chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious report of a rash that looked like sunburn was received from a nurse concerning a five-year-old male.  No medical history or concomitant medication history were reported.  The patient received FLUMIST on 08Nov2007.  On 09Nov2007, the child experienced a rash that looked like sunburn covering large areas of the body, although specific location was not provided.  No outcome was reported.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
warm-hot feeling @ site of DT vax lt forearm; erythematous wheals noted @ forearm;
Pt was given Pfizer on 3/6/21. Pt presented back to clinic and was given Moderna on 3/19.  On 4/23 pt was back in the clinic and it was noticed that she had two different vaccines. No adverse events or outcomes was noted.
Ringing in ears started the day I got my first shot, or very shortly thereafter. It has not stopped. It's constant. Nothing my doctor has tried helped.
about 18 hours later my body ache fatigue and large hard bump on my armpit. Headaches and little fever. Went to the doctor for the armpit bump. The bump was on the same arm
Information has been received from a nurse concerning an unknown number of patients. The nurse reported that unknown doses of PROQUAD (lot # L041627, expiry date 20-APR-2017 and lot # L046507 expiry date 17-MAY-2016) were stored incorrectly and were administered to an unknown patients on unknown dates. Digital data logger indicated that temperature excursion occurred during the storage of the vaccines. Temperature of excursion was 26F and time frame was 16 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
I had a fever of 102°F on August 11, and then I took Tylenol. The fever was cured on August 12, and I went to the Emergency Room  because of rash and itching all over my body at night. I went to the emergency room on the afternoon of August 14th and went to the emergency room on the evening of August 15th. On August 16th, I decided to stop taking the medicine. After 2 days with itching, the pain and feeling improved. There is no recurrence on August 23rd.
Hepatitis A vaccine from a single dose pre-filled syringe was administered to the patient who has an allergy to latex.
8 day s/p getting the smallpox vax, soldier developed generalized itchy rash over entire body a/w myalgias and flu like Sx's.
continued pain on location of injection and then i take a look at my arm and my skin is peeled around the area and i have been monitoring the area to see if the peeling isn?t spreading and it is. my main concern is it doesn?t continue to peel more of my skin.. it?s ugly yo look at and now it?s consuming  e with fear of losing more skin.
Red swollen rash near injection site on day 7 and day 8 size has tripled
Pt recv vax on 12/17/98; on 12/25/98 pt exp cranky, tired, not sleeping or eating well; on 12/28/98 pt exp fever (102), red/raised rash w/ itching over body to 1/1/99; pt imp 1/4/99
Information has been received from a physician for VARIVAX (Merck) and GARDASIL, two Pregnancy Registry products concerning a 32 year old female patient, who on unknown date was vaccinated with a dose of VARIVAX (Merck) (lot # 671030/1064AA, Expiration date 05-JUL-2013) (dose and route not reported). Secondary suspect therapy included GARDASIL (lot # 0121AE, Expiration date 29-SEP-2014) (dose and route not reported) and hepatitis A vaccine (manufacturer unspecified) (lot # AHAVB406AA, Expiration date 10-SEP-2012) (dose and route not reported) on the same day. It was reported that the patient was vaccinated while she was 13 weeks pregnant. It was reported that the patient's last menstrual period was on 25-FEB-2012 an estimated delivery date is 01-DEC-2012. No adverse events reported. The patient sought unspecified medical attention. Follow up information was received from the physician indicating that the patient's pregnancy outcome was a normal infant with no congenital anomaly (date unknown). Additional information is not expected.
This case meets vaccine breakthrough criteria review.  Had positive COVID test 5/17/21, negative 8/10/21, positive 8/31/21.   Patient presents with weakness, failure to thrive.
Dad brought child in clinic today around 10A. Stated he noticed swelling of (L) arm at injection site. No fever, pain or redness. Moves arm well. (Arm assessed. Cellulitis of (L) deltoid noted - warm to touch without redness. Advised alternate warm & cold compresses every 3-4 hours & Childrens Ibuprofen per dosing instructions.
Subjective heart palpitations that began 5 minutes after receiving her first dose of COVID- 19 vaccine.
Patient experiencing nausea and stomach cramping about 15 minutes after vaccine administration. No treatments were given. Vitals at the time were Temp: 99.0 (up from 98.1 before vaccine), BP: 138/82 and Pulse: 76 bpm. As of writing  this (30 minutes later) symptoms are the same, have neither progressed or reduced
Caller received her 1st dose of Moderna COVID 19 vaccine in February, 2021.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of Moderna COVID 19 vaccine in February, 2021.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of Moderna COVID 19 vaccine in February, 2021.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of Moderna COVID 19 vaccine in February, 2021.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided
5 Patients received and dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 022c21A and 014c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Dec-2021. Concurrent medical conditions included Bee sting hypersensitivity, Pollen allergy and Drug allergy (Flonase).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator was on 9 March 2022 and the date of administration of vaccine was on 24 march 2022. The vial did not undergo any temperature excursions. It was reported unknown that if patient experienced a similar event in the past.  No treatment information was provided.
Few minutes after getting the vaccine, patient lost consciousness while seated.  She was put into recovery position and experienced what appeared to be a very transient seizure. she was sweaty and pale. after approximately a minute of that happening, she re-gained consciousness. Patient stated that she was fine. however, she was informed that she experienced a transient seizure, although she didn't report any seizure history. EMS was called and it appears that patient chose not to go to the hospital. She left the pharmacy with her parent.
Child complained of itchy, hot arm approximately 20 hours after vaccination. Upon assessment, arm was red from shoulder to 2/3 of the way down to the elbow. It was hot to the touch and swollen. He was given BENADRYL at the time of vaccination because the same reaction last year. BENADRYL was given for the days following. The redness improved considerably in approximately 3 days.
Patient Name: (Privacy); Patient MRN: (Privacy)                    AdmissionDate: 1/29/2022; Hospital Day: 2    Attending: (Privacy), DO ID Attending:  (Privacy), DO   Date of Consultation:  1/30/2022  Time of Consultation:  10:54 AM    Reason for Consultation: COVID-19   History of Present Illness: The patient is a41y.o. year old  male with a h/o anxiety/depression, HTN and Crohn's disease on Pentasa and weekly Humira who presented on 1/29 secondary to intractable diarrhea and weight loss. States he has had diarrhea every time he has gone to the bathroom since June 2021. Decreased appetite since that time with 60 lb unintentional weight loss and poor appettie. Denies N/V or abd pain. No F/C, sore throat, rhinorrhea, congestion, shortness of breath, myalgias, loss of taste or smell, night sweats. Admits to cough x 2 weeks which is resolving. Did not test for COVID at time of cough. Denies any recent increase on loose stools or acute changes. No recent Abx per patient.  ? accuracy of patient's history. Per GI office note in 12/1/21 patient had gained 8 lbs at that time and was reporting BM's only once a day. No BM's recorded since admission per nursing. Afebrile since admission with normal WBC. Procal elevated at 1.29 with cultures pending. Currently on Rocephin/Flagyl with findings of distal colitis with ? Perianal fistula formation, CXR with no acute process.    Symptom onset unclear ? 2 weeks prior with cough Tested positive:1/29 Vaccinated 4/30/21, 5/28/21 and boosted 11/30/21 Review of Systems: In addition to the pertinent findings noted in the history,  As above in HPI    Past Medical and Surgical History:
Rash and swelling and redness around the injection site. Swollen painful under eye on one side of face.
I was diagnosed with a lipoma, and I have to have it removed.; I ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing; I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm; I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: prior vaccination. There were no concomitant medications. The following information was reported: MASS (non-serious) with onset 11Mar2021, outcome "not recovered", described as "I ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing"; FINE MOTOR SKILL DYSFUNCTION (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 11Mar2021, outcome "not recovered" and all described as "I started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm"; LIPOMA (medically significant) with onset 11Mar2021, outcome "not recovered", described as "I was diagnosed with a lipoma, and I have to have it removed.". The events "i was diagnosed with a lipoma, and i have to have it removed.", "i ended up getting a small lump right after the shot. it stayed there for a year and a half and then started growing" and "i started losing the dexterity of my hand, and some of the use of my right arm and my strength in my right arm" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Unknown results, notes: post vaccination. Other. Therapeutic measures were taken as a result of lipoma, mass, fine motor skill dysfunction, muscular weakness with MRI and surgery. Clinical course: The patient did not received other vaccine in four weeks. Patient ended up getting a small lump right after the shot. It stayed there for a year and a half and then started growing. She started losing the dexterity of her hand, and some of the use of her right arm and her strength in her right arm. She was diagnosed with a lipoma, and she had to have it removed. The patient was tested for covid post vaccination. The patient did not have any known allergy.
Vaccine expired on 1/2/2022 but was administer on 1/3/2022. Vaccine was stored in freezer sine arrival to our site. No adverse reaction following administration.
Running a fever on Wednesday night (4/11/18) treated with TYLENOL/ibuprofen. Continued to run a fever Thursday (4/12/18) and very lethargic and sleepy all day continued to treat with TYLENOL/ibuprofen. Friday (4/13/18) she started to not seem herself at all, no smiling, not babbling, very sleepy still high fever and breathing very heavy and woke up with really crusty pink and gooey eyes. On Satruday (4/14/18) she was only getting worse running a high fever of 103.0 and screaming, crying, not sleeping, rapid breathing. Around 6:00pm we noticed she was not herself almost like having spasms or seizures. She would scream then stiffen up. Her hands and feet were turning purple so we rushed her to hospital that evening. They did a chest x-ray and urinalysis and sucked her nose out. They told us it was an upper respiratory tract infection. We went home around midnight on Saturday. She was not any better still fussy screaming not herself. Sunday (4/15/18) she would hardly eat anything and wanted to sleep all day. She was still running a fever on the TYLENOL of 101.8 and was not smiling or making eye contact with us. Monday (4/16/18) she was still acting the same so I took her back into the pediatrics office and they looked at her and said she had an ear infection. We started the antibiotics right away but she still did not laugh, smile, or act herself.
Large red blotch at injection site, pain and soreness at injection site, flu like symptoms only on Day 2, itching at injection site starting Day 3
This spontaneous report as received from a nurse (also reported as health care worker) via field representative refers to a 84 year old female patient. The patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. Other co-suspects and concomitant medication was not reported. On an unknown date the patient experienced patient developed shingles after receiving ZOSTAVAX. Reporter also stated in her own words that the patient had five small red raised bumps on spine, one week later, patch under arm. Also reported as burning continues. The outcome of the events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2016, the patient was inoculated by a physician at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in-2016, the patient was treated by the same physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Chills that night. Woke up hungry, so I had a snack and then felt immediately nauseous and was in bed with a headache all day. Later that night I was able to eat a little, but didn't start feeling normal again until the next morning (today).
Patient reported redness, swelling and warmth at injection site. Warm moist heat to area.
High fever about 36 hours after second dose of Pfizer COVID19 vaccine. 102.6 degrees. Lasted about 24 hours.  Nausea and diarrhea, lasted about 24 hours.  Extreme fatigue, lasted about 24 hours.
Pt recvd 2 doses of Engerix-B & titer drawn in JUL92, did not seroconvert;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 2:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 30.78.  No concomitant medications were reported.  Batch number 031L20A administered on 13-Feb-2021 underwent temperature excursion with temperature 32 degrees Fahrenheit at 9:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Covid dose #2 given 6 days too early. It was given 15 days after the first dose.
Shingles like rash with pain developed 2 days after receiving vaccine on right medial aspect knee, calf along dermatome.
This spontaneous report as received from a physician assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of VAQTA (lot number, dose and injection site were not known) intramuscularly on 09-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced patient received VAQTA on 09-APR-2012 and on 28-AUG-2012. No known adverse effects. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Breakthrough case. A week before I came down with COVID-19, I started feeling like I had the stomach flu and had a cough a week before. I took a home COVID-19 test. Tested 3 times total and all were negative. Tried going to work and was sent home because of my cough. A day later I took another home COVID-19 test and it was positive. After finally testing positive my symptoms became aggressively worse. Called Dr and was put on COVID watch list. Was prescribed Prednisone only because I take amlodipine. Was also given a Z-pack. But I started getting brain fog really bad and forgot to take it like I should have. Dr. concluded that when I took my first home negative test I was more than likely positive with GI symptoms. The cough lasted 3 consecutive days, it was so bad that I had a hard time functioning. Felt extremely exhausted and weak. Was alone and completely disoriented and could barely function. The practice I use is a home health service so I didn't have to go to the ER. Eventually started taking the Z-pack when they were there to help me and starting taking another round of Prednisone. I have severe insomnia and had major problems sleeping. The Prednisone  make it worse. I wasn't able to get enough rest and only sleeping 3-4 hours a night.. Finally finished my script of Prednisone and  I was able to sleep properly again. Sent a professional out to the house and took a PCR test and am waiting to hear the results.
Fever, excessive crying while awake, red painful swollen injection sight, vomiting, irritability. Excessive sleep, mistrusted parents, mistrusted nurse, mistrusted doctor, withdrew from parents, tried to isolate self from adults, skin rash
Redness and local swelling and tenderness started to appear on (L) upper arm 8 days after vaccine administration, this worsened, seen in office 11 days (11-9-10) after vaccines, there was a 5.5 x 5 cm red swollen sl. warm & tender, mildly bruised centrally, area on (L) upper outer area. This was observed. Phone follow up on 11-12-10 showed no sign of the redness.