chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT; This spontaneous report received from a patient concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20220147325-COVID-19 VACCINE AD26.COV2.S- blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt complained of muscle cramping in right leg, unable to bear weight on right leg starting 6/18/04, approximately 3 days after receiving sq administration of YFS in left arm on 6/15/04. Pt reported above to her private MD, no follow up needed, problem resolved with No medical intervention per patient.
1hr p/vax crying lasted 15020mins;very irritable rest of day-slept 3 1/2hrs that PM was lethargic on waking then awoke 2hrs then slept 14hrs that noc high temp 102 x 2 days-APAP advised
Patient had a fainting episode immediately after receiving HPV vaccine in (R) deltoid. Lasted about 10 sec before coming back and responding to her name.
This case was reported by a physician and described the occurrence of exanthema in a 47 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 16 October 2005 the subject received 1st dose of Fluarix (lot number and site of injection not provided). On 21 October 2005, 5 days after vaccination with Fluarix, the subject experienced "exanthem consisting of urticarial papules on the neck, face and upper trunk." The subject was seen at a physician's office and was treated with prednisone. The physician reported that "laboratory test results including complete blood count, chemistry profile, serology for valley fever or cocci, and IgE levels were all normal." The outcome of the events was not reported. The physician considered the events to possibly be related to vaccination with Fluarix.
Multiple sclerosis; Tired; Out of sorts; This is a spontaneous report from a non-contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced multiple sclerosis, tired and was out of sorts. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient has had worsening fatigue and weakness for approximately 10 days. He also complains of nausea and diarrhea. Patient found to have COVID-19 in ED. Patient will be admitted to hospital. Patient has received a fluid bolus in ED.
Information has been received from a nurse concerning a 2 month old female with no medical history on 10 Oct 2006 was vaccinated PO with the first 2.0mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Concomitant vaccinations administered on that same day included a dose of poliovirus vaccine inactivated (unspecified), a dose of Hib conj vaccine (OMPC) {manufacturer unknown} and a dose of Prevnar. The nurse reported that on 11 Oct 2006, at approximately 0500, the patient vomited. Unspecified medical attention was sought. The nurse noted that this was a single episode of vomiting and the patient did not experience any other adverse effects. On that same day, the patient was considered to be recovered. Additional information has been requested.
FEVER, NAUSEA, SHIVERING, MAJOR HEADACHE, MUSCLE ACHES
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Pt fainted after 3 mins of getting vaccine. He asked for water and passed out. His head jerked every 3 seconds slightly for 25 seconds. Alcohol was provided under nose but provided no relief. After 25 seconds of LOC, he woke up. He drank water and caprisun, and felt better.
Ear infection.  Just on the right ear.  Thought it was unrelated, but now I am not so sure.  Went to outpatient clinic and was told it was ear wax.  NO!  I took drops in ear and it just got so much worse!  Went back a week later with excruciating pain!  Ear was draining and I could feel the heat and knew it was infection.  Got Cipro which helped with inflammation and also took prednisone for 6 days.  Dr  said the infection was behind the eardrum and that is why drops did not work.  I am usually a ball of energy.  tennis, hot yoga,  personal trainer at gym.  I am now weak as a kitten and my hearing is almost  gone in my right ear.
extremely tired; arm was sore; didn't eat a lot that evening; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extremely tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore"; DECREASED APPETITE (non-serious), outcome "unknown", described as "didn't eat a lot that evening".  No follow-up attempts are possible. No further information is expected.
The night that i received the shot it almost felt like i had a jolt of caffeine, i had a rough night's sleep which i kept waking up in. I woke up Thursday 02/11 morning not feeling well at all, it felt like i had been hit by a train. I had a fever that has got up to  as high as 101.3 (my normal temperature is 96 or low 97's so this is very unusual for me even when i get sick)  fevers  lasted until Saturday 02/13/21 in the morning, at which point I had been taking Tylenol and ibuprofen consistently so i stopped taking my temperature (If i were to stop taking those medications i feel i would maybe still have a temperature).  I was so sore it hurt to move and walk, today (Tue 02/16) it doesn't hurt to walk finally. My arm pits hurt very bad and still slightly hurt. I have been very tired and weak as well. My eyes have hurt or felt different and appear glossy throughout all of this and still do.
Ended up in the hospital; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Ended up in the hospital) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Ended up in the hospital) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Ended up in the hospital) outcome was unknown.            The reporter stated she was not at liberty to provide information regarding her friend and stated her friend was receiving treatment.  No concomitant medications were reported   No treatment information was provided  Company Comment: This case concerns an unknown age female patient with no relevant medical history, who experienced the unexpected serious event of hospitalisation. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This case concerns an unknown age female patient with no relevant medical history, who experienced the unexpected serious event of hospitalisation. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of drug is not affected by this report.
1 - 1/2 weeks after inj. , the inj. site began to itch for a few days,then it  started to become red and the inj. site developed into a red warm bump . It resolved after a couple days. At the time of the injection there was no reaction, But 10 days later it reacted and looked like I was just vaccinated at that site.
On 3/11/2021 the patient presented to the ED with diarrhea x 4 days, weakness, lightheadedness. The patient was found to have metabolic acidosis secondary to diarrhea. There are also liver lesions suggestive of metastatic disease.
Around 8:00 PM on December 27, 2021 I noticed soreness and bruising of the injection site and I began getting a fever, which continued to climb as the day went on. Later that evening I developed a headache, body aches, and nausea. The highest the fever reached was 102 degrees Fahrenheit. On the morning of December 28, 2021 the symptoms continued, but the fever started to decrease. Around 9:00 PM that same day, the fever, headache, and body aches were gone. Soreness and bruising of the injection site continued, and lymph nodes under the right arm were swollen and sore.
This spontaneous report as received from a certified medical assistant refers to a 2 month old female patient. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported. On 09-JAN-2018, the patient was vaccinated with a first dose of  VAQTA lot # N020689, expiration date 22-OCT-2018 (dose not reported), route reported as "Left VL" for prophylaxis instead of a dose of RECOMBIVAX HB due to similarity of the boxes. Concomitant therapies included PENTACEL, PREVNAR 13 and ROTATEQ. No adverse reactions were reported.
Adverse effect of other vaccines and biological substances, initial encounter on 2021-01-04.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/26/2023 SEPSIS UNSPECIFIED ORGANISM
WOKE UP WITH CHILLS AND FEVER (103) AT 3AM. TOOK TYLENOL
7 days after vaccination developed irritability & poor feeding. No emesis/fever. Seen ED/admitted.
Extremely heavy period - I bled through super plus tampons and an overnight pad (together) every 30 minutes for 5 days straight. This happened end of March and again end of April. Consistency of the blood was very different than usual bleeding - your was very thin and more like actual blood rather than the heavier, thicker menstration I have always had. I have also already had an ablation so I hadn?t been getting a period for many months. Getting these cycles was not only not expected, but it was heavier than anything I have ever experienced, even from what I had before the ablation surgery.
sore arm after first dose; has eye aches; he still feels drowsy; not feeling quite right/ not feeling like himself; felt tired on the first day so he slept it off for 12 hours; has headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself) and FATIGUE (felt tired on the first day so he slept it off for 12 hours) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself), FATIGUE (felt tired on the first day so he slept it off for 12 hours) and HEADACHE (has headaches). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself), FATIGUE (felt tired on the first day so he slept it off for 12 hours) and HEADACHE (has headaches) had not resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-059660 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; rebound after treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 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: "Htn" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "rebound after treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Positive, notes: rebound after treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received any Other medication in 2 weeks. No known allergies. Anti-viral details: Product: COVID 19, Treatment Brand: Paxlovid, Treatment start date: 21Aug2022, Treatment stop date: 26Aug2022, Adverse event: rebound after treatment, Adverse event country: Adverse event start date: 29Aug2022, If patient recovered: Recovering, If treatment ae: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and known drug safety profile, the causality between the suspect drug BNT162B2 in the occurrence of the event  cannot be excluded.
Was wearing a mask and walking inside a facility and felt out of breath for some time. Felt my heart beating stronger than normal with a slight pumping sensation in my chest intermittently for perhaps 45-90 minutes (could be less).  Stepping out of the building I was in and taking the mask off seemed to ease the shortness of breath. Sat in the car for a while before driving back home to rest. First noticed the symptoms around 2:30p ET and didn't feel that sensation after 4p ET. Was considering calling my doctor but didn't do so as the symptoms eased after some time.
Patient received Moderna COVID vaccine on 3/9/21 and 4/6/21. On 9/27/22, patient with stage IV colon cancer admitted to our inpatient facility (med/surgical unit) with COVID virus infection, pneumonia, failure to thrive, and AKI on CKD4. As of today (9/30/22), patient is still admitted in our med/surg unit.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Consumer stated, patient had this Covid shot yesterday and today patient had a headache and patient wanted to know if it is safe to take aspirin or tylenol or something. Reporter mentioned seriousness for headache was unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It started with body aches, headache and sore arm at injection site. Left side -left leg started getting swollen - it started in middle on knee part - the swelling went down my leg to my ankle and up my leg; up my thigh . It was like there was fluid in my leg. There was no pain.  It went like that for 1 1/2-2 months. Just had to let it run it's course. I was being treated for it and had tests run to test for blood clot. She prescribed 800 ibuprofen  for it; that didn't work. That same day of the vaccine, I also broke out with a fever - 102. And fever blisters all over my mouth. I had those for about a week.
SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 33 year old female of an Asian race and unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. On an unspecified date, following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient experienced felt upset, felt depressed, and had symptoms of covid which indicated suspected covid-19 infection (Dose number in series: 1). On 12-NOV-2021, the patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient experienced symptoms of covid which indicated suspected covid-19 (Dose number in series: 2). On 24-FEB-2022, Laboratory data included: unspecified COVID-19 virus test (NR: not provided) negative. Patient reported that she had no problems after the booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19. This report was non-serious. This case, involving the same patient is linked to 20220258736 (Dose number in series: 1).
Cellulitis at site, red area 5 cm.  Keflex 250/5, 1 teaspoon three times a day for 7 days.
Myalgia, NauseaVomiting, STOMACH ACHE, SWOLLEN LYMPH NODES Narrative:
Started with flu like symptoms. Gradually got worse. Joints hurt.  Migraines worse, hands shaking , head shaking,   nausea,  menstrual like cramps  (menopause done for over 10 years), hot flashes so bad I vomited  lower back hurt,, kidneys hurt.  Started gaining weight. I have gained 30 pounds since being vaccinated. 4 days after 2nd shot I gained 19 pounds in one day. My blood test from obgyn says my ovaries are producing estrogen again therefore I will have to through menopause again.  Once was bad enough
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The pharmacist reported that she has two cartons (x 10 vials) of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) that had "crystals" forming inside the vial (PQC was filed for this defect, onset date unknown). She stated that because of this issue, on an unknown date, she had to "turn a patient down when they wanted to have ZOSTAVAX administered", because she had no more vials in stock. No adverse effects were reported. Additional information has been requested.
Headache, CHILLS, GENERAL BODY MALAISE, JOINTS PAIN,  Narrative:
Vaccine leaked out at injection site; A spontaneous report was received from a pharmacy intern concerning a 29 year-old, male patient who received Moderna's COVID-19 vaccine(mRNA-1273)  and experienced the events, vaccine leaked out at injection site and possible error in administration of the vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient removed the bandage placed over the injection site and reported clear liquid underneath the bandage. The reporter states that the vaccine leaked out at the injection site and a lot of the vaccine got out. The reporter states this may be due to error in the administration of the vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The events, vaccine leaked out at injection site and possible error in administration of the vaccine, were considered resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a 29 year old, male patient.  The patient's medical history is not provided.  The patient experienced the unexpected event of administration of incomplete dose (vaccine leaked out at injection site) after  the administration of the first dose of mRNA-1273 on 4 Jan 2021.
Sunday, March 38 (day 3 post-vaccine) beginning at 11:30am post run which is done every weekend-Beginning of overwhelming sense of vertigo and dizziness where walls tipped and unable to walk unless holding onto wall, also with whirling feeling like being on a boat.  Additional symptoms included being unable to turn head to right and unable to lay on back or on right side as would increase dizziness.   Monday March 29-Fri April 9 (day 4-day 15)continued dizziness, vertigo with feeling not standing up straight and leaning to the right.  Unable to lay on back or right side.  Attempted to do Epley maneuver to relieve without success, Zofran 4mg taken to relieve associated nausea.   April 9 (day 15)-continued dizziness and vertigo with whirling like being on a boat.  Dr called and received prescription for Augmentin 1000mg for possible sinus infection due to dizziness -no other sinusitis symptoms.  Believed is probably due to vaccine. April 9-April 16- (day 15-day 21 post vaccine)-dizziness continued unrelieved by Augmentin, no other symptoms for sinus infection noted. April 16-2nd vaccine due and cancelled due to continued vertigo April 16-April 19 (day 21-day 24 post vaccine)-continued dizziness, vertigo with episodes of whirling and motion like on a boat unrelieved by Epley maneuver or Semi-somersault maneuver.  Meclizine 25mg tried with no decrease in symptoms. April 19-April 22-Resveratrol 500mg and Alpha Lipoic Acid 600mg taken for recommendation by other vertigo reports post-Pfizer vaccine with decrease in symptoms. April 22 (day 27 post-vaccine)-vertigo and dizziness symptoms continue periodically with whirling sensation.