chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness at injection site; itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE PRURITUS (itching at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE PRURITUS (itching at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE PRURITUS (itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
From telephone contact received at manufacturer on 4/25/02, it was reported that a male patient received Tripedia on 4/22/02. Patient developed a pimply rash in the groin and on buttock area on 4/23/02. By 4/24/02, the pimply rash was on his chest and part of his face. Patient was evaluated and treated by physician on 4/25/02. Office filed a report.
This case was reported by a consumer and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several hours after receiving SHINGRIX, the patient experienced fever, chills, nausea and pain in arm. On an unknown date, the outcome of the fever, chills, nausea and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, nausea and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine late Saturday afternoon and since late Saturday evening the patient had a fever ranging from 99 to 101.5 with chills and nausea and lots of arm pain. The patient knew these are typical side effects of the vaccine, but queried if how long do these symptoms usually last on average, it had been more than 24 hours and they were not getting the slightest bit better.
I suffered a major heart attack, I had to have a stent put in. I now have COPD, Emphysema, Congestive Heart Failure. I am having my heart shocked on Oct. 22, 2021 and having a defibrillator installed.  I was a perfectly healthy person until  this vaccine. Now I am unable to work, exercise or anything that involves normal activity.
EQUILIBRIUM TROUBLE; DIZZINESS; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included hot flashes, and previous dizziness., and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808609, and batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced dizziness. On an unspecified date, the subject experienced equilibrium trouble. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from dizziness, and the outcome of equilibrium trouble was not reported. This report was non-serious.
Client received vaccine on 03/21/2008. This was her third dose of HPV. She reported soreness and skin at injection site, slightly red. Denies edema, soreness and redness since time of injection 5 days ago. She denies edema or drainage. She says skin may be slightly warm but not hot. She also noticed and neck and upper back around shoulders is a little sore but unsure if related to injection.
Had a stress test which told that he had atherosclerosis of the arteries. He was having these chest pains and it basically seems like they have started going away when he got the vaccines; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history included ongoing atherosclerosis of the arteries and ongoing chest pain. The patient's concomitant medications were not reported. On an unspecified date, he had a stress test which told him that he had atherosclerosis of the arteries. He was having these chest pains and it basically seems like they have started going away when he got the vaccines. Was wondering if it was actually something involved with the virus or an artery problem. Was trying to get this all figured out. Stated that the atherosclerosis and chest pains are continuing to this day. It basically seemed to start diminishing once he got the vaccine. He thought maybe it was a placebo effect. It seemed as if the vaccines, the first and second, improved his conditions but the conditions did not improve all the way. Stated that he has nothing to report but he thinks it would help to the point where he asked the medical doctor if he could get a third shot. Caller just wanted to get an idea when the expected third vaccine would be rolling out. The chest pains only start at the start of his walking and exercise. It diminishes after a while. He was just trying to figure out his health situation. He hasn't gone back to the doctor since the stress test. He hasn't actually gotten any response from the main doctor after the test. Maybe that means it must not be a concern. He was just trying to figure out about his health diagnosis and trying to reach out and figure out what to do next." On an unspecified date, the patient underwent lab tests and procedures which included stress test: he had atherosclerosis of the arteries. The outcome of event was unknown.  The lot number for [bnt162b2], was not provided and will be requested during follow up.
6 Days after vaccine I experienced a Blood Pressure spikes 190/110 along with Extreme headache, palpitations, clammy hands and shaking. I have had 5 spikes since.  My doctor placed me on 2 Meds- 25mg Metropolol and 1mg Doxazosin daily. The episodes seem to have decreased since 4/27/21.
This case was reported by a Certified Pharmacy Technician and described the occurrence of cut finger in a 30-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 22 May 2014, the subject (nurse) was attempting to administer a ENGERIX B vaccination to a patient. When she tried to flip the cap off the ENGERIX B vial, the vial broke in her hand and she received a cut on her finger. Nurse told pharmacy technician there was no liquid on her hand, and she felt the vial was empty. This case was associated to a product complaint. At the time of reporting, the cut on subject's finger was unresolved. Follow-up information received on 20 June 2014 from the Certified Pharmacy Technician: Subject's details were provided. No medical history was reported. The subject had no known drug allergy. On 22 May 2014, the subject (an infection preventionist) was popping the lid of the ENGERIX B vaccine when it broke in her hand. She discovered that the vial was already broken and glass was in the box where it was stored. There was no vaccine in the vial and there appeared to be no liquid in the box as well. Upon examination, the vial was broken on the bottom. On 22 May 2014, the cut on subject's finger was resolved. A new vial was obtained. Follow-up information received on 14 July 2014: The quality assurance investigation results were received. According to the thorough investigation performed at the different production steps, GSK Biologicals concludes that it is unlikely that the root cause of this complaint took place during the manufacturing process. GlaxoSmithKline Biologicals therefore considers this complaint as unsubstantiated.
At site of injection, very red and raised oval area, about 3 inches by 4 inches. Significant pain and increasing redness and heat as the day continued. Redness and rash spread along the entire upper arm on the inside, extending downward past the elbow. Very tired, difficult to get through the day 10/21 thru 10/23. Today, 10/24, less heat, reduced redness, but some joint pain and several small red spots on face, however, better energy though not completely normal.
Patient is a 85 y.o. female patient of MD .   Patient states that last week she became ill with a cough.  She did a telemedicine appointment with PCP and was prescribed antibiotics and prednisone.  Patient has had increased worsening of shortness of breath over the past few days as well as coughing.  Patient was positive for COVID and reports she has had her vaccine.   Hospital course as below.  Patient improved with medical treatment.  Patient will complete 10-day course of Decadron outpatient.  Patient instructed to follow-up with primary care provider within 1 week of discharge.  Home health care services arranged on discharge.   1. COVID, +10/17, symptoms 10/8, vaccinated: -CXR non-acute -crp elevated, start decadron -decadron  -no indication for remdesivir at this time, out of window -lovenox DVT prophylaxis    2. Intermittent hypoxia: -2/2 above -wean oxygen as able -overnight pulse ox test with desaturation   3. Hx SVT: -cont home meds   4. Seizure disorder: -cont home meds   5. Other chronic medical conditions: Arthritis, asthma, history of DVT, thalassemia trait, history of thyroid cancer, anemia
4/14/2021- urine appears to be very dark in the morning & if it has been a couple of hours since last urination 4/16/2021- went to doctor who thought I might have a UTI but no UTI was found 4/18/2021- entire body started itching, rash on front & back torso area Somewhere in here, I was very nauseous and had trouble eating & drinking.  sometimes vomited after eating. Lot 7 pounds in 2 weeks. 5/3/2021- went to doctor for the itching- she checked urine again since those symptoms were still present- she became very concerned. Bilirubin present in urine.  Doctor drew blood for some tests.
Thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia) in a 37-year-old male patient 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 THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion hospitalization). At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia) requiring hospitalization , meds and platelet infusion 4 days following the Moderna vaccine with no details regarding presenting symptoms, platelet count, treatment outcome.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  This case was linked to MOD-2021-096593, US-MODERNATX, INC.-MOD-2021-096593 (Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. MOD-2021-096593:Same Literature article (11 patients) US-MODERNATX, INC.-MOD-2021-096593:Same literature article (37-yo male)
Red swelling in a circle at injection site, very sore arm with swelling, nausea and vomiting
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 31st January 2020). Concomitant products included carvedilol, Furosemide, omeprazole, latanoprost, Oxybutynin Chloride and SYNTHROID. On 6th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site itching. In April 2018, the outcome of the injection site pain, injection site swelling and injection site itching were recovered/resolved. The reporter considered the injection site pain, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included Latanoprost eye drops. At 2:30 pm, the patient received SHINGRIX on the right arm. Less than a day after vaccination, the patient experienced swelling and itching at the injection site. The events lasted for 10 days.
Slight bruise at injection site. Warmth to touch and red-blotchy skin in 3-4 inch radius from the injection site. Patient reports no ill feeling, no itching, just redness and warmth. Patient presented to pharmacy and I have documented based on signs that are visible to me as well.
Auto immune reaction. Pain, stiffness, nodules on hands, inflammation, malaise, lung/resp. inflammation, irritation.
Patient with history of allergy to IV contrast received first Pfizer vaccine and was sent to 30 minute observation area.  A few minutes later, complained of numbness of lips, tingling of lips and perhaps some upper lip swelling.  Exam was normal.  Calm with strong pulse.  Clear breath sounds, normal voice. No hives.  Given Benadryl 25 mg po and observed.  Symptoms resolved and patient went home.
Left deltoid, swollen and red.  Entire area affected.  Client reported "itching", no pain or difficulty breathing reported.  Informed to seek MD if worsens, and to apply cortisone cream and take one dose of Benadryl.
Low grade fever, swollen/red/hot left upper deltoid/arm, LA-sore/painful, cellulitis. Seen and treated pt prescribed antibiotics to treat cellulitis.
anaphylactic shock  Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at me in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. went unconscious,  - after recovery I had tremors for a few hours such that I could not hold a glass of water, legs felt hot to the touch and ached for several days.  Still feel weak and tired.
Started as a small patchy rash on my chest and one on my face a couple days after the second shot, then slowly increased to multiple dry patches over my chest, torso, hips, and lower legs. Some had an appearance like eczema (dry, scaly, especially on my legs) and others were more like contact dermatitis. The rash patches would slowly grow over time.   Sometimes they were itchy and inflamed, other times I did not feel them at all. It peaked at about 3-4 weeks, with about 100 spots dime to quarter sized, and was mostly gone by 8 weeks. I trialed some triamcinolone cream and it was helpful, but the rash became too big and it was not advised to use a topical steroid for such a large surface area. I also tried some over the counter allergy medications such as Zyrtec and Benadryl but that was not helpful. An appointment was made with a dermatologist but the wait was so long it improved so much by the time of my appointment I cancelled.
pt recvd 1st hep B @ hosp,devel red raised rash w/ white ctr;no tx given & no oth rxn;
Peeling skin on the hands, more on the fingers, more on the palm side, starting on Tuesday. Kept moisterizing without relief. No new detergents, unusual foods. No pain/itchiness.  No peeling on the feet. No pain in mouth. No easily sloughing off.
w/i15 min of vax lt arm deltoid w/hives @ shot site, largest @ inj site size 10mm, smaller hives sizes ranging from 1 to 5mm going to rt & lt inj site;cold compresses to site & did not alleviate hives p/30min;referred to MD;
experienced a very loud intensity of my tinnitus and it has not changed or subsided; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZILEUTON, start date: Feb2014; FOSAMAX, start date: Feb2018. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "Developed an escalation in the intensity of my (relatively minor) tinnitus", "covid", "covid"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "covid", "Tinnitus"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "covid"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "covid", "Tinnitus"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "covid".  The following information was reported: TINNITUS (non-serious) with onset 08Apr2022, outcome "not recovered", described as "experienced a very loud intensity of my tinnitus and it has not changed or subsided". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Patient did not have any known allergies. Approx three hours after receiving her first shot on 22Jan2021 She developed an escalation in the intensity of her (relatively minor) tinnitus. Noticed no difference after second Vax and first booster. But three hours after her second booster 08Apr2022 She experienced a very loud intensity of her tinnitus, and it has not changed or subsided. This one was life altering. She did not plan to take any further covid treatments.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Generalized rash over trunk starting 7 days and lasting up to 12 days. No mucositis.
I started feeling really nauseous at 08:00 pm and had low energy all day. Vomiting followed by chills and body aches that evening and into the  next morning. I was vomiting that morning but it stopped after about 12 hours. The next day, I was tired until 07:00 pm. No treatment.  Estimated date of delivery - Due July 5, 2021; first pregnancy.
I'm not sure if the shot had anything to do with this or not, but my son came home from school on the 9/14/2021, with an upset stomach.  He threw up and later complained of side pain with a low grade fever.  I had to take him to emergency care to get a covid test before returning to school. The Doctor accessed him for covid and determined that his symptoms were more aligned with appendicitis and suggested that I take him to the emergency room.  He was accessed there and then sent to the hospital by ambulance to have his appendix removed.  I'm not saying that the shot had anything to do with it, but I wanted to make sure that I reported it since he was healthy before the shot with no issues.  Hopefully no one else has had this happen so soon after the shot.
The patient called today to express concern over a reaction to the immunization given on 7/5. The patient stated he has flu-like symptoms and body aches the day after receiving the immunization which subsided that evening. The patient called this morning (7/8) to express concern over a swollen lip that he thought might be associated with the immunization as well. The swelling started on the left upper lip then proceeded to encompass the whole lip shortly thereafter. The patient was instructed that, though unlikely, this could be associated with the immunization and was instructed to take OTC benadryl to reduce the swelling. The patient was also instructed to seek emergency medical attention if his symptoms worsened.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Dose button did not work. Pfizer dose 2 on 01Mar2021. Pfizer dose 3 on 09Oct2021. Moderna booster on 26Apr2022. Rebound to Paxlovid. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Vaccination Failure and COVID 19 and the suspect drug BNT162b2 .
Pt received vaccine and became dizzy and layed down flat. Pt was breathing w/ (+) pulses and arousable. Pt was given water and crackers and felt better w/in 5-10 min. Mom stated legs were convulsing but not witnessed by staff.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 9th April 2019, the patient received the 1st dose of SHINGRIX. On 9th April 2019, less than a day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and within 24 hours developed a rash on the left chest. The patient did not describe the rash as painful or itchy, just stated she had a rash.
Patient developed fever, conjuctivitis, periorbital edema on 11/4. He was seen 11/5 with diagnosis of LLL pneumonia and pansinusitis with most severe infections in sinuses. Patient admitted for oxygen, IV Rocephin and Albuterol. Discharged in 48 hours; Augmentin; Flonase; Allegra.
Patient initially called office with HA, myalgia and muscle pain. The patient presented to hospital on 1/17/2022 with a chief complaint of nausea, vomiting, fatigue, muscle aches, bilateral shoulder pain  Septic joint in bilateral shoulders.  Left shoulder had purulence on aspiration. Shoulders thought to be septic from seeding. Also new onset A. fib with RVR
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. In approximately 2015 (reported as "since 17-SEP-2015"), the patient were vaccinated with a doses of MMRII lot # L002873, expiration date 27-JAN-2017, which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
SOB, fluid retention, htn, atrial fibrillation, pulmonary edema, elevated D-Dimer, elevated BNP, elevated troponin, cough