chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 minutes after receiving vaccine began to feel dizzy and nausea. Began to feel better after 5 minutes
Posterior vitreous detachment on the right eye, floaters, and occasional pain behind the right eye.  Light flashes during the first week, no retinal detachment resulted from the event up to date of the report.
Arm swelling and redness at site of injection, myalgia at injection site, fever, headache, and vomiting throughout the entire night following the injection of Prevnar 13. Still experiencing arm redness and headache on 8/6/15.
Sunday: onset of pain and rash on left arm. No fever. Today: headache and nausea, 45mm by 55mm localized swelling and tenderness; maculopapular rash. Poor ROM at elbow. Symptoms lasted approximately 4 days.
pt. recvd. 1/2 dose of vax due to uncooperative behavior.
She noticed redness and itching at the injection site; She noticed redness and itching at the injection site; injection site became sore; She could not sleep on the arm for two days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2020, couple of hours after receiving Shingrix, the patient experienced injection site pain. On 5th March 2020, the patient experienced injection site erythema and injection site itching. In March 2020, the patient experienced sleeplessness. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema and injection site itching were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site itching and sleeplessness to be related to Shingrix.  Additional case details were reported as follows: The patient reported that the injection site became sore within a couple of hours of receiving the vaccination. The patient could not sleep on the arm for two days after receiving the injection. Four days after receiving vaccination, the patient also noticed redness and itching at the injection site. The patient gave permission for her physician to be contacted. The patient did not consent to follow up.
Pt recvd vax 11SEP92 & immediately post vax inject site became swollen; pt's stomach virus persisted; 2 to 3 days following vax swelling had subsides; inject site was ecchymotic;
Patient feeling dizzy and nauseous - doctor spoke to mom 1st day close observation.  Day 2 advised rest/push fluids/use Motrin for HA, if worsening to call back.  Telephone call received from mother with the following information: 10/15 7 pm: feeling dizzy and nauseous a few hours after getting GARDASIL.  Advised close observation and fluids tonight.  Call in am to speak with PCP if persists.  10/16 9 am: spoke with mom this am to check on patient and she was not so great last night - woke up in middle of the night and vomited.  This am had headache and went to school.  Advised to follow up with PCP re future shots.  Discussed that this is likely an intercurrent illness, not related to GARDASIL, but no way to know.
Information has been received from a medical assistant concerning a 65 year old patient who on 23-MAR-2011 was vaccinated with a 0.5 ml dose of PROQUAD (Merck), intramuscularly. (Lot number 667187/1413Z). The health professional reported that the patient was administered PROQUAD (Merck) instead of MMR II. No adverse effects were reported. Additional information has been requested.
The morning of April 3, staff at the Vaccination Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses.   The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects. The District will follow up to monitor their status.
Patient had received Flublok instead of Fluzone High Dose instead/ no AE; Initial information was received on 28-Oct-2021 regarding an unsolicited valid non-serious case from a Patient via Information (under reference- 00833066) and transmitted to Sanofi on 28-Oct-2021.  This case involves a 78-year-old male patient who had received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] with no adverse event (Wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a (total) dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number not reported and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination and a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE via unknown route in unknown administration site for prophylactic vaccination.  It was reported "He received the 18yr + Flu vaccine FLUBLOK and he is wondering if he should have gotten the 65+ FLUZONE HIGH DOSE instead and can he still get it? He states that he believes there was a miscommunication between himself and the person administering the vaccine".   It was a case of actual medication error due Wrong vaccine administered (latency was on the same day).  At the time of reporting, patient had no adverse event.  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.  There will be no information available on batch number for this case.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
Report 2002000558 describes possible rheumatoid arthritis in a 43 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reported that he received his first and second injections of LYMErix in October 1999 and September 2000 (exact dates not provided), respectively. In the year 2000, an unspecified time following receipt of the second injection of LYMErix, the vaccinee reported that he experienced achiness for a couple of months that (he) thought was the flu. The achiness resolved. In December 2001, 15 months following receipt of the second injection of LYMErix, the vaccinee reportedly began to experience joint pain. His body was stiff and sore, and he found it difficult to walk due to arthritic feeling. He was seen by a general practitioner, who reportedly told the vaccinee he may be developing rheumatoid arthritis and referred the vaccinee to a rheumatologist. The rheumatologist saw the vaccinee on 1/11/02. The rheumatologist reportedly was not ready to label (him) as developing arthritis. The rheumatologist prescribed rofecoxib, and advised the vaccinee to exercise and watch his diet. The vaccinee stated that his body stiffness, and body soreness persisted. The vaccinee stated that his facility's health unit considered the events to be possibly related to LYMErix administration. The LYMErix immunization series was discontinued. The adverse events possible rheumatoid arthritis and joint pain do not meet ICH serious criteria, but are being submitted as an expedited report by special request per the 6/28/00 letter.
Hives began on 05/02/2018. They started on the chest and spread to the stomach. They continued to spread over her body and continue spreading as of today, 05/07/2018. No difficulty breathing, throat swelling, nausea, vomiting, headaches, fevers. Patient has not sought care as of this time. She has been taking BENADRYL tabs to help with the itching. There is no resolution at this time.
Developed Bell's Palsy (right-sided) within 3 weeks of receiving vaccine.  Symptoms resolved in 6-8 weeks. Patient then experienced an ipsilateral recurrence on the left-side.
less than 6 hours after Moderna vaccine administered per pharmacist, the site became red, swollen and hot to touch.  It has worsened since then.  Pt reports she has had two Moderna COVID vaccines and she had no reaction.  Pt reports this injection was much lower than previous site of injection.
Rash on my arm, itching very badly; arm was sore; This is a spontaneous report from a contactable consumer(Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 06Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on my arm, itching very badly on Mar2021, arm was sore on Mar2021.Reporter stated, Scheduled date for second shot was on the 3Apr, they told patient to come the first week can come on the 1st or 2nd or third. At first arm was sore. Thinks the rash side only on the 10th. (The 10 of march). The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Headaches; Shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache and shivering. On an unknown date, the outcome of the headache and shivering were unknown.   It was unknown if the reporter considered the headache and shivering to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had headaches and shivering. The patient was very vague about any other side effects. The patient stated, he wanted more information as to whether he would have the same side effects if he got the 2nd dose. The patient did not want to provide any other PII or any information regarding his healthcare professional. The reporter did not consent to follow up. No healthcare professional information was provided.
I had pain when standing with numb feet and such. I get a massager for my feet. It only got worse with prickly burning pain. My doctor gave gabapentin to fix it and it don't work. Went back and gave stronger dose, still did nothing. Advised 600mg at night and again in morning but it made me too dizzy. So on another visit I started with tramadol. This help a little but the pain continues after and during my shift. This is still ongoing. X-Ray was done on 2/14 and did some lab test and will have the results in about a week.
Narrative:  Patient received three COVID 19 Vaccine in Feb/Mar 2021 and Feb 2022. The patient tested positive for COVID 19 on 24 Sep 2022. The patient presented to the ED with generalized weakness, cough, sob with any activity, and black stool. The patient was admitted to the hospital with covid pneumonia and acute kidney injury. The patient was treated with oxygen and antibiotics. The patient was discharged on a 27 Sep 2022 in stable condition. Reported per EUA.
This spontaneous report was received from a consumer concerning her 28 year old daughter. On 26-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) when she was 28 years old. It was reported that the patient had received only one dose of GARDASIL. It was unspecified if the further vaccination was discontinued. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
I went into the emergency room with a right burning itchy spot on the right side of my stomach I was advised that I had shingles.
Information has been received from a physician concerning a father, who was naive to chickenpox, who's 13 month old daughter who on 16-MAR-2006 was vaccinated with a dose of Varivax (Lot# 649999/0910R). It was reported that the patient developed chickenpox, described as vaccine strain, and had since recovered. It was noted that the father will be having samples tested for adenosine deaminase levels. The patient's daughter experienced a reaction following vaccination with Varivax (WAES# 0604USA03984). Additional information has been requested.
I experienced muscle spasms caused me to be unable to breathe, move, or sleep two weeks after receiving the vaccine and had to go to the ER. The doctor performed a series of lab work and tests but could not find the source of my muscle spasms. I was given a prescription muscle spasms medication Buclizine. The extremely bad muscle spasms lasted for 10 days even while taking the medication which made me a bit foggy. My breathing is easier; however, the muscle spasms continue to happen.
3.5 hours after vaccination = fatigue. 20 hours after vaccination = extreme fatigue, fever 101 (with Ibuprofen), chills, sweating, body aches. These symptoms lasted until 50 hours after injection. 4 days after injection, red, swollen, sore injection site on arm about 3"x6".
weakness in legs, suspected guillan Barre syndrome with lower extremity weakness and progression to upper extremities
Around 5:00 PM FRIDAY, 1/11/19 THE DAY OF THE INJECTION I STARTED GETTING SO COLD MY BODY WAS SHAKING. I FELT DRUGGED AND EXTREMELY WEAK. I SLEPT FOR APPROX. 2 HOUR, WOKE UP AND COULDN'T GET AWAKE ENOUGH TO TAKE OUT MY CONTACTS. I ACHED ALL OVER INCLUDING HEADACHE. SO TODAY (1/15/18) WHEN I WOKE UP I REALIZED THAT THE TERRIBLE NIGHT SWEATS AND HEAD SWEATS (HAIR SOAKED) - THAT I HAVE HAD THE PAST 4 NIGHTS, FRIDAY, SATURDAY, SUNDAY AND MONDAY MUST BE RELATED TO THE INJECTION. I AM HAVING DIAHREA TODAY AND UPSET STOMACH. I DIDN'T HAVE ANY OF THIS BEFORE THE INJECTION SO IT MUST BE RELATED.
Severe pain/cramping in lower abdomen, similar to pain from ruptured cysts in ovaries. Vomited multiple times.
Once patient received her second shot, her periods for the past 3 months have been irregular.  They were never irregular before.  She would have a period every two weeks and then go over a month without one.  They are still not regular at this point.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2 NOS), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient got a rebound of Covid after taking Paxlovid.  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-202300148451 same patient, different drug/event;
pt was given vaccine at an off site location but had reaction of high bp, fast heart rate, dizziness, presyncope, and throat numbness that occurred about an hour after the vaccine. the other reactions occurred 20 min after vaccine.
Flushed feeling and rapid heart beat within 45 minutes of injection.  Took 2 tablets of Benedryl.
2 year old patient accidentally received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2854, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 25th March 2022 Reporter's Comments: The medical assistant reported that a patient accidentally received Kinrix. The reporter consented to follow up. Additional Supportive Information: 2 year old patient received kinrix which led to inappropriate age at vaccine administration.
Stomach pain, stomach swelling and nausea off and on. Started on Tuesday morning. Went to the Emergency Room on Friday afternoon and was diagnosed with Pancreatitis. Sent home with pain and anti-nausea meds.
A medical assistant reported VARIVAX was administered after undergoing a temperature excursion; This spontaneous report has been received from a Medical Assistant and refers to a 4-years old patient of unspecified gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 19-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number T028310, that was verified to be valid, with an expiration date reported and established upon internal validation as 20-AUG-2022) (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration were not provided). It was reported that the vaccine was administered after underwent a temperature excursion of 0.4 degrees Celsius (+ 0.4 ° C) with a time frame of 13 hours and 10 minutes, which was detected by data logger (product storage error). No previous temperature excursions were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA006887: US-009507513-2107USA007000: US-009507513-2107USA007007: US-009507513-2107USA006981: US-009507513-2107USA007009: US-009507513-2107USA007049: US-009507513-2107USA007004:
Pt complained of upper arm red, sore, and swollen, all warm to touch all over her right arm from PNEUMOVAX 23 administered on 9/11/18.
c/o redness around vaccination site and neck 10 mins after vaccination, vitals stable, extra time for observation done, no meds given. Symptoms resolved and Dc home stable @2:01 PM.
Patient developed swelling and redness at site of injection the night of vaccine and developed hives on trunk and arms two days after receiving vaccine.
3 hrs p/vax, pt nursed & went to sleep; pt screamed (not usual cry) & became pale, clammy & not visually responsive (eye open, but gaze overted); parents stimulated pt, resulted in scream, limp, irritable, diff breathing, t38.1;
Pt developed a rash on both hands and feet eleven days post vax. Pt was seen by a dermatologist the next day who did a biopsy and prescribed prednisone 5 mg twice daily for a week.
I had a seizure and continue to have them now. No history of seizures prior to vaccine. Cause hasn?t been established to date. The vaccine is the only thing I can contribute it to. I had covid in Jan 2022, after the vaccine and after the seizures had started.