chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosis of COVID-19 who presents with dehydration and COVID pneumonia. She developed cough and runny nose a about a week ago. She had several home COVID tests that were negative. On 9/22 she had a test at Pharmacy that came back with results of "indecisive" on 9/25. She was taken to a clinic that same day where COVID-19 PCR was positive and CXR reportedly with "mild pneumonia". She was seen in our ED yesterday (9/26) for a COVID antibody infusion. Mother reports that patient has previously received a similar infusion when she was sick with coronavirus this past winter. She has had nausea and some vomiting of mucus. She has had decreased appetite. Reports mild sore throat. Denies any headache or abdominal pain. She was taken back to the ED  today due to persistent cough, some shortness of breath, and decreased drinking over the past 2 days. Repeat CXR showed stable findings of mild to moderate b/I opacities. Labs at ED include CMP (HC03 14, BUN 36, Cr 2.43, otherwise wnl), CBC (WBC 10k, H/H 11.5/35, pits 72), LA (20-49 WBC, spec grav 1.020). She received a total of 2L of NS and a dose of ceftriaxone. Patient became critically ill with acute respiratory failure requiring invasive mechanical ventilation secondary to acute COVID pneumonia/ARDS and AKI. Intubated and on mechanical ventilation with improving lung function, however severe critical illness neuromyopathy prevented mechanical ventilation liberation.  On day of death patient developed rapidly (minutes) progressive refractory hypotension and bradycardia. Resuscitative efforts started with chest compressions and meds (CPR form).  Copious amounts of fresh blood noted from ETT unable to be controlled despite continuous suction. This prevented from adequate gas exchange. All resuscitative efforts stopped at 10:34 and patient pronounced dead.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. No treatment medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant follow up: Updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Patient received an HPV 9, Tdap, MCV4, flu, TB test around 8:30 on 11/28/17. Per Dad, everything was fine until around midnight. Patient got very dizzy/lightheaded and vomiting.
Pt received concentrated does of vaccine.  Nurse did not reconstitute vaccine before administering.  No symptoms at this time.
pt recv vax 17APR97 & 7FEB98 pt had one spot & on 8FEB98 pt had another spot;11FEB98 pt presented w/a total of 8 spots & was dx w/a mild case of chickenpox;no fever noted;
A non-serious spontaneous report of man over 49 years of age got nasal pandemic influenza 2009 was received from a registered nurse concerning a 54-year-old male, subsequent to H1N1, Intranasal. The patient neither had past medical history nor was on any concomitant medications. On 13-Oct-2009, the patient received the vaccine for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 17-Dec-2009 and incorporated into the narrative: reporter information, patient's medical history, concomitant medications and confirmation of other adverse event occurrence besides vaccination error.
She only got sore arm and she is fine; "Arm is killing me"; Slept for 12 hours; Feeling "hot and cold"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("Arm is killing me"), SOMNOLENCE (Slept for 12 hours), FEELING OF BODY TEMPERATURE CHANGE (Feeling "hot and cold") and MYALGIA (She only got sore arm and she is fine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY ("Arm is killing me"), SOMNOLENCE (Slept for 12 hours) and FEELING OF BODY TEMPERATURE CHANGE (Feeling "hot and cold"). On an unknown date, the patient experienced MYALGIA (She only got sore arm and she is fine). At the time of the report, PAIN IN EXTREMITY ("Arm is killing me"), SOMNOLENCE (Slept for 12 hours), FEELING OF BODY TEMPERATURE CHANGE (Feeling "hot and cold") and MYALGIA (She only got sore arm and she is fine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: 96.3 (abnormal) 96.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: New event of myalgia was added.
This solicited report was received from a patient's mother via GFK market research agency regarding the 12 year old female patient enrolled in a market research program. There were no concurrent conditions or medical history. Concomitant therapy was not reported. On 01-APR-2016 the patient received the first dose of unspecified quadrivalent human papillomavirus vaccine (manufacturer unknown) in the arm shot (dose, route and lot number unknown). On that day the patient had some side effects-bump, pain, dizzy and pale. The events resolved with sequelae on 04-APR-2016 with duration of 3 days. The reporter considered the events to be related to quadrivalent human papillomavirus vaccine (manufacturer unknown). Additional information has been requested.
her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; her arm is sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck; she feels like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle; This is a spontaneous report from a contactable consumer (patient) via US COVAX Support program. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in arm left on 16Jun2021 11:00 as 2nd dose, single dose for covid-19 immunisation. Medical history included, overweight, heart issues, breathing issues, thyroid issues, CPap, gallbladder removal. Concomitant medications included hydrochlorothiazide taken for an unspecified indication and potassium taken for an unspecified indication. No prior vaccinations were done within 4 weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172 ), via an unspecified route of administration, administered in arm left on 26May2021 11:00 as 1st dose, single dose for covid-19 immunisation. On 16Jun2021, she felt like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle. On 17Jun2021, her arm was sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck. She mentioned that she had no problems with her 1st dose, she was asking if she should get another dose or what she should do. The girl who did the injection, was a tech at the CVS pharmacy. Stated she did not even get it in her biceps; she squeezed her arm not even near there until it puffed out; and then set the bandaid on the back of her arm not where she gave the shot. She tried to rub it but that did not help. She did take Tylenol and that helped a little. It was persisting on 17Jun2021. No additional vaccines administered on same date of the Pfizer suspect. She did not want her kids to get COVID. She mentioned she also take a plethora of supplements. Therapeutic measures were taken as a result of her arm was sore all the way down her arm to her fingers and up to the shoulder and a little up the back of her neck with Tylenol. The outcome of the event she felt like her 2nd dose was administered into the fatty part of her arm and did not reach her muscle was unknown and not recovered for other events.
Headache, Myalgia, severe back pain Narrative: Received vaccine on 1/26/2020 at 0720 am and at 0230 this am started experiencing severe Back pain "like someone was stabbing her with a knife" and headaches has taken otc ibu & acetaminophen and called off work for tonights shift
10/14 0830 Pt reports fever, malaise, body aches that started on 10/13 approx 6pm. Pt advised to report to nearest ER. Pt was diagnosed with Acute Strep Pharyngitis and given appropriate antibiotic treatment. Report states his symptoms are due to combination of strep throat and a normal physiological response to the anthrax vaccine.
Pt denied on his consent form that he had previously received a COVID vaccine but when the clerk was entering his vaccination into TennIIS, she found that the pt had already been fully vaccinated with Pfizer on 1/07/2021 ad 1/29/2021.
WAS HAVING MYALGIAS AND MILD FEVER STARTING ABOUT 12 HOURS AFTER VACCINE, BUT AT 2 AM,  I WOKE UP TO URINATE, FELT SOME DIZZINESS.  AT THE END OF VOIDING I COULD TELL I COULDN'T THINK RIGHT AND HAD TROUBLE FLUSHING.  TRIED TO WALK BACK TO BED AND HAD A SYNCOPE AS I GRABBED THE DOOR HANDLE.  STUMBLED DOWN SLOWLY AND LOSS CONSCIOUSNESS FOR A SHORT WHILE, SECONDS.  LAYED IN THE FLOOR FOR A BIT AND WHEN I STOOD UP AGAIN AND WALKED TO MY ROOM HAD ANOTHER SYNCOPE.  WOKE UP AFTER SEVERAL SECONDS AND WAS NOT CONFUSED AND DIDN'T REMEMBER THE SECOND TIME I FELL BUT COULD UNDERSTAND I HAD PASSED OUT.  MY WIFE SAYS I HAD MY EYES OPEN AND WAS STIFF BUT NO TONIC CLONIC MOVEMENTS.   AFTER THE EVENTS I WAS ABLE TO GET BACK IN BED AND AFTER A LITTLE WHILE TESTED FOR ORTHOSTASIS.  WHEN I STOOD UP I STARTED FEELING THE LIGHT HEADEDNESS AGAIN AND PRODROME TO FAINTING AND LAYED BACK DOWN.    HR 60, MY BASELINE IS 50-60.  HAD A FEVER OF 100.7.  I TOOK 650 MG OF TYLENOL AND WENT BACK TO BED.  I DIDN'T SLEEP WELL BUT NOW (THE FOLLOWING MORNING) I AM FEELING BACK TO NORMAL MINUS SOME MILD SOARNESS.   I HAD A RAPID COVID PCR TODAY THAT IS NEGATIVE.  NO OTHER LABS.  I HAD NEVER FAINTED BEFORE THIS EPISODE.   I DID NOT HAVE ANY TRAUMA FROM SYNCOPE.
Pt received her first dose of the Moderna COVID19 vaccine. When pt sat down in observation she reported feeling a strange sensation in the back of her throat and a funny taste in her mouth. BP 169/85, HR 77 O2Sat WNL. Pt was evaluated by  EMS. Pt signed refusal for transport to the ED.
pt recv vax 14OCT96 & the next day pt exp an erythema rxn @ the inj site;rxn lasted 1wk now 22OCT96 looks bruised;can see where the med had spread in that area but doesn't feel bruised;
This spontaneous report received from a patient via social media through company representative concerned a patient of unspecified age, race, ethnicity, and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination (dose number in series: 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient reported "I had a myocardial infarction after having the J&J but who knows?" The action taken with covid-19 vaccine was not applicable. The outcome of myocardial infarction was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211263270-covid-19 vaccine Myocardial infarction. This event(s) is considered unassessable. The event(s) 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(s).
The night I got my booster shot I noticed a huge hive on my shoulder then woke up the next morning with them all over both my arms as well as my wrists being swollen. I went to an urgent care and they told me I was having an allergic reaction and to take Claritin. It?s been  almost two week since I?ve gotten my shot now and I still am getting HUGE hives all over my body. They line my butt and backs of my legs with huge welts above both my knees almost everytime now. The most recent incident is happening now, my forehead is swollen from hives as well as the rest of my body. The hives usually go away after a few hours if I take the Claritin but they still come back eventually.
Pt entered the vaccination area to receive her single dose of the Janssen vaccine today 8/9/21. Post vaccination, pt disclosed that she had received two doses of the Moderna CV19 vaccine, dose #1 on 2/19/21, dose #2 on 4/1/21.  Pt was educated on the unknown effects of mixing both the Moderna EUA approved vaccine with the Janssen EUA approved vaccine. Pt reported that she was feeling fine. No immediate reaction occurred within the 15 minute observation period post vaccination.
On 10-18-2019 I administered both vaccines listed in this report. Shortly after receiving both of her vaccines, the patient fainted while seated at the private consultation area and lost control of her bladder. I was able to hold the patient up in the chair which prevented her from falling to the ground. Then I immediately instructed my technicians to call 911. After making sure the patient was breathing, I began to check for consciousness. After a few seconds she regained her consciousness. While my technician was on the phone with 911, I asked the patient if she is OK and if she would like the ambulance to come. The patient said that she is OK and does not want them to come. Naturally she felt embarrassed, so I used the divider to give her some privacy. She also informed me that she did not eat. I offered her banana bread and water. This appeared to help the patient. Shortly after she contacted her family, they were able to come and take her and her two children. Approximately at 7 pm that evening, I called the patient to make sure she and kids were OK. She thanked me  and informed me that they are doing well.
8pm tried to get up out of the bathtub, called husband he helped me to the toilet and i passed out.  He helped me up and I vomited twice. Very  crazy experience, I never had something happen to me like that.  I only received one regular flu shot in my life no other shots.
Severe nausea; unable to keep water down for greater than 24 hours progressing to vomiting; Severe muscle aches in back and legs; Severe fatigue; Chills.
SORE THROAT; HANDS WARM TO TOUCH; FEVER; LOOKING FLUSHED; HANDS FELT HOT; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight was 220 pounds, and height was not reported. The patient's past medical history included accident bruise in spine, neuropathy of four limbs, issues bowel movements after spinal surgery, shoulder surgery on both side, appendix taken out, tonsils taken out, and spinal surgery, and concurrent conditions included dog dander allergy, alcohol user, smoker, and controlled hypertension, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient allergic to mouse feces.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced looking flushed. On 02-AUG-2021, the subject experienced hands felt hot. On 02-AUG-2021, the subject experienced hands warm to touch. On 02-AUG-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) Normal, and Body temperature (NR: not provided) 100.8 F, 98.9 F. On 03-AUG-2021, the subject experienced sore throat. Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from looking flushed, hands felt hot, and hands warm to touch on 02-AUG-2021, and fever on 03-AUG-2021, and had not recovered from sore throat. This report was non-serious.
Headache, nausea, dizzy, metallic taste in mouth, pain at injection site
Information has been received from a pharmacy manager referring to a number of unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # J007952, expiration date: 27-JUN-2015, first dose on 26-AUG-2014 and last dose on 05-MAY-2015; lot # J014960, expiration date: 26-NOV-2015, first dose on 07-AUG-2014 and last dose on 25-AUG-2014; lot # K002917, expiration date: 26-FEB-2016, first dose on 27-AUG-2014 and last dose on 13-JUL-2015; lot # L005298, expiration date: 17-FEB-2017, first dose on 21-JUL-2015 and last dose on 02-SEP-2015; lot # K005427, expiration date: 15-APR-2016, first dose on 08-JUL-2015 and last dose on 28-AUG-2015; lot # reported as L003856, expiration date: 05-FEB-2017, first dose and last dose both on 18-AUG-2015; strength, dose and route unknown). The VARIVAX (Merck) was stored in a clinic freezer which had operated for 13 months with excursions above 5 degree Fahrenheit for 10-20 minutes three times a day. These temperature variations continued until the problem was discovered on 04-SEP-2015. At that time all VARIVAX (Merck) was sequestered and new vaccines ordered. This is one of several reports received from the same reporter. Additional information has been requested.
I received the first dose of the Moderna vaccine in the vaccination clinic. It was in the morning, but I am not sure of the exact time.  I received the shot in my left arm and went to sit down. About two minutes passed and I started feeling short of breath, lightheaded, and a racing heartbeat. I shouted out to someone and that I couldn?t breathe. A few people came to assess me, my heart was racing into the 130s, the staff called a rapid response and I was rushed to the emergency department. While in the ER, I was given IV Benadryl, IV pepcid, and IV solumedrol. I continued to have episodes of tachycardia that came and went in waves. I also felt strange tongue sensations and left leg pain. After a few hours with the medication given, the tachycardia resolved. I was sent home with Benadryl and steroids. Later that day, I felt muscles aches and fever.
Headache, body aches, fever, fatigue, chills, dry mouth, no appetite, loss of taste, fatigue
Patient is a 75 yof who presented to ED with a 1-2 week history of fever, nonproductive cough, nausea/vomiting, and generalized.   Constitutional: Positive for activity change, chills and fever. Negative for fatigue.  HENT: Negative for congestion, sore throat and trouble swallowing.   Eyes: Negative for photophobia and visual disturbance.  Respiratory: Positive for cough. Negative for chest tightness, shortness of breath and wheezing.    Patient's initial nausea/vomiting was secondary to Covid-19; she also had AKI and dehydration secondary to that. She was treated supportively with IVF, electrolyte replacement, antiemetics and she improved. Her hyponatremia improved too with improvement of her fluid status. She didn't have any other covid symptoms; didn't have any respiratory problems and didn't require oxygen. She was treated with ceftriaxone for UTI; after her symptoms persisted repeat UA was done which still showed elevated WBCs so she was given a dose of fosfomycin which relieved her symptoms. She didn't have any growth in her cultures/ During hospital stay, she had increased ostomy output and had AKI and electrolyte depletion secondary to that which resolved with supportive care. She has been tried multiple therapies for high output stoma in past unsuccessfully; she was open to trying soluble fibers so polycarbophil was started. She takes 500 ml NS and  2 gm MG IV through her port every other day and gets weekly labs that is sent over to her gastroenterologist's office who adjusts her fluid and electrolytes; this was continued at discharge. PT/OT recommended acute rehab so patient stayed waiting on that but her insurance denied it so patient opted to go home with home health, PT, OT; which was arranged for her at discharge..   Discharge Disposition/Condition Disposition: Home with Home Health Condition: Stable (s/sx potential problems absent or manageable)
Patient received a PREVNAR 13 vaccine on 12-9-2015. Patient returned 12-14-15 stating possible reaction. Pt c/o difficulty walking and body ache.
This spontaneous report as received from a physician refers to 3 patients of unknown age. The patient was vaccinated with GARDASIL in 2012 "the entire previous year". Lot#, date and route were unspecified. On unspecified dates, the 3 patients experienced syncope after receiving GARDASIL. The patients sought medical attention for the adverse event occurred in the physician's office. The outcome of patients were unknown. This is one of several reports received from the same source. (1209USA001616, 1209USA003021, 1209USA003023, 1209USA003024). Additional information has been requested. Attempt is being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
05/30/2003: swollen around site of injection about size of golf ball very red.  Started with redness 05/29/2003.  Difficulty lifting arm.  May use warm compresses, alternated with cold 4 times daily.  Over the counter ibuprofen per pkg directed. As 06/03/2003: much better, redness almost gone and swelling also feeling fine.