chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of swelling of fingers in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 4 November 2009 at 10:00 the subject received 1st dose of ENGERIX B (1 ml, unknown). On 5 November 2009 at 15:00, 1 day after vaccination with ENGERIX B, the subject experienced swelling of fingers, (pointer) finger pain and vaccine reaction. The pharmacist considered swelling of fingers, (pointer) finger pain and vaccine reaction were clinically significant (or requiring intervention). Relevant test results included a radiograph (x-ray) on an unspecified date which appeared to not reveal any abnormalities of the subject's fingers. The pharmacist reported that a female subject developed swollen fingers approximately one day after receiving an ENGERIX B vaccine. The subject also reported that she had a painful pointer finger. On an unspecified date, the subject went to an urgent care center where the physician took an x-ray (unspecified). The result of the x-ray was there appeared that nothing was wrong with the fingers. The physician at the urgent care center told the subject that her symptoms were a reaction to the ENGERIX B vaccine. The pharmacist had very little information about the subject at the time of reporting. At the time of reporting the outcome of swelling of fingers, (pointer) finger pain and vaccine reaction were unspecified.
Pain, redness, fever, Dr DX cellulitis, RX of Keflex/ 10 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jul2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Pre-Diabetic" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; ESCITALOPRAM; OLMESARTAN; JARDIANCE; ESTRADIOL; NATURE MADE VITAMIN D3; NATURE MADE VITAMIN B-12; BIOTIN; COLLAGEN; CRANBERRY [VACCINIUM SPP.]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken on 19Mar2023.
pt recv vax 12MAY97 & 14MAY97 pt devel a fever >100 & multiple lesions everywhere;that same day presented to MD;MD dx chickenpox;
Evening following receiving vaccine: Severe Dizziness, Chills, Body Ache, Increased Heart Rate (racing sensation). Following day: Minor/Noticeable Joint Pain throughout body (knees, shoulders, spine). Continuing symptoms: Minor Redness/Itchiness around injection site.
Pt was diaphoretic and pale; Pt was diaphoretic and pale; BP 90/50; Pulse 64; This is a spontaneous report from a contactable nurse. A 26-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3183), intramuscular, administered in left arm on 27Aug2021 14:45 (at the age of 26-year old), as dose 1, single for COVID-19 immunisation. Medical history included patient appeared to be nervous and having a lot of anxiety prior to immunization. The patient confirmed no allergies, was not in quarantine, not sick and denied any medical problems. Concomitant medications were not reported. On 27Aug2021, the patient presented for the vaccine; he tolerated the vaccine and walked with his wife to the waiting room. After about 5 minutes in the waiting room, the nurse was in unit and assisted in care, the patient's blood pressure (BP) and pulse which were found to be 90/50 and 64. At 15:00, the patient was diaphoretic and pale, therefore oxygen was administered and patient was monitored until emergency teams arrived. Once they arrived, the patient had started to come around, his color returned and he was not as sweaty. He got up and walked to stretcher and exited with emergency teams. The events resulted in emergency room/department or urgent care. Outcome of the event diaphoretic and pale was recovered on 27Aug2021 and of the remaining events was recovered on an unspecified date in Aug2021.; Sender's Comments: .As per temporal association , causal association of events(Hypotension, low pulse rate, Hyperhidrosis, pale) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
patient complained of tingling lips onset 10 minutes after vaccine given. Provider consulted and recomended 25mg benadryl oral medication given. 30 minutes later was still a bit tingly per patient but no further symptoms.
Pt was given Tdap walked to lab & had blood drawn - got up to walk back to room - fainted used ammonia to awaken but was still very sluggish, O2 adm. transported to hosp via EMS.
Redness/swelling at injection site, 101 degree F fever, achiness, fatigue.
This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that on an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of VARIVAX (lot # M023379 with expiration date at 11-MAY-2018, lot # reported as M037643 with expiration date at 01-SEP-2018 and lot # L021214 with expiration date at 10-JUN-2017; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature over 14 degrees Fahrenheit (F) and below 46 degrees Fahrenheit (F) for 1 hour and 40 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA000822: US-009507513-1702USA004068.
Chills, injection site soreness radiating to upper arm. Treatment was Tylenol and Ibuprofen
Mother called 7/8, to report NP that saw pt said he had a reaction to vaccine  Child saw np 7/6, and DX with pneumonia caused by reaction to vaccine
Itchy; hard arm; Red; Sore; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (Red), PAIN (Sore) and SWELLING (Swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTIROXIN), VITAMINS NOS and CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (Red), PAIN (Sore) and SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (Red), PAIN (Sore) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.
Soreness, Fever, Temp 100F Axillary, chills, Temp rose to 101.9, urticaria around site 5 X 6 cm.  Spontaneous resolution by 5/24/12.
First off, I've been an avid runner / workout (9-10x week), former elite triathlete and take care of my body very well and know injury maintenance /massage for the last 18 years.  The Moderna vaccine on 10/10/23 put me down the next day pretty good, I did not workout on 10/11/23 due to the headache / not feeling well.  Around lunchtime I noticed my left achilles was sore when I stood up and went out to run some errands.   This pain felt like it was on the verge of pulling/tearing achilles.  So I rested with no workout the rest of the week and the pain rescinded with continuous calf massage with a massage stick, making sure not to get anywhere close to my Achilles to aggravate it.   I decided to go for a small run on 10/16/23 for 1 mile (very easy) but felt my left Achilles was tight so did not run anymore.   (I've ran 15-35 miles a week for 15 years).   On 10/21 I went out for a 3 mile run (easy) and right after the run (1-2 hours) my lower right calf is tight as it's ever been, and as I noted, it was an easy run.   Now I have a left Achilles that is tight and a right lower calf that is very tight.   I can barely walk due to the soreness.     Furthermore, I've had persistent tinnitus after the vaccine as well.      Feel free to reach out to me as this information should be made public as I see some Achilles tears in some papers however they still do not associate it to the vaccine it seems.   I can 100% tell you this was due to the vaccine.
Patient received a Janssen Covid 19 vaccine at 3:15pm and was waiting in the observation area when she felt like she was going to faint (she claimed to feel really warm) so she laid down and within seconds a tech and pharmacist approached her where she was responsive. she said that she was just warm and did not want us to call 911 or anyone for her. She remained seated for another 20 minutes and felt fine so she left and shopped for the next hour and felt fine.
patient received a third dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 94BS5, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on 22nd October 2020) and Bexsero (2nd dose received on 7th January 2021).   On 9th August 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  This report was made by GSK without prejudice and did not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 09-Aug-2022. Reporter's Comments: The physician's assistant reported that the patient received a third dose of Bexsero after the patient finished the series previously.  No additional detail was provided. The reporter declined name and contact for database but confirmed title and zipcode. The reporter did not consent to follow-up.  Additional Supportive Information: The patient received a third dose of Bexsero, which led to extra dose administered.
Crying unconsolably for 3 days post inject; Seen by MD on 3 occasions;
Immediate fever, night sweats, extreme fatigue, shortness of breath, chills, stuffy nose and sore arm  lasting 48 hours
Initially, pain and swelling in the area of the injection site. Flu-like symptoms evolved over a 24-hour period. Redness, pain, and swelling persisted for a few days. Patient was evaluated on 03/21. Therefore local findings, but no fever or systemic findings. Impression was that this was likely a reaction to the PREVNAR vaccine, based on location. Treatment with an antihistamine and topical steroid was initiated. Empiric treatment with an antibiotic was also provided, out of deference to patient history of prior endocarditis. Impression clinically was that this was an allergic response, not infectious. The patient showed a good response to treatment, and reported significant improvement by telephone follow-up, a few days later.
off-balance when walking; mildly dry throat; now mild sore throat; scratchy throat; diarrhea; Nausea; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat) and DIARRHOEA (diarrhea) in a 61-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.     The patient's past medical history included No adverse event.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and NAUSEA (Nausea). At the time of the report, BALANCE DISORDER (off-balance when walking), DRY THROAT (mildly dry throat), OROPHARYNGEAL PAIN (now mild sore throat), THROAT IRRITATION (scratchy throat), DIARRHOEA (diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Day 2 following vaccination-headache, severe diarrhea, vomiting Day 3- mild diarrhea, general feeling of feeling ill, fatigue  Day 4- symptoms had nearly resolved
Experienced colds; Loss of appetite; Sickness in the stomach; Chills; Wanted to throw up; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Experienced colds), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Sickness in the stomach), CHILLS (Chills) and NAUSEA (Wanted to throw up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced NASOPHARYNGITIS (Experienced colds), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Sickness in the stomach), CHILLS (Chills) and NAUSEA (Wanted to throw up). At the time of the report, NASOPHARYNGITIS (Experienced colds), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Sickness in the stomach), CHILLS (Chills) and NAUSEA (Wanted to throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Phone call from pt at 13:24; had Flu shot in am. Stated red raised rash on legs, arms & itching, started 1 hr ago. No SOB, no throat swelling or difficulty breathing. Tx'd w/Benadryl 50mg every 4 to 6 hrs.
This spontaneous report as received from a pharmacist refers to a 16 year old male patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient had presented to the emergency room at her facility with "lock jaw and could not talk." The patient had not been admitted to the hospital. The pharmacist noted that the patient's mother stated that "the only thing that was different, was that he had been administered GARDASIL. It was unspecified how many doses of GARDASIL the patient had been administered. The reporter considered that the patient cannot talk as disability. The outcome of lock jaw and cannot talk was reported as not recovered/not resolved. The relationship between the GARDASIL and the events was not reported. Additional information has been requested.
Patient complained of soreness, irritation, and itching starting that evening after the shot and still ongoing. The patient's arm is red, swollen, and the redness has irregular patterns down the arm. The redness is also very warm to the touch.
Information has been received from a physician concerning a male patient who was vaccinated with a dose of PNEUMOVAX.  The physician reported that the patient experienced redness, swelling and pain at the injection site, on the arm, that extended to the shoulder and neck.  The patient also experienced fever.  Patient had a "decreased" pulse in the affected arm.  No other information was available at this time. The patient recovered.  This is one of three reports from the same source.  Additional information has been requested.
I had a runny nose, sneezing, coughing, I thought it Springtime allergies. I was scheduled to have surgery for a torn meniscus I decided to test for COVID-19 just to be sure, the test came back positive. I called my doctor to discuss my symptoms and get the antiviral medication. I was prescribed the Paxlovid that I started immediately.
This spontaneous report as received from a registered nurse and refers to unspecified number patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M024680, expiration date 18-MAY-2018 (dose and route of administration were not reported) for prophylaxis. The VARIVAX was reconstituted with properly stored diluent (lot number and expiration date were unknown). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions of 7.7 degrees Fahrenheit for 1 hour and 30 minutes, 9.9 degrees Fahrenheit for 1 hour and 30 minutes, 8.2 degrees Fahrenheit for 30 minutes, 13.3 degrees Fahrenheit for 1 hour and 30 minutes, 7.7 degrees Fahrenheit for 1 hour and 8.8 Fahrenheit degrees for 1 hour. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009513507-1703USA013690: US-009513507-1703USA013753.
DTAP-IPV-HIB-HEPB & HIB given at same time
Hospital Course: In summary this is a 76-year-old female with past medical history significant for hypertension, CKD stage III, chronic dizziness, and glaucoma, who presented to the emergency department on 3/11/2021 due to generalized weakness, slurred speech, and confusion.  Patient lives alone and there is no last known well time.  Of note patient had reportedly received the Madera COVID-19 vaccine in the days leading up to her presentation. History was limited due to the patient's altered mental status.  I was later informed by the patient's son via phone that she just recently received her first Covid vaccination here at Hospital earlier this week. Additional information for Item 18:    Due to concern for stroke stroke alert was activated and CT imaging of the head was ordered.  However due to patient's agitation this is not able to be performed despite giving a total of 4 mg of IV Ativan.  As of this point the decision was made to intubate the patient in the emergency department for imaging and further work-up of her encephalopathy could be performed.  Patient was subsequently extubated on 3/12/2021 at which point she was able to report her symptoms started as numbness in her feet and the inability to walk followed by no further recollection until being in the ICU.  She reports similar episode on a trip for which no cause was identified.  The results of her testing remain inconclusive and did not identify any acute cause for her presentation and therefore working diagnosis was possible TIA versus conversion disorder.  Patient was subsequently transferred to the general medical floor on 3/13/2021.  Patient seen by me on:  3/11/2021   Assessment:  76-year-old female with a history of hypertension and CKD 3 presents to the ED with altered mental status, apparent time of onset approximately 7:15 PM, unable to answer questions or follow commands   Differential diagnosis:  CVA, TIA, ACS, electrolyte abnormality, occult infection, metabolic encephalopathy Encephalopaty requiring intubation and intensive care.
The patient began experiencing blood his urine 4 days post-vaccination. It happened twice on 5/8/2021, which is the day he reported it to the pharmacy. The patient advise to immediately contact his PCP for further follow up. No other symptoms or signs reported.
11/21/21 presented to ED by EMS for "cardiac arrest and fall". PMHx of "carotid stenosis, insulin dependent DM, HTN, legal blindness, seizure disorder"
21JUL93 MD visit small round nodule lt leg poss sterile abscess; no tx necessary will follow;
Severe headache lasting 6 days and nights, palpitation, pain in the arm weakness
Arm so sore that I could not lift it, chills, body aches, loss of appetite, migraine, fatigue, general feeling of unwell (as if I was coming down with the flu). Treatment was rest, Tylenol, Fiorinal w/codeine (for migraine), fluids. Symptoms began a few hours after shot & worsened throughout the day & evening. The worst of it lasted 24 hours; felt unwell for approximately 72 hours. I had not heard of anyone feeling this ill after the 1st dose.
immediate local reaction. raised, hard swelling at site of injection approx. 1" in diameter.
Patient with past medical history of type 1 diabetes and cerebral palsy received covid vaccine (unknow manufacturer  or lot number) then several days later presented to ER after not acting like self at home, admitted to the hospital for diabetic ketoacidosis. Patient had been hospitalized for this in past but usually had an infectious source, infectious source was not immediately identifiable
immed pain @ inj site w/edema lt upper arm, redness, red raised rash appeared in AM p/a few hr c/o itching for 1 1/2wk;no SOB, diff breathing;area of redness 10cmx12cm per MD office;
No adverse event reported. Patient received 2 ZOSTAVAX injections: 12/26/2009 and 10/3/2014.