chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme dehydration, high fever causing hallucination. Very high blood pressure and heart rate. Pain in left arm - "Tdap" - no swelling or redness.
pt recvd vax & devel a swollen lower arm & the muscle felt hard; pt could hardly use lt arm over the weekend; no treatmnet;
No adverse event; Moderna bivalent vaccine with NDC (80777028399) beyond the BUD/Received vaccine beyond refrigerated BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with NDC (80777028399) beyond the BUD/Received vaccine beyond refrigerated BUD) and NO ADVERSE EVENT (No adverse event) in a 17-month-old female patient who received mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (batch no. 201L22A) for COVID-19 prophylaxis.     Patient had no acute illnesses at the time of vaccination and upto one month before. Patient had no chronic or long-standing health conditions.  Previously administered products included for Anaphylaxis: Epipen Jr (dose : 0.5 mg, frequency of administration : prn and route of administration : intramuscular) since 30-Jan-2023. Past adverse reactions to the above products included No adverse event with Epipen Jr. Concurrent medical conditions included Peanut allergy.    On 14-Aug-2023 at 10:38 AM, the patient received third dose of mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (unknown route) .2 milliliter. On 14-Aug-2023 at 10:38 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with NDC (80777028399) beyond the BUD/Received vaccine beyond refrigerated BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with NDC (80777028399) beyond the BUD/Received vaccine beyond refrigerated BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with NDC (80777028399) beyond the BUD/Received vaccine beyond refrigerated BUD).    Concomitant medications were not reported.   A healthcare provider reported that they just discovered that they administered an unspecified number of doses of the Moderna bivalent vaccine with NDC (80777028399) beyond the BUD (beyond use by date). The vaccine was administered beyond the refrigerated use by date of 30 days (13-Aug-2023). No adverse event was reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Significant follow-up information received: Patient initials, gender updated, patient medical history updated, start date and batch number of third dose of suspect product updated, event verbatim and onset date updated and narrative updated. On 31-Aug-2023: Follow up received contains non-significant information
STROKE; THICK BLOOD; REALLY BAD SHAKES; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age, race and ethnicity. 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) 1 total, 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 patient reported, "probably had a stroke from blood being thick. My blood got so thick that I could not check my blood sugar. Johnson & Johnson my blood got so thick I could not check my blood sugar, and now I have the shakes really bad. Sometimes I can hardly eat for shaking food off my fork." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, thick blood and really bad shakes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20220221056-COVID-19 VACCINE AD26.COV2.S- stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
swollen left arm; welt on her left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen left arm), URTICARIA (welt on her left arm) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen left arm), URTICARIA (welt on her left arm) and HEADACHE (headache). On 15-Apr-2021, URTICARIA (welt on her left arm) and HEADACHE (headache) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment information was provided by reporter.
This spontaneous report was received from a registered nurse referring to a 13 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 06-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M040558, expiration date on 03-OCT-2018, for prophylaxis (strength and route were not reported). Concomitantly, the vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002514: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002510: US-009507513-1801USA002509: US-009507513-1801USA002508:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, a physician administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries.  On or about 2016, the patient was treated by a healthcare provider for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries.  As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
The next day I woke up with a very sore arm, swollen left armpit lymph node, fever of 101, chills, headache, extremely tired, body aches.   However, at 3:30pm my heart began to race very rapidly. I checked it and my HR was in the 130?s. I felt lightheaded and very bad overall. It wouldn?t go down so I went to the ER an hour later and when I got there it was in the 140s and my fever was still 101 despite taking Tylenol a couple of hours before. They gave me Motrin and the fever went down to 100 but my heart rate was still 129. I had to wait there for over 3 hours to even get taken to a room. When I got back to a room they gave me fluids which finally seemed to help. They diagnosed me with a rare COVID vaccine shot event and said that my body had an extreme immune response to it. It was very scary. I am to monitor my heart rate and to follow up with a cardiologist if it continues. They?re hopefully it is a direct correlation to the vaccine as I?ve never had this before.
Syringe slipped and vaccine went into her fats & not administer it on her muscles; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Syringe slipped and vaccine went into her fats & not administer it on her muscles) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Syringe slipped and vaccine went into her fats & not administer it on her muscles). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Syringe slipped and vaccine went into her fats & not administer it on her muscles) had resolved.            The patient reported that the vaccine provider didn't administer the vaccine on their muscles and the syringe slipped and all vaccine went into their fats.  No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
severe debilitating tinnitus in my right ear started approximately 2 weeks after the 2nd moderna shot on March 17. 2021. Intermittent mild to severe headaches. Unable to sleep as the pitch in ear is constant.
Muscle aching at site of injection no swelling, erythema, increased warmth. Full ROM of UE. No weakness no sensory. No heard vascular issue. Achiness at time of visit.
4/6/21-Chills, severe muscle and body aches (including fingers and toes), severe headache, sore arm, diarrhea.  4/7/21- severe muscle and body aches (including fingers and toes), severe headache, sore arm, diarrhea (muscle pain became less severe by bedtime). 4/8/21- Dizziness, mild sore arm, pain in fingers and toes (dizziness became worse as day progressed), diarrhea, and epigastric abdominal pain began early evening. 4/9/21- Dizziness worse, diaphoretic with activity, epigastric and upper right quadrant abdominal pain, softly distended abdomen, difficulty passing gas, diarrhea. 4/10/21- to present- Dizziness, upper right quadrant pain, distended abdomen, diarrhea, no appetite difficulty passing gas, 2 small stool
Nasal congestion, cough, sore throat, fever, loss of taste and smell in approximately 50%.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2 NOS), on 04Oct2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing), notes: Relevant past drug history. Reaction: Allergy. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: The patient received Paxlovid as treatment for Covid 19 from 05Jan2023 to 09Jan2023. Device Date: 14Jan2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative:  COVID infection following COVID vaccine series 03/08, Pfizer, dose #1 03/29, Pfizer, dose #2 12/22 COVID swab, result: detected 12/20 pt cc: myalgias, rhinorrhea, cough exposure: unknown
Patient experience a left posterior insular ischemic stroke on 10/12/2021 - no known cause at this time, but given recent vaccination, wanted to report on vaers.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In May 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was not enrolled in COVID-19 vaccine trial.  No treatment information was reported.  Company comment- This spontaneous case concerns a 79-year-old female patient with relevant medical condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected non-serious  COVID-19, after receiving a fourth dose of mRNA-1273 vaccine. Patient received as first, second and booster dose (in an appropriate interval) mRNA-1273 vaccine. Details of symptoms, clinical course, investigation reports and treatment were not provided. The current pandemic situation of COVID-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab remains as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 79-year-old female patient with relevant medical condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected non-serious  COVID-19, after receiving a fourth dose of mRNA-1273 vaccine. Patient received as first, second and booster dose (in an appropriate interval) mRNA-1273 vaccine. Details of symptoms, clinical course, investigation reports and treatment were not provided. The current pandemic situation of COVID-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab remains as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
horrible muscle pain in the left leg/ horrible muscle pain in the left side of her leg; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/bath number and expiration date not provided), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller had been having horrible muscle pain in the left leg for 2 weeks now after her first dose in 21Dec2020 and wanted recommendations on what she should do and if she should get her second dose and what the duration of symptoms was. Caller was asking if she can go back and get the second dose at a later date. Told caller no information regarding use outside of 3 weeks, however, her healthcare professional would have access to information from CDC. Caller was the activity director at a long term care facility. Received first dose of COVID-19 Vaccine on 21Dec2020. Has been having horrible muscle pain in the left side of her leg that had been going on for two weeks. Some days it was really bad. Stated she was in constant pain for two weeks. This happened to be a bad day. Stated it was taking her oxygen just to talk to this the agent. Was very leery about taking COVID-19 Vaccine and this was exactly why. She was agitated. Wanted to know if there's something Had been told there's nothing that can be done and to contact her local provider. She stated that sucks. The patient was due for the second dose in 4 days. Doesn't know if she should take it or not. The event was non-serious per the reporter. The outcome of the event was unknown.  Information about lot/batch number has been requested.
About 1 minute after receiving her flu shot the patient passed out on the floor.  Briefly loss of  consciousness. Appeared to have bumped head on carpeted floor.  Pt awoke and was complaining of nausea and stomach pain.  We immediatedly called EMS.  Pt sat up and began to dry heave but no vomit came out.  Pt wanted to stand up and use the bathroom.  Her mom and I walked her to the restroom.  She was very wobbly on her feet.  The ambulance came and checked her blood pressure/ heart / blood sugar.  She began to improve while the ambulance technicians were with her.  Mom did not want her to go to the hospital.  She walked out of the store under her own strength.  I checked in with her at 7pm at pt. was fine.  Belive it was a vagal response to vaccine.
5/18 1600 PM Erythema firm nodule left lower arm (5.5 x 5.5 cm). Warm to touch, itchy. Benadryl 50 mg given PO. 5/19 1530 PM - Reaction- size decreased to 2.5 cm, mild redness with firm nodule, warm pack Benadryl continued.
Pt recvd Engerix-B on 26APR90, 30MAY90, & 23OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
THIS VACCINE IS APPROVED FOR AGE 18 AND OVER, PATIENT IS 14 YEARS OLD
Epiretinal Membrane; Vitreomacular Traction; hearing loss; Information has been received from a lawyer regarding a case in litigation concerning a lawyer refers to a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 25-AUG-2017, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately August 2017 (reported as "Shortly after receiving zoster vaccine live(ZOSTAVAX)"), the pt suffered an abrupt visual acuity and separated retina as well as hearing loss. Pt was diagnosed with Epiretinal Membrane and Vitreomacular Traction. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Macular fibrosis, deafness and vitreoretinal traction syndrome were considered to be disability. Upon internal review, macular fibrosis, deafness and vitreoretinal traction syndrome were determined to be medically significant.
This case was reported by a nurse via call center representative and described the occurrence of underdose in a 78-year-old female patient who received HAV (Havrix 720) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On 30th November 2021, the patient received the 2nd dose of Havrix 720 (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 30th November 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the adult patient received the pediatric presentation of HAVRIX 720ELU/0.5ML (Pre-Filled Syringe) yesterday (day before reporting) rather than the adult strength (1440 ELU) product, which led to underdose and adult use of a child product. The reporter consented to follow up. This case has been linked with case US2021226689, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021226689:same reporter
Area became raised, warm to touch, red swollen, itchy.  Site was 6 inches by 4 inches.  Lasted four days.
Patient mother reports shortness of breath and pain in all extremities 20 mins after receiving vaccine, Mom gave patient 4 puffs of albuterol and Benedryl 10mL (25mg). Patient and mother returned to office at 11:05 am. Vitals assessed: BP 128/76, HR 100, Oxygen 100%, Glucose 83. Patient given Acetaminophen 20 mL (640mg) in clinic and vitals monitored.