chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning her daughter, a female "in her early 20's," who in January 2007, was vaccinated with the second dose, 0.5ml, IM, of Gardasil. The pharmacist reported she did not think her daughter received the full 0.5ml dose, and stated there was "some of the suspension remaining" in the vial. In additional, the pharmacist reported her daughter developed a sore arm, which she believed was "from the nurse's administration technique and not from the product." The patient sought unspecified medical attention. No further information is available.
p/vax pt CXR revealed lt lower lobe atelectasis w/pleural effusion;dx pneumonia;no cultures were performed & the causative organism was not identified;
1.  Began feeling ill and Tested positive for Covid 19 with home testing.  Was seen on telehealth visit on February 11. Was prescribed a course of Paxlovid.  Case of Covid 19 resolved in about 10 days.  2.  Again began feeling ill and tested positive for Covid 19 with home testing.  Was again seen on telehealth visit on March 31.  Was prescribe a course of Paxlovid.  Case of Covid 19 resolved in about 6 days.
Day after vaccine administered fever and chills.  2 days after vaccine administered arm still red and warm to touch.  Area covers whole deltoid muscle of L arm.
Information has been received from a medical assistant concerning her daughter who was vaccinated with the first dose of GARDASIL on an unspecified date. Subsequently the patient experienced extreme dizziness. No further information provided. The outcome was unknown at time of reporting. Additional information has been requested. Follow up information was received froma aphysician via telephone call who verified he had never seen the reporter's daughter. He had never examined the patient  and had never administered GARDASIL vaccine(yeast) to her. There was no patient file on the patientAdditional information is not expected.
THINK THE VACCINATION TRIGGERED MY PSEUDO GOUT. AS SYMPTOMS STARTED FOLLOWING DAY. 9 DAYS LATER I WENT TO MY DOCTOR AND SHE SAID THEY JUST DID NOT KNOW FOR SURE IF THE VACCINATION WAS THE TRIGGER FOR THE PSEUDO GOUT. SHE TREATED ME WITH 3 PILLS OF PREDNISONE 20 MG 1 PILL A DAY. IF CONDITION DID NOT IMPROVE SHE WOULD ADVISE MORE MEDICATION. AM ON SECOND DAY OF MEDICATION. SOME OF THE SWELLING HAS GONE DOWN BUT STILL PAINFUL. CAN USE MY RIGHT HAND A LITTLE AS YESTERDAY I COULD NOT LIFT A FORK.
Increased soreness in my arm but it took a couple of weeks to develop significant weakness in my left arm with pain. went to the doctor on 2/16 and Dr says its possibly a hematoma that is healing but should take up to 6 months to resolve.
PMA administered 10-6-05 at apx 11:00. By evening pt exp soreness at injection site. Took 1 extra strength Tylenol. Next am arm was red, hard and very tender to touch, feverish from injection site to mid biceps/triceps. Place cold compress on area, took Tylenol. Area cont to be sore, feverish and red for 3 days. By 4th day was beginning to feel better, but still some discomfort (primarily soreness)
I was administering the Moderna booster to patient. While the needle was in her right deltoid muscle, I had depressed the plunger enough so that the barrel was at the 0.2mL mark. At that point, the needle prematurely retracted back into the syringe. This is a safety feature that should  happen when the barrel is at 0mL. The patient received 0.05 mL. Some of the 0.2mL was in the syringe and some spilled down the patients arm. Shortly after, within the same day, I administered the remaining 0.2mL to the patient in a different injection site with a new syringe, same lot number, without any issues. The syringe used was 1ml, 25g, 1 inch vanishpoint. Lot number g200314.
Shingles-like rash 7 days after receiving vaccine 5 X 7 inches around vaccine site (right deltoid).
Patient received fluzone HD when they should've received flublok due to their age being 60 and not 65+. Patient did not have any adverse reactions and had left the store before mistake was found.
Extreme fatigue; nausea; frequent (7+)per day loose stool; no appetite (could only tolerate broth);  chills;   all-over body ache; weakness; asthma flairup (need to use inhaler now 1-2x per day); weight loss  as of today (12/4/22) am down to 1 inhaler use per day and 2-3 loose stool;  nausea is still daily but infrequent;  appetite is back;  chills resolved  so getting better but slow
Patient went very pale and limp for about 30 seconds after receiving vaccine 10 minutes prior. patient came to after alcohol prep pads waved under his nose, ice pack placed behind head. patient then ate and drank after coming back, vital signs were normal, B/P was 94/50, pulse 72, respirations 18, @ 850, B/P 104/56, Pulse 71, respirations  18, B/P 110-60. pulse 72 @ 913, patient's significant other called to come drive him home as patient was feeling better but not well enough to drive home. last set of vitals were @ 930 - B/P was 90/58, pulse 72, pulse ox 99%. Patient continued to be perspiring and stated he only felt weird when he looked to the right. S/O did an assessment on patient when he arrived on scene and felt ok to take him home and patient was not critical. patient was advised to go home and rest, go to ER if not feeling better or if he got worse.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
This is a not serious spontaneous case from a consumer involving loss of smell. The reporter causality is not related to FluMist. A 41 year old female reported the loss of smell, loss of taste, and a sore throat three days after receiving one dose of FluMist. This female with the history of MRSA (Methicillin Resistant Staphylococcus aureus) infection and endocarditis received FluMist on 08Nov04 at 5:00PM. She had taken one dose of fluticasone propionate on the morning of 08Nov04. Her physician instructed her to discontinue the use of fluticasone propionate for one week after receiving FluMist. On 11Nov04 by 6:00PM, the reporter was not able to smell or taste anything. On 15Nov04, around lunch the reporter regained the ability to smell and taste without intervention. She stated on 15Nov04 she had a mild sore throat that she believed was due to sinus drainage. On 16Nov04 the reporter continued fluticasone propionate usage. She stated that the events were due to the discontinuance of the fluticasone propionate. No further information available.
Dizziness, headache, tightness of chest, hives, itching. Signs became apparent an hour to hour and a half of vaccine. Took antihistamine making tightness of chest and itching subside. Followed up with my doctor that Wednesday.
she felt horrible; tired; right arm started hurting the same day; experiencing a low-grade fever (99.6 F) that is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (she felt horrible), FATIGUE (tired), VACCINATION SITE PAIN (right arm started hurting the same day) and PYREXIA (experiencing a low-grade fever (99.6 F) that is ongoing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Herpes simplex. Concurrent medical conditions included Penicillin allergy, Drug allergy and Food allergy (kiwi). Concomitant products included TRAMADOL, ZOLPIDEM TARTRATE (AMBIEN), ALPRAZOLAM and ACYCLOVIR [ACICLOVIR] for an unknown indication.  On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm started hurting the same day) and PYREXIA (experiencing a low-grade fever (99.6 F) that is ongoing). On 06-Feb-2021, the patient experienced DISCOMFORT (she felt horrible) and FATIGUE (tired). At the time of the report, DISCOMFORT (she felt horrible), FATIGUE (tired), VACCINATION SITE PAIN (right arm started hurting the same day) and PYREXIA (experiencing a low-grade fever (99.6 F) that is ongoing) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included Motrin, Tylenol.
Lower than authorized dose volume administered of the formulation, recipient pulled away.  While giving vaccine, the patient pulled away, and not all of vaccine was administered.  Plunger was depressed all the way, noted that vaccine liquid ran down the arm of the patient.
SEVERE STOMACH CRAMPS; DIARRHEA; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-infectious intermediate, posterior and panuveitis, and other pre-existing medical conditions included: The patient had no known allergies, no concomitant drugs taken and no reported medical history. The patient received two doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with two doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient additionally received booster dose of Moderna vaccine (elasomeran) (dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, administered on 23-JUN-2022 for covid-19 prophylaxis. Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) 40 mg, 1 time every 2 weeks, from 25-JUN-2022 for non-infectious intermediate posterior and panuveitis. On 25-JUN-2022, the patient experienced stomach cramps, and diarrhea (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and dose of adalimumab was not changed. The outcome of the diarrhea and severe stomach cramps was not reported. This report was non-serious.
11/9-11/12 chills/shivering - no fever 11/9 - started noticing blood in urine,  11/13 - started on 500mg Cipro 2xday, Hemoglobin at 11.5 showing some anemia 11/17 - stopped Cipro, Hemoglobin at 7.4, admitted to hospital 11/17, 11/18, 11/22 - Received blood transfusions, 3 total units 12/2 - Platelet counts dropped from 170 to 44 12/13 - Platelet counts rebounded to 154 12/26 - Platelet counts dropped to critical level of 2, received 2 units of platelet transfusion, platelet levels rose to 6 12/28 - Platelet counts dropped to 1. Started on Nplate 2mcg/kg
Information has been received from a registered nurse concerning an about 4 month old patient with no medical history who on approximately 21-NOV-2007 (about 3 or 4 weeks ago) was vaccinated with a dose of COMVAX. Concomitant therapy included ROTATEQ. (Duration and dose not reported). Other concomitant therapy included PREVNAR and DTap (unspecified) + tetanus toxoid. Subsequent;y, the patient developed a rash at the injection site. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. No product quality complain was involved. Additional information has been requested.
SkinRash & UrticariaPruritus Narrative:  Patient reports an itchy rash from head to toe starting night of injection, missed work
Left triceps redness, swelling, itchy nodule. Given cephalexin 500mg q6h starting 4/17/23 with subsequent improvement on 4/18/23.
This spontaneous report as received from a certified medical assistant (CMA) and a nurse refers to a 4 year old patient (gender unknown). On 28-MA-2014, the patient was vaccinated with VARIVAX  lot # J001177, expiration date: 31-JAN-2015, which was improperly exposed to 10F for 3 days, exposed to 16F for 120 hours and to 59.6F for 360 hours, subcutaneously. No known adverse effects. This is one of the several reports from the same source. Additional information has been requested.
I was sleepy. Had nausea, sore throat, congestion, ears congested, and headaches.
Enlarging red, tender area around injection site. Pain up to shoulder, symptoms first noted 9/16/09.
Swollen and bruised at injection site) bled pretty good after injection). Woke up to being very cold but not quite the chills and felt achy and feverish. Temp 100.4. Took 1000 mg Tylenol which helped a lot. Alternating with 800 mg Motrin. Still feeling unwell but not achy. Fever went away with Tylenol.
AS (aortic stenosis); Cardiac syncope; Pancytopenia; Severe aortic valve stenosis; Symptomatic anemia; Syncope; Syncope, unspecified syncope type
Patient was 5 weeks, 1 day old. Vaccines were given too early. No adverse outcome. Patient will repeat dose 1 of these vaccines after 4 weeks.
fever 105 evening, skin became red & blotch, next day fever came down & pt became limp & pale;
Mother described "restless/flailing, somewhat dazed" lasting 48 hours.  Requiring doctor's visit.
Left deltoid with redness and swelling for one day. Vaccine given 8/3/11. Seen by provider 8/5/11.
Patient received Moderna COVID vaccine on 6/4/21 and 7/2/21. On 1/14/22, patient tested positive for COVID. On 1/17/22, patient was intubated in the field and brought in with medics to the ED. Patient admitted to CCU on 1/17/22  with  acute on chronic respiratory failure with hypoxia and hypercapnia due to underlying COPD with superimposed COVID-19 viral pneumonia and likely secondary bacterial pneumonia. As of today (1/21/22), patient is still admitted in CCU intubated.
Pt had a reaction a couple of hours after the injection where she saw redness and swelling where the injection was. It continually to grow to the size of a baseball now and it itches. Pt has taken some tylenol which helps alleviate some of the symptoms. She has also used some ice packs and benadryl cream to help alleviate some of the symptoms but it keeps coming back.
By night the site of the immunization was sore and swollen. It is hard to move arm. Has not taken any medication.
Initial report received from a health care professional on 06 October 2010. A 41-year-old female patient received on 05 October 2010 at 9:15 an intramuscular (IM) left deltoid injection of FLUZONE SV 2010-2011, lot number UH181AC and received last week a Hepatitis B vaccine (manufacturer and lot number not reported). The patient had no illness at the time of vaccination and no known allergies (NKA). Her medical history and concomitant medications were unknown. On 05 October 2010 at 2:00 PM the patient developed congestion, scratchy throat and flu-like symptoms. She was seen by her physician in the afternoon with swelling of her tongue and mouth. The patient was sent to the Emergency Room (ER) where she was treated with oral BENADRYL, steroids and a nebulizer treatment for having trouble breathing, sneezing, coughing, runny nose and rapid heart beat. The outcome was unknown. Documents held by sender: None.
Diagnosed with Covid after first shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (Diagnosed with Covid after first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (Diagnosed with Covid after first shot). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (Diagnosed with Covid after first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient said she was scheduled for second dose on 03May2021.
At time of injection pain (right arm) at injection site, up through the neck and down to the hand.  I am still having pain in the upper arm muscle.
Pt reported that she was light headed and had an itchy throat following vaccine administration, paramedics were called, patient refused treatment.
Soreness developed again on day 14. Rash that is a halo effect type around the injection area.  Extends from my shoulder allots to elbow.
She got her vaccine, she started limping and it got worse.  Two months later in June she started falling tripping over her own foot.  She went to the doctor on 8/12/22 and informed that she had drop foot and to go see a podiatrist.  The podiatrist could not figure it out as he had never seen it before.  She went to see a neurologist who had never seen it before.  She is scheduled to have an MRI tomorrow.  Her friend told her to go to a chiropractor and he asked about the vaccines, and he said that the vaccine was the only thing that changed in her life to cause it.  She did not have any problems with limping or foot prior to the vaccines.  The chiropractor.  He sent her to get x-rays and said that her left side of her body from her head to her foot is messed up and unbalanced to the other side.   He is thinking that she has a pinched nerve or something, but waiting to have x-rays and MRI reports to make a treatment plan.
Rash all over body x 6 days. Fever off and on. Treatment - Benadryl for rash / itching. Supportive care Tylenol / Motrin for fever.
Seven days post immunization, patient complained of painful bumps behind right ear. About 5 erythematous nodules each 3-4mm and tender were noted in post-auricular region. No pustules, vesicles, LAD.
Pt was in clinic in AM for vaccine. No problems at time of administration. Several his after left clinic mom called & reported rash & diarrhea. Instructed to take to ER. Pt was in no. Rx ZOFRAN, PRELONE, & BENADRYL. Follow up with PMD 2-3 days.
Got the flu shot in 1994 and was really sick that year; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 31-Oct-2020.  This case involves an unknown age and gender patient who got really sick (illness), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE.   On an unknown date in 1994, the patient got the INFLUENZA VACCINE (produced by unknown manufacturer) (batch number unknown) via an unknown route in an unknown administration site for prophylactic vaccination and was really sick that year (illness) (unknown latency).   It was not reported if the patient received a corrective treatment.  Event outcome was unknown, a the time of reporting.  There will be no information regarding batch number for the case.
After the first 24 hours, unable to lift arm fully. Arm more sore than first vaccination. Normal post-vaccination symptoms such as fatigue, tiredness, redness, heat at injection site and pain at injection site. Arm range of motion and muscular pain at injection site did not improve over the next few days. It took about 4 months before I had range of motion in arm and little to no pain. Went to see my general practitioner on 4/27/2021, ran several tests and said it could be an effect of the vaccine or it could be SIRVA from the vaccine administration. It's possible the needle damaged the muscle. Went to see my doctor again on 12/22/2021 for checkup on arm, which appeared normal.
back pain and inability to stand up without assistance and without severe tremors in his legs.  also hallucinations of people that are not there.  These symptoms were not present prior to receiving the mRNA shots.
anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information expected.
Hand and feet aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand and feet aching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Hand and feet aching). At the time of the report, PAIN IN EXTREMITY (Hand and feet aching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-224554 (Patient Link).
06Jun90 pt vax;  Pt fainted & had seizure w/ urinary incontinence.  Appearance was described as cold, clammy, & pale.
Palpitations started the night of the injection and have continued. Right arm erythema, redness.  10 days post injection site remains sore, itchy, and raised.