chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tongue swollen and itchy; tongue swollen and itchy; bumps on it; tongue is starting to itch more; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue swollen and itchy), PRURITUS (tongue swollen and itchy), TONGUE DISORDER (bumps on it) and PRURITUS (tongue is starting to itch more) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (tongue swollen and itchy), PRURITUS (tongue swollen and itchy), TONGUE DISORDER (bumps on it) and PRURITUS (tongue is starting to itch more). At the time of the report, SWOLLEN TONGUE (tongue swollen and itchy), PRURITUS (tongue swollen and itchy), TONGUE DISORDER (bumps on it) and PRURITUS (tongue is starting to itch more) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication  were provided.
Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
whole body broke out in a horrible rash; achy; experienced temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (whole body broke out in a horrible rash), PAIN (achy) and PYREXIA (experienced temperature) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (have some allergies).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced URTICARIA (whole body broke out in a horrible rash), PAIN (achy) and PYREXIA (experienced temperature). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urticaria, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, URTICARIA (whole body broke out in a horrible rash) had resolved and PAIN (achy) and PYREXIA (experienced temperature) outcome was unknown.      Concomitant medications were not provided.  Action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: updated patient contact information, last name spelling, event rash changed to urticaria, outcome recovered, and treatment medication. On 10-May-2021: NNi
It hurt too much; Couldn't sleep; It was a little bit harder/The first night was very hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It hurt too much), INSOMNIA (Couldn't sleep) and VACCINATION COMPLICATION (It was a little bit harder/The first night was very hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (It hurt too much), INSOMNIA (Couldn't sleep) and VACCINATION COMPLICATION (It was a little bit harder/The first night was very hard). On 11-Feb-2021, INSOMNIA (Couldn't sleep) had resolved. At the time of the report, PAIN (It hurt too much) and VACCINATION COMPLICATION (It was a little bit harder/The first night was very hard) had resolved.            Patient was on "High Blood pressure medication" and "Cholesterol medication"  No treatment medications were provided.    This case was linked to MOD-2021-008217.
Subscapular lymphadenopathy on left side of the back just behind the left shoulder. 2 swollen, sore lymph nodes noted 5 days after vaccine. So far, still present 7 days later.
FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient had not known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26/MAY/2021) dose was not reported, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Admission Date: 10/19/2022 Discharge Date: 10/25/2022   Clinical Narrative: Patient is a 86 y.o. female who presents today with weakness, malaise, poor oral intake. She has PMH of bladder cancer/urostomy, untreated right renal mass, coronary artery disease, hypertension, legal blindness, hypertension. She had Covid 5 weeks ago and feels she just had not gotten better since.    In the ED, she was hemodynamically stable, though EMS had given a liter of saline enroute for hypotension into the 90's. Urine was grossly infected. Labs revealed an AKI with creatinine 2.20, GFR 21, elevated bilirubin 1.7, leukocytosis 15,000, lactate 2.6,  13 bands. She was given Zosyn after blood/urine cultures obtained. CT abd/pelvis obtained, which showed mod-severe right hydroureternephrosis, and left renal mass. She requires admission for treatment of severe sepsis due to UTI and AKI.    Urine cultures grew Klebsiella pneumoniae and antibiotics were changed to Rocephin until discharge.  The obstruction of the right kidney was due to the mass, and per discussion with Urology there was not an ability to relieve this obstruction.  Doctor offered placement of a nephrostomy tube for drainage of the kidney but this was declined, and the patient a instead elected to have hospice referral, and to change to comfort care measures at home.  By discharge she was feeling much better without significant kidney pain.  Her vitals were stable and her renal function had normalized.   Medication changes at discharge are as follows: 1. Cefuroxime (Ceftin) 500 mg once daily for 14 days. This is an antibiotic to complete treatment of the kidney infection. 2. Discontinue taking atenolol (Tenormin) as it no longer appears needed for blood pressure control. 3. Discontinue aspirin as it can cause bleeding from the tumors in the kidney. 4. Discontinue atorvastatin (Lipitor) as you no longer need a cholesterol medication in the setting of cancer. 5. Discontinue ibuprofen as it also can cause bleeding and can cause worse kidney function. 6. Increased oxycodone 5 mg to up to 3 times daily if needed for pain control. 7. Discontinue iron supplement, as it can cause constipation especially if taking pain medications.   There was a hospice informational meeting the patient and her son prior to discharge. The patient is discharged under the care of her son as her her caregiver, with plans to follow and sign up with Hospice as an outpatient after returning home.
Throat closing, tongue swelling, splotty skin, rapid heart rate, dizziness, extreme body shaking uncontrolably.  Stopped at fire station. Admistered benydrl, Heart rate high and blood pressure 200/178, put IV port, transferred to ER at hospital.  Hospital through IV gave more benydrl and Decadron, monitored, after three hours blood pressure down and released.  Instructed to take prednisone for five days
Patient received .25 ML instead of .5 ML Patient was notified on 11/22/22 and the Patient will receive another .25 ML of the vaccine.
Rash, hives, and itchiness started at 3:00 am. Located all over body - mostly under arms, fingers, and feet. Pt. took BENADRYL at 6 AM.
Flu like symptoms; the dose was left at room temperature and later administered to a patient the following day, about 20 hours later; It was temperature excursion that makes the vaccine expired; This is a spontaneous report from a contactable pharmacist. A 17-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FA7485; Expiration Date: 30Oct2021), via an unspecified route of administration on 27Jul2021 (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient was unknown reported. The concomitant medication of the patient included few medications, but it was just antibiotics and some cream like. Pharmacist (reporter) reported on behalf of a 17-year-old male patient, who was administered a dose of the vaccine after excursion. Stated she had drawn the Pfizer covid vaccine the previous day at 2:30, however the dose was left at room temperature and later administered to a patient the following day, about 20 hours later. She wanted to know how to proceed after inadvertently administering a dose of expired vaccine to a patient. It looks like it was left out yesterday and administered around noon today on 23Jul2021. The pharmacist stated did not know what that go about, do we give another new dose to that patient if it is possible or what do we do from here because it was 3 days and they don't know what to do and concerned about only Pfizer guidance. So that something would call or what to do. Pharmacist added the vaccine are only good for 6 hours at room temperature, if the vaccine had undergone temperature excursion, pharmacist stated, assuming because it was at room temperature, they drew the dose around like 02:30 so it was good for like 6 hours. So they tried to figure out after that what happens after 6 hours beyond or something. Technically yes it was temperature excursion that makes the vaccine expired, correct. Patient experienced Flu like symptoms on 27Jul2021 at 15:00. The patient did not receive any treatment for the events. Reporter considering events as non serious. Outcome of the event Flu like symptoms was resolved on unspecified date in 2021.  Follow-up (26Jul2021): This is a follow-up spontaneous report from a contactable Pharmacist. This Pharmacist reported for a patient that includes: expiration date of the vaccine was added, new event "Product temperature excursion issue " was added and the event "Expired vaccine" used was deleted and coded as poor quality vaccine administered.  Follow-up (13Aug2021): This is a follow up-spontaneous report from a contactable Other HCP. This Other HCP reported in response to HCP letter sent via follow-up letter which included that: Product start date updated, New Event Flu like symptoms added and other clinical information was updated.  Follow-up attempts are completed. No further information is expected.
I got a sunburn while out on the beach.  I don't normally get sun burns.  I used sunscreen but my skin felt supper sensitive to the sun.  The burn was not severe as it did not peel or act like a regular sunburn.  My skin felt like it was on fire while I was exposed to the sun.  The "burn" or sensitivity lasted for days.  Two weeks later I still could not stand to be out in the sun.  My skin felt like it was on fire.
Numbness to cheeks and mouth, stiffness to neck, lower lip swelling. Pt. reports S/S after 1st vaccine 5/26/17 and after 2nd 5/29/17. 1st vaccine administered in ER. Did not report to nurse at time of 2nd vaccine.
Deep itch at the injection site (itch was inside the arm at the injection site, deep/strong itch), started 30-45 min after injection. and lasted about an hour
pt recv vax 19OCT98 & 22OCT98 pt reportedly devel bilat weakness in both legs progressing to paralysis;
Sore arm after shot, I went to bed at 8:30 & I woke up at 10:30 pm with uncontrollable chills & shaking. I felt so cold & clammy. My head was aching & my stomach was very uneasy. My husband put more blankets on me because I couldn't stop shaking. I couldn't find my thermometer, so no idea what my temperature was although to me I have felt like this before when I have been very sick. I took 2 TYLENOL tablets & a drink of cold water, then back under the covers, the shaking finally subsided, but this morning I feel very weak with a headache and slowness in my thinking process & arm still sore.
pt recv vax 7AUG96 & lab eval 17JAN97 revealed varicella antibody 0.52, which indicated a lack of seroconversion;
Fever. Red flush face hot to touch. Diarrhea for over a week sometimes pooping  twice an hour. Cough and congestion.
Patient received the 1st dose of Moderna and was found deceased in her home the next day.
Anxiety; tiredness; headache; chills; nausea; feeling unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 71-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on right arm on 26Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included chronic back pain. The patient has no allergies to medications, food, or other products. Concomitant medications included unspecified blood pressure and pain medications which he received within 2 weeks of vaccination. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 05Jan2021 at 2:00 PM at single dose for COVID-19 immunization and experienced headaches for a week. The patient received his most recent COVID-19 vaccine at a hospital. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 28Jan2021 at 06:00 AM, the patient experienced anxiety, tiredness, headache, chills, nausea, and feeling unwell. All these feelings come and go but made him very uncomfortable. He was told that it would dissipate in 48 hours. There was no treatment received in response to the events. The outcome of the events was not recovered. The events were assessed as non-serious.
cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that patient best friend's relative received the Moderna COVID-19 vaccine and was knocked out cold after getting it. They had to go to the ER to get their head checked.  Treatment medications were not reported.
Please note: this is not an adverse event rather an administration error  The incident occurred in a Sunday afternoon at around 12:45 pm. This patient showed up in the drop-off window asking for getting her second dose of COVID-19 vaccine. The patient came with her husband/boyfriend (relationship unknown) and a translator. The technician asked whether she received her first dose from Moderna. She assured the technician positively and decided to take the shot.  After administering the vaccine, I discovered in the vaccine card that the patient received her first dose from Pfizer.  While the patient was waiting in the observational area, I called CDC hotline to ensure if she needs further follow-up. An on-call physician assured me that the patient should be fine and should not be re-dosed and also guided me to the CDC recommendation fact sheet. I printed the fact sheet for the patient and assured patient about the CDC recommendation.  I observed the patient for 30 minutes and didn't see any adverse events occurred. Patient left the store without any signs or symptoms of adverse effects.
PATIENT DID NOT EXPERIENCE SIDE EFFECTS FROM THE PFIZER MONOVALENT COVID 19 VACCINE
Patient presented for SARS-CoV2 Vaccination, about 15-20 minutes after vaccination patient complained of feeling a little altered but there was no swelling, rash, or any other indication of a reaction, about 5 minutes later the patient had a weird taste in her mouth and was observed to have a wheal forming on her R forehead. She was phonating ok with questionable swelling to her tongue, but airway intact with non-labored or constricted breathing. She was administered 50mg of Benadryl per pharmacist recommendation. She was monitored for an additional 15 minutes (total of 45-50 minutes after vaccination) with resolution of the wheal and no further symptoms. Patient was advised return/ED precautions and she checked in with vaccine clinic staff an hour later (via text) with no further symptoms.
The only adverse event was the fact that the patient was only 14 years old.  The mother was contacted as soon as we noticed her age.  She had no adverse events and her mother wondered if she could get the 2nd dose which we told her that we could not.
High fever, reaching nearly 103° everyday for about 10 days. About a week after the shot I had chest pains in the center of my chest and difficulty breathing that day. I also had a headache nearly every day for a week.
Moderna booster vaccine (received J&J 3/27/21) given @0930 out of an expired punctured vial. Vial set to expire at 10/26/21 @2130 (12 hours after initial puncture). Pt did not show any symptoms.
Patient presented to the ED and was subsequently hospitalized with pneumonia within 6 weeks of receiving COVID vaccination.
This spontaneous report as received from a physician assistant refers to a 36 year old female patient. On 25-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml (route, lot# and expiration date unknown) instead of VARIVAX (Merck). The patient didn't seek medical attention. No adverse effect was reported. Additional information has been requested.
expired dose of Quadracel was administered to patient; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old patient who was injected with 0.5 ml expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5222AA (Expiry date 20-Jun-2019) via intramuscular route in the right thigh, on 16-Aug-2019.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Redness, tenderness, swollen, hardness around the area, redness spreads down from injection site.
was so sick with fluids in her lungs, and she was gurgling and trying to cough it up; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; his wife was up all night; his wife has thrown up a few times; having body aches; Rash; This is a spontaneous report from a contactable consumer (patient husband). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 61-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included patient got crushed up in a car wreck and lost 53% of her pancreas and had a bad heart valve. Concomitant medications were reported as none. Patient did not receive any other vaccines on the same day as the COVID shot. On 18Mar2021, after her first dose of Covid shot, she was up all night last night because she was so sick with fluids in her lungs, and she was gurgling and trying to cough it up and she stated that she was going to get better, but she was still in bed today. Reporter stated that his wife had fluid in her lungs and stuff, that maybe her heart couldn't push it out and did not get out of bed yesterday to sit on the couch and see the grandkids, but she wanted to be in bed. She was ok but had terrible side effects she was very sick and got bad stuffs, she was bedridden and got helped to her do everything. She had thrown up a few times and was just really sick and also experienced rash on an unspecified date in 2021. He stated that he hopes his wife does not have any permanent damage from this, as she just had a lot of things already, his wife was sick and disabled, having body aches, and is not planning on getting the second dose and he stated his wife does think that she will get well again. Patient did not receive any treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
9 days after the shot  arms started to itch , then a rash , spread to stomach and back very itchy, then spread to legs.  dr recommended benadryl  50mg three times a day . was also taking one 24 hr. clariton.  helped with the itchy.  did this for 7 days before it started clearing up.
No adverse event at this time for patient symptoms.  Patient presented to stations at military mass immunization event that offered the same vaccine.   Inadvertently given two doses of rabies vaccine by station vaccinator.  Patient was under impression he was at Anthrax Station.
CONFUSION; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced confusion, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and confusion was not reported. This report was non-serious.