chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They found a nodules 4 mm on right side and a 2 mm and a 3 mm on the left side; Getting ear pressure in right ear; Ear ache on right side of my ear and kind of went down to my throat when you get hoarse, when you get sore throat, trouble right side of my neck around thyroid area; swollen; Ear ache on right side of my ear and kind of went down to my throat when you get hoarse, when you get sore throat, trouble right side of my neck around thyroid area; swollen; This is a spontaneous report from a contactable consumer. This 59-year-old female patient reported for herself. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EP7534), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date as a single dose for covid-19 immunization. Medical history included blood glucose- an elevated A1C last year, cardiac disorder -Husband has heart issues. Concomitant medication(s) included telmisartan; glipizide ER; empagliflozin (JARDIANCE); rabeprazole; estradiol; mirabegron (MYRBETRIQ). On 24Mar2021, about 3, 4 days later she noticed that getting like an ear pressure, ear ache on the right side of her ear and kind of went down to throat like a when you a get hoarse, when you get a sore throat and had trouble in neck around the thyroid area on the right side of the neck was swollen and lasted for about 3 days. She went to ENT yesterday, by Tuesday it had already gone down but she went yesterday, Wednesday to my ENT to be on the safe side, have it checked out to make sure it was nothing serious. She guess it went down, the swelling and haven't done a blood work yet. On 07Apr2021, they found a nodules 4 mm on right side and a 2 mm and a 3 mm on the left side and they will doing biopsy on the right side. On the neck it just feels very slight. It's kind of very hard to tell if it went completely down or it just the thyroid. She was not sure. There was no soreness to it like it was before. She will be taking the 2nd dose on the April 11th. The patient did not receive any treatment. Outcome of the event thyroid mass was recovering and rest all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a healthcare worker referring a 7-week-old patient of unknown gender. The patient'spertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 01-SEP-2022, the patient was vaccinated with one dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis, lot number W004504 with expiration date 16-JUN-2023 or lot number W002562 with expiration date 12-OCT-2023.  (Healthcare worker did not specify which actual lot number the patient received) (strength, dose, frequency and route of administration not provided) (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 11.3 degrees Celsius (C) for 34 minutes; no previous temperature excursion happened. There was no adverse effect reported.
Myocarditis, trouble breathing; 2 days ago I had headache, I sneezed a lot, short sneezes, and my eyes were crying unitentionally.
After about 1 week after taking her first vaccine, she started to have rashes on her legs   along with her feet swelling and hurting. And after her second vaccine which was given on May 15 (Lot # EW0168) her whole body had rashes and her feet pain got worse.  Her joints (knee and elbow) started to hurt her too. I took her to her pediatrician and her doctor thought it was an allergy but the allergy medicine didn?t work so we did blood extraction and they said to take her to  hospital immediately. After staying for 5 days, the doctors were suspicious with the diagnosis Lupus so they prescribed her Hydroxychloroquine 200 Mg Tablet, Phytonadione 5 MG Tablet, and PresniSONE 10 MG Tablet. Now she is sick at home and taking the medication. She has never been sick or diagnosed with anything before the vaccination. I told the hospital my concerns and everything should be there too.
Patient received H1N1 Vaccine as part of a clinical trial on 9/2/09. She developed Myocarditis of unknown etiology with onset of symptoms 9/21/09. (See attached medical records).   10/28/09 Hospital records received service dates 9/24/09 to 10/7/09.  Assessment: Non-ST segment elevation myocardial infarction Right profunda artery injury, right lower extremity ischemia.   Patient with recent history of fevers, body aches, fatigue, nonproductive cough, chills, weight gain.  Joint and muscle pain, weakness. Trouble talking. Transferred to a highler level facility. Bleeding from right groin.  Patient developed shortness of breath. Chest pain. Fever. Became hypoxic with decreased responsiveness. Intubated. Pancytopenia. Abdomen distended. Bandemia and DCC. Edematous extremities. ARDS. Myelosuppression.  Surgical procedures performed - repair of profunda artery on right side, four-compartment fasciotomy of right lower extremity.   10/28/09 ICD-9 Codes received: 786.06 Shortness of breath, 422.91 Idiopathic myocarditis, 323.9 Encephalitis, myelitis encephalomyelitis unspecified cause, 284.1 Pancytopenia, 790.6 Abnormal blood chemistry, 575.10 Cholecystitis unspecified.
Swollen, painful arm, instructed patient to take Motrin and use an ice pack for comfort.
12/06/21 presents to Triage for "G5P2022 at 40w6d feeling contractions".  PMHX of " Gestational diabetes mellitus (GDM) in third trimester".
Patient given Moderna Bivalent COVID-19 Vaccine on November 14th 2022 when its BUD was after 30 days.
Pneumonia  Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC)  COVID-19 virus infection
FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old male patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV was administered to a patient under 6 months old instead of vaxelis with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 27-JAN-2023 the patient developed a non-serious event of fluzone qiv np (strength, formulation was unknown,dose:0.5ml, batch number: UT7689LA and expiry date:30-Jun-2023 via intramuscular route in Left thigh for prophylactic vaccination) was administered to a patient under 6 months old instead of vaxelis with no reported adverse event (product administered to patient of inappropriate age, wrong product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and VAXELIS.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) was not applicable.  Outcome: Unknown  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 the guidelines. 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.
addiction to Lyrica; exasperating her memory problems; shingles; unbearable pain; Initial information was received on 01-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional via social media under the (reference number: US-SA-SAC20211006000404).  This case involves adult female patient who experienced shingles (herpes zoster), unbearable pain (pain) after she received vaccine INFLUENZA VACCINE and had addiction to lyrica (drug dependence) and exasperating her memory problems (memory impairment) after she started on Lyrica (pregabalin).  The patient's past medical treatment and family history were not provided. Patient has had flu vaccine in the past that resulted into acute pancreatitis.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious shingles (herpes zoster), unbearable pain (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient started therapy with Lyrica for pain (related to herpes).  On an unknown date the patient developed a serious addiction to lyrica (drug dependence) with following the administration of INFLUENZA VACCINE. This events was assessed as medically significant.  Reporter commented that their mom contracted Shingles after a flu shot. She is going on 3 years of unbearable pain now, with a major addiction to Lyrica that is exasperating her memory problems. She also came down with acute pancreatitis right after a flu shot a few years before that but they did not make the connection until they started researching the connection between flu shots and Shingles. Reporter also comments that reporter would personally rather have the flu for a few days than acute pancreatitis and shingles. Reporter also have a friend who used to do mission work in other countries. After her last round of vaccines so she could travel, she contracted Transverse Myelitis and hasn't been able to walk for more than 5 years now.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for all the events.  At the time of this report, outcome of the events (pain, drug dependence) were not resolved.  The event outcome was unknown for the events (herpes zoster).  Information on the batch number was requested.; Sender's Comments: This case involves adult female patient who experienced shingles (herpes zoster), unbearable pain (pain) after she received vaccine INFLUENZA VACCINE and had addiction to lyrica (drug dependence) and exasperating her memory problems (memory impairment) after she started on Lyrica (pregabalin). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine and drug cannot be assessed.
Dizziness, Headache, c/o sweating,chills, injection site sore and swollen. Told to follow up with primary care physician if promblems persist. Narrative:
Information has been received from a laboratory technician, concerning her 19 year old daughter, with no pertinent medical history and no known drug allergies, who on 08-JAN-2008, was vaccinated with the first dose of GARDASIL (dose and route not provided) (lot number 659657/1487U). On 06-MAR-2008, the patient received the second dose of GARDASIL (dose and route not provided) (lot number 659657/1487U). On 15-JUL-2008, the patient received the third dose of GARDASIL (dose and route not provided) (lot number 660389/1968U). Concomitant therapy included hormonal contraceptives (unspecified). There were not concomitant vaccines administered. On 28-DEC-2008, the patient experienced neck stiffness which eventually became a swollen neck. On approximately 08-JAN-2009, "after the first week and a half", the patient had night sweats with a fever. On 15-JAN-2009, "a week after the nights and fever" the patient broke out with a septic rash on her legs, then went to urgent care. On 15-JAN-2009, the patient got a computed axial tomography scan on her neck and found enlarged lymph nodes. On 16-JAN-2009, the patient got a computed axial tomography scan of the abdomen and showed enlarged lymph nodes and pericardial "infusion". On 26-JAN-2009, "the end of January", the patient was hospitalized for 5 days because her left leg was swollen and the patient could not walk on it. The patient's feet and toes were swollen as well. On 27-JAN-2009, the patient ended up having an ultrasound (also reported as sonogram) of the left leg, and showed swelling but no blood clots. On 30-JAN-2009, the patient had a magnetic resonance imaging of the ankle and calf and the result was negative. The patient was also tested for Guillain-Barre and Epstein-Barr virus and both were negative. Prescription treatment included pain medications (unspecified), steroids (unspecified) and antibiotics (unspecified). The patient sought chiropractic care and was seen by a rheumatologist. No diagnosis was made. On an unknown date, the patient initiated a peripherally inserted central catheter line for antibiotics (unspecified). At the time of reporting, the patient was still recovering (also reported as "mostly recovered"), although the patient still occasionally had swollen joints. The reporting laboratory technician considered swollen left leg, feet and toes as disabling since the patient could not walk for a period of time and then needed to wear a special boot. Additional information has been requested. On 26-JAN-2009, the patient was admitted to Medical Center.
Given vaccine in lower arm not in Deltoid, I have been having pain in my shoulder, neck, back and at the injections site. The injection site is hot, swollen and bruised. I am having tingling up  and down my arm to my fingers. It also itching.
Tingling sensation in fingers and toes. Also, moderate pain in hands and legs, even after 10 days of vaccination 2nd shot.
Saturday slightly red, Sunday patient and family noticed child's arm, 1 1/2 inches from top of shoulder, swelling, redness that extends 3 1/2-4 inches down the arm. No changes at time of report, widest portion being approx 4 inches.
2 Swollen lympnodes (l) supraclavicular area of neck  tender to touch appropriately 1 cm and the other 1/2 cm in circumference. I went to ER yesterday  1/22/21 around 7pm or so   I watched and monitored them all day and they advanced they started showing.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG-2015 the patient inadvertently received an expired first dose of GARDASIL (dose, strength and route were not reported) lot # H020002 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
One week after receiving the vaccine, a dollar coin sized rash appeared at the injection site. It is red, inflamed, itchy, and hot to the touch. It has been 3 days and the rash has not yet resolved. Hydrocortisone cream helps relieve itching, but the swelling and color is the same as it was when it first appeared.
C/o dizziness, nausea, warm to touch, visual disturbances feels like "stomach is turning."
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates the patients were vaccinated with GARDASIL (dose, lot number and route not provided), which was improperly stored since 28-OCT-2014. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Received the PPSV23 shot (along with Tdep and Influenza shots) on 9/30/2022. Site where PSSV23 shot was given produced redness and swelling quickly. Within 12 hours the entire front and inside surface of my upper arm, including bicep area, was swollen, bright red, and extremely sore from elbow to shoulder. Experienced weakness, fatigue, and headache for additional 24 hours. Now 48 hours after initial injection, fatigue and headache are gone, however swelling, pain and redness of arm have not lessened.
Myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Myasthenia gravis) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia gravis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYASTHENIA GRAVIS (Myasthenia gravis) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient took the Moderna vaccine, had Myasthenia gravis and was in ICU. No treatment information was provided.  Company comment: This spontaneous case concerns an adult male patient with no medical history information reported, who experienced the unexpected serious (hospitalization and medically significant) AESI of myasthenia gravis. The event occurred on an unknown date. Temporal relationship with a dose of mRNA-1273 bivalent BA.4/BA.5 is unclear. Dose number and vaccination schedule were also not provided. As reported, the patient received Moderna vaccine, had Myasthenia gravis and was in ICU.  No further information about the event was provided. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-717748 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717748:Son case
Immunizing technician came out of the vaccination room to inform me (pharmacist) that patient stated he was not feeling well right after the vaccine.  As we walked to the room, we heard a falling sound and came rushing. Patient was on the floor, sitting with Dad on his side. Dad stated he fell. Patient was conscious and alert but looked pale. He sat on the floor for 5 minutes then moved to a chair with Dad's help.  He passed out again about 5 minutes later for only a few seconds. Dad stated patient usually had these reactions after blood drawn. Patient was alert and oriented after 30 minutes observation. They stayed for more than an hour before leaving the pharmacy.
Patient received vaccine and left pharmacy shortly after (did not wait 15 minutes), approximately 15-20 minutes later, patient's friend called in stating that the patient reported feeling "numb" around the injection site.  Clinical database did not have any data for "numbness" and told friend that is not of a concern.  Friend felt it may "be in her head".  Friend did not report any redness or tingling.  Patient did not have any signs of trouble breathing.  Informed friend to keep an eye on patient if any redness or trouble breathing appears and friend aware to go to emergency facility if that were to arise.
Headache; chills; fatigue; complete body aches; sore joints (similar to an RA flareup).; This is a spontaneous report from a contactable consumer(patient). A 74-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number, expiration date were not reported), dose 1 via an unspecified route of administration, administered in left arm on 12Feb2021 14:00 as SINGLE DOSE for covid-19 immunisation. Patient was 74 years old at the time of vaccination. Medical history included rheumatoid arthritis and the patient has been previously diagnosed for covid-19. Patient had no known allergies. Patient did not receive vaccines within 4 weeks prior to the COVID vaccine. Patient also had other medications within 2 weeks of vaccination. On 13Feb2021 at 13:00 the patient experienced headache, chills, fatigue, complete body aches, sore joints (similar to an RA flareup). Patient received Tyleol for treatment of the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Wheezing tightness itching difficulty breathing.  3 tsp Benadryl  pox 92%, neb t/x given followed by 2nd neb sat 91-95%. Ambulance arrived 2:45pm  pt given 60 mg. of orapred. Decrease in itching and difficulty breathing. 12/09/09 Ped Outpatient records received for DOS 12/07/09. Pt. presents with itching in throat and difficulty breathing 10 minutes following administration of vaccines. Treated with benadryl, nebulizers. Sx. improved and transported to ED. DX: Anaphylaxis 12/08/09 ED records received for 12/07/09. Pt presents with sob, wheezing; hives; cough. Treated with IV benadryl prior to arrival. Discharged home, stable. DX: influenza vaccine reaction
14 hours after Chills and freezing  for the next few hours, 18 hours after shot 102.7 fever - headache - jaw hurt,  fever slowly went down through out the day,  about 30 hours after rash on legs under knees both legs.  about 48 hours after still have a rash on legs
Dizziness, Headache, Fever,  DESCRIBES FALL IN PARKING LOT DUE TO DIZZINESS  Narrative:
Patient was up about 2 AM with slurred speech, head spinning & around 6 AM pt could not move from waist down. She was taken to ER & admitted to hospital & given fluids. Patient was told that the symptoms are consistent with Guillain-Barre.
Extreme Nausea for 36 hours migraine for 2 days Change in taste started the morning of day 2 after Fever for 36 hours after Arm soreness still happening Knot and heat at injection site
The shot was painful but that wasn?t unexpected. I immediately felt woozy after the shot but thankfully I had brought a cold full sugar ginger ale and started drinking it. My sensation was kind of like a low blood sugar event where a soda can help. I was not surprised to feel this way and felt somewhat reluctant to report this as I didn?t really think it was unusual. and I didn?t report  it at the time. The shot was at a drive up event at a University.. After chugging the ginger ale I felt a bit better and was given the  ok to leave after 15 minutes. Back at work, I felt  better but still just a bit  ? off?.  But this passed in an hour and I was good the rest of the day. For a few days afterwards  I had a mild headache but no other real symptoms.  My usual  blood pressure under medications is 116/72.  It could be possible that the shot caused some lower blood pressure immediately or within the hour  after the shot?  Or perhaps the effect was low blood sugar for which the ginger ale helped.
Patient developed redness and swelling on right upper inner arm. PNEUMOVAX injected in right deltoid. Reports no itching, no shortness of breath, wheezing, difficulty breathing. Minimal redness/swelling warmth on (R) outer arm.
Narrative:  Patient is an 81 y/o male who received the COVID-19 booster vaccine on 9/30. On 10/1 he presented to the ED for SOB, tachycardia, and cough. Chest CT revealed small branch PE, and the patient was started on rivaroxaban 15 mg BID. He was d/c home on 10/4 and directed to continue rivaroxaban 15 mg BID x3 weeks then 20mg daily for at least 3 months.