chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a rapid pulse rate; Nausea; I just had flu like symptoms without a temperature; my blood pressure is not as crazy but it scared that hell out of me; I am extremely tired and wiped out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2 (BNT162B2), on 19Apr2022 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: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), administration date: Feb2021, for COVID-19 Immunization, reaction(s): "I was fine for all three"; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "I was fine for all three"; Covid-19 vaccine (Dose: 3, First Booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "I was fine for all three". The following information was reported: FATIGUE (non-serious) with onset Apr2022, outcome "recovering", described as "I am extremely tired and wiped out"; BLOOD PRESSURE ABNORMAL (non-serious) with onset Apr2022, outcome "recovering", described as "my blood pressure is not as crazy but it scared that hell out of me"; HEART RATE INCREASED (non-serious) with onset 20Apr2022, outcome "recovering", described as "I had a rapid pulse rate"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Apr2022, outcome "recovering", described as "I just had flu like symptoms without a temperature"; NAUSEA (non-serious) with onset 20Apr2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer was informed about the role and was informed that is the concerned department to answer the question. Consumer was also informed that Pfizer Medical Information works from Monday to Friday. Consumer further stated, "I have to wait till Monday to find out if this is normal?" Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain; swelling; tummy aches; sore mouth; redness at the injection site; low dose of Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth), VACCINATION SITE ERYTHEMA (redness at the injection site) and UNDERDOSE (low dose of Moderna vaccine). At the time of the report, PAIN (pain), SWELLING (swelling), ABDOMINAL PAIN (tummy aches), ORAL PAIN (sore mouth) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown and UNDERDOSE (low dose of Moderna 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.   No concomitant medication were reported No treatment medication were reported
Pain/redness starting 6/11/2009.  R arm 8cm x 9cm redness, warmth, slight indurated area,  faint bruise under erythema able to move arm.  Ice/tylenol-ibuprofen. F/u prn.
lump under skin on leg where vaccine was administered/1 month later still has a lump under skin on leg where vaccine (not sure which one) was administered; irritability; Fever; rash on belly; This spontaneous report was received from a physician via company representative and refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose, frequency, duration and indication were not provided), for prophylaxis.  Other suspect therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, frequency, duration and indication were not provided), for prophylaxis.  On an unknown date, seven days after vaccination,  the patient experienced irritability,  rash  on belly and  fever (pyrexia).  On an unknown date, the patient experienced a lump under skin on leg where vaccine was administered (vaccination site mass) which one month after the patient still had.  At the time of reporting, the outcome of irritability, rash and pyrexia was unknown.  The reporter did not provide a causality assessment between the suspect therapies and the events.
pt recv vax 18AUG95 & 11MAR96 a titer was checked that showed the pt did not seroconvert p/2 doses;no further info was provided;
rash with both vaccines/rash now is on her neck, chest, and shoulder area; her neck is on fire; itchy; hot; This is a spontaneous report from a contactable physician (patient) A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Sep2021 14:00 (Batch/Lot Number: FC3182) as DOSE , SINGLE for covid-19 immunisation  .Age at vaccination 46:years.  Medical history included , Allergies: many medications.Age at vaccination :46 years old.The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 21Aug2021 (Time: Between 10:00-11:00AM;LOT: FC3180; vaccine site :  left arm ) and experienced rash. There were no concomitant medications.None prior vacciantions within 4 weeks.  The patient stated that she  experienced rash with both vaccines. She Got her second vaccination Saturday 11Sep2021. This morning, 13Sep2021, noticed the rash. Rash appeared after the same amount of time as it did with the first dose. Rash was reported as worsened but clarified her rash now is on her neck, chest, and shoulder area. All around her neck. Her neck was on fire.  Wants to scratch up into her scalp. Might be in her scalp, but not able to see it because of her hair. It is itchy and hot. It is on her back. Therapeutic measures were taken as a result of rash :She Has been taking Benadryl the entire time. The event didn't  result in ER or Physician office visit but she spoke with doctor and dermatologist. The outcome of the events was unknown.Additional information: Vaccination Facility Type: Pharmacy or Drug store;; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198306 same reporter/patient, different dose/event
Site of injection; itchy, rash, spreading 5 minutes after injection ( flu) - Throat itchy, feeling  starting to close approx 1/2 hr after injection - Epinephrine 0.3 sc given (R) arm at 9:40 AM
Patient is a 61 y.o. male with history of hypospadias/epispadias who presents to the emergency department for evaluation of urinary issues. A few days ago the patient noticed burning pain in his penis with urination and some residual pain, urinary frequency, and difficulty holding in his urine. The symptoms came on subtly, but have progressively worsened. He urinated 2 times at night last night, which was very unusual. He called a doctor and was told to come in. No hematuria, cloudy urine, fever, chest pain, scrotal pain, penile drainage, nausea, vomiting, constipation, diarrhea, abdominal pain, flank pain, or rectal pain. He denies dietary or lifestyle changes. He is married and not concerned for sexually transmitted infection. As well, the patient has had 4-5 days of sore throat and cough, and was put on a z-pack by his telemedicine doctor 3 days ago. He has taken 2 days of that. He notes he initially had flu-type symptoms, but they have resolved. He has a COVID test scheduled for tomorrow. He has been vaccinated with the Johnson & Johnson COVID-19 vaccine. He had a physical exam 2 months ago, and he reports he had a normal prostate and PSA. He has no history of UTI.
Vaccine 3/4/21. 2nd day extreme tiredness for 2 days; then weak, dizzyish, tremors, blurred vision right eye which is near legally blind, poor concentration, generally poor feeling.  These symptoms went on for 2 weeks, until I had to do my routine lithium level on 3/18/21.  I was toxic at 1.7.  Have been on lithium 40 years and have never been toxic.  My doctor sent me to ER, where they gave me fluids and potassium.  When checked in ER, my BP was 214/87.  I never have high BP - 120/80 is normal.  On discharge, my BP was 194/79.  Saw my doctor ASAP on advice of ER.  My doctor put me on amlodipine for BP which I started today.  He said I had essential hypertension and heart rate is irregular.
injection area still sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection area still sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection area still sore). At the time of the report, VACCINATION SITE PAIN (injection area still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment details were not reported.   This case was linked to MOD-2021-124820 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received and contains no significant information.
12/11/01, healthy, immunizations given. 12/12/01, red raised and tender area at the site of right thigh of 4cm in diameter. 12/13/01, temperature 102.9F (ax) at night. 12/14/01, redness gone, temperature 103.6F (ax), increasing cough, watery eyes and runny nose. 12/15/01, seen in office and was given Advil, fluids and observed. 12/17/01, watery eyes, runny nose, temperature 99.2F (ax) and decreased cough. Taking fluids well.
Wife said no problems following vaccination on 5-30-19 until 6-4-19 when right arm started aching and became very sore. Woke up 6-5-19 states barely able to move right arm. Diabetic. Told wife he has not felt good since receiving vaccine.
This spontaneous report as received from a medical assistant refers to a 20 years old female. The patient had no concomitant medication and drug reactions/allergies. No pertinent medical history. The reporter reported that the patient received the second dose of VARIVAX (Lot# 0418AA, expiry date: 16-MAR-2013 as reported), subcutaneous, dose and location unspecified for vaccination in January 2012. On 03-SEP-2013 the patient had varicella titers drawn for nursing school, and the results were negative. No treatment was given for the event. The patient did not seek medical attention. At the time of report, the outcome of the event was unknown. Additional information has been requested.
My Child started feeling ill around 3;30pm the day after.  Her stomach started to hurt she became light headed and threw up twice. She also could not pick up her arm that the shot was given.  Around 5pm she began screaming crying of her head hurting (pain 10 on pain scale) and projectile vomiting due to the pain of her head.  She then began to run a fever of 103.5.  She could not function due to her pain in her head and high fever.  Tylenol and Ibprofureon did not break the fever.  Her fever finally broke Thursday am around 6am and was 101.  By Thursday afternoon 3pm she was all better no complaints, head did not hurt nor did she have a fever or vomiting.
Lethargy/fatigue, mild headache (off and on) since approx. 5.5 hrs after vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colitis with full colectomy and ileoanal pouch" (unspecified if ongoing); "full colectomy" (not ongoing); "ileoanal pouch" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263290 same patient, different drug/event;
24hours following vax pt exp fever 103 & a macular welt at the inj site; red & warm to touch; treated w/biaxin bid, tylenol & liquids for fever;
tiredness; headache; fever; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered), PYREXIA (fever), FATIGUE (tiredness) and HEADACHE (headache) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 23-Apr-2021, the patient experienced PYREXIA (fever). On 26-Apr-2021, the patient experienced FATIGUE (tiredness) and HEADACHE (headache). On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. On 25-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 104 High.         No concomitant medications were reported. The patient had acetaminophen 600 mg for fever.   This case was linked to MODERNATX, INC.-MOD-2021-090443, MODERNATX, INC.-MOD-2021-090451 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-090451:Mother's case dose 2 MODERNATX, INC.-MOD-2021-090443:Mother's case dose 1
Approximately 3-5 minutes after administration, mother came out of the room and stated patient was c/o his hands feeling itchy. He was directed back into the room to be monitored. Within 30 seconds-1 minute patient began retching and was having a small amount of emesis. Increased oral secretions also noted. The patient was laid down on his side with his legs elevated as there was suspicion of a vasovagal reaction initially. The child quickly became increasingly irritable and fussy with decline in LOC. EMS call initiated. Patient placed on 15L O2 via mask. Unable to obtain initial pulse oximetry reading and blood pressure due to poor perfusion, patient became somnolent. Verbal order obtained to give Epi-Pen Jr. X 1 and Benadryl IM X 1. Patient was able to maintain his own airway. EMS to bedside in clinic and took over care. Patient was transported to nearest ED with subsequent admission to the ICU.
Systemic: Exhaustion / Lethargy-Mild, Additional Details: pt sat for 15minutes and felt better. rph left message on home phone
After administering the vaccination, the vaccine provider discovered that the vaccine had expired 2 days prior.  The vaccine had been granted an expiration extension, but the vial was labeled with the incorrect expiration - using the 30 day refrigerated BUD rather than the expiration, which was less than the BUD at the time the vaccine was removed from ultracold storage. The clinic notified a hospital pharmacist, who contacted Pfizer for direction regarding additional stability data.  Pfizer did not have data to disclose and referred to the CDC guideline which states that the vaccination should be repeated.  The patient has agreed to return for another dose on 3/16.  The patient has not reported any symptoms.
High fever, body aches, chills, stomach pain, headache, nausea/vomiting
had the vaccine and still got shingles/suspected vaccination failure; shingles; very painful don´t know what to do; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: very painful don´t know what to do). The patient was treated with calamine. The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and still got shingles. The patient had shingles five years ago and he/she had shingles now.  The reporter stated that they were very painful and sometimes you just did not know what to do.  The patient used calamine lotion on shingles and that helped them from spreading. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
101.2 degree Fever, Chills, Shaking, Aching. Still symptomatic 10/21/2016 at 3:20PM.
Severe chills, muscle aches and joint pain. High fever. Lasted for 24 hours.
Left deltoid with large red area, hot, indurated, tender. Dx Cellulitis Rx Keflex 500 mg one tab PO TID X 7 days, Ibuprofen prn
8/23/17 noticed slightly sore and red, the next day more red and hive swelling and hot, and today still swelled and red.
Eleven minutes after injection the patient had generalized pruritis,  warm "crawly" sensation all over body and itchy eyes.  She developed 2 - 1cm urticaria.  One on the lower part of left upper arm and the other on the left distal lower arm., but none at injection site.  A third developed on left hand.  Patient had no respiratory/GI/hoarseness/angioedema/cardiovascular symptoms.  Patient responded to benadryl and pepsid.   Patient was observed for 3 hours.  Itching, warm "crawly" feeling on skin subsided.  The 3 urticaria stable.  Discharged home.  Patient instructed to go to ER if conditions worsen,  increase in hives, any respiratory, swallowing issues arise or allergy symptoms.   NOTE that with first dose of vaccine the patient had only a headache, chills and eye pressure.  Denied any allergic symptoms.
about 12hrs p/vax pt started having sz like activities lased 35-40mins;
expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comments: A medical assistant reported that, an expired dose of Bexsero vaccine was administered on 1st March 2023 which was expired on 28th February 2023. The reporter had consented to follow-up. Additional supportive information: The patient had received Bexsero vaccine which was already expired in 28th February 2023, which had led to expired vaccine used.
Starting next morning after getting vaccine I was dizzy when getting up from bed lasting a minute or so. During day when getting out of recliner I have same dizziness. 11 days later still having same symptoms.
Patient presented to the Medical Clinic on 9/2/08 with c/o Chest Pain, fever, and SOB for 3 days. Temp 99.6, diaphoretic at time of visit, CP rated 3 out of 10. Unable to obtain ECG due to equipment failure. He was given ASA 162mg, Nitroglycerin SL, IV started given MS 2mg IV Push, transferred to another ER, ECG in ER noted normal sinus rhythm, early repolarization, with possible ST segment elevation in lead 1. Possible incomplete right bundle branch block. Labs: Positive Troponin and CK-MB, negative rapid strep. Started on Nitroglycerin grip and Heparin, transferred to another hospital for Heart Cath. Admitted to hospital and discharged on 9/3/08 with normal echocardiogram, normal ejection fraction, started on Beta blocker and ace inhibiter for 2-4 weeks with follow up with cardiology scheduled at 4 weeks. According to Immunization record received Smallpox vaccination on 8/20/08, Manufacture is listed as Baxter Healthcare. Lot number not given.  9/12/08 Reviewed hospital medical records of 9/2-9/3/2008. FINAL DX: none provided Records reveal patient experienced chest pain, SOB, muscle aches, decreased appetite & dizziness for 3-4 days prior to admit.
Excessive fatigue (AE): resting (treatment), fatigue (outcome). Persistent back pain (AE): hot patches & rest (treatment), temporary relief (outcome). Intermittent headache (AE): hydration & rest (treatment), temporary relief (outcome).