chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had flu shot in Oct - (first shot ever for flu). By next am lips were swollen and remained for the day. By evening lips started getting dry and chapped and have remained so in particular a spot on upper L lip. Denies changing makeup, new soap, etc.
Pain in upper arm when lifting, stretching or extending arm.  Painful to lie on my arm (right side)  Pain often extends down arm to forearm.
Patient received the J and J  vaccine June 20. For the next 4-5 days, patient had vomiting, fevers, chills. After that patient developed full body aches, cramps. Patient states that the initial pain was in the level of her spine and radiating down to her legs.  She then states that she has and numbness difficulty with walking. She had walking difficulty especially when climbing up steps and initially later needed having help with ambulation.  She also has reports that after initial symptoms 7 days after she started having some abdominal discomfort.  Most recently she started having some urinary retention issues and was seen evaluated outlying hospital ER on 5th of July.  Patient also states that on July 9 she presented a.m. to ER for facial numbness, right side of the mouth .  She also has noticed some left-sided finger tingling because of were deficits patient present to ER.  Neurology Consultation Note from 7/10/21. Pt is currently admitted to our facility currently.   Right facial weakness new  Paresthesias weakness Demyelinating process MRI brain with t2 flair hyperintensity  differential ADEM vs CIS vs MS vs NMO spectrum disorder Left side ptosis hearing impairment chronic secondary to acoustic neuroma Low suspicion of GBS good distal strength 5/5 ankle bilaterally and knee except for left knee extension 3/5 intact distal reflexes ankle and patellar  -Time of onset of symptoms was:  Patient has had a progressive course of multiple neurologic complaints from June 20, 2021 when was reported that she received at a intake COVID vaccine -Had symptoms of:  Initially had flu like symptoms, followed by bilateral lower extremity weakness, numbness, progressive to have urinary retention, facial weakness on the right side    MRI brain  Multifocal abnormal white matter T2 hyperintensities, most pronounced involving the subcortical white matter, left greater than right   Abnormal signal within the upper cervical spinal cord.     Diffusely low marrow signal on T1 imaging suggesting red marrow hyperplasia.  Plan: LP ordered for tomorrow AM Follow up CSF results  methylprednisolone 1gm x5 days will check blood sugars q.8 hours  q4h neuro checks Message Lab for myelin oligodendrocyte glycoprotein (MOG) IgG autoantibody and the aquaporin-4 (AQP4) IgG serum autoantibody Follow up to see if sent.
Throat tightness and nausea after exam, seen at ER for urticaria and anaphylaxis
Got the vaccine subcutaneous/intradermaly; A spontaneous report was received from a 52-year old, female nurse who received Moderna's COVID-19 vaccine (mRNA-1273) subcutaneously/intradermally.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, the patient received their first dose of two planned doses of MRNA-1273 (Lot Number: 039K20A) subcutaneously/intradermally in the right deltoid zone for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the nurse received the mRNA-1273 vaccine subcutaneously/intradermally. No treatment for the event was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, she got the vaccine subcutaneously/intradermally was considered resolved on 20 Jan 2021.; Reporter's Comments: This case concerns a 52 year old female nurse who received her first dose of two planned doses of MRNA-1273 (Lot Number: 039K20A) subcutaneously/intradermally in the right deltoid zone for prophylaxis of COVID-19 infection. There were no reported adverse events associated with the event of incorrect route of product administration.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 49 years, in left arm 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 included: "Ankylosing Spondylitis" (unspecified if ongoing); "Type II Diabetes" (unspecified if ongoing), notes: Type II Diabetes. Concomitant medication(s) included: RELAFEN, start date: 19Aug2011; METHOTREXATE, start date: 19Aug2011; METFORMIN, start date: 01Jun2018. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: (unspecified date) Unknown Results; (Jun2022) Negative, notes: day 8; (Jun2022) positive, notes: on Day 12. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Other medication in 2 weeks was reported as yes. She had taken Paxlovid for 1-5 days, tested negative day 8, sore throat, cough & nasal congestion returned day 10-still testing positive on Day 12. If treatment ae was no. Known allergies was reported as no.  No follow-up attempts are possible. No further information is expected.
wanted to sleep; joints hurt; muscles hurt; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (wanted to sleep), ARTHRALGIA (joints hurt), MYALGIA (muscles hurt) and PYREXIA (Fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 007B21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 29-Dec-2020.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-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 SOMNOLENCE (wanted to sleep), ARTHRALGIA (joints hurt), MYALGIA (muscles hurt) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (wanted to sleep), ARTHRALGIA (joints hurt), MYALGIA (muscles hurt) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive (Positive) COVID-19 Positive..         No concomitant medications reported.  The patient didn't had nausea and chest congestion which she experienced during covid.  No treatment information was provided.  This case concerns a 86 year old female with  reported medical history Covid 19 last 2020 ,  who experienced Non-serious  unexpected event of  Somnolence  and expected event of Arthralgia , fever and myalgia which occurred on an unknown time after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine) . The re- challenge for this case is not applicable. The benefit -risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) is not affected by this report.; Sender's Comments: This case concerns a 86 year old female with  reported medical history Covid 19 last 2020 ,  who experienced Non-serious  unexpected event of  Somnolence  and expected event of Arthralgia , fever and myalgia which occurred on an unknown time after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine) . The re- challenge for this case is not applicable. The benefit -risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) is not affected by this report.
pt recvd MMR vax on 15AUG91 & 10 seconds post vax pt fell back from exam table, eyes rolled upward, salivation inc & arms & legs made jerky movements; exp lasted approx 10 seconds & the pt did not remember any of the incident;
A red , big and hot circle of 2 inches of diameter at the injection site; Swelling at injection; Fever; Headache; A red , big and hot circle of 2 inches of diameter at the injection site; Pain in arm; She was in bed for 3 days due to events; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE SWELLING (Swelling at injection) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE SWELLING (Swelling at injection), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (She was in bed for 3 days due to events). At the time of the report, VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE SWELLING (Swelling at injection) and FATIGUE (She was in bed for 3 days due to events) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: New events provided; reporter information updated; outcome of event swelling at injection updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This patient has a two doses of vaccine Pfizer for Covid-19.. First dose was on June 16, 2021 and the second dose was on july 8, 2021. When the personnel was working in Emergency room they saw that the girls don't have 12 yrs and the mother  was filing false information about the birthdate. The mother fill all the blanks that required birthdate put in march,23,2008 when the girl born on march 23, 2010.  We call to Health Department and inform the incident
Local reaction only - central area of induration measuring about 3cm. Surrounding erythema for another 3-4cm. Minimally tender. No drainage or necrotic area.
Inconsolable crying for 4-5 hrs 13APR92; px-neg; lab-neg; LP-neg in ER;
sore throat, body aches, shortness of breath, headache, shoulder ache, diarrhea, coughing
This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown gender and age. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with 1 dose of improperly stored dose ZOSTAVAX (incorrect product storage). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
On 16-Apr-2020 @8:00PM, approximately 72 hours after patient received anthrax vaccination, he reported to Medical Department with complaint of mild headache and redness to upper right arm, at site of inoculation. Denied fevers and chills or other systemic symptoms. All vital signs were normal. Pain level reported 3-4/10, constant, with "warm" feeling around inoculation site. Physical exam showed erythema of right upper arm, blanching, non-pruritic, rash at the lateral aspect of the arm. No induration, discharge, or crepitus. Showed no ecchymosis. No lesions. Patient has no Hx of MRSA, very low suspicion of MRSA at this time. No purulence or abscess. No fluid collection in the fascial plane. Superficial cobblestones see consistent with cellulitis. DIAGNOSIS: CELLULITIS. PLAN: Patient administered Ceftriaxone 1gm IV for loading. Prescribed Cephalexin 500mg taken by mouth 1 capsule TWICE A DAY for 7 days. Follow-Up Instructions: Patient will be "Sick In Quarters"(Bed Rest) for 24 hours and instructed to return to clinic after for follow-up. Patient verbalized understanding of Rx and Follow-Up instructions.
Approximately 3cm firm induration at vaccination sites (bilateral thigh) noted one day after the vaccine was given.
FREEZED VIAL, THAWED AND INJECTED; THE PHARMACIST AND THE STAFF KEPT THE VACCINE  IN THE FREEZER; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced the pharmacist and the staff kept the vaccine in the freezer. On 18-NOV-2021, the patient experienced freezed vial, thawed and injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the freezed vial, thawed and injected and the pharmacist and the staff kept the vaccine in the freezer was not reported. This report was non-serious. This case, from the same reporter is linked to 20211149908 and 20211149780.
Information has been received from a physician concerning a child who was vaccinated with  Varivax. "Some time ago" the patient experienced shingles and was hospitalized. It was reported that the shingles lesions were located on the leg. It was also noted that, while hospitalized, the patient was going to undergo a MRI possibly to rule out a tumor in the hip area. Recovery status was unknown. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a other health professional referring to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with ROTATEQ for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA003158: US-009507513-1709USA003178.
it's just a little bit of body aches; Flu symptoms; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration date was not reported) via an unspecified route of administration, administered in deltoid left on 13Feb2021 11:40 (age at vaccination: 79-years-old) as dose 1, single for COVID-19 immunization. The patient actually seeing 3 doctors this week. There's the skin cancer that the patient was seeing the dermatologist for. A surgeon about the patient hand disorder. An appointment with primary care next Friday about his foot drop. Caller was asked to clarify what the patient meant by hand disorder and explains that fell and broke one small bone in the finger, it's a fracture and broke it about 2-3 months ago. The patient has had no positive covid test before the first dose of the covid vaccine. The patient most recent covid test was just less than 2 weeks ago and has had no issues with vaccines in the past. The patient has no relevant family medical history and has not had to go to the ER or physician office for his fly symptoms. Concomitant medications included oscillo-coccinum (homeopathic medicine) he then then took another a while ago at 8AM, he states that it's supposed to be taken 6 hours apart, it knocks out the flu symptoms. The patient reported, a reaction to Pfizer covid vaccine to get on the 13Feb2021. On the evening of 14Feb2021, the patient had experienced flu symptoms and it's just a little bit of body aches and not too bad, it started late last night around 11PM last night. He described that he has a sore throat and body aches. Therapeutic measures were taken as a result of flu symptoms (influenza). The outcome of event Flu symptoms was not recovered, and rest event was unknown.   Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history was unspecified. On an unknown date, the anonymous patient was concomitantly vaccinated with ZOSTAVAX (lot# J007209, expiration date: 20-SEP-2014, dose and route were unknown), PNEUMOVAX 23 (lot# J009067 is an invalid lot no, expiration date, dose and route were unknown) and unspecified flu vaccine (manufacturer unknown) (lot#, expiration date, dose and route were unknown). Concomitant medications were unspecified. On an unknown date the patient experienced extreme lethargy. The patient sought medical attention with the pharmacist and the treatment given was unspecified. The outcome of extreme lethargy was reported as recovered on an unknown date. The causality of the lethargy was not reported. No product complaint was reported for ZOSTAVAX, PNEUMOVAX 23 and unspecified flu vaccine (manufacturer unknown). This is one of three reports from the same reporter. Additional information has been requested.
Headaches started 2 days after vaccines.  A week later upon arising saw black spots, dizzy, could not see well.  Laid down and symptoms resolved in one minute.  Called ER and told to wait to see if symptoms reoccurred.  Checked in with Dr's. office.  Currently has headache's daily but only last about 5 minutes.
Had minor soreness at injection site, resolved in about 24 hours.  About 24-48 hrs after vaccination, experienced soreness in lower back.  Site of soreness over several days moved from lower back to shoulder/neck area.  Have experienced some chills primarily in late afternoon/evening.    On Oct 27 had edema in lip area, resolved in 48 hrs.  No significant fever, ie, readings above 98.0.  Today, 10/30 am still experiencing myalgia in upper back/neck area and some degree of lethargy.  The muscle soreness persists and prevents full arm and head motion.  Have not experienced any reaction similar to this in previous influenza or covid vaccinations.
Myalgia, Fever, fever (101.4), chills, body ache, and injection site pain on 1/21; fever resolved within 24 hours Narrative:
Sore at injection site; Supraclavicular lymph node coming up when I got my shot in my right arm/lymph node swelling/it's just weird and it's always concerning; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; manufacturer: Pfizer-BioNTech; lot number: EK9231) via an unspecified route of administration at arm right on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The nurse stated she was just, she had the vaccine on Wednesday and of course it's sore at the injection site, but it got better. But she noticed a right supraclavicular lymph node coming up when she got her shot in her right arm as well. But it's right there in the supraclavicular area. The nurse stated, yes, it's a lymph node, it's the size of a pea that has come up. It just came up there right after her injection. The nurse stated, "Can I ask you a question? Have you heard of people having on the same side, like if I have it on my right, have you heard of lymph node swelling or nodule?" and stated she looked at the studies and they showed like there were 0.6. The nurse stated it's just weird and it's always concerning. The dates of all events were unknown. The outcome of event sore at injection site was resolving, and of other event was unknown.
This 64 year old white  female received the Pfizer Covid shot on  3/30/21    and went to the ED on  4/16/21     and was admitted  on4/17/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) BLURRED VISION SPEECH PROBLEM
Information has been received from a registered nurse concerning a 9-year-old female who on 06-MAY-1999 was vaccinated with her first dose of Varivax. ON 01-JAN-2007 the patient experienced approximately 50 itchy lesions. On 03-JAN-2007 (day 3) it was noted during an office visit that the lesions were in various stages throughout the body, some crusted over. It was noted that a sibling had been diagnosed with chickenpox last week. Treatment was not specified. Subsequently, the patient recovered. It was also noted that the patient's brother experienced vesicular rash (WAES # 0701USA04728), and had also been vaccinated with Varivax. Additional information is not expected.
nausea, dizziness, felt like an explosion in my arm, achy, teeth chattering and severe shivering, chills, in too much pain from aches to sleep, feel like I got hit by a truck, brain fog, headache, urinary incontinence, peeing after not drinking, lack of appetite, sore arm.
blindness in one eye; delirium; Weakness; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 03Feb2021 11:15 at a single dose for covid-19 immunization. Medical history included congestive heart failure, diabetes, glaucoma, breast cancer survivor, high blood pressure and allergies. The patient has unspecified concomitant medications. On 03Feb2021 21:30, the patient experienced blindness in one eye, weakness and delirium. The patient did not receive treatment for the events. The events were assessed serious, disability. The patient has not tested positive to covid prior vaccination. The outcome of the events was not recovered.  Information on Lot/Batch has been requested.
I went in to have a hernia evaluated, my doctor ordered a CT scan to see just how bad it was. The CT scan revealed that I had something abnormal going on with ovaries, the size of the tumor on my ovaries presented cancer. I underwent surgery to remove the cancerous tumor and tissue. I am now receiving radiation treatment.
Information has been received from a licensed practical nurse concerning a 52 weeks old patient who on 11-SEP-2009 was vaccinated with the first and only dose of ROTATEQ.  No adverse effect reported.  It was unknown if the patient sought medical attention.  Follow up information received from the licensed practical nurse indicated that he was a 52 weeks patient with no known allergies or illnesses at time of vaccination.  Concomitant therapy included a second dose of FLUZONE (Lot # V3211AA) given on 11-SEP-2009 intramuscularly.  No diagnostic tests were performed.  No adverse event was reported.  Additional information has been requested.
Guest received a flu shot at Pharmacy, fainted & fell and hit head on floor (said she was dizzy)
IM influenza vaccine was mistaken for "FluMist" and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.
Crying inconsolably for 3 hours, as per pt's mother. When pt returned to our office in the afternoon the pt was fussy but consolable. No continuous crying. Normal PE. AFOSF.