chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On April 13, 2021, I had a routine annual, my kidney function was diminished based on a normal routine blood test at office. Increase my water intake and come back in a couple of weeks and have the test done again.  I went on vacation from 04/18/2021- 04/24/2021 and got a tick bite. I sought medical care on 04/26/2021. They put me on antibiotics- doxycycline hyclate  150 mg bd/ morning and night for 10 days. After taking the antibiotics, they wanted me to wait two weeks before having my blood drawn again. I  had blood drawn again the week of  May  16-23, it was a follow up visit with my PCP and my kidney function had diminished even more.  I had an appointment with the kidney specialist in June 28, 2021, he diagnosed me with Chronic kidney disease stage 3   G3A/A3.  They sent me to outpatient to get a sonogram on August 11, 2021.  I have a follow up appointment with the nephrologist, Doctor, the kidney specialist on January 6, 2022.
"15mins post vaccination pt c/o dizziness and nausea. Vitals: @17:08 BP 104/56, HR 76, RR18, SpO2 100% -- > @17:13 112/68, 68, 16. Pt given water and rest.  Symptoms resolved.  Pt stable and released from the vaccination site @17:22 (32mins post vaccination)"
Taken to acute care setting because of high pitched shrill/screaming lasting 1/2hr;
Family member states flu like symptoms, extreme loss of energy, limp limbs, slurred speech around 8 hours after booster shot. The patient was so weak he fell on the floor and could not get back up until he had slept off the side effects he was experiencing. Overall 48 hours before complete resolution of symptoms.
SOMEDAYS CHEST FEELS TIGHT; NERVOUS; OVERWEIGHT; HEADACHE ALMOST EVERY DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight was 30 pounds, and height was not reported. The patient's past medical history included: headache, and concurrent conditions included: autoimmune disease, overweight, and smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced somedays chest feels tight, nervous, overweight, and headache almost every day. Laboratory data (dates unspecified) included: Weight (NR: not provided) 30 lbs. overweight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the somedays chest feels tight, headache almost every day, nervous and overweight was not reported. This report was non-serious.
This case was reported by a healthcare professional and described the occurrence of aggravated hypertension in a 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included hypertension. On an unspecified date, the subject received unspecified dose of TWINRIX (unknown route, injection site and batch number). At an unspecified time after vaccination with TWINRIX, the subject experienced aggravated hypertension. At the time of reporting the outcome of the event was unspecified.
Difficulty breathing; Warm to touch in area of injection; Fatigue moderate to severe; Chills/Occasional chills; Hardness; Redness; Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Difficulty breathing), VACCINATION SITE WARMTH (Warm to touch in area of injection), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia since 01-Jan-1995. Concomitant products included LOSARTAN from 01-Jan-2014 to an unknown date and ROSUVASTATIN CALCIUM (CRESTOR) from 01-Jan-2021 to an unknown date for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch in area of injection), FATIGUE (Fatigue moderate to severe) and CHILLS (Chills/Occasional chills). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). On 02-Feb-2021, VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown and VACCINATION SITE WARMTH (Warm to touch in area of injection), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE SWELLING (Swelling), FATIGUE (Fatigue moderate to severe) and CHILLS (Chills/Occasional chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 165/135 mmHg 165/135. On an unknown date, Body temperature: 102 102. On an unknown date, SARS-CoV-2 test: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-079715 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: follow up received on 18-apr-2021,height and weight ,race updated, medical history updated, lab data updated,2nd dose of vaccination include batch no,  s tart date updated, concomitant medication  updated, events include chills,fatigue ,difficulty breathing updated
Infection, ended up being infection in it; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6199), via an unspecified route of administration on 05Mar2021 as a single dose for COVID-19 immunization. Medical history included heart transplant on an unspecified date, 20 years ago (as reported) and upper part of lung removed due to cancer, cancer spot on chest which was burned off on an unknown date. The patient has been on unspecified anti-rejection drugs for the heart transplant for the past 20 years. It was reported that prior to the first dose, the patient had a cancer spot on his chest, but they burned it off. After they burned it off, it got worse and so they sent him to an "MOH" doctor that had to go in there and remove the cancer. He was sent to this MOH doctor that goes more in depth, took it out, and patched him up, well it ended up being infection in it. The spot on the chest and the dermatologist burning the spot off occurred before the first dose. The infection was diagnosed on 22Mar2021. The doctor gave Cephalexin 500mg that the patient has not yet started. The outcome of the event infection was not recovered. The reporter wanted to know if the patient can receive the second shot while taking this medicine and if he can get the second dose while having an active infection. The second dose was scheduled on 26Mar2021.
The ensuing weeks after smallpox immunization patient noted typical pustule and scab formation; however, the next month a hypertrophic scar occurred.  Patient reports intensely pruritic nodule, measuring one centimeter diameter, at the immunization site (left upper arm) frustrating pruritic lesion has persisted since April 2011 smallpox immunization.
pt recv vax & 22MAR96 pt exp urticaria @ inj site;10JUN97 pt exp greater than 50 lesions p/exposure to wild virus on 27MAY97;
Deep, wet cough indicative of respiratory infection. Runny nose. Moderate fatigue. Persisted from start of adverse reaction until present (10 days), and has only improved marginally.
Hoarseness, coughing, paleness, fatigue approx 3 days after administered is when symptoms came on.
On 7/11/12, patient noticed "1/2 dime sized" lump at injection site and redness (about half-dollar size). Pt. reported only slight "on and off" itching, but no pain or fever. Pt. states he feels "perfectly fine."
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. Date of placed in refrigerator was on 04-Nov-2021. Vaccine did not undergone any temperature excursion. No other events were reported for patient. No Treatment information was reported.
FELT SICK; This spontaneous report received from a patient 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, route of admin not reported,) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick was not reported. This report was non-serious.
projectile vomit;fussy;not eating/sleeping;push fluids;still projectile vomit;fussy;listless;not eating/sleeping;tx:Levsin;no bowel movement;diarrhea;hosp;IV; CPR;cardiac arrest;differential Dx:aspiration;sepsis;SIDS;shaken baby synd
This spontaneous report was received from a pharmacist via a company representative concerning a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 15-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, strength, dose, frequency and anatomical location were not provided) for prevention of pneumonia. On an unspecified date, the patient developed redness (localized erythema) and swelling that was spreading to the elbow area (peripheral swelling). The patient used ice and paracetamol (TYLENOL) as treatment. Additionally, it was reported that an unspecified flu shot was administered in the same arm. At the reporting time, the outcome of the events was not reported. No product quality complain (PQC) was involved. The causal relationship between localized erythema and peripheral swelling with PNEUMOVAX 23 was not provided.
administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-398854 (Patient Link).
Patient fainted approximately 1 minute after giving Boostrix. Pt was unconscious for approximately 1 minute. Pt recovered and stated they have passed out before in the past but not with a vaccine. He did not each much before shot. Blood sugar might have been low, but cannot confirm.
Deathly sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ILLNESS (medically significant), outcome "unknown", described as "Deathly sick". Clinical course: She was not sure what product she was calling about. Was asking if manufacturer Paxlovid? Reported her last booster the Pfizer bivalent COVID vaccine made her deathly sick. She did not know what to do, she did not know if she had to get another booster shot because her choice would be not to do it. Advised to consult with HCP and offered to transfer to alternate source for inquiry. Stated she had a doctor calling on the other line and she would need to report at a different time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lt shoulder sore, red, hot @ inj site x 2 days; indurated area 5x6cm; pt says arm feels better today; (local rxn);
I passed out; Very hot; Very dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (I passed out) in a 73-year-old female 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 was provided by the reporter.  Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced SYNCOPE (I passed out) (seriousness criterion medically significant), FEELING HOT (Very hot) and DIZZINESS (Very dizzy). The patient was treated with AMMONIA 28-Jan-2021 at an unspecified dose and frequency and OXYGEN 28-Jan-2021 at an unspecified dose and frequency. On 28-Jan-2021, SYNCOPE (I passed out), FEELING HOT (Very hot) and DIZZINESS (Very dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up report was received on 28 -MAY-2021, and included concomitant medication, AE verbatim as described at SD body narrative, onset date for AEs and outcome of event updated.; Sender's Comments: Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
The RN administered first of two vaccine shots in left shoulder of my son.  He was not even aware that the shot had been administered until the RN set that needle down, picked up the other one, and went to his other side for shot #2.  About 5-10, no more than 30 seconds later, he began feeling faint, woozy, nauseated.  The RN quickly repositioned my son on the table to lean back some while we lifted his legs, which I took over as the RN went to get the doc.  Dr. came in, examined vitals as I recall and mentioned, I think, that son's BP had dropped some, but within a few minutes his color came back, nausea dissipated, I was able to lower his legs, and eventually we left.  No additional noticeable reactions since then, tho monitoring.
9/4  9/5  - Fatigue  9/6 - 9/13:  Heart flutters/palpitations (3-5 times a daily).  Head rushes at times so severe, I prepared to faint but would subside (2-3 times a day). Half of the head rushes while having had been seated at my desk for over an hour straight.  Nausea. Circulation issues in legs/feet during any posture outside of standing; tingling feet while sitting and standing; constant movement necessary.  Chest tightness, chest burning sensation throughout the day.  Car sickness. Difficulty sleeping, heart racing and heart palpitations waking me.   9/13  9/16: All of the same symptoms, however, less frequent/intense.   9/17 - present: Circulation issues still present, heart rate quickly rises and difficult
A patient (no other information was provided regarding patient) had received the dose of PENTACEL gave it reconstituted with sterile water. i.e. wrong solution used in drug reconstitution. No adverse event was reported. List of documents held by sender: none.
Patient Passed out immediately after giving vaccine, patient's blood pressure was 68/47mmHg & pulse 52. Pt was sweating and hot. 911 was called and took her to the hospital for further check up.
Vaccine that was administered to the patient was given 23 hours after dilution (per manufacturer guideline should only be administered up to 12 hours after dilution).
Large red approximately 8 -10 inches in diameter circle inches harden  swollen red patch around the injection site on left arm. Warm to the touch. Getting larger by the day. Will seek medical treatment by Thursday. Appeared days ago ...about a week after injection.
RUNNY NOSE; SLIGHT CONFUSION; HOT FLASHES; HEADACHE; NAUSEA; TIREDNESS; INSOMNIA; EXTRA ENERGY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced insomnia. On 12-APR-2021, the subject experienced extra energy. On 12-APR-2021, the subject experienced injection site pain. On 13-APR-2021, the subject experienced runny nose. On 13-APR-2021, the subject experienced slight confusion. On 13-APR-2021, the subject experienced hot flashes. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, slight confusion, hot flashes, and nausea on 13-APR-2021, and extra energy, headache, and tiredness on APR-2021, was recovering from injection site pain, and had not recovered from runny nose. This report was non-serious.
Narrative: Pt experience "extreme weakness" after 3rd dose of COVID vaccine (Moderna). Of note, no reported intolerance or ADRs for the first 2 doses.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gander. There was no information about the patients' concurrent condition, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M031574 with an expiration date 11-NOV-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported.  Administered doses of RECOMBIVAX HB experienced the temperature excursion with range over 32 and under 36 degrees Fahrenheit for 24 hours. A digital data logger was involved. There was no previous temperature excursions. Product quality complaint (PQC) was not reported. Additional information has been requested.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
swollen and red leg; swollen and red leg; blood clot in right leg; Pain in right leg; her husband cannot walk, he is limping; her husband cannot walk, he is limping; This is a spontaneous report from contactable consumers (patient and wife). A 61-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 61-year-old via an unspecified route of administration on 21Apr2021 13:00 (Lot Number: ER3732; Expiration Date: 30Nov2022) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing high cholesterol and ongoing prostate [having to go to the bathroom frequently] (prostatic disorder). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 61-year-old on 26Mar2021 3:45 pm for covid-19 immunisation. Concomitant medications included (LIPITOR) ongoing since unspecified date (reported as 3 or 4 years ago) for blood cholesterol increased, and tamsulosin on an unspecified therapy dates (reported as he has been taking it for years now) for prostate/having to go to the bathroom frequently (prostatic disorder). The patient did not receive other vaccine in the last four weeks prior to vaccination. The patient received the vaccine from a pharmacy. The patient reported that one week after getting the second vaccine, he had pain in his right leg (28Apr2021). He stated that he did know what was going on, but he continued to work. He added that last Monday (10May2021) it got worse, so he contacted his primary care doctor and he went today (12May2021) because his leg was swollen, red and he had pain. His doctor sent him to the ER (emergency room). The patient mentioned that the ER did a CAT scan on 12May2021 and found that he had a blood clot in his right leg (reported as 10May2021). The patient's wife comes on the line and stated the reason her husband called to report was because it could be from the vaccine, but they are not sure. The wife added that her husband went to the pharmacy to pick up the blood thinner and they told him to report this. She also stated that all the side effects could happen, but he did know the side effects and he just wanted to report because the pharmacy told him to report. She mentioned that her husband started complaining his leg hurt because he has to do yard work. She states that it got worse and worse and she saw his leg get swollen and she was like you need to go to the doctor. The wife mentioned that the leg is more swollen and painful, but is the same, her husband cannot walk, he is limping on an unspecified date in 2021. She stated that her husband has just started taking medication, yesterday and today. The outcome of the event thrombosis leg was not recovered while the outcome of the other events was unknown.