chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 15 year old female with chronic sinusitis who on 27-JUL-2007 received the first dose of GARDASIL vaccine (yeast) (lot # 658222/0927U), 0.5ml.  On 08-Nov-2007, the patient received the second dose of GARDASIL vaccine (yeast) (lot # 659437/12660), and on 17-Mar-2008 received the third dose of GARDASIL (yeast) (lot # 659182/1757U).  Concomitant therapy included injected birth control.  After the second dose the patient began to have headaches and abdominal pain.  The patient had her gall bladder removed at that time because of biliary diskinesia.  The patient's headaches and abdominal pain persisted.  The patient sought medical attention.  Additional information has been requested.
spiked fever of 101, shaking chills (rigors), nausea, diarrhea, severe abdominal pain, cough, palpitations, and headache.
Client called me in January to report that in December, 2 months after receiving her flu shot she developed weakness of her lower extremities, hurting all over, burning throat, productive cough with bloody, green, yellow sputum. Went to her primary care provider and had a negative rapid flu test. Returned to the doctor a few days later and tested positive for Flu. I told her that the flu shot is the best protection against the flu, but was not 100% effective.
Sore arm for several days after the first injection; Mild redness, swelling, and itching at injection site 7 days after first injection
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced swelling in the arm like an abscess for one week. The patient received the second dose. This case is one of the 3 cases reported by the same reporter for 3 different patients.
EXISTING TINNITIS TO LEFT EAR BECAME EXPONENTIALLY LOUDER, UNABLE TO FALL ASLEEP, AND OR AWOKEN FROM HIGH PITCH INTENSITY.
The reaction began the day after the vaccine with a fever (under 100.1) and a nickel sized raised, warm injection site. It was very itchy to my son. The injection site continued to grow in size until it was the size of an adult hand approximately 7 inches. It was warm, raised and itchy over the next two days. It took one week to fully subside and left a cyst within my son's leg for a month (30 days). No TYLENOL was given and no other medications were given during this time, we brought my son back to the doctor after the reaction continued to get worse. We were told to monitor it as it was a reaction to the vaccine. The reaction subsided within a week.
Headache for 2-3 days, some minor body aches, arm so sore at injection site that it was hard to lift my arm for 24-36 hours.  Tylenol helped with the headache and it was better after 3 days.
Severe rash Macular involving lips and face around lips from nose to chiN with swelling patchy erythema on hands
When I woke this morning I noticed that I had a rash, my back, my stomach, arms, my neck, legs, foot, wrist pretty much everywhere. Red, spotty. I did back to the pharmacist and she said I have a rash and hives. She recommended that I take Benadryl 25 MG and start taking that according to the directions on the package.   Is vacationing and does not have access to a doctor. Did put in a call to her primacy care provider at home, still waiting on a call.
Rash developed 4/15/21 or 4/16/21. Left side of neck. Very itchy. Worse at night. Rash is red, rlat and splotchy in appearance per patient. Reviewed other possible causes but only thing new was vaccine. Applied hydrocortison cream and use of antihistamines 4/17/21 and 4/18/21.
approx 3PM became listless, vomited about 15min later & c/o h/a;vomited x 5-last time about 430PM;no other neuro sx;did not require med to stop vomiting;by AM on 28MAY98 pt appears to be fully recovered;
patient became itchy on her chest and arms at 1510, felt heart palpitations, and cold Benadryl 25mg given at 1512 and a second Benadryl 25mg at 1530 Patient states feeling better at 1347
14 days after receiving first dose of MMR, pt (employee) stated non-raised rashon face and neck with sore neck (felt glands swollen also). No fever on other effects noted except : tired and sluggish. Employee kept off work for two days  per ID physician.
BLACKED OUT; This spontaneous report received from a pharmacist concerned a 49-year-old and unspecified sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included anxiety about injection, nonsmoker, and abstains from alcohol, and other pre-existing medical conditions included the patient had not known allergy. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, administered on 13-MAR-2021 to left deltoid for prophylactic vaccination.  On 13-MAR-2021, the patient experienced blacked out around 10 minutes after vaccination. EMS was called. They assessed patient and left, no other treatments received. The patient recovered from blacked out on 13-MAR-2021.  The action taken with covid-19 vaccine ad26.cov2. s was not applicable.  The outcome of the blacked out was recovered.  This report was serious (Other Medically Important Condition).  This case is associated with product quality complaint (PQC) number 90000173341. This record contains reports of adverse events that do not explicitly allege a potency issue. No product quality issues were reported. This complaint is approved for void.  Additional information was received from central complaint vigilance on 17-MAR-2021 following information was updated and incorporated into case narrative: Investigational results; Sender's Comments: 20210332620-Covid-19 vaccine ad26.cov2. s-Blacked out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Information has been received from a physician for the Pregnancy Registry of Gardasil concerning a 25 year old female with Von Willebrand's disease with a history of 0 pregnancies and 0 live births and a history of left retinoblastoma who on 13-DEC-2006 was vaccinated with Gardasil, lot # 654389/0961F. On 13-FEB-2007 she was vaccinated with Gardasil, lot # 656049/0187U expiration 29-SEP-2009. On 20-MAR-07 the patient went to the health clinic and a urine pregnancy test was performed and the results were positive (6 weeks gestation, LMP= approximately 23-JAN-2007). On 21-MAR-2007 the patient went to the hospital due to bleeding. A sonogram was performed and HCG levels were monitored. The patient was not hospitalized and she did not miscarry. The patient's HCG levels are being monitored. The patient was not hospitalized and she did not miscarry. The patient's HCG levels are being monitored. This is one of several reports received from the same source. Additional information has been requested.
9 days after receiving Moderna booster for Covid-19, I developed red skin, itching, and severe hives on my chest and back. The hives disappear after about 30 minutes then reappear on different areas of the body. All areas of the body have been affected. Severe itching, antihistamines offer no relief.
Fever of 100+, chills, sweating, headache, fatigue for two days
Started with rash/hives on back. Next morning had extreme flu like symptoms. Body aches and pains. Was prescribed narcotics for pain. Day 5 severe headache, dizzyness. Could not see or hear. Was unable to walk. Rash/ Shingles develpoed after 7dayson the face/neck/ and chest area.  The most severe part of this lasted about 16 days. Still recovering as migraines are consistent everyday. Still have pain in joints, and struggle with breathing.
After injection, she was instructed to stay for observation.  Upon checking on her, patient stated her heart was racing and she felt weak.  She was instructed to remain for 30 more minutes of observation.  Checked patient post 30 mins. and attempted to have ambulate.  She stated she still felt "woozy".  Conversation was had with another RN.  Pulse was checked and 104.  Pupils were dilated and her speech was delayed.  We felt she should go to ED to be checked and she agreed.  Patient was taken by W/C to ED
Patient developed itching, redness, and  swelling in both legs at the site of the injections within 24 hours after administration.
My symptoms began on a Saturday night with a runny nose and allergy symptoms.  Later I had a cough and flu-like symptoms.  I tested positive on May 21, 2023.  I was prescribed Paxlovid on the same day.  After taking the medication I began to feel better within 24 hours.    I had no energy, scratchy throat and aches.  I felt like I was recovered within about 10 days.
DIED; BLOOD CLOT; This spontaneous report received from a parent via social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from blood clot. It was unknown if an autopsy was performed. Reporter stated, "my son had blood clot and died also." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20221246512-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221246512-Blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Swelling under arm where shot was administered.  Swelling was larger than a golf ball.
pt developed right hamstring pain approx 1 week after vaccination. Denies headache, abd pain, sob. Scheduled to f/u with PCP today.
This vaccine was given 7 dayS past the BUD (6/23/22).  Moderna was contacted and the lot was analyzed.  Per Moderna this lot was still active and the patient did not need to be revaccinated.
Within 30 days of the vaccine, I had a urinary tract infection. I have blood work every 6 months to monitor cholesterol since having a stroke.  When I had 6-month checkup. My blood showed my RBC count had dropped. It had showed a reoccurrence of urinary tract infection. I had to recheck in a month, my UTI had gone completely. The hemoglobin, RBC count dropped a little more. I saw a hematologist who checked my RBC count which had gone up a bit. It is being monitored now. I have never had this issue before. I have been prescribed iron and am to take that until my next appointment in January.
Itching hives the facial edema, wheezing SOB increased BP.  Epi pen, Solumedrol, Benadryl, Reglan, albuterol.
Progressive neurologic deterioration within 24 on vaccine. In ICU. Guillain Barre. A 60-day follow up report received 7/29/2003 adds: pt recovered. Follow up on 6/9/04: states unknown whether pt recovered. "Pt transferred secondary to moving".
16 y/o female brought to  clinic regarding facial nerve dysfucntion  symproms.
Janssen 3/5/21. Pfizer 1/21/22. Positive on 2/1/22
Urinary tract infection; high blood pressure; Fall; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. An 83-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: 31Mau2021), via an unspecified route of administration on 02Feb2021 13:12 at SINGLE DOSE for Covid-19 immunisation. Medical history included heart surgery (Between 6-9 years before), Congestive heart failure, blood pressure (problems with blood pressure) and fall (history of falls). Concomitant medication included ongoing carvedilol for Congestive heart failure. The reporter stated that her husband has high blood pressure (occurred on an unspecified date) and was having problems falling. He fell the night of 03Feb2021. She called the paramedics to come help get him up. He was taken to the emergency room on the morning of 04Feb2021. He was found to have a urinary tract infection (on 04Feb2021) and was admitted. The patient was hospitalized for the event urinary tract infection on an unspecified date for 2 days. He is now in rehab and will have to learn to walk again. She is calling to ask what needs to be done about her husband getting the second dose. The patient underwent lab tests and procedures which included blood pressure: 150/90, CT scan, labs, urine test and X-rays: unknown, weight: 175-180 lbs on an unspecified date. Outcome of the event urinary tract infection was recovered with sequelae on 06Feb2021. Outcome of the event fall was recovered with sequelae on 03Feb2021 while outcome of the event blood pressure increased was recovering.
Vaccinated 12/17/2021, 3/26/2021, 2/26/2021. Hospitalized with COVID 3/20/22.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 2 (initial pfizer dose), single (Lot number: 33030BD), in left arm, on 29Dec2021 as dose 3 (booster), single (Lot number: PE3594), in left arm and on 26Jan2022 as dose 4 (booster), single (Lot number: FJ1614) at the age of 65 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 27Mar2021 as dose 1, single (Lot number: 1808609), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing);. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: thru Day 18 mildly positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was no Seriousness criteria reported. The patient was received OTC products with other medication details were with in 2 weeks used Synthroid, Sulfasalazine, Celebrex, Gabapentin, Lisinopril, Wellbutrin, Diclofenac Sodium Gel and Omeprazole. She was treatment OTC received for the adverse events . The AE had resulted in None of the above. The patient with AE was recovered and Recovering. The patient was received treatment for AE .The patient knew allergies did not reported.  No follow-up attempts are possible. No further information is expected.
Chills began at 3:00 AM and continued until 7:00 AM. Headache, muscle aches, and elevated temperature of 99.9 F recorded at 8:00 AM. Treated with alternating Ibuprofen and Tylenol every 3 hours.  Symptoms dissipated within 24 hours.
Called to report continued issues since receipt of 2021 Pfizer vaccines (primary series). He states he is under care for his multiple complaints. States "immediately" to 1-2 days after each vaccine he c/o fatigue, chest pain, ED, and more. He advised since last Oct22 he has had urinary issues, difficulty emptying bladder, severe bilateral kidney pain, hand swelling, poor appetite, chronic fatigue, nose bleeds x 7 months and more.   Pfizer #1 on 03/22/2021 and Pfizer #2 on 4/12/2021.  Lot numbers not available.  Hx covid disease (unsure)   While s/s vary, wax and wane, he has not received any further covid vaccines and wants to report it. Contact made on 5/11/2023. Review of his c/o CP "immediately after vaccination" that persists 1-2 years later 2-3 x/day as a sharp pain over heart that goes front to back w/o other s/s identified: Position does not influence, but activity does. he has had full cardiology w/u (12/2022-1/2023 were normal EKG, EST, CTA) and has never heard term myocarditis. His fatigue is chronic being unable to exercise more than 15 minutes w/o needing to lay down - he is unable to run anymore stating he use to be the one people tried to beat, now he is at bottom of his unit. He c/o flank pain since Oct 2022 under eval by HCP with no problems identified. He states for first 4 months post vaccine he was unable to perform, now can but has difficulty with erections. Seen by HCP, cardiology, neuro, GU, and MHS for reported health issues. PMH: pre covid vac/disease: spondylosis, lower back pain,  urology issues 2018, astigmatism, tinea pedis, anisocoria, rhinitis, gastroenteritis, dizziness -vertigo w/HA Jun-Dec 2015 tx in ER/ENT -dx vestibular migraine; plantar fascial fibromatosis 2015; chronic rhinitis 2018 w/headache, GU strictures. PMH post covid vac/disease chronic LBP x several years now with left hip/flank pain & urinary frequency under care of neurosurgery (negative GU workup for stones, masses, etc), h/o nose bleeds,  Sees MHS for anxiety, sleep issues-Insomnia PSH: urethroplasty for stricture 2005 and vasectomy 2022. Current meds: Gabapentin, lidocaine patch, Cymbalta (not taking), metoprolol tartrate (not taking), Trazadone (not taking).
Since the middle of July I also have tremors in my hands.; Inflamation in my lower 5 vertebrae; excrutiating back pain; Pain went from my waist to my right ankle; right knee collapsed; This spontaneous case was reported by a consumer and describes the occurrence of SPONDYLITIS (Inflammation in my lower 5 vertebrae), BACK PAIN (excruciating back pain), PAIN (Pain went from my waist to my right ankle) and ARTHROPATHY (right knee collapsed) in an 81-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 was provided by the reporter.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced SPONDYLITIS (Inflamation in my lower 5 vertebrae) (seriousness criterion medically significant), BACK PAIN (excrutiating back pain) (seriousness criterion medically significant), PAIN (Pain went from my waist to my right ankle) (seriousness criterion medically significant) and ARTHROPATHY (right knee collapsed) (seriousness criterion medically significant). In July 2021, the patient experienced TREMOR (Since the middle of July I also have tremors in my hands.). The patient was treated with HYDROCODONE for Pain, at an unspecified dose and frequency and TRAMADOL for Pain, at an unspecified dose and frequency. At the time of the report, SPONDYLITIS (Inflamation in my lower 5 vertebrae) and BACK PAIN (excrutiating back pain) was resolving and PAIN (Pain went from my waist to my right ankle), ARTHROPATHY (right knee collapsed) and TREMOR (Since the middle of July I also have tremors in my hands.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO Treatment drug reported. Patient went to the Hospital where they did a CT scan. The Hospital gave him Hydrocodone and Tramadol for pain. The patient has had a CT scan as well as two MRI scans.  The Spine Dr. provided a series of injectable steroids. The steroids helped enough so that when I went to see a Surgeon I was well enough to not need surgery. The patient went to go see a surgeon, however she felt well enough that she did not need back surgery.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Live Follow-up with Patient demography added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On 9/30/2022 I had pain in the abdomen, right thigh, right hip, and right buttock. It went from numbness and tingling to pain that prevented me from standing for long periods of time. There was a similar problem a couple of months later in a different location. On 11/29/2022, I got severe pain in my upper right shoulder and the next day my right arm started going numb. I ended up with lack of strength in my right hand that persisted for a while. Four different doctors treated that. I saw a neurologist, pain doctor, Neurosurgeon, and lastly a hand surgeon. Two weeks ago, I finally got hand surgery, the problem that remained was a nerve pain in my right elbow. Right now, I don't have any symptoms of that pain or the original pain I mentioned earlier. My blood tests were repeated numerous times. My first episode of pneumonia was diagnosed 12/26/2022. I was on antibiotics until 12/30/2022. On 1/14/2023, I went back to the emergency room and was there for three days. I have another CT scan in May.
Local erythema, warmth, fever to 104. Ended up with 5 day hospitalization. MRI showed "non-necrotic inj inflammation of deltoid and fascia". Rx'ed with oral antibiotics.
Noticed a hard lump/knot on left arm at the injection site. Used warm and cold compresses alternated.
14MAY96 pt recv vax 15MAY96 by 730AM had temp of 104.2 & sore arms;called PMD, gave  Cortef & Ibuprofen;by 12noon t102.6;pt has hx of Panhypopituitarism;evening of 14MAY96 c/o tiredness;15MAY96 c/o drowsiness referred to MD;
patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The date of vial initially stored in the refrigerator was unknown.  Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.   The vial did not undergo any temperature excursions.  No treatment information was reported.