chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Consumer (patient). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: EN5318) via an unspecified route of administration on 07Feb2021 as first, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient just taking homeopathic medication, antiviral and I just have an auto immune (sentence incomplete). She stated, I received my first dose Sunday, and then last night I got a call from my daughter to let me know that my granddaughter may have been exposed to COVID-19 either Thursday or Friday of last week and the person who she was exposed to in her school class tested positive for COVID-19 yesterday. So, I am just a little bit concerned because of course after Sunday that I got my first shot, I had no idea that I had a possible exposure. So, it is just, I am trying to find out, what are the effects would be if my granddaughter, she is tested today and what may happen to me because I had the first dose and then I may be exposed to COVID-19. She is scheduled for second dose on 28Feb2021. The event assessed as non-serious. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Local pain, heaviness in the arm, soreness for about an hour. Took 500 mg Tylenol. It kind of helped.  Took Benadryl before she went to bed. Early this morning, everything felt heavy, felt nausea, mild palpitations, and dizziness. Took Famotidine this morning.  Took Motrin and Benadryl this morning also. Having chills. Afterwards a couple hours was able to sleep a little bit. Pain in lymph nodes on the left side under arm by left breast area.  Advil helped with the local pain. Having pain at the injection site.
Entire body weakness next morning, fell to floor, leg weakness, walking upstairs w/ difficulty. Sent to ER
PATIENT SAYS HE IS EXPERIENCING SORENESS AT THE INJECTION SITE THE FIRST FEW DAYS AFTER AND THEN  RINGING IN THE EAR A WEEK AFTER, WHICH HAS NOT RESOLVED AS OF THE DAY OF THIS REPORT. HAD HAD NO OTHER CHANGES IN HIS MEDICATION REGIMEN.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient had injection sit ,bruising redness, the redness had extented all around the deltoid area.  she also had brusing over the arm in other areas that started on sunday.The bruised were around the elbow area, and around the topside of the arm.  (all not in areas of the injection.
Cellulitis like reaction, hot and tender, spread throughout her injected arm. Pt went to hospital where she was monitored, she was discard sometimes later.
One day after being vaccinated, my right hand  swelled up. I could not bend my fingers nor make a fist. My right knee was sore also. My left hand had some slight swelling, but I could make a fist.
Tired; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and FATIGUE (Tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart valve disorders. Concomitant products included DIGOXIN for Heart valve disorders, VERAPAMIL and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Tired). At the time of the report, PYREXIA (Low grade fever) and FATIGUE (Tired) had resolved.            No treatment details were provided    This case was linked to MOD-2021-023665 (Patient Link).
Had a little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a little bit of fever) in an 87-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had a little bit of fever). At the time of the report, PYREXIA (Had a little bit of fever) outcome was unknown.        Patient reported that she was waiting to take Ciprofloxacin after she got the 2nd vaccine.  No treatment related information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-037512 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-037512:First dose case
Rash on the inner side of the arms, both left and right (size if a palm) and under the breasts. Stretch marks-like swelling in the same area. After 30 min the symptoms have disappeared.
7~48 hours post vaccination: fever, chills, headache, sore arm that is red and itchy at injection site 7~80+ hours post vaccination: sore arm that is red and itchy at injection site continued
69 YO M CARDIAC ARREST. PT HAD JUST RECEIVED HIS COVID VACCINATION AND WAS PULLING INTO THE OBSERVATION AREA WHEN HE LOST CONTROL OF HIS TRUCK, BECAME UNCONSCIOUS AND CRASHED INTO A LIGHT POLE. THIS OCCURRED IN FRONT OF THE STANDBY MEDIC UNIT AND OTHER FIRE DEPT STAFF. PT WAS IMMEDIATELY REMOVED FROM THE VEHICLE AND THE PATIENT WAS DETERMINED TO BE IN CARDIAC ARREST. CPR WAS INITIATED WITHIN SECONDS OF BEING REMOVED FROM THE VEHICLE. EMS WAS IMMEDIATELY AVAILABLE AND THE PATIENT WAS DEFIBRILLATED FOR WHAT APPEARED TO BE A SINE WAVE VT/COURSE VF WITHIN ONE MINUTE OF HIS ARREST. PT WAS PLACED ONTO A BACK BOARD AND MOVED TO AMBULANCE IN A PULSED VT AND WAS AWAKE AND RESPONSIVE. ONCE IN THE BACK THE PT WAS WIRED INTO THE FOUR LEAD AND WAS SYNCHRONIZED CARDIOVERTED AT 100 J WITH A CONVERSION TO A PULSED JUNCTIONAL RHYTHM WITH A RATE OF ABOUT 58. THIS RHYTHM CHANGED INTO A SINUS TACH AT ABOUT 100 BPM. IV ACCESS WAS OBTAINED AND 100 MG LIDO BOLUS WAS ADMINISTERED WITH A 2:1 LIDO DRIP HUNG. AMBULANCE BEGAN TRANSPORT TO ER. OVER NEXT SEVERAL MINUTES PT BEGAN HAVING VENTRICULAR ECTOPY IN THE FORM OF PVCs COUPLETS AND EVENTUALLY 4-5 BEAT RUNS OF VTACH WHILE ON PHONE WITH ER MD. DISCUSSED GIVING ANOTHER BOLUS OF LIDO AND INCREASING DRIP TO 3:1 DUE TO INCREASING VENTRICULAR ECTOPY. THE ER PHYSICIAN CONCURRED AND ANOTHER 75 MG LIDO BOLUS WAS GIVEN FOLLOWED BY INCREASING THE DRIP RATE TO 3MG/MINUTE FOLLOWING THE SECOND LIDO DOSE AND DRIP ADJUSTMENT THE PATIENT'S VENTRICULAR ECTOPY RESOLVED AND THE PATIENT REMAINED IN A SINUS RHYTHM / SLOW SINUS TACH THROUGHOUT TRANSPORT AND TRANSFER OF CARE TO THE ER. A 12 LEAD WAS OBTAINED JUST PRIOR TO ARRIVAL IN ED THAT SHOWED SINUS TACH WITHOUT VENTRICULAR ECTOPY BUT WHAT APPEARS TO BE PACs, FLIPPED T WAVES IN aVL, AND ST DEPRESSION IN V4, V5, V6. PT WAS MOVED FROM AMBULANCE TO ER AND CARE TRANSFERRED TO ER MD AND STAFF. HEENT - WHEN PT WAS FIRST PULLED FROM VEHICLE HE WAS UNCONSCIOUS, NOT BREATHING, AND PULSELESS, PT WAS BRIGHT RED BUT DID NOT APPEAR TO HAVE HIVES ON FACE/NECK OR ANGIOEDEMA. CX - PT WAS BRIGHT RED FROM THE NIPPLE LINE UP, NO OBVIOUS HIVES, EKG QUICK COMBO PADS ATTACHED AND PT'S INITIAL RHYTHM WAS WHAT APPEARED TO BE A TORSADES LOOKING VT OR VF WITH THE CHARACTERISTIC SINE WAVE PATTERN. EXTREM - PT WAS PWD, WITH PULSED VT HAD RADIAL PULSES, NO PURPOSEFUL MOVEMENT AT THAT TIME. DUE TO THE PATIENT RECEIVING THE COVID VACCINE MINUTES BEFORE THE PT'S ARREST AND THE BRIGHT RED/FLUSHED APPEARANCE FROM THE NIPPLE LINE UP AN ALLERGIC REATION/ANAPHYLAXIS (ALTHOUGH UNLIKELY) WAS CONSIDERED BUT AS THE PATIENT DID NOT HAVE ADDITIONAL SIGNS OR SYMPTOMS IT WAS DECIDED OBSERVE PT FOR ADDITIONAL OR WORSENING SIGNS AND WITHOLD ANY TREATMENT FOR SAME UNTIL/UNLESS ADDITIONAL S/S PRESENTED. THIS WAS LATER DISCUSSED WITH ER MD AND HE CONCURRED. R/O SUDDEN CARDIAC ARREST WITH ROSC EXAM, CPR, DEFIB, MOVED TO MEDIC UNIT, OXYGEN 15 LPM NRB, SYNCH CARDIOVERSION, VS, IV X3, LIDO BOLUS AND 2:1 DRIP, TX SPH ER, BASE CONTACT WITH ER PHYSICIAN, 2ND LIDO BOLUS AND DRIP INCREASED TO 3:1, 12 LEAD, TRANS CARE TO ER MD AND STAFF
After a week my left eye was all swollen inflamed and red.  After 2 weeks, my top lip was all swollen up with blisters between lip and gum and felt sort of numb.
got Covid-19; got Covid-19; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history includes exposure to COVID-19 since she works in ER with COVID patients. Concomitant medications were not reported. On an unspecified date (reported as 9 days later), the patient got Covid-19. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received my first Moderna shot March 15th is it too late to get second dose?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first Moderna shot March 15th is it too late to get second dose?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I received my first Moderna shot March 15th is it too late to get second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I received my first Moderna shot March 15th is it too late to get second dose?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Additional Details: Patient fainted 5 seconds after recieving 2nd dose vaccine.  Patient was caught in her chair to prevent falling. Patient was unconscious for about 10 seconds. Patient appeared to start shaking slightly for 1 second right before she woke up to her mother calling her name. Patient felt like she woke up from sleeping and was confused as to what had happened. Patient complained of feeling hot/ unwell upon awakening. After drinking cold water patient felt better within minutes. Had not eaten that day
Info has been received from an office manager concerning a 5 year old female who on 10/2/00, was vaccinated with a dose of varicella virus vaccine live. On 5/5/05, the pt experienced breakthrough varicella with about 20 lesions. It was noted that the lesions were almost gone b 5/9/05. No treatment was given and the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Sore upper right arm, more than previous shot, and sore right shoulder, progressively got worse with range of motion limited, painful to move arm at different angles and especially upwards and lifting things that are not very heavy at different angles. At night my arm throbs and now the shoulder pain is felt on the right side of my neck. Also, right before leaving store, I got very faint and light headed
I received the vaccine on 3-12-21 and woke up 3-15-21 with pain in the bottom of my left foot. I scheduled an apt with my PCP on 3-16-21. My PCP scheduled an ultrasound on 3-24-21 where the nurse discovered blood clots in my lower left leg. I started taking Eloquis later that afternoon. I then had an apt with a blood dr. on 4-9-21 where she drew blood for tests. I was experiencing my heart racing and she scheduled me an apt with a cardiologist on 4-13-21 where the cardiologist suspected that the clots had moved into my lungs. The cardiologist did an EKG on the same day. I have a heart echo scheduled for 5-7-21. I am experiencing side effects from Eloquis so 4-19-21 I switched to Xeralto.
Typical arm soreness after vaccine, but pain got worse; about one month later she went to PCP and got steroid shot and steroid oral dose pack; good for a week, then pain returned; went back to PCP for another steroid shot; still in pain now.
This spontaneous prospective pregnancy report was received from a nurse concerning a 24 year old female patient. No pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were reported. On 16-OCT-2018, the patient was vaccinated with VARIVAX for prophylaxis (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided); it was reported that lot # and expiry date of sterile diluent (MERCK) was not provided. On an unspecified date, the patient carried out an unspecified pregnancy test. Subsequently, on 19-OCT-2018, the patient found out she was pregnant. The patient became pregnant with an estimated last menstrual period (LMP) of 05-OCT-2018 and an estimated date of delivery (EDD) of 12-JUL-2019. The initial exposure to VARIVAX was approximately at 1 week. No treatment nor hospitalization or adverse effects were reported. The pregnancy outcome was pending.
Pt is approximately 11 weeks pregnant. She had a sore shoulder and bad headache for the day after the injection.
12/12/22 presents to ED for "dizziness" "cough, congestion, nausea and SOB". PMHx of "OSA on CPAP, diverticulitis, SSS s/p PPM"
After 29 minutes in observation, the client began complainig about lips tingling, chest tightness and feeling like she had heartburn.  Client was watched, given Benadryl after she refused Epinephrine. 02 per mask was administered.  EMS was called and assessed the client. Blood pressure was elevated, rapid heart beat. Client declined transport to hospital.  Vital signs improved 35 minutes after Benadryl was administered.  Client left the facility on her own accord 1 hour and 20 minutes after receiving the Janssen covid-19 vaccination. Client has history of previous reaction to FLU vaccine.
Patient developed large rash an arm not at site of injection but the entire area below. Rash was elevated and blotchy out patient reported not itchy. Patient was going to take BENADRYL.
An ASPP (Anonymised Single Patient Print) was received from the MCA (regulatory authority) on 01/03/2002, concerning a 55 year old female patient who experienced bronchopneumonia, 2 days after receiving the Fluvirin vaccine on 10/15/2001.  The receiving was receiving diclofenac concomitantly. The patient has no other medical problems, no allergies and no previous drug reactions.   On 10/15/2001, the patient received the Fluvirin vaccine. On 10/17/2001, the patient experienced bronchopneumonia. She was treated with steroids and antibiotics. The patient recovered on 11/30/2001 after treatment.   there was insufficient information to determine the reporter's casualty assessment.
Large baseball size red, warm raised hard sore to right delt BENADRYL/rotate heat and ice.
Maybe vaccine immune response made me extra sensitive; broke out in a rash on face and chest; racy heart rate after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER26B) via an unspecified route of administration in left arm on 25Mar2021 at 11:00 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization. Medical history included Colitis ulcerative (from May 2000-ongoing). Patient was allergic to clindamycin, fennel, cinnamon, adhesive. The patient previously took clindamycin and experienced allergy to clindamycin. Concomitant medication received within 2 weeks of vaccination included adalimumab (HUMIRA). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6198) via an unspecified route of administration in arm on 04Mar2021 at 15.00 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization and no reaction on previous exposure to vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. On 31Mar2021, 6 days later patient broke out in a rash on face and chest. Patient went through her week to see if any new products, topical ETC, food, touched anything etc but no other unusual culprit. Patient had a friend trouble shoot this with her as well. The only X factor was the vaccine. On 31Mar2021 at 13:00 hours, patient stated maybe vaccine immune response made her extra sensitive. The rash was still there. If it does not go away, She will check with in with her allergy doctor. Patient stated living in covid, She was able 2 isolate the one change -vaccine. On unspecified date in 2021, she also had racy heart rate after vaccination. Cleared up by June. Patient took lots of Benadryl plus oatmeal baths for broke out in a rash on face and chest. Since the vaccination, the patient had not been tested for COVID-19. Reporter assessed the seriousness as important medical event. The outcome of the event racing heart rate increased was recovered on an unspecified date in Jun 2021 and outcome of the other events was not recovered.
Pt recvd 1st dose of Hep B vax & 24 hrs p/vax pt exp malaise & devel petechiae covering a 5x12 in area on the inner surface of thighs;
tinnitus and slightly hearing loss; tinnitus and slightly hearing loss; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER87 30), via an unspecified route of administration on 06Apr2021 (received at 24-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient was not pregnant. She did not have COVID prior to vaccination. The patient experienced tinnitus and slightly hearing loss on 07Apr2021. The outcome of the events was not recovered. She was not tested for COVID post vaccination.   No follow up attempts are possible. No further information is expected.
Chronic headache for 3 months, it does not respond to medication.  Had a MRI, found a brain aneurism and had a stint put in. The headaches are still there. Taking Gabapentin. No specific diagnosis.
Pt c/o h/a, dizzy, nausea and itchy injection site (RD), laid in supine pt in exam room.
Pain; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain) and SWELLING (Swelling) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain) and SWELLING (Swelling). At the time of the report, PAIN IN EXTREMITY (Pain) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Escalated from onset. Started with pain in arm, tiredness, headaches, dizziness, nausea. She is cold to the touch at 8:00 PM on 8/11/2016.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Round red itchy rash around the injection site.  Likely been there since injection  and still noticeable on day 9 post vaccination
Warmness at the injection site; Soreness at the injection site; Itchiness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; 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.
Patient experienced dizziness and a burning sensation in chest and throat within minutes of this injection, that initially resolved only to reoccur later that afternoon in conjunction with chills, body aches, headache. Patient was feeling so bad with confusion and dizziness the next morning such that she was unable to get out of bed and had call in sick to work. Patient symptoms continued for the next week and she was unable to return until 19 January (but still symptomatic and short of breath on exertion). Patient was tested for COVID-19 infection on 19 January which was negative. Patient then followed up with her primary care doctor the following and retested for COVID-19 (also negative again). Primary care provider performed basic labs without revealing any abnormalities. Patient does not feel back to normal at this time - she continues to have intermittent chills and the headaches only stopped in the past 7 days.