chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold sore outbreak worse than ever experienced.  Haven?t experienced a cold sore since Covid protocol began and never to this extreme
Had seasonal flu vaccine and H1N1 vaccine on 10/28/09. Developed vomiting, loose stools, and headache on 10/29. Treatment: TYLENOL/2tabs, PRN for headache , clear liquids.
11/12/2014 Received shots. 11/13 Thursday night felt feverish but did not take temp. She had chills and body aches and went to bed. 11/14 felt better in am. Fever again at 10pm of 101.4 took 2 ibuprofen. 11/15 no fever during the day. Felt fine. Then at 6 pm temp is 101.2. Took 2 ibuprofen. Noticed light pick rash in the left upper arm on medial side. 11/16 felt fine all day. Rash has turned to a red/purple color. Does not itch. Is not warm to the touch. Note: Pt received radioactive iodine in 2007 and a thyroidectomy.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Benadryl injection allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid. Clinical course: The patient received treatment of Paxlovid for COVID-19 from 15Apr2023 to 19Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300077566 same patient, different drug/events;
The patient experienced a high temperature the day of the vaccination which increased. The patient experienced a rash about 10 days later.
On 03/05/01 at 10:00 AM, the patient called reporting a reaction to Tetanus vaccine given on 03/01/01 in the right arm. The area became red, swollen, warm to touch, the size of a baseball. Fever accompanied. She went to the urgent care center on 03/03/01. Placed on Keflex and Prednisone.
On 1/15/20 at 10am, i noticed my L arm at the vaccine injection site was itchy and felt like it had a couple of raised bumps.  I was at work so i didn?t look at it until i got home after 5pm, when i discovered a blotchy rash around the injection site,  around 2 inches long by an inch wide.  It was itchy.  As the night went on, it grew larger, became more raised like a welt, and became painful/tender.  It was also still itching and burning, and hot to the touch.  I didn?t take my temperature but i was very cold and have felt fatigued for two days.   I applied ice, which seemed to help some, and took Benadryl.   It has grown a bit larger overnight.
Information has been received from a registered nurse concerning a 16 year old female who on 06/28/99 was vaccinated with a 2nd dose of Hepatitis B vaccine recombinant.  She had been vaccinated with Hepatitis B vaccine (Engerix B) as the 1st and 3rd doses on 04/07/99 and 03/31/00. Subsequently, the patient experienced the inability to tan at the injection site on both the left and right arms in an area a quarter in size. Medical attention was sought. No further information is available.
Vaccines administered to client on 11/27/07 at 11:30 am.  Client appeared lethargic but was responsive.  Ammonia inhalant administered with immediate response from client.  BP & pulse taken.  911 phoned.  Fire dept. assessed client.  Client appeared okay and left the clinic walking and talking.  Mom states client did not eat breakfast.  (never unconscious)
Pt. state soreness, and redness. RPh - observe redness span 3 inches all direction from injection site.
Right arm weakness, soreness, headache, generalized body aches and malaise, noted to have bilateral swollen submandibular lymph nodes dime-sized.
Pt received Zostavax in left triceps area on 6/5/07. Noted a quarter-sized area of redness and itching surrounding vaccine site on evening of vaccine receipt. Itching increased and did not improve with trial of topical steroids or oral Benadryl. By 6/9/07, pt noted rash on left upper arm and swelling. Felt tingly and tight'. Denies fever, chills, body aches, headaches, malaise or joints pains. Denies any history of previous vaccine adverse reactions Physical exam: In no acute distress. No oral lesions. no adenopathy. Multiple, pink papules were seen on left upper arm (appear to look like goose bumps). No vesicles or blisters. no other rashes or lesions were seen on patient's trunk, other extremities, back or face. Injection Site without significant edema or erythema.
"No significant PMH. She reported that she tolerated Pfizer dose #1.   20 minutes post vaccination, on her way walking out of the clinic with her father, she felt dizziness and very thirsty. She was alert and oriented x 4.  Did not pass out and was able to walked to the Medical facility for further observation."
irregular menstrual cycle, menstrual cycle always regular Cycle was 8 days late lasted form 8/18/21-9/11/21 and only stopped after being prescribed Tranexamic acid and progesterone oral tabs Bleeding was heavy some days and light some days
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter pharmacist stated that, other patients experienced pain at the injection site. The reporter consented to follow up. No further information was provided. This case has been linked with case US2019014453, reported by the same reporter.
About the middle of November, I noticed patient having problems speaking fluent sentences. I didn't think much of it. By Christmas, he was really struggling with conversation. I would ask specific questions to try to assist him with finding his words. I requested that he make an appointment with our family. When he did not, I did. We saw Dr. He noticed the decline in patient's speech and ordered an MRI. We then received a call to see a neurologist. We met with Dr. We had a lengthy visit. He ordered an EEG and put patient on a week of steroids thinking that if this was a reaction to the flu shot, which never even crossed our minds, the steroids my slow or stop the deterioration of this reaction on his speech. We saw him again yesterday and Dr. was amazed by the improvement to patient's speech. Dr's best hope was for an overall 25% improvement. We are guestimating that this treatment has helped somewhere around 25% - 35%.  He ordered another month's worth of steroids and we will see him again in about 30 days.  The ultimate hopeful outcome is that patient will recover near 80% of the speech ability he demonstrated prior to this event.
leg problem after the 2nd dose; 1st dose 05Feb2021; 2nd dose 21Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (leg problem after the 2nd dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05Feb2021; 2nd dose 21Aug2021). On an unknown date, the patient experienced LIMB DISCOMFORT (leg problem after the 2nd dose) (seriousness criterion hospitalization). At the time of the report, LIMB DISCOMFORT (leg problem after the 2nd dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05Feb2021; 2nd dose 21Aug2021) had resolved.            Concomitant medications was not provided by the reporter Treatment information was not provided.  On 08-Oct-2021, he again experienced the same leg problem this time more extensive than the 1st one. He was admitted in the hospital for the night. MRI was done and they could not find anything wrong with him.  This case concerns Inappropriate schedule of product administration in a 77 year-old male patient with no medical history provided, who experienced the unexpected non-serious event of Limb discomfort. The event of Limb discomfort occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge considered positive based on report of reoccurrence of event after third dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The seriousness criteria of hospitalization is removed for this event since the source document does not support this seriousness criteria.   This case was linked to MOD-2021-350768 (Patient Link).; Sender's Comments: This case concerns Inappropriate schedule of product administration in a 77 year-old male patient with no medical history provided, who experienced the unexpected non-serious event of Limb discomfort. The event of Limb discomfort occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge considered positive based on report of reoccurrence of event after third dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The seriousness criteria of hospitalization is removed for this event since the source document does not support this seriousness criteria.
Sudden out of the blue testicular pain that comes and goes and now became more like dull and my testicles can easy feel slight pain even when sitting on a chair.
pt to ER w/mom c/o pt getting goose bumps & shaking, turned pale & diaphoretic lasted 5min;
Fifteen minutes after FLUMIST administered. Father noted eyelid redness and swelling and brought pt back in the office. Patient c/o eyelid itching but no other difficulties.
pt recv vax &  felt dizzy, then vomited & lost consciousness;pt had pea sized bumps on forehead & scalp;
This spontaneous report as received from a physician refers to a non-pregnant female patient of unknown age. Concomitant medication, pertinent medical history and drug reactions or allergies were unknown by the reporter. On an unknown date, the patient was exposed to measles and subsequently, she was vaccinated with a dose of M-M-R II (dose, lot # and expiration date were not reported) subcutaneously as pot  exposure  prophylaxis. On an unknown date, the patient developed fever and a rash post vaccination with M-M-R II. The patient had polymerase chain reaction (PCR) testing done on an unknown date, post fever and rash, and the patient was positive for measles of an  unknown strain. It was reported that the therapy with M-M-R II was continued. The outcome of the adverse events was unknown. The relatedness between the adverse events and M-M-R II was not reported. Upon internal review, the event of measles were determined to be medically significant. Additional information has been requested.
Severe chills; Aches; This is a spontaneous report from a non-contactable consumer (patient).   A non-pregnant 25-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration, administered in arm right on 12Feb2021 10:30 (at the age of 25 years old) as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included prazosin, and sertraline. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262) administered on arm right on 23Jan2021 (at the age of 25 years old) as dose 1, single for COVID-19 immunisation. On 12Feb2021 23:30, the patient experienced severe chills and aches. The facility type vaccine was reported as hospital. The patient received no other vaccine in four weeks. No COVID prior vaccination and not COVID tested post vaccination. There was no treatment for adverse events. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Caller's hair gradually become more and more curly, "hair changing" after the vaccination.; Dose: 3rd; Date: 16Oct2021; off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team from a Pfizer Sponsored Program. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 16Oct2021 (Lot number: FE3590) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "T & A", start date: 1941 (unspecified if ongoing); "Miscarriage", start date: 1959 (unspecified if ongoing); "D&C - conization", start date: 1959 (unspecified if ongoing); "vaginal delivery" (unspecified if ongoing), notes: Birth of six children 1960, 1961, 1963, 1969, 1970, 1972 with normal vaginal delivery; "Vein stripping, Left leg", start date: 1971 (unspecified if ongoing); "Cholecystectomy", start date: 1990 (unspecified if ongoing); "Hysterectomy", start date: 1993 (unspecified if ongoing); "Cataract removal, bilateral", start date: 2012 (unspecified if ongoing); "Emergency incarcerated umbilical hernia repair", start date: 2016 (unspecified if ongoing); "Insertion of pacemaker", start date: Jan2018 (unspecified if ongoing); "Pneumonia", start date: Oct2020 (unspecified if ongoing); "Congestive heart failure", start date: Oct2020 (unspecified if ongoing); "macular degeneration" (ongoing), notes: because of old age. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing); CARVEDILOL taken for blood pressure measurement (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); FUROSEMIDE (ongoing); POTASSIUM (ongoing); ISOSORBIDE MONONITRATE (ongoing); SIMVASTATIN taken for blood cholesterol (ongoing); ALPRAZOLAM (ongoing); ASPIRINE (ongoing); VITAMIN D [VITAMIN D NOS] (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 16Feb2021, when the patient was 85 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EN6206), administration date: 09Mar2021, when the patient was 85 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Oct2021, outcome "unknown", described as "Dose: 3rd; Date: 16Oct2021"; OFF LABEL USE (non-serious) with onset 16Oct2021, outcome "unknown", described as "off label use"; HAIR DISORDER (non-serious), outcome "unknown", described as "Caller's hair gradually become more and more curly, "hair changing" after the vaccination.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hair disorder.  Additional information: Patient had no Specific relevant test for thromboembolic events with thrombocytopenia.  Follow-up attempts are completed, and no further information expected.
Child left the office and within 30 mins developed hives and facial swelling. Took BENADRYL and went ER. No further action was needed.
Patient called 3 days after receiving FLUVIRIN multidose influenza vaccination and reported severe illness. Vomiting, fever, etc. flu-like symptoms.
High fasting blood sugar; Felt off; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (High fasting blood sugar), FEELING ABNORMAL (Felt off) and INSOMNIA (Couldn't sleep) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Anxiety. Concomitant products included METFORMIN for Type 2 diabetes mellitus.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced HYPERGLYCAEMIA (High fasting blood sugar), FEELING ABNORMAL (Felt off) and INSOMNIA (Couldn't sleep). On 06-Mar-2021, HYPERGLYCAEMIA (High fasting blood sugar), FEELING ABNORMAL (Felt off) and INSOMNIA (Couldn't sleep) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood glucose: 180 mg/dl (High) The morning after receiving the vaccine patient's fasting blood sugars were "sky high", in the 180's, 174, 179 and it would last throughout the day as well..         Treatment information was not provided. Patient wears a diabetic sensor. Patient's normal fasting blood sugar is around 107. Patient noticed that fasting blood sugars altered with both the doses. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-047708 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter contact information updated
Fever, chills, body aches, vomiting, moderate upper back pain, headache, temporary loss of hearing, nausea, frequent urination. Fever, and chills started around 9:30p and ended around 7:30a. Body aches, headache and nausea started around 10:30p and vomiting started around 1a. Vomiting continued off and on until around 7a (1/14/22) along with frequent urination. Temporary hearing loss always noticed around 9:30a (1/14/22), but resolved it?s self but 1/15/22. Moderate upper back pain started 1/15/22
Upon admission pt was already on hospice, brought into the ED via MMR for concerns of an accidental opioid overdose.   patient to be unresponsive.  They then called EMS for further assistance.  When EMS arrived, patient was unresponsive in the administered 4 mg of Narcan intranasally, with improvement of patient's mental status.  He was found to be 84% on room air, so he was placed on a non-rebreather. Found to be COIVD positive, placed in isolation.  Pt will be discharged to SNF on hospice.
Patient reported pain lasting longer than 2 days that was not alleviated by ice packs she followed up Kw/ the doctor who performed imaging who suspects the vaccine "nicked a nerve". Doctor is considering PT.
Pt  received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility.  abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased
sore throat/throat felt very tender; arm felt a little warm to touch at the injection site; head ache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat/throat felt very tender), VACCINATION SITE WARMTH (arm felt a little warm to touch at the injection site) and HEADACHE (head ache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (arm felt a little warm to touch at the injection site) and HEADACHE (head ache). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat/throat felt very tender). At the time of the report, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat/throat felt very tender), VACCINATION SITE WARMTH (arm felt a little warm to touch at the injection site) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The arm felt a little warm to touch so the consumer used a heating pad on the injection site. That evening she started to get a headache and went to bed early. When she woke up on 14Jan2021 she started to have a sore throat. Her throat felt very tender.  Concomitant information not provided. Treatment medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
presented to ED with Ventricular tachycardia. Preliminary autopsy finding of myocarditis.  4/3/07 Spoke w/ME who stated prelim COD as acute myocarditis, presumably viral.  States patient had PMH of heart murmur which was evaluated by ped cardiologist who found mild aortic & mitral valve insufficiency & regurgitation.  ME states did not see evidence of that on autopsy but did find cardiomegaly.  Also states patient had been taken to ER on day of death for abdominal pain w/fever & was dx w/gastroenteritis.  CXR at that time revealed cardiomegaly.  No EKG or cultures were done.  Was d/c to home & continued to not feel well.  Parent found patient in bathroom unresponsive at approx 2AM & was transported to a second ER where she expired.  ME states patient had approx 2 week hx of cough & runny nose prior to death.  6/12/07 Received final Autopsy Report which reveals COD as acute probable viral etiology myocarditis & manner of death as natural.  6/29/07 Received ER records from hospital where patient expired which reveal patient was in respiratory arrest & had been intubated by EMS.  ACLS measures were unsuccessful & patient pronounced.  8/24/07 Received cardiology consult which reveals patient evaluated for heart murmur in 2005 which had been diagnosed for long time but never evaluated.  Patient admitted to palpitations & nervousness.  Patient history did not reveal any evidence of rheumatic fever.  Antibiotic endocarditis prophylaxis recommended prior to dental & surgical procedures.  Patient was to f/u w/cardiology in 2-3 yearrs to document progress of valvular insufficiency.  FINAL Cardiology DX: Aortic & mitral valve insufficiency of unknown etiology.
Soreness in arm; Rash covering neck, chin, scalp, ears, arm (non-shot arm)
Red, sore, and raised area in the back of the arm that was 3 inches in length and 2 inches wide, it was also hard.  She also noted some considerable pain in injection site.