chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea, vomiting, high fever, Caused an IBS flare, the feeling of glass in my joints, migraine trigger, and a cellulitis infection in injection site arm, vertigo
Hives and rash on feet, fingers, persisting for months, stlil have them
pt reports waking the morning p/vax w/itchy hives on lt arm & scattered over body;applied cortisone cream to worse area (lt arm);states itching & hives are resolving slowly;
Red bumps appeared in left side of face and left thigh 2 days after vaccinations. Red bumps spread down entire left leg and slightly spread to right leg. Bumps turned to a bright red  raised rash down entire left thigh. Rash is still on thigh and bumps still on left shin area.
Headache and tired. 25th I was really tired and generalized malaise - on and off for four days. Had a swollen auxiliary lymph node; size of golf ball. Went to a Walk-in clinic on 12-31-2020. They said it should decrease and to watch it and use hot compresses and massage it. I took Tylenol for pain as needed. Took a few days I was extremely tired and run down that three days. And had on and off  nausea. One bout of vomiting and diarrhea on and off.  Resolved eventually on it's own.
Within hour: (Thursday) Muscle pain on opposite side of body (neck, arm, leg) Joints locked up 5 hours after shot, pain continues 9 hours after shot, whole body pain, joints and muscles Uncontrollably shaking and moaning, fever of 102.4 Vomiting, dizzy.  Next day (Friday)woke up still in pain, dizzy, right leg pained in spots under back of knee. Fever, headache chilled, shaking. Continual pain thru the night   Next day(Saturday) woke up head ache slight fever 100.4 Little body pain, dizzy  Next day (Sunday) woke up fine with pain in right leg back and under knee   Currently Tuesday still have pain under right back knee, all other effects have disappeared.
C/O feel faint, throat closing up, but eased somewhat after drinking water.  Also c/o feeling really hot.
C/O of right sided numbness and tingling. No SOB, NO Diaphoresis, No Chest pain. Pt transferred to the ED in no distress.
Appendicitis followed by appendectomy with symptoms beginning 3/11 (+5 days from vaccination) and appendectomy on 3/12.
Redness and swelling of legs,feet and fingers 10 minutes after injection given. 1/2 tsp, benedryl given by clinic RN when symptoms noticed.
arthritis pain has been gone for 2 days; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 08Jan2021 at a single dose for an COVID-19 immunization. Medical history included osteoarthritis. The patient's concomitant medications were not reported. Patient took the 1 dose of BNT162B2 on 19Dec2020. Patient had no side effects with the first injection but she had a few with the second. Patien had something happen that was very unexpected. She had osteoarthritis and her arthritis pain has been gone for 2 days now on Jan2021.  No follow-up attempts are needed. Information about lot/batch number could not be obtained. No further information is expected.
After a few hours, had a slight headache that went away with a Tylenol type pain killer.  Twelve hours after injection, woke up with strong abdominal cramps.  The cramps became strong enough that I became dizzy and thought I may pass out.  After several loose bowels and vomiting, the cramps stopped about an hour or two later.
Vaccination site warmth; vaccination site pruritus; Injection site erythema; This spontaneous case was reported by a consumer and describes the occurrence of   in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL / HCT CENTRAFARM) for Blood pressure high, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-091924 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant follow up appended to AER
both breast are severely soar,; pain on the right side of the face over the forehead spot; patient did not felt better/ still not ok."; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok.") in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 024C21A.) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Gabapentin 100mg bid, Lexapro 10 mg OD and Zen ax TID for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 29-May-2021, the patient experienced BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok."). At the time of the report, BREAST PAIN (both breast are severely soar,), FACIAL PAIN (pain on the right side of the face over the forehead spot) and MALAISE (patient did not felt better/ still not ok.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Painless bleeding from nose and rectum for 4 days after receiving the 2nd vaccine, stopped spontaneously
Information has been received from a physician concerning an 8 year old male who on 10-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) 1350 unit/0.5ml SC (Lot# 666821/0223Z, site unknown). On 12-AUG-2010, the patient's mother called the physician office to report that her son developed a red hard itchy knot at the injection site that measured 4 inches across. At the time of this report, the patient was recovering. This is the 5th patient in this office who had an adverse event reported for this lot# 666821/0223Z. A lot check investigation has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that lot # 666821/0223Z conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the physician concerning the patient with no illness at time of vaccination and no any pre-existing allergies, birth defects or medical conditions who on 10-AUG-2010 at 14:00 was vaccinated at left arm with the second dose of VARIVAX (Merck) (Lot# 666821/0223Z). On 12-AUG-2010 at 10:00 the patient experienced arm red, hot, swollen and 4 inches itchy. On an unspecified date, the patient recovered. No further investigation is available.
dysplasia; Route of GARDASIL 9 administration: oral; This spontaneous report has been received from a company field employee referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was unknown by the reporter.      On an unknown date, the patient was vaccinated with an unspecified number of doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, lot number and expiration date were not reported) orally for Human papillomavirus (HPV) prevention (Incorrect route of product administration).         On an unspecified date, the patient experienced dysplasia after receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9); and she was given unspecified treatment. She did not seek medical attention. The vaccine of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was discontinued. The outcome of the event was not reported.  The causality between the even and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. The patient did not have any pertinent medical history, concomitant therapies and drug reactions or allergies. On 11-JAN-2017, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported), VARIVAX (dose, route of administration, lot# and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, indication, lot# and expiration date were not reported) without incident. On 11-DEC-2017, the patient was vaccinated with a dose of (therapy type: rHA) PROQUAD subcutaneously, lot#N022954 and expiration date: 19-FEB-2019 (dose was not reported) reconstituted with sterile diluent (lot# and expiration date were not reported) and QUADRACEL (dose, route of administration, indication, lot# and expiration date were not reported). On 14-DEC-2017, the patient developed a rash on face. Treatment was given for the event. Strep test was performed on an unknown date (results not provided). The patient sought medical attention - saw physician. The outcome of the event was reported as not recovered. The relatedness between the suspect therapies and the event was not reported.
PT HAD MUSCLE ACHES, FEVER, CHILLS, FELT BAD, FATIGUE...
Right away, they were watching me because I felt like my throat was tightening up a little bit. My blood pressure sky rocketed. Then I was okay after awhile. They pharmacist said to take some Benadryl when I got home if I needed it. He knew I had taken Claritin D earlier. I was okay though. But the next morning, I was so exhausted I could barely get out of bed. The next day, I was still really tired. On Sunday morning, 10th, it hit me - I woke up at 04:00 in am. Nauseous; light-headed; gastro-intestinal issues; extremely ill. I called my brother in and was afraid to be by myself. I could barely move around to even get water or go to bathroom.  I got through it somehow that day and on Monday I was just maybe a little but that isn't saying much - still severe. By Tuesday, I called the pharmacy - I was so light-headed I thought I was going to pass out and they told me to go to ER and someone took me and doctor said he was seeing a lot of this.  Gave me IV fluids. It was difficult to stay hydrated - they gave me paperwork on what to drink to stay hydrated - Pedialyte - anything that had water in it. I drank Essentia Water, too. I couldn't stay hydrated and I was so light-headed  (kept feeling like I was going to pass out) that I could have gone to ER again two days later. Doctor said take it easy - he said my body was busy making antibodies. That light-headedness for about a week - but I couldn't drive for two weeks because of it - was still so dehydrated. I had a strange sensation - like I was outside my body - I couldn't think straight. I was feeling pain in my back by my kidneys and went to my doctor.
Medical Assistant inadvertently gave a vaccine DAPTACEL to patient instead of ADACEL with no adverse evnt; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional and physician via Medical information (under reference number -00768917).  This case involves a 64-year-old female patient who was accidentally vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] with no adverse event (Wrong product administered).  The patient's medical history past medical treatment, vaccination, concomitant medication and family history were not provided.   On 19-Aug-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5765BA and expiry date 28-08-2022) via intramuscular route in the left arm for prophylactic vaccination (Wrong product administered).  It was reported "They want to make sure it's okay and when/if to vaccinate patient with the correct vaccine?".  There were no laboratory data/results available.  It was case of an actual medication error due to wrong vaccine administered (latency was on same day)  At the time of report, no adverse event was reported.  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.
Near fainting 1/6/19 x 2. Lightheadedness daily from 1/7/19 to 2/4/19. Sought care at urgent care, primary care, cardiology, and ENT. Results revealed elevated blood pressure, right branch bundle blockage resulting in stress test, echocardiogram, wearing of monitor for one week (results WNL). Also had an ER visit on 1/14/19 with a referral to see ENT. CT scan of head indicated all okay. Carotid artery scan on 2/7/19. ENT ruled out vertigo and indicated lightheadedness result of blood pressure issues. To date, 2/9/19 the lightheadedness is less frequent but present at times. I am now on 5 mg of Amlodipine.
after my initial injection swelling and rash went away but about three days after no side effects i had a rash that was about three inches long and one inch wide with a huge mass underneath. four or five hours after the new rash appeared, bruising and a burning sensation started to occur but the rash significantly reduced.
Patient returned to site where flu shots being administered saying did not feel right.  Pulse in 130's.  Waves of feeling a little better then bad again.  No respiratory difficulty or skin rash.  Ambulance called when continued to feel poorly.  Pulse rate improved, but ambulance crew recommended patient be checked out; proceeded to nearby Emergency Department.
Narrative: Patient with covid breakthrough infection. Received 1 dose of moderna vaccine before and one after. Treated with monoclonal antibodies
This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015. It was reported that on 12-FEB-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports from the same reporter. Additional information has been requested.
morning after Vertigo set in, and has been going on for 11 days. Physical Therapy has been prescribed to start this week for me.
Patient is fully vaccinated.  Tested Positive for COVID on admission to hospital. This patient was admitted through the emergency room because COVID-19 pneumonia and hypoxia. The patient presented to the hospital with chief complaint of progressive shortness of breath and cough.  The patient not checked her O2 saturation at home and was about 86%. blood . tests showed creatinine of 1.34. Lung perfusion scan showed multiple large wedge-shaped perfusion defect in the left upper pulmonary lobe.  Venous Doppler lower extremity bilateral, no evidence of DVT. CXR: mild pulmonary congestion. The patient was put on oxygen titration, she did fairly well to 2 L nasal cannula.  The patient was put on steroids in addition to anticoagulation. Remdesivir given. D-dimer elevated.  Acute pulmonary embolism, started on Lovenox treatment, on therapeutic dose, continue monitoring oxygen therapy. Pt discharged 1/14/2022 and then readmitted on 1/14/2022. Pt daughter states pt discharged from hospital today. Pt daughter states pt had episode of dizziness, jerked back on toilet and not responding. Questionable seizure. Troponin now elevated. Cr 1.44. Hg 9.9.  discharged 1/26 . Ativan as needed for breakthrough seizure . CT scan:1. No acute intracranial abnormality. 2. Senescent changes including cerebral volume loss and sequelae of chronic microangiopathy. 3. If there is sufficient clinical concern for acute ischemia, further evaluation with brain MRI is recommended. 1/17 CXR progressive b/l pulmonary infiltrate. IV antibiotics.   Discharged.
immediate shoulder pain upon vaccine administration with increasing  pain over the day and continued pain  and inability to use left shoulder normally due to pain, pain waking  patient up during sleep. patient referred to orthopedic clinic which she visited on 12-8 and diagnosed with rotator cuff tendinitis due to injection into tendon patient is in a sling and taking  pain meds and doing prescribed exercises
Tinnitus began within approximately 48 hours after second dose; very pronounced in left ear; unresolved after 10 months
5 minutes after shot patient became unconscious and dropped to floor and recovered in 1 minute. called 911 . Ems took him to hospital for further investigation.
That night, I spiked a super high fever that lasted around 48 hours and was extremely tired. The next morning. I noticed the lymph node under my right arm was swollen. It got to about golf ball size and was really sore, I couldn't put my arm down properly. I called my doctor's office and spoke with a nurse. She stated that it was probably just from the shot and advised that I monitor it and come in if it didn't improve. The swelling lasted for a few weeks and went away on it's own.
Redness then to rash up left arm across chest, up neck; burning pain. Patient has had yearly flu vaccine in past for over 10 yrs without reaction. ER gave BENADRYL and prednisone. Dx possible drug reaction vs suspension reaction.
This is a 92-year-old woman with past medical history of CAD, aortic stenosis status post TAVR in January 2023, anemia, DM, & HLD who presented to emergency department due to presyncopal episode.  Patient describes spinning sensation, feeling of weakness and loss of balance.  She did not pass out or hit her of her head.  She had multiple episodes throughout the day, she was called by her cardiac monitor company to check on her due to " abnormal rhythm" called on monitor, she has informed them of the above therefore she was requested to present to the emergency department. Reportedly abnormal rhythm read was "Mobitz type II", monitor reading provided by cardiology was reviewed 2/5 at 9:33 AM heart rate ~ 32 with AV dissociation with narrow complex QRS.  Possible Mobitz type II. Upon evaluation, patient denied dizziness 2/6 while sitting in bed, her heart rate however was in the 70s, hemodynamically stable.  Oriented x3.  Labs without significant abnormalities, troponins indeterminant, hemoglobin is stable.  EKG with initial QTc of 515, reviewed, left bundle branch block was noted which has developed between January 21 and January 31 per EKGs reviewed.
This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age with hypertension, hypothyroidism and allergy to sulfa and MEDROL. The patient had no concomitant medications. On 19-JUL-2018 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N029303 with an expiration date in 21-APR-2019), intramuscular, to prevent pneumococcal disease (prophylaxis), (dose, frequency and strength were not provided). On an unspecified date in July 2018, the patient developed redness and warmth at the site of PNEUMOVAX 23. It was also reported that the patient sought medical attention with the pharmacist and an unspecified treatment was prescribed for the aforementioned events. At the time of reporting, the outcome of injection site erythema and injection site warmth was reported as not resolved. The causal relationship between PNEUMOVAX 23 and the reported events was not provided.
contracted COVID-19; Booster; contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "haemodialysis" (unspecified if ongoing), notes: I am a haemodialysis patient I immediately went to the hospital as a precaution. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "contracted COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive, notes: I was scheduled for surgery and was required to take a pre-surgical COVID test. As a result, thereof, I learned that I had contracted COVID-19.  Clinical course: Last year I was vaccinated with the Pfizer vaccine. Just days before I would have been eligible for the "BOOSTER" shot, I was scheduled for surgery and was required to take a pre-surgical COVID test. As a result, thereof, I learned that I had contracted COVID-19. Because I am a haemodialysis patient I immediately went to the hospital as a precaution. I was admitted ONLY to quarantine. I did not have a single symptom. The vaccine works and my experience should be marketed in a live commercial.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccines given 2/7/14-- left thigh received Hep A (lot 55PZ4, Glaxosmithkline) and VZV (lot J006108, Merck); developed increasing tenderness, redness, and warmth around injection site on left thigh; by day 2 after the vaccine (2/9/14) pt was seen in urgent care and was noted to have cellulitis (large area of redness 4-5cm diameter, with induration and tenderness); improved within 24hrs on cephalexin.  Unclear of local reaction vs true cellulitis.
Approx. 30-45 minutes, post vax, the pt developed a feeling of her throat closing and dyspnea which progressively increased. She returned to the office. Her lungs were clear but SOB and coughing. She was given Epi, Benadryl, Solu-Medrol and O2. It resolved but was considered an anaphylactic reaction. She was discharged on prednisone and Benadryl. She was observed for 2 hours.