chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARM; RASH ON LEFT ARM AT ADMINISTRATION SITE (LEFT DELTOID)/3 OR 4 RASHES UNDER OR CLOSER TO THE ARMPIT (ABOUT 1-2 CENTIMETERS)/THE OTHER ONE BY INNER ELBOW/LIKE A MOSQUITO BITE THAT WELTS; HEADACHE; NAUSEA; BURNING; ITCHING; This spontaneous report received from a patient concerned a female of unspecified age. 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, intramuscular, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced burning. On JUN-2021, the subject experienced itching. On 05-JUN-2021, the subject experienced sore arm. On 05-JUN-2021, the subject experienced rash on left arm at administration site (left deltoid) /3 or 4 rashes under or closer to the armpit (about 1-2 centimeters) /the other one by inner elbow/like a mosquito bite that welts. On 05-JUN-2021, the subject experienced headache. On 05-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on left arm at administration site (left deltoid)/3 or 4 rashes under or closer to the armpit (about 1-2 centimeters)/the other one by inner elbow/like a mosquito bite that welts, itching, burning, headache, sore arm and nausea was not reported. This report was non-serious.
Uncontrollable shaking and chills set in 6.5 hours post injection. I was shivering and freezing. Then very severe body aches. Overnight- Fever 102.5. Migraine. The worst of it lasted about 15 hours in total.
Started to see a white spot on my neck; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 17:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo which stopped spreading long time back. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient started seeing white spot on his neck 4 days after vaccination and the patient reported that there was no change in his diet or medication prior to or after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of white spots on neck (vitiligo) was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Redness, warmth to left arm 3 1/2 inch x 3 inch. Given KEFLEX (250/g) 8ml PO TID x 10 days.
Left arm swollen 14 1/2 " in diameter after the injection. Arm also hot and feverish and sore. Right unaffected arm 13 1/2" in diameter.
Symptoms - tickle in throat, pressure in ears and jaw, difficulty breathing, heavy chest Treatment - used own epi pen in right thigh
Frequent heart palpitations. Presented at emergency department and diagnosed with atrial arrhythmia (frequent PACs). Discharged home for primary care follow-up. Current outcome is no change from presenting complaint. Follow-up scheduled for 1/7/2022 with primary care physician.
about 14 hours after the second dose I had gross hematuria for 48 hours it continued to show up in lab tests for 2 months following however in trace amounts.    Tested for kidney stones and one was found in the left kidney.  It may be the cause of hematuria but it is unknown.
Post vax, pt developed rash on trunk which was macular in appearance with few lesions on face.
Patient described red, blistering rash in the arms, waist and legs the following evening after receiving the vaccine.
cough; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer. A male patient (Husband) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose for covid-19 immunisation. He went to his family physician for a cough and was prescribed amoxicillin for a few days. 21Jan2021 he received the first dose Covid vaccine, wondering if he can start a prescription of amoxicillin right now. It was not confirmed if he had cough before getting Covid vaccine or not. Outcome of the event was unknown.  Information about lot/batch number has been requested.
atrial tachycardia/heart irregularities/extra beats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient in their 70's received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: ATRIAL TACHYCARDIA (medically significant) with onset Apr2023, outcome "unknown", described as "atrial tachycardia/heart irregularities/extra beats". The event "atrial tachycardia/heart irregularities/extra beats" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (2023) unknown results. Clinical course: The patient reported: "I received two of your COVID-19 vaccinations. I was 73 at the time. In Apr of this year (2023), I was in the ER at withheld for what turned out to be atrial tachycardia. I have since visited the ER a total of four times this year, all related to tachycardia. I have long since felt that this medical condition is related to the COVID vaccinations, as I have never had heart issues before and this came on with a bang in Apr. Finally, I was able to get a medical professional to admit that there is evidence that the vaccine has caused heart issues in many people, especially older people. I also read an 18 page report on the web by a panel of medical people who said they are seeing an alarming number of heart-related issues directly related to the COVID vaccine. I want you to know that my life is pretty much ruined. Prior to Apr, I was a fairly vibrant, very active "senior", who traveled the world and hiked and biked. Now I sit, take my blood pressure twice a day, and try to be comfortable with my heart irregularities and such hard extra beats that sometimes I swear it will either burst or bump me off a chair or out of bed. This is truly awful Someday, some dever attorney will file a class action lawsuit and, assuming I'm still alive, I will join.".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Patient had requested a Moderna Bivalent Booster and was mistakenly given a Novavax vaccine instead. Patient was notified of the mistake and told to contact the pharmacy if any adverse reactions begin. At the time of notification, patient had no adverse events. Will be in contact with her to monitor any ongoing issues.
Pfizer 2nd dose response. Fever, aches, headache, nausea, stabbing pains in muscles.
12-18 Hours after receiving injection size 2X2 inch in circumference pruritus, pain + Erythema Tx Benadryl + Cold compress.
Achiness 4 hours after injection, fatigue 16 hours after injection.  All seemed normal and expected from the vaccine.  But then, Digestive tract unsettled around 12:45pm, abdominal discomfort and gas 12:45pm - 1:30pm, multiple bowel movements 1:30 - 2:15pm, diarrhea 2:30 - 2:45pm.
The evening of the immunizations, patient described having arm pain, (more severe than the first shot), headache, joint aches, shaky feeling, couldnt get warm and couldnt sleep. The next day the symptoms persisted and she had no appetite.By the third day, she was feeling better, but the injection site pain and headache were still bothering her.
gave the liquid portion of the Pentacel without mixing it with the powder with no AE; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from the other health professional via phone at call center as Agency inquiry (reference number: 00316061).  This case involved a five month old male patient for whom it was reported that they gave the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing it with the powder with no adverse event (Wrong technique in product usage process).  It was an actual medication error due to wrong technique in product usage process.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Oct-2020, the patient received second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ227AAA, expiry date: 23-Apr-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was reported that only part was of Pentacel vaccine was administered and reporter was wanting to know more information regarding issues and what 2 parts (liquid/powder) contain. Further it was reported that they gave the liquid portion of the Pentacel and not the powder portion (Wrong technique in product usage process).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (Accelerated heartbeat) and DIZZINESS (Really dizzy feeling like passing out) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. Concomitant products included GARLIC [ALLIUM SATIVUM] for Blood pressure high, VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced HEART RATE INCREASED (Accelerated heartbeat) and DIZZINESS (Really dizzy feeling like passing out). At the time of the report, PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (Accelerated heartbeat) and DIZZINESS (Really dizzy feeling like passing out) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had some slight redness and then a rash that was about 5 inches around. The rash was right at the site of the injection. That went away in about 5 days. Then just about 3 weeks ago I got some numbness in the right side of my face, and I am still dealing with it today. The DR thinks it could possibly be due to a sinus infection, but it seems to be clear on CT Scan. The DR told me to follow up in a few weeks. The numb area is from my ear to my nose area on the right side. I also have some soreness in the right ear as well. I did take 10 days' worth of amoxicillin, that didn't seem to do anything though.
Patient received 1st dose on 2/24/21, then was hospitalized on 3/21/21 for NSTEMI. Patient received 2nd dose on 3/24/21, then was hospitalized on 3/27/21 for congestive heart failure. These visit is within 6 weeks of receiving covid vaccinations. Patient died on 01/07/2022.
New Medical Assistant in charge of monitoring vaccine storage unit temperatures. Freezer temperatures out of range for several days before recognized. Freezer malfunctioned. Five patients received nonviable vaccine: three (3) received vaccine on 04/28/16 and two (2) on 04/25/16.
Extreme fatigue, headache, diarrhea, no appetite, hand cramps, every joint ached, very weak, vomited blackish stuff, mouth full of white substance in the morning, had to wipe out with kleenex, both shoulders hurt for 4 days
Heart palpitations, shortness of breath, head ache, tingling in right hand, sore right arm
Treatment of COVID-19; Treatment of 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 female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jun2023 at 13:15 as dose number unknown, single (Lot number: GJ3268) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "thyroid condition" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Meclyzine, reaction(s): "known allergies: Meclizine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (Sep2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Aug2023 to 02Sep2023. Clinical course: Negative test result 2days after last Paxlovid dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296484 Same reporter/patient, different drug/AE.;
Shortly after receiving third dose of immunization, my daughter began to demostrate unusual psychological behavior.  Atmosphere of self-destructiveness and potential Bi-Polar elements came about.  As example, being in her senior year of highschool, she had scheduled several college visits and held a good deal of excitement about going to college for psychology or special education.   Within a short time of receiving this vaccine, her performance in school tanked, she stopped visiting schools and began alienating her friends.  In January she met a young man, got ingaged in 5 weeks, moved out 8 weeks later(still in school) and got married.  I realize this could appear as a parent looking for an excuse for a child's ill behavior but the dramatic change and lack of having any accountability for actions, still, is at an unnerving level.  Conversations with her still indicate no ability to understand impact of actions, behavior is completely reactionary.  I also want to add that this is not only something which her parents noted, but her guidance counselor, her teachers and even the support counselor.  On the last day of school the support counselor pulled me aside, knowing all that had changed overnight and said "There is something dramatically wrong with your daughter - her wiring has gone haywire, there's more to this than a child acting out".  Would like to know if there are any other reports of psychological issues on other patience
About 5 minutes after the immunization the patient started complaining of a headache and dizziness. No difficulty in breathing. After couple of minutes the symptoms did not subside and she asked us to call 911. The paramedics took her vitals and her blood pressure was normal and oxygen stats were fine. But the headache and dizziness did not resolve so the patient was taken to the hospital. I called the patient later and she was at home and doing much better.
Vaccine reaction upper right arm (DTAP).  (+) swollen right upper arm.  Warm to touch.  Local reaction to vaccine.
6-7 cm of redness, swelling, warm to touch at injection 2 days after inoculation to present. Treat w/warm compresses, Tylenol 325mg 1-2 tabs ever 4 PRN.
nurse w/no hx of eye infect on 20AUG97 accidentally splashed a small portion of varicella vax into eye;eye was flushed for 5-10min;pt exp eye irritation;
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included Pneumococcal Conjugate Vaccine 13.  It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  Documents held by sender: none.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypertension-Mild, Systemic: Nausea-Medium, Additional Details: The vaccine was administered at 0940, pt was instructed to wait 15 minutes. Pt reported feeling lightheaded, nauseous, and weak around 1010. RN had pt lay down on exam table and took vital signs. HR fluctuating from 60bpm - 80bpm, BP 144/84 and 154/86, O2 100%. Pt reported worsening lightheadedness and chills. RN informed NP. NP suggested a blood glucose check. Pt blood glucose was 84. NP evaluated pt, symptoms did not resolve. Ems was activated.
Increased tinnitus symptoms on day 3 following 2nd vaccine dose.  Humming in ears is much louder.
Left deltoid swollen and redden 05/30/02 pm. Client treated with warm moist cloth, alcohol and took Tylenol. 05/31/02 states "tender", 3mm approx size redness where vaccine given. No swelling noted at this time.
Soreness at injection site radiating to whole arm and shoulder. Body aches, fever, chills, mild SOB x2days thus far
Sore arm; slight fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 13:45 (Lot number: EL3247) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. Concomitant medication(s) included: WELLBUTRIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021 13:45, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset 03Mar2021 13:45, outcome "recovering", described as "slight fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional Information: The vaccine was given in a workplace clinic. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
After recieving the Covid 19 vaccine, my tinnitus is significantly worse than it was before. I also get random bouts of ringing in ears getting louder for no apparent reason, as if I had a loud sound go off in my ears. I was hoping it would get better, but it has not.
Strong headaches day after second shot, went away after ibuprofen at 10pm (on the day after the shot). Arm sore for a few days for both, nothing bad though, just felt like a bruise.
erythematous papular confluent rash w/blanching on palpation;rash began shortly p/vax;
COLD SWEAT; FATIGUE; FEVER; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 15-MAR-2021, the subject experienced cold sweat. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, cold sweat, and fever. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TAMOXIFEN and clindamycin                                                    as needed for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (extreme fatigue). At the time of the report, FATIGUE (extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.