chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 77y.o. year old female with PMHx of chronic kidney disease stage IV s/p renal transplant, CHF, A.fib s/p watchman procedure who was admitted to BFH on 10/24/2021 for shortness of breath and generalized weakness that has progressed over the past week. Admits to anorexia, fatigue, diarrhea, loss of taste/smell, and cough. She states she has been short of breath with progressive leg swelling for the last three weeks. Denies chest pain, abdominal pain, or worsening LE swelling. COVID-19 vaccine: Pfzier 3/4/2021 and 3/25/2021. Patient admits that she is not sure when exactly her cough or loss of taste/smell started. Contacted daughter for further information. Patient admits that she is in/out of the doctor's office for many appointments. Also admits that her husband, who she lives with, has been coughing for about 1-2 weeks also. (He has not been tested for covid). She denies contact with known COVID-19 positive people. Daughter notes that patient has had shortness of breath for 3 weeks (which daughter admits is similar to her prior shortness of breath caused by cardiac reasons), but one week ago she became drastically worse. Three days ago, patient's fatigue and weakness prevented her from getting out of bed.  On the night of admission, patient's daughter noticed that the patient's lips turned blue and patient was slow to respond, prompting them to seek medical attention. ED/Hospital Course: Vitals on arrival: 100/40, HR: 53, RR: 22, Temp: 97F, SpO2: 77% on room air. Patient was palced on 4LNC. Patient received Solu-Medrol, DuoNeb treatment in the emergency department with improvement in respirations. She was weaned down to 3LNC s/p treatment. Since then, patient has required increase in supplemental oxygen at is currently on HFNC FiO2: 57% and 45L/min. Labs: WBC: 8.4 with lymphopenia. BMP remarkable for CO2: 18, potassium: 3.3, with CR: 3.09, baseline approx 2. Hypoglycemia: 46. BNP: 1922, LDH: 357. COVID-19 inflammatory markers: CRP: 94.5 LDH: 357. Ferritin: 1922. D-dimer: 1855 Procalcitonin: 0.43.  ABG: 7.31/33/128/16
Local reaction to same arm as injection, per provider, no second vaccine series should be administered at this time.
13 hours post (second) vaccination, I developed the usual/listed symptoms:  sore arm, extreme chills, overall body aches, fatigue and a bad headache.  All of those lasted about 3 solid days.  I also developed muscle spasms, similar to the feeling of a "charlie horse" during that time in my feet and left arm and hand.  The next day, they developed in my groin (both sides).  It feels like the muscles in my feet are curling inward when they occur.  The ones in my arm, hand groin usually subside after a 3-5 minutes.  These muscle spasms have continued daily and the ones in my feet are especially bad at night when I am lying down.
patient was given adjuvant suspension only . It was not mixed with antigen. Patient was contacted and asked to return for correct mix.
FATIGUE; NAUSEA; This spontaneous report received from a consumer 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced fatigue. On 06-MAR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and nausea. This report was non-serious. This case, from the same reporter is linked to 20210314997.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 11:32 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
started spotting every week with her menstrual cycle, and then eventually one night bled so much that she felt as though she was hemorrhaging; started spotting every week with her menstrual cycle; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient in her 40's (unknown if pregnant) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "started spotting every week with her menstrual cycle, and then eventually one night bled so much that she felt as though she was hemorrhaging"; INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "started spotting every week with her menstrual cycle".  Additional information: Description of Event: The doctor was a female patient in her 40s. She states that after receiving the primary series in 2021 that she started spotting every week with her menstrual cycle, and then eventually one night bled so much that she felt as though she was hemorrhaging. It occurred one month after she completed the primary series. Stated that she was completely regular prior to this and prior to receiving the primary series. She said a lot of female doctors she talked to noticed the same.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Small clusters of itchy red bumps on the side of the body where vaccine was administered. One on lower leg, one on hip.
pain at injection starting overnight. It was worse with the first vaccine.  Pain in right lower mandible on both vaccines started the day after the vaccine.  This pain was 5 on a scale of 10.  Lymphedema after 2nd vaccine only on the same side as the vaccine was given so only in the right axillary LN,  began the 2nd day and lasted about 4 days.  Tired more after 2nd vaccine.  Continued to work, no time off taken.
Case number PHEH2016US005427, is an initial spontaneous report received from a consumer on 29 Feb 2016. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient suffered with allergic reaction to influenza vaccine. The outcome, seriousness and causality of the event were not reported.
This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of ROTATEQ oral liquid (lot # K011948 with expiration date 07-JUN-2016, lot# K020181 with expiration date 24-JUN-2016, lot# K024700 with expiration date 30-JUL-2016 and lot# L013190 with expiration date 16-NOV-2016; dose and frequency were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a male patient, who was well at the time of vaccination and with no history of allergies who was vaccinated on an unspecified date with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M).  Subsequently the patient developed a large red area at the site of the injection and a very sore arm.  Unspecified medical attention was sought.  On 01/21/2003 it was noted that the patient had recovered.  The physician would like an investigation into this particular lot.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The physician also reported that a female patient was vaccination with pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and had a sore, red arm (WAES # 0301USA01505).  Additional information has been requested.
I also felt like I was struggling to stay conscious./but I had to get up and move around.; I began to start sweating a lot; I felt a warm heat in my body almost like when you get hives. I also felt like I was struggling to stay conscious. I had to get up and use the bathroom and get a drink; I felt a warm heat in my body almost like when you get hives. I also felt like I was struggling to stay conscious. I had to get up and use the bathroom and get a drink; This is a spontaneous report from contactable consumer (Patient). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection: Lot Number: EW1076) via an unspecified route of administration in left arm on 15Jun202 at 16:00 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included the patient had known penicillin allergies. Concomitant medications included methadone, ergocalciferol (VITADONE) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 15Jun2021 at 16:00, the patient experienced a little nervous because the Agency didn't approve it yet, so I did not know if that what messing with him. After i got the vaccine like 5 minutes after the shot i began to start sweating a lot and i felt a warm heat in my body almost like when you get hives. I also felt like i was struggling to stay conscious. I had to get up and used the bathroom and got a drink but if they would've made him sit in them chairs in the isles, I think I would've passed out. I knew they had them chairs there just in case someone passes out i thought, but i had to get up and move around. The patient did not receive any treatment for the event. The outcome of all events was recovered in 2021.
Scattered varicella like rash- Trunk & at hair line- few on legs- Also few insect bites- Rt. elbow with cellulitis. Prescribed Acyclovir 1/4 Tsp q 10. Keflex 250 2/4 tsp TID.
Pt. received vaccines on 2/18/02, swelling and warmth of shoulders immediately post
This medically confirmed report (initial receipt 18-Nov-2013) concerns a 65 year old patient who had a medical history of chronic sinus infection and several food and drug allergies. Concomitant medications included SYNTHROID and ARMOUR THYROID. On the 13-Nov-2013, at 9.30am, the patient received AFLURIA (batch number 08949211A) 0.5 mL once, via the intramuscular route. On the same day, the patient had unspecified allergy testing completed. On the 13-Nov-2013, later on in the evening, the patient felt faint and then passed out. The patient notified the doctor's office the following day on the 14-Nov-2013. No treatment was sought by the patient, and it was reported that the patient was doing fine now. Outcome was recovered.
second fatigue; first fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (first fatigue) and FATIGUE (second fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced FATIGUE (first fatigue). On 03-Dec-2021, the patient experienced FATIGUE (second fatigue). On 26-Nov-2021, FATIGUE (first fatigue) had resolved. On 07-Dec-2021, FATIGUE (second fatigue) had resolved.            No concomitant medication reported. No treatment information was provided.
A non-serious spontaneous report of administration of FLUMIST to a patient over 50 years old was received from a nurse concerning a 55-year-old female. There were no observable changes in the patient following dosing with FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 06-Oct-2009 confirmed that no adverse event was associated with this medication error.
Initial unsolicited report received from nurse on 14 October 2016. This case involves female patient (age not reported) who was vaccinated with dose of Adacel (Batch number, expiration date, dose, site and route of administration was not reported) on April 2016. Medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had a large dark area around the upper arm; injection site was warm and feverish to the touch. Lab data and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
12FEB92 pt recvd 1st dose of Engerix-B & the next day devel several abdo pain & cramps; 12MAR92 recvd 2nd dose of vax the next day arm swelled up (huge) all the way to elbow;
asked for a shingles vaccine despite needing a varicella vaccine; patient is 39 year old and was administered Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 39-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The pharmacist reported that a 39-years-old patient asked for a shingles vaccine despite needing a varicella vaccine and the patient would be going to travel which he was administered with Shingrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up.
Cannot put his arm behind his back; Severe muscle pain for 4 months; Injection administered on biceps muscle; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot put his arm behind his back), VACCINATION SITE PAIN (Severe muscle pain for 4 months) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection administered on biceps muscle) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot put his arm behind his back), VACCINATION SITE PAIN (Severe muscle pain for 4 months) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection administered on biceps muscle). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot put his arm behind his back) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection administered on biceps muscle) outcome was unknown and VACCINATION SITE PAIN (Severe muscle pain for 4 months) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Chills for 5 hours, Fever 100.9, Headache, Achy body, Nausea.     Still had fever of 99.0 24 hours later.    This same thing happened with the 1st shot, but not as intense and as long as this 2nd shot.
At 6PM suddenly experienced excruciating pain in my hands.  Felt like they had been plunged into an acid bath OR hands being attacked by a million needles.  Could not bare hands to be touched and I could not touch ANYTHING with my hands.  Could not sleep all night - had to keep hands away from sheets and in the air.  In AM took tylenol every 6 hours. After 24 hrs very slight improvement still could not bare hands to be touched.  After 48 hours still painful but bearable.  Gradual improvement daily.  After 7 days still pain in my index fingers.  8th day I could touch index fingers.  Today still slight tingling on top of hands. Minimal.
Symptoms: Woke up around 07:30 feeling off balanced, warming more than usual per EE (did not take temp) and HA.  EE took temp at 09:30 (99.6) and again at 14:00 (99.9), EE did not take antipyretics.  EE reports later in the day temp of 98.6.  EE reports at time of call pain at injection site and mild swelling to lymph nodes under L axilla. Last day of work and shift - 1.13.21. Home remedies: Rest. Any improvement: Mild improvement. Recommendation: EE encouraged to take ibuprofen as outlined in the Medical Directive and to apply a cold compress to injection site.  EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns.  EE reports she called out of work yesterday and today.  EE educated to manage her according to the Illness in the Workplace policy.  EE verbalized back understanding and denied further questions at this time.
9/15/10 around 8 PM, started to ache all over, then started shaking. Stiff, tight muscles in neck, hands crampy & achy & sore. Knees weak & legs painful to walk, Lasted until about 10 AM. Took 1/2 XANAX 0.25mg before retiring. Miserable all night. Took 2 ADVIL early AM - seemed to help Dr. said "immune response".
Flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INFLUENZA (Flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine). At the time of the report, INFLUENZA (Flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.
suffered ocular migraine; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration at the left arm on 25Jan2021 09:30 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a public health clinic/veterans administration facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient suffered ocular migraine on 26Jan2021 22:00. No treatment was received for the adverse event. Clinical outcome of the event was recovered on an unspecified date.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
This case was considered medically important. Information regarding PREVNAR was received from a consumer regarding a female child who experienced autism. The child received the third dose on an unspecified date. The child experienced autism. No additional information was available at the time of this report.
Severe dizziness lasting 6 - 8 hours.  No other symptoms.  Completely resolved in approximately 18 hours.
Patient had vaccine and while sitting in waiting area , patient complained of feeling light headed.  Patient soon had an episode of passing out while sitting in chair that lasted 15-20 seconds.  Patient lowered to floor.  Patient awake and alert after being lowered to floor.  Responds appropriately and able to verbalize surroundings.  Patient vitals taken 97.8-55-18, BP 103/68 right arm lying.  Patient assisted up into sitting position after a few minutes.  Then to standing to have a seat in chair.   Patient monitored for an additional 30 minutes.  She stated she felt better and may have been nervous about taking vaccine.  Patient left clinic at 1125 am
Patient was stating that she had body aches, muscle stiffness, and an itchy left arm (no rash).  Patient was supposed to get Pneumovax 23, but received another dose of Prevnar 13.  After realizing this, the pharmacist on duty gave the Pnuemovax 23 as well.
Client received first dose @12:18 pm, felt  flushed with tunnel vision @12:54 pm.  Client's vital signs stable, no symptoms by 1:04 pm.   Able to go home by 1:14 pm.
After getting both shots for covid19 in March/April I tested positive for covid19 on  July 1,2021
Headache, Sedation Back pain, arm swollen, Narrative: Noted increased back pain and significant headache day of the 2nd vaccine dose which lasted 36 hours. Arm became swollen and painful 3-4 hours after administration lasting several days. Noted increased fatigue the day after administration. Missed work x 1 day. Pt had COVID infection 11/2020.
One dose given from punctured vial that was left at room temperature for approximately 27 hours.
Initial misuse report received from a non healthcare professional on 09 January 2014. A patient (no information was provided regarding the patients) had received 2 doses of FLUZONE on 08 January 2014 that was shipped on 06 January 2014. No adverse event was reported. Documents held by sender: none.
Pain lower left back, then pain in abdomen followed by rash in both places.  Shingles vaccine on 8/26 followed by outbreak of disease 8/30.
Headache and "unable to breath" x15-20 min (in car with mom). No color changes, no gasping, no cough, no fever, no emesis. Seen in office 2 hours after vaccine - exam normal.
pt devel rash (red splotches) over trunk & limbs; no SOB noted but lips became swollen; urticaria;
Pt was giving expired covid vaccine. I spoke with pt parents and insured that there is no cause for harm, however the vaccine will not be effective. I suggested parents bring pt in for another covid vaccine free of charge. Apologized to parents as well.