chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Less than one minute after injection into the right deltoid, an area of bright redness appeared superior to the injection site that quickly spread across right shoulder and across front of throat.  No breathing difficulty was noted.  Lungs were auscultated and were clear bilaterally all fields.  However, it was noted that employee had an irreg/irreg heart sounds that was not known of ever before.  Employee complained of vertigo and nausea, became pale and weak and was sent to the local ER across street for further evaluation.  Lung sounds remained clear during monitoring of employee post vaccination.  Mother reports that she had done this before during infant vaccinations but never since.  Employee did not report this in pre-vaccination evaluation as she was unaware of it. Mother reports no prior cardiac history of any kind. Mother transported to ER located across street. Outcome is unknown at time of writing.
Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 28-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, 5 microgram/0.5 ml injection, thimerosal free (TF), lot # L014418, expiration date 13-APR-2017 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursion. The storage criteria and the type of excursion (R/F) were refrigerator (R). The lowest recorded temperature (Fahrenheit degree (F)) and total cumulative excursion time (hour) was 34 F for 40 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Spontaneous seizure 31 1/2 hours, post vax. Mom of client noticed client to be more quiet. Taken to ER and seen for fever of 104F (R) and seizures. Temperature responded to rectal suppositories of Tylenol and po ibuprofen but a repeat seizure occurred when temperature returned. Incident lasted for 2 days.
I had both doses of the vaccine, but got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both doses of Shingrix vaccine and got shingles. The patient stated did this mean the vaccine was ineffective for him/her. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Cough SOB Muscle or body aches, New loss of taste or smell, Congestion or runny nose and Diarrhea
Rash/breakout all over face and neck - very itchy. Vaccine was given Saturday, side effects started Monday.
Note: must contact doctor for specific names and lots of vaccine.  9/25/19 MA put the syringe for Tdap in the very top of left shoulder about 2 fingers below the bone nowhere near my muscle. Evening I didn't feel well, thought normal from flu vaccine. 24 hours after shot I could not move my left arm in any direction. The pain was excruciating, my arm was heavy. I felt awful, completely wiped out and could barely stay awake. Right arm at site of flu shot was sore but normal.  9/26/19 extreme pain, no range of motion, felt like vibrations or contractions shuddering from my shoulder to fingers in tetanus arm. 9/27/19 could not get out of bed, could not move left arm, extreme pain, fever. 10/1/19 called doctor spoke with nurse told me to get to a Clinic today is 10/14/19 I have 25% range of motion back but I get shooting pain whenever I move arm in certain directions.
Patient forgot that she already had a flu vaccine (Fluarix) back 11/18/21, she came to our pharmacy requesting a flu vaccine. System was checked and said that she is due for a flu vaccine. She has two profile in system that is unknown to pharmacy, under different last names. Patient said she is fine on 2/4/22 when check in.
At 4 15 pm on 1/14/21, 7 hours after the injection, I developed full body chills and Myalgia.  The symptoms were relieved with Ibuprofen and Tylenol.  They persisted for over 24 hours.
My arm was sore at the injection site,achy,itchy, and no signs of rash. If touched feels warm and noticed lump.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 27L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 22-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no treatment medication reported. No maternal history of subfertility was reported.  On 01-Sep-2020, it was reported as the estimated date of conception. On 24-MAY-2014 it was reported that 1st pregnancy ended with live, full-term birth. On 06-DEC-2016 it was reported that 2st pregnancy ended with live, full-term birth. There was no family history of congenital anomalies/genetic disease.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Injection site pain radiating down into the elbow, up the shoulder and into the neck. L arm was sore first week but worsened the 2nd week and is not having  mobility issues with terrible constant pan.
12/5/21   presenting today for loss of smell (started 40 mins ago, chills, runny nose x2 days ) History:  C/o chills, body aches, nausea x 4 days Loss of taste and smell today History from patient and mother He is fully vaccinated against Covid
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's comment: Clinic manager stated that that a patient was administered dose of Havrix that had expired.  The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up via email. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022162501:Same reporter US-GSK-US2022162505:Same reporter US-GSK-US2022162503:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162508:Same reporter US-GSK-US2022162509:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162503:Same reporter
Patient went vasal bagel in the waiting room post receiving the 2 above mentioned vaccines during a routine office visit. Pt was alert at the time of the fall and assisted to the floor by mother from my understanding as I did not witness the event.
Discharge Provider:  MD Primary Care Provider:  DO Admission Date: 3/12/2023 Discharge Date: 3/14/2023  PRESENTING PROBLEM: Hypoxia [R09.02] Generalized weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: Pt is 79 y/o female with past medical history of afib, diastolic dysfunction, vertigo, hld, hypothyroid who presented with SOB, weakness and dizziness. She had been known covid positive and was placed on paxlovid by primary care but unfortunately did not tolerate 2/2 side effects. In ED, pt was hypoxic with ambulation. CXR, cbc, cmp largely unremarkable. EKG did show new t wave depression in V3-V6, hstrop flat at 10->14->12. She was admitted for further treatment.   Following admission, pt was started on remdesivir. She did not require any further oxygen.  Her dizziness resolved. Orthostatics were found to be positive but improved the following day after oral hydration and TED hose applied.  Tsh was found to be elevated consistent with subclinical hypothyroidism. She was counseled to follow up with PCP to discuss changing synthroid dosing. She was seen by OT and no needs identified, PT offered eval but pt and husband declined. On day of discharge, pt was ambulatory to the restroom without dizziness. Husband felt comfortable with discharge home, no additional needs identified, she does have walker available at home.
FULL BODY ACHES; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 60 year old female. 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:20 to left arm deltoid muscle for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 02-APR-2021 05:00, the subject experienced full body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body aches, chills, and headache on 02-APR-2021. This report was non-serious.
Came down with Laryngitis 2 weeks after COVID-19 vaccine. Took a home COVID-19 test and it was negative. Had it for 6 weeks then had a telehealth appointment with my doctor and was prescribed antibiotics and an inhaler. Finally started feeling a little better, and was out doing errands, started to have a coughing fit and pulled into my doctors office. In examination my pulse was 158, O2  levels were 92. Had blood work taken and given an EKG, resulted in new onset Afib. Was referred to a Cardiologist and had an EKG and a 3D Echocardiogram and a Stress test with injection. On follow up said I have heart failure with a 35% ejection fraction, without blockage and was started on ELIQUIS, metoprolol; ENTRESTO; carvedilol; JARDIANCE; LASIX. Doctor had me stop taking insulin and MOTRIN, was later taken off metoprolol and insulin. Two months later started spotting and went to Primary doctor, and was tested positive for a Urinary Tract Infection, given an antibiotic, but it didn't subside. I called GYN doctor because it was vaginal bleeding and had an Endometrial Biopsy, Pap Smear and an Ultrasound. Was diagnosed with Uterus Cancer FIGO. Am being referred to an OBGYN Oncologist.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On 17-DEC-2007, the patient was vaccinated with the first dose of GARDASIL (lot# was reported as 0234U with expiry date: 30-SEP-2009). On 14-MAR-2008, the patient was vaccinated with the second does of GARDASIL (lot#: 655604/0052X with expiry date: 08-JUN-2009) and with the third dose on 26-JUN-2008 (lot#: 654272/0073X with expiry date: 18-JAN-2009) (dose, route of administration and indication unspecified for all). No concomitant medications were reported. All of GARDASIL products listed were stored at 12C for a 6 month time frame. Excursion was not supported. No adverse effects were noted by patient. The pharmacist wanted to know if revaccination was required. Lot number 0234U is an invalid lot number for quadrivalent human papillomavirus recomb vaccine. This is one of several reports from the same source. Additional information has been requested.
Six days after injection there appeared a redness around shot site, warm and itchy. It is about 1 1/2 inches wide and 4 inches long.
Patient came into clinic for Annual Physical. Patient need immunization combos of Proquad and Kinrix. Patient was administered Prevnar 13 instead of Proquad. This will be patients fourth dose of Prevnar 13.
Underarm glands became extremely sore and swollen four days post shot and rash appeared at injection shot one week post shot.
Arthritis flare up in right hand. Severe swelling at knuckles with stiffness and pain making hand unusable and extremely sensitive to touch.  After 10 days some lingering stiffness in finger joints but swelling and pain gone. Took Tylenol at night to sleep. Never had an incident like this before even though arthritis diagnosed from X-ray about 5 years ago.
Second dose not received in allowed timeframe; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received in allowed timeframe) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not received in allowed timeframe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received in allowed timeframe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL.  Subsequently the patient developed vaginal bleeding.  The number of vaccinations was not known.  The timing of the incident or whether it was resolved was not known.  No additional information is available.  Additional information has been requested.
after the 2nd dose she started to have issues with her left foot/serious problems with her feet and legs ever since; both of her feet and legs swelled up, they are puffy at touch; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (after the 2nd dose she started to have issues with her left foot/serious problems with her feet and legs ever since) and EDEMA PERIPHERAL (both of her feet and legs swelled up, they are puffy at touch) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced LIMB DISCOMFORT (after the 2nd dose she started to have issues with her left foot/serious problems with her feet and legs ever since) and EDEMA PERIPHERAL (both of her feet and legs swelled up, they are puffy at touch). At the time of the report, LIMB DISCOMFORT (after the 2nd dose she started to have issues with her left foot/serious problems with her feet and legs ever since) had not resolved and EDEMA PERIPHERAL (both of her feet and legs swelled up, they are puffy at touch) outcome was unknown.            No relevant concomitant medications were reported.  Treatment products included diphenhydramine (Benadryl) and 2 different antibiotics.   This case was linked to MOD-2021-218749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: TCR Follow up received on 02-JUL-2021 contains Non-Significant information, Mailing address updated.
BP which was very low (97/56). Symptoms cleared in about 2 hours. BP high 168/90; Extreme muscle weakness (unable to walk); grogginess; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Extreme muscle weakness (unable to walk)), SLEEP INERTIA (grogginess) and BLOOD PRESSURE ABNORMAL (BP which was very low (97/56). Symptoms cleared in about 2 hours. BP high 168/90) in a 71-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-96) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Hospitalized) in July 2023.    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 27-Oct-2023, the patient experienced GAIT INABILITY (Extreme muscle weakness (unable to walk)) and SLEEP INERTIA (grogginess). On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (BP which was very low (97/56). Symptoms cleared in about 2 hours. BP high 168/90). At the time of the report, GAIT INABILITY (Extreme muscle weakness (unable to walk)) and SLEEP INERTIA (grogginess) was resolving and BLOOD PRESSURE ABNORMAL (BP which was very low (97/56). Symptoms cleared in about 2 hours. BP high 168/90) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 97/56    very low and 168/90    high.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had extreme muscle weakness (unable to walk) and grogginess. Two days later, the patient's blood pressure was very low (97/56). Symptoms cleared in about 2 hours. Blood pressure was high 168/90. The patient had several co-morbidities and was hospitalized with COVID in mid-July 2023 It was unknown if the patient experienced any additional symptoms or events.
On an unspecified date, the pt received a right arm dose of Engerix-B (it was not known whether the pt had received previous doses of Engerix-B) and a left arm dose of Haemophilus influenza type b vaccine. Subsequently, the pt developed a "large" swelling at the right arm injection site. As of 7/17/01, the outcome of the event was unknown.
CLIENT CALLED 10/12 TO SAY SHE WENT TO THE EMERGENCY ROOM ON 10/11 AFTER RECIEVING VACCINES ON 10/10. HER RIGHT ARM WAS VERY SORE AND SHE STATED SHE HAD A HARD LUMP UNDER THE SKIN. THE PAIN RADIATED UP TO HER NECK. PT STATES HER THROAT SWELLED AND SHE HAD A HARD TIME SWALLOWING. CLIENT RECIEVED ATIVAN, BENYDRAL, AND POTAISUM ACCORDING TO THE CLIENT. CLIENT STATED THAT SHE FELT FINE TODAY.
skin test & progressive challenge w/flu-devel generalized itching, urticaria, cough, wheezing;
Swelling and pain at injection site then developing tachycardia and fever leading to diagnosis of SIRS.
Sore throat; This is a spontaneous report from a contactable consumer (the patient, reported herself). This 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EN5318 and expiration date was not provided), via an unspecified route of administration in left arm near the shoulder, on 04Feb2021 at 15:26 PM (at the age of 68-year old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an 04Feb2021, patient experienced sore throat began early evening about 6 PM. Patient queried that one of Pfizer sites didn't have sore throat listed but a different site did have sore throat as one of the possible side effects. So patient was calling to report that and try to clarify if that is associated with the product and asks was it going to be another lengthy hold. Patient did not require a visit to emergency room and physician office for event sore throat. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome for event was not recovered.    Follow-up attempts completed. No further information expected.
SLEPT FOR ABOUT 14 HOURS (SPENT MOST OF THE DAY IN BED); CHILLS; 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 was not reported, administered on 18-JUN-2021 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 19-JUN-2021, the subject experienced slept for about 14 hours (spent most of the day in bed). On 19-JUN-2021, the subject experienced chills. On 19-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, fever, and slept for about 14 hours (spent most of the day in bed). This report was non-serious.
breakthrough case admission after 2 vaccines Pfizer 3/23/21 Lot# EN6202;  Pfizer 4/13/21 Lot# ER8732;
Next morning was very tired, bad headache, slight sore throat. Daytime flu medication helped a lot and by evening  felt back to normal.
Patient complaints of nausea, dizzy and short or breath. BP 150/91 pulse 67. Alert and oriented x4.
Was vacinnated at 13:15 hrs. and stayed at the flu clinic for 20 mins. drove home and about 15:45 hrs.- my arm at the injection site was itching me but I did not scratch it!  I noticed on my left hand; inject. was on my left arm- 2-3 large hives appeared and I wouldn't scratch them. Put Caladryl on my hand(lft.) took 2 Benadryl tabs and went to bed.  Later that evening- the itching stopped and the hives went away.