chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a field representative refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. On an unknown date, the patient received a late dose with the third dose of GARDASIL (1shot) via intramuscular route. Reporting physician stated that the patient received third dose later than 6 months when her treatment began. The patient required medical attention, but no treatment was provided to her. There were no mention of any symptoms apart from the late dose. Additional information has been requested.
12/01/2022   I had slight congestion and I felt like I had shortness breath and had a hard time breathing when I would get up and move around.  I went to Urgent Care and tested positive flu.  Prescribed Tamiflu to take for 5 days.  I started feeling better and was back to work within 5 days.
pt recv vax 28OCT97 & devel rash on 19NOV97;was seen in office dx of varicella;
Itch on body 4/06 (cream). Prostatitis 1/06/06 (antibiotics). 10/2/06 Received medical records from VA which reveal HTN, NIDDM, insomnia, hypercholesterolemia, mixed hyperlipidemia, bachache, chest pain & acute cystitis.
I had severe pain in my back left shoulder (scapula area), weakness in my arm and hand. I called my PCP and made an appointment to see her and was able to get in on 10/11/2022. She did a thoracic spine x-ray that did not show any thing out of the ordinary. I barely have use of my left hand and my left arm is very weak. On my third visit I was given a steroid dose pack that has helped to alleviate the pain in my shoulder (scapula area).
Severe scalp flareup unlike anything I?ve seen in over a decade. Severe fatigue. Brain fog. Feels like a really severe autoimmune flare. Has been going on for almost two months now. Taking supplemental medications prescribed by Dr.s office for recovery (would love to be reimbursed for these!!)
10 days after Moderna booster, I developed chronic urticaria, which I still have today (2/24/2022).
10 days after immunization, redness and itching of arm in the area of the injection that lasted a week.  Immediately after immunization, joint aches in the wrist and elbow of the immunization arm that lasted 2 days.
Hospitalized; COVID-19 positive (fully vaccinated); acute respiratory failure / hypoxia; HISTORY OF PRESENT ILLNESS: The patient is a 62-year-old female.  Patient has a history of Wernickes encephalopathy.  Per EMS her baseline is alert but confused.  Over the past few hours patient has become more lethargic and confused.  She had a recent diagnosis of COVID.  It is not clear what her symptoms were regarding that.  I can see from the chart that the patient had a recent admission for ureteral lithiasis with urinary tract infection and sepsis.  Patient denies any pain.  Denies headache, chest pain, shortness of breath, cough, abdominal pain, nausea, vomiting, diarrhea, dysuria, hematuria.  She has no complaints.  She is pleasantly confused.  Patient is on Eliquis. Admission Date: 8/23/2021; Discharge Date: 08/25/2021; Admitting Diagnoses: Acute respiratory failure due to COVID-19 (HCC); PRESENTING PROBLEM: Acute respiratory failure due to COVID-19 (HCC) [U07.1, J96.00] HOSPITAL COURSE: Patient is a 62-year-old woman.  Patient has a history of Wernickes encephalopathy.  Per EMS her baseline is alert but confused.  On the day she presented to ER she was more lethargic and confused.  She had a recent diagnosis of COVID.  She reports she has a cough and shortness of breath.  The patient had a recent admission for ureteral lithiasis with urinary tract infection and sepsis.  Patient denies any pain.  Denies headache, chest pain, shortness of breath, cough, abdominal pain, nausea, vomiting, diarrhea, dysuria, hematuria.  She has no complaints.  She is pleasantly confused.  Patient is on Eliquis. While in ER she had intermittent desaturations into the 70s that resolved with 2 liters of oxygen. Her lab work was unremarkable, hemoglobin stable, she was slightly alkalotic on blood gas with a decreased O2. CT abdomen inpatient is negative for calculi or obstructive uropathy. She has a small left rectus sheath hematoma and pericardial effusion. CT head negative. The hospitalist service in Big Rapids was contacted and agreed to admit the patient with acute respiratory failure with hypoxia due to Covid-19.  The patient was transferred and admitted in Big Rapids for further treatment and monitoring. Started on decadron and remdesivir. Started on tube feeds. Able to wean down oxygen. By 8/24 she was on RA and appeared comfortbale and stable from respiratory standpoint. She did have a drop in Hg, and given she is anti-coagulated and rectus sheath hematoma was seen on CT, her Hg was trended for another day. It remained stable and she was safe for discharge back to facility on 8/25. No new medications required at this time, in absence of respiratory symptoms no steroids prescribed.
Pt starting feeling adverse reaction on 1/28 (7 days after vaccine) numbness on chin & pt went to clinic that evening. Found nothing wrong. Prior to that patient's teeth were bothering her (left side). Had pain in mouth while sleeping. Dentist seen 1/29 & no problems evident. Same day saw Dr 1/29 & she diagnosed neuropathy (trigeminal neuralgia).
It was reported that a 21 year old female pt received a Menomune A/C/Y/W-135 and a Fluzone SV '99-'00 vaccination on 11/11/99. Reportedly, on 11/12/99, the pt complained of night sweats, dizziness and nausea that lasted 1 day. The pt reportedly, recovered from this experience.
Headache, Sedation, Myalgia, RespDepression, Mild soreness in right axillary lymph node Narrative:  Awoke the day after the 2nd dose (1/21/21) with myalgias, severe headache, and fatigue. Still noted headache on 1/22/21 as well as shortness of breath and soreness in right axillary lymph node. Missed work x 2 days. No known prior COVID infection.  Other Relevant History:
I administered a Hepatitis B vaccination to patient which was not ordered for her. The Hepatitis B vaccine was supposed to be given to her sibling.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown demographics. The pertinent medical history and concomitant medication were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (Lot# K025761, Expiry: 08-JUN-2016; Lot# K022444, Expiry: 13-MAY-2016) (number of doses unspecified). No adverse effects were reported. The reporter enquired about the temperature excursions. This is one of the several reports received from the same reporter. Additional information has been requested.
That Friday evening, I started feeling bad. On Saturday, I had a fever, headache, tired. I rested over the weekend tested positive with a home COVID-19 test on Monday called my doctor who then prescribed Paxlovid, I started taking it immediately. I was starting to feel better by the time I started to take the Paxlovid. I am feeling much better now.
Friday morning (3/5) started to feel a cold sore developing. By Friday night was large cold sore. Dirung the same time, I developed multiple canker sores inside my mouth on my bottom gums.  Saturday (3/6) cold sore increased in size and 2 canker sores developed on my tongue.  This morning (3/7), I noticed a rash on the arm where the injection was given. It is about 4" x 6" and the arm is red, hot, swollen and hard where the rash is. My arm has  been hot, hard and swollen since a few hours after the vaccine was given.  I did not notice the redness until today. This morning I woke up and my lymph nodes in my neck are swollen and sore and my gums in my mouth feel swollen.  The base of my tongue is very sore and feels swollen also.  I have also been getting light headed today - may not be related, but it feels like it is.
Patient reported feeling lightheaded, dizzy, and anxious with early heart palpitations with covid vaccine administration. Patient observed and provided food and water, reported full recovery.
Patient alerted staff of feeling over heated, sweating profusely, dizziness, and was slightly confused while talking.
NSTEMI; Rapid atrial fibrillation; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (NSTEMI) and ATRIAL FIBRILLATION (Rapid atrial fibrillation) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003CZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced ATRIAL FIBRILLATION (Rapid atrial fibrillation) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ACUTE MYOCARDIAL INFARCTION (NSTEMI) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 20-May-2021 due to ACUTE MYOCARDIAL INFARCTION and ATRIAL FIBRILLATION. At the time of the report, ACUTE MYOCARDIAL INFARCTION (NSTEMI) and ATRIAL FIBRILLATION (Rapid atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, SARS-CoV-2 test: positive positive (Positive) positive. On an unknown date, Blood cholesterol: 195 (Inconclusive) 195. On an unknown date, Blood magnesium: normal normal (normal) normal. On an unknown date, Blood phosphorus: normal normal (normal) normal. On an unknown date, Blood triglycerides: 169 (Inconclusive) 169. On an unknown date, Glycosylated haemoglobin: 5.3 (Inconclusive) 5.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Patient reported that he was healthy with no medical problems and took no medications prior to his vaccines. A pulmonary emboli was ruled out, no history or suspicion of sleep apnea.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.   This case was linked to MOD-2021-163089 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.
Janssen COVID-19 Vaccine EUA 03/21/2021 6:00pm: Nauseous for an hour 9:00pm: Bad chills started 10:00pm: Fever starts of 103 11:00pm: Headache Chills starting going away 03/22/2021 in the afternoon 03/22/2021: 5pm -fever broke Continued headache all day 03/22/2021 03/23/2021: 11am - headache went away 03/23, 03/24, 03/25 continued fatigue 03/26/2021: I felt 100% again
I had Moderna vaccination and right after that I started feeling a heart race and when I went to see my doctor he told me that I had AFib. This was a surprise as my heart was very healthy with a very steady heart rate and blood pressure. My heart had been checked prior to that and had no structural problems.
Left upper arm swelling on evening of vaccination. Mild fever (tactile) area red and firm circle of left arm 8". Right arm 7" on 4/15/2004. Parent applied cool compresses and gave Tylenol.
It started with sore arm, then 101 fever for 24 hours, plus joint pain, diareah  on the third day, headache and pain and redness on vaccinations site. Numbness on the shot site On and off body aches for 4 days... still have sore body
This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 54-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 21st July 2018, the patient received SHINGRIX (intramuscular). On 22nd July 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, raised rash and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities and itchy upper limbs were not recovered/not resolved and the outcome of the raised rash was unknown. It was unknown if the reporter considered the erythema of extremities, raised rash and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced red, itchy, and raised areas on a large part of the arm. The adverse events were reported through social media. The redness and itching had continued to increase since then.
open Blisters; Itchy blisters; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMOVAX 23) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix and PNEUMOVAX 23. On an unknown date, several days after receiving Shingrix, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister and pruritus were unknown.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.  Additional information received were as follows: On 12th August 2019, in the morning, the patient presented in the pharmacy. Few days after receiving Shingrix, the patient experienced a severe reaction of open blisters on bilateral arms, knees, legs, and ankles. The patient could not provide pharmacist an exact date when blisters first occurred. The patient stated the blisters were itchy and they opened after he scratched them.  The patient denied nerve pain, pain, fever, and rash. The pharmacist stated that the patient was seen by his primary care provider, who referred him to the pharmacy for further discussion regarding his symptoms and recommendations. The pharmacist consented to follow up. The pharmacist stated that they had been having a system issue where the system automatically populates the expiration date for the product as such, she was not sure whether the expiration date provided for the Shingrix dose was accurate.
Patient briefly lost consciousness immediately following vaccine administration.  Had shaking, chills, flushed and nausea.    Pt had not eaten at all today.  Administered oral water, snacks.  VS within normal limits.  Discharged with mother after 40 min of monitoring.
First 5 days severe body aches and  Stiff neck, headache , cannot turn my head or raise or lower.    After 5th day stiff neck , headaches , arm and severe neck pain remain enough I cannot sit at a computer to work. Today is 32!
Shot at 10am on Thursday, Cold chills around 8pm, Body aches and nerve spasms 12am-10am, 102 degree fever 12am-10am, Low grade fever, body aches, and nerve spasms continuous until Saturday around 10am.
Monovalent mRNA vaccine administered for a bivalent mRNA dose. Patient was given the monovalent mRNA vaccine, as I was not aware at the time, that the EUA had been withdrawal by the FDA.  My supervisor received noticed on 05/01/2023 from Health Department with a link to the Health and Human Services which announced updates to Covid-19 vaccines.  That the Bivalent Moderna & Pfizer BioNTec vaccines were to be used for all doses administered to those 6 months of age and older.  In the announcement, NO where did it state that this change had gone into effect the month prior. I was forwarded the email announcement  on 05/02/2023 and it was read on 05/03/2023 as soon as I returned to the clinic office from doing vaccinations I destroyed all remaining doses of our Pfizer monovalent mRNA FP7136 vaccine.   The patient suffered NO adverse affects and had NO adverse events following her vaccination.  This patient was released from our custody on 05/12/2023 and transferred to Department of Corrections
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a patient of unspecified age and sex. Initial information process along with information received on 06-JUN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received additional covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in JAN-2022 for prophylactic vaccination. 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 an unspecified date in MAY-2022, the patient had covid-19 and the tested negative with resolution of symptoms, after several days patient experienced symptoms again and tested positive (confirmed clinical vaccination failure and confirmed covid-19 infection) (dose number in series 2). On an unspecified date in MAY-2022, the patient received Paxlovid (nirmatrelvir and ritonavir) (oral) , therapy ended on an unspecified date in MAY-2022 as covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000234198. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220606408-Covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient came on 10/14/21 in the morning to request for her Moderna additional dose (3rd dose). Pharmacy technician provided her the consent form and Moderna booster eligibility (attestation) form. Patient gave us a covid card with 2 doses of Pfizer and pharmacy technician placed a sticker for her 3rd dose with lot number and today's date (10/14/21). Rph checked the consent form, Moderna booster eligibility form and received a verbal answer from the patient that the patient is here for her 3rd Moderna dose. At the end of the shift, Rph batched all consent forms and found out this is potentially her 4th Moderna dose (based on rx/tx history). Rph called the patient on 10/14/21 but patient cannot be reached. Rph called again on 10/17/21 twice but pt still cannot be reached. Rph filed an incident report on 10/14/12 through company's (Safeway) website. Rph is currently filing a report on VAERS and will work on submitting QA form today.
Around 4 hrs after vaccine, he felt down and tired. that night he had worsening flu like symptoms. Since the vaccine he endorses  having a fever, feeling tired  and aches all across the body. He also complains of being dizzy and numbness of both his hand that developed since the vaccine. He has taken tylenol and it resolves all the symptoms, however he says that the symptoms return as soon as the tylenol wares of. Denies constipation, diarrhea, chest pain, SOB but endorses nausea. Suggested to contact PCP and to see a doctor, also advised that if symptoms worsen, he should visit an ED.
Info has been received from an LPN concerning a male in his "twenties" with a possible history of seasonal allergies who was vaccinated with a dose of MMRII (lot unknown). Subsequently, he went on a trip to another country and developed mumps when he got back home. It was also reported that "subsequent to his arrival home, he infected his roommate, who in turn infected a sibling". The recovery status was unknown. There was no product quality complaint involved. Additional info has been requested.
Pt c/o fever and chills next day, with redness on left deltoid getting progressively worse. Also c/o swelling and pain in left axillary.
Pt developed acute ischemic stroke in L parietal region on 8/24/21.  Was in gym class when developed slurred speech, acute-onset weakness in R arm, and b/l legs. Continues to have residual tingling of R hand, otherwise all other symptoms have resolved without intervention.
Nausea, patient went to urgent care and received prescription for phenergan 12.5mg.
Development of Deep Venous Thrombosis Right lower extremity; Booster; This is a spontaneous report received from contactable Consumer. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 (Lot number: FF2590) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Lot EL9269. NDC: 59267 100001, Location of injection: Arm Left), administration date: 20Feb2021, when the patient was 71 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Lot EL9269  NDC: 59267 10001, Location of injection: Arm Left), administration date: 30Dec2020, when the patient was 71 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant,hospitalization, disability, life threatening) with onset 16Oct2021, outcome "unknown", described as "Booster"; DEEP VEIN THROMBOSIS (medically significant,hospitalization, disability, life threatening) with onset 18Oct2021 15:00, outcome "recovering", described as "Development of Deep Venous Thrombosis Right lower extremity". The events "booster" and "development of deep venous thrombosis right lower extremity" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis with Rx for Eliquis. Clinical course: the patient had no Covid prior vaccination, the patient was not tested for Covid post vaccination. Patient had no known allergies. No other vaccine in four weeks.
Ever since I got the vaccine my period have chance.  I period is very water and very heavily flow.  I had an ear infection that turn out to be a fungal infection.  I had the HENT specialist for this.
Blood in stools two times several days after the vaccine, mucousy stools 3-5 days after vaccine, diarrhea beginning 5 days after vaccine.
Patient is a 36 yo female, s/p full Pfizer COVID vaccination: dose 1 on 4/8, dose 2 on 4/29. Patient is an employee of this institution with new onset cough, muscle/body aches, and sore throat as of 7/24. Denies known exposure to COVID-19. POCT rapid test results positive on 7/24. Patient meets criteria for both bamlanivimab and casirivimab/imdevimab, however patient declines infusion.