chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day following the second COVID vaccine administration, patient reported chest pain. He went to his pediatrician, where troponin was noted to be elevated (reported to be 0.84 on 9/6) and was referred to ED. Troponin was confirmed to be elevated (0.710 on 9/6) and patient was admitted to pediatric cardiology service for suspected vaccine related myocarditis. Troponin on 9/7 was 0.301. Echocardiogram was normal. Was treated symptomatically with ibuprofen and tylenol, and discharged on 9/7. He will get cardiac MRI in the next few weeks.
dizzy; I have a rash on the site; Just feeling very unwell; vomiting; Nauseated; I had the booster vaccine on Thursday; I had the booster vaccine on Thursday; This initial case was previously invalid due to no adverse event. Upon receipt of follow-up information on 11Oct2021, this case now contains all required information to be considered valid  This is a spontaneous report from a contactable Consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 30135BA), via an unspecified route of administration, administered in arm left on 07Oct2021 (at the age of 70 years old) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from 01Oct2021 (Batch/Lot number was not reported) to 01Oct2021, at unspecified dose for an unspecified indication. Medical history included diabetes mellitus. Concomitant medications included metformin (METFORMIN), insulin glargine (BASAGLAR) and dulaglutide (TRULICITY) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 1, single for covid-19 immunisation and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 2, single for covid-19 immunisation. She had any vaccination 4 weeks prior to COVID 19 Vaccine (Booster), it was reported She received the Flu Shot (Unspecified flu shot) on 01Oct2021. On 07Oct2021, the patient had the booster vaccine on Thursday. On 10Oct2021, the patient experienced dizzy, had  a rash on the site, just feeling very unwell, vomiting and nauseated. the patient took I just took Advil and Tylenol, as treatment medication,it was reported 300 and 75mg, was a combination and  took 2, it's a dual action, took 4 pills, yeah but not all at once, took them earlier in the afternoon and then before bed. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 9.5 on 28Sep2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
he had shingles vaccination, shingles/suspected vaccination failure; just had shingles; pain for about 10 days; miserable for about 10 days; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feeling miserable. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain and feeling miserable were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient had the shingles vaccination and had shingles.  The patient was in pain and miserable for about 10 days.  The reporter stated that it was not transferable to another person. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
After he had the second Moderna vaccine 045B21A at Clinic on 06/01, he had some errands to do after getting home he took a nap for 4-5 hours and after while trying to get up and out of his bed he fell did not have control of his leg. He was able to walk with the help of his wife but he has to use a walker to ambulate as he feels his legs are weak. Weakness is worse on the left. He also experienced fever, nausea, vomiting, and diarrhea.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA; DULOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 08Dec2022 to 11Dec2022 for COVID 19 Treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201372206 Same patient, different product and event;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient came in and the reporting pharmacist was going to give the 2nd dose of SHINGRIX. The patient had a red spot the size of a hand where the injection was given. It went away after a week.
Pregnancy; Pain at injection site (L); This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Pain at injection site (L)) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 041L20A) for COVID-19 vaccination.     The patient's past medical history included Live birth and Migraine headache (Stable OTC before pregnancy) on 01-Jan-2000. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) from 01-Jan-2020 to 01-Jan-2020 for Migraine, LETROZOLE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Sep-2020 and the estimated date of delivery was 09-Jun-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Pain at injection site (L)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy. The delivery occurred, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. The patient was treated with PARACETAMOL (TYLENOL) on 06-Jan-2021 for Adverse event, at a dose of UNK, bid. On 07-Jan-2021, VACCINATION SITE PAIN (Pain at injection site (L)) had resolved. On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had ultrasounds in December 2020 and January 2021, results were unknown. Estimated date of conception 18-sept-2021,date of positive pregnancy test 01-oct-2020 and Date of last menstrual period 02-sept-2021 was reported.
on the 8th she started feeling swelling in her arm pit. Felt like an eternal blister. Could barely lift her left arm.
Syringe separated from needle  when plunger fully depressed. Some backsplash of vaccine, but patient received most of dose. Needle removed safely without incident. Was NOT given a subsequent dose.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 25-OCT-2012, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician, at a healthcare facility, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.  The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a physician concerning a 62 year old male with blood pressure high and no allergies who on 30-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included NEXIUM. On 01-JUL-2008, 24 hours after vaccination, the patient experienced injection site reactions. The patient had slight erythema, tenderness and fullness at injection site. The fullness was further defined as soft and feels like it was fluid filled. The patient's injection site reactions, slight erythema, tenderness and fullness at injection site persisted. The patient sought medical attention. Additional information has been requested.
Rash on left arm about the size of a half dollar.  Using over the counter itching ointment.   Rash is still present after 3 weeks.  Also showing up on right arm 4 days ago.
Low grade fever, body aches, chills, and trouble taking deep breaths which resulted in coughing. Slight trouble breathing overall. Symptoms lasted for about 48 hours and then went away completely.
Within 30 minutes of the shot I became very tired. My body started to ache and I began to have very bad muscle cramps. Within one hour, I started to get chills. My body was freezing for three days. I had to blast the heat in our house to 80 F degrees to try and keep warm, along with wearing many layers of clothes. I also had joint stiffness. For the past week I have had continued constant painful off and on neck pain/cramps and headaches.
1/30/21 Evening-2/1-21 Morning  Body aches, chills, fatigue, nausea, dehydration
A few hours after the shot I started to swell up and I took some Benadryl. The morning after the vaccine I woke up and my face was very swollen. My lips, ears, my nose and everything and Benadryl was not working. After consulting with the Pharmacist, I went to the ER. I was given Steroids and antihistamine. I also went to the doctor because I was experiencing heart palpitations which started a few days after the vaccine. That lasted for two weeks. Emergency Room  Hospital 04/06/2021
Likely varicella despite vaccine. Red bumps developed 21 days after exposure to child with active varicella. No vesicles on my exam. Preschool earlier per mom. I saw child on day 4 at start of illness, 1/17/03.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown demographic patient who administered third dose IMOVAX RABIES (batch umber not reported via unknown route in unknown administration site) on a unspecified date of July. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to Inappropriate schedule of vaccine administered (inappropriate schedule). It was reported that the patient was given 3rd dose on Day 14 instead of on Day 21. 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.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (vaccine administered as if it had a preservative) in a 71-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) (batch/lot# 006C21A) for COVID-19 immunization. No medical history reported. On Aug 20, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 20, 2021, patient administered expired product (vaccine administered as if it had a preservative). On Aug 20, 2021, administered expired product (vaccine administered as if it had a preservative) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received contained non-significant information.
patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) injection, lot # T005406 was valid with an expiration date of 12-AUG-2021, subcutaneously (strength and exact dose were not reported) for prophylaxis (also reported as: well check). Properly stored sterile diluent was used for vaccine reconstitution. The temperature excursions were reported as: from -9 degrees Celsius (C) to 8 degrees C (-6.1 C), multiple excursions, for 13 hours. Time frame was reported as 129 hours. There were no previous temperature excursions. A digital data logger was used to capture the temperatures. The outcome of the event was not reported.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2009USA005097: US-009507513-2009USA005124: US-009507513-2009USA005141: US-009507513-2009USA005142: US-009507513-2009USA005353: US-009507513-2009USA005382: US-009507513-2009USA005515: US-009507513-2009USA005526:
Sharp pain in the posterior left upper back (under the shoulder blade) which started around 10 pm with great intensity lasted through the intense general body aches around Thursday night but still persists today but with less intensity.  It feels like discomfort in my upper left chest which radiates to the front chest at times.  Some shortness of breath but not severe, noticeable but not terribly uncomfortable. This continues to the present.
fatigue, headache, muscle pain, joint pain, nausea, fever, and coordination issues 27 hours
24 hours reaction to Varicella vaccination (lot 0909R), erythematous, hard area to right upper thigh.  Warm to touch.
pink eye type response without the discharge, typical with pink eye; Fatigue; Slight nasal congestion; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ew0161) via an unspecified route of administration on an unspecified date in Apr2021 at 12:00 PM (at the age of 62-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. Concomitant medication included hydrochlorothiazide from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in May2021, 18 days after vaccination, the patient experienced pink eye type response without the discharge, typical with pink eye with fatigue and slight nasal congestion. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event pink eye type response without the discharge which included treatment with unspecified eye drops. The clinical outcome of the events pink eye type response without the discharge, typical with pink eye with fatigue and slight nasal congestion was recovering at the time of this report. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : -PFIZER INC-2021580139 same report/drug/AE, different patient.
Increased resting heart rate (increase of 15bpm); Painful; lots of clotting; heavy period after 1st dose; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Right Arm on 25Mar2021 14:00 (Age at vaccination 38 years old) (Batch/Lot Number: Er8730) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took neomycin and experienced drug hypersensitivity, bacitracin and experienced drug hypersensitivity, chloraprep and experienced drug hypersensitivity. On an unspecified date the patient experienced Increased resting heart rate (increase of 15bpm) Painful and heavy period after 1st dose with lots of clotting. The patient underwent lab tests and procedures which included heart rate: increase on increase of 15bpm. Outcome of the events was unknown.  No follow-up attempts are required. No further information is expected.
One day post vax, the pt has broke out in hives and had an irregular heartbeat. She was placed on Prednisone.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2010, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical group office, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2011, the patient was treated (by an unspecified healthcare professional) at a medical group (office) for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sore arm weeks after vaccine. Pt states they can not move their arm and is experiencing pain from collarbone to elbow.
Pt recvd 3 doses of Hep B vax on 23MAY91 & 28OCT91 & on 31DEC91 lab eval revealed no detectable Hep B surface antibody; FEB92 sl elevated blood sugar;
Breakthrough case admission after 5 vaccines ; Pfizer 2/27/21 lot# EN6202;  Pfizer 3/20/21 lot# EN6207;  Pfizer 9/27/21 lot# 30135BA;  Pfizer 4/18/22 lot# FJ4991;  Pfizer 9/12/22 Lot# GJ5342
It was reported that a female pt received an Imovax Rabies vaccination on 9/28/00 (last in series). Reportedly, sometime after the vaccination (date not specified), the pt developed "flu-like" symptoms, burning down both legs and dryness of eyes.
In reviewing Immunization Information System - it was discovered that based on documentation patient may have received a mixed series of COVID vaccine.  The patient is documented in our computer system to have received Pfizer Covid Vaccine Lot EN6206 on 3/12/21  and Moderna Covid Vaccine Lot 021B21A on 4/2/21.  Only Pfizer was administered in clinic on 3/12/21 and Both Pfizer and Moderna were being administered in clinic on 4/2/21. Patients vaccine care noted pfizer for both doses but lot numbers were as above with Moderna lot as second dose.  The patient was notified of this and was consulted by our ID physician.   Many checks and balances are in place to prevent such errors ? but based on documentation feel patient may have received a mixed series.
Patient is a 58 y.o. male with a PMH of HTN, depression, GERD, COPD, and lung cancer.  Patient presented to the ED for three ground level falls.  Patient states he fell twice on Friday and once last night.  + Dizziness that lead to the falls.  Patient denies any head trauma or LOC.  + Fatigue and BLE weakness x 1 week.  + Mid sternal CP that started in route to BW per patient.  + One episode of N/V in route to BW as well.   + Continued dry cough and sore throat.  Denies SOB.  Patient admits to a 15 pound weight loss over the last 1.5 weeks.  FT in place and barely uses it per patient.  LBM was yesterday and normal per patient.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pt's mother called us on 10/14/21 stating that her son got rash 5 days after getting 2nd dose of vaccine and it started with few patches of rash and eventually getting bigger and was going on and off for about 2 months now so they went to see doctor and got medications ( prednisone and triamcinolone) for rash.
Warm skin, red wheal about 2 1/2 inches in diameter, itchy, hard. Injection was given IM instead of SQ.