chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slightly sore arm for three days.  Not a  problem.  No affect on activities or lifestyle.  Just reporting for thoroughness.
Patient has hyper eosinophilia and myositis, both of which are new and accompanied by severe leg cramping.  This started shortly after her first Covid vaccine was given. Patient is being followed for repeat labs by PCP and seeing specialist at hospital.
Ongoing worsening (Multiple Yes) Osteoarthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Feb2021 14:00 (Lot number: EN6201) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "AFib", start date: 01Jan2006 (ongoing). Family history included: "Heart diseases" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date Jan2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right, Route of administration: Intramuscular, Vaccine Administration Time: 15:00, Lot number: EL9264), administration date: 29Jan2021, when the patient was 72 years old, for COVID-19 Immunization. The following information was reported: OSTEOARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "Ongoing worsening (Multiple Yes) Osteoarthritis". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Prior vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient was not tested for COVID-19. Follow-up attempts are completed. No further information is expected.
20DEC95 3:30 pt eye rolled,started convulsing,lips turned blue pt never stopped breathing,foaming from the mouth;amb came gave 02 brought to hosp was treated w/APAP & Motrin;sent home t103 @ hosp
Stabing chest pains, increased heartbeat(resting heart rate is now about 85-90 while it used to be about 65-70), heart pounding, pain in neck vessels while doing any exercise (even walking or light cleaning), have to take breaks from doing things because I feel like I am going to pass out,  It is still ongoing as of today 07/15/2021  Haven't received any treatment
Fever, pain and aching in jaw muscles. Some runny nasal discharge. Treated with rest, fluids, herbs, bone broth, vitamin C. Jaw pain lasted only one day. More minor symptoms lasted 2 to 3 days.
Patient called after hour with concern of low grade fever of 99 and mild flu like symptoms for 1 day after vaccines. He also reports his arm is very sore he states  "I cannot do a push up". He reports there may be mild swelling but there is no redness. I advised ice, monitor and take tylenol or motrin for the pain. I advised to seek medical attention of symptoms worsen or there was change in skin.  Patient verbalizes understanding.
Six hours after initial injection - headache, muscle ache at injection site; persistent headache most days over the past two weeks; and at day 13, a large bullseye rash and swelling/soreness at the site of injection and red raised rash patches on legs and arms and headache.
her elbows looks a little swollen; ELBOW DARKER THAN SKIN COMPLEXION; SHOULDER IS STIFF; shoulder pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (her elbows looks a little swollen), SKIN DISCOLOURATION (ELBOW DARKER THAN SKIN COMPLEXION), MUSCULOSKELETAL STIFFNESS (SHOULDER IS STIFF) and ARTHRALGIA (shoulder pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced ARTHRALGIA (shoulder pain). On 16-Feb-2021, the patient experienced JOINT SWELLING (her elbows looks a little swollen), SKIN DISCOLOURATION (ELBOW DARKER THAN SKIN COMPLEXION) and MUSCULOSKELETAL STIFFNESS (SHOULDER IS STIFF). At the time of the report, JOINT SWELLING (her elbows looks a little swollen), SKIN DISCOLOURATION (ELBOW DARKER THAN SKIN COMPLEXION), MUSCULOSKELETAL STIFFNESS (SHOULDER IS STIFF) and ARTHRALGIA (shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter. Treatment included ice pack and ibuprofen.
COVID 19 Treatment; COVID 19 Treatment; 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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: ER8736), on 19May2021 as dose 2, single (Lot number: EW0177) and on 02Dec2021 as dose 3 (booster), single (Lot number: HRSAFH8020) at the age of 47 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 14Dec2022 to 19Dec2022.
Healthcare staff attended vaccine administration provided by Public Health Nursing Nurse Manager from  facility was sent JANSSEN EUA prior to the day of vaccine administration and asked by PHN review and  give EUA to eligible staff and residents for review prior to administration date. Staff to receive the vaccine was selected by their facilities Nurse Manager. Staff presented with completed consent form and received JANSSEN vaccine despite being 17 years old
Pt recvd 1st & 2nd dose Hep B vax on 6SEP91 & 11OCT91 & w/in 5 minutes of receiving 2nd vax pt exp dizziness & lightheadedness, sl tachycardia & tightness & constriction of neck & throat; tx DPH & Epi; sx lasted 1 hr & 20 min; pt recovered;
LOST 20 POUNDS; EAR INFECTION; PINK EYE; FLU SYMPTOMS; SUSPECTED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via another pharmaceutical company concerned a 68 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma (took a shot (Unspecified) for it). The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total was administered on 26-AUG-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total was administered on 17-OCT-2021 for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 67 years old. No concomitant medications were reported. On 25-DEC-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient had a severe case of Covid-19 with the symptoms of cough and terrible sore throat which was suspected covid-19 infection (Dose number in series 2), and lasted for one month. The patient received treatment medications (dates unspecified) which included: prednisone and an antibiotic (Unspecified). On an unspecified date, the patient lost 20 pounds and experienced ear infection, pink eye, and flu symptoms (Dose number in series 2). It was reported that Covi-19 was terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on an unspecified date in JAN-2022, and the outcome of lost 20 pounds, ear infection, pink eye, off label dosing frequency and flu symptoms was not reported. This report was non-serious.
As I was pulling out the needle from the vial, the yellow fever vaccine was squirted in my eye.
pustules multiple it's painful; Pustules between her brows and multiples on face; A spontaneous report was received from a 44 year old female healthcare facility staff member who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed painful pustules in between brows, spreading down to the upper corner of the mouth and chin, and multiple on her face.  The patient's medical history was not provided. Concomitant medications reported included vitamin E, vitamin C, vitamin D3, fish oil, biotin and collagen.   On 31 Dec 2020, approximately two hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot# 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 31 Dec 2020, approximately two hours after the vaccine, patient developed pustules in between her brows. On 1 Jan 2021, she noticed multiples on her face, painful and spreading down the upper corner of the mouth going to the chin.   Treatment for the event included hydroxyzine hydrochloride on 1 Jan 2021 and diphenhydramine on 2 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, developed painful pustules in between brows, spreading down to the upper corner of the mouth and chin, and multiple on her face, was considered Not Resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a certified medical assistant concerning a 17 year old female with no medical history or drug reactions/allergies who on 20-JAN-2011 and 08-FEB-2011 was vaccinated IM with the first and second doses of GARDASIL (for both doses: lot # 666987/1016Z, Exp: 22-NOV-2012), respectively. Concomitant therapy included CLINDAGEL and oral birth control. "Approximately 10 minutes after each administration, the patient experienced vomiting and moderate-to-severe shaking for a couple of moments. Within 10 minutes after vomiting, the patient was fine. The patient had completely recovered from both episodes. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Follow up information has been received from the medical assistant indicating that the patient with no preexisting medical conditions and had vomiting at the time of vaccination who on 20-JAN-2011 and 08-FEB-2011 was vaccinated IM into left deltoid with the first and second dose of GARDASIL  (for both doses: lot # 666987/1016Z, Exp: 22-NOV-2012), respectively. The patient stated 5 minutes after the first injection, she had vomiting. The patient thought it was related to something she ate. However, after the second injection, she had moderate shaking and vomiting. No further work up needed. The patient stated that she recovered to normal state in 5 minutes. No alb diagnostics were performed. The patient did not require ER/doctor visit. Additional information is not expected.
Pt. complained of nausea and mild headache, she appeared to have some mild erythroderma of face and both arms, but unclear if it was baseline. She seemed anxious about the vaccine, and wanted to leave as her husband was waiting for her.
The pt received Lymerix on 6/12/99 (LY120E9) and 7/17/99 (LY120E9). In a Statement of Injuries, the pt's attorney alleged that the pt "suffers from a multitude of neuro-cognitive changes, including but no limited to, memory loss, lack of concentration, headaches, lightheadedness, confusion, difficulty with spacial orientation, balance problems, blurry vision and dry eyes". He also suffers from joint pain in his knees and fatigue. His symptoms began in 2/00 and gradually have worsened. He noted he had Lyme disease and was IgM positive and IgG negative for Western blot testing. He was treated with doxycycline 100mg twice daily for 1 month and was recently changed to amoxicillin and probenecid. Intermittently, he feels a burning sensation across his shoulders and a slight stiffness in his neck. He may have slight dizziness described as slight problems similar to a boat moving. The pt was seen by an infectious disease expert who, according to the pt, believed that he had Lyme disease. He had a normal neurological exam. During the course of doxycycline, he removed a tick from under his right arm in early August. He was also seen by a neurologist. From 9/25/00 to at least 4/22/02, the pt was under the care of a physician. He reported that he experienced visual problems, perceptual change, lightheadedness, trouble focusing, tiredness, fatigue, dry eye, lack of focus, strange nagging pain in his back, "spacey", emotionally worse, vertigo, fuzzy, cognitive problems, "balance", "disconnect", general dulling of senses, joint pain, exhausted nor refreshed, pt dropped 15 pounds and his "line broke, line leaking-3rd line". The physician also noted he was "off meds due to liver" and that he was "anxious/psychologic/OCD. Taken off (sic)". Additionally, The physician prescribed intramuscular bacillin, intramuscular tinidazole, elvil, sertraline hydrochloride (Zoloft), cholestyramine and IV Zithromax. He was found to have Lyme disease in the blood. Apparently he had this repeated and it was still positive and he had a neurological exam and a lumbar puncture was unrevealing. He has had multiple treatment for his Lyme disease and he is currently on IV Rocephin. The physician prescribed neutral density filters for his computer to help with flickering. Following the reported onset of blurred vision, the subject experienced thrush. This event was not reported as adverse event due to vaccine administration but was found during the course of review of the pt's medical records. The most recent information received on 9/26/02, did not provide the outcomes of the reported events.  Follow up on 02/27/04: "The most recent information, received on 06/30/03, did not provide the outcomes of the reported events."
Heavy breathing; Felt like he had the flu; Was dizzy; Kidney failure; Liver is failing; Organs are failing; Guillain-Barre syndrome; This is a spontaneous case, initially received from consumer via Med Communications (reference number: SEQ19-05245) on 22-Oct-2019, concerning a 62-year-old male patient.  The patient's medical history included obesity.   The patient's concomitant medications were not provided.  On 11-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right deltoid, batch number: 259809, route of administration and expiration date: not reported] for an influenza prophylaxis.   On 12-Oct-2019, one day after vaccination, the patient felt like he had the flu. The patient was dizzy, had fever and all flu symptoms.   On 17-Oct-2019, six days after vaccination, the patient was breathing heavy and made weird sounds. On the same day, the patient was admitted in critical care unit.  Brain scan, cardiac ultrasound and spinal tap were performed and results were negative.   On an unknown date in Oct-2019, the patient's organs were failing and the patient developed kidney and liver failure. The patient was placed on dialysis for kidney failure.  It was reported that one of the physician thought that the patient might have Guillain-Barre syndrome, however no further information was provided.  At the time of initial reporting, the outcome of the events was not resolved.   This case was assessed as serious and causality assessment was not provided.  Company comment: The patient experienced renal failure, hepatic failure, multiple organ dysfunction syndrome, Guillain-Barre syndrome, dyspnoea, influenza and dizziness after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. Medical history of obesity may have contributed to development of the events. No concomitant medications were provided. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
October 19, 2021 at 4:00PM - Three hive bumps started appearing on left cheek of face and facial redness at jaw line October 19, 2021 at 9:00PM - Multiple hives across right cheek of face and redness October 24, 2021 at 9:00AM - Red dots on left cheek of face after waking up Pictures can be provided regarding the above instances.  I sought treatment from dermatologist Dr. at a HCF on October 25, 2021. Dr. recommended beginning Allegra 180mg daily for 2 weeks. As of November 1, 2021, I have not had a flare up of hives and I am still currently taking the antihistamine.
administered a pediatric dose of Engerix-B to 44 year old female patient; administered a pediatric dose of Engerix-B to 44 year old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 44-year-old female patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 05-APR-2024) for prophylaxis.   On 18-OCT-2023, the patient received the 1st dose of Engerix B pediatric. On 18-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administered a pediatric dose of Engerix-B to 44 year old female patient) and adult use of a child product (Verbatim: administered a pediatric dose of Engerix-B to 44 year old female patient). The outcome of the underdose and adult use of a child product were 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: 19-OCT-2023 The reporter was a medical assistant. The reporter reported that another Medical Assistant administered a pediatric dose of Engerix-B to a patient, which led to underdose and adult use of a child product.  At the time of reporting, no additional doses have been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Mom noticed "red spot" on back on neck at bedtime.  Around 1 pm on 10/27/09 red rash had spread to face, neck, chest.  Face was swollen.  Took to ER at Hospital where they administered Benadryl po and "steroid" po.  Was given liquid steroid to take daily.  On 10/29/09 mom reports child still has rash, swelling, itching.
Upper mid upper gastric pain. I went to the ER. They gave me IV Protonix and then Dilodid for the pain - 2 - 4 mg of that.  That helped me with symptoms. They sent me home with Protonix. Still currently taking that. I am still in treatment. I had a follow up doctor visit and Endoscopy - confirming that I have acute gastritis.
1 of 3 pts immunized from the same vial who devel inject site reaction; pt vaxed 17MAR92, & 19MAR devel erythema & warmth from inject site to elbow, approx 6cm; treated w/Keftab & warm compresses; felt to be cellulitis; skin culture neg;
Fever chills first night.  6 hours of vertigo second night post vaccine.  General fatigue.  Lower back kidney pain for four days and incontinence on the 4th night.
Migraine all day (couldn't open my eyes) was in bed all day horrible fatigue, achy joints, nausea, I was freezing and a fever of 101. Had to go to bed at 10:30 am...stayed in bed until 7:30 the next morning.
Urticarial rash developed immediately at the site of DTaP and IPV injections.
BODY AND MUSCLE ACHES, PAINFUL JOINTS, LOW BACK PAIN, HEADACHES, FATIGUE. Medical Record received on 1/14/2005 states 'probable vaccine reaction and/or serum sickness, transient'. Also, worsening of pre-existing sinusitis and allergic rhinitis, lightheadedness, disequilibrium, difficulty concentrating, shortness of breath, and chest tightness.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/1/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 30-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 72-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 30-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 30-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 30-Jul-2022) 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 (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 30-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.  Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to 346 patients after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
Pain in upper arm immediately after both shots. Tinnitus (ticking sound) one week after 1st shot. Constant tinnitus. No tinnitus or hearing problems previously. Tinnitus worsened after second shot on May 1.
cough; joint ache(all); headache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), ARTHRALGIA (joint ache(all)), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 respiratory infection in January 2021 and Stress.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), ARTHRALGIA (joint ache(all)), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, COUGH (cough), ARTHRALGIA (joint ache(all)), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's relevant concomitant medications weren't reported Treatment information was not provided