chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's face became flush almost immediately after 1st dose of Moderna at 9:27 am.. Vaccinating Nurse called charge nurse to vaccinnation table as patient was holding hands to her throat complaining of shortness of breath. Charge nurse & nurse spoke with the patient to gather her symptoms. Patient was  purple in the face and red in the chest area and said she felt warm. EMS was called. Nurse had epinephrine ready to administer but did not administer as the patient started to speak more calmly and after a few minutes was able to walk steadily to observation area and vitals were taken: B/P: 167/98, HR: 114, Temp.: 98.4, Resp.: 16, O2: 95%. Patient was able to walk outside to get fresh air with Nurse and 5 ml of liquid diphenhydramine was given at 9:35 am. Patient did not show further signs of distress. EMS arrived on site at 9:40, spoke with the patient about current symptoms and vitals were taken B/P: 125/81 HR: 110 No change in temp. or respirations. O2: 98%. Patient decided to go home with mother and signed release of liability with EMS.
Enlarged lymph nodes on left side of neck, clavicle and underarm; Red skin; Feeling very fatigue; Chills; Not feeling well at all; Cannot sleep; Heart rate is elevated; Feel dizzy at times; Headache; Nausea; Haven't been able to eat at all; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 18Sep2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergies to mussels and various face and body creams. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Sep2021 at 16:00, about 4 hours after the vaccination, the patient experienced headache and nausea. The patient still had both the events even 40 hours later. Since an unspecified date in Sep2021, the patient had not been able to eat at all. It was reported that since the night of 19Sep2021 (last night), the patient started to notice many enlarged lymph nodes on the left side of her neck, clavicle and underarm which was in the size of a walnut with red skin on top of them. The patient was feeling very fatigued, was having chills and was not feeling well at all and could not sleep. Also, on the same day, her heart rate was elevated and she felt dizzy at times. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, haven't been able to eat at all, enlarged lymph nodes on the left side of the neck, clavicle and underarm, red skin, feeling very fatigue, chills, not feeling well at all, cannot sleep, heart rate is elevated and feel dizzy at times was not resolved at the time of the report.
Case number PHEH2014US021829, is an initial spontaneous report from a nurse received on 28 Oct 2014. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient received MENVEO (batch number: A14031) subcutaneous injection inadvertently on 17 Oct 2014. No adverse event was reported. No further information was provided.
Patient reported that down on his gowning area is white... with white spots on his thighs... has not cleared.. spots are getting whiter
This spontaneous report was received from a nurse (physician's nurse) via company representative refers to an 11 year old male patient. The patient's pertinent medical history and concurrent condition were not reported. The patient had no concomitant medications. On an unknown date in August 2018 (reported as "last week"), the patient was vaccinated with GARDASIL 9, 0.5 ml once intramuscularly (strength, lot # and expiry date were not reported) to prevent HPV. Other suspect therapies included MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. On an unknown date in August 2018 (reported as "last week"), the patient was given GARDASIL 9 and broke out in a rash on his neck and arms while still in the physician's office. The patient was administered diphenhydramine (BENADRYL) but the rash had begun to recede prior to the diphenhydramine (BENADRYL) being administered. The patient recovered while still at the office and therefore did not seek medical attention. The lab diagnostics/studies was not performed. The outcome of rash was reported as recovered/resolved. The causality assessment was not reported. There was no product quality complaint (PQC) reported.
3 cm x 2.5 cm induration with minimal erythema advised to apply ice.
pediatric patient received FluZone High Dose rather than standard FluZone QIV .5ml dose, no AE; pediatric patient received FluZone High Dose rather than standard FluZone QIV .5ml dose, no AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves pediatric patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date not reported) and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (0.5 ml, lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination in September. (PT: wrong product administered, overdose).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered and overdose (Same day latency).They reported error was made due to product (syringes and box) looking very similar.  No adverse event reported at the time of reporting.  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 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.  There will be no information on the batch number for this case.
The day after receiving the second dose, pt became so weak that she couldn?t get out of bed.  Also complained of chest pain (has CAD with angina).
Pt c/o of lightheadedness during his observation. He initially did not want to come to the triage area as he verbalized that he gets lightheadedness occasionally. Pt mentioned that he had a hx of passing out in the past when he was in hs. No C/P, SOB, DIB, N/V, speaks in full sentences, mentating well. NP, monitored pt. VS stable; BP 119/79, HR 60, R 18, O2 99% on RA. Pt released from vaccination site in a stable condition. ED precautions discussed. Pt expressed understanding.
It was confirmed on Sept 16 that I had COVID-19. I had head congestion, very stuffy nose and really tired. I had a headache for one day. And a sore throat. The sore throat started first. They called in a z-pack. I had a Tele Med with my doctor the day before the 16th. He said that he thought it was just a Rhinovirus and he prescribed me some Prednisone. The next day, the Urgent care prescribed a Z-Pack, so I was on both of them. Those helped for just a few days. I had extreme adrenaline rush from the Prednisone at first. But from Sunday to Wednesday morning, I was so tired. I didn't have the energy to get up and I had the head congestion too. I was still not too much energy after that, but it gradually got better. I still have the head congestion. That is lingering. I am just using nose spray for that presently.  Note: On the 20th, I got the Infusion for the monoclonal antibodies at another Urgent Care.
Woke up incredibly sore. Muscle aches in my legs and arms. My left arm at the injection site feels like lead. Left side of my chest is sore. Pounding headache.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/17/21 2nd dose04/08/21 Diagnosed covid positive:08/02/21 Symptom onset: Exposure:Travel Symptoms:
Limited range of motion in left arm. Extreme pain with some movements. Started physical therapy 3/25/21
developed sx including nausea, cough, aches, fatigue, sore throat 1/4/2022, tested positive for covid on binax rapid antigen test 1/5/2022  fully vax with Moderna plus booster dose listed above
November 10, 2022 my throat was dry on November 11 2022 I started sneezing, coughing, blowing my nose which continued through the 13th of November 2022. A rapid COVID-19 test resulted in a positive.
On 1/14/2020 at 6:00 PM feels face, eyes, mouth, and nose swollen. He took one Benadryl 25 MG, then at 5:00 PM at the moment he feels well. This is notified to the Medical Director.
High fever, arm swelled big and red, 2 weeks later had eye problem, went to ophthalmologist who stated at was a reaction to vaccine.
needle went a little bit into her arm and then the liquid went down her arm.; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (needle went a little bit into her arm and then the liquid went down her arm.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (needle went a little bit into her arm and then the liquid went down her arm.). On 07-Apr-2021, INCORRECT DOSE ADMINISTERED (needle went a little bit into her arm and then the liquid went down her arm.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-071658 (E2B Linked Report).; Sender's Comments:  MOD21-071658:1st dose of vaccine-MOD-2021-071426
Sore arm; Fatigue; Headache; Chills/Could not get warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills/Could not get warm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills/Could not get warm). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills/Could not get warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Pt developed pain in left shoulder and, to a lesser extent, in right shoulder that continues as of report.
shortly after the first dose i felt tingling to my right cheek,lips and nose that resolved after a few hours,  after the second shot, i got the same feeling and about 6 hours later i had a metallic taste in my mouth and all food tasted funny. i continued to have slight numbness to the lips, cheek and nose area. the right side of my tongue on the top feels numb and 6 months later i  still have a diminshed taste and slight numbness to lips and around the area to my nose. all covid testing has been negative. no dental issues
Bilateral Pain in arms, as well as swelling, stiffness.  Pain 10/10 on scale. Unable to lift arm all the way in the air.  Limited motion.   On left arm pain also moves down arm.  Right Arm is 2-3/10 on scale with similiar issues. MD stated to her that she had a "Frozen Shoulder" secondary to post vaccination.  Treated with ice.  Pt went to hospital 30AUG2021 and given brace.
Information has been received from a female healthcare student who in approximately 2006 (about 4 years ago) received the complete GARDASIL (lot # not reported) series. Subsequently the patient had a positive HPV (human papilloma virus) test for a high risk HPV type. The patient had sought medical attention by office visit. At the time of report, the outcome was unknown. Additional information has been requested.
24hrs p/vax had 30cc swelling of the deltoid area w/warmth but not redness;
No adverse event; First dose-24-12-2020/ Second dose-14-01-21; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-24-12-2020/ Second dose-14-01-21) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and LOSARTAN for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-24-12-2020/ Second dose-14-01-21). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-24-12-2020/ Second dose-14-01-21) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-24-12-2020/ Second dose-14-01-21).    Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-662495 (Patient Link).
7cm x 6cm area of redness with mild induration with slightly raised football shaped lesion in the center and 4 papular lesions.
Father reported patient to have slumped over and had shaking with eyes open. Father then brought patient to exam room, walking under own power. Patient awake, alert, at time of re-examination and talking with father.
Mild rash to back and to leg around where shot was administered ((L) thigh). ?Beginnings of several hives to back. Rx for Benadryl given.
Fully vaccinated, not boosted. COVID infection breakthrough with inpatient hospital stay to a general medical unit.
2 days, post vax, I woke up at approx. 00:30 AM, with chest pain,  shortness of breath, sweating and nausea. I was taken to ER by EMS. Ruled out MI but admitted for observation. Released the next day. Had numbness and tingling which began on the left side of my face, left arm, left side and left leg. Numbness and tingling varies in severity from day to day. Chest pain and severe numbness again on 5/2/01 with pain in the muscle where numbness present.
died; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (COMIRNATY) via unspecified route on an unspecified date single dose for covid-19 immunization. The patient medical history included pre-existing conditions (unspecified). The patient's concomitant medications were not reported. The patient experienced died on an unspecified date. The reporter talked to a doctor and the doctor had a patient, who had pre-existing conditions, died. The patient died on an unspecified date. It was unknown if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: died
Severe chills; Had a fever since 10PM; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (Severe chills) and PYREXIA (Had a fever since 10PM) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (Severe chills) and PYREXIA (Had a fever since 10PM). At the time of the report, CHILLS (Severe chills) and PYREXIA (Had a fever since 10PM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.
Office visit 6.18.09 Acute URI 4 mo check-up vaccines given see below- Return visit 6.19.09. Fever within 24 hrs of vaccine administration probably viral were reporting because of proximity to vaccines.
Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our home  (approx 2 hr drive) & were on road. My husband is a physician & when we noticed symptoms administered Benadryl, Claritin, & famatodine.
Information has been received from a physician concerning a 11 year old male patient with many unspecified underlying problems who on 07-JUL-2008 was vaccinated with a dose of PNEUMOVAX (Lot # was 659921/1679U). On unknown date the patient experienced a fever of 101F, arm swelling and vomiting after receiving PNEUMOVAX. The patient was admitted to an unspecified hospital two days later on approximately 09-JUL-2009 for unknown numbers of days. At the time of the report, the patient recovered from the events. Additional information has been requested.
PATIENT COMPLAINED OF FEELING LIGHT HEADED IMMEDIATELY AFTER INJECTION OF THE VACCINE.  THE PATIENT WAS MOVED TO THE PHARMACY BENCH AND WAS ASSISTED IN LYING DOWN WITH HER FEET ELEVATED.  THE PATIENT WAS INSTRUCTED TO TO SLOWLY BREATHE IN AND OUT.  THE PATIENT STATED THAT SHE FELT BETTER AFTER APPROXIMATELY 15 MINUTES AND WANTED TO SIT UP.  THE PATIENT STATED THAT SHE DID PASS OUT FOR A FEW SECONDS.   AT THIS TIME, THE PATIENT WAS FIVEN A BOTTLE OF WATER AND A CANDY BAR.  THE PATIENT STAYED IN THE PHARMCY FOR APPROXIMATELY ANOTHER 15 MINUTES.  A PHARMACY ASSOCIATED WALKED THE PATIENT TO HER VEHICLE TO MAKE SURE SHE WAS OK.  AFTER ARRIVING AT HER CAR, THE PATIENT STATED THAT SHE WAS FINE AND DID NOT NEED ANY FURTHER ASSISTANCE.
Weakness pain deep in buttocks down legs-Pain in bones, muscles, scalding pain in skin-mostly legs- All over lethargy - Difficult walking/rising sitting-standing. No redness at INJ site of vaccine.
pt c/o redness, rash, hot to touch 6"x 4" area;p/20 days arm still sore;pt to see MD 7OCT96 rash gone;arm pain intermittently;
Patient in the recovery area 6 minutes  after the vaccine, patient present with sweating, pale skin and tremors in the body. Patient refer that she had in the past panic attacks. Paramedic take the vitals. Vitals was B/P 110/70mmHg; SO2% 99%, Pulse 90, Glucose 119 mg/dl.
right after vaccine the pain in muscles started and headache and shivering about two hrs later and around bed time i had no apatite started  throwing up and lasted only 24 hours
This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditinos and drug reactions/allergies were not reported. On unspecified dates, the patients were administered with doses of GARDASIL (Lot # K010574, expiry date: 08-APR-2017; lot # J013326, expiry date: 12-FEB-2016; lot # K001500, expiry date: 06-NOV-2016; lot # K011138, expiry date: 08-APR-2017) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA014028, 1506USA011037, 1506USA014024, 1506USA014025 and 1506USA014027). Additionnal information is not expected as the reporter did not wish further contact.
Received PREVNAR 13 1/18/17 AM. Last night started with moderate arm pain, fever, chills, no cough, mild congestion, rhinorrhea. No N/V/D. Seen at noon with temp 99.9. Other vitals stable.
Pain and swelling at injection site, but also in the armpit of that arm. Very uncomfortable. Headache.
Briefly, this is a 76 y.o. male with PMH reviewed in chart and w/ patient notable for multiple falls, CAD status post DES, CVA with L hand contracture. Fib usually on Eliquis, GERD, PVD, BPH  planned TURP tomorrow (eliquis stopped two days ago for this), was presenting to the emergency department with weakness in his left foot.  Wife noticed that the patient was dragging his left foot over the last 2 to 3 days.  Patient also seemed like he was leaning more so to the left side. Patient dx with urosepsis. Four days after hospital admission, patient found to be covid 19 + and received COVID 19 monoclonal antibodies during existing admission.
Patient reported to the clinic to receive her 5th Anthrax vaccine that was due in a series of 6 vaccines. The vaccine was administered after verifying that she was not allergic and had not previously had adverse reactions to vaccines or immunizations. Pregnancy was not verified beforehand. A Qualitative HCG test was ordered afterwards and the result was positive for pregnancy. The patient's physician was notified at that time. She was seen by the doctor who counseled her about the pregnancy and advised that she would be referred offbase to begin her Obstetrical care. There has been no adverse reaction reported at this time.
Tight jaw, entire left side numb start andropathy, hand constantly gripped, arm feels 100 lbs, sensation over all of body that muscles are moving, but are not. Tickles and nauseous over body. "Its like a video game inside of me". Hot prickles over side of leg.  Severe brain fog, twist sentences. Leg would kick out to left. Brain would tell body that stuff was going on, but not to the extreme brain would tell participant. Equilibrium off
Within 48 hours Patient was in ICU after receiving the J&J vaccine.  Fever, Vomiting, Chills.  Treated for Septic Shock. Blood Clots, Renal Failure, Liver Failure, MI,   Drugs for hypotension, Ventilator, Dialysis, Oxygen, Antibiotics,  Patient in hospital ICU 10/24/21 till death 12/07/2021
Fever, lack of appetite, rash from head to toe that would come and go for months after the vaccination. Bulging soft spot on her head and her twin sister.
began to pass out immediately upon receiving flu shot, out for only 5-10 seconds; VS BP 98/68; P68; resp reg skin w/d; woke up alert/oriented p/15 mins sitting down taking fruit juice, BP 90/64, P64; feeling much better p/30 mins sl h/a;
Pt received Janssen Primary and Pfizer booster. 5 mins post vaccination pt had a syncopal episode w/ associated flushing/sweating and dizziness.  Vitals: 133/81, 78, 12 -- > 124/81, 78, 12 Pt given water and advised the patient that the pt's friend should drive home.  Pt observed for and additional 10 mins. Pt stable and released from the vaccination site.