chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine leaked upon administration; Vaccine leaked upon administration; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked upon administration) and DEVICE CONNECTION ISSUE (Vaccine leaked upon administration) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced UNDERDOSE (Vaccine leaked upon administration) and DEVICE CONNECTION ISSUE (Vaccine leaked upon administration). At the time of the report, UNDERDOSE (Vaccine leaked upon administration) and DEVICE CONNECTION ISSUE (Vaccine leaked upon administration) outcome was unknown.        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.   Patient reported a potential cause as a syrinx in the follow up document.  No concomitant product was provided by the reporter. No treatment medications was provided  by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-086536 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient's ethnic group ,race , patient route of administration and expiration date of the suspect drug has been updated .Date of birth/age at vaccination has been amended from the Follow up document.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086536:Crosllinked case
Papular rash along dermatome-shingles, itchy. Treatment with Keflex
I am not completely sure if I was COVID free. I don't know if the symptoms started before or after the shot. When I sleep at night, I cant get air into one nostril. Sometimes it does not go away, I have to sleep thru it. It makes it tough to breath. I get dry nose a lot now but I never had that before. I was tasting food as much as I use to due to loss of taste and smell. When I first got the shot, I had an itchy dry throat which caused me to have to cough to make my throat feel better. I felt fatigued and has less energy than I normally have. I did not treat these symptoms. I didn't see a doctor but I am trying to schedule an appointment. I was having confusion where I felt not fully aware. I have a dirty room and was breathing in bad stuff that could have affected my respiratory for like a month which could have done something to me but I am uncertain. I had gardening materials in my room that I was breathing in that could have also affected me. I have not gotten better.
Patient reports stiff arm for multiple weeks, numbness in the arm, loss of strength, and the inability to bend/flex the fingers to the same extent as compared to prior to vaccine.
body felt very weak; sore throat; running nose; coughing too much; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RHINORRHOEA (running nose), COUGH (coughing too much), ASTHENIA (body felt very weak) and OROPHARYNGEAL PAIN (sore throat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included OMEPRAZOLE, LORATADINE, PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced RHINORRHOEA (running nose) and COUGH (coughing too much). On 05-Apr-2021, the patient experienced ASTHENIA (body felt very weak) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, RHINORRHOEA (running nose), COUGH (coughing too much), ASTHENIA (body felt very weak) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown. Not Provided          Reporter stated that the patient did not experience any symptoms after her first dose. Reporter asked on behalf of patient if it was normal to experience these events post vaccination. Patient received treatment as Tylenol and Advil.
fever 102, rash for several days, swollen glands in neck & behind ears, cranky;
I have anxiety, rapid heart beat especially when waking up unable to sleep, chest pain, higher blood pressure, a little dizziness and weakness.
Diarrhea, headaches, sick to stomache. This started within 48 hours after vaccination.
Boostrix exposed to freezing temperatures; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th September 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Boostrix that had been exposed to freezing temperatures, which led to incorrect storage of drug. The reporter consented to follow up.
Aproximately 1 day after vaccine, I felt shortness of breath.  Symptoms increased over the next few days.  Arrythmia grew worse to the point I felt I might faint.  Visited ER.  EKG showed Mobitz Type 1 Heart Block and Dr. suspected A-Fib though it wasn't appearing on EKG.  (Previous history of A-Fib, but ended treatment approximately 2010 because of long term lack of symptoms and normal EKG, Echo.)  I have been nonsymptomatic for at least 20 years.. Symptoms continued through 3/15/3031 though decreasing each day.
On saturday(7/3/2021) the day after the vaccine instatted already having chest pain. Three days(7/6/2021) after the chest pain I started having chest palpations and felt a ball in my chest  with tightness. I went to the ER and they diagnosed me with pericarditis. I'm still dealing with it 3 weeks later and cant exercise at all.  Before i was a very healthy individual and ran 15 miles a week. Now im not able to jog for 2 minutes without a burning sensation on the left side of my chest.  At night i constantly get chest pains. Ive been taking the medication ibuprofin 3 times a day and cholichine 1 time a day. Its gotten slightly better in terms of pain but I am still unable to perform any physical activities that raise my heart rate.
(No pain) 11/11/08 - 1st sore on outer vaginal area/left side. 11/12/08 - fever 101. 11/14-18/08 - more sores-outer left vaginal area. 11/20/08 DR. takes blood tests and prescribes Famciclovir. 12/11 - 2nd blood test. 12/4/08 - per DR - clearing up.
ACUTE RESPIRATORY FAILURE 11/6/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from pharmacist refers to a female patient of an unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient had received first dose with GARDASIL and on an unknown date, the next dose was given GARDASIL 9 (unknown route, dose and strength). It was reported that GARDASIL and GARDASIL 9 were interchanged with a patient. No additional doses have been administered and no symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Maculo papular blanching pink rash on trunk more than extremities & face.  Post occipital nodes.  No distress.  No fever.
Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old male patient who experienced second degree burn to the right leg and patient was injected with DAPTACEL instead of ADACEL, while he received vaccines DAPTACEL instead of ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Jun-2018, the patient received a 0.5 mL dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine lot number not reported via intramuscular route in the right deltoid. On an unknown date, the patient developed a non-serious the patient had a 2nd degree burn to the right leg, following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. It was also a case of actual medication error due wrong vaccine administered. Relevant tests were not reported. Final diagnosis was the patient had a second degree burn to the right leg. It was not reported if the patient received a corrective treatment. The outcome was not reported for the event. 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. List of documents held by sender: none.
Started with tinnitus - first in left ear starting 4 days after shot, and now bilateral and persistent x 4 days
Diarrhea for the past 2 weeks; Food is not sitting in my stomach, can't hold down food; Lost weight, I'm probably about 160 lbs; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for the past 2 weeks), ABDOMINAL DISCOMFORT (Food is not sitting in my stomach, can't hold down food) and WEIGHT DECREASED (Lost weight, I'm probably about 160 lbs) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided by reporter.     On 03-Sep-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 DIARRHOEA (Diarrhea for the past 2 weeks), ABDOMINAL DISCOMFORT (Food is not sitting in my stomach, can't hold down food) and WEIGHT DECREASED (Lost weight, I'm probably about 160 lbs). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea for the past 2 weeks), ABDOMINAL DISCOMFORT (Food is not sitting in my stomach, can't hold down food) and WEIGHT DECREASED (Lost weight, I'm probably about 160 lbs) outcome was unknown.        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 provided.  Other treatment medication include Ginger ale
Redness, swelling, and itchiness within first 24 hours. Itchiness resolved within the first 48 hours, redness and swelling resolved within first 3 days. On day 7, redness and itchiness returned with increased swelling.
Pt recv vax on 12/15/98; on same day pt exp erythema of left upper arm w/ warmth, swelling; cellulitis of LA at vax site; tx=Rocephin, Augmentin
Educator: On 07-23-2022, patient's mother requested moderna as booster dose for patient.  Both patient and mother were educated, and consent form was completed. After completing the  education process, clients proceeded to register.   Registration: Patient was registered via survey as a walk-in.   Vaccinator: 16 y/o female patient came in to receive booster dose of vaccine. She received Moderna.
Approximately 10 minutes after patient received her 1st dose of the Pfizer COVID-19 Vaccine she told her daughter she didn't feel well.  Patient reported to staff, through her daughter, that she felt lightheaded/dizzy and felt "anxious on [my] heart". Patient was taken to an exam room and was assessed by an RN team. She had an elevated blood pressure, but regular pulse and respiratory rate. She also described, via interpreter, a tingling in her hands and continuously rubbed her left arm. Despite resting for 15 minutes, patient's symptoms did not improve and she was advised to present to the ED via EMS due to the "anxious" feeling on her heart and hand tingling. The patient and her daughter were agreeable to this plan.
Within 2 minutes of receiving the vaccine, he started sweating, he then vomited, lost vision and hearing.  Had trouble breathing. Ambulance called
Information has been received from a registered nurse concerning a approximately 13 month old Caucasian female with Hereditary Fructose Intolerance and no association intolerance to fructose, sorbitol, and sucrose, who on 22 SEP 1997 was vaccinated SC in the right leg with a first dose of MMR. There was no concomitant medication. The patient was diagnosed with hereditary fructose intolerance, after her first vaccination with MMR, and it was noted that this condition is not related to the patient's vaccination. Subsequently, due to the patient's intolerance to sorbital, the patient had a titer drawn in the hope that she could avoid a second dose of the vaccine. The patient's titer was negative for measles. The responsible physician planned to obtain blood work. The registered nurse and physician felt the patient's experience was non-serious. Additional information is expected.
Narrative:  93yo male patient in home hospice care died of lung cancer on 9/16/2021. Pt had received covid vaccines on 3/3/21 & 4/2/21. Likely this death is not related to covid vaccines given patient's advanced age, cancer diagnosis in hospice care, and long length of time between date of vaccines and date of death.
injection side pain; felt sick; she was sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 22Sep2021 as dose 2, single (Lot number: FF8839) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "She got covid a year ago", start date: 05May2021 (unspecified if ongoing); "almost died in the hospital" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot: FF2588), administration date: 01Sep2021, when the patient was 53-year-old, for COVID-19 Immunization, reaction(s): "injection side pain", "felt sick", "she was sick". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection side pain"; MALAISE (non-serious), outcome "unknown", described as "felt sick"; ILLNESS (non-serious), outcome "unknown", described as "she was sick".  Additional information: She stated that with her initial vaccines she has injection side pain and felt sick but no other symptoms. On her Initial vaccine she got, she got sick and had injection site pain. But she did not have swelling or other symptoms. After her first vaccine in the series she was sick for a day and then she was fine. She got covid a year ago and almost died in the hospital. That was 5May2021, before her primary series. Vaccination facility type reported as medicine mart. Vaccine administered at military facility were reported as no. Did any AE(s) require a visit to emergency room was reported as no. Physician office reported as no. Prior Vaccinations (within 4 weeks) reported as no. Relevant tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) were reported as no.  Follow-up attempts are completed. No further information is expected.
The second dose of this vaccine was given earlier than recommended. The patient's first dose was 05/07/21 and therefore was due for the second dose 05/28/21. No adverse events were reported by the patient.
the freezer went too low two weeks ago; expired doses given to two patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 18-May-2022. Reporter was told to record second booster shots that reporter gave on 24-May-2022, but reporter realized that the Moderna vaccines expired on 18-May-2022. Reporter explained that they ordered Moderna in Nov-2021, and the box said frozen. They didn't have a freezer then and found out they could be unfrozen for a month. Then they got a freezer and ordered another supply, which came in on 09-Dec-2021. The HCP called the state department, who referred to Moderna to check if the doses were viable. The HCP connected the doctor on the line to see if could provide information on previous excursions. The doctor stated that there were fluctuations in the freezer two weeks ago. The freezer went too low.  No concomitant medications was reported. No treatment medications was reported.
Severe cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Severe cold) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced NASOPHARYNGITIS (Severe cold). At the time of the report, NASOPHARYNGITIS (Severe cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
After giving patient a flu shot; pharmacist pushed plunger down until clicking however it did not retract and needle scrapped left thumb. Pharmacist did not notice injury until removing gloves. Reported injury after noticing the stick.
Patient received his Pfizer COVID-19 vaccination on Saturday, 3/5/2022 for the first time.  Notes that that evening he began to have nausea and vomiting along with some dyspnea on exertion.  Played a hockey game on Sunday and had severe shortness of breath and dyspnea on exertion.  Since then is also struggled to maintain his breath and occasionally feels some chest discomfort.  No palpitations or rapid heartbeat that he has noticed.  He has had COVID-19 twice previously that was test confirmed.  He denies any history of underlying cardiac issues and no history of asthma or other lung diseases.
I received the vaccine around noon on Thursday, March 4, and by Friday night started experiencing postnasal drip/sore throat. My arm was sore from Thursday night - Saturday morning, and I kept it moving to help with the soreness. By Sunday night I had developed a cough and nasal/chest congestion and have had cold symptoms throughout the week (but feeling slightly better each day). My sore throat disappeared by Tuesday. No fever, loss of taste/smell, or shortness of breath. I?ve been taking Sudafed and Mucinex daily, and NyQuil and Afrin at night. On Wednesday, March 10 I went to receive a rapid test for COVID-19 and tested negative, and was told to continue using OTC medications to treat my symptoms, but to take antibiotics if symptoms worsened over the next 3 days. As of Friday, March 12, I?m feeling much better with less cough and congestion but still fatigued and do not plan on using the antibiotics.
Pt recv vax on 10/14/98; on same day pt exp red, swollen, warm, painful vax site (3-4 in diameter)
Pt stated lt arm began hurting 12APR92 @ 7PM then began swelling; BY Wednesday 16APR92 pt had approx 8cm redness/swelling w/2cm center which was purple in color;  arm seen 17APR92 & it remained same very painful; tx DPH;
pt called to report feverish, chills, vomiting & diarrhea;on noc of 17JUN96
stroke like symptoms; problems walking without being tired; face on the left still sags; This is spontaneous report from contactable consumer.  A patient of unspecified age and gender reported that received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that had both shots the first and 2nd shots. Each time had problems after had stroke like symptoms and still suffered about 2 months in. The patient had problems walking without being tired. The face on the left still sags. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Information has been received from a consumer concerning her husband with no medical history and no allergies who in approximately 1976, when the patient was 5 or 6 years old, was vaccinated with rubella virus vaccine live. There was no concomitant medication. In approximately 1976, the patient experienced hallucinating and developed a fever. it was unknown whether the patient sought medical attention. Additional information has been requested.
decline in her motor functions; she slowed down, weakness in her arms and legs.; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a non-contactable consumer reported for a female patient (her sister in law) A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included guillain-barre syndrome and autoimmune disorder. The patient's concomitant medications were not reported. The reporter stated that "wanted to know any data available for covid vaccine use in GBS (Guillain Barre syndrome) and autoimmune disorder. Her sister in law had scopey episode 4 days prior to getting the vaccine and after taking the vaccine she developed decline in her motor functions, she slowed down, weakness in her arms and legs. Patient was hospitalized". The outcome is unknown and action taken was not applicable. No follow-up attempts are possible; information about lot/batch number cannot be obtained