chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had BEXSERO 6-26-17 left deltoid. Pain to left arm that night and swelling. Warm to touch today.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Patient fainted immediately after vaccine and had a convulsion when coming to-Medium
Starting in December, I started experiencing swollen in my left hand. It would come and go but I did not seek medical care right away. I started receiving shots and has started having unexpected knee swollen. I received a ultra-sound to see if there were any blockage and there was no blockage. My left hand got progressively worse over time and I was not able to make a fist or flex my hand. It was also causing nerve pain. I received a diagnosis of rheumatoid arthritis. I was giving a steroid to reduce the swelling. The swelling and nerve pain has not went away. I am unable to perform normal duties because of my hand.
Approximately 1 hour after receiving the flu vaccine I felt tightness in my airway chest and had wheezing. I took 75mg of Benadryl and used Albuterol inhaler. I continued to monitor symptoms and continued to experience them despite high doses of antihistamines. 4 days after injection I developed a rash on my neck and shoulder on the same side as the injection site. I reported this to the Employee Health RN and was asked to then see my primary care physician. Because of the time of day I reported to a local Urgent Care clinic and was treated with 40mg predisone x5 days. The day following the acute care visit I developed hives on my chest and bilateral arms.
Pt. developed large local reaction on lt deltoid after Hib vax; erythema, non tender-no signs of infection.Seen in office 2 days later; swelling resolving.
Delirious; Severe flu like symptoms; Unable to use the cell phone; Joint pains; Temperature of 101.2 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Chronic pain, Hypertension and Hyperlipidemia. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and GABAPENTIN for Chronic pain, FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression, ATORVASTATIN for Hyperlipidemia, LOSARTAN for Hypertension.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Severe flu like symptoms), IMPAIRED ABILITY TO USE MACHINERY (Unable to use the cell phone), ARTHRALGIA (Joint pains) and PYREXIA (Temperature of 101.2 F). On 16-Apr-2021, IMPAIRED ABILITY TO USE MACHINERY (Unable to use the cell phone) and PYREXIA (Temperature of 101.2 F) had resolved. On 17-Apr-2021, DELIRIUM (Delirious), INFLUENZA LIKE ILLNESS (Severe flu like symptoms) and ARTHRALGIA (Joint pains) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Pyrexia: 101.2 degree f (High) 101.2 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included ibuprofen for joint pains.  Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.
About 6/10 or 6/11 mother noted a hard, red area on left lateral proximal thigh which increased to several inches in diameter by 6/13/04. Patient refused to walk. Seen by me on 6/14/04. 3cm erythema and induration with 3 approximately 0.5cm darker, red areas centrally. Patient ambulatory and afebrile.
pt recv ax 3NOV97 & 2 days later on the 5th of NOV lt tender area;mild lt clavicle;no fever, no aching, no n,v,d;small tender bruise lt arm, negative redness;
receiving the Pfizer vaccine series and COVID 19; receiving the Pfizer vaccine series and COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "receiving the Pfizer vaccine series and COVID 19".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300106905 same patient/reporter; different dose/AE;
Patient received Pneumococcal Pneumovax vaccine IM right deltoid lot #0605R. Called 12/22/05 to report right arm swelling, heat, itching, underarm pain. Advised patient to take allegra and ibuprofen. 12/23/05 called patient. Patient doing better, pain gone, swelling improved.
Chills, body aches, dizzy, migraine, vomiting, low grade fever, neck pain. Took Tylenol and Advil to relieve the pain.
Pt with ETOH w/drawl - tachycardia, trembling & also poss sx 2nd to recent COVID Vaccine yest @ facility. Pt admitted & symptoms dx - vaccine Rxn vs. ETOH w/drawl. Pt admitted to Medicine ward
Extreme sweating (pools on the floor), dizziness, nausea, overly extreme stomach cramping, diarrhea & throwing up, low heart rate (58), low temp (95.6)
Dose given too early, dose one 12/19/22 second dose given 1/10/23 (requires 28 days between doses)
This spontaneous report was received from a physician, via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JAN-2016, the patient was vaccinated with a dose of ROTATEQ, "2ml, 10 unit dose tube", lot # K020183, expiry date: 25-JUN-2016, orally, which was improperly stored at 1.11 Celsius Degrees (34 Fahrenheit) for 24 hours and 8.88 Celsius Degrees (48 Fahrenheit) for 32 hours. The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient passed out after covid 19 vaccine(Pfizer). she woke up within a moment.
Dizzy,extreme tiredness,diarrhea, vomiting, body aches, lymph nodes in right under arm swollen (and still after four days) all symptoms lasted approximately 36 hrs except the swelling
Approximately 9  hours after vaccine administration patient had small hives on right arm. Hives grew worse and spread to both arms, abdomen, bilateral legs, face and neck. 24 hours later she called telehealth and was placed on OTC antihistamines. On Monday ( 4 days after injection) morning she called me (employee health) and was sent to provider for continued hives and  itching. She did not have any difficulty breathing or airway problems. The provider gave her a course of Prednisone to taper and Vistaril for itching. Today, (7days after injection) she is doing better and reports condition is improving.
Asymptomatic Breakthrough COVID-19 case. Hospitalized 8/24/2021-9/3/2021. Patient lives with his sister and she is his caregiver. Sister states PUI had no Covid related symptoms. She took him to the hospital because of low BP and dehydration. Sister states that Patient has only 20% of his colon and its very normal for him to have low BP and not eat as much. Sister suspects that exposure to Covid was within the hospital as he was admitted on 8/12/21 also for dehydration.
Initial unsolicited report received from nurse on 25-Oct-2017. This case was linked to 2017SA210257 and 2017SA210270 (same reporter, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with 0.5 ml dose once of FLUZONE QIV (Batch number: U5896CA, expiration date, dose was not reported) via intramuscular route in right deltoid on 21 Oct 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced softball size bump in deltoid. Lab data was not reported. The patient received corrective treatment with Tylenol. The patient's event outcome was not reported. List of documents held by sender: none.
On 6/28/99, at 10:00 AM, the pt began to experienced pain at the injection site, stiffness, swelling, erythema, arm spasm, mild tingling into the tips of the fingers and the inability to raise arm. Outpatient treatment was required. He was treated with Darvocet, Motrin, and war soaks. He was to rest and elevate the right arm. He was to support the right arm with pillow under the arm when he sleeps tonight. He was taken off work today.  He was advised that if he chose to continue with the Lymerix series, he may experience similar muscular difficulties with the next injection, but that may be able to subdue some the the muscle difficulties by pre treating himself with some Motrin, and Tylenol prior to his injection and then following the injection with warm soaks within a few hours of injection.  7/28/9, the diagnosis is a localized reaction to Lymerix injection to the mid right deltoid.  As of 7/29/99, an MD observed that the pt still had some minimal tenderness localized at the injection site. There was no swelling, no erythema, no ecchymosis, no increase in warmth. He showed full range of motion in the shoulder, neck and elbow. Good grip strength. He showed some very minimal tenderness for forceful humeral abduction and humeral flexion. The remainder of humeral range of motion was without difficulty and within normal limits.  The reaction resolved in less than two days.  The most recent information received on 9/9/99 reports the condition of the pt is resolved.
It is complicated because I also at the same time, had another infection. Which was a tick borne infection. This infection sent me to the hospital and that is why they were investigating further, so they noticed I had blood clots. I had a heart procedure at the hospital on June 10 2021 - a Tavr (aortic valve replacement). While I was there they gave me an injectable drug called Lovanox on the 10th and 11th. I was able to walk and do things when I went home, then I started to run a fever and went back to the hospital for 3-4 days for observation. At home I ran a fever again, I went back to the hospital and they ran tests. My platelets ran extremely low and then they did blood testing and saw I have something called HITT. HITT as I understand it is a condition where a Heparin injection attacks platelets and cause clots in the body. I still have the condition until those antibodies clear out of my body and I do not know if the vaccine of Moderna was a reasoning for this at all, but it is possible.
PREVNAR 13 inadvertently given orally instead of IM as advised. Pt given PENTACEL IM at the same time. Pt mother stated later that day pt had 2 episodes of diarrhea and 1 episode of vomiting. Pt mother denied any other symptoms and stated pt is "fine" today, 05/09/12.
Sudden onset of a cough, fatigue and eyes swelling and difficulty breathing approx. 4 hrs. after vaccine administered.
Chills; Swelling in my arms, legs, feet and ankles and its getting worse each day (over the last 3 days); I'm starting to feel a tingling in my feet I feel like it's gone to sleep and its going into my leg; Runny nose; Swelling in my arms, legs, feet and ankles; Swelling in my arms, legs, feet and ankles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 08Apr2021 (at the age of 72-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 20Apr2021 Tuesday, the patient started having swelling in her arms, legs, feet and ankles and it got worsened each day (over the last 3 days). Patient felt tingling in her feet, felt like it is gone to sleep, and it is gone into her leg. She enquired whether this was normal and how long would it last. Patient also reported runny nose and chills. She was supposed to have surgery on 12May2021 and hoped this would resolve by then. The clinical outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female with penicillin and sulfa allergy and a history of knee surgery and tube placed in her ear as a child who in March 2008, was vaccinated with a first dose of GARDASIL 0.5 mL and in May 2008 was vaccinated with a second dose of GARDASIL. The reporter was unaware if patient received her third dose. Concomitant therapy included "birth control". On unknown date, the patient experienced seizures. It was unknown after what dose seizures occurred. The patient sought unspecified medical attention. At the time of reporting, the outcome was unknown. Upon internal review, seizures was determined to be an other important medical event. Additional information has been requested.
Initial Back Pain, Partial Paralysis, Hospitalized from 9/18/2015 through 9/26/2015. Diagnosed with Acute Transverse Myelitis. Given Intravenous Steroids for days. Had rehab therapy for about 3 months. Still have numbness and back pain.
Fainting and emesis. Patient fully recovered. Monitored for an additional 15 minutes
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Shingrix for prophylaxis. On 17th September 2018 11:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th September 2018, less than a day after receiving Shingrix, the patient experienced pain in arm, felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever, muscle pain and nausea. The patient was treated with ibuprofen and Tylenol. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever and muscle pain were recovered/resolved and the outcome of the nausea was recovering/resolving. It was unknown if the reporter considered the pain in arm, felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever, muscle pain and nausea to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient reported the soreness went from her upper arm to her hand. In September 2018, the outcome of the felt faint, cold sweat, tiredness, shivering, diarrhea, headache, fever and muscle pain were resolved. The patient planned to follow up with her physician on an unknown date. The contact details of the physician were provided.
Patient received his COVID-19 mRNA vaccine #3 (booster) on 11/16/2021.  The following day (11/17/2021), he noticed weakness of both legs, such that he had difficulty lifting his legs to get into his work truck.   The weakness progressed over the next few days to the point that even walking was difficult, necessitating use of a walking cane.  When standing, he feels a cramping discomfort in the posterior pelvis.  MRI of the entire spine was performed, demonstrating multilevel degenerative disc disease.  There are no imaging findings to account for his presentation.    Cerebrospinal fluid shows albuminocytologic dissociation.  He was seen in consultation by neurology.  He has reflexes on exam, and it is felt that we are seeing him early in the course of Guillain-Barre Syndrome secondary to the COVID-19 mRNA vaccine, with progressive bilateral lower extremity weakness starting 1 day after administration.  He was treated with IVIG.
Patient vaccinated x 2 with moderna. Inpatient hospitalization Syncopal episode and chest pain.
4x6cm red, swollen deltoid 72hr p/vax given;Motrin was prescribed for pain, swelling;
a week after both COVID-19 vaccinations (Pfizer) patient had sudden onset of shortness of breath and chest pain with extreme fatigue and malaise. This happened for 3 days after 1st vaccine. Recovered 90%. Same symptoms onset a week after 2nd COVID-19 vaccine but symptoms were a little worse and did not resolve
The only symptom that I noticed was a lot of pain in my joints, especially in my right hand. after three days symptom disappeared.
I had a bad reaction to both Moderna vaccines in the 2-shot series.  I had bouts of Tachycardia and felt out of breath at times.  So when I decided to get boosted I went with the Pfizer vaccine.  But, unfortunately, same reaction--Started getting episodes of Tachycardia.  My resting heart rate went to 145 bpm.  My normal resting heart rate is usually around 60 bpm.
Redness size of quarter and swelling size of apple. No red streaks, no fever.
had shingles and was vaccinated/Suspected vaccination; had shingles in her heart; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles and was vaccinated/Suspected vaccination ) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles in her heart). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-Mar-2023 The case was received from the patient's children via interactive digital media. The patient had shingles in her heart, even though she was vaccinated. The physician said she would of had a severe case of shingles if she was not vaccinated. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
rash on the arm at the site where the vaccination was given; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on the arm at the site where the vaccination was given) and VACCINATION SITE ERYTHEMA (injection site redness) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on the arm at the site where the vaccination was given) and VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, VACCINATION SITE RASH (rash on the arm at the site where the vaccination was given) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
local pruritus, erythema, swelling @ inj site 3 hrs p/vax; swollen, red ext ears, hives; given DPH
Warm, non-tender area of erythema over right deltoid measuring 10cm longitudinal by 7.5cm width.
After patient had his vaccines, I nursed him and he fell asleep. We left the office and he stayed asleep in his car seat for 4 or 5 hours. He never slept that long. After he woke up, he cried all night long. Screamed. We gave him tylenol and he just kept screaming. We comforted him the best we could and eventually he fell asleep and had very disturbed sleep. We believe he suffered from encephalitis.
A wave of dizziness; Burning sensations all through my body; Tingling pins and needles feeling; Numbness; Severe weakness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 08Apr2021 at 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included Bi-lateral cochlear implants and congenital deafness. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included pseudoephedrine hydrochloride (SUDAFED), taken for an unknown indication from an unknown date and unknown if ongoing. On 14Apr2021 at 19:45, 6 days after the vaccination, the patient experienced a wave of dizziness, had burning sensations all through her body, tingling pins and needles feeling, with numbness and severe weakness. The patient felt like a wave that overtook from head to feet which required her to call 911 with an ambulance ride to the Emergency Room (ER) and after ruling out several things, the patient believed that it might be a side effect from the vaccine and still had lingering side effects 3 days after visit from ER. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 14Apr2021, the patient underwent COVID-19 rapid test (nasal swab) and the result was negative. The clinical outcome of the events dizziness, burning sensations all through body, tingling pins and needles feeling, numbness and severe weakness were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
No additional AEs; HCP calling to report that MMR II was administered today 10/13/22 past its lot expiration date of 10/08/22 and requesting guidance.; This spontaneous report was received from a nurse and refers to a 12-month-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 13-OCT-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 ml/once, lot #T034392, expiration date: 08-OCT-2022, administered for prophylaxis (route of administration was not provided) (Expired vaccine used). No additional adverse event were reported.
Tachypnea, CoughWheeze, experienced s/s asthma per noted, and red face,hot skin, seen in local ED , treated with IV antihistamine, nebulizer treatments and oral prednisone Narrative:  experienced s/s asthma per noted, and red face,hot skin, seen in local ED , treated with IV antihistamine, nebulizer treatments and oral prednisone. released after 4 hours