chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Pt is a nurse, she workd in hospital and so is trying to be vaccinate for covid per reccomendations she has had reaction to both Phizer and moderna covid injetions , she has had feeling like she is burning up and has a lump in her thorat the doctor was brough in to evaluate the veteran and she was given bennadryl and monitored closely and she did improve with this treatment. she reports this is a very scarry event becuse is worried about having her throat entirly close off
Delayed cutaneous reaction. Left arm at injection site. 3" in diameter. Red, warm, itchy. Appeared 9 days after injection.
Visual issues , dizzy for almost 3 weeks  couldn?t stand for long periods of time.  , still have it sparatic dizziness that comes on suddenly. Chest pain numbness in left arm .  Could not function all over body aches .   Went to hospital as directed by my doctors office , was to it was a viral infection that was caused by the vaccine.
Pt received immunizations at 0800 at 2100 developed restlessness and extreme aching pain from head to toe. Took 2 ASA and 3 hr later took 2 ibuprofen. Felt good enough to sleep woke up feeling fine at 0900 7/30/09. Skin was extremely sensitive at night as well. This week-body puffy all over and weight gain of 8 lbs.
horrible rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-AUG-2022 Reporter's comments: This case was reported by the patient's spouse via interactive digital media. The patient's spouse took both shots and had no problem whereas the patient took the first shot and in the year 2022 he had a horrible rash.  He went to the physician and he told him not to take the second shot. It had been going on for two months and patient was going to visit the dermatologist.  The reporter said that it was horrible and never thought this would happen and that everyone reacts differently.; Sender's Comments:  US-GSK-US2022AMR121367:Same reporter
No adverse effects. Patient got Pfizer COVID-19 vaccine on  2/5/2021 and 3/1/2021, then booster on 9/26/2021 and 4/7/2022. She came in on 7/25/2022 requesting a "second booster",  even though she already had 2 boosters. She is not immunocompromised. That additional dose was given 7/25/2022. Patient had NO reactions or issues with the extra dose.
Cough; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), COVID-19 (COVID-19) and PYREXIA (Fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included IRBESARTAN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COUGH (Cough) and PYREXIA (Fever). At the time of the report, COUGH (Cough), COVID-19 (COVID-19) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial response within about 6 hours of vaccine was muscle pain  and skin pain, low grade fever and chills , sore throat an runny nose, diarrhea and headache. I realize that these are all normal responses and a sign of immune response. Most symptoms gone after 48 hours but headache persisted on daily basis,  with lessening severity until 2/27 .  A rash developed on 2/12 on neck and upper chest, very itchy and irritated . It is still present.
Report 20020003791 describes aggravation of pre-existing arthritis in a 62 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). The medical history included hypertension and an unspecific form of arthritis. The vaccinee had no known drug allergies. The vaccinee's occupation reportedly put him "at risk for tick bites." Concurrent medical conditions and medications were not known by the reporter. The vaccinee received his first injection of LYMErix (lot LY120F9) on 09/13/1999. He had no adverse experience following receipt of this injection. He received his second injection of LYMErix (lot LY123B9) on 10/14/1999. An unknown time post-immunization, he experienced "extreme" joint pain. The vaccinee reported that he did not seek medical attention for the joint pain. The vaccinee stated tha t"he is in a lot of pain and having difficulty just trying to move about." The adverse event 'arthritis aggravated' does not meet ICM serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
This spontaneous report was received from a medical assistant and refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. No adverse reactions were reported. On an unknown dates, the unspecified patients were vaccinated with improperly stored doses of VAQTA lot # M032492, expiration date 02-MAR-2018 for prophylaxis (strength, dose, route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004019: US-009507513-1701USA005953: US-009507513-1701USA005954: US-009507513-1701USA005956.
fatigue; Pain injection site; headache; myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, injection site pain, headache and myalgia. On an unknown date, the outcome of the fatigue, injection site pain, headache and myalgia were unknown.   It was unknown if the reporter considered the fatigue, injection site pain, headache and myalgia to be related to Shingrix.  Additional case details were reported as follows: While reviewing common adverse events of Shingrix, health care professional mentioned that she had experienced those adverse event post vaccine.  No additional information was provided. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160538:same reporter US-GLAXOSMITHKLINE-US2020160542:same reporter
Breakthrough case admission after 2 vaccines Pfizer 3/30/21 Lot# ER2613;  Pfizer 10/14/21 Lot# FG2589
Day 1 pt developed soreness at site which slowly crept over whole body in the next 24 hours, "like the flu." Day 2 pt stated body sore and muscle aches. Day 3 pt had high temperature and felt delirious. Day 4 pt continued with temp to 103. Day 5 Temp broke in early AM only to return but milder by mid-day. Pt had no nausea, vomiting, diarrhea, cough or headache.
Rashes with bumps starting on her legs and now on her belly, armpits /very itchy; Rashes with bumps starting on her legs and now on her belly, armpits /very itchy; This is a spontaneous case, reported from other non-health professional) via Med Communications (reference number: SEQ20-00615) on 13-Feb-2020, concerning a 71-year-old, female patient.  The patient's medical history included high cholesterol and allergies to neomicin and thimerosal.   The patient's concomitant medications included rosuvastatin, calcium, Fibercon (polycarbophil calcium), Baby aspirin (acetylsalicylic acid), iron and Centrum (unspecified minerals and vitamins) for an unknown indication.  On 10-Dec-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 260387 and expiry date: 30-Apr-2020] for an unknown indication.  On 31-Jan-2020, one month and 21 days after vaccination, the patient experienced rash on her legs which spread on belly and armpits and was very itchy. The patient visited a doctor who prescribed triamcinolone steroid cream for rash.  At the time of initial reporting, the outcome of events was not resolved.  This case was assessed as non-serious.  The reporter did not provide causality assessment to Fluad (TIV).  Company comment: The events of rash and pruritus was considered as related to the Fluad (TIV).; Sender's Comments: The events of rash and pruritus was considered as related to the Fluad (TIV).
THE BIVALENT HAD BEEN ERRONEOUSLY ADMINISTERED  IN PLACE OF MONOVALENT FOR PRIMARY SERIES
This case was reported by a physician via sales rep and described the occurrence of fever in a child patient who received PEDIARIX. On an unknown date, the patient received the 1st dose of PEDIARIX (intramuscular). On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be almost certainly related to PEDIARIX. Additional details provided were as follows: The patient experienced high fever. Limited information was provided by the sale representative from the physician. This was 1 of 4 cases reported by the same reporter (US2016038398, US2016038402 and US2016038403).
I've seen a cardiologist, had an echocardiogram, and a cardiac MRI. My cardiologist said my arrhythmia was a result of the booster I got in  May and that it was a well known side effect. It wasn't well known to me but after deep digging I did find it listed on Pfizer and Cardiology website. They have no solutions for me outside of heart surgery.
The patient presented to the pharmacy to receive the adult bivalent COVID19 Moderna booster. The pharmacist who was preparing the vaccine drew up the pediatric monovalent COVID19 Moderna vaccine for 6-11 years, which was administer to the patient. The pharmacy manager discovered the error on 12/05/22 upon returning to pharmacy after weekend off. The patient was contacted to discuss the incident. The patient stated that her right arm is "pretty sore," which started 12 hours after initial vaccination and persisted through the time of call with patient. The patient also stated that her right arm pit (pharmacy manager suspected a lymph node) was also very tender and sore , and that she experienced chills during the evening of 12/04/22.   The patient stated that she does not have a primary care provider established in the area and discussed outcomes with the pharmacy manager. Upon suggestion from the pharmacy manager, the patient stated she would wait 2 months following administration of the incorrect monovalent COVID vaccine and then receive the correct adult bivalent COVID vaccine.
Patient experienced facial swelling and tingling approximately 8 hours after receiving the vaccine.  The symptoms were resolved on 16 October 2020 (two days later).
dose of ADACEL that was administered had expired on 26SEP2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00905803) and transmitted to Sanofi on 20-Dec-2021.  This case involves a 47-year-old male patient who administered dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] expired on 26sep2021 (expired product administered).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 16-Dec-2021, the patient received 0.5ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5667AA and expiry date: 26-Sep-2021) (Frequency = once) (Strength = standard) via intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  It was reported "Medical assistant asks if there is any information about efficacy of a vaccine that is administered after expiration".  This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event.  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.
itching all over the body; like spasms in the skin, feels strange; pimples; can't sleep because of the reactio; cholesterol was elevated in her blood test; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over the body), MUSCLE SPASMS (like spasms in the skin, feels strange), ACNE (pimples), INSOMNIA (can't sleep because of the reactio) and BLOOD CHOLESTEROL INCREASED (cholesterol was elevated in her blood test) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included blood pressure medication, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and Metformin prediabetic for an unknown indication.    On 11-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 PRURITUS (itching all over the body), MUSCLE SPASMS (like spasms in the skin, feels strange), ACNE (pimples), INSOMNIA (can't sleep because of the reactio), BLOOD CHOLESTEROL INCREASED (cholesterol was elevated in her blood test) and CHILLS (chills). At the time of the report, PRURITUS (itching all over the body), MUSCLE SPASMS (like spasms in the skin, feels strange), ACNE (pimples), INSOMNIA (can't sleep because of the reactio), BLOOD CHOLESTEROL INCREASED (cholesterol was elevated in her blood test) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No new information.
13 x 16 cm area of redness, sl swelling and minimal induration on rt anterior thigh. No fever. Treat with Benadryl 1 tsp BID.
Patient 4th (last) dose of Vivotif oral typhoid vaccine. Pt had done well with first 3 doses. Several hours after taking last dose pt awoke with intense abdominal cramping. Pt had lots of watery diarrhea. No vomiting, no fever. Pt has sore throat and running nose and continued severe cramping and flatulence. Pt did not have any of these symptoms prior to taking the Vivotif.
His Arm had a little bump on it; he was experiencing tiredness; headache; fever; nauseous; muscle pains/muscle aches; couldn't sleep last night, and a general feeling of unwellness; couldn't sleep last night, and a general feeling of unwellness; joint pain; chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3302, expiration date: 05Feb2021) via an unspecified route of administration on the left arm on 14Jan2021 09:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetes, ongoing heart stent from Nov2019, COVID-19 in Mar2020 and blood thinner. Concomitant medication included ongoing metformin for diabetes, ticagrelor (BRILINTA) for blood thinner and carvedilol as beta blocker related to heart stent. The patient received the first of the vaccine yesterday and experienced all of the side effects on the fact sheet. On 14Jan2021, the patient experienced that his arm had a little bump on it, he was experiencing tiredness, a headache, a fever, nauseous, muscle pains, couldn't sleep last night, and a general feeling of unwellness. He was asking asking how long these side effects should last. He was fine all morning and afternoon after getting the vaccine until around 11:30pm-12:00am when he started hurting; talking about a headache; muscle aches; chills; fevers; joint pain; he could not sleep. Outcome of the events was not recovered.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 11/28/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Initial report was received on 17 September 2010 from a consumer, who is also the patient. A male patient with an unreported past medical history, had received FLUZONE No Preservative 2009-2010, lot number U3167AA (route and site of administration not reported) in 2009. An unspecified amount of time later he developed mercury poisoning, inflamed organs, speech problems, facial seizures, fever and an injection site reaction. No further information was available at the time of this reported. The patient's outcome was not reported. Documents held by sender: none
Severe pain and swelling under left arm, fever, chills.  This happened after second vaccine on 4/9/2021 and the booster on 12/22/21.  I will not be getting another until this side effect is remedied.  I have been sick for days.  Never happens after a flu vaccine
Systemic: Flushed / Sweating-Moderate, Systemic: Allergic: Difficulty Breathing-Moderate
I was unable to use my left arm for 3 days, the first 2 nights while laying down, my left arm throbbed with pain.  After the 3rd day my arm was able to move however I needed help dressing and undressing.   I have slowly regained use of my left arm, however, I cannot lift my arm sideways.  If I attempt to lift my arm there is a sharp pain and it takes my breath away.  I also still need assistance  dressing.   The pain is in my upper arm below my shoulder and at the top of my bicep toward the inside of my arm.
S.U.I.D/S.I.D.S? Death cert. not yet available. For autopsy result, contact medical examiner or child's HCP.
62 y.o. male with a history of newly diagnosed DM, CKD, HTN, and hepatitis C who presented to the ED via ambulance for a syncopal episode after weakness. Reports getting pfizer COVID vaccine three days prior and not feeling well since then. Has had poor PO intake due to symptoms. Paramedics found bp to be 77 systolic on scene and 118 once arriving.  Reports family members tested positive the day before.   Admitted after positive COVID test and hypoxia on RA. He was on HFNC with O2 saturation <90% frequently. Acute kidney injury with a creatinine elevation to 4.35. CT head and neck w/o acute pathology. Started on empiric ceftriaxone and azithromycin along with decadron and remdesivir throughout his stay. Breathing improved after a week and negative CT was obtained. AKI improved after fluid resuscitation.   62M who received first dose Pfizer vaccine 3/27/2021, developed illness c/w covid infection 3 days prior to presentation, on the same date as his first Pfizer dose. Admitted with severe covid pneumonia, discharged 2.5 weeks later. Unclear if the patient was already developing covid prior to initial vaccine dose.
Eight hours post vax, the pt experienced 2 episodes less than 30 seconds each with apnea and cyanosis with a spontaneous resolution. The pt was admitted for observation.
second Booster dose recieved 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (second Booster dose recieved 0.5ml) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 026A21A, 037A21B and 032B21A) for COVID-19 vaccination.     The patient's past medical history included Varicose veins from 12-Dec-2012 to 17-May-2017, Prediabetes on 22-May-2015, Wound infection (After surgery) on 26-Nov-2021, Stent placement (Biliary duct) on 25-Aug-2021 and Pancreaticoduodenectomy (Surgery on 18 Nov 2021) on 23-Nov-2021. Concurrent medical conditions included Drug allergy, Penicillin allergy, Hypothyroidism since 14-Nov-2011, Tobacco abuse since 14-Nov-2011, Gastroesophageal reflux disease since 12-Dec-2012, Anxiety since 12-Dec-2012, Depression since 12-Dec-2012, Varicose veins (Left lower extremity with complications) since 16-Dec-2015, Acute pancreatitis (Idiopathic) since 24-Mar-2021, Transaminitis since 24-Mar-2021, Bile duct obstruction NOS since 26-Mar-2021, Pancreatic mass since 26-Mar-2021, Obesity since 26-Mar-2021, Type 2 diabetes mellitus since 30-Jun-2021, Pancreatic adenocarcinoma (Whipple by Dr. 18/11/2021) since 25-Aug-2021 and Hyperbilirubinemia since 17-Aug-2021.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (second Booster dose recieved 0.5ml). At the time of the report, ACCIDENTAL OVERDOSE (second Booster dose recieved 0.5ml) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Liver function test: high (High) Elevated LFTs.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patients fourth dose was as per Moderna recommendation that dose given on 27 Aug 2021 needed to be re-done. No treatment medications were reported.   This case was linked to MOD-2022-539677 (Patient Link).
This spontaneous case, initially received from a pharmacist on 08-Nov-2018, concerns a 59-year-old, adult female patient. The patient had no historical conditions and did not received any concomitant medications. On 08-Nov-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250783 and expiry date: 30-Apr-2019]. At the time of this report, no adverse events were reported after vaccine administration. The reporter assessed this case as non-serious.
At this date and time, became aware that the upper arm where DTaP vaccine was administered 2 days prior was swollen, red, sore, and tender.
(R) arm swelling & redness at injection site 2 days post injection. Mom states size of golf ball. Denies SOB or swelling any other location.