chrisvoncsefalvay/vaers-outcomes huggingface dataset:
congestion; runny nose; cough; left-side headache; PCR test: positive; PCR test: positive; laryngitis; chills; aches; significant fatigue; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative and product quality group. The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 13:00 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies : Sulfa" (unspecified if ongoing). Concomitant medication(s) received within 2 weeks of vaccination included: ALLEGRA. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "PCR test: positive"; IMMUNISATION (non-serious) with onset 12Oct2021 13:00, outcome "unknown", described as "dose number=3"; CHILLS (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 03Jan2022 08:00, outcome "recovering", described as "significant fatigue"; LARYNGITIS (non-serious) with onset 04Jan2022, outcome "recovering", described as "laryngitis"; COUGH (non-serious) with onset 05Jan2022, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 05Jan2022, outcome "recovering", described as "left-side headache"; NASAL CONGESTION (non-serious) with onset 06Jan2022, outcome "recovering", described as "congestion"; RHINORRHOEA (non-serious) with onset 06Jan2022, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, chills, pain, fatigue, laryngitis, cough, headache, nasal congestion, rhinorrhoea.  Clinical course: The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Awareness Date : 06Jan2022. The report was considered as serious.  Follow-up attempts are completed. No further information is expected.
Case number PHEH2014US010051 is an initial spontaneous report received from a nurse on 14 May 2014. This report refers to an adult female patient whose age was in 50s. Her medical history and concomitant medications were not reported. She was vaccinated with an expired dose of FLUVIRIN (batch number: 1308801, expiry date; Apr 2014) intramuscularly on 13 May 2014. No adverse events were reported following the maladministration.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: slurred speech, confusion, possible seizure, minimal right side of body function-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe
vaccine @1539 within 5 minutes of vaccine  left forearm numbness started. Then progressed to wrist, hand, and fingers. b/p 102/62, hr-58, 02 sat 98% ra. 1601 numbness only on palm of hand. 1642 numbness resolved . b/p 104/60. hr-56, r-18, 02 sat 98%ra. Pt discharged to home with husband.
Not feeling well; This case was reported by a other health professional via other manufacturer and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz Xr).   On 24th November 2020, the patient received Shingles vaccine. In November 2020, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were details provided as follows: The age at the vaccination was not reported. The age group was selected as an adult as per vaccine indication. Patient reported had shingles shot and was not feeling well.  Patient was back on Xeljanz with samples from medical doctor office until funding paperwork by medical doctor was completed.  Patient stated missed approximately 2 weeks of Xeljanz due to copay issues, no relapse in symptoms reported. Medical doctor was aware of this only information received from patient.
Redness, swelling, tenderness at site of injection, fever and chills.  Started on antibiotics.
Nausea, joint aches, abd cramping, elevated temp (99 to 100), fatigue, malaise, headache, (all w/onset 16AUG90) lasted 2 wks; Recovered 30AUG90 w/out treatment;
pt recvd flu vax & w/in 48 hrs pt devel baseball-sized induration;
Client stated they were experiencing some tightness in the throat with some numbness and tingling; no difficulty breathing.    Ambulance was called and Client was transported to nearest facility
redness and itching per parent (L) thigh. Went to ER 8-24-08 given KEFLEX. Red area today 8-25-08 4X5 cm (L) thigh
Narrative:  COVID infection following COVID vaccine series 05/27 Janssen, dose #1 09/17 pt cc: chills, cough, fatigue, fever, headache exposure: unknown 10/07 pt admit to ED cc: for covid swab & x-ray dx: Coronavirus LOS: 1 day 10/07 COVID swab, result: detected 10/07 CXT impression: No definite acute cardiopulmonary process.
03/18/22 presents to ED for "fatigue and worsening dysphagia". PMHx of "diabetes mellitus, hypertension and dyslipidemia"
Hospitalization from 12/4/2021 to 12/8/2021,  reason not known, attempt to contact Pt for interview unsuccessful.
Itching site following injection, scalp itching, feet itching later in day-used antihistamine. Continued soreness at site, large red area at injection site 2 days later.
On 13NOV @ 915 pt had sz & was rushed to hosp; later pt had another sz that lasted a minute; MD felt could be from earache;
1.5 weeks after the 2nd dose of COVID vaccine, I had a panic attack at night time. Since that time I had chest pressure, palpitations, frequently could feel my heartbeat, and anxiety from all of that.
MOTHER NOTICED REDNESS AND SWELLING TO SITE OF VARICELLA VACCINE WHEN SHE REMOVED CHILD'S BANDAID.  FATHER BROUGHT CHILD TO HEALTH DEPARTMENT 8/19/09.  THERE IS AN AREA OF 4.5X6CM THAT IS VERY TENDER, REDDENED, WARM TO TOUCH AND SWOLLEN.  APPROX 4 CMS THERE IS A LESION THAT APPEARS YELLOW AND CRUSTY (? IMPETIGO) MOTHER THINKS THAT BANDAID CAUSED THE PROBLEM
Left arm pain, muscle pain, fever, headache, sweats, sleeping excessively in bed for one and a half days
Delayed allergic reaction of a swollen, red, warm welt on arm near vaccination site. Itchy, not painful. Was misdiagnosed on 03/06/2021 as cellulitis.
This spontaneous report as received from a registered nurse refers to an unspecified number of 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 ROTATEQ orally, lot # L013203 with expiration date of 28-JAN-2017, lot # L029615 with expiration date of 15-MAY-2017, lot # M004890 with expiration date of 10-NOV-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 36 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014103.
PATIENT REPORTS INCREASED BRUISING SINCE RECEIVING 1ST MODERNA VACCINE. PATIENT NOTICED DURING USUAL DAILY ACTIVITIES WHICH USUALLY DO NOT CAUSE HER BRUISING HAS NOW STARTED TO CAUSE BRUISING.
Had very cold chill starting about 6:30 pm, about 1:15 am starting to feel better, but arm was still sore and the injection site. soreness site stayed sore  for about another 3 to 4 days, but total top arm around site still sore and aching. Arm is hard to lift up at some times and weak to lift anything up sometimes. Arm feels week for about 2 to 3 days and then starts to fill better. Then after a day of the soreness or no weakness in the arm, it starts back hurting again. It now getting worse at night time and sometimes during the day. Some days it hurts so bad that I can't even move it. I don't bother to tell my wife, because it just last for about a 2 to 3 hours. I have been to my doctor yet. But if it keeps bothering me I will make an appointment to see him.  It just my arm and hand be very weak to use at sometimes every other day.
About 10 minutes after vaccination became pale, unresponsive lasted 3-5 minutes.  See enclosed note. Pt is in today for her pre-kindergarten physical.  Note is in the chart.  She had a syncopal episode after receiving her vaccines.  She received a DTAP, POLIO, MMR, VARIVAX and HEPATITIS A.  Mother states that as she was sitting to her she started complaining that her arm was hurting as they were getting ready to leave.  Then mother said she kind of slumped over and slumped down.  Mother picked her up.  The medical assistant was called in and tried to give her sip of water, then she fainted and fell to the floor.  I was called into the room at that time.  Mother stated that she looked pale prior to her fainting.  No nausea or vomiting.  When I saw her again she was looking pale and was half sitting on mother's lap.  I lied her down on the table.  Her color started to improve.  She was unresponsive at this time; however when I was checking her pulse she did say "Ow".  I put a pulse ox monitor on her.  Heart rate was 75.  O2 saturation's were 95-100%.  She was breathing comfortably.  Heart had a regular rate and rhythm without murmur.  After saying "Ow" she remained unresponsive for about 3 minutes.  Again, her color finally improved.  When I started tickling her feet and her hands she started smiling and again became alert.  After that she remained in the office lying down, gradually sitting up and standing until she was feeling better.  She stayed in the office about a half an hour before mother felt she was well enough to leave.  I spoke with mother on the phone this evening, who states she is doing well.  She is back to herself.  Ate well.  No complaints.  Complains of her arm hurting a little bit and tingling a little bit from her vaccines.  Mother states that Pt has had no history of syncope before.  No history of breath-holding spells.  No history of seizures.  No seizure activity noted during her syncopal episode.  FAMILY HISTORY:  Significant for paternal grandfather with epilepsy and maternal grandfather with some sort of cardiac arrhythmia and hypertension.  ASSESSMENT: Significant vasovagal reaction after vaccines.  No evidence of seizure, cardiac or other etiology.  ? Hypotonic hypotensive episode (HHC) PLAN: Reassurance was given to mother.  Follow-up closely if she has any other syncopal episodes and to let me know.  I will fill out a VAERS report.
PARTIAL BLACK TONGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced partial black tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial black tongue was not reported. This report was non-serious.
This spontaneous report has been received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with GARDASIL (strength, dose, dose number, route and lot # not reported) which was improperly stored. The temperature excursion for GARDASIL was supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. No adverse symptoms reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Started with tree sores in mouth. 2 days later small blisters on tongue and a sore throat.  Altered taste.
I am the school nurse caring for this child. His first Hep A immunization was 03/21/2018. When student enrolled at our school father was instructed to get the 2nd immunization on or after 9/21/2018. Father took child to mobile clinic on 8/18 to get a Varicella and child was also given the Hepatitis A. Father gave staff all recs. I have contacted the  manager of the mobile clinic and left a message. I have not heard back. I then contacted Hospital and left a message. I have not heard back. Immunization was given early. Father states child had swelling to arm and groin area.  Redness to arm as well. Will student have to repeat Hep A in 6 months?
By evening I felt sick. The next three days (Tues, Wed and Thurs), I had a major fever of 101F and chills. By Wednesday, I developed diarrhea and fever blisters all over my mouth and face. My eyes were very stingy. I had a headache. I was very weak. I called the doctor, and I was given a very high-dose of Valtrex for cold sores. The Valtrex made me super dizzy. I took the Valtrex for a week. I am dismayed by the severity of my reaction to my second Pfizer vaccine. I have not been that sick in years and years. I am concerned the dose was too high for me. I have lots of sensitivities and allergies. Have you thought about dose management or does everyone have to get the same dose? I am not going to get a booster if my dose cannot be moderated. I can't express in words how I was sick.
The next day developed laryngitis, annd stuffy nose/head like a bad cold.   This was following my Booster shot.
slight pain at injection site; tiredness; muscle pain; chills; fever; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE PAIN (slight pain at injection site), FATIGUE (tiredness), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (slight pain at injection site). an unknown date, the patient experienced FATIGUE (tiredness), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, INJECTION SITE PAIN (slight pain at injection site), FATIGUE (tiredness), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever) had resolved.
2+ Microscopic Hematuria  Low hemoglobin and hematocrit, decline in RBC (previously all blood work was normal, last check in May 2021 was normal) Worsening of migraines Severe chest pains (cardio check normal) Dizziness spells Palpitations Ringing in ears and hearing loud pulse in ears Mottled skin on upper arms and legs Raynaud?s syndrome  Worsening of chronic pain and fatigue. Progressively worse four months after vaccine Worsening of orthostatic hypotension Debilitating fatigue
2hr p/vax pt devel fever 012, irritability, inj site rxn characterized by warmth & swelling @ the site of vax & loss of appetite;tx w/motrin & APAP, DPH & applications of ice;
vial that was opened and not refrigerated for approximately 20 hours; vial that was opened and not refrigerated for approximately 20 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial that was opened and not refrigerated for approximately 20 hours) and PRODUCT STORAGE ERROR (vial that was opened and not refrigerated for approximately 20 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial that was opened and not refrigerated for approximately 20 hours) and PRODUCT STORAGE ERROR (vial that was opened and not refrigerated for approximately 20 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial that was opened and not refrigerated for approximately 20 hours) and PRODUCT STORAGE ERROR (vial that was opened and not refrigerated for approximately 20 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported No Treatment medications reported
Sore arm like I was punched; Going Numb down the left side  of my body; Diarrhea every hour on the hour; I feel so weak all over; Small stuffy nose; Chills; A spontaneous report was received from a consumer who was an 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm like I was punched, going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose.   The patient's medical history was not provided. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A, Exp. date: 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, the patient experienced, sore arm like I was punched, going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose. Treatment for the events included heating pad for the arm and paracetamol.  On 06 Jan 2021, the patient reported that she felt better. However, the event, sore arm like I was punched was ongoing.   Action taken with mRNA-1273 in response to the events was not applicable.  The event going numb, chills, diarrhea every hour, feel so weak all over and small stuffy nose, was considered resolved on 06 Jan 2021.   The outcome for the event, sore arm like I was punched was not resolved.; Reporter'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.
Initial and follow-up information has been received from a pharmacist concerning a female who on approximately 10-JUN-2008, "yesterday", was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The pharmacist reported in follow up that immediately after the vaccine was given by the patient's physician, the patient began experiencing a reaction that looked like "flat red circle at the injection site that was 3 inches in diameter", which was also reported as " a red circular raised area". The patient spoke to pharmacist to pharmacist to sought unspecified medical attention. Additional information is not expected.
dry tongue; dry mouth; (right eye) very red; (right eye) very itchy; (right eye) very swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: EN9267, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 17Feb2021 09:30 as dose 1, single for COVID-19 immunization (age at Vaccination: 80-years-old) for COVID-19 immunization. Medical history included ongoing anxiety, diabetes mellitus from 1958, hypertension (diagnosed 10 or 13 years ago) and high cholesterol (diagnosed since the patient was in her 40's). Her mother had glaucoma. There were no concomitant medications. Additional vaccines are not administered on same date of the Pfizer suspect. The patient had not received other vaccines within 4 weeks prior to the vaccination, and no AE(s) following prior vaccinations. She had got a flu shot last September, she hadn't gotten any other vaccines since, she also got the shingles vaccine before. On 11Mar2021 the patient experienced (right eye) very red, (right eye) very itchy, and (right eye) very swollen. On unspecific date the patient experienced dry tongue and dry mouth. She had not visited the Emergency room or Physician's office for the events. Patient was using refresh eye drops for her eyes but she stopped using them. She had some condition where she thought her eyes were closed but they weren't but this was from a medication which she stopped taking and it hasn't happened since, she was given the wrong medication for her illness. No investigation assessment done in lab for medical history and, she got her blood test about 2.5 months ago but that was before she received the vaccines. States she cares about her health and sees how many people are dying, and she's older and lives by herself. The disease is very painful and sad and it attacks the lungs, she sees how many people don't care about using protection and it's a mistake, it's a very sad disease. The outcome of the events dry tongue and dry mouth was unknown and rest events outcome was not recovered.  No follow up attempts are possible. No further information is expected.
Caller reports multiple doses of VAXELIS administered since temperature excursion that occurred 16JUN2022. Names of vaccines involved VAXELIS; This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded to Agency on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.
Soreness, swelling, itching pain at injection site. Nausea, aching of joints.