chrisvoncsefalvay/vaers-outcomes huggingface dataset:
malaise, generalized muscle aches, temperature 100.2 F awoke on 04/09 (the day after injection) with the above symptoms; symptoms resolved approximately 08:30 pm the same day; temperature at 10:00 pm was 96.7 F injection site became reddened, firm, elevated, and hot to the touch starting about 02:00 pm on 04/08 (the date of injection) and remains the same as of 12:40 pm on 04/10.
2 hours after vaccine, complained of throat starting to swell while at physician's office.   Was taken to ER and given Benadryl and Streoids. Observed for 4 hours after
headache diarrhea of 3+ weeks duration treated with imodium, ibuprofen  and bland diet
headache; Fatigue; Fever 101; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 27Apr2021 at 18:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 18:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021, the patient experienced headache, fatigue and fever 101. On the same day, the patient underwent body temperature test and the result was 101 (unspecified units). On 03May2021, the patient underwent PCR test (nasal swab) and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events headache, fatigue and fever 101 was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
blood clot at the top/tip of his heart; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (patient had heart attack at age 40.), Bypass surgery in 1993 and Defibrillator/pacemaker insertion in 2006. Concurrent medical conditions included Heart disease aggravated. Concomitant products included METOPROLOL TARTRATE (METOPROLOL CT), HYDROCHLOROTHIAZIDE, PANTOPRAZOLE, ESCITALOPRAM, RANOLAZINE (RANEXA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CLOPIDOGREL, SIMVASTATIN (SIMVASTATIN AL), TAMSULOSIN HYDROCHLORIDE, TOLTERODINE L-TARTRATE (TAMSULIN T), TRAZODONE HYDROCHLORIDE (TRAZODONE FOCUS), FINASTERIDE and LOSARTAN POTASSIUM (LOSARTAN "AGP") for an unknown indication, ISOSORBIDE MONONITRATE (ISOSORBIDE AN).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) (seriousness criterion medically significant). The patient was treated with WARFARIN ongoing from 30-Jul-2021 for Adverse event, at a dose of 5 mg once a day. At the time of the report, INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Echocardiogram: abnormal (abnormal) 29Jul2021, husband received a call from his cardiologist, who said that a blood clot at the top/tip of his heart.         Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Heart attack , Bypass surgery  and Defibrillator/pacemaker insertion, Heart disease aggravated could be a contributory factor.   This case was linked to MOD-2021-280866 (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 events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Heart attack , Bypass surgery  and Defibrillator/pacemaker insertion, Heart disease aggravated could be a contributory factor.
Intermittent hives over entire body from 9SEP89 to 20SEP89; Local rxn (1) (HIB) redness & swelling 1 1/2 in by 1 1/2 in;
The morning after the vaccine, my right eye twitched every 10 seconds all day and night. The following day it slowly stopped.  I was sick with a fever and flu-like symptoms for over 24 hours. Two days after the vaccine I experienced pain in my chest that now three days later has reduced to a dull pain.  The most alarming adverse reaction is numbness and temporary paralysis in my right leg. It starts in my foot and travels up to mid-thigh and I cannot move any part of the leg or my toes. I equate it to when I have had IV fluids and can feel the fluids travel up my arm - that is how the numbness quickly travels up my leg. It lasts 5-40 minutes. It feels like my foot and leg are swelling significantly, but there is no swelling. I have not sought treatment because online it says numbness in the extremities is a side effect. This does not seem right or acceptable. I EXPECT A RESPONSE FROM HHS. This should not happen and I need an explanation and some guidance.
Pt states he received first shingrix vaccine last fall without incident. Upon returning for his second vaccine on June 8th he immediately/next day had a 'nasty' case of the shingles. He was informed by his doctor that the pharmacy had given him a live vaccine causing a severe case of shingles and that the pharmacy and/or manufacturer should be help responsible for him developing a severe 2month shingles outbreak.
January 21st I had covid following my first dose of my vaccine on January 12, My 2nd vaccine was February 10 th and in April 2021, I donated blood and the results of that blood said I had warm autoantibodies and I can no longer donate blood. I saw my primary and I also now have mild anemia and am seeing a hematologist to see if I have any further changes.
Chills, fever 102.2F and whole body ache. took Tylenol. Symptoms went away within 3 days. Day 5, started to notice rashes on face similar to allergic reactions. Rashes has not gone away on day 8.
FEVER; This spontaneous report received from a patient via a company representative concerned a 24 year old male. 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) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Pain from injection site to fingers, large swollen area at injection site, very painful, very red, very hot to the touch.  Took over the counter pain medication in the evening.  Next day - still swollen, red, hot.  Only painful when touched unlike yesterday where my entire arm ached/was in pain
Information has been received from a pharmacist concerning a 69 year old female patient who on 11-MAR-2009 was vaccinated SQ with 0.65 mL of ZOSTAVAX (Oka/Merck) (lot # 663175/1553X). On 13-MAR-2009 the patient experienced shingles. The patient's shingles outbreak included eye involvement. On an unspecified date the patient recovered. The patient was seen at the practice. Follow up information received from the physician's office indicated that she was a 69 year old female patient (weight 159.4 lb) with no illness at time of vaccination who on approximately 15-MAR-2009, "4 days after vaccination" developed shingles on the fifth cranial nerve with eye involvement, and then on an unspecified date experienced encephalitis. On an unspecified date she was hospitalized for 7 days. At the time of the report, the patient had improved. Shingles on the fifth cranial nerve with eye involvement and encephalitis were considered to be disabling. Additional information has been requested.
Background:  Even though I am 75, I am in excellent health.  I was riding 17 miles per day via bicycle at 15-17 mph without any stress or negative feelings. On June 1, the day before receiving the shot, I rode my normal 17 miles with no problems.  On June 2, I had my scheduled teleconference annual exam.  I presented with NO problems, pain, or distress of any kind.  At the conclusion of the exam, which went well, I was given the Zoster Shingles shot.  I was told I would experience flu-like symptoms for a day or so.  Eight hours after receiving the shot I did experience mild flu-like symptoms.  All seemed well after 24 hours, so I went out for my normal 17 mile ride.  I made it about 50 ft. up a small incline from my house and became so out of breath I could not continue.  I had never experienced anything like this in my life!  I was near panic while I gasped for breath for several minutes before getting my breath.  After cycling for 19 years and now being faced with inability to continue and profuse sweating even while at rest, (this situation remained essentially unchanged until 06/16/2019) I went to the emergency room.  I was seen by MD; other staff; and other staff.  I received a chest xray, had blood drawn, and an EKG.  On 06/17/2019 I was examined in the Pulmonary Clinic with a battery of tests.  As far as I was told, nothing was found, I can no longer do any activity without becoming out of breath!  So, I am convinced that something in the Zoster shot caused this adverse reaction because the preceding day I was fine and a day later I encountered the reaction.
Patient developed Shingles on head, face, and in eye.  Symptoms started 12 days after vaccine.
Patient reports pain at injection site at the time of vaccination and since.  She reports pain has worsened since the vaccination date where she has difficulty using her left arm and experiences discomfort and pain when lifting the arm. She describes the pain to be at 10 on the pain scale of 10.  She has been icing the area and taking ibuprofen and acetaminophen for pain relief.  She has not seeked medical attention as of yet but intends to.  She reports there was slight bruising at the injection site which is no longer visible.
23JUL92 itching, no rash, t98.4 (states nl is 97.3) & lethargy continuing through 31JUL92; also c/o burning, watery eyes x 1 on 26JUL92; used cortizone cream topically for pruritus;
This case was reported by a consumer via call center representative and described the occurrence of lightheadedness in a 64-year-old patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received the 1st dose of SHINGRIX. On 18th March 2019, 2 days after receiving SHINGRIX, the patient experienced lightheadedness, pale skin, coldness of skin and injection site pain. On 18th March 2019, the outcome of the lightheadedness, pale skin and coldness of skin were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the lightheadedness, pale skin, coldness of skin and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was received via chat. The patient received the dose of the SHINGRIX vaccine in the left arm. In the morning of the date of reporting, the patient while sitting at the breakfast table her husband noticed that she was pale and cold to touch. The patient reported injection site pain of her left arm. The lightheadedness had resolved and it only lasted a minute. The cold to touch and pale skin had resolved. The left arm injection site pain has not resolved. The patient gave permission to contact her physician regarding these events.
Information has been received from a registered nurse concerning a 17 year old female who on an unspecified date was vaccinated with the first dose of Gardasil. Subsequently the patient developed a very slight case of hives. On an unspecified date, the patient was vaccinated with the second dose of Gardasil and subsequently developed hives all over her body. It was reported that the first case of hives was not as bad as the one after her second dose of the vaccine. Unspecified medical attention was sought. The physician decided to administer the third dose of the vaccine. At the time of this report, the outcome of the hives was unknown. Additional information has been requested.
Hospitalized abdominal pain, possible early appendicitis, sore throat, fever, chills, and voice changes and positive COVID and positive C difficile, also COVID positive in October prior to completion of vaccine series.
Fatigue, syncope sensation, Arm pain - scale 10, arm swelling, fingers numbness, tingling, and swelling. Nausea. GI - Diarrhea. Swollen Lymph nodes, chills, fever, no appetite.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (lot number J012520 and expiration date 30-JAN-2016; lot number reported as K009505 and expiration date 07-FEB-2016; lot number K006366 and expiration date 24-OCT-2016) dose, frequency and route of administration were not provided, which, on an unknown date, underwent a temperature excursion. No adverse effects were experienced by any of the patients. Additional information has been requested.
(L) eye neuroretinitis with visual loss. Progressed gray 10/17, black 10/27/08. Slight improvement 11/24/08 after steroids.
Patient reported arms and legs hurt, body hurts to touch, fever, congestion, and trouble breathing, he could get his breath but his muscles hurt when he breathed in,  informed patient to seek medical care by either going to urgent care or to the ER whichever one the patient thought they needed to go.  Patient said they were going to go seek medical care.  I thought the patient should be checked out due to him reporting breathing problems
Patient was hospitalized with lower extremity DVT and bilateral pulmonary emboli. He is young and previously very healthy and has no risk factors for venous thromboembolism.
Information has been received from a physician concerning a 6 year old male who was vaccinated with a dose of varicella virus vaccine live.  Subsequently the patient developed varicella wildtype breakthrough.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The patient's sister and uncle also developed adverse events after vaccination with varicella virus vaccine live.  Additional information has been requested.
RN erroneously gave Hep A dose after patient had already completed 2 dose series
Pfizer COVID-19 Vaccination Lot # ER8730, Exp: 07/31/21  (Diluent Lot # 6020334, Exp: 11/30/22) given in left Deltoid at 1835, patient observed for 15 minutes then left with wife.  Patient called back at 1905, stating that his left hand was swelling up and he was feeling a bit lightheaded.  NP returned call at 19:15, and patient was instructed to have his wife drive him to the ER.  NP called ER to give report to attending/charge nurse.  While NP was still on hold, patient arrived in ER- charge nurse stated that patient was already being seen by a provider when report was given.
This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Feel tired), NAUSEA (Nauseated) and PYREXIA (Temp 99.1) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced FATIGUE (Feel tired), NAUSEA (Nauseated) and PYREXIA (Temp 99.1). At the time of the report, FATIGUE (Feel tired), NAUSEA (Nauseated) and PYREXIA (Temp 99.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 99.1 (High) Temp 99.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 73-year-old female patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Approximately 25 1/2 hrs after vaccine administration, pt noticed itching to back. Subsequently broke out in hive-like rash all over body. Today (8/10/07) rash is still very visible, red, raised - to entire body. Seen in Urgent Care facility 8/9/07 and given medication to help with itching. Also c/o of pain and swelling to hands and feet.
Technician injected adjuvant suspension only for Arexvy vaccine. Patient received correct dose again on the same day. Did not experience redness or painful arms on vaccine arm.
1-1 1/2 hours post vax, the pt experienced lightheadedness and sweating. She was informed that she needed to see her physician.
HTN s/p Moderna Vax, frontal HA approx 5 hours prior.
chest pain that went around to my upper back also; chest pain that went around to my upper back also; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, expiration date: not reported), via an unspecified route of administration, administered in arm right on 06Feb2021 09:00 (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. Medical history included heart attack in 2019 and 5 stents put in, known allergies (unspecified), known allergies: yes. Historical vaccine patient received included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL2283, expiration date: not reported), via an unspecified route of administration, administered in arm right on 13Jan2021 08:00 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. Concomitant medications were not reported. other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. On 08Feb2021 08:00, the patient experienced 'chest pain that went around to my upper back also'. The patient underwent lab tests and procedures which included bloodwork, chest x-ray, electrocardiogram (EKG) and ultrasound scan, all with unknown results in 2021. Chest pain that went around to my upper back also lead to emergency room/department or urgent care. Unspecified treatment was given for chest pain that went around to her upper back also. The outcome for both events was resolved in 2021.   No follow-up attempts are possible. No further information is expected.
Pt received PNEUMOVAX on 8/31/09. Noted on the evening of the injection, sensitivity and very painful, very reddened. Using ice right deltoid. Pt has R A. Noted right elbow painful. Complaining of chest and back achiness with shortness of breath, noted on Tuesday. 9/2/09 redness, swelling and pain subsiding.
Vesicular rash, pruritis, erythema, purulence, skin lesion, blister.
Right deltoid got very swollen, sore and hot. Patient got BENADRYL and cold compresses. Patient  improved, no more swelling or redness after taking BENADRYL.
After the injection I started to have itching and then as time progressed I had a lot of pain and swelling.  Today 6/20/2016 I have much more swelling and and pain down to my elbow.
I got the chills, nausea and was very tired. I went to bed and woke up with a fever higher than 104. I was extremely sick. I had tightness in my chest and the worst headache. I felt like I should have gone to the hospital. Even after Advil and Tylenol, I had a 102 temperature. I am still weak, tired and nauseous, but my fever is gone. It?s been 33 hours and I?m just beginning to feel better!
Patient is a 39 y.o. female presenting to ED with itchy tongue and throat which occurred 1 hour after second dose of COVID-19 patient received vaccination this morning.  Patient states symptoms started an hour and a half after vaccine administration.  Patient denies rash or swelling.  Patient received 50 mg of Benadryl for presentation. Patient will be discharged and instructed to follow up with primary care doctor in 1-2 days and return to the ED if symptoms worsen. Symptoms believed to be from allergic reaction, nausea. Pt received atarax, pepcid, zofran, decadron.. Patient will be discharged with atarax, epipen. Pt has no oral swelling on repeat exam.. Patient understands and agrees with plan.
Janssen COVID-19 Vaccine EUA  Vaccine was inadvertently given to unauthorized age group (ages 12-17). Patient Guardian was notified of error once realized. No ADR at time of Vaccine.