chrisvoncsefalvay/vaers-outcomes huggingface dataset:
L eye swelling with nodule, fever on day of vaccination, followed by progressive L forearm swelling and nodule; fever 100 x 24 hours; also nausea and vomiting x 24 hours; no lip/oral swelling, no dyspnea noted
Per Ed Note: Patient is a 89-year-old male with past medical history hypertension T4 fracture, dysphagia, recent pneumonia presenting to the emergency department via EMS with complaints of shortness of breath.  Patient was at the rehab facility and subsequently was found to be hypoxic in the mid 70s.  The patient was given 2 breathing treatments with no improvement at the nursing home.  The patient is complaining of shortness of breath but is also somewhat confused.  He is alert and oriented to person and place but disoriented to time.  He denies fever, chills, chest pain, abdominal pain, nausea, vomiting, diarrhea, urinary symptoms.
p/vax pt exp varicella-like rash all over body w/less than fifty lesions;no fever was noted;
This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in a female patient who received ENGERIX B (batch number 94S22, expiry date 4th September 2020). This case was associated with a product complaint. On an unknown date, the patient received ENGERIX B. On an unknown date, 14 days after receiving ENGERIX B, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation and pain were unknown. It was unknown if the reporter considered the burning sensation and pain to be related to ENGERIX B. Additional information was received as follows: The reporter reported that the patient in the same day received an ENGERIX B injection, it was unspecified if it's for adult or pediatric. The female patient experienced burning and soreness two weeks after the injection. The reporter noted this has never happened before. The patient denied permission to contact their physician. The caller was the nurse practitioner but did not wish any contact. The reporter tried explaining the importance of full information. This was all the information she would give. The nurse practitioner reported that she the batch of ENGERIX-B may had caused the adverse event. The reporter did not wish to provide other specifics, nor wished to be contacted about this report. There was no product to return. This case was linked with case US2018GSK085243, reported by the same reporter.
Initial redness and erythema with 4 discrete erythematous papules at the site of injection. Within 48 h some of those papules had opened and crusted. She developed 10 other discrete papules on chest, buttocks, cheek over next 72h.
Client received a pediatric dose for the first dose of the Pfizer COVID vaccine instead of a regular dose, as the client is/was 12 at the time of administration. Legal guardian was notified. Client will receive a regular dose for 2nd dose. No issues reported.
Swelling of face, hives, start of anaphylactic reaction started 2 hours later. Taken to urgent care and treated patient issues were resolved and sent home with rescue EPIPEN for future.
This spontaneous report as received from a medical assistant via company representative refers to a patient of unknown age and gender. On 25-JUL-2012 the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (dose, route and lot# not reported). It was reported that on 25-SEP-2012 the patient was vaccinated intramuscularly with an expired a second 0.5 ml dose of GARDASIL lot # (666121/1778Y, expiration date 19-AUG-2012). It was reported that the patient was not experiencing any known symptoms. Additional information has been requested.
At 4:30pm on Saturday January 9, 2021 I experience a slight fever with chills and back and neck pain. Nothing alarming. I was still able to carry out my normal day activities that included cleaning, tidying, cooking. I did not check my temperature because there was no need, as I said, I could carry on with my day. My arm hurt a lot that day and there was a rectangular red rash around the injection site. That was about the weirdest part at 5:15pm today (Jan 10th, 2021). I noticed this gnarly rash on my chest and back and both shoulders. Red and a little itchy, warm to the touch. It is now 11:50pm same day and the relish has spread to under both of my breasts and down to the bottom of my back. I have pictures of the rash. No fever today. Also, I am both the patient and a member of the vaccination team at my company. My coworker and I are in charge of all admin associated with the vaccine. We are currently vaccinating all our staff. I was the first to get vaccinated in our company. And here it looks like I have an allergic reaction! I have never had an allergic reaction in the past to an injection. I just took some BENADRYL. I'll show a nurse at my clinic tomorrow. Hoping it doesn't spread anymore.
SYNCOPE & FAINT- GAVE WATER , ORANGE JUICE & FEEL FINE IN COUPLE OF MINUTES (Pt's mom with her also & told us that pt din't eat anything from the morning)
unilateral lymphadenopathy on side of injection, nerve pain, weakness in foot and leg side of injection, chills, muscle aches, nausea
13 days following the first dose of the vaccine, the patient sustained right basal ganglia lacunar stroke.
pt recv vax & was crying;immed p/vax pt had hives on chest & lt leg;pt given 3/4tsp DPH 10min p/rxn;
Patient received Fluvirin 0.5 ml in left dorsotransverse /intramuscularly on 1/23/04. On approx. 1/29/04 pt. noticed runny nose, runny eyes, maybe a slight temp but it was not checked also complained of "bad headache" a day or 2 later. On 2/1/04 pt. stated tongue was numb in AM. By the evening her left side of face was swollen and her speech was slurred. Went to ER that evening, cat scan done and referred to a neurologist. Put on Prednisone and Acyclovir. Still unresolved as of 2/20/04. medical records state facial paralysis. msv
Red, raised area at injection site appeared 9/11/02 (2 days after injection 9/9/02).
I began to experience a terrible headache four days and upper abdominal bloating and pain after my vaccine, so bad that I couldn't walk without feeling like I was being punched in the gut. I had never experienced anything like this. Then I began to notice phlegm in my throat and congestion in my lung. I also began to feel random shooting pains in my left chest and heart fluttering. My doctor had me get an xray which found fluid in my lungs. I somehow gained 7lbs of fluid. I couldn't walk without losing breath and couldn't sleep on my side. He said it was likely pericarditis, pneuminitis, or myocarditis, or a strange virus. He sent me to do a CTA scan to check for a pulmonary embolism - luckily they didn't find one. My bloodwork showed a high d dimer rate. My partner says that my skin was yellow during this time. It all lasted two or so weeks and then cleared on its own.
This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Lot#, dose and route not reported) instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Received Tdap vaccine rt. deltoid on 6/16/08.  Received hepatitis-B vaccine lt. deltoid on 6/16/08.  Became nauseated with vomiting on 6/17/08.  Rt. hand and fingers numbness and tingling on 6/17/08.
tinnitus-fullness in ears, insomia, fatigue, sore throat, earache;
Client received 2nd dose Moderna vaccine 4-19-21.  States he felt tired, weak, and noticed drooping of mouth and face 4-21-21.  States was seen per MD, 4-23-21 and diagnosed with Bell's Palsy and was treated. States symptoms persisted for approximately 3 weeks.  Client's reporting date 4-23-21, and states all symptoms have resolved at this time.
PATIENT RECEIVED MODERNA BOOSTER 0.25CC AT AROUND 6 PM, REPORTED FEELING DIZZY, NAUSEAOUS AND HOT AT ABOUT 6:05PM.  GAVE 50MG OF BENADRYL, BISCOTTI AND WATER AROUND 6:09PM. PATIENT WAITED IN STORE FOR 30 MINUTES AND THEN LEFT (HE SAID HE FELT THE HOTNESS DISSIPATED BUT STILL FELT NAUSEOUS).
Woke up & arm was swelling & hard, red, over the next day the area was 5" long, 3" wide and 1" thick.  It hurt, itched, and it was painful to move my arm except slowly.
Mom said baby was tired after taking the vaccine and when he woke up he only wanted to be held. The baby wouldn't stand and wouldn't move his legs. The mom call EMS and they tried to get him to move his legs and he finally moved his toes. When the dr saw him the next day it had subsided and the child was walking.
Labored breathing/ Shortness of Breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Labored breathing/ Shortness of Breath) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Reported.  Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM 600MG WITH VITAMIN D3) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced DYSPNOEA (Labored breathing/ Shortness of Breath). On 28-Feb-2021, DYSPNOEA (Labored breathing/ Shortness of Breath) had resolved with sequelae.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided for the events experienced after 1st dose.   This case was linked to MOD-2021-076411 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Additional information received: Updated patient information, patient medical history, concomitant medications. On 04-Jun-2021: Additional information received: contains VAERS form and updated adverse event outcome.
Local swelling & redness, nausea,  headache, tiredness & fatigue, muscle aches,  chills, low grade fever
Patient was given covid-19 injection at 5:37pm and moved into recovery area  She signaled us that she was not feeling well and felt anxious.  Assessed her along with our Medical Center clinic nurse.  We went out and took her blood pressure at 5:55pm. Reading was 149/96, pulse 78.  Noticed that she had a rash on her chest and also on her chin.  She reported feeling anxious, but no problems breathing.  She was given 50mg diphenhydramine orally. Blood pressure taken again at 6:04pm 153/91.  Oxygen 100%.  Pulse 75.  Patient remained in recovery area for observation.  Rash started to decrease in redness and size.  No report of issues breathing. Blood pressure repeated at 6:46pm:  145/90, pulse 80, Oxygen 100%.  Patient had driver with her and reported feeling better at last reading before leaving recovery.
Moderna COVID-19 VAccine EUA I was 2 weeks pregnant when I had the first dose and did not know I was pregnant at the time. It is my first pregnancy and date of delivery is October 2021.  Also, a few days after the first dose, my neck area was red, itchy and irritated. I went to the doctor and was prescribed prednisone and hydroxyzine. It went away after a couple of days of taking the medicine.
LARGE BRUISE ON THE SOLE OF THE FOOT; BURNING ON THE BOTTOM OF THE FOOT; THROBBING FOOT; VEIN POPPED UP FEELING ON FOOT; ACHINESS; CHILLS; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no current medications. no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 11:27 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced low grade fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 12-APR-2021, the subject experienced large bruise on the sole of the foot. On 12-APR-2021, the subject experienced burning on the bottom of the foot. On 12-APR-2021, the subject experienced throbbing foot. On 12-APR-2021, the subject experienced vein popped up feeling on foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, chills, low grade fever, and headache on 12-APR-2021, had not recovered from burning on the bottom of the foot, throbbing foot, and large bruise on the sole of the foot, and the outcome of vein popped up feeling on foot was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
On 03/15/2023, he had been having congestion over a couple of days. He was very fussy and inconsolable and we took him to urgent care. COVID-19 test was negative, it was determined to be a virus and he was better in a couple of days. He had a cough for a week.
It caused "my" period to skip; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 27Apr2021 at 17:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. On 21Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative (also reported as prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19). The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified birth control medication from an unknown date and unknown if ongoing. On 28Apr2021, it was reported that it caused the patient's period to skip. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19 (also reported as Yes). The clinical outcome of the event it caused "my" period to skip was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Vaccine given in right arm patient then proceeded to experience right arm pain, dizziness, diplopia, and unsteadiness.
received 2nd dose of covid vaccine 2/27 around 0715 and started having a fever last night around 2200 with lightheaded, body aches, HA.
no adverse effect; multiple patients were administered improperly stored doses; This spontaneous report was received from other healthcare professional (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. The patient's concomitant drug therapy include diluent MRK.  On 16-APR-2019 the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # R023513, with expiration date 16-OCT-2020, (frequency, strength, anatomical location were not provided), administered subcutaneously for prophylaxis (product storage error).   Temperature was reported as -14 degree Celsius to -10 degree Celsius (-11 degree Celsius). Time frame was reported as 30 minutes. -9 degree Celsius to 8 degree Celsius (-7.1 degree Celsius). Time frame was reported as 45 minutes. There was no previous temperature excursion.  No adverse effects were reported. The call was because of a data logger.  This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1904USA009842: US-009507513-1904USA009840:
Within hours the arm in which I received the injection was sore. By 12 hours I had a mild fever of 100 degrees, chills, body aches, and a bad headache. The symptoms listed so far were expected and were gone by about hour 36 post vaccination. However, within 24 hours of the injection a red, raised rash around injection sight appeared.  Slightly itchy and very firm and sore to touch. About 2 inches in diameter. At the time of this reporting the rash has not gone away.
This spontaneous report was received from a pharmacist via company representative refers to a 23 year old female patient. The patient's concurrent condition included asthma and used an unspecified inhaler. Concomitant medication included a flu shot (manufacturer unknown) on same day as PNEUMOVAX 23 but it was unclear if both shots given in same arm. On an unknown date (reported as recent past), the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscularly in the arm (lot#, expiry date and dosage not reported) for pneumococcal prevention. On an unknown date, the patient "felt ill" (not specified) and experienced "a lot of swelling, inflammation to the point where there was no movement in her arm." The patient's parents sought medical attention, contacted pharmacy. The patient went to an emergency room (ER) and was subsequently admitted to an unspecified hospital for an unknown duration of time. It was unknown how the patient was treated in the hospital and when patient was discharged. It was unknown the time frame for the patient's arm to swell and visit to ER/hospital admission. There was no product quality complaint (PQC) involved. The outcome of all the events was unknown. The reporting pharmacist did not provide causality assessment for the events. The event "a lot of swelling, inflammation to the point where there was no movement in her arm" led to patient's disability.
Severe pain at injection sight in left arm. Arm red hot to the touch. This occured after 36 + hours after initial injection of vaccine(s). Nausea and continual crying from pain. Advil given for pain but pain returns after Advil wears off. Ice pack was used 2
@0705 patient started to report slight swelling of lips and tight pressure in chest. No SOB. Also reporting numbness to lips as well.  Same reaction to the initial dose. Patient stated it did not feel worse than the initial time. By 0735, symptoms resolved.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/18/2023 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/18/2023 COMMUNITY ACQUIRED PNEUMONIA
Patient was given the incorrect Pfizer vaccine for dose 1 and 2. Patient was given Bivalent instead of the monovalent for dose 1 and 2. Patient recieved these on 11/07/2022 and 11/30/2022. The patients parents have been notified of the error at a follow up visit by the Physician in the office. Patient reported no concerns.
Hospitalization following COVID-19 vaccination - admitted on 12/7/2021 with fever, cough, and congestion with trouble swallowing secretions
This case was reported by a healthcare professional via sales representative and described the occurrence of swelling of legs in a male subject aged 4 or 5 years old who was vaccinated with KINRIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included PROQUAD (non-gsk) ; Merck; unknown; unknown given on an unspecified date.  On an unspecified date the subject received 1st dose of KINRIX (unknown, right thigh).  Within 24 hours after vaccination with KINRIX, the subject experienced swelling around leg.  At the time of reporting the outcome of the swelling of legs was unspecified.  It was reported that the healthcare professional's colleague had two similar events over the past four weeks; please cases A0883034A and A0883035A.  The representative stated the provider has already reported the events via VAERS.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was in bed with flu like symptoms for a few hours. This case has been linked with US2019GSK022777 and US2019GSK022776, reported by same reporter.
Flu like symptoms; headache; Chills; Lethargy; Runny nose; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from regulatory authority. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; LETHARGY (non-serious), outcome "unknown", described as "Lethargy"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My ears are draining water/my ear got started draining with fluid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 03Mar2021 11:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: ESTRADIOL. The following information was reported: OTORRHOEA (non-serious) with onset 08Mar2021, outcome "not recovered", described as "My ears are draining water/my ear got started draining with fluid". The event "my ears are draining water/my ear got started draining with fluid" was evaluated at the physician office visit.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.