chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving Fluzone intradermal, site swelling with red zone ~1.5 inches across.  Slowly went down over several days but I have a scar at injection site after six months.
Dizziness, syncope. Blood pressure 121/77  Vital signs were monitored, hydration was encouraged. The patient was instructed to go to the nearest ER or call 911 for signs and symptoms of hives or shortness of breath.
About 18 days after getting booster I am getting unknown rashes/hives.  Doesn't seem to be tied to any one food.
Ear on same side as vaccination, is showing serious signs of an ear infection.  Child in much pain throughout the night.
Hematoma to upper left thigh. Discomfort to injection site x 1 week.
pt says she had the common side affects for about a week then both legs began to itch. It turned into a red painful rash just below and just above both knees.  she is also itching around her neck but does not have a rash yet.  She still has fatigue and says she will go to urgent care today.
REDNESS, SWELLING AND HEAT SPREADED TO OUTER PART OF UPPER ARM ( FROM SHOULDER TO CLOSE TO ELBOW).
mom states inj site sore & redness an inch or two evening 5JAN99;next AM pt c/o arm hurting;mom stated more redness & aching;6JAN baseball sized redness/swelling;c/o itching & tingling;erythema;
Is here for evaluation of rash on his face and neck x 1 day Post vaccination On 7/3/17 with MMR, varicella and meningococcal vaccine, TDAP, Has developed a rash week later, yesterday, esp on face and neck spreading to chest wall, feels feverish also says he felt like he had painful nodes on his neck but went away. Only has mild itching and has not taken any pills. Denies sore throat, joint pain or neck pain. Erythematous maculopapular rash over face and neck spreading to upper chest wall. Has mild itching, some confluent, no vesicles or pustules and not weeping. Nursing note and vitals reviewed. No joint tenderness or swelling.
the patient became very ill; Symptoms of COVID-19; She described that the mRNA vaccine elevated her body reaction and it went into overdrive; Felt achy; Chills; extreme fatigue/Tired and flat on her back; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), PAIN (Felt achy), ILLNESS (the patient became very ill), SUSPECTED COVID-19 (Symptoms of COVID-19) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Felt achy), CHILLS (Chills) and FATIGUE (extreme fatigue/Tired and flat on her back). On an unknown date, the patient experienced IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), ILLNESS (the patient became very ill) and SUSPECTED COVID-19 (Symptoms of COVID-19). In January 2022, FATIGUE (extreme fatigue/Tired and flat on her back) had resolved. At the time of the report, IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), PAIN (Felt achy), ILLNESS (the patient became very ill), SUSPECTED COVID-19 (Symptoms of COVID-19) and CHILLS (Chills) outcome was unknown.            No concomitant product reported by reporter.  Patient had no reaction to first and second dose of the vaccine. Within 2 days of vaccination patient experienced extreme fatigue.  No treatment medication reported by reporter.
Rash and hives started 2 weeks after vaccination.  Diphenydramine 50mg was administrated on the initiated night followed by 50mg x 2 doses next mooring but it was not help at all. ER visit next day and prednisone 40mg  was given once at ER and discharged with a prescription prednisone 40mg once daily for four days.  Rash and hives were ongoing but controlled by Cetirizine
All of the same covid symptoms from when I had the Covid  virus in June 2020. I was in the hospital for a bit then. Cold child, all joints ache, headache, can?t breathe, tightness in chest.
Pt recvd vax & on 7JUN93 exp generalized motor sz & was presented to ER; lab eval revealed hemoglobin 11.9 & serum calcium 8.2; CT scan revealed a prominent lt occipital horn & an MRI revealed a lt occipital cyst; EEG revealed focal slowing
flu/cold symptoms; on and off sharp pain behind the sternum; lots of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu/cold symptoms), PAIN (on and off sharp pain behind the sternum) and FATIGUE (lots of fatigue) in a female patient of an unknown age 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) (unknown route) 1 dosage form. In July 2021, the patient experienced INFLUENZA (flu/cold symptoms), PAIN (on and off sharp pain behind the sternum) and FATIGUE (lots of fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA (flu/cold symptoms), PAIN (on and off sharp pain behind the sternum) and FATIGUE (lots of fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not provided.  Patient was due for her 2nd dose  on 19Aug2021 but the vaccine provider told her to call Moderna before they are able to give her the vaccine.
Shortness of breath and pain and tender to touch on left thigh. And also into calf on left leg, and this started about 2 weeks after the vaccine. I went to a ER and they told me I had nothing. I followed up with my primary and I was referred to pain management. I was upset and went to an urgent care and they put me in the ER and my d-dime was still elevated and it showed that I had a blood clot in the femoral vein. An MRI could not be done in my lungs because I am allergic to the dye. I took oxygen because I could not catch my breath. I was admitted to the hospital for 4 days before discharged. My short of breath is better but my leg is still swollen. They put me on a high dose of ELIQUIS 5mg 2 of them twice a day.
Patient told me before I gave him a shot, he sometimes faints.  Patient leaned back in the chair just in case he faints.  I gave him the shot then after a few minutes, he said he was going to prop his leg up on the chair.    After a few minutes later, he told he was going to lay on the floor just in case he faints.   Patient had a seizure for less than 1 minute.  Afterwards,  the patient told me he sometimes get seizures especially after vaccination, when he bumps his elbow,  or once when he got his ear cleaned.   He had test in the past to determine root cause but doctor do not know why he had seizure.   He said he did not want his girl friend to come in because he didnt want  her to freak out just in case he had a seizure.   I observed patient for full 30 minutes to make sure he was well to leave and his girl friend took him home.  I did not know about his seizure history and he did not indicate it on the vaccine form.
Messed up sinuses; Muscle ache; Chills; Fever; Flu like symptoms; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Messed up sinuses), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 13-Mar-2021, the patient experienced SINUSITIS (Messed up sinuses), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever ). At the time of the report, SINUSITIS (Messed up sinuses), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101.2 (High) fever of 101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant  medications were not listed. The treatment information was not provided.   Reporter did not allow further contact
This spontaneous report as received from a registered nurse refers to one or two patients of unknown age and gender. The patients' relevant medical history, concurrent conditions or concomitant medications were not reported. On unknown dates, the patients were vaccinated with the first or second dose of GARDASIL (dose, route of administration, lot# and expiry date were not reported). In approximately 2014 (reported as "maybe a year and a half ago"), the patients did not feel good, complained of headache and fever. The patients might have treated their headaches at home with unspecified remedies. The patients did not complete GARDASIL series because of the events. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
pt recvd vax;devel a little red raised knot & a warm area near inject site in the thigh; knot persisted x 3 wks;
hyporesponsive, persistent vomiting & cont lethargy;no high pitch cry;no redness or elevated temp; negative for sx like episodes;
This case was reported by a physician and described the occurrence of nausea in a 23-year-old female patient who received hepatitis A inactivated & hepatitis B recombinant vaccine (Twinrix). On 10 February 2004, the patient received the first dose of Twinrix (lot HAV239A4). Approximately 10 minutes following administration of Twinrix, on 10 February 2004, the patient experienced nausea and vomiting. The events resolved approximately 30 minutes later. On 24 March 2004, the patient received the second dose of Twinrix from the same lot as the first dose (lot HAB239A4). No adverse events occurred with the second dose of Twinrix.
Today, 2nd after the second shot, my eyes are almost totally swollen and red as if I were sunburned. I've never had any allergic reactions in the past, so it's a little new to me.  Ice patches and Benadryl are helping a little bit.
Severe headache; Nauseous; Temperature was 96.9; Extremely cold feet and hands; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Feb2021, the patient experienced severe headache, nauseous, temperature was 96.9 and extremely cold feet and hands. It was reported that the patient received the Covid19 vaccine yesterday morning and had side effects last night and called the 24-hour (insurance company name) Nurse with my (insurance company name) Provider and she told me to call this number to report side effects. The patient confirmed that it was the Covid19 vaccine of Pfizer. The intention of the call was to report side effects. The patient developed a severe headache immediately after and was kept under observation for 30 minutes, then released and came home. The headache continued most of the night. Also, the patient was very nauseous. My temperature was 96.9 and had extremely cold feet and hands. She just called on the advice of the 24-hour nurse associated with (insurance company name) Health Plan. Further probing could not be done as consumer hung up the call abruptly. Laboratory tests on 24Feb2021 included body temperature: 96.9. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Kounis syndrome: Acute myocardial infarct from histamine release.   9/30/08 Case closed with medical records that accompanied report. FINAL DX: allergic induced acute inferior wall MI secondary to histamine release; Kounis syndrome Records reveal patient experienced fever, HA, myalgias, nausea, vomiting, burning chest pain, sleep disturbance, pale, fatigue, injection site redness.  Hospitalized 9/6-9/8/08.  Cardio consult done & felt MI due to massive histamine release leading to coronary spasm.  Tx w/meds & improved.  D/C to home.  Readmitted to hospital 9/20-21/2008 for non-cardiac chest pain thought to be secondary to recent med change. Meds adjusted upward & also referred to allergist.
Pt recvd 3 doses of Engerix-B & titer checked & indicated no response; booster dose 5JUL91 & titer re-checked 5JUL91 & still no response;
Developed dizziness and unilaterial left profound sensory neural hearing loss 5 days after receiving intranasal H1N1.
Information has been received from a healthcare professional concerning an unspecified number of patients who since January 2015 had been vaccinated with doses of VAQTA (Batch and lot No. K004856, exp. 07-DEC-2016; Batch and lot No. L018499, exp. 25-FEB-2017; Batch and lot No. K026529, exp. 02-JUN-2017) (doses and sites not reported), vaccines who on unknown dates underwent temperature excursions. No adverse effects reported. Follow up information has been received from Medical assistant on 25-NOV-2015 via a phone call. The physician was unavailable at the time of call. The phone call was transferred to Medical Assistant. The M.A stated that information was not available on patients, over the phone. Please send a written request. This report is linked to MARRS 1510USA006129, 1510USA007263, 1510USA007264 and 1510USA007265 from the same reporter. Additional information has been requested. Narrative was updated.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L012034 with expired date 07-APR-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
ETOH cardiomyopathy. Medical condition is ongoing and chronic. Listed in medical history. Contributing factors include HTN, hyperlipidemia, cardiomyopathy. Subject admitted heavy ETOH consumption. Followed up with cardiologist.
Fever and chills, entire upper left arm was red and hot with a large welt around the injection area
Red rash about the size of a half dollar at injection site. Rash area is warm to touch.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 78 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016.
Provider administered an expired hep-B vaccine by mistake. Vaccine expired 1/24/21 and visit was on 2/3/21. No patient harm noted.    RN realized the error after patient left the clinic and scanned the vaccine vial for documentation.
Moderna vaccine booster given at a clinic and at this time we were unaware of the 20 dose limit for punctures of each vial.  The vial was punctured 28 times.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: PATIENT INDICATED HISOTRY OF DIZZINESS AND FEAR AFTER VACCINATIONS OR GIVNG BLOOD. AFTER VACINATIN, PATIENT ASKED TO LAY DOWN FELT A LITTLE DIZZY, PATIENT LAYED DOWN AND ELEVATED LEGS, AND FELT BETTER RIGHT AWAY, ASKED PATIENT IF SHE WANTED ABLUANCE, SHE SAID NO AND THAT SHE FELT BACK TO NORMAL. FOLLOWED UP WITH PATIENT AT THE END OF MY SHIFT, PATIENT FELT NO SYMPTOMS AND THANKED FOR FOLLOW UP.
Always have arthritic joint pain after any vaccine, but this booster elicited severe burning, stinging, pyrogenic arthritis that lasted 28 hrs.
After vaccine administration in an hour - about 5 - 6 pm - pt was in car and was witnessed by caregiver in rear view mirror to have very big eyes, staring off, head fell to ground, unresponsive after car pulled over - about 1 - 1/2 min taken to ER by ambulance. "groggy about 20- 30 min afterward the pt recovered. Vitals normal, left together waiting in ER without being seen by provider.
Information has been received from the father of a 21 year old female who on 08-OCT-2007 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and, right afterwards, experienced soreness at the injection site which lasted until the time of reporting. There was no concomitant medication. The patient had not recovered. Additional information is not expected.
Approx 12:30 AM - fever around 102.5; Around 05:00 AM - extremely fast heart rate. Paramedics at about 05:45 AM measured it at about 120bpm but confirmed that it was decreasing at this point. Peak heart rate had been at a higher level than this.   No treatment other than multiple days of rest (without work) and increase in anti-inflammatory substances such as turmeric.
11 days after the vaccine a red dot appeared at the injection site.  It itches and burns severely.  That was yesterday.  Today, the red is bigger and there is a lump forming under the skin.  Itch and burn is worse.
Patient tested positive for Covid-19 on 12/29/21 after being admitted to the hospital on 12/27/21. Patient developed pneumonia and died on  1/12/22
Expired dose was given; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves male patient of unknown age who received an expired dose of vaccine IPV (VERO) [IPOL] (Lot number: N1G11M, No dosing details reported) on an unknown date.  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  It was of actual medication error case due to expired vaccine used.  It was not reported whether adverse event was experienced.  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 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.  List of documents held by sender: none.
pt reported had welts, raised reddened areas on face & chest;pt is a PE teacher & was outside all day &  @ end of day (1 day p/vax) noticed welts;MD called & recommended oral DPH;2MAR stated rash improved;
Immediate, extreme swelling at site of injection, ice was applied to the area & swelling subsided in 25/30 minutes followed up with patient 6 hours later & pt. states swelling was resolved.
Heart palpitations began 7 hours after the second dose Pfizer vaccine. It's been 12 days since the dose was administered and I've experienced about 6 heart palpitation episodes, occurring mostly at night and varying from several minutes to as long as 6-7 hours.
patient developed rash 5 min after administration. Rash subsided within 10 min PT. observed for 30 min
Memory loss; On 01 Apr 2021, she received first dose and On 01 Jun 2021, she received second dose; Lung disorder; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Lung disorder), AMNESIA (Memory loss), DYSPNOEA (Shortness of breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 01 Apr 2021, she received first dose and On 01 Jun 2021, she received second dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 01 Apr 2021, she received first dose and On 01 Jun 2021, she received second dose). In June 2021, the patient experienced LUNG DISORDER (Lung disorder) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced AMNESIA (Memory loss). At the time of the report, LUNG DISORDER (Lung disorder) had not resolved, AMNESIA (Memory loss) was resolving and DYSPNOEA (Shortness of breath) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 01 Apr 2021, she received first dose and On 01 Jun 2021, she received second dose) outcome was unknown.            Concomitant medications and treatment medications were not reported.  On an unknown date, the patient experienced Covid vaccine caused memory loss. In June 2021, the patient experienced lung issues and shortness of breath.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporters causality for the events of lung issues, covid vaccine caused memory loss and shortness of breath was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.