chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom states deltoid warm to touch with redness after receiving vaccines. Redness extended from elbow to shoulder. No treatment needed.
Patient fainted a few seconds after receiving vaccine and regained consciousness a few seconds afterward and started to feel better.  I elevated her feet on the chair and monitored patient until she fully recovered and then also asked her mom to stay a long with her to be monitored for at least another 15 min. Patient has fully recovered from incident.
I started getting chronic diarrhea around March 1st. It showed up in a routine VAERS screen so now I am filling this out. I don't believe it was related to the vaccine but the rep from VAERS said to report it anyway.
Starting around 9PM on 04/03/2021  I noticed itching and bright red hives on my neck, shoulder, arms, and torso, which soon spread to my waist/upper thigh area. The largest patch was on my right shoulder. I took a dose of Cetirizne, and went to the Emergency Room, as the hives were still spreading. I was examined and given 25 mg Benadryl and 60 mg Prednisone. I was told to take 25mg Benadryl every 8 hours, and 40 mg Prednisone every morning for the next three days. By midnight the hives were less itchy and a more dull red color. On 4/4/2021 the hives were reduced, and significantly less itchy. On 4/5/2021 at 10:00 AM the Hives had spread to bright red patches on the lower legs/tops of feet. Still have on more day of Prednisone to take.
Pfizer / BioNTech  start: 27Nov2021 /  COVID-19 Treatment start: 17Jul2022; Pfizer / BioNTech  start: 27Nov2021 /  COVID-19 Treatment start: 17Jul2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech  start: 27Nov2021 /  COVID-19 Treatment start: 17Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had sore throat, then lots of mucus and a low fever. I am still having effects four days later and tested positive yesterday; Positive, notes: 11 days after first testing positive. Therapeutic measures were taken as a result of covid-19. Patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case received from a Healthcare Professional on 05 October 2011 under the reference number 11-0721. A 48-year-old male patient, with unknown medical history, had received his intramuscular dose of FLUZONE (batch number UT445AA) in the left deltoid on 03 October 2011. The patient did not have illness at time of vaccination. It was not reported if the patient had experienced adverse event following prior vaccination. It was unknown if the patient had received concomitant therapy. On 03 October 2011, the patient experienced nausea and diarrhea. He recovered on an unspecified date.
No allergies noted, no medications taken, vaccine screening completed, no issues w/HPV #1. HPV #2 given 12/3/16 w/in 5 minutes of administration patient fainted, falling from exam table to floor, hitting head first - neuro check completed, vitals taken, O2 near by if needed. Pale in skin color, threw up (vomited) a few times. Called 911, in about 10 minutes they arrive. A and Ox3, vitals monitored until rescue squad arrived. Syncope episode.
3x5" wheal at injection site and getting bigger, whole body itch, whole body/joint ache, feels like flu but no fever.
Small painful subcutaneous bump on the bottom of my foot.  Although small, it is interrupting my walking.  I haven't ever had issues like this before leading me to think the cause may be related to the vaccine.   I'm reporting this in case there is some sort of pattern that others may be reporting.   I say it's a small chance that it's related to the vaccine, but I wanted to report it since it was so unusual for me.  In item 21 below I am checking Dr. visit.  Although I have not visited a doctor yet, it looks as if I may have to.
Vaccination site warmth; Vaccination site induration; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (Vaccination site induration) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer.    The patient's past medical history included COVID-19. Concurrent medical conditions included Breast cancer. Concomitant products included LETROZOLE for an unknown indication.   In December 2020, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. In April 2021, 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 WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (Vaccination site induration) and CHILLS (chills). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (Vaccination site induration) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.  Patient was taking Ibrance 125 mg table for 3 weeks on and 1 week off with letrozole daily. Patient was scheduled for 2nd dose on2nd weekend of May 2021.
Patient had headache (5-6/10); starting one week ago, duration 3 days. His headaches are unusual. Took Tylenol, and resolved on its own. He also has tiredness with exertion since first dose. He felt "a little tired" and "out of shape," but denied SOB.
Redness, itchiness around injection site right arm  x 2 days, resolved after 3 days.
flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.  Additional details were received as follows: The age at vaccination was not was reported. The age group selected as per vaccine specification.  The patient reported flu like symptoms after receiving a dose of shingrix. This case was linked with cases US2019AMR165395 and US2019AMR165390, reported by the same reporter.
Sore arm that moved up into neck area and down under arm below the arm pit area, feverish, chills, lump in neck area the size of a jelly bean, very tired, headaches. Went into the doctor's office on Monday...starting to feel better but lump was still there. Dr said everything looked okay and to just keep watch that lump didn't grow or move. As of today, still has the lump but no pain
Within five (5) minutes of vaccination patients right deltoid area became inflamed and began swelling. By 15 minutes after administration of vaccines right deltoid was red, hot, tender and swollen to 1 1/2 times normal size. Pt. was given BENADRYL. Cool compress was applied to the area. He did not develop any further symptoms.
Went to ER 20 hrs later with swelling & redness (R) deltoid & redness in (L) deltoid.
weakness; tingling face; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and PARAESTHESIA (tingling face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 ASTHENIA (weakness) and PARAESTHESIA (tingling face). At the time of the report, ASTHENIA (weakness) and PARAESTHESIA (tingling face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient enquired whether she should take the second dose. Treatment information was not provided.  Concomitant medications were not reported.
Sometime between my first shot and the second shot I noticed ringing in my ears.  Continues until this day.  Steady ringing.
approx 4 hrs p/vax mom stated pt was very sleepy, jerky movements of upper body, & staring-little or no response to stimuli; t104.6;
04/27/2022 I had vaccination. 07/11/2022 I was exposed to a worker that came to my house. 07/14/2022 I had a sore throat. I think I tested COVID-19 positive that day at home. It came up positive. 07/15/2022 clinic COVID-19 test was positive. I was prescribed PAXLOVID. I was only allowed to take 2 days worth before the side effects were too much. I talked with my doctor and agreed I would stop taking the medication. I still am having sinus congestion. 04/2022 I had a Tetanus shot around same time as vaccination. I can not remember the date.
Less energy on 7-16-11; started with itching, swelling (periorbital), fever & rash all over body on 7-17-11 & went to ER 7-18-11 & treated with 2 medicines.
received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication is repported
symptoms started 2 days after getting the COVID vaccine having body aches, cough, headache, fatigue, diarrhea and vomiting. Symptoms are getting worse and not better. Cough is productive thick white sputum with SOB.  It has been 18 days with symptoms that are not improving. Scheduled appointment with doctor for further treatment. Canceled appointment for 2nd COVID vaccine
Administered shot at 4 month interval after completing primary series of Moderna (2nd shot). Regulatory Authority recommends boosters at the 6 month interval after completing primary series of Moderna. Booster shot was administered two months earlier than intended. Patient was counseled on adverse effects to watch for post vaccination (fever, chills, fatigue, body aches) and she was also informed about the error. No other adverse details to report at this time.
Low grade temp, O2 of I2, Local swelling any 2 local swelling and redness and tenderness and location of Dtap hives per MOC ER report. 5/14/06 local swelling and redness only cellulitis. Min erythema, tender and edema at MMR site left arm. 5/15/06 our office min edema and tenderness at Dtap site erythema. Puncture wounds from needle only all other locations
Dizzy - started 8 hours post injection. Swelling of eyelids - started 8 hours post injection. Tired.
Fatigue; Fever; Chills; Severe achiness; This case was reported by a nurse via sales rep and described the occurrence of fever in a 64-year-old patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date unknown), (batch number P2275, expiry date unknown), (batch number 454S2, expiry date unknown) and (batch number YA724, expiry date unknown) for prophylaxis.   On 12th July 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever, chills, pain and fatigue. On an unknown date, the outcome of the fever, chills and pain were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the fever, chills, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The reporter was not sure which one was the correct batch number, because both appeared on separate screens. The patient experienced fever, chills, severe achiness that lasted for 10 to 14 days. The patient experienced fatigue, 2 months before the date of reporting it started to lessen.  Till the time of reporting, the symptoms were not cleared and the patient had to miss work due to it.
Pt developed urticaria the day after receiving Flu Vaccine.  Hives worsened despite usual daily doses of Zyrtec and Singulair.  Parents took pt. to ER-(X4 by 12/10/2007) Over those 4 visits pt was treated with Zantac, Benadryl,and Prelone and given Depo-Medrol, Solu-medrol and epinephrine. Pt continued to have urticaria. Pt also taken to allergist 12/10/2007. Pt saw Primary Care Physician 12/11 and 12/12/2007. Urticaria much improved 12/12/2007. "Recovering"
Patient had vaccine in Left arm.  That same night patient had temp of 100.1 and the right neck at base of head to shoulder began to hurt patient was unable to swallow without pain in the next few days.  Patient went to ER and was hospitalized for 2 days treated with IV steroids and 2 antibiotics (clindamycin and acyclovir).  Patients symptoms resolved and patient was discharged without additional issues.  The admitting physician was unable to identify the cause of these symptoms, but the vaccine could not be ruled out.
About 3 am after the injection I woke up with severe chest pains and headache and went to the ER.  I was admitted for 2 days and was released with a prescription of  Isosorb Monoer, Metroprol, aspirin which is used as a blood thinner.  The diagnosis and prognosis was severe migranes and cardioartery disease.
Approximately 0.1 ml of vaccine dose  leaked back out of the vaccine site after the injection,  There was no appreciable bleeding associated with the leakage.
Area of induration and Erythema in left thigh at site of injection. Area is 3x5 inches approx. Non tender to palpation, Gave Atarax syrup 1/2 tsp TIO and Prelone syrup.
Extreme tiredness the day of the vaccination, for about 10 days I experienced weakness and slight vertigo, along with headaches.
Information has been received from a physician concerning a 11 year old female patient who on 21-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 660499/0132X).  On 09-SEP-2008 the patient was seen in the physician's office with the complaint of chicken pox.  The patient's brother also developed chicken pox after vaccination with VARIVAX (Merck) (WAES# 0809USA02380).  Additional information has been requested.   This is one of several reports from the same source.
pt mom stated pt broke out in fine red rash all over body & had fever of 102;
Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who experienced accidentally received a 0.5 ml dose of vaccine ActHIB lot UI903AA (exp date: 21Nov2019) via intramuscular route in the right thigh with a 0.5 ml (full dose) of PENTACEL lot C5506AA (exp date: 05Sep2019) via intramuscular route in the left thigh on 23-Jul-2018 instead of HEPATITIS B VACCINE (lot number unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTARIX for Immunisation. This is a case of actual medication error due to wrong vaccine administered and extra dose administered. It was unknown if patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
She has been vaccinated with the Pfizer COVID vaccine, and is currently COVID positive; She has been vaccinated with the Pfizer COVID vaccine, and is currently COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 22Sep2021 as dose 2, single (Lot number: FE3592) at the age of 42 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 22Sep2021 as dose number unknwon, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19", start date: 2021, stop date: 2021, notes: She got COVID the first time before the vaccines in Spring of 2021. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "not recovered" and all described as "She has been vaccinated with the Pfizer COVID vaccine, and is currently COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive, notes: She was COVID positive. She took a home test on Monday at 03:00 am. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She was COVID positive. She took a home test on Monday at 03:00 am. She was starting to have extreme pain from COVID. She went to the doctor. She was prescribed Paxlovid. She had pain for 3 days and only slept for 6 hours so her doctor said to try Paxlovid, Batch/lot number: 663457, Dosage text: 5 Blister cards, 300mg with 100mg dose pack, Tablet, Expiry Date of Paxlovid: Feb2024. The problem improve as a result of Paxlovid. Paxlovid: Dosage permanently discontinued. This was her second time having COVID. The first time was before her vaccines, but she has been vaccinated with the Pfizer COVID vaccine. She got her prescription filled and took it as soon as possible. She was still battling COVID though. She got two doses of the Pfizer COVID vaccine: first dose: Pfizer BioNTech given on 17Aug2021, lot number: FC7180 or could be FC3180- the handwriting is terrible on the card. Second dose: lot: FE3592; given on 22Sep2021. She got COVID the first time before the vaccines in Spring of 2021.This is the first time she has had it since the vaccines. Prior Vaccinations (within 4 weeks): If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s):Vaccine Name: Flu vaccine. No concomitant drugs taken within two weeks before the event onset. No Relevant Tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
For the first 10 hours I had a sore arm. 10-12 hours I began having weakness, fevers, chills, bodyaches, low back pain, intermittent neck pain. Following day I had the same symptoms in addition to left sided axillary lymphadenopathy w/ numbness of L hand 4th & 5th fingers and mild cough.  Currently I am about 52 hours post vaccine with left sided axillary lymphadenopathy and intermittent numbness of left 4th and 5th fingers.  Other symptoms have improved.
Patient received vaccine on March 11, 2021.  Became symptomatic on March 22, 2021 and went to the hospital on March 23, 2021.  Per hospital records she reported the following symptoms: right sided weakness, AMS
Dizzy - couldn't walk - stood up and had to sit back down - called a nurse and spoke w/ her, ruled out low/high blood sugar and low/high blood pressure. Went to bed and woke up and was still dizzy so stayed in bed all following day and around 10PM 9/5/13 went away.
Likely vasovagal syncope shortly after covid-19 vaccine. Patient left the clinic shortly after his covid-19 vaccination. However, he was feeling a little bit off/queasy.  While sitting in the car with his dad's friend who was driving him home, he felt lightheaded and had a brief loss of consciousness. Patient did not have any tongue biting or incontinence and able to wake up immediately after and answer questions. Patient notes that he has had a vasovagal syncopal episode several years ago (no further information was disclosed about that episode). Patient seen in ED and was able to discharge home.
This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (I started itching all over) and VACCINATION SITE PAIN (My injection site was also sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (I started itching all over) and VACCINATION SITE PAIN (My injection site was also sore). On 01-Mar-2021, PRURITUS (I started itching all over) had resolved. At the time of the report, VACCINATION SITE PAIN (My injection site was also sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment information was not provided.