chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; aches; confusion; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the right arm on 12Mar2021 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously took acetylsalicylic acid (ASPIRIN) but had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine was administered in a public health clinic/veterans administration facility. On 14Mar2021, the patient had fever, aches and confusion. These events resulted in an emergency room/department or urgent care and hospitalization for 4 days (Mar2021). It was unknown if the patient received treatment. The patient has been tested for COVID-19 since vaccination, a nasal swab with the result of negative on 17Mar2021. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
malaise; About 24 hours p second dose- left axilla became tender and swollen.; Body aches started 9hrs after second dose; muscle aches; Within 12 hours had chills, rigors, fatigue and aches; Within 12 hours had chills, rigors, fatigue and aches; Within 12 hours had chills, rigors, fatigue and aches; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 19Jan2021 at 09:00 AM (age at vaccination was 43-years-old) as dose 2, single for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included reflux and paroxysmal a fib; both from an unknown date and unknown if ongoing. Known allergy to some adhesives. The patient's concomitant medications were not reported. No other vaccines administered within four weeks. No other medications the patient received within 2 weeks of vaccination. The patient previously took bnt162b2 (Lot Number: EK5730), via an unspecified route of administration, administered in arm left on 29Dec2020 at 12:00 PM as dose 1, single for covid-19 immunisation; zithromax and factive, both for an unspecified indication and experienced allergies. On 19Jan2021 at 06:00 PM, 9 hours after second dose, the patient experienced body aches. On the same day, within 12 hours, she had chills, rigors, fatigue and aches which later resolved within 36 hours on an unspecified date in 2021. On 20Jan2021, about 24 hours after second dose, the patient's left axilla became tender and swollen. Since the second injection, she had continued epiodes of fatigue, muscle aches, and chills. They tend to be cyclic and occur after any physical exertion. The cycle of fatigue and malaise last 4-5 days after exertion then slowly wane. This has been happening for the last 4 weeks. The events resulted in visit to doctor or other healthcare professional office/clinic visit. On 17Feb2021, the patient underwent rapid PCR covid test post vaccination with covid test type nasal swab: negative. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. Therapeutic measures were taken as a result of the events. Treatment included Prednisone 20 mg orally twice daily for five days starting from 10Feb2021. The outcome of the events body ache was unknown; events chills, rigors, fatigue, aches was recovered on an unspecified date in 2021; and other events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
dizzy; blurred vision; chills; aches; flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN (aches), INFLUENZA (flu symptoms), DIZZINESS (dizzy) and VISION BLURRED (blurred vision) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ROSUVASTATIN, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE), PANTOPRAZOLE, VITAMIN D [VITAMIN D NOS], MAGNESIUM and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), PAIN (aches) and INFLUENZA (flu symptoms). On 05-Mar-2021, the patient experienced DIZZINESS (dizzy) and VISION BLURRED (blurred vision). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Mar-2021, CHILLS (chills), PAIN (aches) and INFLUENZA (flu symptoms) had resolved. At the time of the report, DIZZINESS (dizzy) and VISION BLURRED (blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications metformin, crestor, lotrel, protonix, vitamin D, magnesium, Vitamin B 12
developed shortness of breath and rehospitalized for unstable angina requiring coronary artery bypass
body ache; arm pain; feeling like I could have the flu; felt sick the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Jan2021 (Lot number: E1123 or E11283) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: ILLNESS (non-serious) with onset 24Jan2021, outcome "unknown", described as "felt sick the next day"; PAIN (non-serious), outcome "unknown", described as "body ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feeling like I could have the flu". Therapeutic measures were not taken as a result of illness, pain, pain in extremity, influenza like illness.  Additional information:Causality: Consumer stated, "Yes.".Reporter seriousness for feeling like I had the flu; I could have the flu: Unspecified.Reporter seriousness for Arm pain: Unspecified.Reporter seriousness for body ache: Unspecified.LOT#: Consumer stated, "E11283 that is twice. For the first one is. I do not know it is E1123 or E11283."Expiration date: Consumer stated, "I do not know. Does it say on the card."Other Medication: Consumer stated, "Thyroid medication. Levothyroxine(Further not appropriately clarified hence not captured)."Laboratory Test: Consumer stated, "None.".Treatment for Adverse Event: Consumer stated, "None.".Consumer stated, "Okay are we done.I thought you wanted to hear what the side effects were. For the first shot 23Jan21 just sick the next day 'meaning' body ache, feeling like I had the flu, arm pain and the same with the second shot 13Feb21. You know just sick the next day and then sore arm, painful arm, nausea, body ache feeling like I could have the flu and then the other one 28Sep21 just felt sick the next day nausea, vomiting that is it."Consumer was unwilling to complete the report. Thus further probing could no be done. Hence limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Convulsion (seizure) diagnosed in hospital on 7/4-7/5 within 48-72 hours post vaccine.
Pressure in the head; Headache; Any change in the body elevation makes the headache worse; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a nurse and describes the occurrence of HEAD DISCOMFORT (Pressure in the head), HEADACHE (Headache) and HEADACHE (Any change in the body elevation makes the headache worse) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 011320A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetes.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEAD DISCOMFORT (Pressure in the head), HEADACHE (Headache) and HEADACHE (Any change in the body elevation makes the headache worse). At the time of the report, HEAD DISCOMFORT (Pressure in the head), HEADACHE (Headache) and HEADACHE (Any change in the body elevation makes the headache worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.Concomitant medication includes  pre diabetes medication
rash on her abdomen; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her abdomen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH (rash on her abdomen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, RASH (rash on her abdomen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported by the reporter.
Noticed light spotting; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E19769 and expiry date unknown) on 06Feb2021 15:30 at single dose via an unspecified route of administration into her left arm for COVID-19 immunization. There were relevant medical history and no concomitant medications. The patient had not had COVID prior to the vaccination, COVID not tested post the vaccination. The patient was not pregnant. She noticed light spotting on 07Feb2021 at 21:45. No seriousness criterion provided. No treatment was received. The outcome of event was unknown.
While in observation, patient felt flush w/ hot/cold sweats. Patient had not had any food yet so a snack was given with water. Patient taken to EMS room where he was laid supine and cold pack applied to forehead; vitals taken. 1158 patient ambulated without difficulty.
July 3, 2021 I woke with 102 degree temperature and then I was sick throughout the week and on Tuesday, July 6, 2021, I called sick for work and on Wednesday, July 7th, 2021 I went into work and got sent home and sent to the doctors. I was tested for COVID and the test results came back negative and I was later diagnosed with an upper respiratory infection. I was not prescribed any meds but he did tell me to take ibuprofen and drinks lots of fluids and get lots of rest. I started to feel better July 8, 2021 but I still had a slight sour throat on Friday July 9, 2021, and was able to return to work. I finally feel normal.
This spontaneous report was received from a licensed practical nurse (LPN) and refers to a patient of unknown age and gender. Information regarding the pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 11-AUG-2017, the patient was vaccinated with improperly stored PROQUAD, Lot # N008825 with expiry date 12-SEP-2018 (dose, route and anatomical location not reported), that was reconstituted with sterile diluent (DILUENT MRK INJ) for prophylaxis. No adverse effects were reported. The administered vaccine underwent a temperature excursion between -9 °Centigrade(C) to 8 °C for a time frame of 4 hours and 43 minutes. Previous temperature excursion was between -9 °C to 8 °C for 57 hours and 40 minutes and between -14 °C to -10 °C for 23 hours and 57 minutes. The call was not because of a data logger. No product quality compliant (PQC) was involved. The nurse stated that she decline to give patient specific data with this report. This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA010551: US-009507513-1708USA009081: US-009507513-1709USA012932:
Patient experienced tingling in the right leg after vaccination. This has expanded to all extremities and has lasted for months. Patient visited Primary Care Provider and completed lab work that returned unremarkable. She is now going to see a Neurologist for this issue.
Pt was given the DTap instead of the TDap. Pt tolerated well with no complaints or concerns.
Day after vaccination the patient woke with a rash, fever, cough and congestion. The patient was treated with Medrol PR. On 6/21/2001 the patient experienced shortness of breath and worsening of rash, fever, cough and congestion due to vaccine. The patient reported no relief from Medrol Pack.
After getting the new Moderna Covid bivalent booster, I had significant heart rate/blood pressure fluctuations requiring an emergency room visit and several medical tests. I have been diagnosed w/POTs like symptoms and now have to take propranolol twice daily.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 at 15:00 as dose 1, single (Lot number: EL9269), in left arm, on 06Aug2021 at 10:00 as dose 3 (booster), single (Lot number: EW0198) at the age of 78 years, in left arm and on 27Feb2021 at 15:00 as dose 2, single (Lot number: EN6200), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No other medication received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
a 6 month old child received the product QUADRACEL instead of PENTACEL with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient who received the product DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, (latency: same day) the patient a 6 month old child received the product quadracel instead of pentacel with no reported adverse event (wrong product administered).   It was reported, a 6 month old child received the product QUADRACEL instead of PENTACEL.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
COVID-19 infection; lack of vaccine efficacy confirmed through positive test; Sore throat; headache; fever; dizziness; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0162), in left arm and on 07May2021 as dose 2, single (Lot number: EW0179) at the age of 34 years, in left arm, all intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2021 as dose 3 (booster), single (Lot number: 070H21A) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 10Apr2022 at 19:00, outcome "recovering", described as "COVID-19 infection"; OROPHARYNGEAL PAIN (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering", described as "Sore throat"; DIZZINESS (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 10Apr2022 at 19:00, outcome "recovering", described as "lack of vaccine efficacy confirmed through positive test"; NAUSEA (non-serious) with onset 10Apr2022 at 19:00, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Nov2021) Negative, notes: Nasal Swab Binax now; (25Mar2022) Negative, notes: Nasal Swab Binax now; (12Apr2022) Positive, notes: Nasal Swab Siemens Clinitest,. Therapeutic measures were taken as a result of covid-19, vaccination failure, oropharyngeal pain, headache, pyrexia, dizziness, nausea.  Additional information:  He received Ibuprofen and rest treatment for adverse events. He did not receive covid prior vaccination. He had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He did not receive any other medications within 2 weeks of vaccination. He was not diagnosed with COVID-19 Prior to vaccination. The patient has been tested for COVID-19, after the vaccination.  No follow-up attempts are possible. No further information is expected.
Bell's Palsy with onset starting 12/28/2021. Left side of my face is paralyzed. Treatment so far has included a 7 day course of Prednisone and a 7 day course of Valacyclovir. No improvement, so far.
REDNESS SIZE OF BASEBALL, HOT TOTOUCH, PATIENT STATES VERY SWOLLEN THE DAY BEFORE BUT THAT SEEMS TO HAVE RESOLVED, INJECTION SITE MIDWAY DOWN ARM NOT IN DELTOID
edema, erythema, soreness @ DTP site 17JUN; resolved by 18JUN; 26JUN edema & erythema reoccurred w/worsened severity w/t101; soreness & rash appeared over DTP site also generalized rash appeared;
Patient states it hurt when I gave her the shot and she felt I gave the shot too high.  She had pain in the sight still 3-4 days later so she called her doctors office.  They told her to give it a week and if it did not get better to come in and be seen.  Patient reports it did get better before the week and she did not have to be seen by her doctor. Patient states she is not currently having any pain now.  Please note that vaccine was administered on 9/30/19 but patient just reported this to me today (11/13/19), this is the reason for the delay in reporting.
Strong body aches, possible fever. Considered going to urgent care but realized they wouldn't be able to really do anything . 12 hours later I still feel minor body aches, stiffness, fatigue, drowsy
Resident entered the Observation, with daughter at side and stated that patient is feeling dizzy, staff lowered patient to chair in sitting position, BP 122/81, P64, R24, O2 sats 94 on room air, resident became slightly unresponsive, BS 109, EMS here, O2 at 100% Endtidal NC, with O2 sats at 92%, HR 42, BP 90/48, P45, IV fluids NS in progress flowing via 20 guage, 911 call.  14:42- 911 here, patient assessed, BP 92/51, P60, R22 patient fully aroused, was taken to hospital at 14:52, family will follow to ER.
This is a follow-up to a previously submitted VAERS report. 7/17/14 1300 hr received MMR and VAR vaccines- "15-30 min later" exam: c/o heartburn, hives to forearms and shoulder, +wheezing bilaterally. Treated with IM BENADRYL and EPIPEN x1 with resolution of itching and heartburn. Wheezing resolved during transport to ER where he was given IV SOLUMEDROL, monitored and discharged with diagnosis of urticarial rash. F/U exam 7/18/2014 reported all symptoms resolved without reoccurrence, just tired on BENADRYL. Also on ZANTAC po. Pt was healthy for next two weeks when given YF vaccine and BICILLIN shot on 9/8/2014 at 1300 hr. At 1620 he returned to medical c/o itching to back and arms, itchy throat similar to reaction 2 weeks ago. Exam: erythema welts/hives on back and arms, flushed face, audible wheezing on exhalation to LUL and LLL. Given IM BENADRYL and EPIPEN x2 and again transferred to ER where admitted for 24 hours and released on 9/9/14. F/U exam 9/10 was normal and given consult to allergy clinic. 10/22/2014 given 2nd BICILLIN shot IM without reaction. Began school in January 2015. 1/13/2015 shot call given Hep A/B and influenza vaccine w/o reaction and referred to allergy clinic for evaluation of past MMR/YF reactions. Seen by allergy clinic on 1/30/2015 and referred to another clinic. He denied any new food groups, detergents, deodorants, clothing, insect stings, dogs, cats, environmental allergies or recent travel (other than relocation). He was not exercising day of vaccination. He reported history of shellfish, fish and tree nut allergy that was cleared by allergies prior to work (completed skin testing to tree nuts (negative) with food challenge to tree nuts, tuna and shrimp asymptomatic and well tolerated). He does east hard boiled egg and uses a powdered egg protein in his workout shakes with no issues. He did have eggs over-easy while in high school and had problems with headaches, feeling bad so he stopped. He did get quadrivalent influenza vaccine (FLUARIX vs FLULAVAL) this year with no adverse reaction reported.
Started with headache on Fri, 8/20. Got tested and tested positive. On Sun 8/22 started to show more symptoms of severe fatigue and nauseous and difficulty with breathing and diarrhea. . 8/25 did a regeneron treatment and after that developed a cough and loss of taste and smell.
Sick for a day and a half; Fever; Rigors in her legs; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (Sick for a day and a half), PYREXIA (Fever) and CHILLS (Rigors in her legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for a day and a half), PYREXIA (Fever) and CHILLS (Rigors in her legs). At the time of the report, ILLNESS (Sick for a day and a half), PYREXIA (Fever) and CHILLS (Rigors in her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's relevant concomitant medications weren't reported Treatment information was not provided