chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; Rash on my nose and below my nose and near bottom lip/ Facial rash; Back of my neck, I had a sharp little pain, stinging sensation; This is a spontaneous report from a contactable consumer (patient, self-reported). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 05Feb2021 at 13:30 PM (age at vaccination: 84 year), as a single dose for COVID-19 immunization at hospital or clinic. Vaccine was not administered at military facility. The patient's medical history included COPD, right sided congestive heart failure, pacemaker, AFib, and she has heart problems (she said that were usual for an old woman). Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior vaccinations. There was no family medical history relevant to adverse event. The patient reported that on 07Feb2021, she had a rash on her nose and below her nose and near bottom lip. On the back of her neck, she had a sharp little pain, stinging sensation on an unspecified date in Feb2021 and she suspected it was the first sign of a rash. Not certain if there was a rash on her neck or not and asked was this a possible reaction to the shot. The patient stated that last night she noticed a scaly patch on her nose that she felt with her finger, then this morning she looked at it good and it was actually a rash, after washing her face she noticed it's not scaly it's a rash, today the rash was between the lip and nose on her face, and on the bottom part of lip, it was slightly tender, and was unusual. On 08Feb2021, she saw rash and hives on the other areas on the face. She assumed her rash was worsening as it was spreading. Her second dose was schedule for 26Feb2021. There were no relevant tests. Outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Her throat hurts still, and when she eats her throat is tight.; Her throat hurts still, and when she eats her throat is tight.; Stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, She knows she has received 5 Pfizer vaccines though), for Covid-19 immunization; Bnt162b2 (Dose 2, She knows she has received 5 Pfizer vaccines though), for Covid-19 immunization; Bnt162b2 (Dose 3, She knows she has received 5 Pfizer vaccines though), for Covid-19 immunization; Bnt162b2 (Dose 4, She knows she has received 5 Pfizer vaccines though), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 30Oct2022, outcome "unknown", described as "Stroke"; OROPHARYNGEAL PAIN (non-serious), THROAT TIGHTNESS (non-serious), outcome "not recovered" and all described as "Her throat hurts still, and when she eats her throat is tight."  Clinical Course: She took the Corona booster on 25Oct2022. She had a stroke on 30Oct2022. She thought it had something to do with the booster. Her throat hurts still, and when she eats her throat was tight. She did not think she had recovered. Her throat hurts when she eats. Her family doesn't let her be by herself now. Her son and family were afraid she might have another stroke. She doesn't have her vaccine card with her information on it. She knows she had received 5 Pfizer vaccines though. This most recent booster was given in her left arm. She received it before noon that day. She was fine before this. She would still cut grass and drive her car. She could mop and vacuum. She didn't even feel bad before the stroke. She was older and felt like she should, but she didn't feel bad. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). There was no Family Medical History Relevant to Adverse Events (AEs). No Relevant Tests performed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient was a follow up from the ED from the day before with possible reaction/insect bite per ED notes. Today (06/15/17) site was red and warm to touch 3cm x 3cm. No other illness to report.  Sulfamethoxazole-Trimethoprim was prescribed. Mom was also instructed to do a cool compress to area and to return if getting worse.
Sore at injection site, red, swollen larger than a fifty cent piece. Advised patient to take BENADRYL, use cold compresses, and hydrocortisone cream. She will let us know on Monday 7/18/2016 if she needs further medical attention. She has not had a systemic nor anaphylactic reaction. I counseled her on systemic/ anaphylactic reaction and encouraged her to seek emergency help if needed.
Patient says he got cellulitis. Not sure from which vaccine. His arm was inflamed and red. He went to clinic and is on antibiotics. MD told him it may be from staph aureus on his skin.
Dry mouth; Metallic taste in my mouth; Blistery on her lips; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Feb-2021, the patient experienced DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips).   At the time of the report, DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Child developed fever up to 103F, headaches and vomiting a few hours after administration of LAIV.  Mom has been giving Tylenol q4hrs.
Extreme stomach cramps for 4 days.  Dizziness and nausea.  Headache.  Continued stomach pain for 7 days.  Had to change diet after vaccine to low fat no dairy and no wheat.  Gall bladder had been removed 3 years ago .  Stomach and chest pain felt similar to gall bladder attack.
5 days after the shot (April 6th) I had a swollen ball (lymph node?) near my left clavicle that was sore and I felt nauseous.
Patient experienced injection site pain, headache, muscle pain, chills, ran fever, injection site - large area swelling, redness, feverish to touch. Got better after 24 hours.
sx started 7/26-neg in am,  fever now with sore throat, congestion, chills, aches
Approx 30 hours after the injection, I began to see a patchy rash appear on my left, lower leg. Over the next several days, the patches spread down my leg and to my foot and blisters appeared.
Patient called office with complaint of rash all over, the size of silver dollars. Office was busy, advised to go to the emergency department as soon as possible.
This spontaneous report as received from a licensed vocation nurse on 13-MAR-2015 refers to unspecified patients. Nurse reported that probably up to 20 to 30 doses of improperly stored (Oka/Merck) VARIVAX were exposed to defrost cycle temperatures and administered to patients since 02-FEB-2015. No adverse events were reported. Product quality complaint was not reported. The outcome of events was unknown. Additional information has been requested.
He has had previous covid 19 vaccines with a little soreness in his arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He has had previous covid 19 vaccines with a little soreness in his arm) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He has had previous covid 19 vaccines with a little soreness in his arm). At the time of the report, PAIN IN EXTREMITY (He has had previous covid 19 vaccines with a little soreness in his arm) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was unknown, the number of previous doses received by patient. Treatment information was not reported.   This case was linked to MOD-2023-748395 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received and added references.
Moderna COVID-19 Vaccine EUA dose given 57 days after the BUD for refrigeration
Agitation, Tachypnea & CoughWheeze Narrative:  Patient has HX of anaphylaxis with animal allergies and has not received the flu shot in many years because reactions (Arm Swelling ) were getting worse. Today after vaccine administration she stated that she was having problems breathing and became tachypneic and that she felt like her throat was closing. She wanted her home dose EPI pen. Doctor administered clinic EPI pen and symptoms resolved quickly. Vital were stable. 911 was called per protocol but patient refused going to ER for 6 hours of monitoring per protocol. form signed.
Pt reported today (10/29) that she had a rash from injection site to elbow a few days after receiving her flu shot. She reported it to her doctor but reported no pain/discomfort with the rash and the rash is no longer present.
PT approached staff to report extreme body heat, itchy feeling, and also has allergies to sulfa, doxy, Bactrim. PT states similarity to allergic reaction to ABR.
Pt began crying w/in 1-2 hrs p/immun & cried for 6-8 hrs (persistent & high pitched);
Case number PHEH2014US025140, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 48 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
lt thigh presented in AM w/silver dollar sized lump 2" from inject site-appears red-denies warmth-t100 fever as well-mom providing APAP;
At about 5 hours after receiving the vaccine at around 5 p.m., I developed a pounding headache. As the night continued, if I moved my head at all it would cause severe pain and a pounding headache. Additionally, I experienced shooting pains through my neck and back, I became extremely hot to the touch, yet I felt freezing cold and could not stop shivering. Then I developed severe aching and tingling from the top of my head to the tips of my toes, with excruciating lower back pain and I could feel my heart beating very fast. My entire body was tense and sore. These symptoms did not alleviate for 12 hours and I could not fall asleep due to the discomfort I was in. I finally was able to fall asleep at 6 a.m. after the aching/tingling/pain/hotness subsided (about 12 hours after side effects started).
VACCINATOR WAS REMOVING THE CAP FROM A CLEAN NEEDLE AND SLIGHTLY STUCK HR LEFT MIDDLE AND RING FINGER.  VACCINE WAS WASTED.  VACCINATOR WASHED OFF AREA WITH SOAP AND WATER.  THIS WAS A CLEAN NEEDLESTICK.  SAFETY, DIRECTOR WERE NOTIFIED.
My wife also experienced a minor reaction after her 1st shot.  The small lymph node under her jaw was a bit swollen.  It hasn't disappeared yet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left (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: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "My wife also experienced a minor reaction after her 1st shot.  The small lymph node under her jaw was a bit swollen. It hasn't disappeared yet".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced pain and swelling in the shoulder, difficulty moving the arm the following day of the administration, difficulty moving her arm resolved two days following vaccination. Pain was still experienced 7 days following vaccine administration.  Patient stated the vaccine was administered too high on her arm.
Information has been received from a health professional concerning a 12 month old male who on 7/26/05 was vaccinated SC with a 0.5ml dose of MMR (lot # 649515/0937P). Concomitant therapy included pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 7/26/05, the day of vaccination, the patient complained of a fever. On 7/27/05, the patient suffered from a fever and loss of appetite. On 7/28/05, in the doctor's office, the patient had a fever of 102.7 degrees F, loss of appetite, and suffered a febrile seizure. The patient was treated with Lorazepam. The patient was admitted to the hospital until 7/30/05, and rechecked at the office on 8/1/05. The patient was noted to be fully recovered at that time. The reporter considered fever, loss of appetite, and febrile seizure to be other important medical events (OMIC).
Chills 3:00am, nausea 4:00am, vomiting 5:15am,  headache 8:00am
expired dose of ADACEL was administered to a patient with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 25 years old male patient who was administered expired dose of Adacel with no reported adverse event, after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Jun-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6702AA and expiration date:20-Jun-2022) at a dose of 0.5ml via intramuscular route in the left deltoid as prophylactic vaccination.  On 21-Jun-2022(latency: same day), the patient was administered expired dose of adacel with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken:Not applicable.  It was not reported if the patient received a corrective treatment for the event .   At time of reporting, the outcome was Unknown for the event    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 the guidelines. 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.
Severe headache; Loss of appetite; High fever (102.5); Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00, (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19.The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 18:00, the patient experienced severe headache, loss of appetite, high fever (102.5), body aches and fatigue. On 21Apr2021, the patient underwent body temperature test and the result was 102.5 (unspecified units). The events resulted in doctor or other healthcare professional office/clinic visit. 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 severe headache, loss of appetite, high fever (102.5), body aches and fatigue were resolved on an unknown date in 2021, which lasted for 9-10days.
Nausea, light headed, fatigued, headache, mild itching Mild itching , light headed, and headache went away overnight.  Nausea and fatigue still experiencing on the second day
12 hours after receiving the vaccine, I experienced fever with sweats, chills, rigors, myalgias, headache and sinus congestion that lasted almost 36 hours.
5:00 pm same day as injection, body aches, headache, fever, severe chills, nausea, lightheadedness, which lasted until fever broke two days later around 9 am and then felt much better.
1JUL97 pt felt sick & went to ER;10 days later 11JUL97 pt was hosp via the ER w/ c/o sore throat, fatigue, chills, n/v & gen body aches;21AUG97 elevated sed rat & elevated rheumatoid arthritis profile;cough GI irritation;
Afloria used on 10/10/08.  4 days later itchy rash on chest.  Presented today for care for rash.  No other obvious etiology found.  Possible reaction to vaccination.  Rash is still present to date.
Patient woke up from nap shortly after returning home from office. Mom reported crying inconsolably with redness on left leg spreading from injection site to further down the leg. No swelling, mildly warm to the touch, patient irritable when leg was touched.  Patient returned to office at 330pm after being triaged by our phone nurse. Patient was given Tylenol in office as parents had not done so and re-evaluated by Dr. who believes patient may be reacting to one of the vaccines and not the technique. Reviewed with parents signs and symptoms to watch for and advised that next set of vaccines will be broken up.
Swelling and soreness in mouth - gums - checks. Very dry. As of 3/22/21 sores almost gone but dry mouth has not. No issues prior to having vaccine.
A nurse reported that the day after receiving vaccines the patient developed a high fever and pain. She recovered. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Acel-Imune lot 469-396 or the concomitantly administered vaccines. A copy of this report has been forwarded to Merck, manufacturer of MMR.
01/01/22 presents to ED for "worsening SOB" "diagnosed w/ COVID 19 on 12/23/21" "w/o any significant medical hx"
This spontaneous report was received from a pharmacist refers to a male patient with currently 73 years old. On unspecified date back in 2012 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous in the patient's arm (dose, lot number and expiration date were not reported). Concomitant medication, medical history and drug reactions and allergies were not reported. On an unknown date the patient experienced painful lump in his arm at the injection site. The outcome of painful lump in the patient's arm at the injection site was reported as not recovered/not resolved. The patient did not receive any treatment for the adverse event and did not seek medical attention. Additional information has been requested.
pt recv vax & devel vesicles & papules on abd, back, face & neck & was described as a mild case;
An expired Covid-19 pfizer vaccine was administered to the patient on 4/25/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Left messages on 5-9,5-10, and 5-11 for patient to return our phone call.
Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Moderna, Dose Number: 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 14Aug2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jul2022 at 13:15 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 02Oct2022 at 14:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing), notes: Both under control with medications; "High cholesterol" (unspecified if ongoing), notes: Both under control with medications. Concomitant medication(s) included: ATORVASTATIN, start date: 01Apr2021, stop date: 06Oct2022; REMICADE taken for psoriatic arthropathy, stop date: 17Sep2022.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Jul2022 at 13:15, outcome "unknown", described as "Name of Drug as Reported: Moderna, Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, latency 16 days 11 hrs after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2022) Negative, notes: tested negative on 17Oct2022, 19Oct2022 & 22Oct2022; (19Oct2022) Negative, notes: tested negative on 17Oct2022, 19Oct2022 & 22Oct2022; (22Oct2022) Negative, notes: tested negative on 17Oct2022, 19Oct2022 & 22Oct2022; (23Oct2022) Positive, notes: tested positive for COVID the evening on 23Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks reported as yes. Vaccine lot unknown reason reported as unable to locate or read the details. Patient took Paxlovid on Friday 14Oct2022 and patient started developing cold symptoms on the morning of 23Oct2022 and tested positive for COVID the evening on 23Oct2022. Had very bad head cold the day of 24Oct2022. Patient was on Remicade for psoriatic arthritis. Last dose was on 17Sep2022. Patient was immune compromised from this drug. Other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
started with a asthma cough, then noticed chest was tight, was reported be be very flushed, and it felt like there was a very heavy wieght on my chest, burning ache all down my arm, and within a half hour, throat felt constricted