chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within seconds of vaccination, patient passed out/had syncopal episode. Patient was in a sitting position when event occurred. Applied cool compresses and laid him down. Evaluated by provider.  No other treatment needed. Patient back to normal within a few seconds. Monitored for 30 minutes. Per mother, this has happened to patient prior, with most injections.  Did not happen with first COVID vaccine, but per mom, patient was lying down during the injection.
Vaccines administered around 12:30 PM approximately 3-5 minutes after administration of vaccines an erythematous raised patches diffusely on face was noted. BENADRYL was administered at 12:38 PM. Rash resolved on face. Patient was observed for 30 minutes after vaccines given. Lungs clear to auscultation b/l after allergic reaction noted and prior to leaving office. Spoke with maternal grandmother at 3:19 PM patient doing well and no allergic reaction or respiratory symptoms.
I developed symptoms of a cough, sore throat, fever, and chills on 12/28/22. That went into joint achiness, continued cough, and loss of taste and smell as well as fatigue and bad headache. That lasted until February 1st. I was still testing positive through January 17th, testing weekly to determine when I could resume treatments. But I was told that because of my cancer and treatments I would test positive longer. They advised I take low dose TYLENOL, over the counter cold and flu medications, and I took CORICIDIN. That did help and I also took ROBITUSSIN. The cough is what lasted the longest. My saturation oxygen was mid to high 80s during week two, but during week three It started to go back up. I practiced breathing exercises during that time.
Once the vaccine was administered, the next day, in the left eye it was a little swollen, reddened below the lash line and it hurt. The eye remained the same for the following days, on the fourth day, the entire lower part of the eye was swollen, and I began to use some medicated drops (Tobramycin / Dexame 0.3-0.1%), however the eye has not improved on the day of Today it has been six days since the vaccination, and 5 days since the eye began with the problem.
The vaccine was incorrectly given in the patient's shoulder joint, not in the deltoid muscle. The patient states that almost immediately she begin having pain that was abnormal for a typical vaccination.  She experienced severe pain, nausea (from pain), redness, and swelling. She states the pain was severe enough that she has not slept the past several nights. She sought treatment the day after from her MD office and was given a Toradol shot and advised to take Benadryl OTC. She says neither provided relief. She is been seen again by her physician later today.
4 full days hardly any sleep, h/a's, loose stomach-arm still hurt p/days;
he was highly confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) at the age of 49 years 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: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "he was highly confused".  Additional information: According to reporter his brother, 15 mins after the first dose he was highly confused, his brother thinks it is still the year 2018, he forgot that his pet is dead already, forgot the name of his daughter, forgot that he and his fiancé separated already, he thinks that he is still working from his previous job. No transfer and manual done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NO ADVERSE EVENT REPORTED OR NOTED.  Jynneos 0.1 ml admimistered ID without production of wheal and Additional dose was given (0.1ml, ID) with production of wheal.
Hives; Itching appeared on her upper body, neck, chest and lower feet; Rash appeared on her upper body/neck/chest/lower feet; This is a spontaneous report from a contactable consumer (parent, patients mother). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0168, expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Aug2021 (at the age of 17-years-old) as dose 1, single for covid-19 immunization. The patient also received meningococcal vaccine (Batch/lot number was not reported, expiration date was not reported) via an unspecified route of administration, administered in left arm on 19Jul2021 as dose number unknown, single for an unspecified indication. The patient medical history and concomitant medications were not reported. It was reported that, reporter is calling on behalf of her 17-year-old daughter who received the first dose of Pfizer covid vaccine. She reports on 09Aug2021 3 hours after her daughter received the Pfizer covid vaccine hives (itching and rash) appeared on her upper body, neck, chest and lower feet. This has now lasted for 3 weeks to this day. She is wondering if she should get the second dose. She declined zip code. Her doctor said he does not have much information and said it is hard to tell. He just gave topical ointment. Her doctor advised antihistamine. When her daughter was a year old she received a vaccine and then after a month she received a call that the vaccine she was given was expired. She has been contacting the healthcare provider and they don't have any information other than topical treatment. The reporter assessed the seriousness as non-serious. The adverse events resulted in physician office visit. Antihistamine was received as treatment for the adverse events. The action taken in response to the events for meningococcal vaccine was unknown. The outcome of the events was not reported.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's drug reactions or allergies, medical history and concomitant medications were not reported. On 17-MAR-2017, the patient might have been inadvertently vaccinated with an unknown dose of VARIVAX (lot # M025870, 24-MAY-2019; route was not reported) reconstituted with sterile diluent instead of PROQUAD. No adverse effects were reported. Additional information has been requested.
redness swelling warmth and shoulder pain with movement. redness 10 cm x 8 cm
Prior to the vaccine I had normal periods. After the second dose of covid vaccine I didn?t have a period. For a month and then when it started it lasted for 34 days. My gynecologist said there was nothing functionally wrong. They did ultrasound and bloodwork and everything was fine. Said it could likely be an adverse reaction to the vaccine based on the timing
TACHYCARDIA, BROKE OUT IN HIVES AN RASH ON CHEST, BACK AND I NJECTION SITE, HYPERTENSION, WHEEZING, TIGHTENING IN CHEST, DIZZINESS
Approx 4hr p/immun pt awakened fr sound sleep w/high pitched piercing cry, inconsolable, flailing arms & legs for 1hr; applied cool compress to inflamed lt leg; felt to be rxn to Pertussis;
PULMONARY EMBOLISM; ACUTE RESPIRATORY FAILURE; PNEUMONIA; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a parent concerned a male of unspecified age of unknown 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 not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in JUN-2021 (in third week of the month), patient received the vaccine because patient was doing shows on ship in the second week of July and had to be vaccinated to do the cruise. On 10-SEP-2021, the patient passed away from a pulmonary embolism and lack of oxygen as per parent but patient's neurologist could not understand why patient died because the rest of organs were functioning well. On 10-SEP-2021, the patient died from pulmonary embolism, acute respiratory failure, pneumonia, and covid-19 (suspected clinical vaccination failure) as per the death certificate. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of pulmonary embolism, acute respiratory failure, pneumonia, suspected covid-19 infection on 10-SEP-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000196332.; Sender's Comments: V0 20211009924-COVID-19 VACCINE AD26.COV2.S-pulmonary embolism, acute respiratory failure, pneumonia, suspected covid-19 infection. 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). V0 20211009924-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: PULMONARY EMBOLISM; ACUTE RESPIRATORY FAILURE; PNEUMONIA; COVID-19
atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). In 2021, ATRIAL FIBRILLATION (atrial fibrillation) had resolved.            Patient was not taking any concomitant medication at the moment of the event.  He had no history of COVID-19 infection nor Myocarditis/Pericarditis. Patient did not required hospitalization.  Back in March and April the patient received two Moderna shots, however, a week after the first shot he woke up in the morning and felt that he had irregular heartbeat. His family doctor diagnosed him with Atrial Fibrillation, which initially kept coming and going, but never went away, got worse and became persistent over the following weeks. At first, he was told by several doctors that it was unlikely that the Covid vaccine would have caused the atrial fibrillation, however, a cardiologist told him that it could not be excluded. He had to undergo a cardioversion to bring his heart back into normal sinus rhythm. He was treated with was blood thinner before electroshocks. After that, he was recovered to normal heart rhythm and symptoms were not ongoing.   Company Comment - This case concerns a 54 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of atrial fibrillation (AESI). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine and had resolved at the time of this report. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Age of the patient and Start date of vaccine updated On 17-Dec-2021: No new information updated.; Sender's Comments: This case concerns a 54 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of atrial fibrillation (AESI). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine and had resolved at the time of this report. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Weakness in lower extremities, tingling & tightness in arms and chest, loss of sensation in lower body, unable to void.  Diagnosed as Transverse Myelitis.
Soar arm muscle approximately 1hr after vaccine, achy joints at approximately 11pm same day of vaccine, and fever at approximately 3am and all throughout the next 24hrs.
She got her vaccine, she noticed her feet were swollen around her ankles to the point that she could not see her ankles.  She had intense pain and like EMG testing for neuropathy.  She would get a jolt, electric shock which got worse.   She was diagnosed with gout in 1980 and was tested for sickle cell and had no injuries.  This vaccine triggered a gout flare.  She went to the hospital and they gave her water pills (Furosemide) and then they gave her a medication for Gout (Colchicine), which she takes 2 at the onset of an attack, and an hour later if she has no relief she takes the 3rd one, then wait 24 hours before she can take anymore.  She is still continuing with the same reaction, kind of  morphed but does have an appointment this afternoon for FU.  She has been using Aspercreme and Preparation H that it helps the burning and soothes the pain.  She is an active person and everyday she walks on her sundeck for 15 minutes in the AM and 15 in the PM.  Unfortunately with this episode she has not been able to do this as she has too much pain to do this.  At first the medication was giving her dizziness, and has to walk up steps to go to the sundeck and afraid to fall so has not been too active.    Her feet were too sore to be able to drive and press the pedals, but she is able to drive now.    She did have a long history of birth control and hormone replacement as she had a complete hysterectomy.    She is not on any medication at this time.  She had been treated in the past for depression and had to be hospitalized for major depression in 2012.
pt recv vax & immed p/vax hives occurred, pt irritable w/decreased cap refill & blueness of extremities;immed given IM DPH & IV access w/fluids;improved-hives gone, pinkness restored to extremities;
stiff neck on the left side; photopsia in the left eye; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from pharmacist and consumer/non-healthcare professional via call center via Agency (Reference number- 00784117).  This case involves a 65-year-old male patient who experienced stiff neck on the left side (musculoskeletal stiffness) and photopsia in the left eye (photopsia) when received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 23-Sep-2021, the patient received a 0.5mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7376JA and expiry date: 30-Jun-2022) via an intramuscular route at a the left deltoid for prophylactic vaccination.  On 23-Sep-2021, the patient developed a non-serious stiff neck on the left side (musculoskeletal stiffness) and photopsia in the left eye (photopsia) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Pharmacist would like to know if photopsia is a reported adverse effect of the vaccine or if there have been any cases of photopsia reported?"  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The event outcome was unknown for all the events.
PATIENT COMPLAINT WAS HAVING A SEVERE EFT LEG PAIN (THIGH AREA) COUPLE DAYS AFTER GETTING THE VACCINATION.
Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.
developed hissing/ringing in ears with some vertigo and dizziness causing headaches, eye aches, general fatigue and anxiousness
I received the vaccine on 4/8/2021 around 8:35am. I felt fine all day, only soreness at injection site. Later that day (around 6:00pm) I started feeling lightheaded, chills and a headache. My hands, feet, nose and hands were freezing but other areas of my body were warm. I also felt body aches- my lower back started with the aches and it spread up to my upper neck. Around 9:00pm I started feeling very hot and this hot/cold changes continued throughout the night. This morning of 4/9/2021 I have less of a headache however, my body is still very sore and I continue to experience the hot/cold changes.
Almost immediate itchiness from injection site that spread down my arm and back shoulder area.  Extreme lower back pain, kidneys or liver, unsure.  Pain and burning that felt like a UTI.  MYOCARDITIS - SELF DIAGNOSED. I have never in my LIFE had ANY illness that felt like this but I work in the medical field and knew the vaccine was a bad idea for me having had Covid about a year prior. Persistent fever above 100 that drops to normal temperatures randomly with no rhymn or reason. Persistent low blood pressure when taken on left arm.  Persistent high systolic and low diastolic  blood pressure when taken from the right arm. Persistent dizziness Constipation Inability to sleep for 3 days.... EXTREME IRON DEFICIENCY ANEMIA THAT ALMOST KILLED ME.  A constant swooshing pressure in my ears and head.  Cold and sweaty hands and feet.
Right upper arm very sore, difficult to move, can't lay on the arm. Pain is on and off. It wakes me up if I'm sleeping.
irritability;fever (hot but no thermometer);rash, hot, red over most of body, itching;eyes watery;eyes swelling 11DEC97;
Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-APR-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 19-SEP-2016, the patient was treated by a physician at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir hydrochloride (VALTREX) and gabapentin for management of her painful symptoms and chronic pain. On or about 17-OCT-2016, the patient sought subsequent treatment from a physician at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster and post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This case was reported in a literature article and described the occurrence of uveitis in a male subject who received Hepatitis A vaccine. On an unknown date, less than a month after receiving Hepatitis A vaccine, the subject developed uveitis. Serious criteria included GSK medically significant. The outcome of uveitis was unknown. The investigator considered that there was a reasonable possibility that the uveitis may have been caused by Hepatitis A vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of vaccine-associated uveitis in a male aged between 11 and 78 year who was vaccinated with unspecified hepatitis A vaccine (manufacturer unknown). The patient was part of observational study conducted to collect data on cases of vaccine-associated uveitis reported from 1984 to 2014 to three spontaneous reporting databases on adverse drug events. In addition a literature search was performed using the keywords of uveitis, iritis, iridocyclitis, or vitritis, in combination with vaccines, hepatitis A, hepatitis B, human papilloma virus vaccine (HPV), Bacillus Calmette-Guerin (BCG), Brucella, diphtheria, pertussis and tetanus (DPT); herpes, influenza, measles, measles, mumps, and rubella (MMR), pneumococcal, smallpox, tetanus, typhoid, Heine Medin, varicella, yellow fever, and zoster vaccine. No information on patient's medical history or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified hepatitis A vaccine (administration route and site unspecified; dosages unknown; batch number not provided). (Information on which dose of a particular vaccine was associated with uveitis was not available in the reporting systems.) On an unspecified date between 1984 and 2014, between 2-30 days after vaccination with unspecified hepatitis A vaccine, the patient developed uveitis. Treatment was unknown. The outcome for the event was not reported. (In this study, out of 5 cases of hepatitis A vaccine associated uveitis, 3 patients recovered while the outcome for 2 patients was unknown). The authors considered the event of uveitis associated to unspecified hepatitis A vaccine. The authors concluded "While uveitis may be a rare adverse effect of vaccines, awareness of this potential reaction to vaccines is important, as is reporting such occurrences to adverse drug reaction registries. That hepatitis B vaccine accounted for a disproportionate number of cases certainly piques curiosity about contributing factors for uveitis in association with hepatitis B vaccine. In a similar vein, we are also left with the question of why a disproportionate number of cases of vaccine-associated uveitis occur in females (199 in females versus 77 in males in our data). Future studies of vaccine-associated uveitis could focus on active surveillance and rigorous clinical evaluation of patients presenting with uveitis temporally related to vaccination". This is 1 of the 14 valid cases reported in the same literature article. This article is not available for regulatory submission due to copyright restriction.