chrisvoncsefalvay/vaers-outcomes huggingface dataset:
palmar digital vein thrombosis of around 2mm in size appeared on my right middle finger at the lower joint, on the left side of the finger. thrombosis appeared on Tuesday, October 4th in the evening, and has continued for 5 days so far. I've attempted to manage it with massage, hot compresses, and asprin but it hasn't gotten any smaller.
Pfizer Vaccine was undiluted, covid vaccine administered to the client.  At this time no reports of needed treatments.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age. 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 (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported and batch number were not reported, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, dose not reported, administered on an unspecified date 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 experienced covid-19 and became violently ill after receiving vaccines and all booster shots (suspected clinical vaccination failure and suspected covid-19 infection) (both events with dose number in series 2). The consumer reported that, "I caught covid from someone who had vaccine and all booster shots. He became violently ill and I contracted it from him. It's like the vaccine caused the virus to mutate into something worse. I am lucky to still be alive and if the vaccine worked all that would have never happened."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000217481. This case, from the same reporter is linked to 20220234819.; Sender's Comments: V0-20220234118- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
NUMB FACE INITIALLY, NUMBNESS DOWN BOTH LEGS. NO FEELING OF HOT OR COLD ON THIGHS, ARMS. LIPS CURRENTLY NUMB. ICY-HOT SENSATION WHEN WIND HITS BODY WHEN SWEATING. HANDS IN COLD WATER FEELS "ICE, ICE, ICE FREEZING COLD". HEAT FROM SUN IS SIGNIFICANTLY ENHANCED AS IF THE SKIN WERE BURNING
Immediately after the vaccine, I had redness around the injection site and a sore arm for about 2-3 days. I received the shot on a Tuesday, and by the weekend my arm felt fine. One week later (Monday 25th), I felt like I had a light fever. My temperature was 99.1F. Tuesday, my left arm where I received the injection was SO SUPER itchy. When I looked at it, there was a huge, red, swollen, bump. The area was about the size of a credit card. The area was also HOT to the touch even though the rest of my arm felt like a normal temperature. From Tuesday 26th through Wednesday 27th (time of reporting), I still have the big, red, hot bump at the injection site, and my fever fluctuates in between 99.1-100.4F. I contacted my doctor who believes it is most likely an allergic reaction to the vaccine. He has advised me to take benadryl and tylenol, and if I still have the fever tomorrow, he will test me for strep, flu, and COVID. I have not taken the benadryl and tylenol long enough to see if there is any sort of impact. I should also mention that I get tested weekly for COVID at work, and my test from Monday January 25 has come back as negative.
Mother of patient, DOS 7-25-08, who is a patient at our clinic, she was holding patient on her lap when immz were being given. After giving immz in thigh, nurse stuck patient with the needle on 5th knuckle R hand. Went to where patient is staying on 10/30/08 cleaned area with 1/2 Str H2O, applied NEOSPORIN and a bandaid. Site has approximately 1 cm area of erythema with edema & tender to palpation. Full ROM of hand (unsure which immz had been given prior to needle stick.)
Tachycardia, dizziness, headache, vomiting, flushed, cold sweats
Today, second day after the second shot I noticed a lump by my neck at the collar bone, on the right side of body. The lump is slightly tender to the touch. Also my arm pit on the right side of the body is swollen, appears as a lump as well.  The shot pain at the injection site only lasted one day, iced my arm overnight and felt fine no other side effects.
Eyes swollen shut next morning, diarrhea. Hives on chest lasting 3-4 days. BENADRYL taken for symptoms.
Patient received her first high dose flu vaccine 10/13/2020 at a flu clinic run by Health District. The next day patient reported her arm was sore, "hot" and red. Also complained of swelling from left shoulder to elbow. Came to health district office 10/15 and left arm was pink, with swelling noted as stated, not warm to touch. Encouraged patient to call her PCP or her GI doctor as she stated she is on medication for Crohn's disease.
This spontaneous report was received from a medical assistant concerning an unspecified number of patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reaction or allergies were not reported. The reporter stated that, since 11-JAN-2016, the patients were vaccinated with doses of PNEUMOVAX23, lot # L019835, expiration date 23-MAR-2017 (dose, dose number, route, and anatomical location were unspecified) that were exposes to 47.9F during 5 minutes. No adverse experience has been reported. This is one of several cases received from the same reporter. Additional information has been requested.
No problems until 3 days after the vaccination that I went out for a walk and I fell, I started having hives all over my arms and legs. I have never had the hives breakout before. It happened at night, so I did not visit my doctor, but I walked to the pharmacy a few blocks down my house and got Benadryl.
Patient sent to the ED by PCP for shortness of breath and cough.  Patient admitted to the hospital with Covid pneumonia and treated with remdesivir.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "shrimp" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ciproflaxin, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive on day 9 after original symptoms; Negative, notes: testing negative for several days. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid started on 20Jul2022 and stop date 25Jul2022. Clinical course: Paxlovid rebound. Tested positive on day 9 after original symptoms (4 days after completion of Paxlovid) after testing negative for several days. Experiencing mild symptoms during rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT RECEIVED PFIZER VACCINE ON 05/10/2021, AND WAS GIVEN MODERNA AS A SECOND DOSE ON 05/31/2021
pt had vax approx 1110 @ 1115 stated rt shoulder, elbow & wrist began aching & going numb @ 12noon; feel numb & cant move my arms; c/o dizziness, nausea; pt becam very anxious stating; rt arm swollen & bruised, stiff & sore by this time;
Information has been received from a consumer concerning his now 5 year old son with developmental delays, who at the age of 18 months was vaccinated with a dose of MMR II (approximately October 2005). There was no concomitant medication. A day or two after receiving MMR II the patient developed a 104 degree fever. The patient was taken to the emergency room which he was there for a few hours, but he was not admitted. The consumer reported that before receiving MMR II the patient was having some developmental delay but after receiving MMR II the developmental delays were getting worse. The patient was diagnosed with autism when he was 2 1/2 years old. The patient had improved due to therapy. The patient saw physician for medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Adverse reaction after Dose No. 2 on 4/1/2021  Bloating, abdominal pain, and extreme vomiting on 4/3/2031 starting around 8:30 p.m.
Patient received first dose of Pfizer vaccine, but the vaccine was erroneously entered into as the Moderna vaccine with the Pfizer lot number. The second vaccine dose was entered as the Moderna vaccine, but corrected to the Pfizer vaccine.
perpetual migraine/daily migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE. The patient was treated with NURTEC for Migraine, at an unspecified dose and frequency and FIORICET for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE outcome was unknown.            Concomitant medication not reported.   Most recent FOLLOW-UP information incorporated above includes on 08-Nov-2021 Significant follow up, lot number and drug start dates given.
2/17/17 Patient went to ER with generalized hives on whole body and across head. Given prednisolone 15mg/5mL 15mg in ER and sent home with ORAPRED 15mg/5mL 15mg Dailey. 2/8/17 Patient brought back to ER Mom states she is much worse generalized hives and facial swelling given BENADRYL, DECADRON, prednisolone. Mother states that child had several immunization shots yesterday. Woke with hives all over body and head today. 19-month-old female brought in for evaluation of a rash with hives all over the body. As per mom a day ago had immunization shots. Denies kid having any difficulty breathing or wheezing. Also denies any nausea vomiting diarrhea or other symptoms. Kid still drinking and wetting diapers. Pt. presents with generalized hives on whole body and facial swelling. Pt seen here yesterday for same reaction but improved with steroids. Mom states today reaction is much worse. 19-month-old kid brought in back with recurrence of rash. As per mother the rash was gone in the night but returned in the morning. No other specific complaints. Kid still eating and drinking and not in any respiratory distress. Denies any fever chills vomiting diarrhea difficulty breathing or other symptoms. No other specific complaints.
Swelling of R thigh starting 26 hrs post injections. Was given 3/4tsp post ER visit on 1/3/03 7:30pm, none before. Swelling decreased but not gone 1/6/03. Rectal temp 101.8 at ER 1/3/03 7:30pm.
Pt complained of an itchy neck and tingling and swelling of left arm.  She was given 25mg of Benadryl IM in the right deltoid at 1616 and 20mg pepcid po at 1616. Symptoms resolved and patient was discharged at 1728 after close observation.
Left arm red, swollen, continues to be red, swollen 11/8/04 went to Dr. received antibiotic.
Upper RT arm hurts, head ache, neck ache, aches & pains - especially joints,  very tired,  generally feel like I have the flu. Ear Temp at 99.7
Pt reported heaviness in her chest, BP 166/88, pulse erratic, slight nausea.  Spoke with pharmacist we agreed to continue monitoring for 15 extra minutes.  After 30min patient symptoms remain with elevated BP and heaviness in chest, patient was sent to ED for evaluation
Red 4 inch diameter area at injection site occurred same day post vax. It was itchy, red, and warm to touch.
No adverse events reported as of yet after patient was vaccinated in right deltoid except a sore arm; pregnant patient was vaccinated yesterday with the COVID-19 vaccine; pregnant patient was vaccinated yesterday with the COVID-19 vaccine; pregnant patient was vaccinated yesterday with the COVID-19 vaccine; This is a spontaneous report from a contactable physician via Medical information team. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, in right deltoid via an unspecified route of administration on 17Dec2020 10:30 at single dose for routine vaccination. Medical history was reported as none. The patient's concomitant medications were not reported. It was reported that patient pregnant was vaccinated yesterday with the COVID-19 vaccine. She received vaccine while pregnant on 17Dec2020 which was non serious per report. The patient was an MD and her age was 35 years old. She was vaccinated yesterday with COVID 19 vaccine and she was pregnant. She was able to speak to Pfizer Drug Safety. The patient was a frontline Healthcare provider and there was no prescriber for the vaccine. She thinks there should be a pregnancy registry so she wanted to get on it so Pfizer can use her data. Her next dose will be on 07Jan2021. The reason she got it was because she was high risk and a front line healthcare worker. The patient was 21 weeks pregnant. She assumed this was going to be a normal pregnancy and normal delivery. The patient had the vaccination in the hospital. No additional vaccines administered on same date.  No adverse events reported as of yet after patient was vaccinated in right deltoid except a sore arm. Onset time of arm being sore was 5pm (17:00) yesterday, 17Dec2020. This did not require a visit to the ER or physician's office. No prior vaccinations within 4 weeks. No AE for prior vaccinations and no medical history or family medical history relevant and no relevant test. The outcome of the events was unknown.
Tested positive for covid on outbreak testing 10/8/21.  10/11/21 diminished sense of taste and smell.
I woke up on Saturday after feeling fine the night before. I could not see and my eyes darted to the right. I could not make my eyes focus. I was extremely dizzy and nauseous. I tried to go back to sleep to see if improved. I woke up again with same issues but now having numbness and tingling to arms and legs. It felt like my nerves were on fire. I am a nurse and was worried i was having a stroke. My husband rushed me to the hospital as now my face was numb also. I was throwing up and still unable to open my eyes. I had IV and fluids with meds for nausea and dizziness. I had a cat scan of head and MRI which are normal. My blood work was reportedly normal also. I was discharged to home. I have very little memory of Sunday, Monday or Tuesday. I was very foggy in my thinking but the nausea and dizziness was resolved. My gait is still off and I walk with an unsteady gait. I had avery sore arm after my first injection only. I did feel for two weeks or so that my nerves were on fire. Just keyed up over nothing and very irritable. I had told my husband my right eye had bothered me for a week. pain in the outer corner. I had done lots of yard work and thought possibly got something in my eye. I had also had a tic attached to my left arm. I told all this to my doctors. I am just not sure any of this is related to the extreme vertigo I was diagnosed with. I am very nervous to take the second vaccine.
Patient had fever present 5 hours post injections. Patient had pain in both arms that night, was unable to move arms. pain in left arm still present at 1300 8/10/2018 with redness and swelling down to elbow, painful to touch. Armpits also painful per patient Pain has reduced since then, but still present. Patient took a tramadol, and pain was relieved. Pharmacist recommended ibuprofen.
Initial reported received from a health care professional on 25 June 2010. A 13-year-old male patient, with no known allergies and no illness at the time of vaccination, received an intramuscular (IM) left arm injection on 22 June 2010 of MENACTRA, lot number U2933AA, and returned on 23 June 2010 to the doctors office with erythema at the injection site, malaise and stiffness in the arms and legs. The patient had no fever. The outcome was reported as not recovered. Follow-up information received on 21 July 2010 from a health care professional. The patient was reported to require no treatment, no further evaluation and recovered from the adverse events (erythema at the injection site, malaise and stiffness in the arms and legs) "the day after onset". The reporter requested no further follow-up. Follow-up information received on 23 July 2010 from a health care professional. The patient was reported by parent to be "100% better" as of 24 June 2010. According to reporter, they had no additional information at the time of the report. Documents held by sender: None.
Problems from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Problems from the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION COMPLICATION (Problems from the vaccine).   At the time of the report, VACCINATION COMPLICATION (Problems from the vaccine) had resolved.      Concomitant product use was not provided by the reporter. No treatment information was provided.
1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms.  2:06 moved via w/c to private observation with EMT on site in Gave patient ice packs for both arms. States that the ice reliefs to burning. attendance. HR 78; O2 97%. Unable to obtain BP due to obesity. Per exam noted on Left lower arm a solid red raised area about 3 inches in diameter about 1/8 cm height. States it burns. Has mildly red scattered hive like areas on right lower arm.  2:15 Gave patient ice packs for both arms. States that the ice reliefs to burning.. Denies any burning or swelling in throat. BBS CTA per EMT assessment. No shortness of breath note;  2:25 States she drove on her own and lives in a senior adult complex. EMT recommended ambulance for further evaluation. Patient declined. EMT instructed patient to contact medical physician or emergency if problems persist or if symptoms worsen. Patient agreed and left ambulatory to private vehicle.
Breakthrough case admission after 2 vaccines Moderna 3/13/21 Lot# 024M20A;  Moderna 4/13/21 Lot# 018B21A
when I lay down to close my eyes, I've had hallucinations; Chest pain; headache; ear ache; nausea; tiredness/ extremely tired; sweating; chills; major night sweats; terrible nightmares; body feels like someone has beat me with a bat; This is a spontaneous report from a contactable (patient) via Regulatory Authority.   A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 11Aug2021 17:00 (lot number: 59267-1000-01; expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a pharmacy/drug store. On 12Aug2021, at 3:00 AM, the patient experienced chest pain, headache, ear ache, nausea, tiredness, sweating, chills, major night sweats, terrible nightmares, body feels like someone has beat her with a bat, extremely tired and when she lays down to close her eyes, she had hallucinations. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered.  .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events hallucination and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Chest tightness, Chills, Dizziness, 'cold sweats'
This initial spontaneous report was received on 21-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In approximately 2015, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and the intended purpose for the long-term prevention of shingles and zoster-related injuries (dose, route, and lot # not provided). The vaccine did not prevent shingles or zoster-related injuries as intended. Later in 2015, the patient was treated at an urgent care for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
per death certificate pt died in the home with COVID 19 being a condition contributing to death; pt being seen by Hospice; tested positive for COVID on 12/23/21 and again on 1/10/22