose: 02, Lot number: EW0151), administration date: 19Apr2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "terribly sick", "Fever", "Headache", "body aches", "could hardly move her limbs because it hurt so bad"; BNT162b2 (DOSE: 03, Lot: FF2593), administration date: 13Nov2021, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "terribly sick", "Fever", "Headache", "body aches", "could hardly move her limbs because it hurt so bad". The following information was reported: PAIN (non-serious) with onset 21Apr2022, outcome "recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 21Apr2022, outcome "recovered", described as "could hardly move her limbs because it hurt so bad"; PYREXIA (non-serious) with onset 21Apr2022, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 21Apr2022, outcome "recovered"; ILLNESS (non-serious) with onset 21Apr2022, outcome "recovered", described as "terribly sick". The events "terribly sick", "fever", "headache", "body aches" and "could hardly move her limbs because it hurt so bad" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller reported after each of the doses, she was terribly sick for a week with fever, headache, body aches, and she could hardly move her limbs because it hurt so bad. She stated it was like the worst flue she had ever had. Caller stated she thinks she had Covid but when she had the test done it was negative. She didn't think it was correct and that was a really bad experience. She wasn't feeling well because she was sick, so she was in her PJs, because she didn't have to go in when she went and got a Covid Test done, so she just wore a long sweater over her PJs. Caller stated she drived that way all of the time and on the way home she got lost and ended up somewhere and she didn't know where she was at, she pulled in to a quick trip and asked how to get home. She stated when she pulled out of the quick trip, she didn't think she stopped to look for traffic before she pulled out of the parking lot and that scared her to death. She stated date is unknown, but it was in the Winter time, not last winter but the winter before, so 2020.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA 3/16/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
SYMPTOMS:    GENERAL Patient to clinic for evaluation of rash on chest and trunk as well as axilla b/l.  He states that the rash has been  increasing for 2 days and it is itchy.  No fever chills or night sweats noted.  No chest pain.  No other constitutional  sx noted.  Has had smallpox vax 15days prior.  He has taken benadryl for 2 days without relief.  No known new  soaps, detergents, etc.    PHYSICAL EXAM:    GENERAL generalized erythematous papular rash along trunk and chest as well as under both axilla. blanches with presure, not associated with follicles.  No signs of infection noted.  Smallpox  vax area clean and no  irritation around vax site noted.    DIAGNOSIS:    GENERAL/SYS. INFECTIONS     oOther Atopic Dermatitis - 691.8  DISPOSITION STATUS:    oReturn to Normal Duty   NURSING NOTE:    DISPOSITION NOTE: ditribution without association with vax site - possible atopic derm.  However, can have  vaccinia in other sites beside inoculation area (usually within days of vax).  reviewed litereature on smallpox vax  adverse rxns and will give supportive care (antihistamines, NSAIDs, etc and f/u). patient will f/u in 2 days Zantac 150mg po bid x 10d Zyrtec 10mg po qd X10d
According to mother who was sitting with client in waiting room, approximately 10 minutes after injections, client became pale and seemed "zoned out." She then started to get "flushed" and red blotches on her arms and abdomen.  Client denied shortness of breath or trouble swallowing.  Vital signs were stable. Nurse monitored client for approximately 30 more minutes.  After about 10 minutes post symptoms, blotches started to subside. Client complained of still feeling warm. Client stated she has not had anything to eat since lunch. Nurse discharged client after a total of 45 minutes in the clinic since vital signs were stable and she denied SOB, chest tightness, or difficulty swallowing. Mother informed of potential serious reactions and VIS was given at time of shots.
Developed dizziness and nausea soon after receiving injection. states watched someone else receive and "kind of freaked out for a second". Once snack and water provided, patient stated feeling better a few minutes arriving.
Body aches; Diarrhea; Fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Body aches), DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Allergy NOS (No known allergy).   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 28-May-2021, the patient experienced PAIN (Body aches), DIARRHOEA (Diarrhea) and PYREXIA (Fever). At the time of the report, PAIN (Body aches), DIARRHOEA (Diarrhea) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
02/04/10 - PNEUMOVAX given in (R) deltoid - C/o onset pain at site, weakness. Area very tender to touch - no redness noted - Swelling present.
Inappropriate age at vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 26-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had 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 medication and treatment information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Additional information was received from the initial reporter: Patient demography and dosage details were added. Upon follow up this case was upgraded to valid
He received the 1st dose of the vaccine on Friday 18DEC2020. He developed COVID the following Thursday.; He received the 1st dose of the vaccine on Friday 18DEC2020. He developed COVID the following Thursday.; This is a spontaneous report from a contactable Physician (patient's wife).   A 55-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) on 18Dec2020 at single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced developed Covid on 24Dec2020 (reported as the following Thursday). The patient underwent lab tests and procedures which included Sars-Cov-2 test: developed Covid. He was fairly symptomatic for 7 days but he was doing well now. The outcome of events was recovering. The reporter quereide whether he should receive the 2nd dose, which is due on 08Jan2021 or should it be deferred.  Information on Lot/Batch number requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported positive Sars-Cov-2 test, which is considered ineffective of BNT162B2, and the administration of BNT162B2.
Injection site is red and warm to the touch.  She felt feverish, SOB, lightheaded, nauseous.
Patient was 13 years old at the time of vaccination with pediatric Pfizer vaccine formulation. This was his first dose of the 2-dose series.
Patient stated she felt warm after getting the vaccine and demanded we called EMS. She did not faint or have any extreme acute symptoms that we could note. When EMS arrived they were familiar with the patient and brought her in to be checked on.
devel of hives all over body between 10-11PM 4OCT96;called ophthalmologist MD-rx for med given started 5OCT96;