chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the worst backache; muscle soreness; muscle soreness at the injection site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid.  A contactable consumer (patient) reported that an 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration at the right arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history included autoimmune haemolytic anaemia (reported as immune system attacks red blood cells). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Concomitant medications included prednisone for red blood cells from Dec2020 and ongoing, folic acid from Dec2020, and omeprazole from 05Nov2020. The patient did not have any symptoms the day she received it except for muscle soreness at the injection site on 21Jan2021. On the night of 26Jan2021, she had the worst backache. Her son went to the store and bought Lidocaine patches for it. Clinical outcome of the event muscle soreness at the injection site was recovered on 22Jan2021 while for the worst backache was not recovered.
Left arm above elbow has a 5 inch in diameter is itchy, swolen,red and warm to the touch. Patient has claimed to have previous reaction with anthrax.
Lightheadedness, dizziness, nausea starting 30 minutes after vaccination, bradycardia.
Have had normal menstrual periods right up to the vaccine now I just barely spot, practically no period at all.
c/o fever w/chills followed by a macular rash on face & back temp:99.4 cervical lymph nodes;
Dose 1 was administered;10 days prior to dose 2 patient began to have shortness of breath.  Dose 2 was administered 3-23-21, Moderna Lot 006B21A.  Severe sob and left sided pain 3-23-21 @ 5:30pm/difficulty moving around.  Sought treatment at Hospital  on 3-25-21 as symptoms were increasing in severity/chest xray and CT revealed pulmonary embolisms in both lungs; Heparin was started/transported by ambulance to another hospital for clot removal. Decided not to do procedure and was kept on Heparin for 24 hours.  Began Eliquis that Friday/symptoms began to resolve and was dc'd on Saturday.
Moderna 3/3/21, 3/31/21, 12/17/21. Positive on 8/5/22
The pt reported pain in the right arm to the nurse on 10/31/2018 and again on 11/08/2018. Today 11/08/2018 she was sent by Clinic to OCC Health to be evaluated.
Information has been received from a physician and a 35 year old female concerning herself with no pertinent medical history and no known drug reactions/allergies who on 14-JUN-2007 was vaccinated with a dose of VARIVAX. There was no concomitant medication. The patient recently found out that she was pregnant. Her LMP was 20-May-2007 and the estimated due date is 24-FEB-2008. Medical attention was sought. Patient's outcome was unknown. No product quality complaint was involved. This case was part pregnancy registry. Follow-up information has been received from a nurse and the patient's husband. The nurse indicating that the patient delivered the baby in February 2008. However she had no outcome information because the patient was not seen in the office for her post-partum visit. The patient's husband reported that the patient delivered a baby boy. The baby had a rash which was reported to eczema, otherwise was healthy. He stated that the patient had no problems with her pregnancy. This is consolidation of two reports concerning the same patient. Additional information is not expected.
CARDIAC DAMAGED; UNABLE TO SLEEP; PAIN ALL OVER HER BODY; FEELING UNWELL; NAUSEA; VOMITTING; EDEMA ON BOTH LUNG; FEELING VERY SLEEPY; UNABLE TO EAT AND DRINK; SHE PASSED OUT; CHEST TIGHTENING; THROAT TIGHTENING; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to eggs, mustard and avocado, allergy and environmental allergens and the patient's pre-existing medical conditions included: The patient was very healthy before getting vaccinated, all her lab test was normal and did not have a history of the same medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 264A21A) dose was not reported, 1 total, administered on 07-SEP-2021 on right deltoid for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride for allergy, epinephrine for allergy, loratadine for allergy, and corticosteroids for allergy.  On 07-SEP-2021, few minutes post vaccination, the patient was unable to breath, her chest and throat was tightening. The patient used epi (epinephrine) pen to alleviate the allergic reaction and passed out on the pharmacy floor. On the same day, once the patient gained her strength and went to hospital and had series of blood works and Chest X-ray. The patient was given IV fluids. On 08-SEP-2021, the patient felt unwell, unable to get up all day, felt very sleepy, tiredness, nausea, vomiting, unable to eat and drink without throwing up. At the evening, she went to the ER again, did a series of blood works, chest x-ray and was given IV fluids, anti-nausea and anti-inflammatory.  On 09-SEP-2021, the patient experienced chest pain which was worsening and experienced pain all over her body and the patient was unable to sleep. Therefore, patient went to ER again, gave her another IV fluids and performed a Pulmonary Embolism protocol and another blood works. The attending physician informed her that her cardiac lab change so much and she has a cardiac damaged and retaining too much fluids. She was referred to a cardiologist for echo and stress test.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from she passed out on 07-SEP-2021, was recovering from throat tightening, had not recovered from chest tightening, feeling unwell, feeling very sleepy, unable to eat and drink, nausea, vomiting, unable to sleep, pain all over her body, edema on both lung and the outcome of cardiac damaged was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210920683-covid-19 vaccine ad26.cov2.s-Pulmonary oedema,Loss of consciousness.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).
Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) 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 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported. No concomitant medication were reported.   This case was linked to MOD-2021-416295 (Patient Link).
upper arm has a large red rash about 3"; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (upper arm has a large red rash about 3") in a patient of an unknown age and gender 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 an unknown date, the patient experienced RASH ERYTHEMATOUS (upper arm has a large red rash about 3"). At the time of the report, RASH ERYTHEMATOUS (upper arm has a large red rash about 3") outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.
Mom noticed lt eye to be swollen & watery also noticed when child talked mouth had noticeable paralysis on the lt side;
Patient says she got a rash and itching on their legs, arms, lower back, chest, and feet.
Client came to the pharmacy requesting Flublok flu vaccination. He had planned to separate his flu vaccination and his covid bivalent booster vaccinations by one week to decrease the intensity of side effects that might be more severe with co-administration.  Due to the large number of people receiving flu vaccines and covid booster vaccines at the same time during this clinic, 2 syringes of Pfizer bivalent booster vaccine were in close proximity on the vaccinator table to the Flublok vaccine distributed by the pharmacists. In error, a Pfizer bivalent booster was administered instead of the Flublok. The client was informed as soon as the erroneous administration occurred. He decided to proceed with administration of the Flublok in the same right deltoid muscle, separated by more than an inch, as he wanted to avoid arm pain side effects bilaterally. This report is of the vaccine administration error. No other adverse effects have been reported related to this error.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 10-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA 25/0.5 (unit unspecified) (lot # N020689 and expiry date: 22-OCT-2018) via intramuscular route for prophylaxis (expired product administered). No adverse effect was reported. There was no product quality complaint (PQC) reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA011184.
Subjective fever, chills, diaphoresis, nausea, vomiting and diarrhea, one episode of urinary incontinence with back pain, improved after 1 day.
Lightheadedness, dizziness, patient lowered to the floor and elevated feet. Moved to a gurney, symptoms improved with pursed lipi breathing
I was admitted for fluid around my heart or Pericardial Infusion towards the end of July 2022. I was having pain in the upper part of my back and difficulty breathing, shortness of breath.
Missed second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included RabAvert (1st dose received on 24th June 2020).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of RabAvert, which led to incomplete course of vaccination. This was post exposure of vaccine case. The reporter did not consent to follow up.
stinging sensation in middle of chest; bp 144/88 5 minutes late 137/85; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST PAIN (stinging sensation in middle of chest) and HYPERTENSION (bp 144/88 5 minutes late 137/85) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CHEST PAIN (stinging sensation in middle of chest) and HYPERTENSION (bp 144/88 5 minutes late 137/85). At the time of the report, CHEST PAIN (stinging sensation in middle of chest) and HYPERTENSION (bp 144/88 5 minutes late 137/85) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 144/88 mmHg High and 137/85 mmHg High.     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. Action taken with mRNA-1273 in response to the event was not applicable.
Swollen leg, hot to touch, stiffness around injection site; called NP at identified pediatric office, was informed to rotate warm and cold compression and administer Tylenol if need be. Was also advised to return to office if not looking better by the afternoon of 09/21.
States on 6/6/23 he began to feel warm without fever, chilled, and would get cold easily.  Has had nausea and vomiting for several months due to gastritis,.  Has been losing weight but has been walking.  Has had decrease appetite past 2 - 3 weeks.  Three to four days ago no energy, tiredness, and dizziness. Due to concern for other illness, he went to his PMD in May who ran blood tests.  States his WBC was low and he had read that low WBC could be caused by the Jynneos vaccine.  Has had additional testing and follow up blood work by PMD for the additional health concerns, unrelated to vaccine.  Explained symptoms presenting today are common with Jynneos, and as a live vaccine would not be unexpected a week to 10 days following vaccination.  That is unaware of decreased WBC following vaccine, asked source of comment, unable to find source during conversation.  States, his WBC count was "just a little low".  Encouraged to follow up c PMD for the additional hear concerns, monitor symptoms, if worsen or no improvement by end of week 12 - 16, to seek additional care. Voiced understanding.
3 separate leg cramps in 2 days. First my left calf - Friday morning, then my right thigh - Friday evening, finally my right calf - Saturday morning.
first dose 6-Aug-2021 , second dose 31-oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 6-Aug-2021 , second dose 31-oct-2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     There were none acute illness at the time of vaccination and up to one month before. There were none chronic or long lasting health conditions.  Concurrent medical conditions included Allergy (Allergy to E-cigs). Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX) for an unknown indication.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 6-Aug-2021 , second dose 31-oct-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 6-Aug-2021 , second dose 31-oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient was treated with Paxlovid from 22Apr2023 to 26Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300181554 same patient, different drug and different event.;
Grand Mal seizures w/urinary incontinence observed on 7-7-07 while at dinner table
pt recv vax & exp an attenuated case of herpes zoster on forehead described as fluid filled vesicular formation on the forehead, confirmed by florescent antibody varicella zoster test;
the patient was inadvertently administered a dose of VARIVAX which was improperly stored.; This spontaneous report has received from a pharmacist, referring to a patient of unknown age and gender. The patient's history condition, concurrent condition and concomitant medication were not provided.  On 06-AUG-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#T00034 with expiration date: 05-JAN-2022; route, dose and strength were unknown) for prophylaxis, which was improperly stored. No adverse effects reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below 38 Fahrenheit degrees (F) for 672 hours. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion.
ganglion on knees and wrist; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (ganglion on knees and wrist) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SYNOVIAL CYST (ganglion on knees and wrist). At the time of the report, SYNOVIAL CYST (ganglion on knees and wrist) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
HIB component was mixed with sterile diluent instead of Dtap/IPV component. Therefore, patient received only HIB component mixed with sterile diluent.
1. Swelling at the site of injection ( Large area ( no fever or  chills  2. Waist high ( right) went to the ER for severe pain  CT angio done to rule out AAA was neg  Blood work ok  U\A  neg  KUB  neg
Urticaria beginning 20 minutes after receiving the vaccine until now which is 2 weeks post-vaccination. She was seen in the ER and given prednisone, Pepcid and diphenhydramine.
PT DEVELOPED CHICKEN POX ON 4/2/2018 AFTER RECEIVED ZOSTAVAX ON 12/10/2016.
Discomfort on inside of arm at elbow, began to itch and turned to rash, began to swell and ski turned red and dry.  Stinging burning and itching, hurt when I bent my arms or when clothing rubbed against it. Skin became extremely dry, red and peeled.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's concurrent conditions, medical history or past drug history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, and lot# were not reported). On an unknown date, 4 weeks later, the patient 'got the same strain in his eye'. It was unknown if any lab work was done. As of 09-APR-2015, it was unknown if the male patient would continue on the ZOSTAVAX and the outcome of 'got the same strain in his eye' was unknown. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Abdominal cramping, belly ache, nausea, diarrhea, headache in the night.  Queasy in the morning.  Sluggish.  Bland diet - rest.  It seems to be resolving.
Started sneezing uncontrollably w/runny nose excreting lots of mucus like during a severe cold. General feeling like having a the flu.
Sleeplessness.  Since getting my shot, I have had trouble falling asleep and staying asleep for two days. I only drink 2 cups of coffee in the morning and no caffeine after 5 PM in the evening (cup of tea). I usually have no trouble falling asleep though prior to Moderna vaccine, I do have a habitat of waking up around 3 AM, but after going to bathroom, I fall back to sleep until 6 AM.  However, these past few days I have had difficulty falling asleep and then tossed and turned waking up frequently each of the last two nights.    While my reaction is not a serious medical issue, I felt I should report my experience with the Moderna bi-valiant vaccine. My previous 3 vaccines were all Pfizer.
INITIALLY EXP SORENESS, TENDERNESS, REDNESS, WARMTH. NEXT COUPLE DAYS EXP ADDITIONAL ITCHINESS AND A KNOT AND SPREADING OF REDNESS. WEDNESDAY RED IMPROVED BUT ITCHING WORSENED.
10 minutes, post vax, pt's left leg was red from foot to groin, swollen with hives present. Had a few hives on abdomen and right leg. She was cranky. Epinephrine was given and sent to MD's office. Area "cleared up" in 10 minutes when he reached the office. Still had a few hives remaining; will see allergist.
All my meds stopped working. Got horrible acid reflux, for 6 months now. Intermittent dizziness and nausea.   Cevimeline for dry mouth stopped working and salivary glands swelled up. Blood pressure went up and Benicar wasn't working as well as before. Started having sleeping problems. It's been 6 months and I'm still suffering. Everything was fine before the vaccines.
Febrile seizure about 3 days after administration of Hep A vaccine. Fever started 2 days after vaccine.
Patient to ED for worsening dementia and fatigue and weakness, spouse states that patient has not been eating like supposed to for the last week, spouse did test positive for Covid-19. Patient at this time denies any new symptoms, denies any chest pain, spouse did admit that he has been coughing for the last few days and congested. This is a patient with very significant history for COPD/Alzheimer, who presented to the emergency department due to complaint of fatigue; the patient is alert/oriented x2; the family has tested positive for COVID-19 in addition to him today; he is on room air. Denies any shortness of breath or chest pain. Wife is concerned about her ability to take care of him at home. 1/18: Requiring 2 L NC; likely due to Atelectasis, 1/19: Repeat CXR pending; high risk aspiration. Changed to DNR advanced c/w  amlodipine 10 mg/hydralazine with holding parameters for SBP less than 110. Continue insulin sliding scale/hypoglycemia precaution. 01/20: VSS, BP better, No signs of infection, CXR- no acute process, Stable for DC to SNF denies CP, SOB, HA, dizziness.