chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sort of feels like there's a little bump there; and the skin color looks like color pink; hardness; it was sore a little bit/tenderness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (sort of feels like there's a little bump there), VACCINATION SITE DISCOLOURATION (and the skin color looks like color pink), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (it was sore a little bit/tenderness) and VACCINATION SITE SWELLING (swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 038A21A and 047A21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (sort of feels like there's a little bump there), VACCINATION SITE DISCOLOURATION (and the skin color looks like color pink), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (it was sore a little bit/tenderness) and VACCINATION SITE SWELLING (swelling). At the time of the report, VACCINATION SITE MASS (sort of feels like there's a little bump there), VACCINATION SITE DISCOLOURATION (and the skin color looks like color pink), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (it was sore a little bit/tenderness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.            No Concomitant Medications were Reported. No Treatments were Reported.
UNSTABLE ANGINA 5/28/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient with 2 COVID vaccines who admitted with positive COVID PCR found incidentally upon routine admission testing.  Provider d/c note:  "51 YO male with h/o metastatic leiomyosarcoma with large pelvic mass, who presented with sepsis and abdominal pain. This was found to be due to infection of the tumor due to fistulous communication with the rectosigmoid colon. General surgery, hospice and palliative care were consulted. Patient had previously been ready to sign up with hospice, but decided against it once being admitted. General surgery discussed case with the patient's surgical oncologist. The tumor itself is unresectable. The decision was made to undergo transverse diverting loop colostomy, which was completed on 11/10/22 with Dr. Patient tolerated the procedure well. Post-operatively, he had significant pain issues and poor appetite. He responded to medical treatment of these issues. ID was consulted to assist with duration of antibiotic treatment. Appetite and pain were improved. Patient was discharged in stable condition for rehab. Prognosis remains poor due to metastatic untreated malignancy
Development of sudden apparent lymphorrhea in the left lower leg. Significant edema, rash (approximately 3 inches in height and 2 inches in width) and leaking of lymphatic fluid. Application of compression garment exacerbated condition, causing small amounts of blood to form under the skin. Condition is ongoing and unresolved.
Patient's mother stated he passes out with any vaccine or blood draw he receives.  I administered the patient's covid vaccine and he did pass out almost immediately.  His mother was holding his shoulders up so that he didn't fall out of his chair.  His mother thought he was doing ok and went to get her other son so that he could receive his Covid vaccine as well.  When she left the patient clenched his fists and began shaking.  His skin became pale/grayish.  I asked one man standing by to call ED.  I asked another man to help me get the patient out of his chair and to the floor which he did.  The seizure lasted maybe 10 seconds or so but the patient lost consciousness during and didn't regain immediately.  He was unconscious for maybe 30 seconds?  We had a cold paper towel on his head, fanned him and talked to him until he regained consciousness.  Patient laid on the floor for awhile until he felt strong enough to sit up.  When the paramedics arrived they checked blood pressure, heart rate and oxygen level.  They stated his blood pressure was slightly low but mother said that is normal for him.  Paramedics and parents agreed the incident was most likely due to extreme nervousness about getting the vaccine and determined he did not need to be taken to the hospital.
jun 30 -31 pain in arm and nauseous did not feel good  and Jun 7th my headache started  so bad I went to the ER - on jun 1o th -my. I had headache from Jun7th to 13 th. Stabbing pain behind my ears , my blood pressure was up and down, I was nauseous and diarrhea.I had migraine before  in 2017 and its took 2days only. This pain was different
Received vaccine on wednesday, and upon waking Friday morning notice red rash in armpits, around chest and neck.  Rash increased into Saturday morning and has now disappeared (monday morning).  I get hives occasionally when I catch a cold or get a flue and this was very similar.
This spontaneous report was received from a nurse referring to a 5 year old patient. On 11-AUG-2015, the patient was vaccinated with PROQUAD (dose, frequency and indication were not reported, lot # L009210 with exp. date 17-SEP-2017). Nurse reported that the patient received an unspecified amount of partial dose of PROQUAD due to a malfunction of a safety syringe. The patient had not experienced an adverse effect. Additional information has been requested.
Felt bad 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine on Wednesday and felt bad for 2 days. The patient felt fine now. The patient stated that marked safe from shingles. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Employee reported significant pain and decreased ROM after Moderna COIVD vaccine, stated vaccine was administered "higher on my shoulder than I have experienced with other vaccines". Treated with OTC pain relief and email f/u with pcp who recommended continuing OTC analgesia and exercise of arm.
2 AM nausea; 4 AM chills, intense frontal headache, nausea, body aches started and progressed through mid-day; 8:00 AM TYLENOL 1 gm and sips ginger ale; 11 AM T-100.7, nausea decreased, headache increased; 2PM T-101.6 and TYLENOL 1 gm; 4 PM temp 99.8; 6 PM TYLENOL 1 gm; In bed all day. 9 PM T-98.7; intense frontal headache continued through 10/17 not relieved with TYLENOL. 10/18 no fever, mild headache, relieved with TYLENOL.
FluBlok given to 15 yo patient.  This vaccine is intended for 18 and up only.
juvenile diabetes diagnosed at age 11 on may, 2005.  7/27/07 Received hospital medical records from ER visit of 5/20/05.  Included endocrinology consult which reveals 10 pound wt loss in 5 mos, polyuria, polydipsia, bedwetting.  Seen by PCP earlier same day & sent to ER for fingerstick glucose greater than 500.  Tx w/IVF & insulin & was to be admitted to higher level of care facility via parents. FINAL DX: Type I diabetes, newly diagnosed w/early DKA resolved. 8/23/07 Received t/c from transfer hospital med recs.  States patient not admitted.  Was seen by MD only in Endocrinology clinic. 8/28/07 Reviewed medical records from transfer Clinic where patient was seen only as outpatient.  Notes of 7/19/05, 4/21/06, 11/6/06, 3/19/07  indicate patient w/IDDM, in excellent to very good control via insulin pump.   8/28/07 Reviewed medical records from initial provider from 5/94-11/97 reveals PMH: neveus flammus, small rectal fissure, mild anemia, viral pharyngitis, rash, URI.
Patient said her arm swelled, it was hard and hot. She said she followed up with her physician, and he said to put ice on it. She said it cleared up.
Patient report to ER for fever, stomach ache, and headache within 12 hours of immunization
Approximately 12 hours after the vaccine I had severe vomiting and diarrhea along with fever and convulsions.  Those symptoms lasted about 6  hours.  For several months afterward I experienced headaches and dizziness.
18MAR92 pt recvd 1st dose of Engerix-B 19AMR92 devel pruritis; tx w/antihistamine; resolved 20MAR92;
Attempting to receive the second dose of the vaccine 21 days after the first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Attempting to receive the second dose of the vaccine 21 days after the first dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Attempting to receive the second dose of the vaccine 21 days after the first dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Attempting to receive the second dose of the vaccine 21 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: TCR added. No new information added.
Had immediate pain and swelling of the arm. Eight hours after you were vaccinated got chills and shakes had fever to 103 Fahrenheit and nausea. No rash no breathing problems. Has seasonal allergies but NKDA. Went to the ER was discharged w/ dx of fever given acetaminophen. Next day still has fever and little nausea.
Two weeks after my second covid shot I came down with shingles. Two of my friends also came down with shingles after their shots and an additional two people that I know of also came down with shingles just weeks after getting  their vaccines. I and my two friends all had the moderna vaccine. I do not know which vaccine the other two had.
Pt recvd Engerix-B & more than 14 pts are reported as being nonresponders or having weakly pos results;
This vaccine should have been injected into the deltoid muscle but it was injected into my shoulder, almost directly into the shoulder joint. It caused pain immediately during the injection which became increasingly problematic over the coming hours. By early evening I was unable to lift my arm and was in excruciating pain. The following day I was in so much pain and unable to use my arm at all, moving my arm or even turning my wrist caused me to cry out from the pain. I called my doctor and he prescribed Tramadol for the pain as I had been self administering 800mg of ibuprofen for the previous 20 hours and getting no relief. The Tramadol provided minor relief, enough that I could get comfortable to sleep. Four days later I am still experiencing pain and difficulty doing basic things like dressing/undressing myself or lifting a gallon of milk.
This case involves a 57-year old female patient who was vaccinated once with a 0.5 ml dose of FLUZONE HIGH-DOSE (batch number, expiry date, dose in series and site of administration was not reported) via intramuscular route on 17-Jan-2018. The patient's concurrent condition includes penicillin allergy and hypertension. The patient's concomitant medications were not reported. On 17-Jan-2018, same day (in the evening) following the vaccination, the patient's neck, back and arms were feeling hot, headache, itchy and was feeling unwell. No rash was reported. It was also a case of an actual medication error due to overdose and inappropriate age at vaccine administration. The patient's laboratory investigations and corrective treatment was not reported. The patient was recovering from the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
After I had my second dose (Pfizer-BiuNtech) I am experiencing  allergic reacting - itchy rash.
Next day after the second of Pfizer Covid-19 dose I got a debilitating pain all over the body - muscles, organs, etc for 10-14 days. In 9 months since the vaccine new allergies started (I did not have any of them before)- spring and fall seasonal allergies, sensitivity to bug bites, allergies to foods, spices. Skin rashes and leisions started appearing. Two weeks ago I had to stop amoxicilin course after only two days due to pain all over the body, muscles and abdominal spasms, and skin leisions. In addition to allergies and sensitivity, I now live with a constant low-level pain all over the body, that oftens comes with a sensation of inflamatory heat. The body feels constantly 'wired up', which prevents me from resting or sleeping.
After receiving the second dose of the Moderna vaccine, I developed a fever of 101.5 around 11:30 pm.  I got up to use the restroom, and experienced a syncopal episode resulting in head trauma.  My other symptoms included muscle aches, flu-like symptoms and pain in my calves.
No adverse event.  Medication Error:  Too Little Diluent  1.3ml diluent mixed with adult Pfizer Covid-19 vaccine. Correct dose of diluent should have been 1.8ml.
Client developed localized eythema of injection site approx. 4-8 mm per Mother of client via phone call.Area reported as triangular in shape with bruising by the same evening of visit date 3-23-09 Client reported to have soreness of the area and not wanting her mother to touch it. As of Mon. 3-30-09,MOC reports a "hive" approx. the size of a quarter with itching. Client has been taking Claritin in PMs. Mother had applied warm moist heat to this area that AM before school.
Crying, irritability, constipation, vomiting. Follow up 7/18/05:My son has PPD NOS (high-functioning autism) and ADHD. There is no cure. When will the drug makers be held accountable for what they have done to a whole generation of children? Subject has autism.  To my knowledge, there is no cure.  I hope one is found soon.  Subject was born with a birth defect.  His stomach was turned the wrong way causing him to vomit his feedings.  This was not known on 5-16-1996 when he was vaccinated.  He should Never have been vaccinated before being examined.  His weakened condition from the birth defect and then the vaccination caused his autism.
After getting the vaccine I felt strange for a few days (my body felt different) and then on Friday my brain crashed and has been foggy ever since. My concussion symptoms have re-emerged and I'm unable to work a full day, drive, or do complex tasks.
Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L045953 (dose, route, site and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.
Complaints of feeling like she was floating. At 9:10 AM complained of feeling shaky. visibly shaky. At 9:40 AM remains visibly shaky. Blood pressure - 117/58; Pulse - 80; Respiratory Rate - 22 - grip present but weak. Reported to have had breakfast.  Had a mint and water post vacination at about 9:10 AM.  Continued to remain supine with frequent checks.  Symptoms did not worsen but did not resolve.   9:50 AM - reported to Medical Director.  Medical Director concurred with followup - per medical evaluation.  Patient has no MD to folow up at an ER. Attempted to check with previous MD not seen in 5 years.  Office could not see her today. By 10:03 AM - discharged with Grandmother - ambulatory - No longer visibly shaky but continues ot complain of shakiness and dizziness.  Remained verbally responsive  and appropriate throughout. Grip remains weak. Vital signs at discharge - BP - 108/60; pulse- 80; respiratory rate = 22. Grandmother comfortable with leaving and will follow up with medical evaluation.
pt has a rash over entire body;pt sees MD for intensely pruritic rash that sporadically responses to high dose steroids;d/t worsening of skin rash, intense pruritus, n, fatigue, arthralgia & myalgia;erythematous papillar,lichenification
3/25/03 collapsed approximately 2 min post receiving vaccines, was unresponsive. Had brief (a few seconds) of jerking movement of both hands. Carried to procedure room-HR <50+ irregular. O2 given. P OX 100%. HR remained < 50 (upper40's) for several minutes and gradually increased to 60's then 70's. After approximately 10 minutes was in 80's; still unresponsive. Medics arrived. Regained consciousness/followed  directions approximately 20 mins after incident. Taken to hospital.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Chest pain since 10/16/22 and low O2 sats in the ER on 10/20/22. Treatment includes admission, assessment, and medication.
Pt is fully vaccinated. + COVID test on 12/15/2021.  Hosptialized on 12/15/2021.80-year-old male with a past medical history of hypertension, atrial fibrillation who presented to the emergency department with complaint of dry cough and worsening exertional dyspnea. CXR: Cardiomegaly, no acute pulmonary process. Assessnent:  COVID 19 viral infection.  Acute hypoxic respiratory failure.  Treatment:  supplemental oxygen, decadron, remdesivir.Discharged
3 incidents of bloody stools, 3 to 6 days p/shots;constipation;no bowel movement for 2wk; marked depression of appetite;breast fed baby difficult to nurse during period;no weight gain;lasted about 6 wk;
This spontaneous report as received from a nurse refers to an 8 months 4 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Information has been received from a registered nurse concerning her currently 16 year old son who, at one year of age, in approx 1991, was vaccinated with a dose of MMR II. The mother reported that her son has problems due to the thimerosal in MMR II. The pt has many unspecified lab tests (results not provided). Unspecified medical attention was sought. At the time of the report, the pt had not recovered. The pts experience was considered to be disabling by the reporter. Additional information has been requested.
Started running low grade fever and broke ou in fine rash on trunk, did not fade after taking benadryl.  Rash still present 11-5 however fever less than 24 hours.
Started not feeling well on 06/07/2022 with head cold symptoms (stuffy, sore throat and felt I had a temp). I took my temp which was elevated for me. I took an at home test and it was almost immediately positive. I isolated and stayed in a different room. On 06/08/2022, I had my telehealth visit that day and they prescribed me PAXLOVID which I took until the following Monday. On 06/09/2022, I was able to work and my temp went up to about 100.1 and then went away and never came back. 06/10/2022, I worked some as well and I felt mostly okay, but had a lack of appetite and a slight cough. It took until this past weekend (06/18/2022 - 06/19/2022) to get my appetite back. I was out of quarantine by the end of last week. I still have a mild intermittent cough to this day.
Approx. 10-15 minutes, post vax, pt was seated in lab waiting area. He then fell from the chair onto the floor, quickly recovered, was pale for a few minutes, then was normal. Parents say he collapsed onto the floor.
Pt c/o starting hives around vaccine site (left arm) & spreading across chest. Pt denies itching, swelling SOB, etc. Benadryl 25 po. 4:11pm hives completely resolved. Discharged after recovery