chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became immunocompromised and started to receive chemotherapy after getting booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (Patient became immunocompromised and started to receive chemotherapy after getting booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (Patient became immunocompromised and started to receive chemotherapy after getting booster dose) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Patient became immunocompromised and started to receive chemotherapy after getting booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient received first, second and booster dose with a regular schedule, but became immunocompromised after he received his booster dose. He started to receive chemotherapy and was asking about the forth dose due to his new condition.  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected serious event of Immunodeficiency. Patient became immunocompromised and started to receive chemotherapy after getting booster dose of mRNA-1273 vaccine. No further information was disclosure and follow up was not granted. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected serious event of Immunodeficiency. Patient became immunocompromised and started to receive chemotherapy after getting booster dose of mRNA-1273 vaccine. No further information was disclosure and follow up was not granted. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt received incorrect mfg of covid vaccine,  She should have received her second moderna , not the janssen.  Pt had received her first covid shot (moderna mfg) in January.  She thought that since it had been so long she should start over with a different mfg.   The patients history was not checked  prior to giving vaccination.
Achiness in bil legs and pain in bil legs 7/30/14 in PM worsened 8/1/14 contacted drs. office and took Ibuprofen resolved by 8/3/14.
The patient is a 38 year old, with an estimated due date of 7/24/2021 whose pregnancy was notable for suspected Trisomy 21, based on duodenal atresia, nuchal thickening, echogenic bowel, and transient left renal pyelectasis. Cell free DNA screening indicated a high risk of Trisomy 21, and the patient declined amniocentesis. From a maternal health standpoint, her pregnancy was notable for Gastroesophageal reflux disease, iron deficiency anemia, and a history of cold knife conization. The patient had a sonographic assessment of the fetus two days prior to receiving the vaccine at 30 weeks gestation, which demonstrated new development of polyhydramnios. Given the patients multiple risk factors for stillbirth, it was recommended that antenatal testing commence by 32 weeks gestation.   The patient reported that she stopped feeling her baby moving the day she received the COVID vaccine (two days after the ultrasound report demonstrating the above findings). She had reassuring antenatal testing two days subsequent to vaccination, but then had intrauterine fetal demise confirmed 9 days after vaccination. She underwent a labor induction. Her postnatal workup including chromosomal analysis which confirmed the Trisomy 21 diagnosis and a 2.8Mb 2q32.1 duplication thought to be a variant of unknown significance. The placental pathology report demonstrated a umbilical cord stricture with significant clot burden within the stricture.  There was also evidence of meconium staining, and some scattered infarctions in the placenta but no large infarction.  Maternal antiphospholipid screening was normal. Our clinical impression was that the fetal loss was most likely secondary to Trisomy 21, but given the temporal association between vaccination and change in fetal movement, we have submitted this report as a possible vaccine complication.
PT was given the Moderna vaccine around 12:15pm. Pt did not seem in any distress at time of injection. After injection, he moved to an observation area chair with armrests. He appeared to have a vaso-vagal response around 12:20pm causing him to pass out and fall out of chair. He hit his head on the floor causing a minor laceration on left eyebrow and some bleeding. He appeared to have some swelling around eyebrow and forehead area. His mother accompanied him and informed us post-injection that this has happened in the past, that he had syncope related events from vaccine. The paramedics were called and the PT was taken to the local hospital for further evaluation.
ITCHING OVER ENTIRE BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced itching over entire body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itching over entire body was not reported. This report was non-serious.
The booster shot was on the 23rd of October and my AFIB lasted until the 22nd of November I'm going to need a TEE. This is scheduled on December 8th depending on the outcome I might need an ablation.
A patient was given the liquid DTaP-IPV portion of Pentacel in the right thigh without using it to reconstitute the lyophilized powder portion (Hib) of Pentacel/No AE; Initial information was received on 12-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 18 month old female patient who received the liquid DTaP-IPV portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without using it to reconstitute the lyophilized powder portion (Hib).  Medical history, medical treatment, vaccination and family history were not provided.  No other vaccines were received.  On 09-Dec-2019, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot number not reported via unknown route in the right thigh.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  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.  Information on the batch number was requested.
Extreme chills for several hours, then fever, then very extreme muscle pain and aches, dizziness, slight nausea. Symptoms began 8 hours after dose was administered, and lasted for 18 hours.
Dizziness, Headache, Myalgia, NauseaVomiting, fatigue, injection side pain and swelling Narrative:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 13:00 as dose 4 (booster), single (Lot number: Gj2524) at the age of 44 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 was not reported. Concomitant medication(s) included: ETHINYLESTRADIOL;NORETHISTERONE ACETATE, start date: 13Jul2022. Past drug history included: Gadolinium, reaction(s): "Known allergies: Gadolinium"; Vancomycin, reaction(s): "Known allergies: vancomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment with Paxlovid, treatment start date: 15Jul2023 and treatment stop date: 19Jul2023.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE,COVID-19 and The suspected drug cannot be ruled out.
No adverse effects reported; a dose of expired PNEUMOVAX 23 was inadvertently administered to the patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 20-JUL-2019, the patient was vaccinated, inadvertently, with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # N030987 (verified to be a valid lot number), expiration date reported and established as 15-MAY-2019, for prophylaxis. No adverse effects were reported.
Patient is a 55 y.o. male presenting to the hospital with shortness of breath and facial swelling.  On arrival to the ED he was found to have angioedema with swollen tongue and lips.  He did not have a generalized rash. Patient is being treated with decadron, famotidine and benadryl. Patient is intubated and sedated in the ICU unit.
3 minutes after patient received the vaccine, patient experienced lightheadedness and dizziness and fell forward from a standing position. Pharmacist caught the patient, and laid him onto the ground. Patient was responsive and was then moved to sit on a chair. Patient received water, felt better, and was able to leave the pharmacy with his dad after 10 minutes.
Noted left arm soreness without swelling or redness. Shoulder was sorer the next day.  Upon arising noted BL facial swelling/tightness similar to past reaction with lisinopril. 0 lip/tongue swelling. Swallow and breathing is normal.
Patient required hospitalization due to breakthrough infection. Patient received Pfizer vaccine (2nd dose in series) on 04/16/21. Patient was hospitalized from 08/11/21 - 08/20/21 and then was discharged. Then, patient was readmitted on 08/24/21 until 08/28/21. Below is copied from discharge summary:   08/28/21 - comfortable, denies any SOB, remains on RA Will complete 5 days of remdisvir this afternoon, abort solumedrol as has been on RA for last several days PT/OT advised RW; Agent to arrange and DC home on 20 days of isolation 8/16-9/14   08/20/21 - 34 M, non compliant, seen in Facility, is accepted from ER to hospitalist as DKA has resolved. Has T2DM x age 25, ESRD (  biopsy at hospital - diabetic glomerulosclresos with arteriohyalinosis ) on HD x 5/2021, HFpEF 50%, HTN, Rt 5th toe amputation hx and multiple infections on Rt foot was brought to ER by EMS 8/11 for " feeling tired", sugar was "hi", missed HD, and said had a Rt foot wound x 1 wk. Was admitted to ER in Facility for bed constrints, for DKA, was drowsey. CT showed 6 cm abscess along Rt foot lateral border and fluid collection extending along xxtensor digitorim tendon sheath c/w tenosynovitis, erosive bases of 4th and 2nd MT c/w OM. Podiatry did bedside I&D and plan OR I&D today. On vanco and zosyn, has closed with insulin and pt tx'ed to hospitalist 8/12.
Appx 3 wks after 2nd shot i began to get tingling and numbness on bilateral hands and feet.. my fingers were numb.  The symptoms on my feet eventually went away about 2 mnths after but hands did not change.  I can no longer pick up small things .. i cannot grab with thumb and pointer finger.  At this point my tips of my fingers are always tingly and numb.  I went to see a neurologist thinking it was a disc in my neck being compressed.. we did an mri c spine and that was normal.  We did carpal tunnel and it showed both wrists.. but more severe in the right.  I was told to see a hand specialist to see if there was anything that can be done to help me.  At this point i dont think it can.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On 9th November 2020, 1 week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. It was reported that the patient got the first dose of the Shingrix vaccine, one week before the date of reporting and on 9th November 2020 he had fever.  No additional information was available. The case has been linked to US2020222176, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222176:same reporter
3/28/21 Patient presented to ED w/SOB x 5 days, fever and cough for one day. RA pulse ox 42%. CXR showed bilateral infiltrates. Pt refused intubation and was started on BiPAP w/FiO2 of 100%. Given Remdesivir and Decadron. Was placed in ICU. Also covered with zithromax and rocephin which was stopped after procalcitonin found to be normal.  4/1 Pt was weaned off BiPAP to HFNC 4/3 Pt was weaned off HFNC to 4L per NC. From 4/3-4/5 he had significant improvement. On 4/5 did not require O2 at rest but still had desaturation to 88% with ambulation. The team wanted to keep him an additional night but he demanded D/C. He finished 5 day course of Remdesivir prior to D/C and was to finish 10 course of Decadron after discharge
3/13/2021 11pm chills, body aches 3/14/2021 fever, sweats, shaking chills 3/15/2021 midnight : swelling of face and eyes, chest pressure, shortenss of breath 3/15/2021 3am : swelling of tongue 3/16/2021 11am EMS called : symptoms had improved per patient but face was still puffy; Patient notes SpO2 98%. She refused EMS transport to ER. 3/16/2021 6:45pm : I had a virtual visit for the patient's workman's comp case. She continues to have some chest pressure but noted improvement. I advised her to seek in-person evaluation and treatment for her continued symptoms. 3/17/21 I spoke with patient. She feels better but did not seek in-person treatment. Symptoms resolved.
No symptoms until April 20, 2021, when I developed at work a thromboembolic stroke to the left internal capsule, resulting in right hemiparesis, facial droop, and slurred speech. Head CT angiogram obtained via the ER was negative for bleed. INR was 2.9. Thrombolytic therapy was not given because of INR. I was transferred to the stroke unit at the Hospital. I began to have improvement of symptoms within 6 hours. By the time of discharge 4-5 days later, I was able to ambulate with a walker. Much of my strength in my right side had improved. I required the use of a walker for about 2 weeks. I underwent aggressive PT, OT, and speech therapy in a day neuro program, and was discharged from rehab about 3 weeks later. I have since made a full recovery, and am back at work fulltime.
Patient stated "throat feels funny" and felt generalized flushing.  Treated with benadryl 25 mg PO and observed 30 minutes with improvement of symptoms.
28 YO female with PMH Asthma, environmental allergies, pregnancy. Patient at appointment with PCP received immunization with flu vaccine on 9/19. Patient reports waking from her sleep because she was unable to breathe. Patient noted to have developed cough and wheezing several hours after the flu shot- which worsened overnight. Patient went to the ER. Patient had persistent SOB/wheezing and used her albuterol inhaler and did okay. Next day patient reported feeling fine to PCP. Patient told this was an allergic reaction to the flu shot and she should never receive it again.
Pt said his arm was sore evening of the injection and the following day. 2 days later, his arm became red/blue bruised in the area around the injection site and down towards the elbow on the inner side of the arm. Pt came into the pharmacy the following day (3 days later) and showed his arm to the RPh on duty and was told to go to the doctor to get it checked out. Pt came back to pharmacy the following day (4 days later) and said the doctor told him it was likely due to the flu shot and told him to come back in a couple days to recheck arm. Pt will update pharmacy once he returns to doctor and pharmacy will call pt to check on him.
swollen lymph nodes, feels lousy, arm heavy-can't lift; 2OCT skinned a raccoon, subsequently on 16OCT cut hand when trying to remove fat from the pelt & started on post exposure regime;
This spontaneous report was received from a medical assistant refers to multiple unspecified patients. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL [Lot# K008931, Expiry date: 04-MAR-2017, Lot# K016966, Expiry date: 10-MAY-2017, Lot# K010215, Expiry date 05-MAY-2017]. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I cannot use my right arm ever since I got your vaccination) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I cannot use my right arm ever since I got your vaccination). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I cannot use my right arm ever since I got your vaccination) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient cannot use right arm ever since getting the vaccination.  No treatment medications were reported.
My dad's PSA levels skyrocketed from 2021 to 2022 resulting in a diagnosis of curable Prostate Cancer.  As of the date of this diagnosis he had received 4 covid vaccinations.  He received the 5th covid vaccination shortly after beginning radiation for curable Prostate Cancer.  Prior to the 5th dose on 9/2022, my dad had no other cancers.  The scans and bloodwork showed no metastases.  On 10/2022 my dad was diagnosed with Stage 4 gastric cancer.  Unrelated to the existing prostate cancer.  The Gastric Cancer was a second primary - which is very rare.  Additionally, his gastric cancer was PDL1 positive and metastasized at an unusually aggressive speed.  He went to heaven on 12/2022.
Subject participated in a non-company sponsored clinical trial at a college.  Report was sent to an agency by one of the investigators, but as the company is not involved in this trial, the report was databased as spontaneous report.  A 16-year-old young man, born on 24 OCT 1991, was vaccinated for the first time with FLUVIRIN, batch-no. 0080685, i.m. into the right deltoid muscle on 17 NOV 2007.  An acute episode of severe abdominal pain localized to the right lower quadrant was reported on 24 DEC 2007.  He was seen in the emergency room where he was afebrile (oral temperature 98.7F), his white blood cell count was normal at 9.500 cells and a CAT scan of the abdomen revealed a possible appendicolith with mild thickening of the appendix.  The patient was taken to the operating room for an appendectomy on 24 DEC 2007.  Histology of specimen revealed mild acute appendicitis.  The subject had an uneventful hospital course and was discharged home on 25 DEC 2007.  The investigator did not see a causal relationship to vaccination with FLUVIRIN.  Medical history: asthma.  Seriousness criterion: hospitalisation.  Causality: unrelated.  Appendicitis was caused by appendicolith and subsequent infection.
red mark that was not at the injection site, it was more on the back of the arm rather than at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 19th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 20th October 2020, the patient experienced red mark that was not at the injection site, it was more on the back of the arm rather than at the injection site. The reporter consented to follow up.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 11-JUL-2013, lot # H010915 expiration date: 13-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Patient was instructed to stay for observation for 30mins due to reported allergies. Approx 20mins after patient reported chest tightness/burning sensation in lungs/center of chest. Pt declined any signs of heart attack and no lightheadedness, swelling of tongue or throat or shortness of breath; and no hives. Patient took Benadryl 25mg tab, used cold cloth/ice pack on neck, drank water. Dose of Benadryl 25mg repeated in 25mins per patients preference. After 1 hour, patient reported just a slight burning in center of chest and took a dose of tums. Still no hives. Patient was comfortable going home at 5:10pm (husband driving)