chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following vaccination patient experienced pain and edema in his lower left leg. Went to the ER that Saturday the 6th. An ultra sound was performed and a DVT was confirmed. Admitted to the hospital to get the ultrasound and blood work. Patient was given Eliquis in the hospital and was discharged with a prescription for Eliquis. Treatment is on going
Breakthrough COVID-19 case with symptom onset 9/1/2021: Fever >100.4, Muscle or body aches, Runny nose/Congestion,  Sore throat, Cough (new onset or worsening of chronic cough) , Shortness of breath or difficulty breathing, Fatigue or tiredness, Headache. On 9/4/2021 her temperature was 103.0 so her daughter took her to the Hospital ER and she was diagnosed with COVID pneumonia. She stayed in the Emergency Room for over 15 hours and did not have a room for her. She was discharged home
Two days following the vaccination, patient (my mom) began to have hallucinations of seeing family members in her home that weren't there, and it was exasperated throughout the week. The first noticeable hallucination was on a Sunday (6/20) and she was sent to the hospital that Thursday evening (6/24). As of today (7/1) she is still in the hospital and experiencing hallucinations. Mom/Patient was recently diagnosed with alzheimers and although there has been confusion over the last few months, the onset and intensity of delusions did not start until the 20th. Patient was initially put on antibiotics thinking hallucinations were caused by a UTI but stopped less than 48 hours later as she did not show bacteria in her urine. Additionally, mom was able to walk with assistance (a cane) prior to hospitalization and now is having trouble with very short distances.
fever (101), chills, neck pain, headache, brain fog, flare up of fibromyalgia symptoms
Information has been received from a physician concerning a 12 year old female patient with unspecified medical history, drug reactions or allergies, who in "November" (year unspecified), was vaccinated with a 0.5 mL dose of GARDASIL, intramuscular route (lot # unknown). Concomitant therapy included MENACTRA administered at same time with GARDASIL. The physician reported that "in September", the patient began her first menstrual cycle and since the patient received GARDASIL and MENACTRA she had no experienced a menstruation. Lab diagnostic studies performed were unspecified. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. No further information is available.
A month after receiving the vaccine I noticed that my cycle was 4 days late and then extremely heavy and painful. The following month my cycle was 5 days late and relatively short, now in August I am 21 days late and after multiple pregnancy tests and bloodwork confirm that I?m not pregnant my dr said that inflammation and effect on hormones could have caused me to miss my cycle.
made her reflux and hernia worse; Couldn't get out of her bed; No appetite; my brain just isn't working right; Periods of confusion; I feel lethargic; I am constantly wanted to sleep; Crushing headache; Throwing up vile; fever; Red; Left arm swelled up (Raised up); arm hot; A spontaneous report was received from a consumer concerning a 74 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like left arm which got swelled up (raised up), hot, red and had fever, crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right.  The patient's medical history was provided. Patient medical history shows that patient had brain tumor extracted years ago (1881) and now as current condition patients suffers from spinal stenosis and Sjogren disease.  Concomitant medications were reported. The patient is taking a list of concomitant medications like Divalproex, Mig Release, Pilocarpine (for Sjogren disease) and Montelukast .  On 14-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 ( Batch Number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (038L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 14-JAN-2021, the patient experienced the events left arm which got swelled up (raised up), hot, red and had fever.  On 11-FEB-2021,the patient experienced the events like  a crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right. event my brain just isn't working right was considered medically significant.  Laboratory details was not provided.  Treatment information was reported. For the event occurred after first dose of vaccination patient took treatment. Cold compresses and Benadryl and Tylenol took but for which event is not mentioned.  On 14-JAN-2021, the outcomes of the events left arm which got swelled up (raised up), hot, red and had fever remains unknown.  On 11-FEB-2021,the outcomes of the events crushing headache, periods of confusion, no appetite, made her reflux, hernia worse, I feel unattached from things, I feel lethargic, I am constantly wanting to sleep and my brain just isn't working right was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Hospitalization with pneumonia and E coli sepsis on 4/2/2021 Symptoms started with sore arm on 3/30/2021.  Patient called healthcare provider on 3/31/2021 because patient developed headache, myalgias, fatigue, fever to 100.   On 4/2/2021, patient presented to ER and admitted to hospital with fever, chills, shortness of breath, productive cough, labored breathing. CXR showed left upper lobe pneumonia and small pleural effusion.  Blood culture subsequently grew E. coli.  Work up for source of E. coli is ongoing including CT scan due to patient's history of rectal inflammation and presacral abscess several months back.
Patient called and said her right arm was hurting ever since she got the flu vaccine. She stated that she got the vaccine in the right arm, however from paperwork, it was in the left arm .  Advised the patient to see MD
Patient complained of night sweats, crazy dreams with persistent palpitations, sweating when awaken from bad dreams from vaccine administration through 4/2/21 at doctor's appointment
Nurse reports an improperly stored PROQUAD that was administered; No other AE reported; This spontaneous report was received from a nurse and refers to a currently 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reactions were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (lot # T003833 has been verified to be a valid lot number, expiration date as 01-AUG-2021) (dose number, route and anatomical location of administration were not provided) for prophylaxis.         The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) ) was exposed to a temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-11.84 degrees Celsius) for 45 minutes and -9 degrees Celsius to 9 degrees Celsius (-4.12 degrees Celsius) for 30 minutes (product storage error), which were detected by the Digital Data Logger. There was no previous temperature excursion. No adverse effects or product quality complaints were reported.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, it did not prevent shingles, it kept the break outs becoming too aggressive. Till the time of reporting, the patient still had to get the antiviral upon the first days. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
body ache; sore hands and feet; sore hands and feet; tired; Fever; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included arthritis, prediabetes and penicillin allergy. Concomitant medications included norethisterone (CAMILA) and citalopram hydrobromide (CELEXA); both for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 22:45, the patient experienced body ache, sore hands and feet, tired and fever. The patient underwent lab tests and procedures which included body temperature on 31Mar2021 and the result was 101.4 (units unspecified). The clinical outcome of the event general body pain, hand pain, sore feet, tiredness and fever was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Narrative: 73yo male with End Stage Renal Disease died on 12/22/21 at dialysis. He resided at at nursing facility. Pt had received covid vaccines on 2/4/21 & 2/25/21. This death was not related to covid vaccines
A report has been received from a Physician concerning a 10 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Dec-2012. The patient experienced LOW GRADE FEVER, SORE THROAT, REDDENED EYES, COUGH and STUFFY NOSE which started on 08-Dec-2012. The patient recovered from the event of LOW GRADE FEVER/FEVER on 14-Dec-2012 and the patient recovered from the event of SORE THROAT, REDDENED EYES, COUGH and STUFFY NOSE during Dec-2012. The report was considered to be non-serious.
SORE ARM; CHILLS; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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, start therapy date were not reported 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 an unspecified date, the subject experienced sore arm, chills, tiredness, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, chills, tiredness, and fever. This report was non-serious.
rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. On 14th November 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shingles shot a week ago.  The patient experienced rash before the day of reporting and physician could not see untill Friday.  The patient was asking should he/she go to urgent care or the shot was going to help from getting severe. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Afyer 15 imuutes of administration patient refers nausea, dizziness and confusion  After 45 minutes symptoms still present
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 19-OCT-2012 11:56, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
The day of the shot, I felt tired and had a beginning headache behind my eyes beginning about 3.5 hours after. I took Tylenol and went to bed early; I woke throughout the night with a fever of 103 degrees F, chills, body ache, headache, and the skin on my legs felt sensitive to touch. This continued the entire next day, so I slept off and on. The third day was better; all symptoms were gone except fatigue and a slight headache.
Staff did not dilute the vial of pfizer and patient received a full vial of pfizer vaccine undiluted
PATIENT COMPLAINING OF TACHYCARDIA AND SHORTNESS OF BREATH. PATIENT CALLED HER PRIMARY CARE PHYSICIAN. PATIENT  WILL  TAKE PRESCRIPTON PRESCRIBED FOR HIGH BLOOD PRESSURE.  PATIENT STATES BLOOD PRESSURE IS CURRENTLY 124/85.
Mom states during night vomited, fussy, fever; also noted "twitchy" at times; 101ax @ home; 101.4R @ time of ER visit;
Covid-Arm:  Red lesion around injection site, redness on upper arm, itchiness, hardness/lump on upper arm
Joint and muscle pain that has increased over time until present. Saw FMD and referred to Rheumatologist for  evaluation. X-ray of hands and multiple blood test.  No other reason except arthritis in hands . Increased in drug  duloxetine.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 93 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
A few hours after the yellow fever injection the patient felt extremely tired for 3-4 days.  Patient also report headaches in front of head and on top of head.  Headaches would come and go every few hours.  Eventually the headaches have made the patient miserable most of the day.  Patient continues to feel "foggy" and increased amount of headaches.  Patient has taken acetimenophen.  It takes a long time to take effect, and then does not work well. Patient requests immediate contact with CDC/vaccine manufacturer.
Vaccine expiration date 2/12/23. Vaccine administed on 2/13/23. No reactions observed or reported
About 2-3 hours after injection started to have a headache along with extreme mental fatigue/forgetfulness. Headache lasted over 24 hours. Mental fatigue eased up after a day. Did not feel like I was safe/should be trusted alone at home from the mental fatigue.
Pt felt clammy, sweating a lot. He stated that he felt like he was going to faint.
Lots of pain and aches in my left arm.  Large gold ball size lump under skin at injection site.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had drug reactions/allergies to AMBIEN and morphine. On 29-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose was unknown) lot # K012924, expired date 29-NOV-2015, subcutaneously. After receiving ZOSTAVAX in approximately December 2014 (date unspecified), the patient experienced pain, redness, swelling, burning, warmth and itching at the injection site. The reporter also mentioned the patient had been having numbness in her arm after ZOSTAVAX was administered. The patient contacted the pharmacist to seek medical attention. There was no lab diagnostics studies performed. The therapies with VISTARIL were given for the treatment of the events. The outcome of the events was reported as not recovered. Additional information has been requested.
Initial report received from a patient on 13 November 2006.  A 48 year old, female patient experienced hives red, burning sensation of hands, felt faint and palpitations, 2 days after she received Fluzone (lot number, site and route of administration not reported) on 02 November 2006.  She had an ear/sinus infection at the time of vaccination.  The signs and symptoms began 1/2 hour after she took Omniceph (antibiotic) for an ear infection.  The duration of the signs and symptoms was 2 hours.  As per the reporter, the patient recovered.  Follow-up information received on 11 December 2006 from a health care professional.  Fluzone SV 2006-2007, lot number U2248AA, was administered intramuscularly in the right deltoid.  The patient had an ear and sinus infection at the time of vaccination.
swelling at the injection site; redness  at the injection site; pain at the injection site; This case was reported by a consumer and described the occurrence of injection site swelling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 11th May 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.     Additional Information: GSK receipt date: 13-May-2022 Reporter's comment: The patient self reported this case. The patient received her second dose two days ago in unknown arm and on the date of vaccination (that evening) she developed pain, redness and swelling at the injection site. The pain, redness and swelling was continued. The patient had nothing else to report. The patient did not use email. Consented to follow-up and might follow-up with health care professional.
Area above elbow is elevated, red and painful. It is located little lower than the site of injection. Patient stated that symptoms started on 02/01 (2 days after the administration).
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unspecified dates in 2013, the patient was vaccinated with the first and second dose of GARDASIL (dose, route, lot # and expiration date were not reported). It was reported that the patient would received the third dose of GARDASIL on 15-JUL-2015 (reported as today). There was no adverse effects reported. Additional information has been requested.
Developed ascending paralysis, currently hospitalized and being worked up, but felt to be inflammatory with extensive spinal lesions and brain lesion.
Hot flashes, began within 10min of injection?resolved after 2hours Dizziness, began within 40min of injection?resolved after 3hours Hallucinations, began approx 45min post injection?resolved after 3hours Wild mood swings, laughing then crying, began approx 45min post injection?resolved after 2hours Vision improved, began approximately 12hours post injection?continues, previously -4.25 now approx -2
Information has been received from a licensed practical nurse for the pregnancy registry for HPV vaccine, concerning a 17 year old female with petit mal seizures and bipolar disorder who in August 2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included GEODON and TOPAMAX. The nurse reported that on 24-SEP-2008, the patient did a home pregnancy test which was positive. The patient's LMP was 18-JUN-2008, and her EDD was 25-MAR-2009. The patient did not seek medical attention; her first obstetrics appointment would be on 08-OCT-2008. Follow-up information has been received from the licensed practical nurse concerning her now 19 year old neighbor who delivered a fine baby on 16-APR-2009 (she's not sure that's exact date). As far as the nurse knew, the baby had no anomalies and was doing well. The patient had a "bad kidney infection" prenatally, but she was "OK" now. The nurse didn't think there were any other prenatal complications. The patient had another infant after the one born in April 2009. The information has been captured in WAES #1004USA00607. No further information is available.
Four day after vaccine-coughing-congestion excess phlegm, headache. This lasted a week-went to Dr. diagnosed with acute bronchitis. Treatment-antibiotic and promethazine DM (cough syrup).
red elevated, itchy rash with pronounced circular patches, sudden appearance predominantly on left arm and small area on right arm  applied cortisone cream to area and took 10mg tablet of Cetirizine  rash calmed within about 45 minutes