chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the weeks following vaccination, patient developed progressive fatigue, dyspnea. Found after presenting to ED to have large pericardial effusion with tamponade requiring urgent pericardiocentesis. New diagnosis CML made at this time, but per hematology pericardial effusion is not a known complication of CML, and was more likely due to a reactive process like reaction to the vaccine. No other known vaccinations or viral infections in the months prior to the event.
Wheezing; airway constriction; tightness in chest; Epi administered; sx resolved w/in 5 min; no further problems; checked w/client 22NOV no problems;
The initial infection was mild; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The initial infection was mild) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included BALSALAZIDE from January 2010 to an unknown date for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (The initial infection was mild). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (The initial infection was mild) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive (on day 9 and began testing positive ).         Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On 30-May-2022, patient started with rebound symptoms and repeat COVID test was positive. It was stated that the initial infection was mild and took a 5-day course of Paxlovid. Tested negative on day 6 of Paxlovid treatment. Symptoms returned on day 9 of Paxlovid treatment and began testing positive again with much stronger symptoms and more persistent. Patient was still testing strongly positive 5 days later.  Company comment: This is a spontaneous case concerning a 39-year-old male  patient with Ulcerative colitis, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Clinical course  were not provided. It was reported that the initial infection was mild and patient was treated with Paxlovid for 5 days. On day 9 symptoms returned and SARS-CoV-2 test was positive again. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 39-year-old male  patient with Ulcerative colitis, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Clinical course  were not provided. It was reported that the initial infection was mild and patient was treated with Paxlovid for 5 days.  On day 9 symptoms returned and SARS-CoV-2 test was positive again. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Narrative:  COVID infection following COVID vaccine series 02/24 , Pfizer, dose #1 03/17, Pfizer, dose #2 09/29, Pfizer, dose #3 08/26 COVID swab, result:  detected 08/26 pt cc: No symptoms exposure: unknown 08/27 CXR- impression: clinically resolved 09/10 CXR impression: NO evidence of acute cardiopulmonary process.
several hrs p/vax pt ran temp 106, jerking/convuls occurred again 1wk later
Flu-like symptoms started nearly 24 hours after the shot. Felt the effects for about 12 hours.
One day after vaccine was given, onset of temperature to 102 axillary and diarrhea. Illness resolved in 3 days total.
This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 5 year old male patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a medical history of atopy: asthma and 'other (cashew and pistachio nuts)'. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received trivalent influenza vaccine (manufacturer and batch number not reported). On an unspecified date, 3 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized urticarial, pruritus, rash and shortness of breath. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. He received treatment with oral antihistamines and oral steroids. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Loss of vision; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration from an unspecified date single dose for COVID-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced loss of vision in her right eye on an unspecified date. The outcome was unknown  Information on the Lot/Batch number has been requested
Lost of taste; Lost of smell; Pain in chest, back, middle to right side; Pain in chest, back, middle to right side; Tingling in my jaws, whole mouth, something was happening there; Redness in leg; Heaviness in my head; Buzzing in my ear; Non-sense irritation on site of injection; Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room; Tired all the time, sleep 3 hrs a day; Nausea, took tums and did magic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side) and PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer and Reflux gastritis. Concomitant products included LETROZOLE for Antiestrogen therapy, OMEPRAZOLE (MEDOPRAZOLE) for Reflux esophagitis, LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side), PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there), ERYTHEMA (Redness in leg), HEAD DISCOMFORT (Heaviness in my head), TINNITUS (Buzzing in my ear), SKIN IRRITATION (Non-sense irritation on site of injection), FEELING ABNORMAL (Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room), FATIGUE (Tired all the time, sleep 3 hrs a day) and NAUSEA (Nausea, took tums and did magic). At the time of the report, AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side), PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there), ERYTHEMA (Redness in leg), HEAD DISCOMFORT (Heaviness in my head), TINNITUS (Buzzing in my ear), SKIN IRRITATION (Non-sense irritation on site of injection), FEELING ABNORMAL (Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room), FATIGUE (Tired all the time, sleep 3 hrs a day) and NAUSEA (Nausea, took tums and did magic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not provided by the reporter   Reporter did not allow further contact
This spontaneous report was received from a medical assistant, referring to multiple unspecified patients, from unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, improperly stored doses of PEDVAXHIB (lot #K008679, expiration date: 05-MAR-2017, L014427, expiration date: 09-MAR-2018) (strength, dose and route were not reported), were administered to multiple unspecified patients. Concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 10.3 degrees C, time frame was 4 hours, it was no previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information is not expected because the reporter did not allow further contact.
Patient had a syncopal episode in office, stated that it happened with last one, the day after the injection.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JAN-2017, the patient received a dose of improperly stored VARIVAX lot number M008171, expiration date 16-FEB-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. No further information was provided. Administered dose of VARIVAX was exposed to a temperature excursion of >5°F but <14°F for 10 minutes. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012278: US-009507513-1702USA001826: US-009507513-1702USA001827: US-009507513-1702USA001828.
The patient has developed marked swelling and cellulitis around the area of Prevnar vaccination site, starting one day after the vaccine was given. The vaccine was given on 12/08/00.
This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # L027282, dose, route and site of administration and expiry date were not reported). On 27-MAY-2016 and 28-JUN-2016, the patient was vaccinated with the second and the third dose of GARDASIL 9 respectively (lot # L02782; lot # M007728). No adverse effects were reported. Additional information has been requested.
began rash on Sunday palms of hands, under arms, groin;started DPH;saw MD on Monday who administered IV Pred;Cot on PO pred;
COVID vaccine adverse reaction from 1st vaccine and worsened after 2nd vaccine. Pulmonary embolism diagnosed 5/19/21 after 4/21/21 vaccine. 2nd Modena vaccine 5/20/21 and the patient with  78% oxygen saturation  on room air  to 4L NC and rehospitalized on 5/22/21. 32YM who is an inmate at corrections facility, presented 5/19 with exertional dyspnea, found to have a pulmonary embolism. Diagnosed with Acute pulmonary embolus with left lower extremity DVT:  He also noted some left leg discomfort, but no swelling.  He was ultimately found to have bilateral pulmonary emboli.  Initial laboratory studies including troponin and BNP were normal.  An echocardiogram noted reduced right ventricular function.  The patient was initially managed with intravenous heparin and subsequently transitioned to oral agents, warfarin. Discharged on 5/20 and readmitted on 5/21. Patient was started on a heparin drip.  Chest x-ray at outside hospital showed right upper and middle opacities.  CTA chest was ordered to evaluate for pulmonary infarcts and showed multifocal pulmonary opacities on the right suspicious for pneumonia.  Patient was started on ceftriaxone and completed 5 days during this hospitalization.  Echocardiogram showed no evidence of right ventricular dysfunction.  He remained normotensive.  Heparin drip was transitioned to therapeutic enoxaparin.  Initially he required 4 to 6 L nasal cannula.  Oxygen requirement resolved on day of discharge.  He was discharged on 5/26/21 with bridging enoxaparin therapy and the warfarin therapy that he was prescribed on last admission.
pt diagnosed positive for COVID on 6/7 and hospitalized until 6/12/21; presents to ED with c/o severe fatigue, weakness, diffuse pain; PMH metastatic small bowel CA; will complete dexamethasone; pt's condition worsened while in the hospital and she was placed on comfort measures; she died in the ICU
MILD PAPULAR RED RASH TO THE TRUCK OF THE BODY,  SAME AS WITH 4 MO VACCINES ( PENTACEL, PCV13, HEPATITIS B)   MUPIROCIN 2% TOPICAL OINTMENT  TREATMENT, THE RASH NORMALLY RESOLVES ON OWN IN 1 WEEK AFTER VACCINES
Patient in clinic 10/10/02 at 12:57 PM Thursday. Next day, began swelling/hardness and red at site. Also tenderness and pain at site. 10/21/02-Patient states is better but still swelled at site some. Has been very uncomfortable. Went to ER 10/11/02. Has appointment with doctor 10/22/02.
Information has been received from a physician concerning a patient who on 27-MAY-2010 was vaccinated with a 10mcg (adult) dose of RECOMBIVAX HB. On 29-MAY-2010 the patient tested positive for surface antigen for hepatitis B infection. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. No further information is available.
Left arm, deltoid, 5cm erythamatous area warm to touch with induration with very small (1mm) macules noted over erythematous area. No pustules, no streaking noted. Cellulitis ceterizine, keflex, and benadryl (PRN-QHS)
he did not even have a headache just a pulse of pain from sitting to standing which was so minor; a little lethargic; cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine; cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine; cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine; soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness around the injection site), LETHARGY (a little lethargic), PYREXIA (cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine), CHILLS (cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine) and HYPERHIDROSIS (cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE PAIN (soreness around the injection site). On 07-May-2021, the patient experienced LETHARGY (a little lethargic), PYREXIA (cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine), CHILLS (cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine) and HYPERHIDROSIS (cycles of fevery chills that turned to profuse sweating for about an hour, was fine then fevery chills sweats and then fine). On 08-May-2021, the patient experienced HEADACHE (he did not even have a headache just a pulse of pain from sitting to standing which was so minor). On 08-May-2021, VACCINATION SITE PAIN (soreness around the injection site) had resolved. At the time of the report, LETHARGY (a little lethargic) and HEADACHE (he did not even have a headache just a pulse of pain from sitting to standing which was so minor) outcome was unknown. Not Provided      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.   This case was linked to MOD21-088377 (E2B Linked Report).; Sender's Comments:  MOD21-088377:Crosslink
Severe neck pain starting 1 day after the vaccination. No fever, has full range of motion, no injection site issues such as swelling, pain, redness. 3 days post vaccination feeling a little better but still bothersome make seek urgent care treatment.
Large local rxn: that afternoon: large swelling noted on right arm. By second day- from shoulder to elbow- right arm swollen (extensor surface) 20cm x 13cm at site of reaction, with increased warmth, heat and tenderness, mild itchiness of arm. no systemic sxs.
Awakened by very loud roaring , tinnitus, in right ear only.  Approximate time 0300.  Loud noise, roaring subsided at approximately 0600. No other side effects other than pain at the site of injection,, left arm. Pain in left arm eased up after two days. FYI:: Patient had contacted COVID-19 in November and had recovered.
Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, numnous in hands
transverse myelitis/progressive lower extremity weakness and numbness of her hands; Information has been received from a lawyer, concerning a case in litigation and referring to a female patient of an unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On or around 09-JUN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, lot #, expiry date, route and vaccination site were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered progressive lower extremity weakness and numbness of her hands and was diagnosed with transverse myelitis. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality was related.  Upon internal review, the event of transverse myelitis was determined to be medically significant. The event of transverse myelitis was considered to be disabling.
Hives/Severe itching. Went to ER was given treatment of medrol pack.  Patient did complete treatment course with full resolution of hives.
Patient fainted after 30 seconds to 1 minute after receiving the vaccine for 30 seconds to 1 minute. Symptoms include excessive sweating, dizziness, headache, and shortness of breath.
Dad of patient called and said patient was vomiting severely and could not keep anything down. He was advised to bring patient to emergency room to be evaluated.
hearing loss; ringing in ears; This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 4749N, expiry date 14th November 2021) for prophylaxis.   On 17th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, couple of weeks after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the hearing loss was not recovered/not resolved and the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient had hearing loss that occurred weeks after the injection.  The patient also had ringing in ears but did not know when this occurred after the injection or if it was still ongoing till the time of reporting for the patient.  The patient had a baseline hearing test done in December 2019.  The reporter did not consent to follow-up.
DEPRESSION; HEAD PRESSURE; NECK PRESSURE; This spontaneous report received from a patient concerned a 40 year old female. 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 11-MAR-2021 13:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced depression. On APR-2021, the subject experienced head pressure. On APR-2021, the subject experienced neck pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from depression, head pressure, and neck pressure. This report was non-serious. This case, from the same reporter is linked to 20210502135.
devel hives approx around 3PM on 27JUL93; mom called hosp ER around 530PM & was told to give DPH; devel stuff nose also had problems breathing; area on lt leg where vax given reddened/swollen 1/2 dollar size;
felt faint; soreness at the vaccination site; swelling at the vaccination site; Redness at the vaccination site; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (felt faint), VACCINATION SITE PAIN (soreness at the vaccination site), VACCINATION SITE SWELLING (swelling at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt faint), VACCINATION SITE PAIN (soreness at the vaccination site), VACCINATION SITE SWELLING (swelling at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site). At the time of the report, DIZZINESS (felt faint), VACCINATION SITE PAIN (soreness at the vaccination site), VACCINATION SITE SWELLING (swelling at the vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) outcome was unknown.        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.   Concomitant medication information not provided. Treatment information not provided.