chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since this vaccine I now have frequent painful mouth ulcers and tiredness. I seem to lose my breath more easily than before. I am afraid to get the second dose.  There is a study that COVID has these sores as a symptom - why are we not learning of this? Also, no one provided me with any information that would indicate the vaccine could create a problem if given while taking other medications. I have all of my paperwork from that first shot. Yet at this site there is a file full of possible adverse interactions.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number K003074 with expiration date of 13-MAR-2015 (route of administration and anatomical location were unknown). The sum of hours of the vaccine excursion was 424 hours and the lowest recorded temperature reported was 33 degrees F (0.555555556 Celsius degrees). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Diagnosed with a blot clot in the left leg lower below knee.; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21a) for COVID-19 vaccination.     Concomitant products included HYDROCODONE for an unknown indication.   On 22-Apr-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. On 13-May-2021, the patient experienced THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
patient being administered an expired dose of Tenivac with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves patient with unknown demographics who was being administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Sep-2023, the patient received a dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7183AA expiry date: 24-Sep-2023 via unknown route in unknown administration site for immunization.  On 25-SEP-2023 the patient being administered an expired dose of tenivac with no reported adverse event (expired product administered) on the same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient being administered an expired dose of tenivac with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reported rash, swelling, redness, and soreness all at injection site 2 days after receiving vaccination. Pt was counseled to take BENADRYL and Ibuprofen by mouth and apply a cold compress to the injection site. Her soreness improved the next day, but her redness and rash were still present. Pt was then counseled to continue the OTC treatment like before and if it didn't improve or got worse, she was to contact her PCP for medical treatment if needed.
COVID-19 pneumonia; COVID-19 pneumonia; The Rinvoq kept the patient from getting immunity from Covid vaccines; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4294615-00.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "recovering", DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19 pneumonia"; DRUG INTERACTION (non-serious), outcome "unknown", described as "The Rinvoq kept the patient from getting immunity from Covid vaccines". The patient was hospitalized for covid-19 pneumonia, drug ineffective (hospitalization duration: 11 day(s)). The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of covid-19 pneumonia.  Causality: COVID-19 pneumonia (COVID-19 pneumonia), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Reasonable possibility, Dechallenge: N/A   Causality: COVID-19 pneumonia (COVID-19 pneumonia), Action(s) taken with drug: Dose Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A  The reporter's assessment of the causal relationship of the (COVID-19 pneumonia and The Rinvoq kept the patient from getting immunity from Covid vaccines) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical course information: The patient's daughter reported that the Rinvoq kept the patient from getting immunity from Covid vaccines and that he was admitted to the hospital for 11 days due to Covid pneumonia. In 2022, he was on supplemental oxygen. Stated that she was fairly certain that the patient had been taking Rinvoq as of 25Feb2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and Drug Interaction.
broke out with a rash; muscle aches; joint ache; severe diarrhea with no stomach cramps; extremely tired; feeling horribly sick for 5 days; feeling lousy; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy), DIARRHOEA (severe diarrhea with no stomach cramps), FATIGUE (extremely tired) and MYALGIA (muscle aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TRIAMCINOLONE ACETONIDE cream for Rash.    Concurrent medical conditions included Dystonia (has limited use on her right arm.).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TRIAMCINOLONE ACETONIDE (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy) and FATIGUE (extremely tired). On 07-Feb-2021, the patient experienced DIARRHOEA (severe diarrhea with no stomach cramps), MYALGIA (muscle aches) and ARTHRALGIA (joint ache). On 08-Feb-2021, the patient experienced RASH (broke out with a rash). At the time of the report, ILLNESS (feeling horribly sick for 5 days), FEELING ABNORMAL (feeling lousy), FATIGUE (extremely tired), MYALGIA (muscle aches), ARTHRALGIA (joint ache) and RASH (broke out with a rash) outcome was unknown and DIARRHOEA (severe diarrhea with no stomach cramps) 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 relevant concomitant medications were reported.    Treatment included 2 Imodium (reported as Immodiums) (loperamide hydrochloride) to treat severe diarrhea.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-Jun-2021 contains No new Information- TCR is attached
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that patient developed Shingles after receiving first dose of Shingrix. The reporter consented to follow up.
The patient reported a rash developed on her abdomen, left breast and left shoulder the evening of 05/20/2021. By 06/09/2021, the rash covered more of her body including shins, calves, buttocks, right breast and shoulder. Her PCP prescribed triamcinolone cream and Zyrtec 10mg on 07/09/2021, but it has not been effective in treating the rash. He is now adding prednisone to the regimen in hopes of alleviating the itching associated with the rash. The patient reported the rash began as welts, then after being itched, developed into dry, scabby blisters.
Abnout 5 minutes after getting her vaccine she began to feel short of breath, tightness, and palpitation. In the ED, patient was given IM epi x 1, IV benadryl & solumedrol. Patient states that she felt better. Patient has had a similar allergic rxn in the past to shrimp, beta blockers and lisinopril (cough). Pt has never had to use epinephrine for her allergic reactions in the past. Patient has an epi-pen at home for her son (peanut allergy).
Shortness of breath; bradycardia; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the second dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EN6200), intramuscular in left arm on 24Feb2021 12:00 PM (received at the age of 89-years-old) at a single dose for COVID-19 immunization. The patient did not receive any other vaccines within the four weeks prior to receiving BNT162B2. Medical history included known COPD (chronic obstructive pulmonary disease), hypertensive heart, CKD 3 (chronic kidney disease stage 3), and history of breast cancer. The patient had no COVID prior to vaccination. He had no known allergies. Concomitant medications included multiple unspecified medications. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number: EL9265), intramuscular in left arm on 02Feb2021 at a single dose for COVID-19 immunization. It was reported that the patient developed shortness of breath (SOB) and bradycardia 3 days after vaccination, on 27Feb2021. 1 day after that, 28Feb2021, it worsened, and the patient was admitted with SOB and bradycardia. Has known COPD, not on any negative chronotropic medication. The patient was cleared after a day in the hospital. The reported adverse events resulted in an emergency room/department or urgent care visit and hospitalization. The patient was hospitalized for 2 days (28Feb2021 to 02Mar2021). As corrective treatment, the patient received oral steroid. The patient recovered from the events on an unspecified date. The patient underwent Covid test post vaccination: Nasal Swab on 28Feb2021 with result of negative.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
10 out of 10 pain/pain in every part of body from head to toe; lethargy; severe nausea; headache; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (10 out of 10 pain/pain in every part of body from head to toe), LETHARGY (lethargy), NAUSEA (severe nausea), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN (10 out of 10 pain/pain in every part of body from head to toe), LETHARGY (lethargy), NAUSEA (severe nausea) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 650 milligram. On 20-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN (10 out of 10 pain/pain in every part of body from head to toe), LETHARGY (lethargy), NAUSEA (severe nausea) and HEADACHE (headache) outcome was unknown.            No concomitants medications was reported.   This case was linked to MOD-2021-395725 (Patient Link).
pt recv vax OCT97 & 22JAN98 concurrent blood testing revealed elevated LFTs (ALT 38 & AST 60);blood test result for hep B was negative & for hep C was not yet available;
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out about 2 minutes after vaccine administration.  EMS was contacted and vitals were all normal as reported by EMS personnel.
Burping like crazy; A terrible headache; Became freezing cold; arm was sore; Had many body aches/Body aches and right side really hurts; My head feels like it is in a vice; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Became freezing cold), FEELING ABNORMAL (My head feels like it is in a vice), ERUCTATION (Burping like crazy), PAIN IN EXTREMITY (arm was sore) and MYALGIA (Had many body aches/Body aches and right side really hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder (only have one prescription and its thyroid).   On 19-May-2022 at 9:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced FEELING ABNORMAL (My head feels like it is in a vice). On 19-May-2022, the patient experienced MYALGIA (Had many body aches/Body aches and right side really hurts). On 19-May-2022 at 5:30 PM, the patient experienced PAIN IN EXTREMITY (arm was sore). On 19-May-2022 at 6:30 PM, the patient experienced FEELING COLD (Became freezing cold). On 20-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERUCTATION (Burping like crazy) and HEADACHE (A terrible headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FEELING COLD (Became freezing cold), FEELING ABNORMAL (My head feels like it is in a vice), ERUCTATION (Burping like crazy), PAIN IN EXTREMITY (arm was sore), MYALGIA (Had many body aches/Body aches and right side really hurts) and HEADACHE (A terrible headache) was resolving.     No concomitant medication was reported. It was reported that, patient had her second booster and unfortunately had the same problems. Patient went to bed at 9.00 PM. On 20-May-2022 she woke up still freezing cold, a terrible headache, she had been blessed her whole life with never having headache except when got the vaccines. Patient took Advil and there was a little improvement. Patient reported that she had only one prescription for thyroid. Patient reported that she did not have a lot of medical problems. Patient was normally fine. She was hoping that this did not last for 2 weeks again like it did after her last booster. Patient also stated that the temperature was 88 degrees outside so patient should not be cold at all. Normally patient was too warm so this was unusual.   This case was linked to MOD-2022-570128 (Patient Link).
administered Kinrix instead of Pentacel; 15 month old was administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: The health care professional reported that the patient was administered Kinrix instead of Pentacel. Additional Supportive Information: The 15 month old patient received Kinrix instead of Pentacel which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
devel "mumps" like illness; seen hosp ER; f/u visit this clinic 20APR94;
syringe malfunctioned and patient did not receive her full dose, and the amount the patient did receive is unclear; Pfizer was contacted and they recommended based on guidelines that the patient should receive another dose in the  opposite arm immediately, however the patient refused to get a second shot today
Headache, Fever, NauseaVomiting, Local symptoms: Pain-discomfort. General symptoms: Chills, fever, headaches, joint pains, muscle pains, fatigue, nausea Narrative:
Had convulsions and seizure. I have never experienced a convulsions since prescribed Gabapentin on 7/4/2014 and had never had a seizure until receiving the Moderna booster vaccination.
BLOOD CLOT IN FOOT; This spontaneous report was received from a patient via a company representative and concerned a male patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, two days after vaccination, the patient experienced a blood clot in his foot. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcome of blood clot in foot was not reported. This report was serious (other medically important condition).; Sender's Comments: V0:  This male of unspecified age and ethnicity reported to have experience blood clot in foot 2 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  No other information was reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 43-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 8737) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Unknown results; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
I experienced the sore arm and fatigue, and also chills and fever for a few days. Then I had nerve pain and diagnosed with autoimmune small fibro myopathy , and tachycardia which was treated in the ER.  Gastrointestinal issues and increase joint pain and myalgia. Headaches.
Breakthrough case admission after 3rd vaccine 1/6/21 Pfizer Lot# El0140 1/27/21 Pfizer Lot# EL3259 10/18/21 Pfizer FF2590