chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reporter states pt did not seroconvert p/receiving Engerix-B series; all injections were administered IM;
2/1/2022 I noticed that my heart rate felt unusual, would skip a beat and then would beat hard. I went to Urgent Care that day and had an EKG. I was diagnosed with an arrythmia. I saw my PCP on 2/16/22 who referred you to a Cardiologist. I started wearing a heart monitor on 2/21/22 that confirmed I had an arrythmia.  I saw my Cardiologist on 3/14/22 and had an EKG that confirmed the arrythmia. I had an Echocardiogram and Stress Test 4/25/22.  It was confirmed that I did have an arrythmia and I was started on Metoprolol and Magnesium Oxide. I seem to be okay on the medication. I still have a mild arrythmia, but the medication has slowed it down.
6cm erythematous symmetric annular almost welt around small visible injection site on left upper arm c/w hypersensitivity reaction
Pt reports that vaccinator put the needle into his shoulder.  He felt a lot of pressure and has had continuous joint pain and can't life his harm since injection.  He has tried ice, heat, and IBU without relief.  He is now seeking care and we will be referring him to orthopedic services.
I started experience muscle, ligament and tendon pain in March of 2022. I went to to see my Primary Care Physician. He ordered many test that were inconclusive. I was referred to a Rheumatologist who ordered test, including a MRI the diagnosis is Axial Spondyloarthritis.
On day 7, a red rash appeared just below the injection site and is indurated, hot, and tender. It spread in size within the next day.
Following my vaccination, I began to experience severe symptoms. These included fevers of up to 104 Fahrenheit (beginning night of), diarrhea which caused me to lose 6-8 pounds (beginning following day), multiple bouts of vomiting, and difficulty breathing at times (both beginning the following day).
w/in 24 hrs p/vax 9OCT92 pt exp an allergic reaction; devel welts over entire body; seen in ER 10OCT; presented to ER on 11OCT & was hospitaized; pt had severe itching @ time of hospitalization;
Pt vaccinated with DTP/OPV/HIB developed large sterile abscess rt thigh, induration 4x4cm, identical to rxn /w lst DTP lt thigh (Report # 26262)
Faver, cold, shivering, shaking, tired. Symptoms started 2 hours after vaccine and dissipated 36 hours later.
Has had ongoing fatigue and weight gain since 3rd dose, but started feeling severe brain fog as well. Saw Doctor and had Respiratory testing along with Blood work drawn, testing was inconclusive.
Patient reports pain in right arm injection sight area that is persisting  from 11/5/2019 till present and may be getting  worse. Patient indicated that pain is upon moving arm and not when left immobile.
Pt with history of anaphylaxis to lisinopril but also reports that she is on this med for HTN.  Reported sense of throat tightness, numbness in feet and hands Cheeks appeared flushed Given zytec 10mg  Monitored for 30 minutes and felt much better
pain and inflammation in the joints of the ankles knees and her jaw; pain and inflammation in the joints of the ankles knees and her jaw; Inflammation in the jaw was making difficult to eat and chew; Inflammation in the jaw was making difficult to eat and chew; she was infected with the COVID-19 virus on January; she was infected with the COVID-19 virus on January; This is a spontaneous report from a contactable consumer.  A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient calls for information about the side effects she experienced after the administration of the first dose of the Pfizer's COVID-19 vaccine. She was experiencing pain and inflammation in the joints of the ankles, knees and her jaw and the inflammation in the jaw was making difficult to eat and chew. She is managing this symptoms with Tylenol and she has not visited her Physician for more information and management. She was infected with the COVID-19 virus on January. She has an appointment for the administration of the second dose of the Pfizer's COVID-19 vaccine on April the 22nd. Treatment received. Outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377325 Same reporter/drug/event, different patient.
This spontaneous report was received from a pharmacist refers to a 53 year old female patient. No medical history and drug allergies were reported. On 17-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001010, expiry: 24-APR-2014), 0.65 ml, subcutaneously in the left arm. No concomitant medications were reported. On 18-JUN-2013, the patient experienced a 2 inch by 1 inch area that was red, raised and warm to touch at the injection site. Patient sought medical attention: saw pharmacist. The pharmacist suggested the patient use Hydrocortisone cream for the reaction. Pharmacist also stated she had another patient that experienced the same reaction when given ZOSTAVAX from the same Lot #. Laboratory diagnostics studies performed was none. The outcome of the events was reported as not recovered. This is one of 2 reports from the same reporter. Additional information is not expected.
Hyponatremia/sodium level of 100; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of HYPONATRAEMIA (Hyponatremia/sodium level of 100) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, BPH and Drug allergy (Hydrochlorothiazide). Concomitant products included ALFUZOSIN, CLONIDINE, FELODIPINE, IRBESARTAN, ROSUVASTATIN, SPIRONOLACTONE and TRAZODONE for an unknown indication.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPONATRAEMIA (Hyponatremia/sodium level of 100) (seriousness criteria hospitalization and life threatening). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, HYPONATRAEMIA (Hyponatremia/sodium level of 100) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, Blood sodium: 100 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Pfizer co-suspect product for COVID-19 treatment from 18-May-2022 to 22-May-2022 orally.  Company comment: This spontaneous case concerns an 67-year-old male patient, with no relevant medical history reported, who experienced the unexpected, serious (life-threatening, hospitalization) event of Hyponatremia (reported as Hyponatremia/sodium level of 100), and the unexpected, non-serious Adverse Event of Special Interest of COVID-19. The event Hyponatremia occurred 6 months, 11 days after the third dose of mRNA-1273 vaccine administration while the onset date of COVID-19 is unknown. Patient took Pfizer co-suspect product for COVID-19 treatment for 5 days.  The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. Intake of felodipine and irbesartan could be a confounder for the event Hyponatremia. Outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 67-year-old male patient, with no relevant medical history reported, who experienced the unexpected, serious (life-threatening, hospitalization) event of Hyponatremia (reported as Hyponatremia/sodium level of 100), and the unexpected, non-serious Adverse Event of Special Interest of COVID-19. The event Hyponatremia occurred 6 months, 11 days after the third dose of mRNA-1273 vaccine administration while the onset date of COVID-19 is unknown. Patient took Pfizer co-suspect product for COVID-19 treatment for 5 days.  The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. Intake of felodipine and irbesartan could be a confounder for the event Hyponatremia. Outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Day #1 and #2: Fainting, loss of balance and incoherent. Both long term and short term memory severely. impeded. Day. #4: Cold sores appeared.  02/05/21: First shot Moderna 037K20A (same symptoms listed above) 03/05/21: Second shot Moderna 025A21A (same symptoms listed above)
Chronic Spontaneous Urticaria after receiving my Booster shot on 12-11-2021.  On Dec. 23rd, I had severe itching with major hives on my back, legs, groin and arms.  This has continued to date...1/9/2022.  I take Zyrtec during the day and Benadryl at night along with cortisone creme.   I have never been so itchy for such a long period of time.  I have no severe allergies, very healthy and now I severe itching and hives.  All due to this booster.....what is happening to the inside of my body and organs?  Something and someone needs to contact me......!!!!
Patient stated that starting 3 days after vaccine he started with pain in his left arm and chest, pain in his joints to his bones.  He says he has trouble sleeping.  He did go to the Emergency Room and was evaluated.  He says he still currently has the pain.
Swelling of left arm, rash at injection site, mild erythema, no tenderness.
swollen/inflamed gallbladder; swollen/inflamed gallbladder; discomfort; very sharp pain in my upper right abdomen; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (Batch/Lot Number: EN6208) as SINGLE DOSE, 48 years old. Medical history included none from an unknown date. The patient's concomitant medications were not reported. No known allergies. No COVID prior vaccination. Not tested for COVID post vaccination. No other vaccine in four weeks. There were no other medications in two weeks. On unspecified date after first dose patient suddenly experienced very sharp pain in her upper right abdomen. Patient went to hospital. They could not pinpoint anything. The doctor believes it is a swollen/inflamed gallbladder. The pain lessened due to the new diet. I still have pain and discomfort. Scheduled for a gallbladder scan. Treatment includes change to low fat diet. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the events were reported as not recovered. The second dose was administered in Arm Left on 01Apr2021 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.
The pt received the vaccines on 4/25/00, on 5/1, she started having seizures. She is currently on Phenobarbital, Phenytoin and Klonopin. She is still averaging about 1-2 seizures per day.
MMR dose #1 given 2/18/2021 MMR dose #2 given 6/4/2021 (error) instead of ordered Varicella dose #1  Ordering physician and parents notified immediately after, no adverse reactions noted at this time.
Arthritis symptoms in both knees. Pain is excruciating, to the point patient remained in bed for over 3 days. Patient had a phone appointment with his family Dr. Dr was asked if the symptoms could be related to the vaccine, as he has never had such excruciating pain in his knees. He also has pain in most of his joints. The worst being his knees and shoulders.
Discharge Provider: Primary Care Physician at Discharge: DO Admission Date: 4/9/2023  PRESENTING PROBLEM: Shortness of breath [R06.02] Hypoxia [R09.02] AKI (acute kidney injury) [N17.9] Elevated brain natriuretic peptide (BNP) level [R79.89] Multifocal pneumonia [J18.9] Sepsis with acute hypoxic respiratory failure and septic shock, due to unspecified organism [A41.9, R65.21, J96.01] COVID-19 [U07.1] Acute respiratory failure [J96.00] Acute respiratory failure with hypoxemia [J96.01]   HOSPITAL COURSE: Patient is a 97 year old with extensive past medical history most significant for CAD, CKD, peripheral vascular disease, MR, hypertension with recent admission from 4/4-4/7 for weakness and near-syncope, diagnosed and treated for Ecoli UTI and diagnosed with COVID-19 on 4/4; presented to hospital ED 4/9 afternoon with dyspnea and lethargy.  CXR and CTA with marked bilateral infiltrates suspicious for progression of COVID-19 pneumonia with possible bacterial pneumonia.  Hypoxemic requiring HFNC 100%/55LPM.  AKI on arrival.  Discussion with patient's family established DNR/DNI status.  Also developed hypotension and started on peripheral Norepi.  She was admitted to MICU for ongoing management.  Extensive conversations between providers and family detailed the severity of her illness and comorbidities likely to prevent recovery though continuing aggressive care to establish trajectory.  By 4/10AM, off Norepi but still requiring HFNC 95%/55LPM with NRBM to maintain SpO2.  AKI worsening. Noted worsening of oxygen needs with frequent desaturations 4/11. Family and DPOA at bedside - decision made to transition to comfort measures.    Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Patient presented with shortness of breath and palpitations.  He had some cough and sore throat which started around 1/13.  He was found to be in atrial fibrillation with RVR.  Chest x-ray did not show any infiltrates.  He remained on room air, saturating well.
This case was received from a health care professional on 09 May 2008. A 17-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number U2423AA) on 01 May 2008. Approximately four hours later, she developed lightheadness, described as intermittent dizziness, which was still ongoing at the time of the report. She was seen by her physician on 09 May 2008, and laboratory testing was performed, including CBC, Chemistry, TSH, T4, and Monospot; results were not provided. The subject had no medical history, and was not ill at the time of vaccination. Follow up information was received on 23 August 2008 from a health care professional. The patient's blood work from 09 May 2008 was normal. Her symptoms resolved after a couple of weeks. No treatment was required.
Patient arrived to receive first dose of the Pfizer Covid Vaccine and stated he had not received any other covid vaccines.  After appropriate screening questions and signed consent obtained, Pfizer Covid vaccine was administered to this patient.  While documenting this vaccine administration, it was noted that he had received the J&J vaccine in April 0f 2021.  Afterwards patient admitted to receiving the J&J vaccine in April 2021 and wanted to receive the Pfizer mRNA vaccine as a booster.
became aware that he needed a second dose / received it on 01/02/2021; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 14 months before the time of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.   Follow up information was received from consumer on 20th April 2021: This case was reported by patient himself. The patient demographics were updated. On 30th November 2019, the patient received 1st dose (intramuscular) of Shingrix in left deltoid.  The patient was not aware that he needed to take 2nd dose, then he became aware. On 2nd January 2021, the patient received 2nd dose (intramuscular) of Shingrix in left deltoid, later then the recommended schedule, which led to lengthening of vaccination schedule. The patient went day before reporting to take another dose but was told that he did not need to restart the series. The patient called GlaxoSmithKline to confirm if this was true. The VAERS details were updated. The reporter did not consent to follow up.
Myalgia, Arthralgia & Fever Narrative:  DOSE 1-DAY 2 SORE ARM/ SWELLING DOSE 2 DAY 2 SOREARM/FEVER/CHILL/JOINT PAIN; DAY 3 FATIGUE
Diagnosed with Shingles on 6/9/21 by Dr.  Treatment with valACYclovir (VALTREX) begun 6/10/21 for 7 days
Case number PHHY2011US54746, is an initial report from a physician received on 17 Jun 2011. This report refers to a 50-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. The patient developed Premature Ventricular Contraction (PVC) arrhythmia after receiving FLUVIRIN. The patient had been seen by a cardiologist.
Shingles; This is a spontaneous report from a contactable consumer (patient himself). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration, in left arm on 09Mar2021 09:45 (age at vaccination: 46-years-old) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EL3247), via unspecified route of administration, in left arm on 17Feb2021 09:45 AM as dose 1, single for covid-19 immunisation. Facility type vaccine was workplace clinic. Medical history of patient was not reported. No other vaccine in four weeks was administered to the patient. Concomitant medication included Acutane 10mg, taken for unspecified indication, start and stop date unknown. Patient had no known allergies. On 25Mar2021 15:00, patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment regimen was given as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was recovering.   No Follow-up attempts are possible. No further information is expected.
Went in for the rabies vaccine and when I came out I had the usual side effects: feeling nauseous, headache, pain, flu-like symptoms. However, starting the next day (12 July 2017), I began feeling worse with the flu-like symptoms - severe symptoms-severe muscle aches, severe headaches, severe confusion/unclear or foggy head/sight, etc. I take my last booster tomorrow, and right now my head is very foggy, I have a severe headache, all of my joints hurt bad, and I'm extremely anxious right now. This is one of the worst things I've dealt with medically in my life.
Fever, feverish, chills, muscle aches, runny nose, sore throat, cough, nausea, vomiting, headache, fatigue, diarrhea.
Patient passed out in the pharmacy hit her head on the floor, was bluish in the face and had low blood pressure
Information has been received from a physician concerning a 15 year old female pt with a history of "some psychological problems" and no history of chickenpox who on 4/14/98 was vaccinated with a dose of varicella virus vaccine live after exposure to her cousin with natural chickenpox. On 5/4/98, the pt was seen in the physician's office because the pt developed chicken pox and was scabbed all over. It was reported that the pt was doing fine. Also reported, was the pt's aunt (WAES01052608) who was not vaccinated but experienced adverse events following exposure. No further information is expected.
As soon as I got home from 1st dose, started menstural cycle after menopause at age 50ish. Having period every month since.
Health District held booster vaccine clinic for Residents and staff of Facility where patient was a staff member.  Staff member attested to receiving 2 doses of Pfizer vaccine previous.   When entering information into database, patient had actually received 2 doses of Moderna vaccine.
No adverse event; given vaccine which was beyond the 30 day use by; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by) and PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion).    No concomitant medicine were reported. No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682168 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682168:
Flu like illness day 8 after vaccination. Papular rash on face and arms day 9? Erythema nodosum day 9
Pt presented to hospital with worsening shortness of breath. remdesivir and other antibiotics given. iv dexamethasone given and oxygen. Pt was discharged home.
Patient stated she "fainted when receiving vaccines." Received vaccine and walked to waiting area. Sat down and became faint at 8:45 am  02 sat 99%; BP 100/80; P 88.  Laid down and was diaphoretic and clammy.  Cool compress applied to forehead and back of neck.  Drank juice and had some water.  Patient at u.  Stated she felt much better.  8:55 am walked to chair. BP 11/79 P 88.  Stated she was fine.  Left waiting area on her own at 9:00 am.
Warm, raised, itchy rash appeared 2 days after vaccination. The rash is a couple inches wide and 3 to 4 inches long. The patient had no reaction with the first 2 shots.
A spontaneous report was received from a consumer concerning an  64 -year old,  female patient who received COVID-19 Vaccine (mRNA-1273) and experienced Bottom half of left lip got numb / Hypoaesthesia oral, Tip of tongue was tingling/ Paraesthesia. The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications was  not reported. On 3 Feb  2021 prior to the onset of the symptoms, the patient received their  first  of two planned doses of mRNA-1273 (Batch number 015M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 03 Mar  2021, after vaccination patient experienced  the events bottom half of left lip got numb, tip of tongue was tingling. Treatment information  provided was Zyrtex and advil. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the events  bottom half of left lip got numb, tip of tongue was tingling. Based on MSA comment, Paraethesia and Hypoaesthesia oral are Unlisted in CCDS.