chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine, stood up to walk around corner, then collapsed, hitting her head on floor.  An EMT was in the area and stepped in.  Pt was unresponsive for about a minute, pulse very weak.  911 was called.  Pt was moved into a separate room once slightly responsive, she was very pale and seemed confused and was very nauseated.  Her blood pressure dropped to 68/44, but over the course of a few minutes started coming back up.  EMTs arrived and took patient to hospital to evaluate.
Patient a  Vaso Vagal even.  became pale , slight diaphoresis.   and LOC momentary. . recovered when patient placed in supine position .  MD  arrived. on scene. patient awake  HR 49  B/P 100/60  Resp 16    02 sat 96%.  no Respiratory distress or Rash.  Patient. recover after po fluids.  and snack given.
Fever, Hypertension, influenza-like disease, nauses - Information has been received from a 39 year old caucasian female consumer with a penicillin allergy, cononary artery disease, asthma, hypertension and hyporlipidemia and a history of bypass surgery in 1998 who on 14 mar 2000 was vaccinated with varicella virus vaccine live.  Concomitant therapy included atenolo 75 mg daily. atorvastatin calcium (lipitor) 60 mg daily, folic acid, vitamin A & C, albuterol sulfate (vantolin) and aspirin (ecotrin) 335 mg daily.  On 17 Mar 2000.  The patient experienced a temperature of 99.5 degrees fahrenheit.  On 18 mar 2000 the patient ws nauseous and had an elevated blood pressure of 160/120.  The patient went to the emergency from where the health care provider postulated that the patient;s experience was due to the vaccine.  Additonally, it was reported that the patient had been in bed with flu - like sysmptoms but as of 20 Mar 2000 was feeling better.  Acetaminophen Tylenol was prescribed prn and the patient will follow up with her health care provider.  Follow up information from a physician reported that the results of the blood tests were not available.  Additonally it was noted that the patient's bood pressure was 147/83 on arrival to the emergency room.  The patient remains recovered.
Patient came to Pharmacy to receive primary series of COVID vaccination. RPh, was on duty during event. RN, was vaccinating administrator. RN administered Pfizer Bivalent to patient who never initiated COVID primary series.
pt recvd vax; exp sweating, abd pain & d;liver nl; er md required no tx given;
Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot number not reported). On approximately 06-JUL-2009 the patient experienced soreness around the injection site. Unspecified medical attention was sought. At the time of the report, the patient not recovered. Additional information has been requested.
About 1-1.5, she experienced strong lethargy and slept for several hours. The next day she had a long-lasting headache.  Site-specific soreness for several days.  I erroneously reported for the first shot that she had. She had it at Senior High.
This spontaneous report as received from a pharmacist via company representative, refers to a 52 year old male patient. On 27-DEC-2012 the patient was vaccinated with ZOSTAVAX (strength, dose and lot number were not reported). On 31-DEC-2012, the patient developed Bell's Palsy, droopiness in face and problems blinking after receiving ZOSTAVAX. The patient sought medical attention, he spoke with his wife who was a pharmacist. The patient was treated with acupuncture for the adverse events. The outcome of Bell's Palsy, droopiness in face and problems blinking was reported as not recovered/not resolved. The relatedness between Bell's Palsy, droopiness in face, problems blinking and ZOSTAVAX was not reported. Additional information has been requested.
very sore arm - hard to use that arm - still an issue 2 days later Fever between 100 and 102 for 8 hour on 2/9/21 - took tylenol and advil - fever persisted even with meds - was completely gone after 10 hours body aches started around 11:00pm on 2/8/21 and persisted until about 10:00pm on 2/9/21 Headache - began around 5:00am on 2/9/21 - is better today but still have it on 2/10/21
Patient started with soreness and pain on right arm later in the day after receiving vaccine. Patient with trump of 103. Mom then gave 4 tabs of ibuprofen.
Patient received Bexsero subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2022, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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: 15-NOV-2022 Reporter's comment: The reporter stated that a patient received Bexsero subcutaneously. The reporter consented to follow-up via postal. Additional Supportive Information: The patient received dose of Bexsero subcutaneously, which led to intramuscular formulation administered by other route.
Patient received Mono -Valent Pfizer BNT vaccine instead of newer bivalent booster vaccine, No other adverse outcomes
Initial and follow up information had been received from a registered nurse and another healthcare professional at the doctors office, respectively concerning a 79 year old white female patient, with allergies to amlodipine besylate (NORVASC), atropine sulfate (+) diphenoxylate hydrochloride (LOMOTIL), acebutolol hydrochloride (SECTRAL), verapamil hydrochloride (CALAN), alendronate sodium (MSD), and metoprolol tartrate (LOPRESSOR), who on the morning of 25-JAN-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#651320/1008P).  Initially it was reported that in February 2006, the patient developed redness and swelling at the injection site, and has chills.  The patient's status was reported as recovering for swelling and redness at the injection site and "subjective" chills.  Follow up information from the healthcare professional confirmed that at 3:30 pm on 25-JAN-2006 the patient developed swelling and "subjective" chills.  The patient also developed myalgia, pain, and 'subjective" fever.  The patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) and tramadol hydrochloride (TRAMADOLOR).  Outcome of myalgia, pain, and "subjective" fever was not reported.  It was also reported that there was no illness at the time of vaccination.  No product quality complaint was involved.  Additional information is not expected.
nurse gave a fluzone high dose quadrivalent dose of a patient, after the vaccine had a temperature excursion of below 0 C with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves male patient of an unknown age and nurse gave a Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] of a patient, after the vaccine had a temperature excursion of below 0 c.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2023, the patient received a dose of 0.7 ml of suspect Influenza Quadrival A-B High Dose Hv Vaccine (expiry date: not reported, lot UT8072EA, Frequency: once, Strength: high dose) unknown route in unknown administration site as Immunization and after the vaccine had a temperature excursion of below 0 c with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
Myocardial Infarction, heart attack, caused by single unexplained clot.  Aching pain that spread from chest to left shoulder and behind my neck. Hands were numb and tingling, feet were numb and tingling. Struggled to breath. Had cold sweats and nausea. Extremely tired. Pain became unbearable. Didn?t go to hospital for about 3 hours
My arthritis has been acting up bad and has spiked; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. Medical history included ongoing arthritis. The patient's concomitant medications were not reported. The patient stated that she was out of medication and her arthritis has been terrible, she just got her COVID shot three weeks ago and on an unspecified date her arthritis has been acting up bad and has spiked. Patient was prescribed with Xeljanz 5mg. The outcome of the event was unknown.   Information on the lot batch number has been requested.   Follow-up attempts completed. No further information expected.
Information has been received from a licensed practical nurse concerning a 62 year old female with a sulfa allergy and no medical history who on 03Oct05 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650331/0749P). There was no concomitant medication. On 04Oct05, the pt presented to urgent care with complaints of right shoulder pain, upper arm pain, swelling and redness. The pt was treated with Prednisone and amoxicillin (+) clavulanate potassium (Augmentin). The pt was released from urgent care. No laboratory diagnostic studies were performed. On 05Oct05, the pt went to the doctor's office and her symptoms were improving. Subsequently, the pt recovered. Right shoulder pain, upper arm pain, swelling and redness were considered to be other important medical events (OMIC). Additional information has been requested.
My esophagus is inflamed and food is having a harder time going down. I have a diagnosis of Ineffective esophageal motility disorder; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old non-pregnant  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 28Jan2021 11:30 (Batch/Lot number was not reported) as 1st dose, single ( at the age of 55 years) for covid-19 immunisation. The patient's medical history included ineffective esophageal motility disorder, GERD and known allergies to  numbing agent for upper endoscopy. The patient has not had covid prior to vaccination. Concomitant medications included cimetidine (TAGAMET [CIMETIDINE]) and Multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 28Jan2021, 11:30, the patient experienced my esophagus was inflamed and food was having a harder time going down. She have a diagnosis of ineffective esophageal motility disorder. It was further reported that as soon as she was given the vaccine, her esophagus had a reaction. Her esophagus was inflamed and food was having a harder time going down. She had a diagnosis of ineffective esophageal motility disorder, and still having issues it has not cleared up, since the vaccination. It was reported that the event was treated with Carafate. The patient was not tested for Covid post vaccination. The outcome of the event was not recovered.  Information on the Lot/Batch number has been requested.
Starting 07/06/2022, I was experiencing headache, congestion and sore throat. I had an exposure to COVID due to visiting my father. So, I reached out to the urgent care clinic at the pharmacy to get a PCR test done which came back negative (9 days past first exposure). I had been doing at home tests the entire time prior (since being exposed) and all have came back negative. When I was at the clinic, she checked my ears, nose and throat just for safety and noticed I had a mild ear infection. She recommended I take Afrin and told me, if the infection feels worse in the next few days, to go to my PCP or come back to the clinic. However, my symptoms abated within a few days.
Ten days after my second shot, I began experiencing dizziness and light-headedness, with the resultant nausea.  I went to see my doctor on March 8.    I am still having issues (need to lie down several times a day to cope with nausea), but effects are gradually decreasing.
PATIENT DID NOT HAVE AN ADVERSE EVENT.  Simply filling out form to document patient had asked for Moderna but was given Janssen in error.  Patient was notified of error. Patient was understanding of error and verbalized that it did not matter much to him which COVID vaccination he received.
Pain in arm; lump size more than 50c coin in injection site; lump on injection site; nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), EPISTAXIS (nose bleeding), VACCINATION SITE MASS (lump size more than 50c coin in injection site) and VACCINATION SITE SWELLING (lump on injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, LISINOPRIL and CLONIDINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced EPISTAXIS (nose bleeding). On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (lump on injection site). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MASS (lump size more than 50c coin in injection site). The patient was treated with AMLODIPINE BESILATE (NORVASC) for Adverse event, at an unspecified dose and frequency; HYDRALAZINE for Adverse event, at an unspecified dose and frequency and CLONIDINE for Adverse event, at a dose of 1 UNK. On 19-Mar-2021, PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MASS (lump size more than 50c coin in injection site) had resolved. At the time of the report, EPISTAXIS (nose bleeding) outcome was unknown and VACCINATION SITE SWELLING (lump on injection site) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) elevated. On 10-Mar-2021, Blood pressure systolic: 208 (High) increased.         patient lab data contain diastolic blood pressure done on 10 Mar 2021. Patient visited emergency room with elevated blood pressure and was treated by Norvasc and hydralazine. Patient had previously High blood pressure and treated it by metoprolol and lisinopril but never had so unexpected elevations. Occasionally Patient had experienced nose bleeding after vaccination and Physician added clonidine to patient's daily medication to treat the symptoms.   Crosslinked with case MOD21-065683 Caller was returning call from safety, contact information was provided.  The caller does not have a computer, and has no way to receive e-mail.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: initial addition information received on 14 May 2021 reporter information updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Adverse drug reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy women received dose of Shingrix and had problem  with the dose and  had to go to bed for a couple of days.  The follow up consent was granted. This case has been linked with case US2020025224, reported by same reporter
Right hand severely swollen the next morning. Never had this happen and last this long. I thought my hand fell asleep and maybe I slept funny, but this does not seem to be the case. I?m pretty sure it?s a reaction to the booster shot, I don?t know, thought I should report it just in case. It?s been over 24 hours since the booster and my hand is still swollen.
Soreness and swelling in injection site, then 3-4 days later, muscle pain developed in left arm between elbow and shoulder. Muscle weakness still present. Pain and difficulty when raising my left arm. The act of pulling a top off and over my head almost impossible due to pain. It started as minor and annoying, and today, 2/26/18, is to the point that I can't lift left arm straight up.
In the left arm where I received my first dose of Covid-19 vaccine (Pfizer) I started getting a numbness feeling in the area of the injection.  It feels very similar to when a limb falls asleep. There is numbness and tingling feeling .  So far there is no pain or weakness. There has been no treatment.  This started on 1/14/2021 and has continued through today.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age. On an unknown date in between 02-JUL-2015 and 04-AUG-2015, the unspecified number of patients were vaccinated with improperly stored ROTATEQ (lot# K013410, expiry date: 27-FEB-2016 and lot # K015841, expiry date: 01-MAY-2016). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Cold, sore throat, sneezing, sinus infection, congestion, fever, chills.
onset 12OCT93 ached all over & felt terrible denies fever & other sx; seen by MD 13OCT; states still feeling poorly;
patient experienced rash, hardening of skin at area of injection, fever, nausea, and metallic taste
feeling that bad; muscle soreness over injection site; fever; body aches; very tired; slept mostly; This case was reported by a consumer and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad. On an unknown date, the outcome of the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad were unknown.   It was unknown if the reporter considered the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle soreness over injection site. The patient had fever, body aches, very tired and slept mostly 25hrs out of 48hrs. The patient could not afford to miss 2days of work after being out of work 2 months for the Covid virus. The patient was very hesitating to get 2nd dose. This case linked with US2020AMR091617, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR091617:Same reporter
14 y/o gentleman with PMH only significant for R orchiopexy 3 years ago who presents for persistent right inguinal pain and lymphadenopathy. The patient was last seen on 6/10 for right inguinal pain with workup significant for right inguinal lymphadenopathy on US and normal scrotal ultrasound. Patient was reportedly started on antibiotics by his PCP with no improvement. He reports overall decrease in appetite and nausea, but no emesis. He has been febrile at home up to 101F.
Pt. was given GARDASIL 9 and BEXSERO meningococcal vaccine and about 1 minute later she passed out on the exam table; she then became pale, had a headache and started vomiting. She was kept at the office for 2 hrs after vaccines.
Low grade fever; Muscle aches; Chills; Brain fog; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, the patient experienced low grade fever, muscle aches, chills, and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, 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 low grade fever, muscle aches, chills, and brain fog were recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had typical post-vaccine symptoms with generalized achiness and arm pain. A few weeks after, his right leg wound began to develop signs consistent with pyoderma gangrenosum , an autoimmune disease that is rare but can be seen in leg wounds. He has no history of autoimmune disease or pyoderma gangrenosum.
I have been in a lot of pain since my shot. I can't lift my arm past a certain point without aching. It is tough for me to change my shirt or even wash my hair. I called my doctor but only spoke with the secretary and have not gone in to see her. I a relieved to see it is not just me though.