chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 4 days of the third HPV shot (he had the original shot and the first booster without issue), my son started having severe abdominal pain at 3am.  Took Pepto-Bismol and Tylenol to try to reduce pain.  Neither worked and he then threw up 6 times.  We took him to an Urgent Care facility because it was not getting better and because he kept throwing up.  He had to have anti-nausea medicine and pain medication administered through an IV because he threw up trying to receive the medications orally.  After the IV administered medications took effect, he started to feel better and was able to leave the Urgent Care facility.  He has stopped throwing up, but 2 days later still has a smaller amount of pain in his stomach.   I am hoping that will continue to subside.
Itching of mouth, tongue, throat, hives on hard palate, given epi.
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with oral, ROTATEQ (lot # K010222, expiration date 12-MAY-2016). It was reported that the vaccine administered underwent an temperature excursion which occurred on 15-AUG-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Tested positive Wednesday for Covid 19.; Tested positive Wednesday for Covid 19.; This is a spontaneous report received from a contactable reporter consumer or other non HCP from product quality group. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Lot number: FE3590), as dose 4 (booster), single (Batch/Lot number: unknown) and in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive Wednesday for Covid 19.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive Wednesday for Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated that she kept everything within the Pfizer family was twice vaccinated and had three booster shots since then. Had her final booster in Sep. Had basic symptoms but did not have problems worth reporting. Stayed in the Pfizer family because of it. Tested positive Wednesday for Covid 19. Almost did not test because she had a little bit of a scratchy throat and did not think much of it. Wednesday morning had scratchy throat that progressed to laryngitis. Almost did not test because she did not have any symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED   HYPOTENSION 4/9/2021 COVID-19 PNEUMONIA  ACUTE RESPIRATORY FAILURE 4/9/2021 COVID-19 PNEUMONIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/10/2021 COVID-19 PNEUMONIA  HYPOTENSION 4/9/2021 FOLLICULAR LYMPHOMA GRADE 2, UNSPECIFIED SITE  ACUTE RESPIRATORY FAILURE 4/9/2021 FOLLICULAR LYMPHOMA GRADE 2, UNSPECIFIED SITE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/10/2021 FOLLICULAR LYMPHOMA GRADE 2, UNSPECIFIED SITE
Within 10 days of receiving the second Maderna vaccinations I began having chest pain and shortness of breath. I was rushed to ER after vivisiting a walk-in health clininc when they determined I had acute pulmonary embolism. After a CT scan it was determined that I had many blood clots in both my right and my left lung, my right ventricle of my heart was enlarged from the strain of poor oxygen levels. I was gasping for air. While in the hospital I was given injections of Warfarin twice daily and After four days in the hospital, I was released was a prescription of Eloquis 2x's daily and follow up with Pulmonologist and Cardiologist as well as a hemotologist.
felt kind of low; got hot; got a burst of energy as if she had an energy drink; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 22May2021 11:00 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, caller stated, after she received the Pfizer COVID vaccine on 22May2021, she got a burst of energy. At first she felt kind of low and got hot and then got a burst of energy as if she had an energy drink on an unspecified date in May2021. Reporter would like to know if this has been reported before or not. Reporter stated people did not think she received the Pfizer COVID vaccine because she had a burst of energy. Reporter stated she had only heard of this being reported once before. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Information has been received form a female patient who was vaccinated with ZOSTAVAX (Lot # not reported). Patient called because she wanted to know if she needed to stay away from her mother for a certain time because her mother had leukemia. Patient had been coughing on the phone. At the time of the report, the patient had not recovered. No further information is available.
This spontaneous report was received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the RECOMBIVAX HB had a temperature excursion of 48 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10 Pk 5mcg/0.5ml SDLLokCap Ped" which had a lot number of K018986 and expiration date on 03-APR-2016 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
He developed periorbital swelling, excessive lacrimation and sore throat with an hour of receiving vaccines. No rashes or wheezing noted. Epinephrine was administered and he was transported to hospital.
No additional AEs were reported; patient received MMR II and VARIVAX shorter than recommended interval. The patient received MMR II on 10/16/2021 and VARIVAX on 11/11/2021.; This spontaneous report was received from a registered nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-OCT-2021, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant human albumin (rHA), lot # t022310, expiration date: 30-JUN-2022, for prophylaxis (strength, and route of administration were not provided). On 11-NOV-2021, the patient was vaccinated with 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot # u002394, expiration date: 22-JAN-2023, for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).
Case number PHEH2013US005087, is an initial spontaneous report receivd from nurse on 27 Feb 2013. This report refers to a 22-month-old female infant patient. Her medical history and concomitant medication were not reported. She was vaccinated with expired MENVEO, (batch number: M10054A) intramuscularly on 27 Feb 2013. No adverse event was reported following this administration error.
This spontaneous report (IRMS US12-052952) as received from a consumer refers to a 72 years old female patient with possible celiac and hypertension. The patient's medical history included alcoholic and smoker and a possibility of having had a PNEUMOVAX23 before in the past. The patient was vaccinated with PNEUMOVAX23 on 23-OCT-2012. Route of administration and dose is not provided. No other co-suspects were reported. Concomitant medications included DIOVAN, diltiazem hydrochloride and atenolol for unknown indication. Date, route, dose and frequency were not provided. On 23-OCT-2012 the patient noticed her arm started to swell and hurt. On 24-OCT-2012 her trunk of her body, front and back had a red rash and it was hot. On 25-OCT-2012 the rash spread to her legs, arms and face. On 25-OCT-2012 the swelling and hurt in her arm resolved. On 26-OCT-2012 she started the rash started to fade. On 26-OCT-2012 the patient experienced itching. On an unknown date the patient experienced sore throat. No treatment information was reported. It is unknown if there is any relevant laboratory data. As of 29-OCT-2012 she will not have another PNEUMOVAX23 and the rash is resolved and itching is better but not gone. The relatedness for arm swelling, itching, the rash spread to her legs, arms and face, hot. her trunk of her body, front and back had a red rash, sore throat and hurt in arm is unknown for PNEUMOVAX23. Additional information has been requested.
3/4 Evening: injection site VERY sore. Too painful To sleep on.  Disturbed sleep due to pain.   3/5: Morning; headache, fatigue Evening/overnight: arm still tender   3/6: Morning: fatigue, nausea, headache, lack of appetite, stomach upset.  Hot flashes, no fever detected Afternoon: very nauseous, vomiting, headache  Evening/overnight: not getting restful sleep  3/7: Morning: mild headache/lack of appetite Evening/overnight: woke in the middle of the night with severe stomach cramps, loose stool, nausea amd vomiting. No fever detected.    3/8 continues to be nauseous, lack of appetite and extreme fatigue.
She was barely four months vaccinated when we got Covid; She was barely four months vaccinated when we got Covid; This is a spontaneous report from a contactable consumer. A 39 years old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on 07Apr2021 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) at age of 38 years old as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient was barely four months vaccinated when got covid on 24Aug2021. The outcome of events was unknown.
Information has been received from a physician concerning a 64 year old female patient who on 04-NOV-2008 at 10:00, was vaccinated with a dose of PNEUMOVAX (lot# 661529/0868X) into the left arm. The physician reported that after receiving pneumococcal vaccine, the patient experienced severe pain in her arm and redness (approximately 5 inches below injection site). The patient was treated with ZYRTEC 10mg every 12 hours, PRN and MEDROL 4 mg dose pack. The patient sought medical attention in doctor visit. This is one of two reports received from the same source. Additional information is not available.
Itchniness, BPs 137/97 (pulse 112), 137/82 (pulse 105). Benadryl 25 mg PO, 50 mg IM given.
Pt Reports trouble walking and trouble weight bearing. States she was on bed rest the entire weekend. Symptoms are now resolved.
Mom called office on morning of 2/11/22 to state that child had a swollen right arm, and that it was also red and itchy  since the evening of receiving the vaccine on 2/8/22. The area extended from the site of injection in the right deltoid area down to just below the elbow. Child advised to use 1% hydrocortisone cream and to take Benadryl 12.5 mg/tsp (1-2 tsp) as per directions. Mom also advised that he could be given benadryl prior to future flu vaccines.
Developed fever of 103.7 degrees F and headache.  Taken to primary care provider + diagnosed with reaction to Tdap.  No other medical problems identified.  Medical
Allergic reaction; Rashes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction"; RASH (non-serious), outcome "unknown", described as "Rashes".  Additional information: This reporter was not related to study or programme. The reporter stated that his son (patient) had an allergic reaction to the shot and he had the rashes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives; rash; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm left at age of 32 years on 17May2021 15:00 (Lot Number: EW0182) as single dose for covid-19 immunisation. The patient medical history was included diagnosed COVID-19 prior to vaccination. No known allergies. Concomitant medications included cefalexin (Cephalexine), sulfamethoxazole, doxycycline. The patient previous took fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at age of 32 years on 26Apr2021 15:00 (Lot Number: ER8736) as single dose for Covid-19 immunization. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent covid-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient has not been tested for COVID-19. Hives and a rash started to appear on body roughly 24-26 hours after second shot. The rash started around both arms, mostly above the elbow and slightly on the torso. By the next morning, the rash spread to the rest of body, growing denser in many areas on arms and back and middle of the chest and stomach. The adverse event resulted in Emergency room/department or urgent care. Treatment received for the adverse event included prescribed prednisone, taking Tylenol and Benadryl. Adverse event start date was 18May2021 19:00 PM. Seriousness reported as no. The outcome of the events was recovering.  Follow attempts are needed. Further information is expected
Numbness/tingling in right big toe approximately 12 hours post vaccination. Numbness/tingling in left big toe and middle on right foot approx 20 hours post injection.
Given shot on Monday, January 11, 2021 at 10:15 am .  Was fine until 7:30 pm that night. Felt like I was drugged and couldn't keep my eyes open. Slept (except for bathroom stops) until 7:30 pm on Tuesday night. Very red and large knot on shot arm. Lasted many days. Very sleepy for days,  Dull headaches. Stomach upset. Very foggy thought processes for more than a week. Blurry vision for a few days. Joint pain.  Spoke with Moderna and they suggested I talk to my doctor.  Doctor told me the side effects would go away within ten days.  Most of they did.
improperly stored PROQUAD that was administered; No other adverse event reported; This spontaneous report was received from registered nurse concerning a currently 4-year-old patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (rHA) injection, as prophylaxis (frequency, strength, route of administration, and anatomical location were not reported; lot number S023651 has been verified to be a valid lot number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live with expiration date on 26-JAN-2021).  The administered dose of vaccine experienced temperature excursion between -14 degrees Celsius up to -10 degrees Celsius (-11.84 degrees Celsius) for 45 minutes and of -9 degrees Celsius up to 8 degrees Celsius (-4.12 degrees Celsius) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No other adverse event reported.
Tight feeling in throat 10-11-10 AM No rash - at college health center received BENADRYL - all per mother's phone call to BVCPH 10-11-10.
Pt vaccinated with MMR developed hyperpyrexia to 103 w/convulsion approx 10 hrs following administration.
01/12/2022: Patient is a 23-year-old female with a significant past medical history for mental illness presented to the emergency department for mental instability.  Of note, patient is COVID-positive.Lungs: Symmetrical chest rise breathing comfortably.Abdomen: Soft, non-tender, nondistended, non-peritoneal.  NO treatment for  COVID positive, pt asymptomatic.  Hospitalized for non-COVID reason.
Terrible pain in front left of temple, on forehead.  Arm hurt and I  still have  pain. I have a terrible pulling pain on the base of my neck going down my left side of back.   The skin on my scalp hurts , my joints hurt so bad continuously.   I have more to say but I rather talk to someone Thank You
its been over 2 years never got 2nd shot / If 2nd shot was not given in 2 years; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot (1st dose received 2 years prior to the report).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccnation was not applicable. Till the time of reporting, the patient did not received the 2nd dose of Shingles shot, which led to incomplete course of vaccination. The patient asked, if he/she need to get 1st shot again if it's been 2 years of never getting 2nd shot.
Information has been received from an investigator concerning a 12 year old male with migraine headaches who entered a study. On approx 6/16/06 and 8/16/06 and on 11/16/06 at 16:15 the pt was vaccinated with a first, second and third dose of HPV vaccine. On 11/17/06 the pt woke up at 6:40 and went to the  bathroom and he reported that he had trouble walking. He returned to bed. The pts father woke him up at 7:45 and noted that he had a fever of 101.3F. the pt stated that his arms and legs were heavy feeling and he didn't think he could walk. the pt experienced muscle weakness. The pts parents call the physician and were advised to take the pt to the ER. The pt went to the ER via ambulance. When the pt arrived the ER his temp was 99.5F (Pt was treated with Advil at home. It was noted that the pts neurosigns were normal and the pt reported to have a headache but refused Imetrex. the pt was discharged and no further tests were done. On 11/17/06 the pt recovered. The reporting investigator felt that muscle weakness was related to study therapy. Muscle weakness was considered to be an other important medical event (OMIC).
Admission Date: 9/4/2022 Discharge Date: 9/6/2022  PRESENTING PROBLEM: Weakness Generalized weakness COVID-19   HOSPITAL COURSE: The patient is a 83 y.o. male who presented to the emergency department with weakness and a fall.  Patient has past medical history of atrial fibrillation, B12 deficiency, GERD, hyperlipidemia, CKD stage 3, prostate cancer, RLS, and early-onset Alzheimer's. Patient was brought into the emergency department earlier in the day following a fall while ambulating with his walker at home.  Imaging showed no acute abnormalities and patient was discharged home per family request.  After returning home, patient was unable to exit the car despite assistance from his daughter and spouse.  He was brought back to the emergency department for further evaluation.  In the emergency department, patient was febrile, bradycardic, tachypneic, but did not require supplemental oxygen.  Complete blood count was unremarkable.  CMP showed renal disease, which appears to be chronic.  Family confirmed that this is the case.  COVID-19 was positive.  Chest x-ray shows no acute cardiopulmonary abnormalities.  Suspect generalized weakness secondary to COVID-19.  Patient has been admitted for further evaluation and management of generalized weakness.   Patient's generalized weakness improved back to his baseline. His respiratory status remained stable, he remained stable on room air. PT/OT evaluated patient and recommended home with home health care services in addition to the health aid services already being provided in the home. The patient was discharged home in stable condition with home physical and occupational therapy services. He is recommended to follow up with his PCP and pain specialist as scheduled.
inconsolable crying 7-8hr periods of lethargy 8hr duration;paleness 7-8hr;blank stare as in post ictal state;no seizure noted;
Soreness at the site; Body ache; Headache; Administered first dose. with expiration date of March 11, 2023. was administered on March 28, 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered first dose. with expiration date of March 11, 2023. was administered on March 28, 2023), VACCINATION SITE PAIN (Soreness at the site), MYALGIA (Body ache) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered first dose. with expiration date of March 11, 2023. was administered on March 28, 2023). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the site), MYALGIA (Body ache) and HEADACHE (Headache). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered first dose. with expiration date of March 11, 2023. was administered on March 28, 2023) outcome was unknown and VACCINATION SITE PAIN (Soreness at the site), MYALGIA (Body ache) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient reported that the events soreness at the site, body ache and headache lasted for 24hrs. It is unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.