chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Directly after receiving vaccine pt became disorriented for approximately 15 seconds and then had syncopal episode for approximately 60 seconds., pt was layed down. EMS called initial BP 92/69 P- 58 with pt awake stating this happens everytime he gets any vaccine. After continued observation Bp 123/80 P- 64 and pt stating he feels fine. Pt taken to high obs for additional 30min obs and released.
The night, post vax, his right arm began swelling with redness and pain at injection site. On 8/3/00, RX cold compresses, ASA.
Developed highly pruritic rash which progressed from neck to entire body. MD prescribed Prednisone and Benadryl too. Rash lasted 4 days.
minor injection muscle site tightness & pain; minor injection muscle site tightness & pain; fevers; muscle aches; shortness of breath; lung pain; severe swelling; pain in my neck&shoulders; pain in my neck&shoulders; fatigue; On April 6th, I tested positive for Covid; The patient received the Pfizer unspecified vaccine on the same date (28Mar2021).; This is a spontaneous report from a contactable consumer (patient).   This is the 1st of 2 reports, for the 1st dose.   A 59 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 13:00 (Lot Number: ER8737) at age of 59 years old as single dose for covid-19 immunisation.  The patient received the Pfizer unspecified vaccine (lot number=ER8735, dose number 2, vaccine location=Left Arm) on the same date (28Mar2021).  Medical history included restless legs syndrome, poison ivy (severe allergy to poison ivy). Concomitant medication(s) within 2 weeks of vaccination included clonazepam 0.5mg. Reported Event: "I had my first shot in my left arm on March 28th. I only had minor injection muscle site tightness & pain that resonated down my left arm for 2-4 days. On April 6th, I tested positive for Covid (Nasal Swab) and experienced fevers, muscle aches shortness of breath, lung pain, severe swelling & pain in my neck & shoulders which persisted until April 16th. I had a second COVID PCR test on April 16th (Nasal Swab). which was also positive. I also have experienced severe fatigue since the onset of Covid on April 6th with only mild relief coming over the last few days beginning on May 1st." Adverse events result in Emergency room/department or urgent care, patient recovered with lasting effects, and no treatment received for events. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome for events was Recovered/Resolved with Sequel(except for Product use for unapproved combination).  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497277 same patient, same drug, different AE, different dose of vaccine.
Patient received varicella #1, Hep A#1 and DT #4 at his 18 month physical.  He developed a mosquito-type rash within 24 hrs.  Mother took him to ER where he was diagnosed with hives.  I saw him 5 days post vaccines and his rash had resolved.
Patient exhibited no reaction during administration, but then commented that it burned inside his arm.  This continued through 15 min onsite. Checking in with patient via phone call later, he reported it had resolved in about 1 hour after administration.
Notice rash under Rt Breast on Sunday night , red itchy irritated. took Benadryl and use hydrocortisone cream to area, Monday morning rash was the same, Monday evening rash spread to my back on the right side.  Tuesday Morning went to Doctors office and was Diagnosis with shingles.
Pt had a 2-day history of abdominal pain, nausea, and vomiting.  She has dyspnea on exertion and orthopnea.  Pt admitted for acute hypoxic respiratory failure and COVID-19 pneumonia.
She got her vaccine, the next morning she was hearing echoing in her left ear while speaking and then a whistling sound.  It lasted all day on the 14th.  On the 15th she did not have that issue anymore.  Then on 4/20/22 starting at 2-3:00 AM a loud ringing in her ear awoke her from her sleep.  It was in both ears and now predominantly in the left, still ongoing every day.  She went to two doctors since then on 4/25/22 and then yesterday, 5/12/22 she went to two audiologist and they have confirmed that she has tinnitus.  She does not listen to loud music, is not around loud noise and has no trauma to her ears, and believes that this is tinnitus is from the booster shot.  She is healthy, has never had any problems with her ears ever, never even had an ear infection.   Her hearing tests were normal, but she still has the ringing in her ears.  She asked if there was anything that could be done surgery wise, was told no.  She was given some anxiety medicine (Ativan) to calm her, but she is not taking it due to it's adverse reactions.  She has been taking Lipoflavinoid and is hoping that this will go away.    Yesterday she went to the VA audiologist who did the same tests as the private practice doctor, same results and she is going to recommend a device for calming (white noise), and that should help.  If she gets to a point that it does not go away and she gets to a point that it really too much all the time and then they try some different side effects and possibly a hearing aide to listen the symptoms.
sore; tired; arm hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little bit), PAIN (sore) and FATIGUE (tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, METOPROLOL, SITAGLIPTIN PHOSPHATE (JANUVIA), VITAMIN D2, DIAZEPAM and LEVOTHYROXINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit). On 13-Mar-2021, the patient experienced PAIN (sore) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (arm hurt a little bit), PAIN (sore) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking blood thinners. No treatment medicines were provided.
No adverse event.  CDC advised to give everyone Moderna Bivalent vaccine and didn't release guidance regarding  which vial or dose until after the vaccine was given.
chills; fever; general body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (general body aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for an unknown indication.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (general body aches). At the time of the report, CHILLS (chills), PYREXIA (fever) and MYALGIA (general body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Irreconcilable crying for 4-5 hrs /p vax administration; pt was taken to MD who gave her a "shot" & some pain medication
Friday evening pt complained of dizziness followed by hoarseness, headache and weakness. Noticed pale skin coloration. She also complained of SOB, beginning on Sunday evening. Client went to see PMD. No Rx's given.
I received my first shot of Moderna on the 26th of February. No problem, just achy arm, and fatigue. Then almost a week later on the 4th of March, I developed a very itchy round rash around the injection site. It is still red but not itchy today.
Tingling around my left ear started in October 2021.  Bloodwork conducted during a doctor's visit to discuss the tingling revealed an ANA titer reading of 1:640 and elevated liver enzymes.  A liver ultrasound revealed mild coarsening of my liver and a biopsy led to a diagnosis of mild chronic hepatitis that is neither viral nor autoimmune in origin.  My ear tingling continues and exams by an ENT and a brain MRI showed no abnormalities there.  A rheumatologist conducted separate labwork and cannot identify a reason for my elevated ANA titer reading.
Fever over 101 F for about 27 hours. Peaked at 102 F. Muscle and back aches, Chills, headache, sweats. All symptoms resolved at about 46 hrs after the jab.
Temp up to 100 on 3/14. That night developed right upper arm pain and swelling. Pain extended to right axilla. Symptoms worsened the following morning. Also has some warmth in right upper arm.
She got her vaccine, had sore arm and pain and it never went away and getting worse.  She cannot fell her index finger, cannot feel her thumb, and at the elbow area she is growing a knot in that area, ? whether it's a blood clot or not.  She went to the pharmacy and told them about her arm, and they tell her that the symptoms should go away.  She then told her to report it to us.    She went to her doctor and saw them, told her about it a few times, and prescribed some pain medicine which she did not take unless it's really bad, but is not a pill person for pain.  They did not run any tests, and is going to go to a new doctor on Tuesday as her previous provider left the practice.  The pain goes from the injection site itself, and then extends up the back of her neck on the left side like a sharp shocking pain that shoots up to the back of her neck.  It goes up the shoulder to the neck.   She cannot sleep on that side as when she does it feels tired, and feels like it weighs about 100#.  It just hurts all of the time.
Mother reported temperature of 102.9 with nausea 10/06/2005.
10 days following the Moderna booster, the patient developed new onset generalized urticaria that did not respond to prednisone. He has no allergy history. His workup for a secondary cause has been completely negative. He has had several office visits and urgent care visits for this. He is now taking cetirizine, famotidine and montelukast in an effort to control the symptoms, with modest results. He is scheduled to see an allergist in the next month.
patient received first dose of Pfizer covid 19 vaccine, after 5 minutes her friend yelled to us that she wasn't doing well.  We went out and shook her to see if she would come to, after a minute she came to and asked where she was.  we called 911 and emts arrived to check her out and took her out of the store.
This case was reported by a consumer and described the occurrence of renal pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included renal disorder.   On an unknown date, the patient received the 1st dose of Shingrix. On 8th December 2021, unknown after receiving Shingrix, the patient experienced renal pain. On an unknown date, the patient experienced hepatic pain. On an unknown date, the outcome of the renal pain and hepatic pain were unknown.   It was unknown if the reporter considered the renal pain and hepatic pain to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and on the day of reporting (this AM), the patient had extreme live or kidney pain. The patient had a slight problem with kidney and would see urologist this Friday on 10th December 2021, but this pain was extreme. The patient asked that if this normal. The reporter consented to follow-up GSK note- Since not clearly specified, live pain is conservatively considered as liver pain.
Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LEVOTHYROXINE, FUROSEMIDE and APIXABAN (ELIQUIS) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
7/8/15 Employee reports on 6/8/15 for 2nd dose of RECOMBIVAX HB. States he had side effects from first dose and does not wish any further doses. States that within 10 days after 1st dose felt fatigued, spells of dizziness, extreme fatigue and on one particular day his heart was racing the entire day. Had poor nights sleep the night before. States he is getting better the past few days. States he did not miss any work and he has not seen his physician. Referred to primary care physician.
Client received a Pneumonia Vaccine on 11-17-2005 in the right deltoid. (late afternoon). That same evening by 1800 hrs. he developed swelling and severe pain in the right shoulder joint. He went to the E.D. where he was admitted. Fluid was removed from his shoulder that evening in the E.D. IV antibiotics were begun. On Sat 11-19-2005 client went to surgery for more drainage of fluid from his right shoulder joint. Cultures of both fluids were done and were both negative for any growth. Client was released from the hospital on 11/22/2005 apparently recovered. Clients wife reported all of the above information. Client has a history of Chronic Lymphocytic Leukemia. Discharge summary states arthritis of shoulder. msv
Side of neck where shot was administered got numb and stiff, then numbness progressed to side of face, down the entire leg.  Slight dizziness.  Numbness lessened an hour later, but still present.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from Physician Assistant. This case is linked to cases 2018SA269762, 2018SA274507, 2018SA274519, 2018SA274520, 2018SA274523, 2018SA274524, 2018SA274525 and 2018SA274522 (same reporter). This case involves a 65 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via unknown route (site of administration not reported) on 12-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that temp indicator in shipping container did not show a change in temperature- that doses were not viable from shipping excursion, doses were given to nine patients. It was unknown whether patient experienced any adverse reaction after vaccination. 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 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. Documents held by sender: none.
Patient had a #14 weight loss over 4 weeks starting with the first immunization (has never lost that much wt in that period of time).  Pt last colonoscopy showed left sided disease fall of 2020.  He had a colonoscopy 3rd week in May (2 weeks after Covid shot #2) and he had pancolitis.  Pt had worsening of his coliits symptoms within 24 hours of his first immunization.
Client reported on 2/17/21, at approximately 9:30am, she had shortness of breath that started at about 5:00am. Client was clearly in mild respiratory distress. She was able to walk and talk, although those activities exacerbated shortness of breath.  Asked client and spouse if they would like me to call ED; and both declined. Referred to nearest ER. Spouse reported he would take her to the ER. Assisted client to car and client left with spouse driving.
This report describes the occurrence of increased alanine aminotransferase concentrations in a 59 year old female patient who received hepatitis B vaccine recombinant for prophylaxis. This report was received from the patient, who is a physician. The patient's medical history and concurrent conditions were not reported. However, alanine aminotransferase concentration was normal in September 2002. Concurrent medications included celecoxib, which was discontinued on 4/29/03. On 4/29/03, the patient received the 4th dose of Engerix B. The reason for receiving a fourth dose was not provided. At an unknown time post immunization, the patient experienced increased concentrations of alanine aminotransferase to 138. The patient consulted another physician regarding the event. The increased alanine aminotransferase concentrations persisted as of 6/17/03, which was six weeks after onset.
c/o local redness @ site 24 hr p/vax; rash small, red 1/8cm raised papules on lt arm & across chest; rash chest & back
Information has been received from a physician, who saw news on a website, concerning a 5 year old pt, with a genetic defect that made him susceptible to thimerosal, who was vaccinated with a dose of MMR II. Subsequently, the pt developed a developmental problem. No lot number or further info available. Unspecified medical attention was sought. No further info is available. Upon internal review, developmental problem was considered to be an other important medical event (OMIC). In follow up informaiton it was reported that the physician has no personal experience with any patients who have been or who have claimed to have been harmed by measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live or any other vaccine. The physician reportedly saw a story broadcast on the news that linked measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine lvive with thimerosal and developmental delay. No further information is available. Upon internal review, developmental problem was considered to be an other important medical event. Measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live does not contain thimerosal.
On January 20, 2022 I had a runny nose that turned into a cough no fever. I experienced fatigue and I was tired.
gave Moderna Covid 19 vaccine to a 17 year old (not approved under 18).
Daily and multi daily uncontrollable nose bleeds for well over a month,  tried to get a doctors appointment, ever appointment was well over a month out. After over a month of the nose bleeds, I did research and figured out iron might help,  So I started to mega dose iron, one iron pills a day was not working.
Child woke with fever 102.6 rectally, vomited, had seizure and taken to ER.
excursion vaccine was administered with no reported adverse event; Act-HIB for which cold chain break is reported with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Familial Mediterranean Fever is something I already have been diagnosed with years ago. I am not 100 percent sure if one has anything to do with the other just thought it was information that one would appreciate. November 11, I started to have flu like symptoms a fever as high as 102 and to be safe I tested and was positive. November 11, I started to have flu like symptoms and to be safe I tested and was positive. On the morning of the 12th, I went to the ER because I was having difficulty breathing. I was then given a diagnosis of Insomnia was then treated with mononomial antibodies. Within 24 hours I started to feel better, and my breathing was so much better. Still recovering but I still have lots of fatigue.
pt recvd vax & devel fever & high pitched cry; pt was seen in ER w/lt thigh edema; mom gave around the clock APAP over weekend; Monday pt had high fever & dec appetite; CSF WBC 255;
Patient was supposed to receive a Tdap not Td. No adverse events occurred, just wrong vaccine given.
Patient got 2 immunizations  on 11/9/2020 the Fluzone HD  on  right arm & Pneumovax 23  on left arm . Pt is complaining of pain on her right arm only , told her to contact her MD  and she  did. Dr gave her Ibuprofen & Diclofenac .  I just spoke to her again today that's 12/4/2020 to check on her. She said she feels little better today .
started with rash on chest then became itchy everywhere, had shot Friday started benadryl  Monday night
This spontaneous report as received from a pharmacy intern (other) refers to a 61 year old male patient. No medical history and concurrent condition was reported. The patient had a history of drug allergy while on therapy with lisinopril (manufacturer unknown) (case # 1503USA011015). On 12-FEB-2015, the patient was vaccinated with ZOSTAVAX lot # K020801 with the expiration date of 31-JAN-2016, 0.65 ml, subcutaneous. Concomitant therapies included VIAGRA. On 20-FEB-2015, reporter received an electronic prescription from the patient's unspecified physician for an unspecified antiviral medication. The reporter did not know the reason for the prescription for the unspecified antiviral medication. Patient sought medical attention. No intervention to prevent serious criteria was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.