chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had little infection; diarrhea; little bit of soreness the next day in arm; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 24Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had little infection. On 30Mar2021, the patient experienced little diarrhea and little bit of soreness the next day in arm. Patient stated, patient took the vaccine the 24Mar2021 and have been sit in the office. There was no yell, was quite feeling for about 4,5 minutes before patient took the shot that want to say it really. It would have been some mess was happened by visit. There was, patient just wanted to know it was alright to take it had little infection. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9263) via an unspecified route of administration on 03Feb2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced "positive COVID-19 test with symptoms" on 11Feb2021. The clinical course was reported as follows: "On 30Jan2021 I had a negative COVID-19 test, which I got every week because my wife is terminally ill. On 03Feb2021 I had the first dose of the Pfizer vaccine with my wife as well. On 10Feb2021, 7 days later, I started to be symptomatic. On 11Feb2021, I did a lab test and on 12Feb2021 I did an instant test, both came back positive. Today, on 14Feb2021, I had a monoclonal antibody infusion (the product was Bamlanivimab monoclonal antibody infusion)." The patient was scheduled to receive the second dose of the COVID-19 vaccine on 23Feb2021 (also reported as 24Feb2021) and asked if he should receive the second dose or not. When probed if side effects were due to the COVID-19 vaccine, the patient stated, "No, there must have been a window from when I contracted it. It is just the timing was altogether. Really, the other reason I called was to check on the status for the secondary but in my opinion no" (as reported). The clinical outcome of the event "positive COVID-19 test with symptoms" was not recovered/not resolved.
Patient developed bilateral leg pain, headache, chills, fatigue ~4 hrs. after vaccine. This progressed over a week & had shortness of breath, chest pain.
Generalized vaso-vagal response, given orange juice, returned to work.  Approximately 45 minutes after injection, employee returned with c/o persistent dry cough and developing scratchy throat with puffiness tearing and itching of eyes.
Breakthrough covid case. Patient tested positive on 5/20/22 with Abbott ID Now test at the Hospital.  Presented to ER with chills, sore throat, cough, shortness of breath, fever. Symptoms started on 5/17/22. Discharged home.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain) and RASH (severe rash all over the legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (severe rash all over the legs). On an unknown date, the patient experienced PAIN (Body pain). At the time of the report, PAIN (Body pain) outcome was unknown and RASH (severe rash all over the legs) had resolved.            Treatment information and relevant concomitant medications were also not provided.  Action taken with mRNA-1273 in response to the events was not reported.    Reporter did not allow further contact
It started with me feeling very tired and dizzy.  So I went home and went to bed.  Then I was shaking and chilled with my teeth chattering uncontrolably, even though I was completely (including my head) under two heavy blankets.  Next I vomited so hard that I was also incontinent at the same time.  The fever was making my head ache.  The chills and shaking continued for the next six hours with me having to go to the bathroom every half hour.  Because I was obviously losing a lot of fluid I tried to drink something but my throat was so swollen and sore that I could only trickle the fluid in.  My muscles were aching.  I am not allergic to eggs, latex, Thimerosal and I have never had Guillian Barre Syndrome.  In fact, I have taken a flu shot every year for more than a decade because I work at a center and come in contact with 3000-10,000 people on any given night.  I am not very young or very old and I am otherwise very healthy.
Had a hard time breathing/difficulty breathing; Had the hives/experience the hives in his throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had a hard time breathing/difficulty breathing) and URTICARIA (Had the hives/experience the hives in his throat) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Had a hard time breathing/difficulty breathing) and URTICARIA (Had the hives/experience the hives in his throat). At the time of the report, DYSPNOEA (Had a hard time breathing/difficulty breathing) and URTICARIA (Had the hives/experience the hives in his throat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Patient was taken to ER. Patient was administered with steroids for reaction and reported that luckily it turned out to be nothing.
sore arm for 4 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (sore arm for 4 days) in a 69-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm for 4 days). At the time of the report, VACCINATION SITE PAIN (sore arm for 4 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. .   This case was linked to MOD-2021-051495 (Patient Link).
patient suffered a 2-minute long seizure. She has a history of known seizure disorder. Her last sezure was 3 months ago. She also suffers from severe anxiety. patient was alert and oriented times 3 and refused transport to a local hospital by EMS.
She developed a raised, hard, red, itchy bump at the injection site the day of the injection. She complained about it hurting and itching. By Saturday morning, the bump was 2 1/2 inches in diameter, warm to the touch, and she was in a lot of pain. We took her to the doctor who prescribed an antibiotic (Cephalexin) and 5ml of Zyrtec.  She recovered over the course of a week, but she still has discoloration- what looks like a large bruise at the site as of today (which is 3 1/2 weeks after the shot was given).  She does not have pain at the site any longer and it does not itch.
Pt received Tdap in ER on 12/3/11 following a laceration. She called our risk manager on 12/13/11 to report that after receiving the Tdap she had a 2-3" area of redness, swelling & tenderness, but it was gone & she had no further problems. She called our risk manager because she had been to Health Dept & was told to contact hospital & report the reaction.
Patient requested Moderna Bivalent Booster but received the Moderna Monovalent vaccine.
On Feb 23rd I began experiencing intense itching and hives all over my body. It has been over 1 week and I am still experiencing itching throughout my body and dermatographia. The welts caused by light touch are very uncomfortable and add on to the already intense itching. Called my doctor and was ordered 5 days of prednisone, but experienced no relief. Started taking allegra and it makes the itching less intense and my skin less reactive touch.
Patient complaining of swelling and itching at the injection site along with fever and fatigue. Patient was educated that this is not uncommon reactions (with greater risk in low dose methotrexate patients) but insisted the event be reported.
PERSISTENT PAIN IN THE INJECTION SITE EVEN 6 MONTHS AFTER VACCINE WAS GIVEN
Developed Dermatographia from the Moderna Booster about a week and a half after the shot. I still have it after 2 Months and a week but it seems to be slowly getting better.
ADULT OBSTRUCTIVE SLEEP APNEA 5/31/2022 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT
The wrong student was vaccinated.  Staff went to a classroom and called for someone to get her flu vaccine. Patient got up and the VAR was handed to her.  She went to the nurse, who called her by name, and she was vaccinated.  The child that was to be vaccinated was also the same name but was not in the classroom that staff went to.
Presented with CP/SOB; dx Covid 1 week PTA; CXR consistent with atypicl multifocal PNA; Chest CT with groundglass airspace consolidation; afib with RVR on arrival; Labs: D-dimer 1.98; CRP- 21.13; Ferritin- 1562; Tx: started on Remdesivir, Vit C, Rocephin, Vit D3, Decadron, doxycycline, singulair, xarelto, zinc, cardizem; Fio2 via NC initially; 1/28 Fio2 via venturi mask 1/31 Fio2 on Bipap; started on Tigecycline & lovenox 2/2 To ICU; Intubated; initiated prone ventiliation 2/3 Rec'd Actemra; developed thrombocytopenia; lovenox d/c'ed; R Pneumonthorax (no CT required)  2/4 NGT with bloody drainage; nose bleed requiring packing; hgb stable 2/5 Pneumo resolved; amio started for aflutter 2/7 extubated to bipap; pt remained unresponsive after extubation; 2/8 Head CT "showed multiple areas of intraparenchymal hemorrhages and hematomas with vasogenic edema." pt transferred to other hospital for neurosurgery eval; pt reintubated at other facility due to airway protection; family discussion with poor prognosis and decided to transition to comfort care and pt subsequently extubated and died.
A report has been received from a Pharmacist concerning a 43 year old, female subject, who had been receiving nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated that the patient has administered full dose in 1 nostril clip moved which started on 11-SEP-2013. The outcome of the event of administered full dose in 1 nostril clip removed is unknown. The report was considered to be non-serious.
Pt. called office to report that starting 9/15/18 AM she started with headache, vomiting and dizziness that lasted into the next morning. Pt. was not seen at clinic due to happened over the weekend. Sx's Tx'd at home and resolved on their own.
After 1st dose: Skin itching starting on left arm and traveled upward to left side of neck.  Some torso itching.   After 2nd dose: Developed severe itching on torso and left side of body. Diagnosed with shingles after one month post vaccine . Continue with other skin issues and finally skin biopsy was taken 6 months after final dose of vaccine, diagnosing  PERIVASCULAR DERMATITIS.
Transient weakness of right leg, onset approx 10pm, went to bed approx 11pm still with weakness, awoke next morning feeling just fine.
Nauseous; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nausea in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced nausea (Verbatim: Nauseous).  The outcome of the nausea was not reported.   It was unknown if the reporter considered the nausea to be related to Arexvy.     It was unknown if the company considered the nausea to be related to Arexvy.   Additional Information: GSK Receipt date: 03-OCT-2023 This case was reported via interactive digital media. Follow up was not possible as no contact details were available.
Child was administered Hepatitis A, Varicella, MCV-4 and TB Test. Once he was in lobby to leave, he felt dizzy and fell. He was brought in to pt. room, vital signs taken; 116/64 69hr 18r. He was placed on exam table, mom stated he had not eaten, he was given some orange juice. After approx. 10 minutes, vital signs repeated; 114/64 83hr 18r. Child stated he felt better and was hungry. He walked around room, no further dizziness or complains. Discharged ambulatory with mom at side.
After 1st booster patient felt pain in her arm for a week and a half; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After 1st booster patient felt pain in her arm for a week and a half) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 030A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to cephalosporines) and Allergy to intravenous contrast media (Allergic to IV contrast). Concomitant products included GABAPENTIN for Migraine, ATORVASTATIN CALCIUM (LIPITOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (After 1st booster patient felt pain in her arm for a week and a half). On 20-Nov-2021, PAIN IN EXTREMITY (After 1st booster patient felt pain in her arm for a week and a half) had resolved.     Treatment information was not provided.   This case was linked to MOD-2022-584152, MOD-2022-584154, MOD-2022-584156.
Patient called 11/08/2005 and had described Pain in injection arm after flu shot, subsiding and state tingling in left hand, pinkie, and ring finger. Recommended to patient that if continues or worsens to contact his doctor and make appointment.
Left thigh red, warm to touch. Hardened itchy now, was painful. Physician diagnosed as abscess, prescribed antibiotics. Spoke with guardian 09-02-2014 site now clear.
It arm swelled to elbow and reddened around injection site sore to touch.  100.1 temp persisted 24 - 48 hours.  Symptom free on 3 days later on 10/13/09.
I took a home test (Binax) yesterday 15May2022 and it was positive; I took a home test (Binax) yesterday 15May2022 and it was positive; 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 male patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "I took a home test (Binax) yesterday 15May2022 and it was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive.  Clinical course: The patient stated that he received the second booster of the Pfizer-BioNTech COVID-19 Vaccine last tuesday 10May2022. His wife was diagnosed with COVID last monday 09May2022. She took a PCR test and it turned out positive. He took a home test (Binax) yesterday 15May2022 and it was positive and asked is there any correlation with people receiving the vaccine an getting a false positive and his understanding is that the vaccine puts in a fake spike protein, and asked is that right, like a synthetic spike on the COVID-19 vaccine , would that be picked up as an antigen.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness and swelling and induration right deltoid. Pain in neck, shoulders, right arm and fever. Decreased appetite.
unfortunately we were supposed to inject the GARDASIL 4 vaccine by ourselves and we weren't alert about shaking it before; This spontaneous report was received from a 27-year-old female patient reporting on herself. The patient's concurrent conditions, medical history and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (lot#, expiry date, dose and route of administration were not provided).  The reporter stated that she and her sister were supposed to inject the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine by themselves and they were not alert about shaking it before the injection (wrong technique in product usage process). It was reported that they were concerned of what would happen and what should they do.  This is one of two reports received from the same reporter.
my knees started hurting worse than they ever had before! all my joints started hurting, neck and shoulder especially. I also got a numbness in my left hand that came and went for a few days and then it stayed and it is still numb.   This nurse that I have worked with before told me I could come in  get the shot. She told me that I should come on Friday around 3pm  if I am there and they have vaccinated all the people with appointments I could get one if there was one left. I was turned away so I called around and finally found someone (he was a CEO or something) and he told me to come in to get the vaccine. He left just as I got there to go inside and get the vaccine. When I made it inside I told them he had told me to come and get the vaccine and the nurses told me I couldn't get it without an appointment. I was persistent and they finally took me back to get the vaccine. I hope they did not give me something expired or bad.
headache; body aches; chills; fatigue; fever of 102; This is a spontaneous report from a contactable nurse (patient). A 28-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on the left arm on 21Dec2020 07:30 at a single dose for covid-19 immunization. Medical history included anxiety and Covid-19. Prior to vaccination (covid-19 vaccine), patient was diagnosed with COVID-19 (Covid prior vaccination: Yes). The patient has no known allergies. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT), ascorbic acid (VITAMIN C), zinc and colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 at 18:00 hour, the patient experienced headache, body aches, chills, fatigue and fever of 102 around 6pm the same day receiving vaccine. The events were considered non-serious by the reporter. Since the vaccination, the patient has not been tested for COVID-19 (Covid tested post vaccination: No). No treatment was received for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (merck) PROQUAD (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Merck) PROQUAD: lot# L004219 with expiration date 23-JUL-2016 or lot # reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Adverse unexpected extreme dizziness, disorientation, headache and behind "eye" aches (most prominent on left side), along with mild fever of 100.4 degrees on day 6 after vaccine (prior to day 6 the dizziness and disorientation was mild).  Symptoms got increasingly worse and peaked around day 6 and 7 after vaccine.  Sporadic bouts of "dizziness" or "glitching and buzzy" feeling in head continue, but are not constant as they were in the 2-10 days following the vaccine.
This spontaneous report was received from a nurse  (also reported as healthcare worker) refers to unspecified number of patients of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date an unspecified number of patients were vaccinated with improperly stored ROTATEQ (lot # K020181, expiration date 24-JUN-2016). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient reported sores in mouth "popping up" the day after receiving vaccine.  Within 2 days (3 days after vaccine), sores forming on tongue and lips, crusting and sores at corners of mouth and lymph node enlargement with facial swelling on left side of face.