chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 66 or 67 years. A little over 1 month ago from the date of reporting, the patient received a dose of SHINGRIX. The patient had pain at the injection site that started immediately after receiving the dose of SHINGRIX, and did not resolve at the time of this report. The reporter did not give consent to follow up. At the time of this report, the patient still has a sharp pain in his arm where the shot was injected.
Difficulty walking. It started on the 7th of this month with slowness to his walking, then sensory deficit started in his feet and has over the course of the last 2 weeks ascended to the level of the midthighs.
I started getting dizzy and then heart palpitations, shortness of breath, chest pains, sharp shooting pains on left side of neck by my ear. All but chest pains continue. Legs are swollen.  Will be seeing clinic on July 7th at 2pm.
Pt was given HPV & meningitis vaccines. After receiving shots, pt became very pale. She was assisted to lying position. Pt did not lose consciousness; however, did become very pale and somewhat diaphoretic. This lasted approx.10-15 seconds and then pt symptoms significantly improved. She denied any nausea or vomiting with this episode.
Dizziness, Headache, Myalgia, Arthralgia, Fever, FATIGUE, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative:  Other Relevant History:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 08:15 as dose 1, single (Lot number: EN6204), in left arm, on 30Mar2021 at 08:15 as dose 2, single (Lot number: EP7533), in right arm and on 16Oct2021 at 14:15 as dose 3 (booster), single (Lot number: FF2590) at the age of 73 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical Course: Other medical history was reported as None. The patient received COVID-19 Treatment as Paxlovid (Lot. Number: GA1513, SN891636340047) from 13May2022 to 17May2022 (Indication treatment of COVID-19).
Within 4 hours: light headed and headache continued to present time of filing report.  Within 15 hours: high fever 102-104.7, skin feeling like it was on fire, extremely fatigue with severe muscle pain.   High intensity last about 12 hours and complete gone in 17 hours except for low graded fever which lasted another 5 hours. Headache and fatigue still present as of filing of this report.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive; (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid 5 days treatment and last on 06Sep.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a health professional concerning a 19 year old female with no past medical history who on 23-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 657005/0314U) into her hip. There was no concomitant medication. A few days after vaccination, on approximately 25-MAY-2007, the patient experienced a fine rash from waist down both legs. She was treated with BENADRYL. Subsequently, the patient recovered from fine rash from waist down both legs on 01-JUN-2007. Additional information has been requested. Initial and follow-up information has been received from a health professional concerning a 19 year old female with no past medical history or known drug allergies qho on 23-MAY-2007 in the morning who vaccinated intramuscularly into the left upper outer quadrant with a first 0.5 ml dose of GARDASIL vaccine (lot # 657005/0314U). The was no concomitant medication. On 26-MAY-2007, according to the patient, she developed a very fine rash in  the boxer short area of her legs. The patient sought unspecified medical attention. She was treated with BENADRYL and used calamine lotion to the affected areas. No laboratory diagnostic studies were performed. On 01-JUN-2007, the patient recovered. No product quality complaint was involved.
Arm soreness at site of injection. Over a month later the arm is still sore. Can't lift objects above head or across body.
I feel sick with a cold; I feel sick with a cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I feel sick with a cold) and NASOPHARYNGITIS (I feel sick with a cold) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 MALAISE (I feel sick with a cold) and NASOPHARYNGITIS (I feel sick with a cold). At the time of the report, MALAISE (I feel sick with a cold) and NASOPHARYNGITIS (I feel sick with a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   Reporter did not allow further contact
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 at 15:45 as dose 1, single (Lot number: EK9231), in left arm and on 25Feb2021 at 15:45 as dose 2, single (Lot number: EL8982) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2022 at 15:45 as dose 3 (booster), single (Lot number: 022T21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Sinus allergies: pollen" (unspecified if ongoing); "Sinus allergies: dust mites" (unspecified if ongoing); "Sinus allergies:pet dander" (unspecified if ongoing); "knonwn allergies:Sulpha Drugs" (unspecified if ongoing); "knonwn allergies: penicillin" (unspecified if ongoing); "knonwn allergies: eggs" (unspecified if ongoing); "knonwn allergies: soy" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "knonwn allergies: cinna" (unspecified if ongoing); "known allergies narcotic drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "known allergies Augmentin"; Codeine, reaction(s): "known allergies codeine"; Morphine, reaction(s): "known allergies morphine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Jan2022 at 15:45, outcome "unknown"; 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Feb2023 to 21Feb2023.
swollen arm evening of shot; swelled more next day inspite of APAP & applying ice; seen in ER given oral ATB & mom told had staph infect @ site of inject; no improvement adm Sunday AM & d/c Monday or Tuesday;
In November after Thanksgiving I was having a small dry cough and tickle in my throat. I was coughing while talking that turned into worse over four days or so. I became fatigue with chills headache  and cough. I contacted a nursing line and I told to come in for a X-ray. I was coughing up mucas and my ribs hurt so bad from coughing.  I was tested and positive for Influenza A.  The said I was too far in for a prescription and recommended over the counter Mucinex.  I believe a week later or two I was still couging but getting slowly better. In March on a Friday morning on the 17th of 2023. I woke up with a sore throat, it gotten worse through out the morning and by the afternoon I had chills and a headache. I went to the clinic and was tested for STep and never got the results. I was given a Z Pack to take. By the weekend after taking the medication I was fine on Monday.
03/24/21: Patient presented and was admitted through emergency department for Altered mental status and Suicidal ideations. PMH Charcot foot requiring multiple surgeries in the past, paroxysmal afib on Eliquis, stage III CKD, type II DM, HTN, HLD, previous stroke, blind in right eye. On admission pertinent objective findings: XR foot - Cortical erosion over the bony prominence of the right medial midfoot concerning for osteomyelitis Hospital diagnosis: Right foot with large open wound, suspected osteomyelitis of right foot. CT scan of his head shows no acute finding. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.  Hospital diagnosis:
Pain, warmth, and swelling at injection site. Pain subsided today, swelling had decreased.
Pt's mother called office today - pt. has redness and lump at immunization site - Mom applying ice and giving pt. ibuprofen - Reaction to VARIVAX.
Starting 8 Feb severe acute pain which was suspected of kidney stones but CT Stone protocol was clear.  Pain continued for three months during which several imaging protocols were done and showed mild hydronephrosis and mid-level constriction in the ureter on the left side. On 16 mar 2021, a "Cystoscopy /Ureteroscopy & Indwell Stent Insertion with string" procedure was performed to relieve the obstruction.  The stent was removed on 22 Mar 2021. Starting about AUgust the pain subsided and subsequent imaging showed a relief in hydronephrosis and ureteral obstruction.  Further imaging tests scheduled for February 2022.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 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: "hbp" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim"; Levaquin, reaction(s): "Known allergies : Levaquin"; Cipro, reaction(s): "Known allergies : Cipro"; Erythromycin, reaction(s): "Known allergies :Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. No further information is expected.
Headache, body aches, joint pain, feeling hot and cold, sweaty, feeling tired, insomnia, congestion with cough, nausea and vomiting, on and off since March
rash on back; had hives on his back a couple of days; headaches; stomach aches; weakness; Initial information received  on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient who experienced headaches, stomach aches, weakness, rash on back and had hives on his back a couple of days after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Jun-2023, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (batch/lot number, expiry date, strength, route: not reported) in unknown administration site for prophylactic vaccination (immunization). Information on the batch number was requested.  On 30-JUN-2023 the patient developed events headaches (headache), stomach aches (abdominal pain upper) and weakness (asthenia) (latency: 1 day) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  On 01-JUL-2023 the patient developed events rash on back (rash) and had hives on his back a couple of days (urticaria) (latency: 2 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Patient was given the vaccine too early by 1 week. Patient is still okay, patient has recovered from the event. Patient was told to come back for the next vaccine.
This spontaneous report was received from a pharmacist concerning a 22 year old male patient with drug hypersensitivity to quinolones, cephalosporins, penicillin, vancomycin and tetracycline, asthma and tobacco user. The medical history was not reported. On 14-MAR-2016, the patient was vaccinated on an unspecified arm with an unspecified dose of PNEUMOVAX 23 lot # L024129, expiration date 21-JAN-2017, 0.5 ml, intramuscular. Concomitant therapies were not specified by the reporter. On 16-MAR-2016, the patient called the pharmacist to report that "his whole arm felt sore and tender and underneath his arm pit felt swollen, like a gland was swollen", this was the same unspecified arm where PNEUMOVAX 23 was administered. The patient did not receive any treatment and not laboratory tests were performed. The patient sought medical attention since he spoke to the pharmacist. The outcome of pain in extremity and lymphadenopathy was reported as not recovered. The causal relationship between PNEUMOVAX 23 and adverse events were not reported. Additional information is not expected as the reporter did not want to be contacted.
I started experiencing a chest cold with coughing and heaviness in the chest. My sinuses got all stuffy and runny. That's been going on for about three weeks. I've been using over the counter medications. I took several COVID-19 tests, but they were all negative. My right ear started hurting. I called the doctor to see if I could get in antibiotic for it. I couldn't because my doctor was out of town. The nurse took me off one of my allergy medications and told me to take CLARITIN D and FLONASE. They also took my off MUCINEX and asked me to take ROBITUSSIN.
Covid Arm:  Vaccination area became pink (half dollar sized), itchy, lump under skin.  Lasted 2-3 days.  Still itches occasionally.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-Mar-2021 and the estimated date of delivery was 06-Dec-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medication was reported.
Edema, redness of left thigh. Treatment with Benadryl. Will f/u on 03/24/2005.
12/31/20  around 11am Numbness in right hand and right cheek, 5 minutes later, slurred speech.  Episode lasted approximately 10 minutes.  Treated in ER.  Labs, MRI, all normal 1/3/21 Swollen lymph node to left axilla 1/4/21 Rash to injection site
flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or other non-professional.  This case involves a male patient (age unspecified) who experienced flu (influenza), after he received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was reported that, patient was forced to get the shot at work.   It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was reported as unknown for influenza.    It was unknown if patients physician provided consent to be contacted.   There will be no information available on the batch number for this case.
Generalized urticaria @ 24 hours persistent  w/dermographophim > 3 wks.
Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 11/3/2022 Discharge Date: 11/7/2022 COVID positive Date 11/3/2022 PRESENTING PROBLEM: Generalized weakness [R53.1] History of falling [Z91.81] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 90 y.o. male who presented to the emergency department with weakness.  Patient has a past medical history of asthma, coronary artery disease, hypertension, hyperlipidemia, and GERD. Patient states that over the past 2-3 days, he has developed symptoms of weakness, cough with sputum production, dizziness, sore throat, and diarrhea.  He denies fever, nausea and vomiting, or shortness of breath.  He also states that he has sustained 2 falls due to his weakness.  Patient states that at baseline, he uses a walker for ambulation, however, he has been unable to fully support his weight and fell while ambulating to the bathroom.  He presented to the emergency department for evaluation.  In the emergency department, patient's vital signs were stable.  Complete blood count was unremarkable.  BMP was unremarkable.  Troponin was indeterminate at 59 with a repeat of 53. RSV and influenza were negative.  COVID-19 was positive.  EKG shows presence of right bundle branch block.  CT of the head showed no acute intracranial abnormality.  Chest x-ray shows small pleural effusions with adjacent atelectasis that could have superimposed pneumonia.  Suspect generalized weakness secondary to COVID-19.  Patient has been admitted for further evaluation and management of generalized weakness secondary to COVID-19.  Patient was admitted and remained stable throughout his stay.  He was initially quite deconditioned and weak but Physical therapy Occupational therapy worked with him and were able to stabilize him adequately for discharge home with home health PT OT and nursing.  His markers remained relatively stable and he never developed any respiratory symptoms associated with the COVID.  He was seen on the day of discharge doing well and discharged home to follow-up with his primary care provider.  He was to resume his regular medications as previously ordered.  There were no additions to his regimen.  He could return to diet and activity as tolerated.  He was recommended to complete 10 days of respiratory isolation from the day of his 1st symptoms.  He was to follow up with his primary care provider in the next 7-10 days to ensure complete resolution of his symptoms.  He understood all these instructions and was discharged home with his family in stable condition.
Initial unsolicited report received from a nurse via other company (Pfizer) on 11 Oct 2016. Manufacturer Report Number: 2016454215. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID ADSORBED/TETANUS VACCINES and TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had allergy to vaccine tetanus toxoid, absorbed, tetanus vaccines and toxoid. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 24-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Breakthrough case admission after 3 vaccines Moderna 3/1/21 LotA#023M20A;  Moderna 4/11/21 Lot# 018B21A;  Moderna 11/1/22 Lot# 020H22A
PATIENT'S WIFE STATED PATIENT WAS HAVING NUMBNESS IN LEGS WITHIN APPROXIMATELY 20 MINUTES AFTER IMMUNIZATION. WIFE SAI DAUGHTER IS TAKING PATIENT TO THE HOSPITAL.
3 days later on 7PM severe heartburn was severe and painful the next day, when to see the doctor got meds.
Significant  drop in blood pressure.  Fainting in a store  35 point systolic drop in bp