chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started experiencing a lot of pain in my body. I started noticing a big difference in what I was able to do at the fitness center. It has gotten harder for me to walk and exercise. My endurance has drastically declined. I can't do a circuit at the fitness center no more like I used to because of my declined endurance. Before the vaccine I was doing a full circuit, but after the vaccine I just couldn't do the circuit anymore. It was too painful for me. I would get tired and worn out. I just had to quit doing it. I started to get progressively worse over the months. Now I am limping. I am going to an orthopedic doctor. The doctor said that I have are crystals in my joints that's causing my pain. It radiated from my joint to the other parts of my legs. It happens mainly in the left leg. I have a lot of stiffness in my neck. At night I would wake up in pain. This is not normal for me. The bone doctor has not been able to pinpoint what happened. None of the doctors know exactly what happened. This all happened after the vaccine. It is an ongoing issue for me. We are still trying to figure out what's happening. It's getting harder and harder for me to do normal things.
States had Td- 12 hours later had chills and fever continues to have chills/fever muscle and joint aches, denies cough-coughing when on phone advised to go to the ER and see a doctor. 12/11/06 Seen in ER, no treatment presented with rash - knee joint pain, fatigue.
A patient received her first dose of the Moderna-Covid 19 vaccination. Several minutes later, I checked on her. She mentioned her eyes were doing something funny. She reported feeling dizzy and seeing black dots. I took her blood pressure, and it was 98/71. The patient reported having a blood pressure that normally runs high. I gave her some water and an ice pack. A Code white was called. I waited 5 minutes and attempted to check her BP on the alternate arm, but the machine would not read. This happened 3 more times even with alternating arms. The patient continued to report feeling faint and began to be lethargic and only mildly responsive. EMS was called and came on the scene several minutes later. The patient did not exhibit issues breathing at any time. The patient left with EMS.
Patient reported rash at injection site on right arm (not left that was written on immunization consent form). Symptoms per patient, were itching and rash that occurred shortly after being given immunization. Informed patient that they should take diphenhydramine to deal with the itching and to see their doctor.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced cellulitis, very high fever, redness, swelling all on an unspecified date with outcome of unknown. The patient was treated with antibiotics for cellulitis. The events were assessed as non-serious.
FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue. This report was non-serious. This case, involving the same patient is linked to 20220610242.
I vomited a few hours after the flu shot was administered. Very violent emesis episode. I'm not sure when the vaccine was administered but it was in Nov or Dec of 2014.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant medications was not provided. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23, strength, dose and frequency were unknown (lot # N030987, expiration date 15-MAY-2019) intramuscular for prophylaxis. Administered dose experienced temperature of excursion of 47 degrees Celsius to 77 degrees Celsius for 100 hours. There was no previous temperature of excursion. Data logger was involved.
5 hours after vaccination patient experienced minor HA, nasal congestion, "funny" throat. Next morning PT went to clinic with extreme HA, sweats, nasal congestion, "funny" throat. Clinic dispensed APAP and Benadryl. Told PT to continue these meds and rest. PT to return if symptoms persisted or worsened.
Breakthrough case admission after 5 vaccines Pfizer 2/9/21 Lot# EL9267;  Pfizer 3/2/21 Lot# EN6202;  Pfizer 11/8/21 Lot# 301358A;  Pfizer 4/24/22 Lot# FK9894;  Pfizer 10/20/2022 LOt# GJ2524
cold chain break is reported with no reported adverse event; poor quality vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA124713 and 2023SA129811.  This case involves Infant and unknown gender patient for whom poor quality vaccine HIB (PRP/T) vaccine [ACT-HIB] administered of which cold chain break with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date the cold chain break is reported with no reported adverse event (product storage error) and patient received a dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with unknown strength, dose, batch number, expiry date via unknown route in unknown administration site for prophylactic vaccination was administered with no reported adverse event (poor quality product administered) (latency: same day). Batch number was requested.  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 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.
accidentally gave a 2 month old baby PENTACEL resulting in an extra does of HIB with no adverse event.;Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via phone call (under Medical Information Inquiry Number: 00843694).  This case involves a 2 months old male patient who was accidentally given a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] resulting in an extra dose of HIB with no adverse event (extra dose administered).   The patient's medical history, past medical treatments, vaccinations, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and ROTAVIRUS VACCINE for prophylactic vaccination.  On 24-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: uJ424AAA and expiry date: 21-May-2022) via intramuscular route in the left thigh (left vastus lateralis) for prophylactic vaccination.   It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported "Caller states that she gave a two-month-old a pentacel injection and a pediarix which resulted in the patient receiving two doses of dtap and ipol. Caller states that she reported the incident to the physician, but she just wanted to check with the manufacturer."  At the time of reporting, no adverse event was reported.  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 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.
INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs-  no fever
ARM SWELLING; ARM HARD; ARM PAIN; FATIGUE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced arm swelling. On 31-MAR-2021, the subject experienced arm hard. On 31-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from arm swelling, and arm hard, and the outcome of arm pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Information has been received from a RN concerning a 15 yr old female who was vaccinated with a dose of varicella virus vaccine live. On 08Jun05 the pt was seen at the health dept with various red spots (approx 25) behind the knees, along the waist at her back, few on her face. Initially the spots appeared as fluid filled papules then began to scab. The nurse practitioner said the spots looked "more like chiggers and the location on the body were along skin folds and underwear lines. However, it was reported that the pt was in bed all day not feeling well the day before. The parent was advised that the rash could represent varicella disease but cannot rule out other etiology such as insect bites and to consider the child contagious for at least 4-5 days until all of the area are scabbed over. The nurse also reported adverse events experienced by the child's siblings after receiving varicella virus vaccine live (WAES0507USA0715, 0507USA03558, and 0507USA03559). Additional information has been requested.
er records indicate pt noted to pass out with seizure like activity, taken to er and found in status epilepticus, stabilized and transferred to tertiary care facility.  tertiary center records not yet available but report from family indicates ongoing seizures as well as recalcitrant cardiac arrhythmias.  Pt was intubated and never recovered despite 3 days care and resuscitation.  Autopsy report available to me indicates lymphocytic myocarditis as  primary cause of death
redness on spot; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had redness on spot. For tolerances of 2nd dose of Shingrix, refer case US2019AMR211850.
Recieved Moderna vaccine on 2/2 at 10AM. Shortness of breath symptoms at 2pm. Adverse effects started at 10PM- extreme body aches. 2/3 at 3:00am took temperature 102F fever. Admitted to Urgent Care Facility at 7AM. Doctor ran EKG test, X-ray lungs, checked breathing with stetoscope. Given benadryl, tylenol, Albuterol treatment, and liquid steroid to open the chest. Recieved a COVID-19 test. Results = Negative. Fever lowered to 98F before being released at 9:30AM. Shortness of breath still persistant with cough, nausea, and shortness of breath on 2/4/21.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (large burning welt where ther injection was) and PAIN IN EXTREMITY (arm hurt and was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Muscle spasms, Dysautonomia, Lung disorder (Frozen Lungs) and Bladder infection. Previously administered products included for an unreported indication: botox (doctor injected into paraspinous muscles to stop muscle spasms). Concurrent medical conditions included Paralyzed (Patient was already paralyzed from  an intramedullary, Spinal cord, tumor.), Headache (Constant Headache) and Hypertension. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (large burning welt where ther injection was) and PAIN IN EXTREMITY (arm hurt and was sore). At the time of the report, URTICARIA (large burning welt where ther injection was) and PAIN IN EXTREMITY (arm hurt and was sore) had resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: high (High) high. On an unknown date, Blood glucose: low (Low) low. On an unknown date, Blood pressure measurement: high (High) high. Concomitant medication included a monthly infusion of Intravenous immunoglobulin (IVIG). Patient had phone visits with G.I, Pulmonologist, Dermatologist, PCP, and Neurologist several times. Pulmonologist thought patient had Long Hauler Syndrome. Patient was never tested for COVID. Patient reported that Moderna Vaccine and monthly IVIG infusions helped to get rid of the botox, after suffering extreme symptoms for 6.5 Months.
rt deltoid present w/swelling, 1+ warm to touch w/reddness; pt c/o pain to area; no fever present; instructed to use warm compress to area & APAP;
Flu shot given. 4 hours later pt called asking about swelling, lump that was sore on her face near left ear & jaw. Not red.
Vision issues, hard for my vision to focus correctly, confusion, short term memory problems, headaches, white welts on my thighs.
patient reported feeling light headed, dizzy, eyes closed. drank some water. recovered quickly (within 20 minutes). stated that he always feels that way after a vaccine, blood draw, declined emergency support or additional support measures
Heart palpitations that started 2 hours after injection. Continuous since 11.23.21. Heart rate between 150-160. Abnormal EKG. Swollen lymph node the size of a softball under arm
persistent screaming for 24 hrs; no sleeping; irritable; fever >102 for 36 hrs;
14 patients administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-385976 (Patient Link).
Site red et pt. c/o itching - BENADRYL 12.5mg IM - Rt deltoid.
got A Fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male 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: ATRIAL FIBRILLATION, outcome "unknown", described as "got A Fib". Clinical courses: age was reported as 63 without unit provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DId not know body site of injection Worsening confusion, exposed at a birthday party  daughter wanted patient to come in / patient was very cofused per daughter  patient is poor historian dry cough at exam considelation on right lower love on chest x-ray  patient did an infusion on 7/12 casirivimab-imdevimab  patient was admited on 7/18/2021 to hospital.
Starting at 2:00 pm 12/21/21 patient experienced vertigo, nausea and headache.  At 4 pm 12/21/21 began having chills.  Experienced chills nights of 12/21, 12/22 and 12/23.  C/O headache since 12/21/21.  At injection site redness and tenderness developed starting 12/21/21.  In the days since the redness and tenderness and spread around arm.  C/O decreased appetite since receiving vaccines.  This nurse encouraged patient to see her healthcare provider.  Voiced understanding.
headache; This is a spontaneous report from a contactable consumer (patient).  This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 28Dec2020 11:15 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache on 28Dec2020 23:00 with outcome of recovering. She rarely gets headaches, works in the hospital in pulmonary rehab as a coordinator. She will be going for a COVID test today.  Information about lot/batch number has been requested.
My son did not sleep well during the night and the next morning when I changed him he had big red blotches on his back. I called his doctor and were able to get in. She doctor did an exam and was stating she thought it was eczema but wanted to make sure it was not hand foot and mouth which is going around. He does not go to day care or anything so that was ruled out. She gave us a cream for the rash and in about two days it cleared up. He did get other vaccines the same day but I do not have all the information for them but he also got DTAP, Pneumonia, and Hep B on the 9th when he got his COVID-19 vaccine.
ADMINISTERED UNDILUTED PEDIATRIC VIAL, DOSAGE 0.3ML VOLUME.
Overnight and each night my right hand cramped into a fist that I could not open. In the mornings, I regained use of my right hand by pulling it open with the left and exercising it for awhile. The condition persisted, then went away and did not recur.
Uncomplicated urticaria - periperal only 1-2 hours after vaccination. Treated with oral BENADRYL.
Patient came in for a Moderna Vaccine but received a Janssen Covid Vaccine.  Did not know that there were still signups available on our website scheduling system, so I did not know that he was coming specifically for a Moderna Covid Vaccine.  Usually we do let them know it is the Janssen one shot vaccine, but in this case I did not.  He was provided with the information about the vaccine but after it was administered.  Patient was very upset and really wanted the Moderna.  I apologised for the error and I immediatly took any mention of the Moderna vaccine off of our website and scheduler.
Patient received first dose of Moderna - Covid-19 Vaccine on February 4, 2021 and was scheduled to receive her second dose of Moderna-Covid-19 Vaccine on March 4, 2021.  She inadvertently received a Pfizer-BioNTech Covid-19 vaccine for her second dose instead of the intended Moderna-Covid-19 Vaccine.
Patient diagnosed with cellulitis 10 days after receiving varicella vaccine. Treated with PO Keflex and resolved.
vaccine gave her the shingles / in her Back and arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The reporter was patient spouse. The patient experienced shingles in back and arm. The reporter stated that the vaccine gave the patient shingle.   The patient did not have symptoms of shingle before. The reporter stated that the patien's shingle was treated. The information regarding consent to follow up was not reported. Call got disconnected. The reporter was called back twice but unsuccessfully. A voice mail was left with GSK phone. No additional information could be provided or collected.
Similar to the first dose that I had not fully recovered from the first dose but I had similar reaction within 24 hours of all over joint and aching w/brain fog but this time it lasted two weeks. It also subsided into the joint knee, ankles, and feet. On July 22, 2021 I did seek care from my PCP and she did labs but I didn't follow-up until after booster. My labs were normal. I would say that I mostly recovered from this but not entirely.
This spontaneous report was received from a registered pharmacist concerning a 24 year old female patient who on an unknown date was vaccinated with a dose of MMR II (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated the patient might have had a negative titer for mumps but the pharmacist could not confirm that titer result. The pharmacist was not sure if patient received MMR II as a child or MUMPSVAX. The pharmacist stated that the patient went in for a booster shot for mumps (unspecified) only. The outcome of negative titers for mumps was unknown. The relatedness for negative titers for mumps was unknown for MMR II. Additional information has been requested.