chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 44 y.o. female patient of CNP with history of HTN, IDDM2, Anxiety and depression, CKD3, morbid obesity, OSA   presented to Hospital with SOB, chills, cough, sore throat .   Acute COVID-19 Viral Infection  Acute Hypoxic Respiratory Failure P/w cough, sore throat, SOB. Pt is vaccinated x 2  Onset sx: 9/10/23, positive Covid test 9/11/23  Temp on arrival 99, HR 106, RR 24, BP 187/100 satting 95% on RA Initial CBC w 8.37, VBG 7.32/48  CT PE study: no PE, limited peripheral evaluation, no acute findings  No hypoxia on admission, placed on oxygen for comfort, hyperventilation due to panic attack Does not qualifies for remdesevir (due to elevated Cr) Start decadron as hypoxic, but could have hypoxia also due to untreated OSA as she is non-compliant with CPAP Continue supportive care with Albuterol q 4H, robitussin-DM, tylenol PRN Encourage IS use Contact precautions Heparin  for DVT ppx Patient improved and on RA, will discharge home on course of decadron, recommend outpatient sleep study once recovered for OSA     Hypertensive Urgency BP uncontrolled in ER, due to not taking home medications and anxiety Chlorthalidone and Losartan on hold from Nephrology since 9/2023  Resumed adalat, Metoprolol 100 mg BID  Labetalol PRN BP better controlled today    AKI on CKD3 Follows with nephrologist Dr  Initial creatinine in ER 1.8, last creatinine 9/5/23 1.9 Baseline appears to be 1.7-2 Given contrast in the ED for CT for PE Acute rise in Cr afterwards to 2.4, given 500ml of IV fluids Cr appears to be plateuing at 2.4 Avoid nephrotoxic meds, renally dose    Elevated Troponin without Delta Change Likely elevated in setting of illness, elevated BP and CKD3  Troponin 21> 21 EKG: tachycardia, no ischemia  No further work up  Anxiety/Hyperventilation  Depression , Bipolar  Had a panic attack in the ED Has hx of anxiety Hydroxyzine  PRN ordered Resume home meds Effexor and Seroquel    Hypothyroidism TSH was elevated 6.4 12 days ago , T4 normal No adjustment made to  Synthroid 200 mcg , unsure of compliance Follow up with PCP    IDDM2 with Hyperglycemia , poorly controlled with CKD3 Last A1C 10.6 6/6/23  Home meds: farxiga, metformin, Trulicity, no fill history on insulin per pharmacy  but she was on Lantus 60 units BID per PCP note, unsure of compliance Started on Lantus 40 units daily, Pre-prandial insulin at 5 units and increase Sliding scale sensitivity to normal   Morbid Obesity  OSA Body mass index is 48.55 kg/m².  Documented noncompliance with CPAP Life style modifications recommended   Chronic anemia Hgb 11.2 At baseline Resume iron  Monitor
2nd shot received on 5/24.  Back pain days 1 and2.  Headache, chest pain, neck pain days 1-3.  Day 4, right half of tongue swollen, 5 canker sores on bottom.  Day 5, difficulty swallowing, prescribed Prednisone.  Mouth healed within 5 days of medication.  Headache started on June 4th.  Mild for 2 weeks then increased in pressure and duration.  Visited doctor on 7/1, CT scan pending insurance approval.  Advil does not help at all.  Allergy medicine and nose spray have no effect.  Benadryl & Excedrin Migraine work for a couple of days then stop.   Debilitating pain that I cannot deal with any longer.
7/12/04: complained of local red and swollen area on left thigh where DTP and IPV was given. No pain or fever. Ice packs and Tylenol recommended for 2 days. IT began to improve 2 days later on 7/14/2004 in the am. No further complaints noted.
Received vaccine in the early afternoon, was fine during the day, after supper was vomiting. Vomiting continued throughout the night. Had to use the bathroom and had incontinence episode which then caused her to slip and fall hitting her arm on bathtup.  Overnight continued to feel tired, worn out. The following day slept most of the day. Ate some Wednesday and went to bed around 9-10 then slept like normal.
Lump appeared the day after vaccine in the morning. Bullseye appearance appeared the 26th or the 27th and the area started itching at that time.  The reaction is where the immunization was placed.   Patient is treating with Benadryl.
EXTREME body aches and headache.  Joint pain. Dizziness.  Nausea. Weakness.  Fever.  All lasted about 8 hours.  Woke up the next morning feeling completely normal.
This spontaneous report was received from a Registered Nurse, who was also a vaccine coordinator, referring to 19 unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD with lot # M032496 and expiration date on 02-JAN-2018 (anatomical route of vaccination was not provided) for prophylaxis. The reporter stated that, PROQUAD, was exposed to a temperature excursion of 15 °F to 46 °F (42 °F) for a 6 hours time frame. Furthermore it was stated that, PROQUAD was not expose to any previous temperature excursions and that the call was made due to a data logger. No adverse effects were reported and no product quality issue was involved. Additional information has been requested.
Red, swollen hot (L) upper arm 15 x 17.5 cm. Dx cellulitis given KEFLEX.
Sore left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (Batch/Lot Number: EL3247) as single dose, dose 2 via an unspecified route of administration on 16Mar2021 10:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunization. Medical history included glucose tolerance impaired. Other medical history: pre-diabetes. There were no concomitant medications. On 23Feb201, the patient experienced sore left arm . She stated she had events on each of the day she got the shots. No other vaccine in four weeks and no other medications in two weeks was given to patient. The patient was not priorly vaccinated for covid. The patient was not covid tested post vaccination. The patient had no known allergies. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
No additional AE reported; ROTATEQ improperly stored and administered; This spontaneous report was received from a medical assistance, referring to a 6 months patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 28-DEC-2020, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1684157, expiration date 26-JUN-2021, for prophylaxis (strength, dose and frequency were not reported).   The temperature excursion was of 32.1 Fahrenheit degrees (°F) for an hour. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Headache, body aches, shivering, shaking, shooting pain in top part of head lasting 24 hours
Patient received her second COVID-19 Moderna vaccination at 0941 today.  She remained in the Clinic for observation following the vaccination due to a very long list of allergies and a reported history of developing a headache, "organic taste in her mouth, like cut grass" and severe fatigue hours after receiving her first dose of COVID-19 Moderna vaccine on 8/18/2021.     Approximately 20 minutes following the vaccination patient developed tingling on the lower right side of her mouth.  She had an equal rise in her smile bilaterally.  This tingling progressed to numbness on the right side of her face extending to the right ear and up the side of her right eye.  Patient verbalized that she felt her lips were swelling but visually her lips did not look enlarged.  She repeated several times, "I just don't feel well"    The Emergency Medical Response Team was called.  Patient became progressively less responsive.  She continued to sit upright on the exam room couch.  She was not answering the paramedics questions and not following commands.  She was eased down on the exam room sofa.  An IV was started by the paramedics and patient was transported to ED.  Patient  gradually improved in the ED and was discharged from the ED on the same day of the vaccine reaction at  1409.
Left upper arm feels a knot and warmth to touch. Pain is on back shoulder blade and left upper chest. Hurts to breath.
patient was in our office with his wife. his wife was due for Tdap and patient was due for Flu vaccine. I had the vaccines laying on top of signed consents. I cleaned and dried patient's arm, and while having a conversation with the patient, I grabbed the wrong vaccine and administered Tdap vaccine rather than Flu vaccine.
Comfort measures only status, history of A. fib on warfarin, prostate cancer status post radical prostatectomy. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
My sons left eye turned in within 1 week after receiving MMRV 2nd dose and hep A dose 2.
No adverse event; Moderna dose administered to patient after expiration; Patient received a 0.30 mL dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration), INCORRECT DOSE ADMINISTERED (Patient received a 0.30 mL dose) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration) and INCORRECT DOSE ADMINISTERED (Patient received a 0.30 mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration), INCORRECT DOSE ADMINISTERED (Patient received a 0.30 mL dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration) and INCORRECT DOSE ADMINISTERED (Patient received a 0.30 mL dose).    No concomitant information was reported. The patient received the second booster dose. No adverse reactions had been reported for the patient. No treatment information was provided.
Information has been received from a health care professional concerning a 10 year old male who in 1998 was vaccinated with one dose of varicella vaccine. In 1998, the pt experienced an anaphylactoid reaction. The pt was brought to an ER and administered epinephrine. Upon medical review. the pt's experienced was considered an "other medical event".  Follow-up received on 8/1/00 experienced anaphylaxis, not anaphylactoid reaction as previously reported. The pt developed respiratory symptoms that included wheezing, ocular edema and rhinitis soon after receiving the vaccine. Following epinephrine treatment in the ER, the pt recovered. A follow up report received 6/1/2001 adds: Info has been received from a health care professional concerning an 8-year-old male who on 04/11/1998 was vaccinated IM with the 1st dose of varicella virus vaccine live in the right deltoid (lot #625043/1567E). It was noted that the pt had constipation at the time of vaccination. On 04/13/1998 the pt experienced an anaphylactoid reaction. The pt was brought to an ER and administered epinephrine. Upon medical review, the pt's experience was considered an "other medical event."  Follow-up info indicated that the pt experienced anaphylaxis, not anaphylactoid reaction as previously reported. The pt developed respiratory symptoms that included wheezing, ocular edema, itching skin and rhinitis "within 15 minutes" after receiving the varicella virus vaccine live. Following epinephrine treatment in an ER, the pt recovered. The pt remained in the ER for 3 hours and then was discharged with diphenhydramine hcl (Benadryl) x5 days. No further info is expected.
Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering.    No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.
03/25/23 presents to EC ED for "shortness of breath". PMHx of "OSA, morbid obesity, cirrhosis"
Itchy in the shot area after a minute of getting it. After about 30mn, a red spot appeared on the vaccine shot. I was about half of an inch in diameter. Flesh was a little bit rigid to the touch after an hour. A little of inflammation of the same area after 7 hours accompanied of pain. The pain is not strong but its is alike as the pain when I have a black bruise and it only happens when I move my arm. After 24hr of the shot, the itchy and ache continue even though I am taking Tylenol of 500 every 6hr. My head ache too.
This case was reported by a nurse and described the occurrence of dizziness to a 53 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 28 October 2005 the subject received 1st dose of Fluarix in the left arm (lot AFLUA151BA). "Approximately 20 minutes after receiving Fluarix," on 28 October 2005, the subject experienced dizziness, nausea, and "felt like fainting." The subject was seen at a physician's office. The events had improved as of the time of initial reporting 28 October 2005. The nurse considered the events to possibly be related to vaccination with Fluarix.
On April 2, 2021, following the 2nd COVID-19 vaccination of 2, I got severe pain in my lower gut. It ran horizontally right above the pelvic area. It was constant. On April 4, 2021 I started having loose and runny stools an average of 7 (5-10) times a day. Aside from the constant pain there was not more cramping nor warning. After 2 weeks of no improvement I called my Drs. clinic. Other symptoms were on and off sweating spells whicH were worst at night.
NAUSEA & VOMITING ALL NIGHT -FOLLOWED BY HEADACHE, DIARRHEA, LOW GRADE TEMPERATURE AND CHILLS THE FOLLOWING DAY
Within 7 minutes of injection employee complained of itching of left forearm and hand, stated she had a fine red rash and numbness, coldness and tingling in forearm. Numbness had gone to upper arm, deltoid area and not in hand or forearm. Also complained of vision being blurred. Symptoms were subsiding before leaving employee health office.
Chest pain; Left arm pain; Tingling and sore in the injection site; sore in the injection site; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Left arm pain), PARAESTHESIA (Tingling and sore in the injection site), VACCINATION SITE PAIN (sore in the injection site) and MYALGIA (Muscle pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Left arm pain), PARAESTHESIA (Tingling and sore in the injection site), VACCINATION SITE PAIN (sore in the injection site) and MYALGIA (Muscle pain). At the time of the report, CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Left arm pain), PARAESTHESIA (Tingling and sore in the injection site), VACCINATION SITE PAIN (sore in the injection site) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided. No treatment information was provided.
Left foot, ankle and leg. Swollen within 8 hours of receiving 2nd shot of vaccine. Feeling of Plantar fasciitis in both right and left feet. Sever muscle ache from waist down to toes. Extreme swelling of left foot and ankle Unable to walk for almost two years without pain Caused right hip to  injected with steriods do to walking improperly.
I experienced sudden onset joint pain in my hands and knees. It's been over a month now. It is very painful. I am awaiting an appointment with a specialist.  My blood came back positive for inflammation. I also had headaches the first couple of days.
chills and muscle pain; chills and muscle pain; couldn't stand up and it was as if he would "fall into a puddle."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills and muscle pain), MYALGIA (chills and muscle pain) and DYSSTASIA (couldn't stand up and it was as if he would "fall into a puddle.") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills and muscle pain), MYALGIA (chills and muscle pain) and DYSSTASIA (couldn't stand up and it was as if he would "fall into a puddle."). At the time of the report, CHILLS (chills and muscle pain), MYALGIA (chills and muscle pain) and DYSSTASIA (couldn't stand up and it was as if he would "fall into a puddle.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I experienced rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included tab paxlovid.  Clinical Course- Patient experienced rebound COVID. So far, mild symptoms like a runny nose. Patient should had mistaken it for allergies maybe it is).
Got HSV/herpes in May. First out break lasted a month even on medication. I get out teams weekly even while on suppressant medication  (Valacyclovir 1g daily)
test on 02Feb2021 came back positive; test on 02Feb2021 came back positive; ran a fever; i was barely sick; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) intramuscularly, administered in left deltoid on 16Jan2021 (at the age of 65-year-old) as single dose for Covid-19 immunisation in workplace clinic. Medical history included, the patient had in lifetime, 3 episodes of vasovagal syncope in her lifetime (all related to blood draws) and her blood pressure was naturally low. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the first administration date of the suspect vaccine. The patient did not receive any other concomitant medication within two weeks before the event onset. On 30Jan2021, the reported that she ran on fever and started isolated. The patient was barely sick enough to warn me to isolate, possibly because the first shot had already generated some useful antibodies. On 02Feb2021 came back positive to COVID 19. Clinic on 06Feb2021 was clearly not helped the patient. The clients, however, were cleared from isolation in time to get their second shots on the 06Feb2021. Staff later told patient; the whole house was wiped out the next day. Everybody wanted to stay in bed, some even refused meals in favor of rest. Our whole group home, all clients and every staff that consented, got the first shot at the office on 16Jan2021. Clinics scheduled 3 weeks apart, so the second shot was due on 06Feb2021. After that, 27Feb2021, and so on until no one needed the second shot anymore. The patient was very relieved to finally get her turn to get the vaccine. Unbeknownst to her, one of the staff (who did not take the shot that day) had infected by her S.O. and was industriously exposing the clients the very day they were getting their shots. She worked double shifts two days in a row just before she started showing symptoms, so, max exposure. The patient did her best with the masks and bunny suits but was not trained nurse, and the house was just a virus stew by that point. She could not exactly open all the windows in the month of January. The patient lab test included SARS-COV-2 test was positive on 02Feb2021. Outcome of the events was unknown.  Follow up attempts are not possible. No further information is expected.; Sender's Comments: Based on the know safety profile and limited information in the case, a contributory role of BNT162B2, to the reported events cannot be excluded.
Patient noticed a swelling to the left side of her neck which became very tender and sore. Client saw PCP when swelling did not decrease and pain worsened. The physician completed a CT scan of the neck and determined that the employee has enlarged lymph glands in her neck. The PCP also ran a blood test that showed positive for a history of epstein barre. The client's PCP determined that the employee sustained an autoimmune reaction from the Influenza vaccination
Patient has dark red patch approx. 1x3 inches surrounded by a lighter pink area. Patient said everything felt fine all day on Friday, but noticed the redness and soreness Saturday morning. Pain at the touch and pain internally radiating down to the elbow. No fever or other symptoms.