chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced uncomfortable flu like side effects for 2-3 days.; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had the first of two Shingrix vaccine injections.  The patient experienced uncomfortable flu like side effects for 2-3 days. The patient originally planned to get the second injection soon after March 24.  However, the reporter was concerned that the vaccine side effects symptoms could mask any onset of corona virus (which he/she do not now have). The reporter wanted to know what happens if he/she skip the second injection.  Do still have partial benefit from having received the first injection.
Pain in left shoulder, Sleeping for hours, Out of control shakes and chills, Hot face. High blood pressure, Temp 98.2
My arm started hurting at the site of injection about a month after the second shot (given on 1/27/21) and every few weeks since then. It does not limit my activity or hurt for very long (no more than a day), but I still wanted to report it.
Had vaccine on Thurs 6/10/21 afternoon. By friday 6/11/21 afternoon 100.5 f fever. Gave motrin to treat the fever. Woke up on Sat 6/12/21 with a swollen upper arm, red, painful, tight and sensitive to the touch. Called doc at 9:30am to ask them about the reaction. They instructed to motrin and draw a circle around the redness. However, when informed that the entire upper arm  was red, they had us come in. We saw a PA and instructed us to give him motrin, tylonal alternating. Give him clariton during day and benadryl at night. We kept ice packs on it and by monday (6/14/21) the injection site is less swollen, redness is slowly clearing and not as painful.
Recieved the Moderna Booster on 11/08/2021.  Approx 3 weeks later started to have a bad itchy rash on my back and arms.  I noticed that my moles that I had prior to the booster on my back began to accelerate in size.  Went to the Dermatologist  early December where she had to remove several large moles on my back because they became so inflamed and large.  Went back several more times for removal of the moles and the rash.  I saw my Oncologist on 01/21/2022 and showed him the rash and the moles that were removed and He, MD and another Dr agreed it was a reaction to the Booster. I was prescribed Prednisone and Steroid cream. Rash is getting better and I am still having moles removed.  Some days the rash is more intense than other days, but is a lot better than  the end of November when this all started.
Sore arm; swelling in arm; fatigue; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration on 13Jan2021 12:30 PM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included bad back and bad left knee. Concomitant medication included unspecified drug (reported as "Other medications in two weeks: Yes"). The patient previously took Levaquin and experienced allergies. Facility type vaccine was hospital. No other vaccines in four weeks. No COVID prior vaccination. The patient experienced sore arm, swelling in arm and fatigue for 24 hours after the shot on 13Jan2021 12:30 PM. Slowly dissipated over next 24 hours. All adverse events went away after 48 hours. No treatment for the events. Patient was not tested for COVID post vaccination. Outcome of the events was recovered on 15Jan2021 12:30.
Shingles; This case was reported by a consumer via patient support programs and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th March 2021, the patient received Shingles vaccine. On 9th March 2021, less than a day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself. The age at vaccination was not reported. The  patient experienced shingles after vaccination The reporter did not consent to follow up.
Information received from the review of scientific literature on 02JUL2018. This is case 5 of 6 (18000138LT, 18000139LT, 18000140LT, 18000141LT, 18000142LT, 18000143LT) The article notes a 27-year-old active duty male who presented to the ED with left-sided pleuritic chest pain 11 days after receiving ACAM2000. His pain was worse with movement, but otherwise non-exertional or positional. His ECG showed diffuse ST elevations and PR depressions. The patient's chest x-ray and bedside transthoracic echocardiogram were unremarkable and his troponin-I was elevated at 0.25. Cardiology was consulted from an outside hospital, and the patient was then transferred for further evaluation and treatment of myopericarditis. The patient was given toradol and started on colchicine prior to transfer. As an inpatient, his formal echocardiogram showed trace effusion, but otherwise, there were no structural changes and he had a normal ejection fraction. Ibuprofen and colchicine were continued and he was followed by Cardiology as an outpatient. The patient was then made non-deployable and placed on a 6-month medical profile. Approximately 1 month after initial presentation to the ED, the patient returned with 1 day of similar chest pain. He had been compliant with medication and his initial ECG was normal without signs of ST elevation of PR depression. On repeat ECG, he showed non-specific ST changes in leads II, III, and aVL. His troponin-I was within normal limits and a bedside transthoracic echocardiogram was normal as well. Due to dynamic changes in ECG and recent history of myopericarditis, the patient was transferred to an outside hospital for further evaluation. The patient's outcome was not reported in the article. Additional information has been requested.
No adverse event reported. Patient received a second Moderna bivalent booster four months after his original bivalent booster.
Patients husband called office today stated that wife was admitted to hospital with fever, chills, body aches and swelling at injection site.
Patient had a headache, ringing in the ears, irregular heart rate, dizziness, mild fever. Patient contacted her PCP office after hours and they told her to go to the ER. Patient just told us about this reaction that she had on 1/11/22
Swollen salivary glands started within a few days after second dose and have continued for over a month.
Extreme pain in my left elbow; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Apr2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received dilaudid (MANUFACTURER UNKNOWN) reported as dilauted and morphine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient experienced extreme pain in left elbow. The clinical outcome of the event extreme pain in left elbow was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
FEELING DIZZY; CHILLS; MUSCLE ACHES; NAUSEA; FEVER OF 103.5; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 23 year old female. 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, intramuscular, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced feeling dizzy. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced muscle aches. On 13-AUG-2021, the patient experienced nausea. On 13-AUG-2021, the patient experienced fever of 103.5. On 13-AUG-2021, the patient experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 103.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, nausea, fever of 103.5, chills, feeling dizzy, and severe headache. This report was non-serious.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 32-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Abortion spontaneous (Miscarriage (9 weeks)was reported.) on 02-Oct-2018. Family history included Turner's syndrome (Sister with turner's syndrome - still born). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, FAMOTIDINE (PEPCID [FAMOTIDINE]) for Heartburn, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 14-Nov-2020 and the estimated date of delivery was 21-Aug-2021. On 28-Nov-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2020, Pregnancy test: positive (Positive) Positive. On 24-Mar-2021, Ultrasound antenatal screen: normal (normal) Normal except mild placenta previa. On 24-Apr-2021, Ultrasound antenatal screen: normal (normal) Placenta previa resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's estimated date of conception 28-Nov-2020 was reported. The complications that were occurred during this pregnancy were Gastrointestinal virus and upper respiratory infection besides placenta previa which was resolved. Prior use of alcohol before 28-Nov-2020 was reported Treatment medication was not reported. .   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received as pregnancy report form with pregnancy details, dose 1 and dose 2 details, concomitant medications. This case was received for pregnancy data clean up, but at QC level it was observed that FU 1 was not processed . hence FU 1 information is added now into this case as well as changes were made in pregnancy data field.
RECURRING RASH ON BOTH ARMS, BOTH LEGS, BUTTOCKS, CHEST AREA RIGHT BELOW THE NECK, BACK AREA RIGHT BELOW THE NAPE OF THE NECK, FACIAL RASH WHERE I NORMALLY SHAVE, MY FOREHEAD, AND THE DISCHARGE FROM MY TWO EYES ARE WATERY AND BURNING SENSATION.
Blood and pus to stool x2 stools, otherwise asymptomatic. No treatment.
Pt. experienced itchiness first day, few hours after injection. She came in to the pharmacy on 5th day, left arm presented large "warm" erythema around injection site, pt. was informed to contact her primary care physician.
A day after the booster he had a fever of 102.  The day afterward, he developed a slight wheeze. (Sunday) We went to the Dr on Monday and he was given a steroid.  He went back to the Dr the following Thurs and they did a dual-neb and x-ray.  The wheezing and shortness of breath stopped a week later.
This spontaneous report was received from a register nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that from 21-NOV-2014 through 16-JAN-2015 the patients were vaccinated with doses of PNEUMOVAX 23 0.5 ml, intramuscular, (lot # and expiration date were not reported) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
HIVES APPROXIMATELY TWO HOURS AFTER RECEIVING THE VACCINE  , WAS GIVEN BENADRYL BY CO-WORKER AND PATIENT WAS SENT TO LOCAL URGENT CARE FOR EVALUATION
I had vaccination on 04/01/2021. On 04/02/2022 I was miserable from onset of wicked migraines and nausea. These symptoms lasted for a couple of days.
Pt presented to the ED with complaints of constipation and vomiting. Of note, patient has a hx of colon cancer with metastasis and is s/p right hemicolectomy. She is being treated with radiation and transitioning to a new chemotherapy regimen. Patient states that she has not been eating for several days and her oncologist referred her to the ED due to concerns of a bowel perforation. Patient has been evaluated by trauma and is currently being kept NPO with frequent abdominal exams. Patient remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
passed out; ischemic colitis; This is a spontaneous report received from a contactable consumer (patient). This 51-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8727) at single dose via an unknown route in left arm on 22Mar2021 09:45 for Covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. Other medications the patient received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC), levothyroxine, colecalciferol (VITAMIN D 3), cetirizine hydrochloride (ZYRTEC), and fish oil.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient passed out on Weds evening 24Mar2021 at 09:00 PM, followed by nausea, vomiting, passing of blood, and stomach cramping and was admitted to the hospital on 25Mar2021. Duration of hospitalization was 5 days. Patient was diagnosed with ischemic colitis. This was a condition she had never had before and considered herself completely fine before this incident. A battery of tests uncovered no reason for the passing out to have happened. Lab data included nasal swab on 26Mar2021: negative. The adverse event result in Emergency room/department or urgent care. It was unknown if treatment received for the adverse event. Outcome of the events was resolving.
10-20 flat red spots on face, chest, and legs, obvious case of chickenpox.  Diagnosis varicella, treated with Acyclovir.
Pt had swelling, redness and warm on arm where injection was administered.  Location of reaction was not at injection site.  It was on the under aspect of the upper arm.  Gravity appeared to draw the swelling down.
10 days progressive flu-like symptoms including fever, body aches, nasal and chest congestion, cough. Negative at-home antigen COVID tests on days 1-5 of symptoms. Teledoc on day 7. Began antibiotics and prescription cough suppressant on day 8.
Allergic reaction to the shot; Rash; Itching; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration in Arm Left (age at vaccination 53-Year-old) on 21May2021 09:30 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included sulfonamide allergy. The patient's concomitant medications were not reported. The patient previously took influenza vaccine and polysorbate 80 and experienced drug hypersensitivity. On 21May2021 09:45 the patient experienced allergic reaction to the shot, rash and itching. Therapeutic measures were taken for the events and included treatment with antihistamines. On unknown date in May2021 the events were resolved.  The lot number for the vaccine [BNT162b2] was not provided and will be requested during follow up.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Approx three weeks after vaccination 5-21-2022, I started having a sore throat with a low grade fever of 99.5. I decided to take a home Covid test and it was positive. The next day on 5-22-2022, I started having a cough and sore throat was worse. I went in to the urgent care that day and was ordered a prescription for altered dosage of Paxlovid due to kidney function. I feel better today. I am reporting my breakthrough case of Covid.
Severe nausea and lightheaded and sweating mild headache  for 1 week
Patient's mother described symptoms as "left arm puffed up, hot, sore". Patient saw doctor around 4:30 pm on 1/5/07. Patient took a Claritin. Mother stated patient much better the next day.
varicella - Information has been received from a registered nurse concerning a 4 year old female patient who on 04 Apr 1997 was vaccinated with varricella virus vaccine live.  There was no concomitant medications. Known allergies or past medical history.  In March 2000 the patient developed a mild case of chickenpox.
Received Moderna 1st dose within 15 minute observation time, c/o "tingling to top of throat" and " circumoral numbness and tingling. Declined intervention/Benadryl.  Dr. in clinic and evaluated. Monitored x30 minutes. Symptoms subsiding.
This spontaneous report was received from a pediatrician via company representative, concerning a male patient of unknown age. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (Strength, dose, route, lot # and expiration date were not reported) as prophylaxis. On an unknown date, the patient developed postural orthostatic tachycardia syndrome. The outcome of postural orthostatic tachycardia syndrome was unknown. The reporter did not provide the causality between the event and GARDASIL.
Found down, found to have basal ganglia hemorrhage with intraventricular hemorrhage. Cause unclear. Patient has well controlled blood pressure in the community and at presentation. No family history of brain hemorrhages. No evidence of ischemic stroke with hemorrhagic transformation. MRI pending, but already had extensive CT imaging.
chest pain and pressure. Pain radiated to left shoulder and neck. Started at 9pm on 9/8/21 and did not resolve for 2 days.
Pt states that he became short of breath with sputum production around 2 days after discharge on 12/7.  Pt was COVID negative on 12/2, and positive on 12/18.  Pt admitted due to COVID pneumonia.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions or concomitant medications.  On or about 28-OCT-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Patient states Saturday morning she woke up with 2 strips of redness near armpit and under armpit the area was sore. She went to the walk in clinic where the P.A. gave a steroid cream and oral KEFLEX because she believed soreness under armpit was an infection. Patient used steroid cream Saturday and the redness resolved. No sign of fever, soreness feels much better but still a little sore.
Information has been received from a certified medical assistant referring to a patient of unknown age. No current condition and medical history was reported. On 09-APR-2015 the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot# were not reported) (expired on 27-MAR-2015). No adverse effects reported. Additional information has been requested.
Recieved two doses of Covid-19 vaccine but tested positive for COVID a month later.
This patient received DTaP / Hib combination on 09/04/2001 in the left thigh. By PM of 09/05/01, noted local reaction over the thigh. Seen afternoon of 09/06/01. Had 14 x 10 cm erythematous, warm local reaction, indurated on anterior lateral aspect of the thigh. Not painful, not limiting activities.
Injection site redness swelling, tingling, Warmth, Itching, Growing every day now at 6 inches wide after 6 days.