chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's companion mentioned that the patient has fainted with vaccines before and that's why he wants to be in the room with the patient. After I administered the patient and observed the patient for a few minutes and he said he felt fine. I then asked them to sit in the imz waiting area for 30 minutes. I asked the companion to keep an eye on the patient while I went in the pharmacy to get a technician to observe the patient.  As I was grabbing a technician. The technician was informed by another customer that the patient was not doing well. I rushed to the patient who was alert at this time.  The companion stated that the patient fainted (had his held tilted and his eyes closed)  and started to shake to which he nudged the patient who then regained consciousness. He stated that right before he nudged the patient he was shaking. I had my technician grab an ice pack and I applied it to his forehead. The patient appeared to be sweating and stated he was nauseous. He asked for something to drink or eat. I told him that since he's nauseous giving him food right now could cause problems. My technician paged code white and management arrived. At this point patient was feeling better and was alert. Since I did not like the fact that the patient was shaking, management called 911.  I explained to the 911 operator what had happened.   My technician stayed with management and they observed the patient till the paramedics arrived.  The paramedics checked his vitals and the patient signed a consent form stating that he did not want to go with them.  The patient later came to ask a question regarding his IMZ records and was feeling fine
Product storage error; No adverse event; Bivalent dose administered to 7 patient after temperature excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Oct-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    Storage condition at the time of the excursion was refrigerated. The vaccine was an individual vial. The size of the vial was 2.5mL. The highest temperature reached was 46.5 F. The excursion duration was 15 minutes. The vials were returned to the refrigerator. The vaccines appeared normal during visual inspection. The Lot numbers and Expiration Dates of the vaccines that underwent temperature excursion were 083B22A, 051D22A and 28Nov2022 and 19Nov2022 respectively.   This case was linked to US-MODERNATX, INC.-MOD-2022-664063, US-MODERNATX, INC.-MOD-2022-664049 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664063: US-MODERNATX, INC.-MOD-2022-664049:Same reporter
Itching with rash around vaccination 1 week and 1 day later. Itching  started a few days after getting the shot and rash appeared around 11 days after getting the vaccination.
Brown spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Brown spot) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Brown spot). At the time of the report, VACCINATION SITE RASH (Brown spot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment details were not reported by the reporter.
heat murmur; This is a Spontaneous report from Pfizer sponsored. A contactable Consumer or other non-hcp (Patient) reported that a 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown and expiration date not reported) via an unspecified route of administration on 21Feb2021 (at the age of 54-years-old) as unknown, single dose for COVID-19 immunization. The patient's medical history included COVID-19 on an unspecified date in May2020. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced heat murmur and patient was asking that, was this a side effect of vaccine. The outcome of event was unknown.  Follow-up attempts are needed, information about lot/batch number is requested.
Patient experienced between golf ball and tennis ball sized swelling at site of Meningococcal vaccine.
Muscle pain; Peripheral artery disease; Could not put my foot down because it felt as if I were stepping on broken glass; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Peripheral artery disease), LIMB DISCOMFORT (Could not put my foot down because it felt as if I were stepping on broken glass) and MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Peripheral artery disease) and LIMB DISCOMFORT (Could not put my foot down because it felt as if I were stepping on broken glass). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Peripheral artery disease) and MYALGIA (Muscle pain) outcome was unknown and LIMB DISCOMFORT (Could not put my foot down because it felt as if I were stepping on broken glass) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  At the time of hospital visit her left leg had no pulse at one point.  Patient had multiple tests including CT Scan and doppler of the right and left leg but the results were unspecified.   Patient refused to take the medications and does not took any medication drug or alcohol.  Patient did exercises and her foot has improved.
Case number PHEH2014US020729, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 65 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). Nurse stated that the person who opened the cooler stated that the gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
I experienced severe chest pain, like I had a avocado pit in the middle of my chest, stinging pain in my elbows.
Very painful immediately. Then bruising x 2-3 weeks. Pain laste4d 6-7 weeks. I did use one of those spring loaded syringes.
My shoulder and arm bones are hurting still from the day of the shot over a month ago. Difficult to lift my arm or carry anything heavy.
Pt had second Moderna vaccination on 6/16/2021. Later that evening he noticed a red rash on his legs and arms. Denies any itching, easy bleeding pain, or other concerns.
rapid heartbeat; high blood pressure; This is a spontaneous report from contactable consumer (patient) from Pfizer-sponsored program COVAX US Support.A female patient of an unspecified age received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021 as dose 1,single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rapid heartbeat and high blood pressure on unspecified date. It was reported that the facility set her second dose on 11Apr2021 and wanted to know if she can reschedule that.The patient underwent lab tests and procedures which included blood pressure measurement which was high and heart rate which was rapid on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Got pneumonia injection 7/8/08. No pain noted with injection, but didn't fell well after shot. Chills and arm shaking. No fevers. Today arm red. Also had blood drawn same day and it took two sticks. Cellulitis and abscess of upper arm and forearm due to culture blood draw or injection. Treat with AUGMENTIN 875 mg BID x 10 days. RTC if site enlarges.
Information has been received from a 23 year old female nursing student, with no medical history and no allergies, who on 08 Nov 2006, was vaccinating a baby with a dose of rotavirus vaccine and the baby spit up some of the vaccine and it went into her left eye. There was no concomitant medication. The nursing student felt warmth in her eye. She immediately washed her eye out with water and felt burning. The nursing student reported no other symptoms. The patient reported that her eye felt fine later the same day. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Severe swelling and redness at site of injection. Arm warm and uncomfortably swollen from shoulder area down to elbow.
Rash 2 days after vaccination on torso. No itchy - reported restless sleep and muscle aches also symptoms are resolving.
On May 20th, I experienced a sore arm and malaise. On May 21st and 22nd, I experienced severe abdominal pain, nausea, diarrhea. Those symptoms abated on May 23rd. On May 24th, I experienced a sore throat and felt generally unwell. After that, I started feeling better and was able to resume normal activities. On June 13th, I experienced severe fatigue, hoarse voice, and joint pain that were not related to any activities or other events in my life. Those symptoms lasted until June 19th. During the end of June and the beginning of July, I experienced shortness of breath while walking normally. On July 3rd, I experienced joint pain, overall pain, and fatigue. From July 12th to July 26th, I experienced extreme fatigue and an elevated temperature. On July 27th, I started to feel better. On July 25th, I contacted my doctor. She ran a series of blood tests which ruled out Lyme Disease, Valley Fever, and a few other things. The results were negative aside from low thyroid function. On 07/28, I started taking thyroid medication. As of July 27th, I started having good days and was feeling back to normal.
Seen by ems and pt refused to go to hospital. Pt states he feels back to normal.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 25-MAR-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J004271, expiry date 12-JUL-2014, 0.65 ml, subcutaneous. No adverse experience was reported. Additional information has been requested.
her arm was sore; felt fatigued; This is a spontaneous report from a Pfizer Sponsored Program from a contactable other hcp. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral from 15Feb2021 (Batch/Lot Number: DK6867) to an unspecified date, twice a day for an unspecified indication. Medical history included benign tumour excision from an unknown date and unknown if ongoing She had a surgery due to benign tumor in her right ear, sulfa allergy from an unknown date and unknown if ongoing , surgery from an unknown date and unknown if ongoing, facial paralysis from an unknown date and unknown if ongoing. Patient indicated that previous to beginning tofacitinib citrate she had surgery due to a benign tumor in her right ear. Patient reported that during surgery "They hit a nerve and the right side of my face is paralyzed". Concomitant medications included hydroxyzine HCL for an unspecified indication, start and stop date were not reported; duloxetine HCL for an unspecified indication, start and stop date were not reported; folic acid for an unspecified indication, start and stop date were not reported; trazodone HCL for an unspecified indication, start and stop date were not reported; hydroxychloroquine sulfate for an unspecified indication, start and stop date were not reported. The patient received her first dose of the COVID-19 vaccine and reported that her arm was sore and she felt fatigued. She denied missing doses (of tofacitinib citrate). The action taken with tofacitinib citrate in response to the events was dose not changed. The outcome of the events, arm was sore and fatigued was unknown.   No further follow-up needed. No further information expected
PROQUAD was administered after temperature excursion; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 07-DEC-2020, the patient was vaccinated with one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 ml, subcutaneously,  Lot # T013542, expiration date 17-0CT-2021 for prophylaxis (dosage regimen was not reported). The storage temperature was reported to had been at 32.4 °Fahrenheit (F) for 4 hours.      There was digital data logger involved and no previous temperature excursion was reported.  This is one of multiple  reports received from the same reporter.
Patient with history of COPD/asthma heavy smoker presents to ED with cough and chills and difficulty breathing for 2 days.  tested negative for Covid-19 via PCR. Patient was put on nasal cannula oxygen therapy.   Discharged on azithromycin, guaifenesin, prednisone and nictotine patch.
This spontaneous report was received from a registered pharmacist refers to a 60-year-old female patient. Current condition included allergy to NEOSPORIN ear drops. Patient had experienced rash with NEOSPORIN ear drops in the past. On 20-MAR-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX, (lot# H022153, expiration date 18-MAR-2013) subcutaneously. Concomitant therapies included SYNTHROID and estrogens (unspecified), progesterone. On 22-MAR-2013, two days after vaccination with ZOSTAVAX, the patient experienced rash in on the forearm of the vaccinated arm and was vesicular. He reported that it was itchy but he stated he did not believe it to be varicella-like. The patient had not seen her physician nor had she taken any treatment for the rash. The outcome of the event was unknown. Medical attention was not sought for the events. Causalty was not reported. Additional information has been requested.
Fever to 106 degrees, chills, one episode of vomiting, and local pain (probably LPS-related).
Inflammation of lymphglands along the neck. Possible myocarditisis. Uncontroled Hypertension , atypical chest pain.
Dermatographia and hives started on mildly on 12/14. No previous experience with this issue. By 12/16, hives were worst behind ears and on arms and the itching was unbearable.
Right upper arm developed redness, warmth and induration, started day after vaccines and increased redness today mildly itchy. Given Cephalexin Rx for possibly secondary infection.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 029L20A), in left arm, on 20Feb2021 as dose 2, single (Lot number: 022M20A), in right arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 012F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing); "Obesity" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing); "known allergies gluten" (unspecified if ongoing); "known allergies latex" (unspecified if ongoing); "known allergies dairy" (unspecified if ongoing); "Allergy:Tetracycline" (unspecified if ongoing); "Allergy:Codeine" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement, start date: 07Jul2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid for COVID 19 Treatment. On 06Aug2022, after taking Paxlovid, the patient had the sour/metallic taste in mouth and also diarrhoea and some nausea/loss of appetite.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 19-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
LAUGHING 10 HOURS AFTER THE SHOT WHICH LASTED MORE THEN 10 MINS AND WAS UNCONTROLLABLE; This spontaneous report received from a vaccine facility concerned a male 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced laughing 10 hours after the shot which lasted more then 10 mins and was uncontrollable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from laughing 10 hours after the shot which lasted more then 10 mins and was uncontrollable. This report was non-serious.
The patient was checked in and had went through several check in processes. I received the patient, and accidentally misgave a Moderna vaccine instead of the Pfizer vaccine as a booster dose to an underage individual. I misheard the patient stating their birthdate, and it turned out the patient was 16 1/2 years old. The patient was requesting a Moderna dose, and had parental consent to be vaccinated. The patient displayed no signs and symptoms within the 30 minute time Fram after being vaccinated. The patient left to home with mom.
Temperature range 6°F to 14°F Time frame 80 hours; This spontaneous report was received from an office manager, referring to a 13-month-old patient of unknown age. The patients' pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.    On 19-AUG-2020, at the age of 13-month-old, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S004554 which has been verified to be valid, expiration date reported and validated as 14-FEB-2021) as prophylaxis. The vaccine administered experienced a temperature range from 6 degrees Fahrenheit (F) to 14F, for 80 hours, as recorded by a data logger (product storage error). There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA007316: US-009507513-2009USA007304:
During  preparation of employees second vaccine she informed this staff member that she had a reaction roughly 15 minutes after her first vaccination. The employee stated her symptoms at that time were "cold sweats", nausea and pallor. The employee stated her symptoms lasted 5-10 minutes. No treatment was provided due to the employee not informing staff until greater than one month after the reaction occurred.
Shooting and stabbing pain started in my right leg and the injection was given in the right side of butt about a hour after injection. Primary Care physician diagnosed me with sciatica after not being able to bare any weight on my right leg.  Dr. prescribed anti inflammatory drugs and pain medicine. I was out of work from the time of injection until 7/22/13. Once I returned to work I couldn't walk on my leg and I've been out since until today. I had an MRI and Xray performed and nothing showed up in those test. I was also given an EMG to test for permanent damage. The pain management Dr. told me to take anxiety medication before the test and I read in a brochure that this could alter the testing therefore I'll be receiving another EMG on 10/24/13. I've been receiving physical therapy from August and still receiving treatment. I was walking on a walker but I've started to walk on my on but with a limp. My period has been irregular since the shot was administered.
Pt has long history of back pain and questionable arthritis. He noted increased joint pain, stiffness and malaise. He missed several days of work, but did not see MD until RN suggested on 2/28/2000. He also noted, some dizziness and
Severe pain at site plus great swelling visible to anyone fron site to left side of neck up into ear area.  Lasted through 06/13/2010.  Began to subside 06/12/2010.
Immediate flushing, high heart rate, high blood pressure, lightheadedness and dizziness (within 5 minutes of shot). Was kept at the site for 1 hour to monitor.   Continued episodes of flushing, high heart rate, palpitations, high blood pressure, dizziness, and ear fullness for six months after vaccine.
Patient called and states she is unable to move her arm very well. Pt advised to ice area and try to move her arm a few times a day.