chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed spontaneous report (initial receipt: 26-Sep-2011) concerns a female patient, who had a medical history of unknown cancer, chemotherapy that ended last year, 2010, and pneumonia 'in the last month' but more than three weeks ago. Concomitant medication included omeprazole. On 23-Sep-2011 the patient received a flu vaccine as well as one 0.5 mL of PNEUMOVAX 23 (batch number: 1158AA exp: 10-Apr-2013) via subcutaneous injection of immunocompromised status. On 26-Sep-2011 the patient's arm was swollen down to the elbow. She had a fever with nausea and vomiting. On the same day she went to an urgent care where she was given a 3 L normal saline bolus and some antibiotics. She was then sent to an emergency room with a diagnosis of being septic. At some time in Sep-2011, after receiving flu vaccine and PNEUMOVAX 23, she was told it was an aseptic infection. Relevant laboratory data included a temperature of 104.2 and a white count of over 30,000 on 26-Sep-2011. The patient was no longer receiving the PNEUMOVAX 23 and it was unknown if she continued to receive a flu vaccine. Dechallenge was not applicable. The event outcome was unknown.
Prominent left axillary lymph node swelling, was made aware of this after mammogram in April 9th, not appearing before on 2020 Mammo Narrative: Prominent Left axillary lymph node swelling
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing.  I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to  vaccine.  Felt as if my face and lips were swelling  so I took benedry and laid down again and the next morning  when I woke up and my face and lips were super swollen.  But by the 3rd day the symptoms began to subside a little.  By the 24th my HR had balanced out and I only had residual swelling around the eye area.
swollen vaccination site; warmth at vaccination site; tender; became red around the injection site; itching at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at vaccination site), VACCINATION SITE ERYTHEMA (became red around the injection site), VACCINATION SITE SWELLING (swollen vaccination site), VACCINATION SITE WARMTH (warmth at vaccination site) and VACCINATION SITE PAIN (tender) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical history provided.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at vaccination site). On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (became red around the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen vaccination site), VACCINATION SITE WARMTH (warmth at vaccination site) and VACCINATION SITE PAIN (tender). At the time of the report, VACCINATION SITE PRURITUS (itching at vaccination site), VACCINATION SITE ERYTHEMA (became red around the injection site), VACCINATION SITE SWELLING (swollen vaccination site), VACCINATION SITE WARMTH (warmth at vaccination site) and VACCINATION SITE PAIN (tender) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided/unknown by the reporter.    Event treatment: Not specified.
PATIENT CALLED PHARMACY ON 7/31/19 AROUND 1:20 PM, STATED THAT HE STILL HAD SOME SORENESS AT THE SITE OF INJECTION.  HE ALSO STATED THAT HE NOTICED  (2) SMALL DIME SIZED RASH ON STOMACH AND BACK THAT HAD SMALL DOTS, PT DID NOT MENTION ANY PAIN WITH THE RASH, DID NOT SEEM TO BOTHER HIM, HE WAS CONCERNED THAT THEY SHOWED AFTER THE VACCINATION. AND WAS CONCERNED ABOUT SECOND DOSE.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose number unknown, single (Lot number: EL9269), in left arm, on 21Mar2021 as dose number unknown, single (Lot number: EP7534), in left arm and on 21Oct2021 as dose number unknown, single (Lot number: 32030BD) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.   The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Within 3 days after 10 days of isolation from initial contamination; (04May2022) Positive, notes: experienced new symptoms and tested positive. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient did not had any known allergies.  No follow-up attempts are needed. No further information is expected.
Pt. experienced pain originally just with lifting and backwards motion and tingling sensation. Pt. received prednisone therapy, which helped, but pain returned post therapy. Pain is now present (at injection site) with all motion; primary CNP is referring her to musculoskeletal specialist and further testing.
disoriented; dizzy; I felt drunk; Patient was also having paranoid thoughts; chills; nausea; forgetfulness; slightly depressed mood; fatigue; This is a spontaneous report from a contactable consumer(patient).    A 49-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Zn6208), via an unspecified route of administration, administered in arm left on 23Mar2021 (at the age of 49-years-old) as dose 1, single for COVID-19 immunisation. Medical history included OA HTN PMDD (premenstrual dysphoric disorder), food allergy, gluten sensitivity, dairy intolerance. The patient had COVID prior vaccination. Concomitant medication included sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), lisinopril, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE], vitamin c [ascorbic acid], colecalciferol (VITAMIN D [COLECALCIFEROL] (taken for an unspecified indication from an unspecified start date to an unspecified stop date). Patient was not pregnant at the time of vaccination. Patient reported after her first dose, later in the day, on 23Mar2021 at 20.00, the patient experienced disoriented, dizzy, felt drunk. It lasted for several hours. Patient was also having paranoid thoughts. Patient had to ask her husband to pick her up because she did not think she could drive. After that patient had the effects that most people report chills, nausea, forgetfulness, slightly depressed mood, fatigue, etc. The patient received Psych care treatment for the events. On 23Apr2021 patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative (nasal swab). The patient had COVID test post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient describes onset of pain in left shoulder soon after injection; severe, radiating down arm, making it impossible to move arm @ shoulder; then radiating into left breast and upper back. Symptoms have persisted x 9 days now. Also had some chills and gassiness that resolved the next day.
itchy rash on my lowerneck and upper chest.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER-8732) via an unspecified route of administration in the left arm on 28Mar2021 at 13.45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Mar2021 at 13.45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After 3 days of injection, on 31Mar2021, the patient experienced slightly itchy rash on lower neck and upper chest. It was about 2inches x 3inches and spread further upper chest. No therapeutic measures were taken as a result of the reported events.  The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events slightly itchy, rash on lower neck and upper chest was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pain,  arm swelling, fever, chills, fatigue, muscle aches, and headache for 36 hours.
Left arm sore for 1 month after Flu shot. Limited range of motion when lifting arm above head or across body.
Janssen COVID-19 Vaccine EUA I experienced headaches and body aches during the evening of the day I received my shot.  The body aches went away during the night, but the headaches have continued into today
NOT FEELING SO GOOD; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine (unspecified manufacturer) (dose number in series: 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. No adverse events were reported following covid-19 vaccine (dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 24-MAR-2021 for prophylactic vaccination which was off label use for inappropriate schedule of vaccine administered (dose number in series: 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the patient was fine all day. On 25-MAR-2021, the patient experienced not feeling so good (dose number in series 2). The nurse suggested the patient to take Tylenol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling so good, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
First COVID-19 vaccine: little bump on arm; First COVID-19 vaccine: nose bleed; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EP7534, Expiration Date: not reported) intramuscular, administered in left arm on 15Mar2021 as dose 1, single for COVID-19 immunization (at the age of 52-year-old). Medical history included ongoing sjogren's syndrome and ongoing Lupus, its been years since she was diagnosed. This condition was hereditary- her mother, grandmother and her sister had it. She did not take any medication for it , thyroid disorder, allergic to the contrast. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for thyroid disorder. Patient took Synthroid once a day in the morning for her thyroid, but confirmed she was taking this beyond the 2 week time period leading up to her first dose. She had been on Synthroid since she was young, a teenager. Additional Vaccines was not administered on same date of the Pfizer suspect. Patient did not receive prior vaccinations within 4 weeks and had no AEs prior vaccination. The patient experienced first covid-19 vaccine: nose bleed on 20Mar2021and first covid-19 vaccine: little bump on arm on an unspecified date. Investigation Assessment was provided. It was reported that, She just noticed when she had her first dose on 15Mar2021, the nose bleed happened within that week also. On 20Mar2021, she experienced a very bad nose bleed which she was able to get under control after 15-20 minutes. This kind of alerted her because she was not a nose bleeder. But she didn't think anything of it. She stated she left it alone and continued to not think anything of it. She never had that type of experience. She mentioned with the first dose, she didn't get a reaction on her arm. She had a little bump that went away. She felt she needed to report these nose bleeds because she took Pfizer's vaccine and was getting blood clots. The outcome of the event first covid-19 vaccine: nose bleed was unknown and first covid-19 vaccine: little bump on arm was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
One week after vaccine:  Developed a ?palm sized? raised welt around injection site on right arm. It was hot to the touch and itched like crazy (like a yellow jacket bite). The next morning I took 2 Benadryl for the itching and 2 Aleve for inflammation and that resolved the issues within 24 hours. The arm welt went away after 2-3 more days.
MONOCLONAL GAMMOPATHY OF UNCERTAIN SIGNIFICANCE, AN IgM GAMMOPATHY
I had my Moderna done on 04/02/21, about 40 min after I felt like my heart was coming out of my chest and it was very difficult for me to breath. After that from time to time my heart was bothering me, which is unusual. On July 23 I suffered an incident that felt what heart attack would feel like a sharp stabbing pain in my heart. I called 911 and went to ER. Troponing came in clean, do did covid test. After that incident it was extremely difficult for me to breath and I couldn't walk for no more that 20 min without losing my breath. My doctor told me that I have myocarditis and most likely from vaccination. which is inflammation of the heart muscle. It has been a struggle since
Discharge Provider: MD Primary Care Provider: MD Admission Date: 9/4/2022 Discharge Date: Sep 15, 2022  PRESENTING PROBLEM: Pneumonia [J18.9] Pneumonia of left lower lobe due to infectious organism [J18.9]   HOSPITAL COURSE: Patient is a 79 yo female with PMH of oxygen-dependent COPD/asthma, PAF on anticoagulation, chronic diastolic heart failure, essential HTN, chronic pain on Morphine, depression with anxiety and morbid obesity with OSA. She presented to the ED due to increased fatigue and reportedly positive COVID-19 test at assisted living facility. Her spouse also tested positive for COVID-19.    In the ED lab work was notable for mild leukocytosis but patient also noted to be on steroids chronically. COVID-PCR testing was negative and CXR demonstrated left > right bibasilar airspace disease vs atelectasis. She was admitted to the medicine service for sepsis on presentation secondary to PNA   Given prior positive test and spouse having COVID, patient was treated for COVID-19 PNA. She was started on Remedisivir and her home 10 mg Prednisone was increased to 40 mg daily and she completed a ten day course (decadron equivalent dose and duration). She was noted to have a negative pro-calcitonin but antibiotics with Ceftriaxone and Doxycycline were continued as she was immunocompromised being on chronic steroids. She wears 2 liters NC continuously and did not have any significant increase in her baseline oxygen requirements.     She was eligible for clearance from COVID isolation on 09/15/2022.  She had to be out of COVID isolation or have a negative COVID swab prior to caregivers coming back to her assisted living to care for her.  She was discharged on 9/15/2022.   at the time of discharge patient was in good spirits and eager to leave. debility was her only complaint. all questions and concerns addressed, all meds and follow-ups reviewed.
loss of weight/ got down to 52 pounds; very ill/sickness/sick; can't even work anymore; constant nausea; constant vomiting; constant diarrhea; can't eat; can't gain weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 2, single (Lot number: FA6780) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: WEIGHT DECREASED (medically significant), outcome "unknown", described as "loss of weight/ got down to 52 pounds"; ILLNESS (non-serious), outcome "unknown", described as "very ill/sickness/sick"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "can't even work anymore"; NAUSEA (non-serious), outcome "unknown", described as "constant nausea"; VOMITING (non-serious), outcome "unknown", described as "constant vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "constant diarrhea"; FEEDING DISORDER (non-serious), outcome "unknown", described as "can't eat"; WEIGHT GAIN POOR (non-serious), outcome "unknown", described as "can't gain weight". The patient underwent the following laboratory tests and procedures: Weight: can't gain weight; Weight: 52 pounds, notes: got down to 52 pounds.  Additional information: Caller was a patient. Caller mentioned that she got Pfizer covid-19 vaccine Lot number FA6780 on 08Jul2021 (unverified) and she completed the 2 doses required on her job. She said that she was very ill since then, she never had covid, she consulted HCPs but they cannot point out the reason of her sickness, she was still sick and can't even work anymore. She experienced loss of weight, constant nausea, constant vomiting and constant diarrhea for almost 2 years now, got down to 52 pounds, can't eat and can't gain weight. Caller wanted to know the contents of the Pfizer covid-19 vaccine. She also mentioned that her mom had experienced the same symptoms who also received Pfizer covid-19 vaccine (she was not sure which formulation). She also added that she felt like 80 years old even though she was only 53 years old.
Symptoms developed the night of the vaccine. Fever, 100.1, Joint pain, Muscle pain, headache, dizziness (intermittent), chills, feeling unwell, currently taking Tylenol, still has symptoms. Will send to physician
12/31/2021: began experiencing sore throat. Treated with throat lozenges 01/02/2022: began experiencing nasal congestion and headache 01/03/2022: began experiencing cough. Treated with OTC cold medication (Day-Quil/Ny-Quil) 01/04/2022: congestion, cough, and headache became more severe. Also became more fatigued/tired. Received COVID-19, PCR test. Continued treatment of throat lozenges, cold medication and ibuprofen. 01/05/2022: received positive result of COVID-19 test. 01/06/2022: lost sense of taste/smell 01/08/2022: congestion, headache, and fatigue began to subside 01/19/2022: taste/smell began to return As of 01/27/22: cough still remains, at times severe, but not as constant
From initial info received on 7/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 36 year old female pt, who had stepped on a nail, received a dose of TD ADS ADULT, lot U0998AA, IM, in the left arm on 5/10/04. An unspecified amount of time after immunization, the pt started having arthralgia. Reportedly, she tried over the counter treatment. She was seen in the office on 7/2/04 and started on Vioxx. At the time of the report, the pt's recovery status was unknown.
About 3 min. after vaccines given, pt. vomited and hive noted to (L) thigh under MMR injection site. No resp. distress. BENADRYL given as ordered (12.5 mg po). Pt observed 20 min, no distress, no further hives.
Acute respiratory failure due to COVID-19 (CMS/HCC) SOB Severe sepsis (CMS/HCC) Hyperlipidemia  IV remdesivir IV dexamethasone
Vaccine was given in the ED because the employee had a history of allergic reaction to shellfish. She reported feeling like her throat was closing up and she was having shortness of breath soon after receiving the Covid vaccination. By the time the physician evaluated her she reported her symptoms had resolved. She was observed in the ED for an hour with no return of any symptoms. No medication or other treatment was required.
VIRAL INFECTION WITH SORE THROAT, RUNNY NOSE, COUGH, EAR PRESSURE, FATIGUE, MILD FEVER. TREATED AT HOME WITH OTC MEDICATIONS FOR 17 DAYS. SAW NURSE PRACTITIONER AT 17 DAYS DUE TO PERSISTENCE OF SYMPTOMS. THREE COVID SELF-TESTS AND ONE TEST AT NURSE PRACTITIONER OFFICE WERE ALL NEGATIVE. INFLUENZA AND STREP TESTS AT NP OFFICE WERE ALSO NEGATIVE. PRESCRIPTION FOR ANTIBIOTIC DOXYCYCLINE WAS ISSUED AS PRECAUTIONARY MEASURE. SYMPTOMS HAVE IMPROVED, BUT NOT YET RESOLVED COMPLETELY. NOT LIKELY RELATED TO COVID VACCINE.
This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EJ1685), on 09Jan2021 as dose 2, single (Lot number: EL128), on 30Oct2021 as dose 3 (booster), single (Lot number: FF8841) and on 21May2022 as dose 4 (booster), single (Lot number: WA7478) at the age of 53 years for Covid-19 immunisation. The patient's relevant medical history included: "Asthma, that is why I took Paxlovid in the first place" (unspecified if ongoing), notes: Asthma, that is why I took Paxlovid in the first place; "Allergies: Sulfa" (unspecified if ongoing), notes: Allergies: Sulfa. Concomitant medication(s) included: Breo Ellipta; Montelukast; Prilosec [Omeprazole]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Negative, notes: I had a negative test on Day 5 after starting the medication; (09Jul2022) Positive, notes: On day 11, my test was positive again; (15Jul2022) Negative, notes: I am finally negative today on Day 7 after my rebound. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: I had a negative test on Day 5 after starting the medication and went on with life. On day 10, I started to feel badly again. On day 11, my test was positive again. (Rebound). I was much sicker than the original illness (bad cold so not serious) I am finally negative today on Day 7 after my rebound. The patient received treatment for the event with Paxlovid on 29Jun2022, stopped on 03Jul2022. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
PATIENT RECEIVED 2ND DOSE OF SHINGRIX DURING THE DAY AND STARTED TO EXPERIENCE ADVERSE REACTION AT NIGHT ON THE SAME DAY. SHE HAS BEEN EXPERIENCED NAUSEA, BODY ACHES, STOMACH UPSET AND RASH NEAR THE INJECTION SITE. THE RASH WAS WHAT CONCERNED PATIENT THE MOST AND IT INITIATED THE PATIENT TO CALL THE PHARMACY. THE RASH (AS DESCRIBED OVER THE PHONE) IS ON HER LEFT DELTOID, CLOSED TO THE INJECTION SITE, DOES NOT ITCH BUT PAINFUL TO TOUCH.