chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was administered to a patient after the expiration date with no reported adverse event; Initial information was received on 20-May-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 65years old male patient to whom vaccine was administered to a patient after the expiration date with no reported adverse event while receiving vaccine Typhoid VI Polysaccharide Vaccine [Typhim VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Toxoid, Vaccine Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) for Immunisation.  On 20-May-2022, the patient received 0.5ml dose of suspect Typhoid VI Polysaccharide Vaccine (batch/lot number: T2a371m) (formulation, strength, expiration date: unknown) via unknown route in unknown administration site for immunization after the expiration date with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event (expired product administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I received the vaccine around 10:40 am on January 8th, 2021. My arm was a little sore that night, but nothing too bad. I took some ibuprofen before I went to bed (400mg, I think). I felt fine the morning of January 9th; I went and bought some groceries and then took a walk in the neighborhood. I did get pretty chilled while walking since it was so cold. When I got back to my apartment around 2:00 I took a nap, then took a very hot shower trying to get warm again. Around 3:00 pm my arm started to become noticeably more sore so I took ibuprofen (600mg). Between 3:15 pm and 3:30 pm I suddenly started to feel warm and nauseous. I felt light-headed and while I was upright (standing or moving around) I would get some black spots in my vision. I went and lay down around 4:00 pm. I stayed in bed that whole evening with a fever (at its highest, 102), I was pretty nauseous, my arm hurt to the point where I couldn't move it and my wrist and hand felt very weak. I took some more ibuprofen (maybe another 600mg?) sometime after 8:00pm. The next day, Sunday January 10th, I mostly stayed in bed and ran a light fever (99.9) and was very fatigued. Arm was very sore and I had limited use of it until the latter part of the day. Monday, January 11th, I felt mostly fine, I could use my arm with no issue, but I stayed home from work due to the fatigue. By Tuesday I was fairly normal, just tired.
Enlarged lymph nodes in armpit. Unable to move arm. Missed work and graduate school obligations
Slight swelling upper (L) chest wall - tender to touch. No swelling, redness, or pain at vaccine entrance of (L) deltoid. After receiving vaccine - worked out at gym - next morning above symptoms appeared.
It felt like I drank something to hot. My mouth was very tingly. I stuck my tongue out and looked at it in the mirror and it was very white. It was very white on Saturday, and continued to be white on Sunday, then, on Monday, the white cleared up, but it was still a little bit tingly.  I'm trying to make an appointment with my doctor, but they haven't called me back yet.
expired dose of Daptacel was administered to a patient with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other health professional on 07-Oct-2020.  This case involves a 17 month old male who received a dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (FLU), HEPATITIS A VACCINE (HEPATITIS A) and HIB VACCINE (HIB) all used for prophylactic vaccination.  On 07-Oct-2020, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Lot number-C5523BA, expiration date- 30-Sep-2020, once dose) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication due to expired vaccine used. (latency: at the same time of vaccination)  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dehydration; incredibly irritating dryness, dry mouth; incredibly irritating dryness, dry mouth, dry skin; Bloody nose; Gastrointestinal issues; Stomach pains; Difficulty breathing; Congestion; Muscle pains/ Sore muscles; Feet pain; This is a spontaneous report from a contactable consumer, the patient. A 17-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 28Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The medical history included aspergers syndrome(ASD), attention-deficit hyperactivity disorder (ADHD), depression and anxiety. It was unknown whether the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The concomitant medications included citalopram (MANUFACTURER UNKNOWN), lisdexamfetamine (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if on going. On 29Apr2021, the patient experienced dehydration, incredibly irritating dryness, dry mouth, dry skin, bloody nose, gastrointestinal issues, stomach pains, difficulty breathing, congestion, muscle pains, sore muscles and feet pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dehydration, incredibly irritating dryness, dry mouth, dry skin, bloody nose, gastrointestinal issues, stomach pains, difficulty breathing, congestion, muscle pains, sore muscles and feet pain were not resolved 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 stated she received the second dose of the Moderna vaccine on 03/30/2021. Stated later in the day, she noted that her right eye was watery. Also stated that the right side of her mouth was drooping. The following day, noted some heaviness and swelling in the right eye and could not lift the eyebrow. Patient was seen at the ER on 03/31/2021. Patient was diagnosed with Bell's Palsy and prescribed steroids. Patient was referred to follow up with PCP.
Skin on upper arm where injection was received became itchy, red, and warm to the touch and developed hives off and on during afternoon and evening.
hypersomnolence;shallow resp for good hr-no tx pt responded p/brought in by mom;
Many many balls in both hands. No itching, no burning, and after the medications my hands completely peeled off and it's still like that.
The patient described redness, itching and swelling at the injection site that persisted for 1 week. Patient's brother is a physician and the brother recommended Benadryl and Hydrocortisone on the site.
Client very nervous prior to receiving shots. After receiving the 2 vaccines, she was alert, talking, color slightly pale. Suddenly, about 2 minutes after vaccination, clients eyes. Fluttered, color pale and began to slump in chair - completely fainted. Revived with seconds with smelling salts. After resting and sipping H20 x 15 min, client left facility to sit in car before leaving > 15 min later.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 12-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Received Moderna COVID vaccine #1 at 1207. Experienced tingling, chills BUE 7 minutes after vax admin. Then seeing black dots, head felt heavy, nausea, tingling now BLE as well as BUE, and rash beginning to anterior chest. Did not give diphenhydramine in vaccine clinic because patient nauseated.  ED Charge nurse called and patient transported to ED for treatment.  She received IV diphenhydramine  and experienced vertigo, then given 1 dose of meclizine and IV fluids.  Symptoms resolved, including rash.  Discharged from ED at 1718.
Pt was scheduled to receive her 2nd dose of Moderna ( Covid 19).  She received her 1st dose at another facility.  Nurse administrator injected pt with Pfizer Vaccine instead of Moderna.
Low grade fever of 100.0 degree; This is a spontaneous report from a non-contactable nurse (patient). A 24-year-old female patient received the first dose of BNT162b2 (Lot number: ELO142), via an unspecified route of administration at right arm on 06Jan2021 13:00 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included citalopram, venlafaxine, methylphenidate hydrochloride (CONCERTA), diphenhydramine hydrochloride (BENADRYL). The patient experienced low grade fever of 100.0 degree on 06Jan2021 18:45. It was unknown if the treatment received for the adverse event. The patient was not pregnant. The outcome of the event was recovering.   No follow up attempts are possible. No further information is expected.
MRN 2941254 -Loyola med ctr. racing heart around Jan 11/13 for week to 10 day. got immediate care and got Ablation done in Feb 4 2021...Not sure but heard of this  side effects in news.. but could be related to my HEART ISSUES. but i was fine before ALL ECHO/STRESS/EKG all ok. !st shot might have hit nerve? slight pain even now and bother me to sleep on that side /radiate slight pain to shoulder/right chest? not sure?
11 Doses administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the Moderna vaccine put out of the freezer on 01-Dec-2021 and placed in the refrigerator , so it was not supposed to be used beyond 31-Dec-2021 but 11 doses were administered on 5-Jan-2022. And also stated that the vial did not undergo any temperature excursions.  No concomitant product use was provided. No treatment medication was provided.
fast heart beatings; feels uncomfortable and scared; feels uncomfortable and scared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart beatings"; DISCOMFORT (non-serious), FEAR (non-serious), outcome "unknown" and all described as "feels uncomfortable and scared". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received second dose on 28Sep2021, after that she started to feel fast heart beatings, occasional in the beginning but now it happens every day, even more than one time a day. She reported that she never felt this before the vaccine, that she is a healthy person who usually exercises; she practices swimming and walking. Her doctor find the heartbeat abnormal, Patient describes this as a very fast heartbeat like her heart is getting out of the chest or like getting out of the mouth, she feels uncomfortable and scared. Her doctor recommended to visit a cardiologist. Patient asked for the frequency that this adverse reaction is reported, if this will be a long term or short term lasting effect and if she would be vaccinated with booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
circular rash at the injection site; left arm was itching around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (left arm was itching around the injection site) and VACCINATION SITE RASH (circular rash at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (left arm was itching around the injection site). On 12-Feb-2021, the patient experienced VACCINATION SITE RASH (circular rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (left arm was itching around the injection site) and VACCINATION SITE RASH (circular rash at the injection site) 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.
APPPROX. 1 HR. AFTER VACCINE GIVEN, BEGAN EXPERIENCING JOINT PAIN, ESP. IN NECK THAT PROGRESSED TO HER FINGERS, TOES, LOWER BACK, AND KNEES.  THE FOLLOWING DAY BEGAN DIAPHORESING. ONE AND A HALF DAYS LATER, TEMP 100.8 AND COMPLAINS OF STIFFNESS EVERYWHERE.  HAS TAKEN MOTRIN 800 MG. BUT NOT CONSISTENTLY AND APPLIED HEATING PAD TO AFFECTED JOINTS.
Injection site pain and itching. Pain severe enough to disrupt sleep (pain scale 7-8).
Myalgia & Fever Narrative:  Yesterday I received my second vaccine and in not feeling well, I have body aches chills, fatigued, a slight temp of 99.1 and headache.
Varicella - Information has been received from a registered nurse concerning a 5 year old patient who in approximately April of 1999 was vaccinated with varicella virus vaccine live.  On Approximatly 20 Apr 2000, the patient developed varicella.  The patient sought unspecified medical attention.  Follow up information from a registered nurse indicated that she does not have any additional information.
7 days after injection, site started itching and developing hive type bumps. Swelling started an hour or so later. The swelling started as a golf ball and swelled to the size of a softball and was hot. Went to the doctor Wednesday at 11 and was prescribed methylprednisolone tablet pack. Swelling is down and feeling much cooler.
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 1993 the patient was vaccinated with a three dose series of hepatitis B vaccine (manufacturer unknown), and may have also received an extra dose, (dose, schedule, route, anatomical location, lot number and expiration date were unspecified) at that time. Concomitant therapies were not reported. Since an unknown date and at the moment of this report, the patient experienced hepatitis B antibody negative. The related between hepatitis B antibody negative and Hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Pain in diaphragm within one minute of vaccine, shortly followed by shortness of air. Vision disturbance, numbness in face/neck, tingling in hands, hives on chest/neck area, tachycardia.
GAINED THE ABILITY TO SET THINGS ON FIRE WITH MIND; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced gained the ability to set things on fire with mind, and slight fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight fever, and the outcome of gained the ability to set things on fire with mind was not reported. This report was non-serious.
LAT swollen, hard and red. Very painful for my son. Red area was approximately 2 inches morning of 10/15/2013. By next day, read area had increased to 4-5 inches in width. I have photos with ruler if you like. Now, on 10/18/2013, redness is subsiding but his skin is discolored and he still has a large hard area. He has had NO previous problem with any vaccines.  No treatment other than cold pack for his comfort at home because it is impossible to get through staff to contact/be seen by pediatrician, and the med group's urgent care is horrible (For instance, I was gravely ill from electrolyte imbalance when they repeatedly refused treatment to me during a viral illness.)
Shingles; Information had been received on from a lawyer and the patient (pt), regarding a case in litigation referring a female pt of unknown age . Medical history, concurrent conditions, and concomitant medication were not provided. In 2016, the pt was inoculated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, route, anatomical location, lot number and expiration date were not provided) long-term prevention of shingles and zoster-related conditions. Subsequently vaccination, the pt was treated by a healthcare provider for shingles.As a direct and proximate result of pt's use of the Zoster Vaccine Live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies.
This spontaneous report as received from a physician refers to a 6 year old male patient. The patient's pertinent medical history included eczema. The patient had not drug reactions/allergies. On 17-NOV-2014 the patient was vaccinated with a dose of (Oka/Merck) PROQUAD (lot # J007859, expiration date 28-DEC-2014, subcutaneous, dose and dose # not reported). Other suspect therapies included RECOMBIVAX HB (lot# J007298, expiration date 05-FEB-2016, intramuscular, dose and dose # not reported), a polio vaccine by Sanofi Pasteur and a hepatitis A vaccine by GlaxoSmithKline (both on 17-NOV-2014, lot#, dose, dose#, route and indication not reported). The reporter reported that his patient was pretreated with an unspecified dose of ibuprofen (unspecified manufacturer) before receipt of these vaccines. The physician reported that after receiving these vaccines, on 17-NOV-2014, the patient began crying, itching and complaining of a stomach ache. The patient's mother attempted to take the child home, but the child broke out into diffuse hives and the child was brought back to the office within minutes of leaving. The physician reported that upon assessment, the patient was very uncomfortable and had a mildly elevated temperature and elevated heart rate with a stable respiratory status - pulse oximetry above 94% throughout this episode. The patient was administered an unknown dose of BENADRYL as treatment and observed for one hour. It was noted that the patient's hives were almost completely resolved and his heart rate was down. The patient ws then sent home with his mother. The outcome of the events was reported as recovered on 17-NOV-2014. No product quality complaint PQC involved. Additional information has been requested.
So many of my friends got sick every year after getting the shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020. This case involves a patient of unknown demographics who reported that so many of my friends got sick every year after getting the shot (Illness), while received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.  On an unknown date, the patient stated that so many of my friends got sick every year after getting the shot (Illness).  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Had a fever, with coughing and a headache. Took a home COVID-19 test and was positive. Had a telehealth appointment and was prescribed PAXLOVID. Finished course of medication and waiting to feel better.