chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received via a company representative from a certified ophthalmic technician at a different office from the treating physician's office: refers to a 63 year old female patient with hypertension, elevated cholesterol, gastroesophageal reflux disease and insomnia. Patient's drug reactions/allergies included penicillin, codeine, CIPRO, amoxicillin, AUGMENTIN, KEFLEX, morphine and mold. On an unspecified date in 2010 the patient was vaccinated with subcutaneously with a standard dose of ZOSTAVAX (lot number, expiry date unspecified). Concomitant therapies included BENICOR 20 mg, PROTONIX, aspirin 81 mg and AMBIEN for insomnia. The patient developed dizziness and vertigo within 24 hours of vaccination with ZOSTAVAX in 2010. The symptoms lasted for approximately 24 hours after onset. The patient had not sought medical attention. No treatment was given. The outcome of vertigo and dizziness was reported as recovered/resolved. Additional information is not expected.
Brought to E.R. at 3:30 AM with hives and irritability.  No breathing difficulties.  Diffuse on trunk that improved while in ER 2-3 on back, 2-3 on legs, 2-3 on abd.  Benadryl offered but not used in ER.
I woke up the following morning with a headache but otherwise fine. I took some ibuprofen and received some relief but then began to have nausea and loss of appetite until about 6pm. Beginning around noon I had severe chills without fever and extreme fatigue. These lasted until about 9pm.
Pfizer- BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer- BioNTech vaccine on 1/17/2021, 2/2/2021, and 12/11/21. Presented to the ED via EMS following witnessed cardiac arrest.  Upon arrival CPR was initiated, and patient underwent 20 minutes of CPR prior to ROSC being achieved.  Patient was brought intubated, with 5.5 ET tube.  ET tube was then exchanged in the ED. During stay pt exhibited multiple episodes of clinical seizures and myoclonic jerking with no change in clinical or neuro status. MRI and SEEP was indicative of extensive anoxic injury.  Care was withdrawn and pt expired on 9/12/22. Pt treated with remdesivir, vancomycin, and cefepime.
Patient died within 72 hours of second dose. Extensive medical history including HTN, ESRD on dialysis and DM. Autopsy revealed cause of death to be Hypertensive and atherosclerotic cardiovascular disease with DM in part two. Vaccine didn't contribute to death.
Telephone Health Dept 5/6/03. Reports some minor discomfort in right and left arms 1-2 days after injections, but that she has had a "deep ache" in her left arm, unable to lay on left and hurts to move, especially to lift. Advised pt to contact private MD. Pt called Health Dept 5/12 informing that she had made an appointment, but had canceled as her arm was almost back to normal.
bad reaction after receiving the; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was recovering/resolving.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction after receiving the vaccination and resulted in hospitalization for 3 days. The details of the events are unknown. The follow up consent was not granted
Narrative: 69yo male with history of paroxysmal Afib, coronary arteriosclerosis s/p CABG, ischemic cardiomyopathy, HTN, GERD, and sleep apnea. Patient was administered covid vaccinations on 04/12/21 and 05/10/21. Patient died at an outside hospital and there is no information available about the patients death. Unable to assess if death was related to covid vaccinations.
Patient hospitalized after first dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Patient hospitalized after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient hospitalized after first dose) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Patient hospitalized after first dose) 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.   Nurse had the date and lot number for the first dose but the patient can't remember where they got the vaccine. Patient who was in the hospital and about to be given his second Moderna vaccine. No concomitant product was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Non-significant follow up; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the serious per hospitalization criterion unexpected event of vaccination complication. The event occurred on unknown day after the first dose of mRNA-1273 vaccine administration. The event was conservatively assessed as related to the product administration as the temporal association cannot be assessed. Very limited information available at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 24-MAY-2018, the patient was vaccinated with VARIVAX with lot # N030409 and expiration date 30-OCT-2019, subcutaneously for prophylaxis (dose not reported) and with PROQUAD recombinant Human albumin, with lot # N019249 with expiration date 20-DEC-2018, for prophylaxis (route and dose not reported) instead of M-M-R II. No adverse effects reported.
Pt was to receive COVID SARS-2 booster dose of 0.25 ml but instead received 0.50ml dose. Reports that arm was sore for a few days after. Denies any other issues
two shots 8 weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 047A21A)) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided. Vaccine information in narrative included Patient states his wife got two doses of Moderna COVID19 Vaccine 8 weeks apart: 28Jan2021 and 26Mar2021 (lot #047A21A). No further information provided. Consent for safety to contact was not obtained.   Reporter did not allow further contact
Pediatric (0.5 ml)dose / to a 33 year old / patient; Pediatric (0.5 ml)dose / to a 33 year old / patient / All doses / in / series was pediatric dose; Drug dose administration interval too short; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B pediatric with an associated reaction of product administered to patient of inappropriate age (1st dose received on 22nd December 2020, batch number-4CL44, expiry date-24th January 2022, refer case US2021AMR132394) and Engerix B pediatric with an associated reaction of product administered to patient of inappropriate age (2nd dose received on 02nd January 2021, batch number-4CL44, expiry date-24th January 2022, refer case US2021AMR132393).   On 8th June 2021, the patient received the 3rd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 8th June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too short 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 details were received as follows: The age at vaccination was not reported.  The 33 year old patient had received 0.5ml pediatric dose of Engerix B in the 3 dose series, which led to underdose and adult use of a child product. The patient received 3rd dose earlier than the recommended schedule, which led to shortening of vaccination schedule. All doses given in the series was pediatric doses. The reporter enquired to draw a titer or revaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR132393:Same reporter. US-GLAXOSMITHKLINE-US2021AMR132394:Same reporter.
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ, (dose, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Left arm NumbNess going from the forearm to the side of his Neck. Chills and slight HA. No fever Noted.
refrigerator malfunction Max/low temperature reached: 30.6 F for 2 hours 46 minutes with no reported adverse event; DAPTACEL was administered to a patient post temperature excursion after it was not suitable to use with no reported adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2022SA388282(CLUSTER) and 2022SA388426(CLUSTER).  This case involves 18 months old female patient who was administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] post temperature excursion after it was not suitable to use with no reported adverse event and refrigerator malfunction max/low temperature reached: 30.6 f for 2 hours 46 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 10-Aug-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml once (lot C583AA, expiry date: 11-May-2023) via intramuscular route in the left thigh for immunisation.  On an unknown date there was refrigerator malfunction max/low temperature reached: 30.6 f for 2 hours 46 minutes with no reported adverse event (product storage error) for diphtheria-15/tetanus/5 AC pertussis vaccine. On 10-Aug-2022 the patient was administered diphtheria-15/tetanus/5 AC pertussis vaccine post temperature excursion after it was not suitable to use with no reported adverse event (poor quality product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
1st.  Your neat system here would not let me go back to add: Not saying here they did anything wrong. 2nd.  Got Fluzone high dose in one arm and Pneumovax 23 in the other at the same time because they said I could do that.  Get flu shot yearly, no reactions.  So it's likely the Pneumovax 23.  Got the Pneumovax13 last year.  Do not recall any reaction.  This year from about two hours after the shot until the next morning, mid-morning, I felt sick.  For about 19 hours I felt dizzyish, a warm forehead, general malaise/fatigue, weakness, and some swelling in the right Pneumovax arm.  There was NO redness, muscle aches, fast heartbeat,  difficulty breathing.  I want you to know because we should be warned this may occur.  What if I had work the next day?  (Yes, I still work.)  Just tell them to tell us such a reaction MIGHT happen and we can set our schedules accordingly.
I experienced feelings of easily fatigued muscles in forearms within about 1 week of vaccine.  I have experienced ongoing periodic feelings of sharp needle-type sensations in lower legs.  Starting ~mid-June I have a pain in my right index finger between first and second joint, similar to as though a piece of glass is in my finger.  But when i push on it, i sense there is no foreign object in there.  I sometimes have experienced tingling in my right hand and up my right arm.  I have had intermittent slight headaches.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Patient tested positive for Covid-19 on 7/21/21 after being fully vaccinated for Covid-19 He was exposed to a family member who tested positive for Covid-19 on 7/17/21 on 7/18/21 patient developed cough.
began with sinus congestion and moved into general illness, achy, slight fever, etc. started on Thursday Am moved into Friday. Weekend was general malaise and managed through OTC cold medicines.
2/7/06-fine red rash on abdomen. Gave Benadryl. No other symptoms.
Employee reports onset of fever, chills, and joint pain after second dose of vaccine. Employee denies taking any over the counter medication. Side effects did not interfere with ADL's.
She tested positive for COVID-19 8/16/22. She started having symptoms on 8/13/22. She had a cough, fever, headache, body aches, and fatigue. They prescribed PRIVITUSS, medisolone, SMATIN, CEFTIL, NOTTEMON patch, and she took TYLENOL. She is doing much better, but still has a cough.
Pt received vaccine 5/17/11 - developed cellulitis 5/21/11 at site of injection & further down arm. Received ROCEPHIN & AUGMENTIN to treat in ED.
started feeling small symptoms of AFib sometimes/that on the next day he was definitely having the A fib symptoms; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EN6203), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 at 12:30 (at the age of 61-year-old) as dose 1 single dose for COVID-19 immunization. Medical history included ankylosing spondylitis, psoriasis and atrial fibrillation, corrected by ablation surgery in Jan2017 with no problem. The patient did not have allergies to medications, food, or other products. Concomitant medications (within 2 weeks of vaccination) included metoprolol 25 mg taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19 and since the vaccination, the patient had not been tested positive for Covid-19. It was reported that on 28Feb2021 the patient received first dose of vaccine and stated that on an unspecified date he started feeling small symptoms of atrial fibrillation sometimes. He stated that he received second dose on 21Mar2021 and after that on the next day he was definitely having the A fib symptoms again short breath just walking doing simplest little things and had rapid heartbeat again and mentioned that he had no problems before when took first dose of Pfizer vaccination. The patient did not receive treatment received for the event. The reporter provided seriousness of the event as non-serious. The patient was not recovered from the event.  Follow-up attempts are possible. Further information is expected.
PATIENT SAID HER LEFT ARM HURT THROUGHOUT THE WEEK. THEN, 1 WEEK AFTER RECEIVING SHOT, PATIENT WOKE UP WITH LARGE CIRCULAR RED RASH THAT WAS VERY PAINFUL, HOT, GROWING, AND RAISED.
Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis associated with mRNA COVID-19 vaccination. Radiology. 2021:211430     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: negative (Negative) Negative. In 2021, Magnetic resonance imaging heart: abnormal (abnormal) Late Gadolinium Enhancement (LGE): epicardial Left Ventricular (LV) inferior and anterolateral basal wall, epicardial and mid myocardial inferior wall mid ventricle and apical. T2w signal abnormality in corresponding locations as LGE. Pericardial enhancement, no effusion. Left Ventricular Ejection Fraction (LVEF): 54%, Right Ventricular Ejection Fraction (RVEF): 53%. Ipsilateral axillary lymphadenopathy. On an unknown date, Angiocardiogram: negative (Negative) Negative. On an unknown date, Electrocardiogram: abnormal (abnormal) Inferolateral T-wave inversion. On an unknown date, Troponin I: 12.19 ng/ml (abnormal) 12.19 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant medication was provided by the reporter  Patient was hospitalized due to acute onset of chest pain with diagnosis of acute myocarditis. Patient had received his second dose of mRNA-1273 vaccine 3 days before onset of chest pain and 5 days before onset of cardiac symptoms. Patient had following symptoms after vaccination subjective myalgias, malaise, nausea lightheadedness and chest pain. COVID-19 test was negative for 4 patients out of 5 patients.  No treatment medication information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-293220 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The day following the injection, I experienced mild pain/stiffness at the injection site. The second day after the vaccine, I began coughing. Since then, I've experienced chills, body aches, fatigue, increased coughing and diarrhea, as well as a low fever and a touch of laryngitis.
DID NOT FEEL WELL; FEVER; This spontaneous report received from a consumer concerned a male 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, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced did not feel well. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and did not feel well was not reported. This report was non-serious.
Sedation, Myalgia, NauseaVomiting, HOT FLASHES Narrative: VACCINE WAS NOT GIVEN AT FACILITY
PATIENT BROKE OUT WITH SHINGLES LESIONS ON HANDS, ARMS, LEGS.