chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 1/7/2022; COVID-19 positive 1/7/2022; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/7/2022 Discharge Date: Jan 15, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Necrotizing pancreatitis [K85.91] COVID-19 [U07.1]   HOSPITAL COURSE: The patient is a 62 y.o. male with PMHx including type II diabetes, hypertension, hypertriglyceridemia, obesity, and alcohol use disorder who was admitted for management of necrotizing pancreatitis. He presented to the ED on 1/8/22 with abdominal pain. He was incidentally found to be COVID positive on admission with minor opacities on CXR without hypoxia. CT-abdomen demonstrated pancreatitis, partial splenic vein thrombosis, and a left adrenal gland nodule. RUQ ultrasound showed gallstones and a mildly dilated common bile duct. However, an MRCP done several days later did not demonstrate a stone in the common bile duct. Additionally, patient admits to having 3 beers/day for 15 years. Pancreatitis likely due from gallstones vs alcohol use. Due to COVID positivity, surgery recommended to follow up with general surgery team for possible elective cholecystectomy. GI was consulted and patient was started on aggressive IV fluids and made NPO. Therapeutic Lovenox was given for his splenic vein thrombosis.    While being fluid resuscitated, he developed pulmonary edema leading to an acute hypoxic respiratory failure and IV fluids were stopped. He was then hypoxic requiring 6L NC. Lasix was give for fluid overload and decadron was started for COVID, first dose 1/10. He was able to be weaned off oxygen to room air.   There was some concern that he had blood in his urine, but UA found no RBCs. His diet was advanced and his oxygen was weaned as tolerated. Lovenox transitioned to DOAC therapy, but patient cannot cover cost of 3 months of DOAC therapy, and as discussed with patient would have inadequate follow up on coumadin with INR checks in coumadin clinic or with follow up with PCP weekly. Patient was given one month prescription for eliquis at time of DC for noted splenic vein thrombosis, and was given a coupon to cover one month of cost. Patient will need repeat CT to reevaluate splenic vein thrombosis and adrenal adenoma. In the outpatient setting. On day of discharge patient was tolerating a low fat diet, he had ate chicken, rice, and green beans. He stated his pain was a 2/10. He denied any nausea, vomiting, chills, fever, SOB. He was hemodynamically stable at time of discharge He was given Decadron prescription at discharge to complete a 10 day course.
Pt started feeling tightening in throat after getting flu shot (FLUCELVAX) 5-10 min asked pt if she felt she needed epinephrine she said not. Requested she stay longer for observation. Started feeling worse gave epinephrine 0.3 mg called 911. Paramedics took her to hospital. Pt was released after couple of hours.
no adverse event; An MMR-II vaccine which was 2 days expired; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history and concurrent conditions was not provided.    On 12-OCT-2021, the patient was vaccinated with a 2 days expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 0.5 mL, route of administration was not provided (Lot # S032036, expiration date 10-OCT-2021) for prophylaxis. Sterile diluent (Lot #S024969). No adverse event or product quality complaint (PQC) was reported.
Mild vaccine rash developed 5/31/19 (14 days post-vaccine).  Diffuse flat (non-raised) circular red spots across body, focused primarily on torso but also some on head, face, legs, arms, feet.  Non-itchy, requiring no medication to treat.  No associated fever, change in appetite.  Baby did not appear in distress.  Spots beginning to fade 3 days after first appeared.  Baby was diagnosed with an ear infection on 5/28/19, and treated with amoxicillin oral suspension for 10 days.  Also URI (cough, runny nose) since 6/1/19 (no medical treatment).
Received Moderna vaccines on 3/31, 4/28, 1/14/22 COVID-19 positive by PCR on  1/16/22, asymptomatic admitted to hospital on 1/13/22 d/t abd pain/ulcerative colitis flare, found to be COVID positive during hospitalization.
Information has been received from a health professional concerning a 65 year old male patient with diabetes and hypertension who on 30-JUL-2007 was vaccinated IM with PNEUMOVAX 23 lot #655290/0959F.  The patient was seen in the doctor's office on 31-JUL-2007 for injection site soreness.  It was unclear when the soreness started but on 31-JUL-2007 the injection site was swollen, red and painful.  On 31-JUL-2007, the patient was given CLARITIN and CELEBREX for the pain and swelling.  No other information to report at this time.  The outcome was unknown.  The reporter has requested a lot check on behalf of the physician.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  Additional information has been requested.
The only issue post vaccine was a sore arm equivalent to a flu shot.  Nine days later (yesterday)  I developed an itchy red rash at  the vaccine site.   Today is about the same but the itching  subsided quite a bit this afternoon.  Still red, a little bit raised and feels hot to the touch.  I realize this reaction is called "Covid Arm" or "Vaccine Arm" and  harmless, and I will still have my second injection on April 11th.   Just reporting it to you so you know it's probably more widespread than actually reported.  Just a note:  I had a much worse reaction to pneumovax 23 last October, with swelling  and erythema of my upper arm, creeping down my arm to past the elbow over several days,  and a low grade fever.  Had anaphylaxis in 1982 or so with a Gamma Globin injection.   Was a medical assistant, cut myself on a surgical blade, patient had left and no record of her hepatitis history so the doc I worked for gave me the injection.
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-361706 (Patient Link).
Suspected stroke; Bell's palsy; High BP; A spontaneous report was received from a healthcare professional concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bell's palsy, suspected stroke, and high blood pressure.    The patient's medical history, as provided by the reporter, included hypertension.  The patient stopped taking hypertension medications since Aug-2020.The concomitant product use was not provided/unknown by the reporter.      On 16 Feb 2021, approximately 9 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 16 Feb 2021, approximately 9 hours of receiving vaccine, the patient developed left ear fullness/pain/pressure. On 17 Feb 2021, the patient developed left eye watery and pain behind left ear. On 18 Feb 2021, the patient dribbled when drinking water when working overnight shift. On 19 Feb 2021, upon awakening in the afternoon, patient's speech was "off" and noted left side of face drooped and unable to close left eye. The patient went to Urgent care and referred to ED for suspected stroke due to High blood pressure. The patient was diagnosed with bell's palsy. Treatment for the vent included steroids, eye ointment and metoprolol.  Action taken with the drug in response to the event was not provided  The outcome of the events, bell's palsy, suspected stroke, and high blood pressure, were not resolved.; Reporter'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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026086:Same reporter
vomiting.dizzy.  Vomiting stopped, dizziness improved but did not go away.  unbalanced/dizzy constantly, difficulty orienting spacially and with balance
Weakness; Sleepiness for 3 days; Rash from shoulder to elbow; Pain; Redness; Iching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), ERYTHEMA (Redness), PRURITUS (Iching), ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness for 3 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatty liver in 2020. Concurrent medical conditions included Drug allergy (Asprin allergy), Spinal stenosis since 1980, Tremor (Benigh tremmors) since 1989, Diabetes since 2020, Blood pressure high (High blood pressure) since 1980, Asthma since 1980, Osteoarthritis since 1989 and Tachycardia since 1989. Concomitant products included INSULIN DEGLUDEC (TRESIBA), INSULIN LISPRO (HUMALOG), ALBUTEROL SULFATE;IPRATROPIUM BROMIDE, METOPROLOL, METHOCARBAMOL, LISINOPRIL, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE), GLIPIZIDE, METFORMIN HYDROCHLORIDE (GLIPIZIDE/METFORMIN) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.   On 24-Feb-2021 at 9:16 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 9:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Pain) and PRURITUS (Iching). 25-Mar-2021, the patient experienced ERYTHEMA (Redness) and RASH (Rash from shoulder to elbow). On 25-Mar-2021 at 1:10 PM, the patient experienced ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness for 3 days). On 28-Mar-2021, ASTHENIA (Weakness) and SOMNOLENCE (Sleepiness for 3 days) had resolved. On 30-Mar-2021, PAIN (Pain), ERYTHEMA (Redness), PRURITUS (Iching) and RASH (Rash from shoulder to elbow) had resolved.            The treatment medication was not reported   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Additional document added on 25 Jun 2021 was the Email attachment of the case and had no new information.
Patient was given her first dose of flu vaccine on 9/11/18 in clinic. Second dose was to be given on her next clinic visit 10/23/18. Per CDC guidelines the flu vaccine should be given at least 4 weeks (at least 21 days is also acceptable) apart. However, patient was admitted from 9/24-9/27 for pancreatitis and neutropenia. On the day of discharge she was administered the flu vaccine. This was given 2 weeks after her first dose. Per PH if the 2nd dose is given too soon, then another dose should be repeated at least 21 days after the first dose. Advisory Committee allows a 4 day grace period with most vaccines. So the patient got her third flu vaccine in clinic today.
VOMITING; SICK; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, fatigue and sick was not reported. This report was non-serious.
Bone pain  left lower leg last night.  Had a little leg pain this morning but went away. From the middle of nose down felt like she had flushing which went away yesterday evening.
Severe nausea and vomiting 4 hours after shot, lasted "a few hours"; felt weak the next day.
mild eruption of varicella lesions on trunk, rt ear & forehead;tx w/DPH & observe PRN;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 29-MAR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 lot # M043424, expiration date 16-JUN-2018 (dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 49.8 degrees Fahrenheit for 2 hours and 34.9 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Throat got itchy, began slurring my words when speaking, wheezing on inspiration.  Was at work so co-worker called for another nurse who called nurse practitioner who administered EpiPen followed by Benadryl IM.
No adverse reactions reported  To whom it may concern: In November 2022 our Vaccine program did our every-other-year audits in both of our offices. It was discovered at that time, that some Covid Vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received.) The Program directed us to fill out VAERS forms and send them to you. They also counselled us that it was our providers and parents joint decision as to whether to re-vaccinate pts or not.  We only use Pfizer vaccines for Covid - and the listed lot #'s given outside the expiration date are listed below.  Location #1 FM0698 (orange top) FM0698 (purple top) FL8095 (orange top) FL8094 (orange top) FM7553 (purple)  Location #2 FM0698 (purple) FP4554 (purple) FL8094 (orange) FL8095 (orange) FT1551 (orange)  Please see the attached VAERS forms, and feel free to contact the office for further questions or concerns.
My tongue became swollen and my mouth became dry. I began chewing on the inside of my cheeks and my teeth left groves on the perimeter of my tongue.  The swelling lasted around 2 months and I am still experiencing extremely dry mouth and issues swallowing, especially at night.   Initially my Dr prescribed an oral rinse for non-typical thrush,  but it didn't really help.  I saw an ETN who told me to take a multi vitamin.  Both Dr's ran blood work.
1 PM shot. 4 M symptoms onset. Chest pain, heavy phlegm, difficulty breathing, vomiting, rapid heart beat. ER administered antihistamine and EPI (patient reported adverse event to pharmacy on 10-17-14).
With in 8 hours experienced loss of appetite, tiredness;  At night symptoms included muscle aches, nausea, fever: Upon awakening in the morning and being upright, I became increasingly nauseated and fainted. My blood pressure initially dropped but then became elevated compared to my usual readings.  48 hours after the injection, I still feel tired, weakened and continue to monitor blood pressure.  Blood Pressure still more elevated than usual; monitoring.
Mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild arm pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Knee replacement. Concurrent medical conditions included Rheumatoid arthritis, Heart disease, unspecified and No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Mild arm pain). At the time of the report, PAIN IN EXTREMITY (Mild arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a certified medical assistant concerning a 18 year old female with no allergies and no medical history, who on 08-AUG-2007 was vaccinated with a 0.5mL first dose of Gardasil (Lot# 658222/0927U). Concomitant therapy included meningococcal vaccine (unspecified). On 08-AUG-2007 the patient experienced lightheadness, her blood pressure dropped, she felt odd, she became pale, and she felt nauseated and had a feeling that she was going to vomit but did not. Three blood pressure measurements were taken the first reading was 94 over 52, the second was 80 over 52, and the third was 90 over 54. The patient sought unspecified medical attention. On 08-AUG-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. Guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Vasovagal syncope, came to within a few second. No medical intervention needed. Parent was present.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. During 2016, the patient was treated at a hospital for a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX 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. Additional information has been requested.
Information has been received from a pharmacist referring to a 60 year old patient of unknown gender. On 05-JUN-2015, the patient who was indicated for ZOSTAVAX was vaccinated with a dose of VARIVAX (Merck) (dose, strength and route were unknown, lot # L002870, expiry date: 27-JAN-2017) (wrong vaccine administered). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Seizure.  Had shots today, has had cold for past 2 weeks.  Was eating normal.  Became spacy, glassy eyed and started convulsing per mom.  Rash on face and chest, just coming on per mom.
Mom called to report episode of limpness (lasted 1/2hr) however occurring few hrs p/vax; Seemed fine afterwards & next day when called to report; noted dec neuro function later next day, trouble rolling over which resolved w/in 48hrs;
bruising on her legs; This is a spontaneous report from a contactable pharmacist via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced bruising on her legs. Reportedly, patient received the first dose of the Pfizer COVID 19 vaccine last Friday and ended up with bruising on her legs. Patient questioned any information about platelet issues and on whether she should receive her 2nd dose. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Right upper arm and shoulder pain began about six hours following injection, and developed edema of entire right upper arm with redness and warmth to touch.
By 3:00pm. 10/7/10 pt began to feel a pressure on her chest & her throat felt thick. By 500pm. headache, fever, chills, body aches & scratchy throat - felt terrible all night till Fri. AM. Headache lingered & didn't feel well all Fri but felt better on Sat 10/9/10.
Patient received Moderna underage; eligibility is 18 years old; patient was 2 weeks shy from 18 year old at the time of vaccination for his booster shot
1/6/21 Developed fever, chills, headache &  respiratory cough. Fever lasted 2 days (101.7). Chest congestion continued to 1/10/21. On 1/9/21 lost sense of smell and taste and is still ongoing as of 1/11/21.
Received the first shot on 3/17/2021. 2 days later, arm was red and a little swollen...nothing to be concerned about. Pt began feeling tired/run down around the 19th/20th. By the 24th, she was not able to stay awake and for the next 10 days, she slept off and on all day and did not eat. She lost 10 lbs during this time. She was fine before the shot and is doing much better now. I have been in contact with her drs and there was nothing else going on with her that would have caused this. She did not run a fever or have any Covid type symptoms....just severe fatigue and loss of appetite. This was the first shot...I don't know what she will do with the 2nd.  She had lung cancer but completed radiation in January. She isn't on any medicine that is new either. She is almost back to normal at this point.
Patient vomited and got dizzy within 15 minutes of receiving vaccine. She stated her tongue felt numb and she had chest pain. We gave her 50mg of Benadryl and sat her down to observe her. She said that her symptoms somewhat resembled what she experiences in an episode of POTS but she never had the tongue numbness or chest pain before.  When talking to us she could not make eye contact and her responses were slow but clear. Within the next 15 minutes her symptoms did not improve and she stated her right hand felt numb. We called 911. The EMTs said all her vitals were good but they took her to the closest ER.
A couple hours after the vaccine on April 21, 2021 I developed a fever, headache and chills. That evening my face and tongue swelled and my fever spiked to 102. The next day I was dizzy and still had a high fever and facial swelling so I called in sick to work. I took Tylenol and allergy medicine but over the next few weeks I started to develop allergic reactions whenever I would eat foods I was previously not allergic to. A reaction to mango caused severe burning, blistering and a lump inside my mouth even though I was previously not allergic to mango. I visited urgent care and my primary physician and continued taking Benadryl, Zyrtec and Claritin but my condition worsened and the lump on the roof of my mouth got bigger. When my throat felt tight one evening, I went to the Emergency Room at the hospital. They examined the lump and blisters inside my mouth and prescribed prednisone. They also recommended that I see an oral surgeon and an allergist.  The oral surgeon determined that the swelling was due to irritation from the allergic reaction and that surgery was not necessary. While on Prednisone the irritation inside my mouth started to heal but my histamine levels are still elevated according to recent blood work. I am awaiting consultation with the allergist concerning the results of the lab work.