chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has developed a red spot on his arm where they gave him the vaccine; The red spot is slightly warm to touch; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received second dose of BNT162B2 via an unspecified route of administration in left arm on 01Apr2021 13:00 (Lot Number: ER8734, expiration date was unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included apixaban (ELIQUIS) taken as blood thinner for a long time about four or five years now. The patient previously received first dose of BNT162B2 via an unspecified route of administration in left arm on 11Mar2021 at 13:00 (Lot Number: EN6206, expiration date: 24Mar2021) for covid-19 immunisation. He had no reaction at all after his first dose. After a couple days of second dose of BNT162B2 in Apr2021, the patient had developed a red spot on his arm where they gave him the vaccine. The red patch was about as big as his hand. The red spot was slightly warm to touch He felt that it might have increased in size over night. It was not sore, and his arm was not impaired at all. The outcome of event "a red spot on his arm where they gave him the vaccine" was not recovered. The outcome of event "The red spot is slightly warm to touch" was unknown.  No follow-up attempts are possible. No further information is expected.
Patient received the vaccine the afternoon of 12/01/09 at school.  Patient was fine and went to school the following day (12/02/09.   When I picked her up at school at 2:30PM, she was complaining of a headache that had come on at school.  I gave her some Motrin and we completed the usual afternoon/ evening routine.  She began complaining of a severe headache and dizziness.  Patient's temps have stayed within the 101.1 - 102.9 range.  Motin or acetaminophen have been administered regularly because of the severe headaches, but do not help.  On 12/03/09, we saw Dr. at the Pediatric office.  She said that this couldn't be a reaction to the vaccine.  Temps continued to be high.  The night of 12/03/09, patient sweat profusely and soaked her bed.  The sweat smelled strange and medicinal.  Her breath smelled the same this morning when she woke up.  Today 12/04/09 she is weak and shakey, running a temp of 101.1, still severe headache and dizziness, still lacks appetite.  Had severe stomach cramps last night.   No diarrhea or vomiting.
I developed an itchy leg one week after the vaccine which was diagnosed as prurigo nodularis. A number of people in a prurigo nodularis forum on social media have also said they developed this condition right after getting the vaccine.
having itching on her back and on her chest; a spot on her arm that appeared at the same time with the rash; a spot on her arm that appeared at the same time with the rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "having itching on her back and on her chest"; CONTUSION (non-serious), RASH (non-serious) all with onset 2021, outcome "unknown" and all described as "a spot on her arm that appeared at the same time with the rash".  Additional information: Patient called to report an adverse event 4 weeks after receiving her 2nd dose of the Covid19 Vaccine. Patient reported that there was a spot that looks like an "old person's bruise" as she described, but it doesn't felt like a bruise, patient mentioned it was small, oval-shaped but it's not painful. Patient stated that she had itching that she never had before on her back and frontside chest that started a week ago and is not as bad as it was. She also developed a spot on her arm that looks like a old person bruise on her right arm. It appeared about the same time as the itching. She said that it does not feel like a bruise and she was concerned.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have intermittent A-Fib and didn't have an episode of A-Fib for 3 weeks.  In fact I came out of A-Fib immediately after the first dose of the vaccine on February 15, 2021.  After the second dose of the vaccine at 10:00 A.M. on March 8th I went into A-Fib at approximately 2:00 A.M. on March 9th. I was out of A-Fib and back into a normal sinus rhythm at approximately 2:00 P.M. on March 9th.
they just had a sore arm after the 1st injection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "they just had a sore arm after the 1st injection.". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient receive any other vaccines within 4 weeks prior to the COVID vaccine, List of any other medications the patient received within 2 weeks of vaccination, Prior to vaccination, was the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19 were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm hurt; Red; delayed reaction; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), ERYTHEMA (Red), INJECTION SITE REACTION (delayed reaction) and INJECTION SITE SWELLING (swollen at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ERYTHEMA (Red), INJECTION SITE REACTION (delayed reaction) and INJECTION SITE SWELLING (swollen at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), ERYTHEMA (Red), INJECTION SITE REACTION (delayed reaction) and INJECTION SITE SWELLING (swollen at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2022 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The patient had no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17Oct2022, outcome "unknown", COVID-19 (medically significant) with onset 17Oct2022, outcome "recovered" (23Oct2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: been testing positive for last week; (17Oct2022) Positive (POS); (23Oct2022) Negative (NEG); (24Oct2022) Positive, notes: Positive again. Therapeutic measures were taken as a result of COVID-19, which included Paxlovid from 17Oct2022 to 22Oct2022. Clinical course: The patient was positive (POS) on 17Oct2022, negative (NEG) on 23Oct2022, positive again on 24Oct2022, and had been testing positive for last week. It was further reported that the patient had COVID rebound after Paxlovid on 24Oct2022 at 09:00 AM and was recovering with no treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
diaphoretic, flushed, skin burning, dry heaves Narrative: Employee received the vaccine the morning of the 26th. That evening was felt ill since her Covid 19 vaccine she states she had a flulike illness diffuse myalgias some mild congestion but no chest pain or palpitations. The next day at work she experienced: She became diaphoretic, flushed and c/o skin burning also the dry heaves. Pt was able to maintain airway on won. Transported to ED for evaluation Initial Vital Signs: BP: 175/104 HR: 117 RR: O2 Sat: 95 code white was called and employee was taken to he ER for further evaluation. She denies chest pain denies pleuritic pain denies dyspnea, she denies melena she denies any actual vomiting just dry heaving Past medical history list limited to hypertension, severe allergies and hypertension severe allergies EKG: Normal sinus rhythm rate of 89 bpm normal intervals and normal axis st-t wave changes were there some subtle ST really PR interval abnl. primarily in leads 2 and 3 given this a troponin was done EKG had very subtle abnormality in leads 2 and 3. Given this is a troponin was ordered. The troponin was 000 Fortunately, after the solumedrol was given and patient felt wonderful she looked much better her edema was improve she was stable for discharge
Swelling and tingling in finger tips numbness. Burning sensation in fingers. Started 3 days after immunization.
Within two hours I could not move arms from sides more than two inches from body. Extreme pain. Also rec?d pnuemovax in right front shoulder and in left front shoulder shingrix
With shot # 1.  Intense pain in the vaccinated arm, extending from hand to left, back shoulder blade starting a couple hours after the shot.  Unable to sleep. Day two, used ice pack to attempt to move the arm, which only wanted to stick next to the body and not move.  Attempts to use the arm were excruciating, so nothing worked on that level.  Continued icing throughout day 2.  End of day 2, took an Aleve and continued to ice the shoulder.  Day three, took an Aleve; no improvement in the morning, then saw some improvement throughout day three, but not to the point of being able to use the arm.  Total focus was on that arm.  Day 4, pain improved to being able to use the arm for small tasks.  Day 5, pain [but for injection sight] gone.  Shot #2.  Effects were entirely different but equally intense.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was recieved to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extention time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is recieved the staff have to determine the expire date and then COVID vaccines are constatly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
w/in 4hr of vax site was red, hot, & very painful, sl swelling;area noted was 2" in diameter;pain was throughout the upper arm diff w/ROM;all sx lasting 2 days;began to subside by 8JUN;no induration today;ROM complete;
Ag positive 24Apr22; Ag positive 24Apr22; cough; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 22Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 22Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 24Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 24Apr2022, outcome "unknown" and all described as "Ag positive 24Apr22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, cough, fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination Failure and COVID - 19which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
pt had a positive home COVID test on 1/5/22; was seen in ED on 1/11/22 for SOB, given oral steroids and home O2 and dc'd to home; back to ED on 1/20/22 with cough and increasing SOB; O2 sat 85% on 6L O2 via NC in ED; increased O2 supplementation and admitted pt; PE found in left lung; ARF with hypoxia; COVID pneumonia; critically ill; given COVID direct therapy; pt experienced a PEA cardiac arrest, code was run, but pt expired in the hospital
This spontaneous report as received from a certified medical assistant refers to 21 year old female patient who, on 27-MAY-2014, was vaccinated with a dose of GARDASIL (lot # J006850; expiration date 31-MAR-2016) in right "UT" (dose and route not provided). The GARDASIL that was administered to this patient had been stored below 36 degrees F, outside of the temperature ranges indicated in the prescribing information, on 10-APR-2011, 11-APR-2014, 22-APR-2014, 23-APR-2014, 24-APR-2014 and on 08-MAY-2014. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red Rash at injection side (Approx size 3" x 4") - Hot to the touch & raised  Had fever for  approx 12 Hours,  Headache for 36 hours.  Felt tired for 2 days.
Patient inadvertently administered Covid 19 vaccine to person under the age of 18. Patient administered 2nd dose of  Covid 19 vaccine on 3/5/2021 with approval of Chief, and Medical Director Dr.
Pain at injection arm really sore "like I was punched in the arm"  then 2 days later started having numbness down arm into the middle and ring Finger of left hand.  Constant, notes that in some positions the tingling will go away.
Patient's left arm had some severe swelling, pain, redness, hot to the touch, and rash on the entire arm that was injected. Patient also stated that her back began to ache.
This spontaneous report as received from a pharmacist via a company representative and refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # K003599, expiration date: 13-MAR-2015). On an unknown date the patient experienced a bright red area around the injection site and knot at the injection site. The patient was diagnosed (date unspecified) with cellulitis. The patient sought medical attention (unspecified0. The outcome of event was not reported. The reporter considered event to be related to ZOSTAVAX (reported as adverse experiences related to this lot). The reporter wanted a lot check on #K003599. This is one of several reports from the same reporter. Additional information has been requested.
SLUGGISH; POUNDING HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had unspecified underlying conditions. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced sluggish. On 10-APR-2021, the subject experienced pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pounding headache, fatigue and sluggish was not reported. This report was non-serious.
approx 3yr p/vax pt was dx w/varicella, approx 10 chicken pox
Area swollen, red; hot to touch; rev 6/24/2005 - normal L leg and decreased swelling; no redness
This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with GARDASIL. Concomitant medications were not reported. It was reported that the GARDASIL vaccine was exposed to 11 degree celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of GARDASIL are administered consistently throughout the period of January 2014 to May 2014. No adverse effects were reported. The outcome of administered vaccine exposed to 11c for 84.5 hours, and then for -2.5c for 47 hours and no adverse effects was unknown. This case was linked to 1406USA000392, 1406USA000393, 1406USA000394 and 1406USA000395 (same reporter link).
3/4 10 am Headache, body aches, and fever-rested 6 pm joint pain, and fever of 101.7-took 2-500mg Tylenol 9 pm fever breaks, but still have body and joint pain and headache 10 pm  take 2-500mg Tylenol-go to bed 3/5 8 am no fever,  minor headache 12 pm no headache and feel about 80% normal 4 pm feeling about 90% normal 3/6 8 am minor body aches, no headache
Big droplet of the vaccine fell out of the syringe; Big droplet of the vaccine fell out of the syringe; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Big droplet of the vaccine fell out of the syringe) and DEVICE CONNECTION ISSUE (Big droplet of the vaccine fell out of the syringe) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced UNDERDOSE (Big droplet of the vaccine fell out of the syringe) and DEVICE CONNECTION ISSUE (Big droplet of the vaccine fell out of the syringe). On 12-May-2021, UNDERDOSE (Big droplet of the vaccine fell out of the syringe) and DEVICE CONNECTION ISSUE (Big droplet of the vaccine fell out of the syringe) had resolved.            No concomitant medication was reported by reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 contains no significant information.
Pain upon administration of vaccine and immediately thereafter, with little or no improvement until present. Severe pain and drastic decrease in range of motion subsequently. Treatment includes: 3 visits to orthopedics surgeon, 2 courses of MEDROL, 1 cortisone shot, MRI, physical therapy, VICODIN, ULTRACET for pain.
Hospitalized Cough, sore throat, fatigue, fever positive covid test at home. Hypoxic to the low 80s in the ED.  Treated with Remdesivir, and dexamethasone
Moderna 3/3/21, 3/31/21. Positive on 2/26/22
Unrelenting crying and irritability in > 30 minutes post vaccine. Poor sleep when sleeping. Awoke crying now 24 hours. Got fussy but not normal pre vaccine. Tylenol 0.4ml/E4l, warm compresses.
she almost passed out; dizzy; fast hearth beats; sick; high fever; throwing up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she almost passed out) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, COPD, Cholesterol, Hypertension and Cyst of kidney (Cyst in left kidney).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (she almost passed out) (seriousness criterion medically significant), DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea). At the time of the report, LOSS OF CONSCIOUSNESS (she almost passed out) had resolved and DIZZINESS (dizzy), HEART RATE INCREASED (fast hearth beats), ILLNESS (sick), PYREXIA (high fever), VOMITING (throwing up) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatments were reported. No concomitant medications were reported. Patient asked if she can receive another company's vaccine as a second dose.; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of loss of consciousness, nonserious unexpected dizziness, heart rate increased, illness, and expected pyrexia, nausea, vomiting. Event onset the same day as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.