chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left radial artery left arm blood clot; Left radial artery left arm blood clot; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL THROMBOSIS (left radial artery left arm blood clot) and PERIPHERAL ARTERY THROMBOSIS (Left radial artery left arm blood clot) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced ATRIAL THROMBOSIS (left radial artery left arm blood clot) (seriousness criterion medically significant), PERIPHERAL ARTERY THROMBOSIS (Left radial artery left arm blood clot) (seriousness criterion medically significant) and DIZZINESS (Dizzy). At the time of the report, ATRIAL THROMBOSIS (left radial artery left arm blood clot) was resolving and PERIPHERAL ARTERY THROMBOSIS (Left radial artery left arm blood clot) and DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication information was provided. Patient was waking up in mornings and dizzy. It was unknown if patient was  enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided.  Company comment: This is a spontaneous case concerning a 50-year-old male patient with  medical history of hidradenitis suppurativa receiving Adalimumab, who experienced the serious (medically significant) unexpected events atrial thrombosis and arterial thrombosis of the arm, on an unknown date after receiving an unspecified dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Pfizer Biontech COVID-19 vaccine Tozineram and concomitant Adalimumab (Humira) were also reported as suspect drugs.  Further information has been request. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 50-year-old male patient with  medical history of hidradenitis suppurativa receiving Adalimumab, who experienced the serious (medically significant) unexpected events atrial thrombosis and arterial thrombosis of the arm, on an unknown date after receiving an unspecified dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. Pfizer Biontech COVID-19 vaccine Tozineram and concomitant Adalimumab (Humira) were also reported as suspect drugs. Further information has been request. The benefit-risk relationship of mRNA-1273 is not affected by this report.
p/vax pea-sized pimple devel;itchy;scab @ inj site;may have itched the site;rash spread to full length of upper arm-just above elbow elbow;itchy & swollen;hot to touch;sit itchy;
Swelling and hives on right thigh after administering VAR,  PCV 13. Patient was given BENADRYL and it cleared up after couple of minutes.
Severe sternal/epigastric pain event happened twice. First episode at 4pm day of injection. Lasted 2.5-3 hours. Very concerning , sharp, pin radiating around to back and through to back. Unrelieved by anything. Left abruptly like onset. Second episode was at 4am the following morning, same presentation and duration.  Took Tylenol, used heat for some relief. Pain was def 10/10.
7 days after the first shot  the injection site became very itchy  and has continued  .no treatment was given and the site did not appear to be red or swollen.
No adverse event, treatment, or outcome has occurred yet.  Patient was given first shot in Covid series of Moderna Brand and is only 17 years old.
On 10/3/18 patient woke up complaining of itchy rash at injection site, she also had elevated temp at 99.3 and headache reported by school nurse. The rash continued to get worse with significant redness and swelling along the entire upper arm. The rash looked pustular in nature and is currently being treated with topical diphenhydramine, she was given ibuprofen for the headache and temp. Since reaction has not yet resolved, outcome and time course still to be determined.
pt recvd vax,next day exp rash & water blisters on neck & upper shoulders; events lasted 2 days & resolved w/out tx;
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 23-MAY-2016, the patient was inadvertently administered an expired dose of ROTATEQ lot # K009900 with expiration date on 04-MAY-2016, oral (strength, dose and anatomical location were not reported). No adverse effect was reported and no product quality complaint was involved. Additional information has been requested.
Approximately an hour after receiving the J&J vaccine, I noticed a loud constant ringing in my ears (tinnitus) which has continued. I still heard the ringing in my ears on April 8.  The ringing was so loud on April 9, that it woke me up during my sleep. The morning of Saturday, April 10, I called insurance company Advice Nurse and was advised to go to an Urgent Care to discuss my symptoms. with a doctor who checked my ears and blood pressure--both look normal. He also recommended going to an ENT, for which I have set up a future appointment. Last night, I slept better, but still hear the ringing in my ears this morning. I am very concerned about this ongoing side-effect.
Overnight pain in back (kidneys?) Severe weakness. Slept almost continually for 24 hours. Could not turn over in bed or get out of bed without major difficulty.
Around February 7th, 2023 in the morning I was experiencing AFIB. This was especially happening in my sleep. I was waking up with the chest pains. I contacted my doctor and got an appointment to have a monitor on for a week. That concluded early last week that I need to take ELIQUIS; metoprolol to regulate my heartbeat. But I cannot take it until the report comes back official. I had another attack in March and had to go to the ER. I had some tightening in my chest it was a very fast heartbeat over 150. I also had flu like symptoms, I was very cold. I noticed this happens when I'm having my attack. I was monitored and given fluids and injected me with something to calm the heart, CARDIZEM and sodium chloride. The ER confirmed my AFIB, and I now taking the medications. The following day I had another attack and started taking the medication right away.
I feel off; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2021.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL. At the time of the report, FEELING ABNORMAL outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician concerning a 11 year old female patient with no pertinent medical history and no drug reactions or allergies who on 17-JUN-2009 was vaccinated with a first dose of GARDASIL (lot# 661952/1129X) intramuscularly into left arm. Concomitant therapy included (MENACTRA). On 20-JUN-2009 " 72 hours after the first dose" the patient developed neck stiffness and some tremors in the left arm. On unspecified date magnetic resonance imaging (MRI) was performed (results not reported). The patient sought medical attention was saw by the physician. Additional information has been requested.
Patient picked up medication at  her local Pharmacy and hand brought vial to our clinic . Patient was given injection in office . As Medical assistant was logging into patients chart  she noticed  vial was expired . We did  contact the pharmacy Department  . Report competed withy VAERS.             Meeting with Staff to verify 3 times . Patient was contacted and was discussed with Provider. Patient did come back and received new dose. PER CDC    recommendations..
Dizziness for 36 hours; Weakness for 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness for 36 hours) and ASTHENIA (Weakness for 36 hours) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIZZINESS (Dizziness for 36 hours) and ASTHENIA (Weakness for 36 hours). At the time of the report, DIZZINESS (Dizziness for 36 hours) and ASTHENIA (Weakness for 36 hours) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
At 4:05pm vaccine was administered to patient. While we were waiting for the 15 minutes to elapse, patient looked visibly ill by 4:12pm. I asked him what was wrong and he replied that he felt sick and really tired. I told him to take a seat near me. When he sat next to me he said he was really tired and wanted to go to sleep and proceeded to close his eyes. I told him to stay awake. I then called one of the nurses and i helped them put patient in an observation room. They proceeded to take his vitals for the next 30 minutes. Patient was laying down feeling very fatigued with the feeling of nausea as well. During the course of 30 minutes, his heartbeat fluctuated between 70bpm and 100bpm. After 30 min, nurses recommended an ambulance be called since symptoms were not getting better. Once EMT?s arrived, they determined that patient was stable and that we (his parents) should take him to the ER for further observation. Upon checking in to the ER, he was given medication for nausea. His vital signs were stable and we stayed at the ER for approx 2 hours for observation. At Approx 8:15pm, symptoms improved and we checked out of the hospital. The following morning, patient stated he was feeling dizziness and nauseated when standing up. We decided it would be best for him to stay home from school & we were able to setup an appt with his PCM. His doctor was not sure why he had this reaction to the vaccine and was given nausea medication.
Information has been received from a licensed practical nurse (L.P.N.) concerning a female patient with allergy to BENADRYL who on unknown dates was vaccinated subcutaneously with 0.65 mL of ZOSTAVAX (Merck) (Lot# and expiration date not reported) and with a dose of PNEUMOVAX 23 (Lot# and expiration date not reported). It was reported that the patient received ZOSTAVAX and PNEUMOVAX 23 on separate occasions and a couple of years ago she experienced shortness of breath. The nurse seemed to think that it was on patient's head that she experienced the same reaction on two different occasions. The patient sought unspecified medical attention (Just called the office). As treatment for the adverse event the patient received albuterol. At the time of reporting the patient's outcome was unknown. No further information is available.
NO reaction ROTA- aged out and wasn't needed but was given VAXELIS- combination vaccine given when single HIB and Dtap were what was needed. patient received extra Hep B and Polio (NO REACTION)
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA005084: US-009507513-1802USA005085: US-009507513-1802USA005090: US-009507513-1802USA005086: US-009507513-1802USA005087: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA007559.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: patient became very faint and nauseated.  she was seated, i checked her blood pressure (which stayed about 90/60 or higher), and provided water.  she also expressed concern over tingling and cramping of hands.  she recovered completely in less than 30 minutes.
COVID-19; COVID-19; Joint pain; This is a non-interventional study report from the marketing program facilitated collect received from a contactable consumer or other non hcp received by Pfizer. (Manufacturer Control No: 2016-0191204). A 59-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN), solution for injection, Batch/Lot number was not reported), via intramuscular on an unspecified date as dose 1, single for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for psoriatic arthropathy. The patient medical history included psoriatic arthritis. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date in Aug2021, the patient experienced covid-19, joint pain. The outcome of the events was unknown.  The reporter assessed the causality between humira and events as Reasonable possibility. The reporter assessed the causality between BNT162B2 and events as possible.; Sender's Comments: Based on the information in the case provided, the causal association between the events Suspected Covid 19 and Arthralgia and the suspect drug BNT162B2 cannot be excluded.
Like 5-10 mins after receiving the vaccine I began to have right temporal pain. This stayed for 2-3 hours. The pain then started to creep over my right eye and then my entire right face. Within the next 4-5 hours I was having pain over both eyes. By midnight I woke up with pain at the right backside of my head along with chills and body aches. The headache lasted for 2 weeks. I called my Dr. after 1 week. He prescribed prednizone 40mg which did not work. He then prescribed 600mg Advil every 4-6 hours which also did not work. Then imotrex which also didn't help. Also, the last 3/4 days, I had increased jaw tightness. I usually have TMJ issues but this was extraordinary.  Eventually the symptoms resolved themselves.
Initial unsolicited report received from pharmacist on 02-Oct-2018. This case involves a 73 years old female patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (Batch number: QFAA1810, expiration date: 30-Jun-2019, site of administration: right deltoid and route was not reported) on 25-Sep-2018 and 01-Oct-2018. The patient's concomitant medications included SHINGRIX. The patient's medical history were not reported. It was an actual medication error due to Extra dose administered (received FLUBLOK last week and again yesterday). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient was given the 5-11 dosing of the 23/24 Covid Vaccine when she was supposed to receive the 12+ dosing. No adverse reactions from vaccine.
Fever of 104.3 Fahrenheit, chills, body aches, headache, soreness at injection site.
Too weak following day to even roll over in bed Tues); some mobility the second day, although still mostly bedbound due to extreme fatigue (Wed). Excessive urination throughout the period; able to eat very little; took some fluids the second day. Massive night sweats that second night. Felt much better at beginning of third day (Thurs), but over the space of four hours became dizzier and dizzier, blood pressure fell gradually and steadily. When it reached 60/40, decided ER visit would be necessary. While attempting to reach bedroom to get some clothes, fainted and fell in hallway. County Fire had to establish IV and transport to Medical Center ER. ER continues hydration through IV all that day (Thurs) thru 4:00 PM Fri, then released me from hospital. Extensive tests during this period were all negative.
FEVER ONSET 6-12-08; HOSPITALIZED FROM 6-15 THRU 6-16 RASH ONSET 6-13-08 UNTIL PRESENT TO GENERALIZED BODY 7/24/08-records received for DOS 6/16/08-presented to ED with C/O fever since 6/13/08- temp in ED 102.1 (T).  PE normal. DX: Acute pyrexia. Pancytopenia. Discharged home.
Complained of dizziness, nausea and headache after receiving flu shot.  10:35 BP Right 120/86, Left 130/86 Pulse 80. 11:00 BP Left 120/86, Right 140/80, Pulse 70
Left arm pain starting day of vaccine, continued for 5 days after vaccine Low-grade fever for 2-3 days after vaccine Joint pain for 3-4 days after vaccine Petechiae on the back of right hand and distal forearm appeared one week after receiving vaccine
HPI:  50 Years old   Female  with history of diabetes and hypertension who presented to the emergency department for rash to her neck and ears.  Patient states that she received her shingles vaccine, COVID vaccine and her flu shot on February 2, 2022.  She states since after receiving the vaccines she began having red bumps and rash to her neck and ears  TX: Motrin 600 mg Percocet 10 Benadryl 50 upon reevaluation patient itching improved as well as pain  Medical Decision Making:  After consideration of a broad differential, patient appears to be having a non-specific mild allergic skin reaction that does not have ongoing systemic symptoms. Patient has no evidence of other emergent process such as, but not limited to, anaphylaxis, sepsis, vasculitis etc.  Patient will be discharged with strict return precautions and follow up with primary MD within 24-48 hours for further evaluation. Patient understands that they may require reevaluation if their symptoms recur or worsen.
body aches; headaches; high fevers; some lymph node swelling which prevented the patient from attending work; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (headaches), PYREXIA (high fevers) and LYMPHADENOPATHY (some lymph node swelling which prevented the patient from attending work) 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 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-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 PAIN (body aches), HEADACHE (headaches), PYREXIA (high fevers) and LYMPHADENOPATHY (some lymph node swelling which prevented the patient from attending work). At the time of the report, PAIN (body aches), HEADACHE (headaches), PYREXIA (high fevers) and LYMPHADENOPATHY (some lymph node swelling which prevented the patient from attending work) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.