chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity. 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 was not reported, 1 total, administered on 20-MAR-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported.  On 06-JAN-2022, the patient tested positive for Covid-19 via Polymerase chain reaction (PCR) test (confirmed clinical vaccination failure, and confirmed covid-19 infection) and he experienced a fever, cough and body aches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220139528. This report was associated with a product quality complaint: 90000213267.; Sender's Comments: V0:20220139639 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination 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.
a patient received a 0.25CC dose of Moderna Covid19 Vaccine as a first dose instead of a 0.5CC dose.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient received a 0.25CC dose of Moderna Covid19 Vaccine as a first dose instead of a 0.5CC dose.) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient received a 0.25CC dose of Moderna Covid19 Vaccine as a first dose instead of a 0.5CC dose.). On 18-Nov-2021, ACCIDENTAL UNDERDOSE (a patient received a 0.25CC dose of Moderna Covid19 Vaccine as a first dose instead of a 0.5CC dose.) 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.   No concomitant drug details were reported. No treatment details were reported.; Sender's Comments: Non-serious Case
On 10/9/99, post vax, pt experienced severe nausea and itching. Approximately 5 days later, the pt developed a varicella-like rash, consisting of approximately 12 lesions, over a 7 day period of time. Unspecified medical attention was sought. Additional information has been requested.
Didn't feel well @ 1130AM 23AUG, c/o h/a, took APAP fell asleep-OK; @ 7PM c/o chills, headache & stomach ache, t103 @ 930PM; Taken to Hosp ER t103 given APAP emesis x 1; felt better 26AUG91;
The vaccine given had a expiration of 3/18/22.  A stability report has been requested from Moderna.  The patient reports zero adverse events with the booster.
This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (flu-like symptoms), asthenia (weakness) and arthralgia (joint pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had influenza-like illness (flu-like symptoms), asthenia (weakness) and arthralgia). The patient treated with Tylenol (paracetamol), oral, at a dose of 500 milligram; two pills. At the time of the report, influenza-like illness (flu-like symptoms), asthenia (weakness) and arthralgia) outcome: unknown. No concomitant medication provided. Action taken with mRNA1273 Moderna vaccine: not applicable.
My arm was super red a little bit swollen and sore arm. It lasted for 4 days. After a month I got pneumonia I never had that before and because of the pneumonia my heart was weak.
Minor cold for about a week and a half. Then a fever started on 9-19-08. Doctor visit/urgent care the next day on 9-20-08, doctor found nothing wrong. Urgent care and ER on 9-21-09 after an episode of shaking and a higher fever. Vomiting at urgent care. IV was inserted at urgent care. Diarrhea started after IV. Ambulance to the ER. Extreme lethargy. Spinal tap. Doctors weren't sure what was wrong. A CT scan around midnight (Sunday night) didn't find anything wrong. Second CT scan on 9-22-08 found swelling on the brain. MRI later on 9-22-08 found a blood clot. Our daughter died on 9-23-08. We were told by two specialists that it was vaccine-related, but they wouldn't tell us more.
Nausea, vomiting, fever x 5 d began 2 hrs after vaccine.
Admission Date: 11/7/2022 Discharge Date: 11/9/2022 COVID positive date on 10/22/2022, recheck on 11/7/2022 and was COVID positive. Dr. Attending discharge note: PROCEDURES PERFORMED:   none HOSPITAL COURSE: A 27 y.o. G3P2002 female at 32w3d with Estimated Date of Delivery: 12/30/22 dated by 1st trimester ultrasound who presented to triage on 11/7 with generalized malaise, fever, muscle aches, and congestion. Her children were also feeling sick. On presentation she was also having and feeling painful contractions. There was no vaginal bleeding or loss of fluid.  She previously was diagnosed with COVID 19 two weeks prior. She completed 4 days of therapy with lovenox. Temperature was noted to be 38.8 C. Respiratory pathogen fil array was positive for influenza A. She was admitted for inpatient supportive treatment and continuous monitoring of contractions. She was started on Tamiflu 75 mg every 12 hours to complete for a total of 5 days. Cervical exam on admission was 0/30/-3. This remained unchanged and contractions resolved. FFN was negative. She did not required supplemental oxygen during stays and vital signs remained stable. She was discharge after hospital stay #2 and >24 hours without a fever in clinically stable condition. She has already received a COVID 19 booster and the flu vaccination during current pregnancy. She already has a follow up in our office scheduled for 11/11 and she plans to attend.   OB note from admission ASSESSMENT / PLAN: a 27 y.o. G3P2002 female at 32w3d who presents with: Principal Problem:   Influenza A virus present   Plan: 1. Influenza A  - Presented to OB triage for fever, body aches, congestion - symptoms started yesterday night - Positive on respiratory pathogen film array, negative for all other tested pathogens - previously COVID+ 2 weeks ago (10/21/22)   - Plan: - Admit to labor and delivery for continuous monitoring and supportive care - IV access - General diet - Tamiflu 75mg BID x 5 days    2. Preterm contractions - ctx q 4-5 minutes, palpate mild  - SVE 0/30/-3 - FFN negative    3. Fetal well being: - Continuous EFM              - Fetal status currently reassuring              - Baseline 130 bpm, moderate variability, + accels, no decels - 10/17: anterior placenta, cephalic presentation, EFW 1697g 91%, AC 89%, AFI 26.92cm - Polyhydramnios               - 10/31 AFI 28.27cm - NIPT low risk male  results: IMPRESSION:    The exam was limited to evaluation of AFI at 31w3d.  The AFI is c/w mild poly at 28.27 cm.  Patient sees, Certified Mid-Wife for Prenatal visits
I went 3 months without a period after having my second COVID-19 vaccine. I did have one between my first and second vaccine.  I also had a fever, chills and terrible tremors 12 hours after having my 2nd vaccine. I did not have any of these problems with the first. I had no symptoms or signs of my period for 3 months.
Intussusception. Pt had blood in stool & vomiting at 3AM. Pt came to office with blood in diaper after stool. Pt sent to hospital. Air contrast enema was given for reduction which was successful.  1/12/09 Reviewed hospital medical records of 11/11-11/12/2008. FINAL DX: Intussusception Records reveal patient experienced blood ini stool. Developed reduced oral intake & vomiting.  Admitted overnight for observation s/p enema reduction of IS.  Progressed well & d/c to home.
For about 4 hours, had chills, exhaustion, nausea, head ache, temperature of 99.8
Side effects began with mild shortness of breath, mild body aches chills and fever increasing in severeity throughout the day  lasting until midnight.
Developed headache, scalp tenderness, jaw claudication, elevated temp (101), feeling generally unwell.  Went to ER, was diagnosed with  Giant Cell Arteritis (autoimmune disease).
Lymphadenitis to axilla same side as injection, which has spread to  jaw, neck, chest, abdomen, and legs.; Lymph nodes are tender and enlarged; Lymph nodes are tender and enlarged; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 31Aug2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, rosacea, lymphedema, lipedema, allergy to gluten and soy. 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. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO), boswellia serrata (BOSWELLIA), curcuma longa (TURMERIC) and zingiber officinale (GINGER); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received minocycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 01Sep2021 at 07:00, the patient experienced lymphadenitis to axilla same side as injection, which had spread to the jaw, neck, chest, abdomen, and legs. The patient's lymph nodes were tender and enlarged but had no other complication. 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 lymphadenitis to axilla same side as injection, which has spread to the jaw, neck, chest, abdomen, legs, lymph nodes are tender and enlarged were resolving at the time of report.
soreness, redness, swelling @ inj  site, hard & raised in middle 3" diameter feels achy & terrible-flushed-stuffy nose;
night sweats; First dose on March 19, 2021, Second dose April 12, 2021; injection site arm soreness; chills; The patient has had 2 cases of Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), COVID-19 (The patient has had 2 cases of Covid-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on March 19, 2021, Second dose April 12, 2021), VACCINATION SITE PAIN (injection site arm soreness) and CHILLS (chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 037A21B and 031H21A) for COVID-19 prophylaxis.     Concomitant products included ROSUVASTATIN, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40), MELOXICAM and HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced COVID-19 (The patient has had 2 cases of Covid-19). On an unknown date, the patient experienced NIGHT SWEATS (night sweats), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on March 19, 2021, Second dose April 12, 2021), VACCINATION SITE PAIN (injection site arm soreness) and CHILLS (chills). At the time of the report, NIGHT SWEATS (night sweats), COVID-19 (The patient has had 2 cases of Covid-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on March 19, 2021, Second dose April 12, 2021), VACCINATION SITE PAIN (injection site arm soreness) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient receive other vaccines in the 4 weeks prior to COVID-19. No treatment medications were provided.    This case was linked to MOD-2023-705065 (Patient Link).
Received Pfizer vaccine for 2nd dose; Received Moderna vaccine for 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Moderna vaccine for 1st dose) and PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for 2nd dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Moderna vaccine for 1st dose). On 28-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for 2nd dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received Moderna vaccine for 1st dose) and PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for 2nd dose) outcome was unknown.        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.   Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.
Arm was indurated, tender, warm, not red, but he had swollen lymph node in his axilla.
This case was extracted from the VAERS database via QScan on 11 March 2009 (lot number 293359). A 33-year-old female patient received an intramuscular injection of FLUZONE SV2007-2008(reference U2498AA) on 11 October 2007. Following vaccination, she developed a sore throat, shortness of breath, wheezing, red blurry eyes, and low grade fever. She also experienced tingling and soreness at the injection site, which lasted approximately 20 minutes. The patient sought medical attention, and the events subsequently resolved.
stroke; heart attack; ringing in her ears; irregular heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Apr2021 09:00 (Batch/Lot Number: EW0172) as a single dose for COVID-19 immunisation. Medical history included asthma and autoimmune diseases. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergy to codeine. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination and the patient did not test for COVID post vaccination. The patient received the vaccine on 22Apr2021 at 09:00 and by 20:00 on 22Apr2021, the patient was already having symptoms the one that scared her was the ringing in her ears which lasted a good hour. She was afraid that it was going to be permanent and then she shattered having irregular heartbeat and she didn't know if she was going to have a heart attack or stroke as it was beating very slow. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 22Apr2021 20:00. The outcome of event, ringing in her ears, was recovered on an unspecified date and the outcome of events, irregular heartbeat, heart attack and stroke, was unknown.
Injection site soreness w/ widespread red, non-blistering rash from injection site to elbow lateral and proximal upper arm. No itch, no warm, no pain, no swelling.
Pt given vaccine 4/16/09 - Mother called with complaint of half dollar size of local swelling where shot given.  Told to ice ibuprofen or TYLENOL
pt received vaccine at 10:49 am, at 11:00 pt complained of dizziness and numbness to extremities. notable hyperventilation. pt denied: chest pain, throat swelling, difficulty swallowing, nausea. no visible swelling noted. B/P 126/79 HR 83 at 11:05. RN coached breathing and provided juice to pt which was tolerated well without choking. pt advised to stay on-site an additional 15 minutes. at 11:20 pt reported dizziness returning with new onset chest pain - 11:22 B/P 138/101 HR 116 O2 100% on RA. Adult dose Epi-Pen administered at 11:25. symptoms continued and EMS were called for additional evaluation. EKG normal- pt declined transport to hospital via EMS- EMS left at 11:50 after pt refusal form was signed. pt left clinic with spouse with ED precautions given.
COPD; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 04Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast Cancer", start date: 2019 (ongoing), notes: Spring 2019, Mastectomy, Cancer gone, in post cancer 5-year treatment; "Mastectomy" (unspecified if ongoing), notes: Mastectomy, Cancer gone, in post cancer 5-year treatment; "Weakened immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 2, Time: 10:00, Anatomical site of injection: Right Arm, Route of administration: Intramuscular), administration date: 04Feb2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "fatigue"; BNT162b2 (Dose: 1, Time: 10:00 AM , Anatomical site of injection: Right Arm, Route of administration: Intramuscular), administration date: 04Jan2021, when the patient was 75-year-old, for COVID-19 Immunization. The following information was reported: BRONCHITIS (non-serious) with onset 2021, outcome "not recovered"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "not recovered", described as "COPD". Therapeutic measures were taken as a result of chronic obstructive pulmonary disease, bronchitis. Additional information: Onset date of evet Bronchitis/COPD was Autumn 2021. The patient took anoro inhaler. Too many Relevant Test to recall would need 5 years Medical records and at least 5 typed pages.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
felt like the flu for 24 hours exactly 9am day after vaccine until 9am the following day muscle aches chills fatigue 2nd vaccine No side effects after 1st vaccine except sore at injection point.
low grade fever; Stomach cramps; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A contactable male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 31Mar2021 as single dose for COVID-19 immunization. Patients medical history and concomitant medications were not reported. It was reported that the patient and his wife both took the first dose on 31Mar2021 and scheduled for 2nd dose on 23Apr2021, which was more than 21 days. On an unknown date, patient and his wife, both experiencing low grade fever and stomach cramps. Patient asked if they need to take the 2nd dose today or not. The outcome of events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021470375 Different patient, same drug, same events
Pt reported local pain, redness, swelling at site.  Increased through out night and began feeling low grade fever.  Pt also had nausea, chills about 6 to 8 hours after vaccine with body aches.  Fine rash appeared on back about 9 - 10 hours later.  States arm remained red, swollen and painful.  Pt appeared ill and weak.  Left upper arm with a 7 cm induration diameter across injection site.  Rest of physician exam within normal limits.
My pain always goes away with the covid vaccine . I suffer from sciatic severe spinal stenosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sciatic severe spinal stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "My pain always goes away with the covid vaccine . I suffer from sciatic severe spinal stenosis".  Additional information: The patient wanted to know if there were people like them as their pain went away with the covid vaccine. They suffered from sciatic severe spinal stenosis.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse (R.N.) concerning a 11 year old male with no pertinent medical history and no allergies who on 18-May-1998 was vaccinated with a dose of VARIVAX (Oka/Merck). There was no concomitant medication. On 10-May-2008 the patient developed symptoms of shingles, left arm pain and a rash. The patient was seen by the physician on 15-May-2008 and the rash was cultured for varicella Zoster virus (VZV) by a polymerase chain reaction (PCR) test. The PCR test results returned with a positive diagnosis on 19-May-2008. No other symptoms were reported. At the time of the report, the patient was recovering from shingles. Follow-up information was received on 24-June-2008 from the R.N. concerning an 11 year old male student with no pre- existing allergies, birth defects or medical conditions who on 18-May-1998 was vaccinated in the right arm with a first dose of VARIVAX (Oka/Merck) (lot #625375/0065H). There was no illness at time of vaccination. On 08-May-2008 the patient developed left forearm pain and new rash on hand and lateral arm. The cluster scabbed vesicles with red base were on left thumb and lateral forearm following C-6 dermatome. The patient also developed body aches for a few days. He had no fever. On 15-May-2008 the patient went to office. A polymerase chain reaction (PCR) test was performed on 19-May-2008 and results revealed "Varicella Zoster confirmation". The patient recovered from the event. Additional information is not expected.
Death on 1/17/21.  Death certificate reports:  Septic Shock, UTI, Pneumonia, Chronic Renal Failure
Patient was given a "double dose" of Vaccine. Medication was not reconstituted correctly.