chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild pain/soreness at the injection site; This is spontaneous report from a non-contactable consumer, the patient. An adult patient of unknown age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced mild pain/soreness at the injection site on 18Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken as a result of mild pain/soreness at the injection site. The clinical outcome of mild pain/soreness at the injection site was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Localized erythema at injection site, pain, inflammation of lymph nodes in right axillary region, chills, area warm to the touch.
loss of appetite; loss of taste; headaches; fatigue; This is a spontaneous report received from a contactable consumer or other non hcp (patients son). This consumer reported for mother. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) (age at vaccination was reported as 77 years) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number not reported) as single dose for covid-19 immunization. Patient's Medical History including any illness at time of vaccination was reported as none. The patient's concomitant medications were not reported. The patient experienced loss of appetite, loss of taste, headaches, fatigue on an unspecified date. Additional context reported as report that his 78-year-old mother experienced side effects after administration of the fist dose of Pfizer Covid-19 Vaccine. The patient has already gone to the physician for the management of the symptoms. The patient was dosed with first dose of Pfizer Covid-19 Vaccine less than 2 weeks ago but does not have the actual date of administration or the Pfizer Covid-19 Vaccine Lot and things like that. The patient underwent lab tests and procedures which included chest x-ray: not have pneumonia on 09Jul2021. She does not have pneumonia. The clinical outcome of the events was not recovered.  Information on the lot/batch number has been requested
Janssen COVID-19 Vaccine EUA  Between 6-7 hours after receiving the vaccination I started to feel increasingly cold. After putting on a sweater and trying to stay warm I also started to get sore. Around 8-9 hours after vaccination I decided to go to sleep to hopefully sleep of the symptoms. I was extremely cold and sore, but attempted to sleep. Around 12 hours after the shot the fever broke and I was sweating. After that I slept much better and woke up the next morning feeling fine. No further issues.
Case number PHEH2012US023403 is an initial spontaneous report received from a consumer on 27 Nov 2012. This report refers to a male patient whose medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. On an unknown date he experienced flu like symptoms. The second day after injection, he experienced a sharp pain along his spine and was unable to walk and get around by himself for 3 weeks. It was reported that he still complains of some pain when walking and was unable to go to physician. The outcome of the event was not reported. No further information was provided.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient called back regarding reaction to the vaccine. She had noticed few rashes on both of her legs. She took xyzal (antihistamine) then the rash started getting better and she will contact her doctor to follow up.
Headache; Runny nose; Cough; Back pain; Cold; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (bnt162b2, formulation: Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 21May2021 at 10:30 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22May2021 the patient experienced headache, runny nose, cough, back pain and cold. Patient had undergone unspecified lab tests a month ago before the shot on an unspecified date and not recently. Patient had mentioned the second dose will be taken on 09Jun2021. Patient didn't receive any other vaccinations with in 4weeks of vaccination. The outcome of the events headache, back pain was recovering whereas outcome of other events was unknown.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 64-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 23-APR-2019, the patients were vaccinated with improper stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted with properly stored sterile diluent. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Pt given Pneumonia vaccination 14NOV. Unknown to MD was that the Pt had received Pneumonia vacc one yr earlier.  On 15NOV arm reported as swollen and black.  16NOV89 on exam, arm was swollen and red about 1 ft w\small bruise at inject site
Insomnia; Injection site pain; Joint pain in her fingers and hands; Muscle pain in her fingers and hands; Fatigue; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), INJECTION SITE PAIN (Injection site pain), ARTHRALGIA (Joint pain in her fingers and hands), MYALGIA (Muscle pain in her fingers and hands) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), SERTRALINE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced INSOMNIA (Insomnia), INJECTION SITE PAIN (Injection site pain), ARTHRALGIA (Joint pain in her fingers and hands), MYALGIA (Muscle pain in her fingers and hands), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, INSOMNIA (Insomnia), INJECTION SITE PAIN (Injection site pain), ARTHRALGIA (Joint pain in her fingers and hands), MYALGIA (Muscle pain in her fingers and hands), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatments were not provided.   Reporter did not allow further contact
Within 24 hours of vaccine dose, patient had one episode of blood in urine. No further episodes. No other symptoms
Has a little sore throat; He is not drinking anything; not eating anything; He gets up and plays a little but he gets real tired; He doesn''t feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FK5127) as dose number unknown, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Has a little sore throat"; FLUID INTAKE REDUCED (non-serious), outcome "unknown", described as "He is not drinking anything"; DECREASED APPETITE (non-serious), outcome "unknown", described as "not eating anything"; FATIGUE (non-serious), outcome "unknown", described as "He gets up and plays a little but he gets real tired"; MALAISE (non-serious), outcome "unknown", described as "He doesn''t feel good".  Additional information: NDC number, expiry date and UPC number were reported as unknown. The patient got the Covid virus shot on Wednesday, wanted to see how long it lasts. He had a little sore throat, he was not drinking anything and not eating anything since he got up today. He did told that 10 o'clock last night, the Covid shot was given Wednesday. He gets up and plays a little, but he gets real tired. Wanted to know if getting him the flu shot (unspecified flu shot) and the covid shot at the same time was going to affect him worse. Unknown if patient took flu shot and covid shot at the same time. He doesn't feel good.  No follow-up attempts are possible. No further information is expected.
Patient came in for their appointment for a 1st dose of Moderna. Patient was screened by myself and then was immunized by one of our nurses. When they were being entered into the database, we noticed that they had received previous doses of Moderna (7/31/2021, 8/28/2021; confirmed with EMR) [name spelt differently on database and our EMR instead of as written on form. Patient did not report being immunocompromised so patient should have received booster instead of a full dose of Moderna. Patient felt fine after their waiting period and a note was made under their second appointment.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and dose unspecified) "In the back lower area of the arm" instead of in the deltoid muscle. No adverse effects reported. Additional information is not expected because reporter refused additional contact.
Information has been received from a physician concerning a male who in September 2005, was vaccinated with a 10mcg first dose of hepatitis B virus vaccine rHBsAg (yeast). The physician was unsure if the vaccine administered was hepatitis B virus vaccine rHBsAg (yeast) or hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B). "Sometime after the first dose" the patient developed bells palsy "from the vaccination" Unspecified medical attention was sought. The patient's outcome was unknown. There was no  product quality complaint involved.
Pt vaccinated with HIBtiter/MMR administered at approx 1130AM on 25SEP90 8:30PM - mother reported rt leg shaking, then whole body shaking & eyes rolled back. Afterwards drowsy, temp 104F at that time. temp folowing day 100. Developed rash.
This case was reported by a physician and described the occurrence of unintentional overdose in a 2-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PENTACEL. Previous and/or concurrent vaccination included (non-gsk) PREVNAR; non-GSK manufacturer given on 20 July 2009; (non-gsk) ROTATEQ. On 20 July 2009 at 14:15 the subject received 1st dose of PEDIARIX (unknown left thigh) and unspecified dose of PENTACEL (unknown) and experienced unintentional overdose. The pediatrician was concerned that the subject received PEDIARIX and PENTACEL in the same day. Follow up received from healthcare professional 11 August 2009: The subject was male. The subject had not experienced adverse events following previous vaccination. The healthcare professional indicated that the subject experienced business following vaccination with PEDIARIX and PENTACEL, no more than usual, which resolved the next day and the subject was fine. The time to onset since vaccination was not specified. The healthcare professional did not consider the events serious and identified the suspect products as PEDIARIX and PENTACEL. The healthcare professional considered the events could have been associated with erroneous administration; subject received PENTACEL and PEDIARIX in error, no adverse effects.
7/25/17 Hard knot at injection site 7/19/17. Knot went down 7/20/17. Then area turned red. Red area 6 ins. in diameter - by 4 ins. across. Circled area, will recheck. Area checked by FNP - patient on 7/27/17.
None. No Symptoms. Facility is in outbreak testing.  Resident was vaccinated with the second shot 1/8/21 and tested positive today 5/26/21
The left side of my face felt numb starting after the first hour and for the whole day. Also, my throat was slightly tightening; The left side of my face felt numb starting after the first hour and for the whole day. Also, my throat was slightly tightening; This is a spontaneous report from a contactable Nurse (Patient, self-reported). A 39-years-old not pregnant female patient received first dose of ( COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29 Jan 2021 09:15AM as an unspecified dose for covid-19 immunisation. Medical history included hypothyroid, known allergies was No. Concomitant medications included levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid], vitamins. On 29 Jan 2021 10:00, the patient experienced the left side of my face felt numb starting after the first hour and for the whole day. also, my throat was slightly tightening. Treatment received for the evets was unknown. The clinical outcome of the event was recovered on unspecified date of 2021. Information about lot/batch number has been requested. Follow-up (16 Apr 2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
palpitations 3 hours after receiving vaccine; This is a spontaneous report from a non-contactable other healthcare professional. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Jul2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history, and concomitant medications of the patient were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 31Jul2021, the patient experienced palpitations 3 hours after receiving vaccine. Still had intermittent palpitations 10 days post vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event palpitations and included treatment with EKG. On an unknown date in Jul2021 the patient underwent EKG (Electrocardiogram) and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event palpitations was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Infection from unknown source in cheek.   Was hospitalized for 6 days on IV antibiotics and released on antibiotics\.  I saw  the following  health care providers, Dentist, Endodontist, Internal Medicine, Hospitalist, ENT, Oral Surgeon and no one really knew why I had the infection.  Mouth is still numb.
Fainted in chair right after the booster.   Threw up several times within minutes of the vaccine.  Was held at facility for several hours and got sick several times after.   Husband picked me up as I could not drive.   Was sick for several days, contacted my physician and she recommended I go to the ER on 11/25/2021 as I could not hold down water and was dehydrated - directly attributable to being sick from the Booster shot.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Date refrigerated of suspect product was given as 13-APR-2021 and Temperature changes was 41F.  Treatment information was not provided.
330 patients Received expired dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (330 patients Received expired dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (330 patients Received expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (330 patients Received expired dose of the vaccine) had resolved.      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.   Concomitant medications was not provided by the reporter.  Treatment information was not provided.
I do not know the manufacturer.  Pain, local swelling, warmth, redness (About 2.5 x 3" oval). This has lasted 1 week so far. Improving but still painful, red and warm. Have not needed treatment. Notified MD
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-NOV-2014, the patient was inoculated with ZOSTAVAX at a public health department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUL-2017, the patient was treated by a physician an a community healthcare center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. He was prescribed acyclovir and acetaminophen (+) hydrocodone (NORCO) for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
On March 11th at around 10pm I experienced severe shaking, fever, headache and delirium. The next day I improved but had a fever on and off of 99.1. I felt like I was stable, but felt dizziness increasing, and was lethargic through the weekend.   Then on Monday the 15th, I had a noticeable cramp in my right abdomen. At around 8pm CST I began feeling like I needed to burp and that I had GI problems.   The problems increased that night at around 10pm I had pain where the cramp started. Two hours later I started throwing up because of the pain and feeling of too much air inside of me. I could not stop vomiting after 2 hours so went to the Hospital ED at around 2:30 AM Tuesday the 16th.   I was admitted after a CT scan showed and white cell counts confirmed and infection and drastically enlarged appendix. I was diagnosed with an appendicitis and they immediately scheduled me for surgery.
I tested on November Seventh and did a video call with my Doctor who prescribed Paxlovid for five days, I began symptoms of a sinus infection @ 11/19/2022. On the 20th of November I was prescribed Augmentin. I had a very deep wet cough and it led to the doctor prescribing a chest x-ray on November 28th 2022 which resulted  no result. On November the 27th I was having pain left hip that remains an t the time of the reporting this event. On November 21st my Doctor changed my prescription from Flovent to Advair 250.
after fluzone HD patient had minor itching and redness after vaccine administered at site of injection, patient thought it could be from bandaid so we took it off. she stayed additional time in the pharmacy and monitored and she felt fine with no additional complaints. patient came in today (2 weeks later) and said the following tuesday after vaccine she went to the dr for something else and she reported the dr said the arm was red and swollen. today patient lifted up her sleeve and showed me where she believed I gave vaccine, asking if another dose would be needed. I showed the patient where her deltoid muscle is and that the vaccine was given in the deltoid. there was also a dark bruise about the size of a fist further down her arm, not near the injection site. she said the vaccine caused this and I asked when it appeared. the patient stated it showed up after she had a blood draw that tuesday on the same arm. I said clinically the bruise could be from that and she should have her dr look at it. she said she wasnt worried or upset, but wanted to let me know incase i could learn anything from it.
The day after the injection, patient noticed red area on arm. About 3/4 inch in diameter, it looked like a scab had been scratched off. I saw the area today, it is smaller (about 1/2 inch) and red around edge. It does not look infected and no drainage. Patient has been applying neosporin and will continue to do so.
Chronic Spontaneous idiopathic Urticaria. Onset at twelve days from vacination. Prutic eruptions moveing from one location fading then starting in another location. Whole-body effected. Treatment with prednisone on a tapered dose with Dyphenhyramine and Cetirizine.   After three weeks Ceyirizine daily with Dyphenhyramine as needed for breakthrough.  The time course: currently ungoing from 07/14/2022 to present with daily treatment needed to alleviate symtoms.
Local allergic reaction 3 inch reddened area.  Pt unsure if had disease as a child.