chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site red, raised, extremely swollen, hot to touch. Redness is beginning to travel down. It is just above elbow and working around to the posterior side of arm. Dizziness accompanied with generalized weakness and nausea.
one dose of MENQUADFI was administered post excursion,with no reported adverse event; Initial information was received on 24-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old male patient who reported that one dose of menquadfi was administered post excursion,with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Jan-2023, the patient received a 0.25 ml to 2 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine(supsection for injection) (lot U7299AB,Expiry date:04-Aug-2024) (with unknown strength) via intramuscular route in the left arm for immunization.  On 24-Jan-2023 the patient developed a non-serious event of one dose of menquadfi was administered post excursion,with no reported adverse event (wrong product administered) (latency: same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event one dose of menquadfi was administered post excursion,with no reported 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.
Patient presented to the ED on 10/31 with midsternal chest pain. She was diagnosed with a NSTEMI and subsequently had to be transferred to another facility. Patient reported her J&J vaccine was on the thursday prior to presentation.
Pfizer COVID-19 vaccine given 1 day after expiration. Expired 9/30/2022. Patient did not experience any adverse effects.
Starting the same day of the vaccine around 1pm, I started feeling head pressure and flu-symptoms like body aches. I had no energy and ended up leaving work early. It took about 3-4 days before I started feeling better. I experienced a headache for longer than the other symptoms, but I do not recall for how long I had it.  Exposed a few times to COVID in November and was tested for COVID (tested negative). On 12/13/2021 I tested positive for COVID via a COVID19  at home test (brand: Binax now). I called the Health Department and they sent me to an infusion center to be treated with monoclonal antibodies. For about 10 days, I had significant symptoms and it wasn't until about Christmas that I started feeling better.
she feels like her legs are hurting; when she sits her knees has bruises on both legs/bruising on her left knee; This is a spontaneous report from a contactable consumer (patient's sister). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route of administration in arm left on 08Jun2021 at 18:00 as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration in arm left on 18May2021 as a 1st dose, single dose for COVID-19 immunisation, LOT# (First dose): EW0186 (When clarified as EW0176, reporter confirmed the same, contradictory information hence not captured in tab). Age at vaccination was 14 years. The patient had no prior vaccination within 4 weeks, just Pfizer. On 12Jun2021 at 14:16:17, the reporter wanted to report a Covid vaccine side effect was called on behalf of her 14-year-old sister. Stated that, she filed a report with yesterday and they gave her the Medical Information contact information to further discuss her sister's adverse reactions. The reporter stated that, her sister was 14-years-old and she got the 2nd dose of the Covid vaccine of Pfizer on Tuesday this week, on 08Jun2021 and began having bruising on her left knee, after a day on 09Jun2021, the patient felt like her legs are hurting and when she sits her knees has bruises on both legs. Stated that, the patient had got the first vaccine when she was 14 (further not clarified hence, not captured in tab). Stated that, on her research she has found that could be a rare side effect and wanted to know if they had any further data or report of this side effect. Stated that, the reporter had read all about the side effect and saw lot of scary things, it seems like rare condition to have, so the reporter concerned, was that really bad, do they had to run any test or something. Stated that, the reporter was calling and got disconnected so, she called in again. Stated that, the reporter was in the middle of filing a case about COVID vaccine side effect. Stated that, the reporter has concerns because her sister does not have a primary healthcare provider or insurance so she was unsure of what she should do. Stated that, the reporter was provided with the number of health department and she got the questions so, she wanted to call them tomorrow, it's Saturday so when they were working. Everything was good regarding this case right. Response included was advised caller, Pfizer cannot make independent patient recommendations and that she would have to seek further medical advice from a primary care provider. The dates and seriousness for the events were unspecified. The reporter stated that, the patient did not take any treatment yet. The investigation assessment was reported as no. The outcome of the events was unknown.  Follow-up actions are needed. Further information is requested.
Heart rate increase to 140-150 BPM A.Flutter had to be treated with shock to heart twice.  Arm still hurts from injection.
On 01/18/2001 the patient developed chicken pox with symptoms of rash, fever, pruritis and lesions over the whole body. The patient had an extremely itchy rash. Also noted, the number of lesions were undetermined by the the reporter. The symptoms lasted for 5 days. The patient was treated with Atarax and Aveeno Bath and recovered. The patient sought unspecified medical attention. Additional information has been requested.
tested positive for COVD-19 despite full vaccination on 10/07/2021 admitted 10/11/21 with SOB and hypoxemia (on monoclonal antibody treatment at the time) in hospital given steroids, barcitinib and oxygen discharged 10/21/2021
Swelling and bruising at injection site. Swelling to lower part of upper arm, down to elbow. Advised to treat with Benadryl and ice pack.
I experienced Atrial tachycardia and I was treated with Diltiazem and Felecainive.  An EKG, U/S cardiac, holter heart monitor and extensive lab work was performed.  I have no symptoms today.
Chills, fatigue,  nausea/ actively throwing up for 24 hours. Stomach flu like symptoms
Immediately following the vaccination, my heart was racing, a sore throat, a metallic taste in my mouth, facial flushing. I felt concerned I was having an allergic reaction. The pharmacist was concerned, but I didn't want to go to the hospital on spot after receiving the vaccine at the pharmacy. Eventually, the symptoms started passing and I went home. The next morning, I had a fever, body chills, and a swollen arm. Some days later, I was driving and felt faint; my face was red and flushed when I looked in the rear view mirror. I pulled over and felt exhausted and rested for 2-5 minutes. I called my doctor and made an appointment. I had like 10-15 more similar episodes up until July. I was seen by another doctor; because of the reaction I had immediately after vaccination, they thought it was just an allergic reaction. So I was suggested to take Zyrtec. They did an ECG and saw progress in my report; they thought it was myocarditis but didn't diagnose me (just a prognosis).
Headache, stomachache, nausea, vomiting shakes/ tremors.  Can't hold any food or drink down.  Symptoms lasting 4 days and counting.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALLOPURINOL, ENTECAVIR, INDAPAMIDE, LOSARTAN POTASSIUM (LOSARTIN), METOPROLOL and NIFEDIPINE for an unknown indication.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.      No treatment information was provided.
Phone call from mother the afternoon after receiving shots to say that her daughter had a reaction follow vaccines that morning.  States she walked to the car and complained of feeling tingly, her eyes dilated and her arm jerked for about 30 seconds.  States her daughter "came to" and is doing fine since then.
Pt, 93 y/o female with a PMH Skin Cancer, Gout, HL, HTN, Diastolic CHF, Afib not on anticoagulation, CAD s/p PTCA in 1997, Mitral regurgitation, OA and Malignant neoplasm of transverse colon s/p Colectomy in 2017 and ILD on 3 L oxygen at night, who presented to ED on 10/3/21 with shortness of breath, fever and low oxygen saturation at home.     She was diagnosed with Sepsis with Pneumonia given fever, leukocytosis, tachycardia, and lactic acid of 3.1. Pt had elevated inflammatory marker with CRP 55; procalcitonin was less than 0.05. Pulmonology consulted.  CT chest show CHF with pulmonary edema, bilateral effusion, interstitial lung disease.  Patient was treated with IV Azithromycin, Vancomycin and Solu-Medrol;  IV steroid initially held as patient developed suspected allergic symptoms with it on 10/3/21 night.  Oral prednisone started.  Vancomycin was discontinued as MRSA nasal PCR negative on 10/05/2021.  Pt completed treatement with IV antibiotics and steroid taper.  She did end up testing positive for COVID 19 on 10/11/21.   Infectious disease consulted as per Pulmonary request and IV Remdesivir was deferred as pt was improving.  She was not interested in use of tocilizumab. Pt doing well and is now on home oxygen at 3 L via NC.   Pt also had an acute exacerbation of diastolic heart failure with Cor pulmonale.  Cardiology consulted.  Pt to continue Lasix orally.  Pt with anemia and had a drop in Hgb from 11.4 to 9.8 on 10/7.  Hgb last 9.4.  PCP to follow up as outpatient.   Family requested pt to go to HCF for Rehab.  Pt was accepted and was stable for discharge. However, pt had COVID 19 test prior to discharge that was positive.  Pt was to go home with HHC on 10/19, but she felt weak so she was kept.  Pt decided that she would like to go to HCF again. HCP has placed pt at HCF.  Pt stable for discharge at this time.  Pt to follow up with PCP in the next 3-5 days if possible.
BLOOD CLOTS; STROKE WHILE ON VACATION; COULD NO LONGER SPEAK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. He had a Computed axial tomography (CAT) scan and all his regular checkups. He was fine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 1 total administered 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.  It was reported that, after vaccination he had a stroke while he was on vacation and could no longer speak. Now he wanted to get back to his original place so that he can stay alive, for that he needed to pay for air ambulance. He was healthy and now he had all these blood clots (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, and could no longer speak, and the outcome of stroke while on vacation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220104382-Covid-19 vaccine ad26.CoV-2.s- Blood clots, Stroke while on vacation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
torso rash that looked like scratches, apparently a form of hives, slight to moderate itching/burning sensation on torso and face, developed about 13 hours after injection and appears about 75% resolved within 36 hours after appearance, no treatment administered
I contracted COVID a day before the November holiday. I took my flu shot the same day as my COVID vaccination. I had a sore throat to start then the next day I had a cough and phlegm. The fatigue hit me hard then. I felt really bad for the next 3 days, although no fever, felt amplified. Doctor gave me PAXLOVID and I got better between 3 to 4 days however I still have lingering fatigue and brain fog.
PROQUAD and KINRIX given on 4/10/2017 but was discovered that these were already administered on 05/23/2016.
Approximately 1 month following second dose of COVID-19 vaccine (Pfizer), patient noticed increased in spotting on active tablets of birth control prior to starting placebo pills. Patient states that this lasted for a few days prior to starting placebo pills, then subsided. She attributes this increase in spotting a month following her second COVID-19 vaccine dose.
Information has been received from a registered nurse concerning a 15 year old female with no medical history or allergies, who on 03-SEP-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Approximately one week later, the patient experienced a fast heart beat, dizziness and pain in her chest. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a registered nurse concerning a 15 year old female with no medical history who on 31-AUG-2007 (previously reported as 03-SEP-2007) was vaccinated IM into the left arm with a first dose of GARDASIL (lot# 657737/0522U). Illness at the time of vaccination included genital warts and bacterial vaginosis. Concomitant therapy included ORTHO TRI-CYCLEN LO, metronidazole and calcitonin. On approximately 10-SEP-2007 the patient experienced a fast heart beat, dizziness and pain in her chest. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Approximately 30 hours after vaccination we had noticed that he developed a fever. I gave him a dose of ibuprofen and around 4 AM he woke up, was warm to the touch and fussy. He fell asleep around 06:00AM and that next day he was with my mother-in-law and he was very flushed, lethargic, and fatigued. He was not able to calm down or sleep. 48 hours after vaccination he was presenting a fever of 104.4 and was very flush. He would wake up periodically with a fever and the next day we made an appointment to make sure everything was okay. I did an active COVID-19 swab at home and it was negative. At the pediatrician recommended MOTRIN and TYLENOL, and urine analysis came back clean however, on Saturday the results of the analysis then came back to 10,000+ colonies. KEFLEX was started on Sunday afternoon. He was beginning to have a lot of diarrhea on the KEFLEX, and so we got off of it. No active fevers, appetite is back, and much happier now.
p/vax pt went home fell asleep-has been unable to wake the child, limp, pale
Redness, swelling at site of injection (50mm x 50mm), hardness. Symptoms still resolving. Treating with Motrin for pain, observation.
Redness, swelling, hardness, and warm to touch at injection site approximately 19 hrs following vaccination.  Pt also had chills/body aches/headache that resolved quickly.  Redness continued, and area is growing.  Pt is seeking medical attention at this time.  Pt has contacted PCP but is awaiting appointment.
MOM STATES CHILD HAS A LUMP ON LEFT THIGH SINCE INJECTION OF IMMUNIZATION.
uncontrollable shaking; fever up to 103; This is a spontaneous report from a contactable Other HCP (patient). This 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284) intramuscularly on 11Jan2021 06:00 at SINGLE DOSE on left arm for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included atorvastatin. The patient previously received first dose of BNT162B2 (lot number EH9899) intramuscularly on 21Dec2020 06:00 AM at SINGLE DOSE on left arm for covid-19 immunisation, and experienced sore arm. The patient experienced uncontrollable shaking, fever up to 103 on 12Jan2021. No treatment received for the adverse event. The outcome was recovered. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Patient called to report that she had numbness of the right arm and a funny sensation in her chest as well as fever and chills. The adverse event has resolved at 3 days after vaccination.
can't walk; hurts to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk) 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 GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk). At the time of the report, GAIT INABILITY (can't walk) and PAIN IN EXTREMITY (hurts to walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-218564, MOD-2021-218567, MOD-2021-293322 (Patient Link).
Patient reports severe muscle soreness at injection site, eight hours later could not touch site due to tenderness and pain. That night experienced one bout of loose bowels, large amount, felt bowels completely emptied, approximately 10 hours after receiving vaccine. Difficulty sleeping due to pain in arm.  By next morning, patient observed swelling in left axillary and palpated nodules in same area, also felt swelling at left groin area.  On the third day, nodule swelling at both sites, groin and axillary, had receded, no tenderness, but lateral deltoid muscle started to be tender that lead to a moderate-severe deep ache.  Pain began in lateral deltoid, wrapped around lower arm to thumb and first two fingers. Client self medicated with ibupropen 600 mg and repeated this dose every four hours with little to no relief.  On 12/23/2013, patient returned to Public Health Center to report his reactions to the PPSV23 vaccine and was on his way to the local clinic for help in achieving pain relief in his arm
Dose received 3; Pain in stomach; Pain in stomach and gall bladder; This is a spontaneous report from a contactable pharmacist, the patient. A 35-year-old male patient received third (booster) dose of COVID-19 VACCINE-MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU VACCINE) for immunisation on an unknown date (within four weeks prior to the COVID vaccine). The patient previously received first dose of covid-19 vaccine (MANUFACTURER UNKNOWN, Lot Number: UNKNOWN), and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN, Lot Number: UNKNOWN); both on unknown dates for COVID-19 immunisation. On 20Nov2021 at 13:30, the patient experienced pain in stomach and gall bladder. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in stomach and gall bladder was not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Very nauseous; Vomiting; Fever; Very fatigued; Bloody mucus from my nasal; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 2, single (Lot number: EW0158) at the age of 63 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (lot number: EN6203, administered in right arm as dose 1, single), administration date: 20Mar2021, when the patient was 63-year-old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very nauseous"; VOMITING (non-serious) with onset 2021, outcome "recovered" (2021); PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very fatigued"; EPISTAXIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Bloody mucus from my nasal".  Additional information: With her second shot, the patient was very nauseous, vomited, with fever, very fatigued, and with bloody mucus nasally. These lasted 10 days. She has no COVID prior to vaccination and was not tested for COVID post vaccination. She received BNT162b2 (BNT162B2), on 28Aug2021 as dose 3 (booster), single (Lot number: FC3184), in right arm for COVID-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201256368 same patient and drug, different dose and events;
Breakthrough case admission after 3 vaccines Pfizer 3/29/21 Lot# ER8730  Pfizer 4/19/21 Lot# ER8729;  Pfizer 01/14/22 Lot# FJ1614
Pt developed slow cognition and difficulty forming what she wanted to say on the evening she received vax. Pt stated that her cognition and speech gradually improved.  Pt has developed a headache also which has lasted off and on up to one week post vax.