chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/2021  Patient/Date: 3/18/2021  Subjective:  a 47 y.o. male who was seen at SVH COVID Vaccine Clinic today for his first  dose of the COVID Pt is a 47 y.o. male who was seen at COVID Vaccine Clinic for his first does of COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given and once pt was feeling better he was transferred to the ER bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for awhile we cooled down and he was allowed to leave. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness, and hot and sweaty: CONT negative, HENT negative, Eyes negative, Respiratory negative, Skin negative, GI negative, Musculo negative,  Previous Reactions: None, Objective: Vitals - There were no vitals filed for this visit. Physical Exam - Constitutional: Appearance - He is well-developed. HENT: Head -Normocephalic and atraumatic. Right Ear- External ear normal. Left Ear: External ear normal. Nose - Nose normal. Eyes - Conjunctiva/sclera: Conjunctivae normal. Pupils - Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm - Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort - Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General -Normal range of motion. Cervical backN -normal range of motion and neck supple. Skin: Coloration: Skin is pale. Neurological: Mental Status - He is alert and oriented to person, place, and time. Assessment/Plan: Treatment include - water and snacks. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash). Pt was released at 3:26, he was accompanied by his wife. APRN Electronically Signed 3/18/2021 3:19 PM
Pt received Hep B 0.5ml (5mcg) IM Left thigh and checked 10-15 minutes later and pt left thigh was red, swollen, with hives developing to left thigh, buttock, right buttock, papular rash developing to abdomen, arms, face and lips. No respiratory problems. Sent to ER.
expired (9/30/23) Tenivac vaccine was administered to an 8 year old child with no adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves expired (9/30/23) tenivac vaccine that was administered to an 8 year old child with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2023, the patient received a  dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection lot U7189AA, expiry- 30-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination (strength, dose: unknown) with no adverse event (expired product administered) (latency same day).  Action taken: not applicable.   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 the 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.
Symptoms: severe headache, muscle ache, fatigue, pain at site of vaccination Signs: redness at site of vaccination Time: 48+ hours Treatment: Advil Outcome:  Symptoms declined
Extremely swollen lymph nodes- armpit, collarbone, neck, chest left side. . Pain/ pressure/swelling/hardness on left side of body. Chest hard and visibly swollen above breast, wrapping around to armpit and up neck.
On 8/30/00, the pt experienced aches in joints and a fever. On 8/31/00, the pt developed chickenpox and itching which worsened on 9/1/00 at which time the lesions were all over the pt's body. The lesions lasted until 9/8/00 before they crusted and dried up. The pt was off work for 9 days and recovered on 9/9/00. The pt sought unspecified medical attention. Follow-up received on 9/27/00, from an RN stated that the pt was incapacitated for 9 days in that she was covered with vesicular lesions. The RN did not actually see the pt but it was reported to her by the pt. The pt was 6 weeks post-partum when she received the varicella vaccine and it was noted that she also had a 2 year old at home.  It was noted that since varicella virus vaccine is an attenuated virus, the children could experience a rash up to 42 days from the mother's rash. The reporter will provide the information if the children develop chickenpox.
Pt states the day following the vaccine his skin felt irritated to the touch, and was experiencing "crawling like" sensations
I was feeling OK earlier that day but 2 hours after the shot I started hurting and feeling bad.  I couldn't sleep that night.  Next day I got a ride to a emergency hospital room.  They checked me out and sent me back to my facility room.  The next day I started feeling better.  I feel better today.
Received Boostrix instead of Flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The medical assistant reported that a colleague received a dose of Boostrix instead of an unamed flu vaccine, and wished to know how to proceed, initials, and gender were given for the patient, but specific age was withheld.  The vaccine administration facility was the same as primary reporter The reporter consent to follow-up. Additional Supportive information: The patient received Boostrix instead of an unamed flu vaccine, which led to wrong vaccine administered. This case has been linked to the cases US2022168201 US2022168197, reported by the same reporter.; Sender's Comments:  US-GSK-US2022168201:Same reporter US-GSK-US2022168197:Same reporter
Right deltoid presented with brightly erythema 8cm x 4cm macule with casor.  High ROM compartively, bleanching and non-tender and extended to upper arm.
Starting around noon the following day I had muscle aches which spread across right side of my body throughout the afternoon and evening. Around the same time I also experienced fatigue. The morning after the aches and fatigue I experienced nausea after brief periods of physical activity.
Lg localized area of erythema (L) upper outer thigh with warmth in induration, no fluc mass x 1 very small tender (L) inguinal node area 6" by 3"
Pt complained of hives on his face, trunk, hands, and back at 7am on 03/13/2002. Encouraged mother to take the infant to private Md for evaluation. No fever noted.
arm soreness within 2 hrs of injection. Around 1pm started to feel worn down, a slight headache, warm in the face and arm of injection site. Took temperature at 4pm recorded 101.8 F. I took 400mg ibuprofen tabs. Left Arm of injection site and body became sore and achy throughout the night. Continued to monitor my fever. The next morning at 6:30am, took my temperature and recorded 103 F, and again took more Ibuprofen. The body aches had gone away, only had an annoying and constant headache in the front and back of the head. Placed an ice pack on the head to relieve discomfort. My body started to get warm again around 1pm, I took my temperature and recorded 102.8. I then took some ibuprofen 400mg tabs. Still experiencing a headache and fever, so I had notified employee health and was told to report to VAERS.
This spontaneous report as received from a nurse refers to a 43 year old female patient with asthma, Demerol allergy, pyridium allergy, sudafed allergy and amoxicillin allergy. The patient's medical history included shortness of breath. On 22-APR-2013 the patient was vaccinated with PNEUMOVAX 23 (Lot # reported as H022064, Exp date 25-JAN-2014, route and dose not reported). Concomitant therapies included PROTONIX, meloxicam, cetirizine hydrochloride, unspecified "inhalers for asthma" and SINGULAIR. On 23-APR-2013 the patient experienced the patient developed a "50 cent piece" size area around the injection site that was, red, raised, swollen and sore after receiving the vaccine. The nurse reported on 24-APR-2013, this area "was bigger and was all over the patient's arm" and the patient experienced feeling lightheaded and "an overall feeling of not feeling well". The patient was sent to the emergency department for treatment. The outcome was recovering. Additional information has been requested.
This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with the first dose of ZOSTAVAX subcutaneously (dose, lot# and expiration date were not reported). In 2015 (date unspecified), she was re-vaccinated with the second dose of ZOSTAVAX subcutaneously (dose, lot# and expiration date were not reported). She did not experience any adverse reactions from being re-vaccinated. Product quality complaint (PQC) was not involved. Additional information is not expected, as there was no contact details provided.
No additional AE; Customer reports the administration of 2 doses of PNEUMOVAX 23 to a Patient/ Nurse confirms both doses were 0.5mL. The first dose was administered 9/13/2022 and the second was administered 9/29/2022.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies, drug reactions or allergies were not reported.  On 13-SEP-2022, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter (lot number U032086 had been verified to be a valid number; expiration date reported and established as: 29-AUG-2023). In addition, on 29-SEP-2022 (also reported as between a 2-week period), the patient received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with the same lot number, both administered as prophylaxis (strengths, vaccination schemes, route of administration and anatomical location were not provided) (inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Arm Soreness, exhaustion, headache, achyiness,  thirsty,
got lightheaded , patient laid down on the floor. We observed the patient .We took vitals at 2:38 pm heart rate 80, o2 98 and BP 128/80.  We asked how he was feeing and he states that he was feeling back to himself so we left him leave.
vaccines administered on 2/9 and on 2/11 and 2/12 noted to have small amount of blood in the stool.  resolved thereafter but on guaic of stool on 2/14, heme positive.  no other symptoms.
Patient received shots the became "hot" appr. 3 minutes post-vaccinations. She stated her "head was cloudy" then she became flush, eyes rolled back, and began convulsing.
7 days after receiving the vaccine, I felt a lot of itching in the site of injection, some inflammation and very hot and red, which I had not felt since the moment they gave me the vaccine
I have a heart condition and I was starting to feel tightness in my chest and a cough that sounds like a goose. I had gained 12 pounds in 2 days. It was confirmed I was in congestive heart failure. I was given LASIX to reduce fluid. I was released after about 6 hours. Today I had an Echocardiogram.
muscle soreness following the covid-19 vaccine; gum infection with HUMIRA; Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4256243-00 (AbbVie).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 62 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. Relevant medical history included: "Rheumatoid arthritis flare", start date: Nov2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen (Daily Dose: , 1st dose (1 in 1 Once), Route of Admin: Intra-muscular, Indication for use: Covid-19 Vaccination, Therapy Dates/Duration: 20May2021 - 20May2021), administration date: 20May2021, when the patient was 62 years old, for Covid-19 immunization; Covid-19 vaccine janssen (2nd dose (1 in 1 Once), Route of Admin: Intra-muscular, Therapy Dates/Duration: 2021 - 2021), administration date: 2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Nov2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; MYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "muscle soreness following the covid-19 vaccine"; GINGIVITIS (non-serious) with onset Nov2021, outcome "unknown", described as "gum infection with HUMIRA". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for humira (ADALIMUMAB): The reporter's causality for the event(s) of rheumatoid arthritis flare, muscle soreness following the covid-19 vaccine and gum infection was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of muscle soreness was possible; rheumatoid arthritis flare and gum infection was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and RHEUMATOID ARTHRITIS , MYALGIA, GINGIVITIS ,cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 001B21A and 037A21B) for COVID-19 vaccination. No Medical History information was reported. On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022 at 8:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Feb-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medications were not reported. It was reported that, the vaccines were initially placed in the refrigerator on 19-Jan-2022 and were administered to the patient beyond the 30-days use by date on 25-Feb-2022. The vial did not undergo any temperature excursions. Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up received contains Non significant information.
I was supposed to give pcv13 and I gave PEDIARIX to a 16 mo. boy.
Confusion, Headache, Myalgia, NauseaVomiting, FATIGUE Narrative:
10/7/13: Patient received the FLUMIST vaccination at her school. By 7:00 PM, patient complained of a headache and went to sleep. 10/8/13: She began complaining that she still had headache, now followed by stomach pain. 10/9/13: She was sent home from school due to headache, dizziness, and stomach pain. My daughter did not return to school until January 2014. Visited ER 10/12 for symptoms and was told that it was FLUMIST side effects and that they should go away. Was told to take laxatives (probably MIRALAX) to help with stomach. The problem did not go away. She had numerous trips to her family doctor and to the ER for her symptoms. X-rays showed mild to moderate constipation but blood work showed nothing. She was told to take more laxatives, have more enemas, etc. to help. Patient began having difficulty speaking and eating. At the end of October, she saw a GI physician. Right off the bat, this doctor diagnosed it as a reaction to the FLUMIST based on dates of illness and side effects. She attempted two clean out methods for patient. My daughter now had enough MIRALAX and laxatives in her to kill a horse. The problem was still not solved. Patient was admitted to hospital on November 7 and was there until November 12. They used an NG tube to clean her out, and she had an endoscopy, colonoscopy, and stomach ultrasound. No results popped from these tests. She also saw a neurologist for the headaches. She passed the basic neurological exam.
Dark circle appeared on right shoulder. It turned into a rash and has been on shoulder for 60 days.
I received the 1st dose Moderna vaccine rec'd yesterday 3/24 and I got really dizzy and nauseated and had a bad headache, as well. Today I woke up and I couldn't move my left arm at all, its stiff and pain radiated down to elbow on the arm, I don't have strength to do anything and I'm super cold. I don't know if I should get 2nd dose in April
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805458 was crossed linked to the original case 201804863 due to same reporter.
Information has been received from a registered nurse concerning a 36 year old female patient with allergy symptoms who on 05/02/2005 was vaccinated intramuscularly with a fist dose of hepatitis B virus vaccine.  Concomitant therapy included Allegra, 180 mg daily indicated for allergy symptoms, started 4 months ago.  On 05/03/2005, the patient began to feel lower back pain and a sore throat developing.  She described the lower back pain as muscular, as though she had lifted heavy boxes using only her back.  Her back pain resolved on 05/20/2005, however the sore throat developed into a cold.  It was reported that the patient felt that the cold symptoms seemed to be resolving at the time of this report, on 05/10/2005.  The patients outcome is recovering.  No additional information regarding the adverse event was provided.  There was no product quality complaint reported.  Unspecified medical attention was sought by the patient.  Additional information has been requested.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. My husband has become completely disabled as a result of the anthrax vaccine and has been on Social Security Disability since 2000. He has chronic pain in all parts of his body. He has Charlie horses in his muscles when he does too much activity. Too much activity consists of things like walking around for a half an hour...activities that any normal person could do with no problem. He can't even sit at a desk and type for too long before his fingers cramp up. Before being vaccinated, he was the supervisor of a saw shop and his job was very physical. He was always very active and loved to be outdoors. He received his vaccinations in the military; he was very proud to serve his country, but his life has been taken away from him because of the anthrax vaccine. He was only 27 when his symptoms started. His blood has tested positive for squalene which is an adjuvant in the vaccine which is causing his autoimmune disease. If this vaccine is licensed for public use, I can't imaging the devastation that it could cause. Please take our comments into consideration.
Baby was fine for two hours after shots, then began screaming and crying. My son was inconsolable as if he were on fire. The screaming went on for many hours in which I gave him Tylenol, eventually he became malaised and passed out. He was groggy for the next few days.  Later that month I began to notice he was having staring spells that I could not break him out of, that would last a minimum of 1 minute. I am, certain that they were indeed seizures. He also experienced muscle twitching. Thankfully after a few months they have appeared to subsided, but I am still uncertain of the long term effects of the shot on my son.