chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUPERFICIAL LEG THROMBOSIS; CHEST CONGESTION; TERRIBLE HEADACHE; LEGS WERE FROZEN; BRUISES ON HER LEGS; This spontaneous self-report was received from a patient and concerns a 68 year old female of unspecified race and ethnicity. Initial information received from the patient on 13-APR-2021 was processed with additional information received from the patient on 14-APR-2021 and telephone follow up with the patient on 20-APR-2021. The patient's weight and height were not reported. The patient had tuberculosis and had completed TB medication course. The patient does not have hypertension or diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, date, vaccination site, and batch number were not reported) for prophylactic vaccination. The batch number will be requested in follow up. The patient was not taking any concomitant medications. On the third day after vaccination, the patient experienced terrible headache. Two days later, both her legs were frozen, and she had bruises on her legs. She went to a physician who advised her to go to the Emergency Room (ER), where they did an ultrasound on her legs. The physician told her that she had superficial leg thrombosis and asked her to take aspirin. No labs or any other diagnostic tests were performed. On the fifth day post-vaccination, the patient had chest congestion for 1 day. At the time of report, the patient was feeling better, and her bruises were disappearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest congestion and terrible headache, and was recovering from superficial leg thrombosis, legs were frozen, and bruises on her legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 68-year-old female patient of unspecified ethnicity was found to have superficial blood clots in both legs 5 days after receiving COVID-19 VACCINE AD26.COV2.S intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient reported "terrible" headache 3 days after vaccination, "chest congestion" and that both her legs were "frozen" and with bruises 5 days after vaccination.  Ultrasound on both legs showed superficial leg thrombosis during emergency room consultation and was advised to take asprin as treatment.  The event is recovering. Based on the information that is available, the event is assessed as plausible per the causality classification for adverse events.  Considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information has been requested for further assessment.
Patient felt nauseous and faint immediately after vaccination. Assisted to supine position with legs elevated. After approximately 15 minutes of rest, patient felt well enough to move to post-vaccination area.
3/30-Adverse events experienced and are they still occurring now:  Caller c/o fatigue & generalized "feeling sick" since receiving 2nd vaccine on 3/25/2021. C/o  shortness of breath beginning on Sunday 3/28/2021, called out of work yesterday and today, stayed in bed both days due to "feeling exhausted", no distress while on phone. Reports taking tylenol/ibuprofen as needed as well as using rescue inhaler for asthma as needed. Advised to follow up with PCP or Urgent Care due to SOB and asthma history.  4/1-Follow up call by Patient feeling better than yesterday, no longer feeling shortness of breath. Recommended to follow up with physician if symptoms worsen.
This spontaneous case initially received on 05-Oct-2016, was reported by a health professional and concerns a female patient. Weight: not provided; Height: not provided Administration of company suspect drug(s): The patient received AFLURIA from 30-SEP-2016 to 30-SEP-2016. Dose regimen: 0.5 ml, single dose, Route of administration: Intramuscular. Batch number: not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced a limited range of motion in the left shoulder (outcome: not recovered / not resolved). Reporter comments: The reporter assessed the event as non-serious. Follow-up information received 07-Oct-2016: This report concerns a 51-year-old female non-pregnant patient. On 30-Sep-2016, the patient received AFLURIA (batch number: WT52305), no other applicable suspect products. The product was stored correctly. Treatment of the adverse event included the patient being seen by a doctor, no treatment at this time.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In approximately 2016 (reported as on or after 19-JAN-2016), the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L024124, expiration date reported as 30-DEC-2016, lot # L040414, expiration date reported as 13-APR-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 5.1 Fahrenheit degrees for 8 hours 45 minutes. Data logger was not involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 1/12/2006 patient received flu shot.  Wife states patient had episode of transient dizziness that evening.  Has been having light-headedness and dizziness off and on since that time.  This RN instructed the wife to take patient to his physician.  Wife felt symptoms might be related to flu shot.  Apparently she has already notified VAERS and called to request the vaccine lot number from the Health Department.
Feb 24 2021 that night when I was in bed, my heart was pounding and was racing fast and I waiting it out. The next am I called  my primary care, they told be to go urgent care EKG noted proventricular contractions.   I went to my primary care for a follow up. he ordered a holter monitor for 48 hours. nothing showed on the monitor. I was also having intermitted high blood pressure. Early march 2021, I spoke to cardiologist and he had me on Prilosec for 2 weeks for 20 milligram and after the 2nd week for 40 milligrams.  Then I had on March 26 had an Echo.  The cardiologist gave me Diltiazem on Apr 162021.
Case number PHEH2016US023386, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 38-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into right arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
feeling dizzy/dizziness; tachycardic/tachycardia; This is a spontaneous report from a non-contactable Nurse.   A female patient of an unspecified age received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 22Dec2020 at single dose  for covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  After receiving the vaccine on 22Dec2020, after 15 minutes of sitting and waiting, the patient started feeling dizzy and tachycardic which lasted for 1 minute and 30 seconds, then it subsided.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt c/o bilateral hands and feet pain since April 21,2021 last night. Also stated feeling very tired. Pt concerned its due to possible s/e of covid 19 vaccine Pfizer that she got on 04/20/21. Denies any redness or loss of sensation on both feet and arms, Can able to move her both hands and feet. Pt speech clear, comfortable. AO X3. Also denies emergency sx at this time. Advised to monitor for her sx, have enough rest and drink fluids but  pt requested UC MD f/u appt for these mentioned concerns.Scheduled an appt with UC provider telephone f/u 4/22/21Notified if any emergency sx arises call 911 or go to nearest ED, Pt assure understanding.
Had vaccine 8/11/16 at 2:30 pm. Developed fever 101.3-101.6 at 5 am 8/12/16 chest pain and shortness of breath at 7 am. Took to emergency room , chest x-ray, EKG and urine-done-all normal. Told allergic to immunization.
Right over 24 hours after administration of vaccine, severe itching began on both arms and quickly escalated to both legs, abdomen and back over the following days. Severe irritation with rash that is unrelieved with antihistamine cream occurred as the itching increased. I am still taking Benadryl and using topical creams to relieve the symptoms, but the rash has continued to worsen 6 days post vaccine.
Breakthrough case admission after 4 vaccines Moderna 2/28/21 Lot# 010A21A;  Moderna 3/28/21 Lot# 018B21A;  Moderna 11/15/21 Lot# 039F21A;  Moderna 6/15/22 Lot# 060A22A
Morning of 10/31/2022, complaining of arm and leg pain, stated heart was fast and pounding. Heart was beating hard and fast for about 10 minutes, then resumed normal rhythm. Then Pediatrician contacted and asked for an EKG that day  This was performed at an urgent care. This revealed an "abnormal P axis". Urgent care advised to get chest x ray in ER. ER ran chest x ray and EKG, both normal, and recommended Pediatric Cardiologist, who ran EKG and chest X ray, all normal 11/1/2022.
Administered a 1 mL dose instead of 0.5 mL; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Administered a 1 mL dose instead of 0.5 mL) 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 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 09-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered a 1 mL dose instead of 0.5 mL). On 09-Sep-2021, ACCIDENTAL OVERDOSE (Administered a 1 mL dose instead of 0.5 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Pt. said she had sore arm started on 11/29/17 and on 11/30/17 has site of vaccination became black and blue (2" x 1 1/2") site. She came to Pharmacy a 8:30PM on 11/2017.
chronic spontaneous urticaria; extreme itchiness of his scalp,the rest of his body started with the extreme itchiness/It was on his thighs, groin, chest, feet, & the palms of his hands; the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), PRURITUS (extreme itchiness of his scalp,the rest of his body started with the extreme itchiness/It was on his thighs, groin, chest, feet, & the palms of his hands) and SENSATION OF FOREIGN BODY (the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 030L20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), PRURITUS (extreme itchiness of his scalp,the rest of his body started with the extreme itchiness/It was on his thighs, groin, chest, feet, & the palms of his hands) and SENSATION OF FOREIGN BODY (the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria), PRURITUS (extreme itchiness of his scalp,the rest of his body started with the extreme itchiness/It was on his thighs, groin, chest, feet, & the palms of his hands) and SENSATION OF FOREIGN BODY (the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant details were not reported by the reporter. Treatment details was not reported by the reporter. Ten days after the booster dose patient experienced extreme itchiness of his scalp after taking a shower.  He thought it might have been from the shampoo that caused it, so he took another shower.  After the 2nd shower the rest of his body started with the extreme itchiness.  It was on his thighs, groin, chest, feet, & the palms of his hands.  Also, the next day he had a lump in his throat that was like a wad of bread that won't go down when swallowing
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L003218, expiry date: 30-APR-2016, dose and route unknown). The temperature excursion for ZOSTAVAX was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Three days after getting my first vaccine I started having swelling and soreness under both arms. It has been 3 1/2 months and these symptoms still exist. I did wait 2 weeks after last shot (3-1-2021) and had a DTP vaccine also.
Constant pain in the neck, diagnosed as arthritic after MRI in 2004 showed nothing related to trauma, treatment still ongoing, as traction only temporarily relieves pain, issued a cervical device to provide self administered traction for use during periods of no health care coverage. Prescribed Celebrex to lessen the pain, however due to inadequate medical care, after release from active duty, could not afford to continue regimen.    Inability to focus on tasks within a few days of the initial series, and spouse noticed almost immediately a marked loss of short term memory continuing to the present.  No treatment.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 11-JUN-2015, the patient was inadvertently administered with improperly stored, MMR II vaccine, lot # K002528, expire date, 18-FEB-2016, therapy type not provided, (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Area surrounding injection was warm to touch starting day of injection.  5 days following injection pt noticed raised, red, warm, itchy rash about the size of a golf ball around the site of injection.
Dizzy, nausea, vomiting, headache, fever, chills, body aches, body tremors, left side ache and pain for weeks, dull ache in left arm and side for weeks., muscle weakness no grip strength in left side for weeks.
Body temperature increased; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Body temperature increased) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced BODY TEMPERATURE INCREASED (Body temperature increased). At the time of the report, BODY TEMPERATURE INCREASED (Body temperature increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Patient received monovalent Pfizer instead of bivalent Pfizer. No adverse side effects to report.
This spontaneous report was received from a Licensed Practical Nurse referring to a unspecified multiple patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L009155 with expiration date of 29-OCT-2016, lot # L044917 with expiration date of 05-OCT-2018 and lot # L044707 with expiration date of 16-OCT-2018 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of 23.4 degrees C for a time of 3842 minutes. Data logger was stated. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Flu like symptoms the next day. Most concerning was swollen lymph nodes under left armpit.
Patient had a mini stroke (TIA) approximately 14 hours after the 1st Moderna COVID vaccine which is when the doctors put him on Plavix, the blood thinner and an aspirin.  The patient had a massive stroke with brain hemorrhage within 24 hours of the 2nd Moderna COVID vaccine  which resulted in his death.
pain at injection site; redness at injection site; Circumstance or information capable of leading to medication error; Vaccine administered at inappropriate site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 20th September 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site erythema, circumstance or information capable of leading to medication error and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injection site erythema, circumstance or information capable of leading to medication error and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received Shingrix and experienced pain and redness at injection site. The patient might get the 2nd dose at either the gluteal or anterolateral thigh site, which led to circumstance or information capable of leading to medication error and vaccine administered at inappropriate site.
Headache - still continuing; Felt fever - like - for 3 days; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (lot number: EL3246) via an unspecified route of administration on 11Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included controlled diabetes. The patient was allergic to Penicillin. Concomitant medication included metformin, atorvastatin (LIPITOR), lisinopril, and Multivitamin. On 11Jan2021, the patient experienced headache - still continuing, this is the 5th day after the vaccination. On 11Jan2021, the patient also had felt fever - like - for 3 days. The patient received Advil as treatment. The patient is not pregnant. Events outcome was not recovered.
Pt recvd inject approx 2PM; By 6PM temp was elevatd above 104; Pt was crying continuously, appeared very shakey; Mom unable to get temp down; Phoned MD told to double up on APAP & put in tub of water;
Appearance of spontaneous circular epidermal ulcerative lesion 4cm adjacent to injection site.  Lesion is 1cm in diameter, limited to upper/superficial  layers of epidermis, oozing serous fluid. Lesion was noticed approximately 26 hours after second vaccine dose was administered. Area of erythema surrounding lesion present.  Urticaria present.
When he came home from work, he ran a fever of 102.9F.; This is a spontaneous report from a contactable consumer or other non hcp (parent). This consumer reported for a 30-year-male (Son) Patient. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced when he came home from work, he ran a fever of 102.9f. The patient underwent lab tests and procedures which included body temperature: 102.9 Fahrenheit on an unspecified date. The clinical outcome of the event was unknown at the time of vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
pt apparently exp one sz;had fever up to 103 per mom;mom stated pt had been giving APAP & ped advil to keep fever down p/vax & prior to sz, but temp still went to 103;tx @ hosp;
Adverse event began on 02/18/2018. Right posterior arm reported over the phone to be red and itchy. Worse the following day on 2/19/18 and worse and larger area of redness on 2/20/18.  Advised to seek medical attention at an Urgent Care.
Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint Pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 031A211A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression. Concomitant products included METFORMIN, OMEPRAZOLE (OMEPRAZOLE ABBOTT), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA), METOPROLOL, ATORVASTATIN and GLIPIZIDE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint Pain). At the time of the report, ARTHRALGIA (Joint Pain) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-292622 (Patient Link).
Pain and swelling near left ear beginning 1 day after vaccine administration                  area is somewhat hot         patient took antihistine which seemed to help
c/o of slight headache after taking the first dose of vaccine.   No medical history reported.  no history of allergic reaction reported.    vital signs stable.  BP 129/74, O2 98, P 93, R 18.  Pt. verbalized feeling better prior to mom driving her home.  Advice mom to monitor pt. and report to PCP and abnormal changes.