chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of left arm; Swelling of left arm, extremely sore and swollen; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 24Apr2021 at 15:00 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00, as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced swelling of left arm, extremely sore and swollen. The patient was still experiencing it into the fourth day (current day) and was not any better. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of left arm, extremely sore and swollen was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
FEVER; MILD HEADACHE; BODY ACHES; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 150 pounds, and height was 167.6 centimeters. The patient's concurrent conditions included ace inhibitors allergy, heart problems, acid reflux, hypercholesterolemia, sleep problems, high blood pressure, back pain, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was no ill at the time of vaccination and had no past history of similar events. the patient had no pre-existing acute illness and no history of hospitalization in last 30 days prior to vaccination. the patient had family history of heart problems and diabetes. the patient had no history of drug abuse. The patient experienced arm soreness when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 14:00 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, gabapentin for back pain, ergocalciferol for bone health, and to improve immunity, acetylsalicylic acid for heart health, bisoprolol fumarate/hydrochlorothiazide for high blood pressure, pravastatin for hypercholesterolemia, trazodone for sleep problems, and zolpidem for sleep problems. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced loss of appetite. On 13-MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 100.9 F. Treatment medications included: paracetamol. On 13-MAR-2021 03:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, fever, and mild headache on MAR-2021. This report was non-serious.
Eight days after the vaccine I developed a red, hot, swollen rash on my arm.  It was tender to the touch.  Within 2 days the rash had become larger and itchy.  As of 2/5/21 the rash is still present and itchy, but the swelling and heat from the rash have gone down.
Received Fluzone 10-23-07, left  deltoid, as part of employee Flu vaccination campaign.  On 11-1-07 presented in office to see CFNP for worsening pain on her left side, left upper back and shoulder. Patient was taking ibuprofen 400-600mg qhs, extra strength Tylenol 2 pills bid and Bengay patches without benefit. Left trapezious tenderness, with mildly redulced flexion, normal extension, normal lateral motion, normal rotation, normal stabiltiy, strength, and tone.  There was minimal edema of the left trapezius area.  The was left rib tenderness. She experienced left deltoid tenderness, with full range of motion, normal stabiltiy, strength, and tone. Bicep reflexes were symmetrical, skin temp was symetrical with no discoloration.  CFNP ordered Naprosyn 500mg, one BID and Prednisone dose pack.  By 11-6-07 the patient reported feeling 100% better. She experienced severe pain and tenderness which did not improve until she was placed on the the Medrol dose pack.
Patient developed itchiness, redness, swelling, and pain to right arm intramuscular.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 1/08/21 and 1/29/21. Covid + 1/27/22. Presented to ED with acute anemia Hg 5.9, right hip hematoma measuring 9.2 x 5.8 cm along with acute respiratory failure, acute renal insufficiency, acute transaminitis and clinical evidence of volume overload. Recently hospitalized with Staph epi bacteremia and treated for infective endocarditis despite negative TEE dt recurrent + bld cxs with 6 weeks of IV vancomycin and rifampin SOT 12/29/2021 and 1/4/2022 respectively. Resp status continued to decline, transitioned to comfort care. Tx'd with meropenem and daptomycin. Expired on 2/09/22.
lump the size of a quarter / non-tender lump; redness; swelling; This case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA197A, expiry date unknown) for prophylaxis.   On 14th July 2020, the patient received the 1st dose of Menveo (intramuscular). On 28th July 2020, 14 days after receiving Menveo, the patient experienced injection site lump, injection site erythema and injection site swelling. On 1st September 2020, the outcome of the injection site lump, injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site erythema and injection site swelling to be related to Menveo.  Additional details were provided as follows: The patient received Menveo and had lump the size of a quarter, that was a non-tender lump, with redness and some swelling.  The patient had not contacted again HCP, so HCP thinks patient had recovered from the lump.  The exact dates of onset could not provide but an estimate was given by reporter. The reporter consented to follow up. The HCP mentioned Menveo was given subcutaneously but then said that it was intramuscular administration. This case linked with US2020176181, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176181:same reporter
Nausea, fatigue and loss of appetite a few hours after injection on Friday.  Felt terrible until I woke up Sunday morning with severe abdominal pain and vomiting.  I had an appendectomy Sunday night.  9/10/2008 MR received for DOS 8/3-4/2008 with D/C DX: Appendicitis.  Pt presented with 1 day hx of RLQ/umbilical abdominal pain, nausea and vomiting.  P$E (+) for McBurney's point tenderness and epigastric tenderness. Taken to OR for laparoscopic appendectomy.  appendix was thickened and mildly inflamed.
Headache; Arm sore; Runny nose; Cough; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old non pregnant adult female patient received first dose bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EK4176), administered in left arm via intramuscular, on 06Jan2021 (at the age of 37-years-old) as SINGLE DOSE for covid-19 immunization. Medical history included supraventricular tachycardia, hypertension, drug hypersensitivity (known allergies: Sulfa drugs). Concomitant medications received within 2 weeks of vaccination included metoprolol succinate, losartan, atomoxetine hydrochloride (STRATTERA), Amfetamine aspartate, Amfetamine sulfate, Dexamfetamine saccharate, Dexamfetamine sulfate (ADDERALL) and fexofenadine hydrochloride (ALLEGRA). On 07Jan2021, the patient experienced headache, arm sore, runny nose and cough. No treatment was received for the adverse events. The outcome of the events was recovered. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab smear test was negative on 10Jan2021 POC COVID-19 ID NOW. The most recent covid-19 vaccine was administered at hospital. The patient receives no other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had allergies to medications, food, or other products included sulfa drugs.  (Follow-up (01Feb2021): Follow up received from contactable Other Health Professional (patient) reported new information included: suspect dosage and event information for dose 2.  Follow-up attempts completed. No further information expected.
Received the vaccine in left arm, I think possibly the person gave it to me in the wrong area?   My arm was warm, red, swollen, rash and it still itches.   The site on arm still has pain, and feels like pins and needles if I touch it.    My 2nd dose was done in same arm, but in a much higher spot and it is fine.
Loss of appetite began at around 5:00 pm, followed by mild nausea. Symptoms progressed to a severe headache and a mild fever. by 10 pm that night. Headache was so severe that even moving my head caused severe pain. Headache lasted at least 12 hours and did fully subside until late the next day.
Shingles; This spontaneous report was received from a lawyer and a male patient of unknown age regarding a case in litigation on 06-FEB-2020. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date in 2015, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of the use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient had and would continue to suffer ongoing injuries, including but not limited to mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses and damages in the future. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
The adverse reaction started on November7th, They started with Muscle weakness and joint pain, Slight fever, Slight cough, Headache And general malaise. It is now November 9, 2021, And I believe all of these symptoms are at there apex.
Onset of dyspnea, wheezing, chest pressure, nausea immediately following immunization. Patient was treated on-site with IM epinephrine before transport to hospital, with resolution of her difficulty breathing but continued nausea. In Emergency Department treated with oral Benadryl, prednisone, famotidine, Zofran.
PATIENT HAD NUMBNESS ON THE RIGHT SIDE OF THE ARM/BODY, ONSET WITHIN 20 MINUTES OR SO OF VACCINE. ADVISED PATIENT TO TAKE SOME BENDARYL. FOLLOWED UP WITHIN AN HOUR AFTER BENADRYL AND PATIENT CONFIRMED SHE WAS FEELING MUCH BETTER.
Discharge Provider: DO Primary Care Provider at Discharge:  Admission Date: 7/27/2022 Discharge Date: 7/28/2022  PRESENTING PROBLEM: Weakness  History of rheumatoid arthritis Arthralgia, unspecified joint COVID-19 virus detected    HOSPITAL COURSE: Patient is an 85-year-old female who presented to the ER on 07/27/2022 with chief complaint of weakness and falls at home.  The patient reports having fevers on 7/24 and 7/25 along with poor oral intake and appetite for the last 1-2 months.  She believes her poor oral intake is related to dental work causing pain with eating.  The patient was brought to the ER due to the weakness and falls.  In the ER, initial lab work showed mild elevation in renal function with creatinine of 1.3.  She did test positive for COVID-19.  However there is no leukocytosis, lactic acid of 1.7, and procalcitonin of 0.1.  A UA does show positive nitrites, large leukocytes, large blood and many bacteria and urine was sent for culture.  She was given ceftriaxone for suspected urinary tract infection and admitted to the hospitalist service for ongoing management and evaluation of weakness, COVID-19, and suspected acute cystitis.  Initially the patient was going to be discharged from the ER however the patient's family verbalized concern with her going home given the weakness.  The patient was admitted under observation status to the hospitalist service.  While admitted PT and OT evaluated the patient and recommend a walker and outpatient physical therapy.  The patient had no further fevers or respiratory symptoms to suggest worsening COVID-19 symptoms.  The patient received 1 dose of ceftriaxone and we are currently awaiting final urine culture results.  The plan will be to discharge the patient home with the above recommendations.  The patient and family agree with this plan of care and all questions and concerns were addressed to patient's satisfaction.  The patient will be discharged in stable condition.
Flu vaccine given around 5pm on 12/1/06. Mom did not notice problem until Sat morning. Child had hives on arms, legs, and trunk taken to ER. Nothing given. Called Doctor. No reaction at injection site. Received the vaccine last year 2 doses.
4 months after the vaccine I started getting earache and sore throat. The doctor used a scope to take a look down my throat and did not find anything. The doctor asked me to monitor it. My symptoms have improved but I still have slight discomfort. I was not prescribed any medicine to treat the symptoms.
Urticaria. Sudden , transient, onset. Episodes lasting anywhere from 10 mins to multiple hours.
Stated that injection "felt different".  No immediate pain, burning, numbness, tingling, tenderness or other symptoms upon or immediately after injection.  No symptoms experienced until at least ? 2 days later.  The arm bothers her in the left deltoid area (very localized)upon raising.  No "pain" upon rest or with some types of movement - only with certain types of movement.  Had "rotator cuff" problem in right arm and it may feel something like that but no awareness of injury to left arm.  Is unable to characterize the "pain".  Did not report or seek treatment from her private physician because it "costs too much money".  She stated that she did not try to self-treat with heat, cold or medication.  She states it has gradually improved but was concerned because of the length  of time since receiving.  She may mention to her PMD during her routine checkup in May 2007.
Approximately 12 hours after dosage, I started to feel fatigued, weak, lack of appetite, and an inability to regulate my body temperature. I also felt abdominal pain below my belly button, along with recording a temperature of 99.1. I have been taking Motrin every 4-6 hours and have been resting since these symptoms started. As for the abdominal pain, I started taking Gas-X mid afternoon on November 2nd.   As of this report, I have not recovered from these symptoms.
Hands and feet numbness. Progressed into full body paralysis. Guillain Barre Syndrome confirmed on 10/26/2010. Had a tracheotomy and was on feeding tube for life support. Unable to move below head. Had treatment with both plasmapheresis and IVIG. Hospitalized for near 2 months followed by PT & OT.
This spontaneous report as received from a medical assistant refers to a 19 year old patient of unknown gender. On 26-AUG-2013 the patient was vaccinated with a dose of VAQTA (lot# and frequency unknown) injection, strength: 25/0.5 (unit unknown), 0.5 ml, intramuscular. No adverse effects were reported. Additional information has been requested.
Information has been received from medical records regarding a case in ligation with rofecoxib (WAES# 0590USA03739) concerning a male patient (age unknown), who on 26-NOV-2002 was vaccinated in the left upper outer arm with a dose of PNEUMOVAX. The next day, on 27-NOV-2002, the patient developed pain and mild swelling in the left elbow, especially medial aspect as well as the medial proximal forearm. The patient was having trouble getting his rings on and off. Within the next twenty-four hours the patient had improved. It was reported that the patient had no previous vaccinations with PNEUMOVAX. The patient was seen by the physician and appeared to be pleasant and well. Examination of the left upper extremity revealed no tenderness, warmth, or erythema at the injection site in the left deltoid region. There was some tenderness involving the medial aspect of the elbow and proximal forearm medially. There was no joint swelling, no warmth, or erythema, and no swelling of he hand. The distal neurovascular function was intact. The patient was advised to try ibuprofen or ALEVE as needed, ice, and to follow-up with the physician as needed. No further information is available.
NEAR SYNCOPAL EPISODE PALE/WARM/DIAPHORETIC PT REGAINED SKIN TONE, NO OTHER PAIN DENIED HOSPITAL TRANSPORT
Shortness of breath, tight lungs, tingling of face, tight lips, very dizzy, and extremely fatigued.
42hrs p/vax pt awoke w/itchy, hive rash on fingers, hands & eyes; self treated w/DPH; hive rash spread to shoulders neck & almost covered face w/swelling of lips & eyelids; no resp sx;
high fever up to 103F; very bad headache; felt dizzy; has nauseas; back pain ¨like if it is going to explode; bone pain; feels the same way as when she had Covid; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever up to 103F), HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas) and BACK PAIN (back pain ¨like if it is going to explode) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (high fever up to 103F), HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas), BACK PAIN (back pain ¨like if it is going to explode), BONE PAIN (bone pain) and COVID-19 (feels the same way as when she had Covid). At the time of the report, PYREXIA (high fever up to 103F) had not resolved and HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas), BACK PAIN (back pain ¨like if it is going to explode), BONE PAIN (bone pain) and COVID-19 (feels the same way as when she had Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment was reported as 3 pills of ibuprofen 200mg since 11-Mar-2021.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE], start date: 01Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment: Paxlovid: Treatment start date 15May2023 till treatment stop date 20May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right upper arm - deltoid area with erythema and streaking. edema at injection site - fever and warm to touch, tender to palpate clindamycin 150g 1 PO TID/Ibuprofen
ACUTE NON ST ELEVATION MI 4/13/2023 ALCOHOLIC CIRRHOSIS HYPOTENSION 4/21/2023 ALCOHOLIC CIRRHOSIS ACUTE NON ST ELEVATION MI 4/13/2023 ALCOHOLIC CIRRHOSIS HYPOTENSION 4/21/2023 ALCOHOLIC CIRRHOSIS
Pt called about 11:45 today, Wednesday 10-28-15, and told me that she received a flu shot on Monday, 10-26-15. On Tuesday night or early Wednesday morning, patient said that she woke in the middle of the night with big, red, itchy welts and she said that the welts were all over her body; Her husband recommended Benadryl so she took some. The welts "cleared up quickly, within about 30 minutes" most had receded. After 90 minutes there was still some evidence of welts but her skin was nearly back to normal. At some point she realized that she still had a beige band-aid on her shoulder. When she took it off, the skin beneath the adhesive part was "red and bumpy." The skin under the gauze portion of the band-aid was not irritated as much. We discussed the possibly of this being a flu vaccine reaction or a latex allergy. I told her that I'd do learn more and call her back. Patient received Quad Flu 0.5cc, lot #UI432AE from RN at about 1:40 pm on 10-26-15. Health Department advised pt to visit PCP to discuss reaction and determine if future flu vaccinations would be recommended.
Pt was given the varicella vaccination intramuscular and the vaccine should have been given subcutaneously. The pt tolerated the IMM with no reaction. Incident documented and parent notified.