chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erectile Dysfunction; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 62; Unit: Unknown) received bnt162b2 (BNT162B2), first dose (lot: EL0142) via an unspecified route of administration on 05Jan2021 at single dose, second dose (lot: EN5318) via an unspecified route of administration on 26Jan2021 (administered between 1:00-2:30PM) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced erectile dysfunction on an unspecified date. The patient asked What is the mRNA half life. He stated that he received the Pfizer vaccine on the 5th and the second on the 26th. He was asking if there were any reports of erectile dysfunction after receiving the vaccine. He also asked if the ingredient Hexane was a poison, if this is safe. The patient had some questions, he is really worried because he has seemed to be experiencing something. He is wondering if Erectile Dysfunction has been reported as a problem from the COVID vaccine. He seemed to be experiencing worsening of his sexual function, and the only thing that is new that he can think, is that he got the vaccination. He received the second dose of the product on 26Jan2021. He asked how long the MRNA last in your system,  how many people were involved in the study, When did it start, if the hexane solvent in the vaccine affect your testes. It was further reported that he was having a bad reaction he believe to the vaccination (Covid Vaccine) and asked if there were any reports of erectile dysfunction or sexual dysfunction regarding males from the vaccine. The patient had an article here it says your system mounts a response against the new protein, because they are seen as foreign invaders, developing antibodies that are specific to SARS-CoV-2 in the process. These infection fighters tick around to help your body fight a future case of Covid-19 but it's not yet understood for how long and this is the sense he wanted to talk to about that body will do its thing and eventually will get rid of the protein or mRNA on its own? The patient said since he had taken the COVID-19 Vaccine injections he has experienced worsening erective dysfunction. He asked if anyone else has reported having that issue since receiving the COVID-19 Vaccine. He was advised he would be transferred to Medical Information for further assistance. He stated he is so sad, and started crying while speaking with the agent. He declined to answer any further questions and asked to be transferred to Medical Information to have his question addressed. He asked the agent if she knew that Hexane is in the Pfizer COVID- 19 Vaccine. He said he did not realize Hexane was in the COVID-19 Vaccine before he got the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
2:30 am intense arm pain 5:30 shivering, fever, body aches lasting 24 hours 4/10 cloudiness in eyes, followed by impaired depth perception
Redness of right arm measuring 60mmx85mm. Patient states redness gone the next day with no further problems.
Generalized tonic-clonic seizure x 3 episodes 12 hrs after vaccines given. Lasting 5 - 10 minutes per episode. Pt. received ATIVAN and phenobarbital IV. Episodes took place over one hour. Patient afebrile.
Bell's Palsy; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a pharmacy (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent after receiving zoster vaccine live (ZOSTAVAX)), the pt was treated by a healthcare provider for Bell's Palsy (facial paralysis). Then, on an unknown date, she was hospitalized due to the event. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of facial paralysis was unknown. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, facial paralysis was determined to be a medically significant event.
I had horrible pain in my left calf that travelled to my thigh. I went to the hospital 2 weeks later a d found that I have a blood clot in my lower leg (front ankle area). I am on blood thinners and will be seeing a Hematologist.
Pt who participated in a RotaShield clinical study 4-5 years ago is now experiencing chronic constipation and profuse sweating.
Case number PHEH2011US02253, is an initial spontaneous report received from a health care professional on 22 Aug 2011: This report refers to a child male patient. This patient was vaccinated with only intramuscular dose of MENVEO (batch number M100061) that was reconstituted with a sterile diluent on an unspecified date. No adverse event occurred following this administration.
rapid test/antibody test at her work and she shows no antibodies on this test; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 as her first dose at single dose, via an unspecified route of administration on 11Jan2021 as her second dose at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took mycophenalate, hydroxychloroquin, dupixent, singulair, allegra and Pepcid, all for autoimmune disease, also took prednisone before and after her first dose of the vaccine. The patient stated that she took a rapid test/antibody test at her work and she showed no antibodies on this test. She was concerned that her use of steroids and other medications have affected her ability to produce the COVID-19 antibodies. She wanted more information on this and wanted to know if she should repeat the series. The outcome of event was unknown. Information of lot/batch number has been requested.
No additional AE; Customer called back about a temperature excursion case stating they just ran a report and found out that 1 patient was administered 1 dose of MMR II that was involved in multiple excursions prior to being administered.; This spontaneous report was received from a certified medical assistant and refers to a patient of unspecified age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-OCT-2023, the patient was vaccinated with improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) 1 dose, lot # W012118, expiration date 24-DEC-2023 (exact dose, route of administration and anatomical location were not provided). Administered dose of vaccine experienced temperature excursion of 12 degrees Celsius for 7 hours. Previous temperature excursions were reported as 1.6 degrees Celsius for 1 hour and 12 degrees Celsius for 7 hours. No additional adverse event was reported.
UTI; A spontaneous report was received from a 28 year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a urinary tract infection (UTI).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Jan 2021, a day prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number 02AL20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.   On 22 Jan 2021, the patient reported that she had experienced a UTI. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, UTI was unknown.; Reporter's Comments: This case concerns a 28 year-old female patient, who experienced a serious unexpected event of urinary tract infection. The event of urinary tract infection occurred 2 days after first dose of mRNA-1273, lot # 02AL20A.  Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Information has been received from a consumer concerning her 18 year old daughter who was vaccinated with the first dose of GARDASIL (lot#, route and site of administration not reported), 0.5ml. The patient experienced malaise, nausea and lack of appetite after vaccination with GARDASIL. She has experienced the symptoms of malaise and nausea for 5 days after receiving her first dose of GARDASIL. Her outcome was not reported. This is one of several reports from the same source. No further information is available.
Toxic clonic seizure with fever for 1 minutes x2.  Positive family history of epilepsy.
Vaccination of underage member (17 years 11 months old when the indications were for those age 18 and over).  Immunization was well tolerated and permission was given by parent for administration.
Red icthy splotch with bruise-like pain appearing on left arm near injection site 3 days after injection.
Shivering around 11 pm, then violent shaking of upper body for 2 hours straight which also included vomiting and diarrhea. Violent shaking was for 2 hours total then another hour of normal shivering.
Patient reported adverse effect 9/20/16 at approx. 4:45 pm. She received shot 9/19/16 however experiencing reaction today at 2pm.
developed blisters inside and around her mouth; This case was reported by a other health professional and described the occurrence of blistering of mouth 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, 1 week after receiving Shingrix, the patient experienced blistering of mouth. On an unknown date, the outcome of the blistering of mouth was unknown.   It was unknown if the reporter considered the blistering of mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received dose 1 of Shingrix and 1 week later developed blisters inside and around her mouth. No additional information provided at this time.
Information has been received from a registered nurse concerning a 17 year old female who on 11-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were noted. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
Patient was in today to pick up other medications and told me that she was still having trouble with her arm with pain and trouble moving it after receiving her influenza vaccine here last month. The patient stated that she thought the vaccine may have been given higher on her arm than it usually would be. I recommended that she make an appointment with her physician to have it evaluated.
Patient came in to get her Moderna Spikevax 12+ vaccine dose but was given Fluzone HD 65+ QIV instead. She left the pharmacy before the pharmacist realized his mistake. She has already had a flu vaccine this season given by her primary care provider. Message was left at PCP office, but patient would not answer her phone, so she is unaware at the moment.
ACUTE PULMONARY EMBOLISM 4/5/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/5/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Felt warm and tingling sensation  underneath where the injection went; Felt warm and tingling sensation  underneath where the injection went; felt like someone punched her in her arm. It hurt for like a day or two; weird sensation, it feels weaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PARAESTHESIA (non-serious), outcome "unknown" and all described as "Felt warm and tingling sensation underneath where the injection went"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "felt like someone punched her in her arm. It hurt for like a day or two"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "weird sensation, it feels weaker".  Additional information: The caller felt it when the vaccine went in and then when she was waiting the 15 minutes, she felt warm and tingling sensation underneath where the injection went in but it was fine. Then the caller had the normal effect, everyone said they have where it felt like someone punched her in her arm. It hurt for like a day or two. Then that really hurting feeling went away. Now she was left with her left arm just feeling "off." It was not painful, does not wake up at night, no rash or swelling that she can see. However, she still has this weird sensation, it feels weaker, maybe a little warm, but would touch it and it does not actually feel warm. It was almost as if tingling, sensitive sensation, anywhere from a little bit where the injection went in or up to her elbow. Her elbow and fingers do not hurt. Her arm does not feel totally normal yet. She was 2 weeks out and does not know what this was about. The caller has heard that with Moderna there was a rash and hives, with Pfizer she has heard people are a month out and their arms are whatever. The caller doesn't know if she should get the second dose in the same arm. She doesn't want her other arm to feel like this one so she wanted to know what she should do. The caller's arm felt sensitive and warm, she doesn't know how to explain it. Stated if she touches both arms she does not notices any warmth difference to the touch. One side does not feel any warmer to the touch.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
May 4th - Therapeutic rest  - had been having contractions for a couple of days and hadn't had sleep- admitted to hospital. May 6 baby was born.  I was full term - 40 weeks and six days. I was in labor and admitted for labor and delivery. Baby was born with a vacuum assist and had some risk for jaundice but didn't get a jaundice diagnosis. Small for gestation age - Baby's size - 6 lbs and 9 oz.  I had some blood loss and did have a blood transfusion after deliver.   It was my first pregnancy.
Headache for 2 days and low fever; Large red, hard, warm inflamed site in upper arm for 8 days (thru March 19), then redness disappeared and on March 22, Day 11 a large circular raised welt (approx 4") around injection site appeared and lasted 2 days and then disappeared.  Still experiencing  general fatigue and muscle aches nearly 3 weeks after first dose of vaccine.
Shortness of breath; Allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Drug allergy (Percocet), Bee sting (Bee sting) and Allergy to chemicals (Industrial floor cleaner). Concomitant products included TRETINOIN (ADINA), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), DULOXETINE HYDROCHLORIDE (CYMBALTA), HYDROXYCHLOROQUINE, SULFASALAZINE and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated postal code,
A few minutes after receiving the vaccine, patient (was sitting), felt dizzy, we put her on the floor, legs raised, took her bp 93/60. She felt nauseated. We monitored her, took bp again, then 93/57. She did not want an ambulance. She had a male with her. She stayed approximately an hour. We took her final bp and it was 117/73, she felt better and left on her own (walking unassisted). She made the statement that she does not like needles, and that every time she has given blood, she had passed out, or almost passed out.
Patient stated all joints achy 1 day after the injection. Unknown fever- Felt achy "for awhile" arm still hurts at injection site.
PATIENT RECEIVED VACCINE AND INSTRUCTED TO WAIT 30 MINUTES  FOR MONITORING. AT THE END OF THE WAITING PERIOD, SHE ASKED TO BE CHECKED FEELING HIVES COMING ON.  I OBSERVED HIVES ON HER FACE ONLY AND GAVE PATIENT 50MG OF LIQUID BENADRYL.  SHE WAS INSTRUCTED TO WAIT AN ADDITIONAL 15 MINUTES. AFTER THE ADDITIONAL WAITING PERIOD, SHE WAS BROUGHT INTO THE ROOM TO TAKE A LOOK OVER HER ENTIRE BODY. NO OTHER HIVES OBSERVED ANYWHERE ON BODY EXCEPT FOR THE FACE. SHE STATES SHE FEELS FINE AND UP TO DRIVING HOME WHICH SHE INDICATES SHE LIVES NEARBY.  INFORMED PT WILL CALL DR AND FOR HER TO CONTINUE MONITORING AND TO GO TO THE ER IF SYMPTOMS GET MORE SEVERE.
Loss of taste, generalized Bodyaches, Dizziness, Nausea, Chills and Congestion
Pt received 2nd dose of Moderna COVID-19 vaccine 5/5/21. In mid June patient developed SOB symptoms, dyspnea on exertion, and upon CT imagining in ER found to have bilateral pulmonary emboli with evidence of right heart strain on CT and EKG.
GIVEN STATE SUPPLIED DOSE OF TWINRIX INSTEAD OF PEDIATRIC DOSE OF HEPATITIS A AND HEPATITIS B.
A Fib with RVR, chest pain and weakness.  Lasted for hours on 4/16/2021.  Has had shorter episodes for the past week .
when It got worse but that's when they discovered that I had a Macular hole; my vision went wavy, got a wave to it and it turned out that I had a macular hole; when It got worse but that's when they discovered that I had a Macular hole; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8730) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RAPAFLO; CLONAZEPAM; ADDERALL. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, LOT#: "EN6202), administration date: 26Feb2021, when the patient was 63 years old, for COVID-19 Immunization, reaction(s): "The first one my vision went wavy, got a wave to it and it turned out that I had a macular hole", "The first one my vision went wavy, got a wave to it and it turned out that I had a macular hole". The following information was reported: MACULAR HOLE (medically significant), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "when It got worse but that's when they discovered that I had a Macular hole"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "my vision went wavy, got a wave to it and it turned out that I had a macular hole".  Clinical course: It was stated, "Sure, she just have some questions about filling in the form but sure, Well, she have to report adverse effects of the macular hole and some other things that she do not even know the name from the doctor. It was reported that, patient had a, within a week of the first one her vision went wavy, got a wave to it and it turned out that she had a macular hole, she was going to say she did not go to the eye doctor until after the second shot when It got worse but that was when they discovered that she had a macular hole. Consumer stated, She did not know the name of that but she also had another eye issue but she do not know the name of it in the other eye also from the shot and did not know the name of it. It was when 'retinol gel pull out' and get stuck and the happened after the second shot, The first and the second shot also then when she got the third shot it got much worse.  No follow-up attempts are possible. No further information is expected.
i tested positive (2 tests) on October 27th, 2022.  i feel like i have a mild cold.  no fever.  a slight cough.  a slight headache.
Rash started on right side torso and continued all over body and has not gone away since March 13, one day before second shot and 29 days exactly after first. Antihistamines and prednisone prescribed at urgent care are not working
PRESENTED TO EMERGENCY DEPARTMENT WITH BELL'S PALSY LESS THAN 24 HOURS AFTER VACCINATION
Itchy within 2 hours of shot, then arm pain, achy, hives and left throat pain
she did get some redness; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 91-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's daughter reported she had taken the Pfizer vaccine. She did get some redness and she got from the vaccine but nothing like she had got on an unspecified date. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Two days later, patient having loose stools-(diarrhea). Treating diarrhea.