chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6198), in left arm and on 15Mar2021 as dose 2, single (Lot number: EN6204) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 051F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves diagnosed", start date: May1977 (unspecified if ongoing), notes: Other medical history: Graves diagnosed May1977. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive; (22Jul2022) Negative; (27Jul2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical information received on 29Jul2022: Reported that I tested positive for Covid-19 on 18Jul2022 and began the Paxlovid series on that date, with symptoms of very runny nose, body aches & general weakness. Quick recovery with negative covid test on 22Jul2022. However retested positive for Covid on 27Jul2022 with symptoms of very runny nose, light fever, cough, general weakness. I do not like this paxlovid rebound. I'm still suffering symptoms on day 3 of the re-bound and would probably been over it if I hadn't taken the Paxlovid. I was happy with Paxlovid at first, but not now.
Abdominal aortic aneurysm (AAA) without rupture. Hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Significant pain at injection site within two hours of the injection that did not respond to 400 mg ibuprofin. An ice pack alleviated the pain enough to make it tolerable. Moderate pain at the injection site, fatigue and nausea the morning after the injection.
At 1140 AM, following a second dose of Moderna Covid vaccine, patient reports itching to her ears, back, and scalp. No hives, welps, or redness noted. patient denies any mouth, lips, tongue, or throat swelling. patient reports she has had anaphylaxis to NSAIDS in the past but no other medications. Nurse Practitioner onsite notified, VO rec'd for Diphenhydramine 50 mg PO x1 dose now. medication administered to patient. patient reports she has benadryl at home if she needs it later and is comfortable going home at this point. no s/s of distress. patient discharged home at 1200 PM.
On Monday, 3/26/01, 3 pts showed up at our clinic stating they had had very sore arms secondary to their pneumovax shot on Saturday, 3/24/01. This pt was one unusual occurrence sent to you. Started to hurt right after injection. Complained of swelling and discomfort when he uses the arm.
After over one hr of getting the flu shot, patient came back and claimed that her face turned purplish pink and her face seemed swollen. She appeared to be lightly shortness of breath. Her BP reading were around 200/100 with HR of 80. She took 2 puffs of Albuterol. One more hour later, she was taken to hospital by paramedics without any worsen symptoms.
24 hours after receiving vaccine, the left side of my face experienced mild swelling (it should be noted I received the injection in my left arm). I experienced heavy allergy symptoms including redness and swelling in left eye, watery eyes particularly in left eye, runny nose and pain particularly in left nostril, heaviness of breath, tiredness.  I think it is of note that as of writing this, I have not received commonly reported symptoms of fever, chills and nausea in conjunction with the reported adverse symptoms.
R thumb swollen painful hot to touch at  IP joint- still tender/ minimally swollen two weeks later and does not yet bend all the way Sore arm x1 day / site of injection only L arm
This case was reported by a consumer and described the occurrence of spongiotic dermatitis in a 54-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Historic vaccination included influenza virus vaccine; manufacturer unspecified; unknown; unknown given in 2007. Concurrent medications included SYNTHROID and LEXAPRO. On 16 December 2011 at 10:00 the subject received 2nd dose of ENGERIX B (1 ml, unknown, right arm). On 31 December 2011, 15 days after vaccination with ENGERIX B, the subject experienced spongiotic dermatitis and vascular dermatitis. The subject was trying to determine if she should take the third dose in the series due to the dermatitis she suffered two weeks after taking the 2nd dose in the series. The dermatitis was biopsied and the diagnosis was spongiotic dermatitis with vascular dermatitis. The subject took 29 days of oral steroid treatments to treat the dermatitis. On 28 January 2012, the experienced spongiotic dermatitis with vascular dermatitis were resolved. The subject reported injection site soreness with influenza virus vaccine (manufacturer unspecified) approximately five years ago in 2007; please see case A0977003B. Follow-up information was received on 01 June 2012 via consumer who further clarified her diagnosis was Spongiotic dermatitis with lymphocytic vasculitis consistent with systemic medication hypersensitive reaction. At the time of the report no further information was available. This case was assessed as medically serious by GSK.
I don?t actually remember exactly when or where I got the TDaP.  It may have been longer ago. I tolerate TD just fine, but not TDaP.  I experienced extreme swelling of the injection site, where a BP cuff had been applied; I was extremely weak and feverish, and had to crawl back and forth from the couch to the bathroom, for about 3 days. Standing was difficult or impossible. I thought I was going to die. I probably had a fever.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 16-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperature outside of the recommended range. There were not concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
"Significant lymphadenopathy left neck and supraclavicular region following COVID bivalent booster IZ 2 days ago, Reassurance given, instructed pt to put ice on swollen nodes PRN. f/u if not significantly decreased in the next 1-2 weeks." per Dr.
Patient fainted after he got the J&J vaccine; as per patient, it had happened in the past after getting blood withdrawn or vaccines;  Patient was conscious;  911 was called. Patient was fine and denied medical treatment.
10 days after receiving the first shot  broke out in a  red rash where the shot was given.  The next day it  spread  down my left arm.   I went to see my doctor ( my PCP)  She gave me 2 RX  for the rash, both are creams,(1) triamcinolone Acetonide  0.1 %    (2)  Mupirocin 2% and  suggest  I call  CDC to report it
Swollen bruised bump on right leg with 5 cm diameter of tenderness and induration.
Immediately after: Significant symptoms. Headaches; body aches; tremors; nausea, those were the major symptoms for about three days. On the fourth day, I felt pretty close to normal. No treatment for those symptoms, let it run its course. In April, I started getting big welts on my face. They were pretty significant, on the front of my face and around my nose. I am continuing to have these symptoms. I contacted my dermatologist via telehealth, mupirocin was prescribed, and it didn't really help. We have started to wear masks again so that could be why it came back. I am going to a different dermatologist for the same issue later this week (in person on Friday) and kind of adding to why I am seeing the doctor. I am having the welts again on my face and also something very odd swelling and soreness. I had a COVID test on this past Monday to make sure the result was negative. A better word for it might be eruptions on my face/nose. My nose was so sore to the touch. My  nose swelled on each side and it was extremely sore to the touch. Which is why I had the COVID test. The swelling and soreness is new to the symptoms, it was last Friday that those symptoms started. And my eyes were somewhat affected. They were kind of bloodshot. It was very odd. (On Friday) I was congested when I was lying down but when I stood up, the congestion went away but the pain continued. I had some chills and some body aches but not loss of smell or taste or anything like that. Today, I'm feeling back to normal but still have some eruptions and swelling and soreness on my  nose/face. Those have improved a bit. I am feeling quite a bit recovered but not completely. I do feel better.
Rash, UrticariaPruritus, itchy, redness, hardened area that is growing Narrative:
a lot of red dots, like a rash; a lot of red dots, like a rash; bruises on both arms, but mostly on my left; sick; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (a lot of red dots, like a rash), RASH (a lot of red dots, like a rash), CONTUSION (bruises on both arms, but mostly on my left) and ILLNESS (sick) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02 Apr 2021, the  patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, the patient experienced ERYTHEMA (a lot of red dots, like a rash), RASH (a lot of red dots, like a rash), CONTUSION (bruises on both arms, but mostly on my left) and ILLNESS (sick). At the time of the report, ERYTHEMA (a lot of red dots, like a rash), RASH (a lot of red dots, like a rash), CONTUSION (bruises on both arms, but mostly on my left) and ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Clouded memory; Sore arm; Headache; Swelling around injection site; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received 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 19Apr2021 at 13:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high triglycerides, high blood pressure, and fatty liver. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included empagliflozin (JARDIANCE), metformin hydrochloride (METFORMIN ER), atorvastatin (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN) all since unknown dates for unknown indications and unknown if ongoing. On 20Apr2021 at 00:00, the patient experienced sore arm, headache, swelling around the injection site, and clouded memory. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm, headache, swelling around injection site, and clouded memory was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
patient having reaction to pfizer shot given on april 11th. patient states symptoms from numbness to extremities, shortness of breath, sores on lip, headache, yellow eyes, weakness. on 4/25 Overnight he felt very "hot", like he was breaking a fever, but was not febrile per vital signs. He sweated and then noticed bubbling of his skin on both hands and feet and then those bubbles popped and his skin is peeling now.
Information has been received from a registered nurse concerning a 3 year old pt who was vaccinated with varicella vaccine. The pt's date of vaccination was not reported. Subsequently, the pt developed chicken pox post vaccination. Unspecified medical attention was sought. No further info is available.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (gave expired vaccine) in a 36-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine), batch/lot# 067H21A) for COVID-19 immunization. No medical history reported. On Apr 25, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form.  On Apr 25, 2022, patient administered expired product (gave expired vaccine). At the time of the report, administered expired product (gave expired vaccine) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to USMODERNATX, INC.MOD2022590501 (E2B linked report).
Patient had vasovagal fainting episode immediately following injection. He was seated entire time. He regained consciousness in a few seconds and was observed and had no other issues. We followed up with parents that night and he was fine the rest of the day.
I got the usual flu symptoms the day after, i.e., chills, body aches. Today, two days after I have a rash on my chest and under my arms.
A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on 25-Sep-2015. Pharmacist reported that the consumer felt the FLUMIST Quadrivalent only went in 1 nostril despite the fact that the pharmacist administered the FLUMIST correctly in both nostrils product quality complaint was reported. FLUMIST Quadrivalent was discontinued on 25-Sep-2015. The outcome of the event of full dose in one nostril and product quality complaint is unknown. The report was considered to be non-serious.
Induration, erythema of the upper left arm, diffuse overlying the entire upper arm laterally.
night sweats; different things like that, joints; The initial case was missing the following minimum criteria: adverse event NOS. Upon receipt of follow-up information on 11Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (Patient's mother). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose (17-years age at the time of vaccination) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, Consumer reported that patient received his first dose. Consumer does not remember the date. On an unspecified date, patient had symptoms (night sweats, different things like that, joints). Patient was sensitive to a lot of things, so consumer is nervous. Consumer heard of healthy people getting the vaccine and dying shortly after. Consumer further wanted to know if he should get the second dose. Consumer indicated he was to have his second dose on Monday but awaiting blood test from HCP, delayed until 14Jun2021. On an unspecified date, the patient underwent lab tests and procedures which included blood test with unknown result. The outcome of events was unknown.  Information lot/batch number requested.
Beginning the 4th day after booster, experienced daily vertigo; worse at night with lying down and turning over in bed. Initially thought I might have been dehydrated, but forcing lots of fluids daily has not lessened symptoms. No adverse symptoms after first 2 injections.
Shoulder pain with rotation becoming more severe as the night goes on.  Discussed with Ortho: recommends NSAIDS and ice.  Next day started Medrol dose pack to minimize shoulder inflammation and further injury.
sore arm; tired after his first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm) and FATIGUE (tired after his first vaccination) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced ARTHRALGIA (sore arm) and FATIGUE (tired after his first vaccination). At the time of the report, ARTHRALGIA (sore arm) and FATIGUE (tired after his first vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       There was no medical history reported. There was no treatment medication reported. Reported information included, patient received first vaccination in his left arm shoulder deltoid muscle   This case was linked to MOD-2022-440662, MOD-2022-440667 (Patient Link).
Vomiting not able to keep down any fluids very lethargic, not making any tears, ER course: IV fluids (normal fluids) CBC, x-ray, and BMP culture.
ED to Hosp-Admission  Discharged 10/25/2021 - 11/2/2021 (8 days)  COVID-19  Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] COVID-19 [U07.1] HPI  Patient is a 81 y.o. male with known history of  Hypertension & obesity has presented to emergency room for evaluation of worsening shortness of breath,nausea, fatigue, poor oral intake & non productive cough of 1 week duration.  Patient tested positive for COVID-19 last Tuesday.  Patient is fully vaccinated including booster dose recently. Onset sudden. No aggravating or relieving factors.Patient denies chest pain, palpitations, vomiting, diarrhea, abdominal pain, burning micturition, joint pain, rash, fever, chills,dizziness, light headed ness, muscle weakness, tingling or numbing sensations. Upon arrival he is noted to be having bilateral infiltrates on the chest imaging with hypoxia on room air.  Subsequently patient was referred to the hospitalist team for admission and evaluation. Patient denies any other medical complaints at this time   Hospital Course   Patient was admitted to med surgical floor with COVID-19 pneumonia and acute hypoxia slowly his symptoms improved with off the oxygen completed remdesivir will need oral steroids at home.   Discharge instructions Patient started to follow with his primary care provider in 1 week.
Narrative: 50 yo M. PMH - CAD s/p AMI/PCI 2010, HFrEF 2/2 ischemic cardiomyopathy s/p ICD, known diverticulosis, HTN, HLD. Presented to ER this afternoon w/ "congestion" and LLQ abd pain. Abdominal pain started on Thursday night after dinner, after which he describes having non-bloody diarrhea. Pain is 10/10, constant, sharp and located in LLQ: it radiates just below the umbilicus. It is minimally relieved with a heating pad; exacerbated by movement. Endorses chills, loss of appetite, nausea, and dysuria. Denies vomiting. Congestion (rhinorrhea, sore throat) started within the past week. Poommate was diagnosed with to COVID-19 over the weekend and subsequently exposed the patient. Patient has been fully vaccinated. In the ER, pt was vitally stable. Physical exam was remarkable for diffuse abdominal tenderness, worse in LLQ and obvious discomfort upon moving. Labs remarkable for elevated lipase, amylase, and ALT. CXR without acute cardiopulmonary changes, but with small amount of free air under the R hemidiaphragm. CT Abd noted perforated sigmoid diverticulitis. Surgery consulted in ER and, given hemodynamic stability, recommended conservative medical management. Admitted to MICU for observation and serial abdominal exams in setting of perforated diverticulitis. Patient never required supplemental oxygen nor treatment for COVID-19. patient was discharged home on antibiotics for perforated sigmoid diverticulitis.
Information has been received from a healthcare professional concerning a 36 year old male pt, who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the pt experienced a "severe local reaction," swelling from his elbow to his armpit, sever arm pain, redness, heat, arthralgia, and malaise. The pt was treated with a Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030, 0209USA01591, 0209USA01592 and 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Previously administered products included SHINGRIX (1st dose received in summer in 2018 with no problem) and Statin with an associated reaction of pain in extremity. On 17th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 17th September 2018, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm, chills and limbs stiffness. On an unknown date, the outcome of the pain in arm and limbs stiffness were not recovered/not resolved and the outcome of the chills was recovered/resolved.  The reporter considered the pain in arm, chills and limbs stiffness to be related to SHINGRIX. It was unknown if the reporter considered the pain in arm, chills and limbs stiffness to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were received as follows: The patient had issued in the past when she was taking statins. Statin caused so much arm pain, hence she stopped taking them. The patient received SHINGRIX vaccine in left arm and Flu vaccine in right arm. On the same day after vaccination with SHINGRIX, the patient presented with pain in her left arm and chills. The chills resolved after 2 days but the pain in her left arm remains. During the day when the patient was moving around, her arm was little stiff but at night when she went to bed she woke up at about 2 or 3am with severe pain in her arm. The patient was given a flu vaccine on the same day in her right arm but did not associate the side effects with this vaccine.
extreme soreness and swelling at injection site, followed by soreness and tenderness up same side of neck
Evening of the vaccine chills, very achy joints (knees especially),  temperature hovering around 100.  Next day, still very achy, tired.