chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports having numbness and tingling in hands and feet when he is lying down. If he stretches out his hands and feet, it goes away. Only happens at night when he is sleeping.
father called next day child with pain, erythema , small erythematous areas and tender to touch.  Patient was already on Clindamycin for inspect bites diagnosed with  cellulites. Patient returned to clinic  two days later with left should pain, swelling and mild edema ; site was warm with rash blanching.
rash at injection site after first dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (rash at injection site after first dose) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at injection site after first dose). At the time of the report, VACCINATION SITE RASH (rash at injection site after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-044975 (Patient Link).
Patient states that she developed shingles post-vaccination and it was also diagnosed by her primary care physician.
Donor had blurred vision, dizziness, light-headedness, nausea, pale, sweaty, felt faint & weak, then fell on the floor in bathroom.
Immediately after the vaccine I felt sore and dizzy. After some time I went home, then I started feeling something sour in the back of my throat. When I got home I felt achy and feverish, I took Tylenol and slept for almost a day. I felt this way for about a week. I couldn't even lift my hands.  Even now, a year later I still feel weakness in my hands. After this happened I started taking vitamins. My Dr. recommended that I have ACL surgery and now I'm taking a lot of supplements.
could not take the second shot scheduled on 10 Mar 2021 due to his bad physical health.; COVID-19 Positive, all the reported reactions lethargy, decreased appetite, cough, throat irritation and arthralgia were turned out to be COVID symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Positive, all the reported reactions lethargy, decreased appetite, cough, throat irritation and arthralgia were turned out to be COVID symptoms) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (COVID-19 Positive, all the reported reactions lethargy, decreased appetite, cough, throat irritation and arthralgia were turned out to be COVID symptoms) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (could not take the second shot scheduled on 10 Mar 2021 due to his bad physical health.). At the time of the report, COVID-19 (COVID-19 Positive, all the reported reactions lethargy, decreased appetite, cough, throat irritation and arthralgia were turned out to be COVID symptoms) and INCOMPLETE COURSE OF VACCINATION (could not take the second shot scheduled on 10 Mar 2021 due to his bad physical health.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Based on the current available information, the event COVID-19 positive is assessed as unlikely related to mRNA-1273. This report also refers to a case of incomplete course of vaccination for mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: The patient was COVID-19 positive on 15-Feb-2021 after 5 days of getting the first shot of  vaccine (10-Feb-2021). All the reported reactions were turned out to be COVID symptoms. He was hospitalized for around 10 days and could not take the second shot scheduled on 10-Mar-2021 due to his bad physical health.; Sender's Comments: Based on the current available information, the event COVID-19 positive is assessed as unlikely related to mRNA-1273. This report also refers to a case of incomplete course of vaccination for mRNA-1273, lot
SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT.  DIZZINESS FOR APPROX 4 DAYS,  HEADACHE FOR APPROX 4 DAYS
Headache, Arthralgia, Fever, FATIGUE, CHILLS. PAIN/SWELLING INJ SITE, Narrative:
Arm hurts for 2 to 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurts for 2 to 3 days) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm hurts for 2 to 3 days). On 22-Apr-2021, VACCINATION SITE PAIN (Arm hurts for 2 to 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided. No lab data has been provided by the reporter.   This case was linked to MOD-2021-148128 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-significant Follow up Appended - NNI received
reconstituted the vaccine ACT-HIB with sterile water instead of the provided saline/ no AE; Initial information received on 30-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a two month old female patient who was vaccinated with a 0.5 mL first dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ161AAA and expiry date 26-Nov-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 26-Mar-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  It is an actual medication error due to wrong solution used in drug reconstitution. it was reported that a dose of ACT-HIB was reconstituted with sterile water instead of the provided saline.  At the time of this report, no adverse event was reported.   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.
The symptoms were dizziness, mental gaps & unable to sleep well, it was hard to rest.  I noted the day the symptoms started until I stopped feeling them.  The discomfort started the day after vaccination, October 28 and lasted around 43 days, when I noted I no longer had the discomforts and could return to my normal life.
Chills shakes, muscle and joint aches for 5 hours then followed by nausea and overall weakness.  Then 24 hours later had a severe headache for approx. 12 hours.
Chills, fever (above 102), headache, sore arm, night sweats, pain in the stomach.  First evening and night.  Fever down to 99 the next day.  Large red rash on left arm for a week after that. Took tylenol the day after the injection.
Adverse reaction/Many Symptoms; Diarrhea; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction/Many Symptoms), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction/Many Symptoms). At the time of the report, VACCINATION COMPLICATION (Adverse reaction/Many Symptoms), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   Reporter did not allow further contact
Arm hursts really bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hursts really bad) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hursts really bad). At the time of the report, PAIN IN EXTREMITY (Arm hursts really bad) outcome was unknown.            Concomitant medication were not reported Treatment medication information were not reported  Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
New allergies; Sick for 1 month; Contact dermatitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic conditions" (unspecified if ongoing); "Food allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DERMATITIS CONTACT (non-serious) with onset 01Dec2022, outcome "recovered with sequelae", described as "Contact dermatitis"; ILLNESS (non-serious) with onset 01Dec2022, outcome "recovered with sequelae", described as "Sick for 1 month"; HYPERSENSITIVITY (non-serious), outcome "recovered with sequelae", described as "New allergies". The events "sick for 1 month", "contact dermatitis" and "new allergies" required physician office visit. It was unknown if therapeutic measures were taken as a result of illness, dermatitis contact, hypersensitivity.  Additional information: Unknown if patient received other vaccine in four weeks. The patient received other unspecified medications in two weeks. Unknown if patient had covid prior vaccination or If covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pregnant patient received expired vaccine dose; Pregnant patient received [expired] vaccine dose; This non-serious initial spontaneous case, was received on 22-Sep-2017, concerning a 29-year-old, adult pregnant female patient.  The patient did not use contraceptives. The patient's last menstrual period date was on 22-Jan-2017, foetus status was not reported. The patient had no pregnancy in the past. The infant gestational age was 34.5 weeks and there was no evidence of defect or adverse findings from prenatal test. Concomitant medication included: Prenatal vitamins for unknown indication.  On 21-Sep-2017, the patient was administered with Afluria (TIV) (Influenza Vaccine, dose: 0.5 ml, batch number: WT54607, expiry date: 30-Jun-2017 (expired dose), route of administration and anatomical location: not reported) for Influenza prophylaxis.  It was reported that the pregnant patient received the expired vaccine (explicitly coded to expired vaccine used). The patient experienced adverse event, but no adverse reaction was experienced in the foetus. The estimated date of delivery was on 29-Oct-2017. It was stated that, the mother and the baby was good with no problem. No other information was provided.  The outcome of the event was not reported.  Follow-up report received from the reporter on 17-Apr-2018: The reporter confirmed that the estimated date of delivery was 29-Oct-2017 and the patient was not enrolled in the registry. It was stated that, the mother and the baby was good with no problem. No other information was provided. Amended narrative accordingly.; Reporter's Comments: A 29-year-old, adult pregnant female patient was vaccinated with expired vaccine. The causality is assessed as not related due to nature of the events.
A vial that was previously punctured and stored at room temperature greater than the allowed 2 hours was used for this vaccination.  There were no known adverse reactions experienced by the patient.
PT. c/o lightheadedness 25 min after rec. injection (a) deltoid; BP 150/86 Pulse 88 no redness injection site. no sig, rash ; c/o feeling achey "like I am getting the flu"
Information has been received from a physician concerning an approximately 4 to 6 year old female patient who on 13-APR-2007 was vaccinated with 0.5 ml dose of Proquad (Lot # 656312/0297U).Concomitant therapy included TB test on the forearm. It was reported that "within 24 hours of injection" on approximately 13-APR-2007, the patient developed redness, swelling, tenderness and induration at injection site. The reaction was reported to be 5x5 cm in area. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Patient called to report abnormal swelling on the left arm extending from just below the arm pit and extending to below elbow. Over the weekend it was fairly swollen but patient stated it seems to be resolving and is less swollen now but still not completely resolved.
cough 18May and positive Ag test; cough 18May and positive Ag test; cough 18May and positive Ag test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 28 years 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), COUGH (non-serious) all with onset 18May2022, outcome "unknown" and all described as "cough 18May and positive Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (18May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, cough. Clinical information: It was reported that ST cough 18May and positive Ag test after travel to (name) this weekend. Covid was tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Patient began to slump in her chair and had problems opening her eyes. She complained of be hot and having heart palpitations. I unable to get a good pulse because it was very week. After a few more minutes patient complained of tingling in her hand and feet as well as cramping in neck but was not affecting her  breathing so Epipen was not administered but 911 was called. Volunteer Rescue Squad arrived and overtook care. Patient began to feel better after about 10 minutes and refuse to go to hospital but remained under my observation for another 20 minutes until her sister came and followed her home.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (003110). The reporter is the patient. A 79-year-old female patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 13Oct2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 16Mar2021, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE), administration date: 16Feb2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset Aug2022, outcome "unknown", described as "extreme fatigue"; DIZZINESS (non-serious) with onset Aug2022, outcome "unknown", described as "light headedness"; DYSPNOEA (non-serious) with onset Aug2022, outcome "unknown", described as "shortness of breath"; COUGH (non-serious) with onset Aug2022, outcome "unknown", described as "terrible cough". Additional information: It was reported that, the patient had 4 Pfizer COVID vaccines, the last one in May of this year. For the past 3 weeks she had a terrible cough, shortness of breath, light headedness and extreme fatigue. She thought these symptoms were related to the vaccines. She wanted to know the remedy and the time till how long it will last The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Second shot on 38th day (after first shot); Sore arm  after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm  after second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot on 38th day (after first shot)) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included LISINOPRIL and HYDROXYZINE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot on 38th day (after first shot)). In April 2021, the patient experienced PAIN IN EXTREMITY (Sore arm  after second shot). On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot on 38th day (after first shot)) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm  after second shot) was resolving.            Concomitant product also included inhaler for COPD.  No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.   This case was linked to MOD-2021-075197 (Patient Link).
High fever woke up screaming during the night; fever continued even w/use of APAP; Seemed very tired h/a & arm sore in the AM; Seen by MD tx children Advil;
Patient was given 4 vaccines on 9/28/18 around 1:30pm. Varicella was given subcutaneous in Right Thigh. Pentacel & Fluzone were given intramuscular in Left Thigh. Around 5pm on 9/29/18, Patient was taken to ED for extensive swelling of left thigh with what mom describes as "red streaks" from injection site towards knee. All previous vaccinations were tolerated with minimal site redness and warmth, and low grade fever.
This spontaneous report has been received from a physician via company representative referring to a 22 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified day in September 2017, the patient was vaccinated with the second dose of GARDASIL 9 by intramuscular route,(strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid,in the opposite arm.  It was reported that, 10 minutes after vaccination, the patient walked to check out and "experienced syncope, fell and hit head (head injury)". The patient refused to go to hospital and "drove himself home". Later at home, the patient developed nausea and vomiting and went to hospital emergency room. The outcome of syncope, vomiting, nausea and head injury was unknown. The causality assessment between therapy with GARDASIL 9 was not reported.
My reaction started with chills and a fever around 6:00 pm of the day of the morning shot. Later in the evening, I felt feverish and spiked a slight fever of 99.  The following day, my temperature kept trying to climb over 101 so I had to take Advil every 4 hours to fend it off.  In the middle of the night on the second day, I hit 102. I then had serious chills and teeth chattering.  On my second day after the shot, I felt dizzy and very fatigued.  That early morning, another bout of chills, bone aches and teeth chattering.  I broke the fever and chills on the third day.  I had heard the the second shot (which I have not had) is worse than the first.  I had full Covid in November of 2020 and am wondering if my reaction was robust due to my previous illness with Covid.  I am still suffering with dizziness and slight fatigue.
Little mild imbalance; This is a spontaneous report from a 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) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced little mild imbalance. The outcome of the event was resolved on an unspecified date in 2021.  Information about batch/lot number has been requested.