chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer who reported for himself. A 62-year-old male patient of received PREVNAR 13 on  28Sep2016 at single dose for immunization. Medical history included hypertension, diabetes, plastic bronchitis, allergies, acid reflux, cholesterol, high blood pressure and thyroid. Concomitant medication included ongoing metformin tablet for diabetes at 500 mg, 2x/day oral, ongoing VICTOZA for diabetes at 1.8 mg 1x/day injection, ongoing NOVOLOG 3x/day (at breakfast 28, at lunch 20 and at dinner 50) for diabetes injection, ongoing ipratropium bromide/salbutamol sulfate in nebulizer via inhalation 4x/day for plastic bronchitis, ongoing SYMBICORT 160/4.5mg  for plastic bronchitis 2 x/day via inhalation, ongoing furosemide water tablet for high blood pressure at 40 mg, 2x/day oral, ongoing levothyroxine tablet at 34mg 1x/day oral for thyroid, ongoing simvastatin tablet cholesterol at 40 mg, 1x/day oral, ongoing montelukast for allergies tablet at 10 mg 1x/day oral, ongoing omeprazole capsule for acid reflux at 40 mg, 2x/day oral, ongoing prednisone tablet for Plastic bronchitis since a year at 10 mg, 1x/day oral, ongoing TRESIBA injection at 100 mg, 1x/day for diabetes, ongoing spironolactone water tablet at 25 mg, 1x/day oral, ongoing SPIRIVA capsule broken and inhaled for Plastic bronchitis at 18 ug, 1x/day and ongoing heparin for blood thinner via nebulizer with a 9% (later 7%) nebulizer solution of sodium chloride, in a junction with a Vibralung (sound vibrating instrument in lungs). On 28Sep2016 the patient experienced redness at injection site: he had a big red patch on arm with a dot. On the first day it was just low red, then redness continually get bigger. The redness at the injection started to lighten up a little bit, but it got up a little bit darker red as the days went on. He was treated with unspecified medications and steroid. It had been about a week, but the event did not get much better. The final outcome of the event was not recovered.
The second night after the shot I was awakened out of a sound sleep at 3AM  with a pain across the entire top of my upper chest (at the top of the breast region) it was a though someone had turned a 2x4 on its side and was standing on it.  I was clammy and had some hives on my back and hips. I sat on the side of the bed I stretched my arms did some yoga type moves trying to see if being less active the day after the shot maybe had my back a little tight causing the pain.  I chewed two tums thinking that might help to get rid of the pain even though I knew it was worse than heartburn. After 15 mins at 3:15 I woke my husband to let him know it was not going away and that I was not sure what was going on but just in case I did not want to be ridiculous and sit there and have a heart attack. I'm not one to run to the doctor, I'm very healthy but thought to myself this may be more serious.  My husband ask about calling for help and I said lets just see what happens and just know if I need help then you at least know my symptoms now . I woke the next morning and felt much better and made a joke about all the crazy people being right stating "they are trying to kill us"  Later in the week on Thursday playing tennis I felt me left arm going numb, I shrugged it off to hitting the ball hard and it never crossed my mind about anything else. Two weeks to the day on Sunday Morning I woke with a migraine that made me feel I was going to throw up.   The news just came out about J& J and the few family members that knew about my adverse reaction urged me to report and go to the Dr.   I'm currently dealing with a bruise (I usually don't bruise badly) on my left front chin- I could have hit it on something who knows but it has been there now over a week.
1 week after the vaccine/injection, the injection site became raised, itchy, and hot to the touch. It remained itchy for a few hours (did not take medicine). It remained red and hot to the touch for 6 days. While it is no longer red or hot to the touch, there is still skin discoloration that covers the same area that the redness and heat did (about a 1.5-2inch area).
Left deltoid remained red, bruised, swollen upper 1/3 arm. Rash locally.
tongue and face swelling occurring on 5/7/21.  shortness of breath and chest pain 5/8/21.   Confirmed pulmonary embolus and left lower extremity DVT on 5/11/21-5/12/21
Following day after vaccine pt felt feverish, body shakes, nausea dry heaves and weakness.
After the first shot, very tired all day. Slept 3 times, a little headache, minor arm pain at spot of injection. Felt lethargic the next day, by the third day I was fine.  After the second shot, a little tired, less than after first shot. No other symptoms. By night time I was fine.
Pain in left shoulder; Nausea; Sleepy; excruciating headache; hot and cold; dizziness; sore/achy body; This is a spontaneous report from a contactable consumer or other non HCP. A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 17:00 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included known allergies to pollen. There were no concomitant medications. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. On 11Mar2021 at 07:45 AM, the patient had pain in left shoulder along with mild Nausea, Sleepy, excruciating headache, hot and cold, dizziness and sore/achy body. The patient not received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  Subjects received doses of Flulaval from 25 September 2007 to 27 September 2007 in either the right or left arm.  This subject developed redness, itching and warmth to the touch at the injection site on a date 25 September 2007 to 27 September 2007.  At the time of reporting the events were resolved.  Six subjects experienced these events.  The physician recommended that the subjects take Tylenol and use cold compresses.
she had intense itching at vaccine site that progressed to general body within 1 min of vaccine. 3 hrs later she developed chills, body aches, severe fatigue, nausea, and explosive diarrhea along with redness, swelling, increase warmth, and tenderness at injection site.
Expired Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received HAV (Havrix adult) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 31-AUG-2022 Reporter's Comments: The reporter was the office manager.  The reporter reported accidentally administered expired Havrix to a patient which was expired on 9th August 2022.  The reporter reported patient had not reported any adverse reactions. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
1st dose of the Pfizer-BioNTech Covid-19 Vaccine on January 25, he tested positive for Covid on the 1st or 2nd week of February; 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on January 25, he tested positive for Covid on the 1st or 2nd week of February; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. It was reported (by a Pharmacy Technician) that after their patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 25Jan2021, he tested positive for Covid on the 1st or 2nd week of Feb2021. Due to this, he missed his original schedule for the 2nd dose. Now, he has already recovered and is scheduled to receive the 2nd dose tomorrow. However, this would already be 49 days after his 1st dose. The reporter wants to know if that is still acceptable. The outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient develops mild transient edema of left wrist on day of vaccine, the next day she developed mild edema in left ankle, 3 days after she develops slight swelling of left knee and lips as well as erythema multiforme rash on abdomen, arms, legs, and buttocks. Patient seen in doctors office 3 days following vaccine and still had slight swelling of left knee, other edema had resolved. Also had the rash still present on exam.
Pain, redness, inflammation on area of injection (left arm). Fever - 39 degrees. Dx. Cellulitis Tx DURICEF 500mg bid x 7 d.
Red and swollen upper arm, chills, body aches, headache, fatigue, blisters in mouth and throat, nerve pain on sides of face and in ears, sore throat.
Symptoms: Redness, swelling, warmth, pain to deltoid. Treatment: Saw APRN, who prescribed Loratadine daily and cold compresses today.
Patient states she had the COVID vaccine on February 15th and noticed since then her left arm feels tired and now has a tremor On February 16, 2021 her neck became stiff and she has been seeing a chiropractor and massage therapist for several visits.  Her last chiropractic appointment was this morning and her last massage a few days ago. Her neck is stiff mostly in the morning which decreases during the day.  She denies any fever or chills or recent URI symptoms
There were no adverse events at the time of vaccinations were given. We will be following up with the baby over the next couple of days (daily) to make sure he is doing okay.
Scratchy throat, difficulty swallowing.  Denies difficulty breathing.  Resolved after monitoring, rest, and water given.
he had high fever of 104; vomiting; headache; He was in bed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's disease" (unspecified if ongoing); "Neck Fusion" (unspecified if ongoing), notes: it has been 3-4 years since he had the Neck fusion.; "had covid virus", start date: 18Nov2020 (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for sjogren's syndrome; PREDNISONE taken for sjogren's syndrome. The following information was reported: PYREXIA (non-serious) with onset May2021, outcome "unknown", described as "he had high fever of 104"; VOMITING (non-serious) with onset May2021, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "headache"; BEDRIDDEN (non-serious) with onset May2021, outcome "recovered" (May2021), described as "He was in bed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On an unspecified date in may2021, the patient underwent lab test for Body temperature and result was 104 degrees. On 03Aug2021, the patient underwent SARS-CoV-2 test and result was negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large, raised, red reaction on the arm where the injection site was. Area was warm to the touch and painful for a day or so.
8:00pm Chills began, 9:00pm Fever of 100.3, muscle aches and joint pain began during the night, 3:30am 100.7 fever. Most of 4/27/21 fatigue and occasional chills.  Took Tylenol and Ibuprofen,  water/Gatorade
Pt recvd vax & had an intraoral herpes outbreak most likely simplex type I but poss zoster; tx Zovirax prescribed for herpes zoster;
This spontaneous report was received from a consumer referring herself as a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (MRK). On an unknown date, the patient was vaccinated with an unspecified shingles vaccine (manufacturer unknown) (dose, units, route and frequency not reported) (lot# and expiration date not reported). On an unknown date, patient's pharmacist advised her to receive another dose of the shingles vaccine (manufacturer unknown) (Circumstance or information capable of leading to medication error and extra dose administered) because studies showed that one dose of shingles vaccine (manufacturer unknown) is not effective. No product quality complaint was involved. This is one of the report received from the same reporter.
elevated sugar levels: 380mg/dL; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (elevated sugar levels: 380mg/dL) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (elevated sugar levels: 380mg/dL). At the time of the report, BLOOD GLUCOSE INCREASED (elevated sugar levels: 380mg/dL) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood glucose: 380 mg/dl (High) 380.         Concomitant medications were not provided. Treatment information was not reported.
The following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
Patient came in for first COVID vaccine. Given at 0942 on left deltoid. At 0957, patient complaint of having a headache and tingling to her body.  Headache pain at 4/10. Denied any dizziness. Was awake, alert and oriented.
3 days after vaccine on left arm, woke up with large bumps covering right arm. Throughout the day, the rash/bumps worsened and spread over my whole body. That night, aches/chills began. The next day the rash was very severe, red bumps covering body, with it slowly spreading up next onto face. Most concentrated and severe on stomach, sides, upper thighs and creases of knees, buttocks, elbows. That day, aches and chills were severe  and could not get out of bed. Heavy chest occurred later that day. These symptoms lasted 2-3 days, with the rash lasting over a week. Doctor prescribed oral steroids (30 pills total) to get rash under control.  Also had lack of appetite and bad headaches
April 15 about 5 minutes after vaccination I noticed my left hand was going numb and They asked me to wait 30 extra min for observation during that time my face started tingling they said to go home and take Benadryl at home my foot started to feel numb I called an urgent care and they said to go to an ED were they only did an cat scan to rule out a blood clot then they sent me home.  I'm still experiencing  symptoms some heavy breathing fatigue and muscle fatigue and the the tingling.
COVID-19 booster vaccination on 11/17/2021. Admitted to hospital 11/20/2021 with multiple embolic infarcts. Treated with anti-platelet therapy.
Short after receiving vaccine pt developed some bruising and a lump about 1 in in size, there was a small amount of blood after injection, put a cotton ball on site of injection with some pressure and then gave pt ice pack to put on site, seemed to help reduce swelling although not completely gone after 20 min, no other symptoms.
Patient presents to the emergency department on 6/1/21 with right flank pain that started the day before. Pain radiates up into his right shoulder. He states he has had nasal congestion for the last month. Did develop a cough on 5/31/21 as well. He denies any fever or chills. He denies any dysuria. No hematuria. He denies nausea or vomiting. No abdominal pain. Denies any diarrhea. No bloody or black stool. Denies palpitations. No swelling in his extremities. Denies any anterior chest pain. The history is provided by the patient.   Treatment -Xarelto 15 milligrams twice a day for 3 weeks. PCP will discuss ongoing therapy after initial 3 weeks, when dose will change.  PCP, NP called to report potential adverse reaction from vaccine.
red itchy rash on arm at injection site; Very red rash; Very painful; Itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (red itchy rash on arm at injection site), INJECTION SITE RASH (Very red rash), INJECTION SITE PAIN (Very painful) and INJECTION SITE PRURITUS (Itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lactose intolerant. Concomitant products included FAMOTIDINE (PEPCID AC), ZOLPIDEM TARTRATE (AMBIEN), ZALEPLON (SONATA ADAMED), ASCORBIC ACID (VITAMIN C ACID), COLECALCIFEROL (VITAMIN D 3) and FISH OIL (OMEGA 3 COMPLETE) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE RASH (Very red rash), INJECTION SITE PAIN (Very painful) and INJECTION SITE PRURITUS (Itchy). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red itchy rash on arm at injection site). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. On 06-Feb-2021, VACCINATION SITE ERYTHEMA (red itchy rash on arm at injection site), INJECTION SITE RASH (Very red rash), INJECTION SITE PAIN (Very painful) and INJECTION SITE PRURITUS (Itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional info received: concomitant medications updated, current condition updated
Not an adverse event.  Janssen SARS-CoV-2 Vaccine given to a 17 year old patient.
No ADR's. Pt did not disclose that he had Jannsen covax prior togetting Moderna. After vaccination, his mother revealed he already got JNJ. I stated that had I known, we are not able to provide shot of Moderna. He misinterpreted my question of is it your 1st shot as is it your 1st Moderna shot. They were aware there is no data per his MD. He asked if he needs to return for 2nd shot. My answer was we don't know
Left Bells palsy abrupt onset on 6/21. House Brackmann scale 5 (severe dysfunction absent forehead movement, incomplete eyelid closure, no movement of the mouth
Patient returned after immunization day 3 DTAP and IPV.  Patient began rash to site 2 days ago.  No complaint of pain only itching, mild erythema to left deltoid region approximately 3 cm x 3 cm.  Treated with warm compress, Tylenol, Benadryl cream.
Initial report received on 14Jul06 from a health care professional. A 27 yr old female pt with no current illnesses, and no significant medical history, who had exposure to a bat had received a series of Imovax Rabies vaccine, lot number Z0313-1, on 23Jun06, 24Jun06, 25Jun06, 29Jun06 and 06Jul06. The routes and sites of admin were not reported. 15 days post immunization with the first injection of rabies vaccine, the pt experienced visual changes, and fluid in the retina of the right eye. She required medical evaluation and was subsequently diagnosed with neuroretinitis. Per the reporter, the pt's vision eye chart result was 20/20 vision. Treatment for the neuroretinitis was not reported. The recovery status of the pt was reported as not recovered. (OMIC)
Within 15 minutes: Dizziness, light headed, seeing stars, blurred vision, racing heart rate.  I thought at the time I was having a panic attack. I tried to slow my breathing and relax. It did not help any. I monitored my Heart rate on my watch. My EKG said my heart rate was high and marked 138 at one point while at rest when my average resting rate is 52.   By the time I walked to my car I felt chest pain and pain in my neck. It was a tightening and burning.  In my car, at 1:25 I took antihistamine in a 24 hr dose of Claritin and an inhalation of OTC Flonase.   I felt my body calming slightly, but not 100% returning to normal. I alerted my Dr. and she agreed I should not have the second dose without first taking an otc antihistamine and also having an epi pen on hand.   I stayed with a friend so I was not alone, and continued to rest.  At 6:12 i tried to move around and my hear rate shot back up to 132. I sat back down.  At 9:30 I still have pain like I?ve been punched really hard in the chest.
Patient came in for a flu shot, the wrong consent form was given to the pharmacist marked that the patient was requesting a Covid shot, Pharmacist asked patient if there were any questions, counseled on possible adverse effects, patient did not indicate this was contrary to what he was expecting. Pharmacist realized after giving the Pfizer vaccine that the patient was expecting flu shot.  Made sure the patient was aware of the error and asked if he was ok and did he still want to receive the flu shot,  Patient indicated he was ok and did still want the flu shot. was administered. Patient was observed for 15 minutes at which time he left.
Patient with known history of ventricular arrhythmia s/p AICD placement.  Per patient, no defibrillations in past 5 years. Received second dose of Pfizer COVID vaccine on 3/11 and started to feel ill that night into the following morning. States he felt like someone punched him. AICD monitoring program called patient to notify of defibrillation and sent to ED on 3/12. ED evaluated, wrote for amiodarone, and discharged home. Patient had two additional defibrillations at home and returned for admission 3/13. Patient has had repeat bouts of pulsatile ventricular tachycardia while inpatient. Placed on amiodarone infusion, AICD evaluated and adjusted per cardiology. Remains inpatient as of 3/16 when submitting this report.