chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweating; Fast Heart Beat; Not able to lift the Injected Arm; Lightheaded; Red Injection Site; Tender Injection Site; sore and Pain with movement (Injected Arm); injection site swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat), MOBILITY DECREASED (Not able to lift the Injected Arm), DIZZINESS (Lightheaded) and INJECTION SITE ERYTHEMA (Red Injection Site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat), MOBILITY DECREASED (Not able to lift the Injected Arm), DIZZINESS (Lightheaded), INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), MYALGIA (sore and Pain with movement (Injected Arm)) and INJECTION SITE SWELLING (injection site swelling). On 09-Apr-2021, HYPERHIDROSIS (Sweating), HEART RATE INCREASED (Fast Heart Beat) and DIZZINESS (Lightheaded) had resolved. At the time of the report, MOBILITY DECREASED (Not able to lift the Injected Arm) outcome was unknown and INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Tender Injection Site), MYALGIA (sore and Pain with movement (Injected Arm)) and INJECTION SITE SWELLING (injection site swelling) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Fallow up received on 12-APR-2021 contains no new information. On 19-Apr-2021: Fallow up is received at 19-APR-2021 included new events and out come of the event was updated
5 minutes after the shot, I began experiencing severe hot flashes, sweating, paleness, and vasovagal syncope. This continued for 10-15 minutes while the fire department and physician on site checked my vitals. After being laid down at roughly 10 minutes after the shot, I began to regain consciousness. An ambulance was called, but was not needed.
COVID Vaccine Breakthrough  Pfizer Dose 1 3/8/21 (EN6203) Pfizer Dose 2 4/9/21 (ER8737) COVID Positive 9/30/21 Presented to and discharged from ED 9/30/21  10/1/21: Patient is an 84-year-old male who presents to the ED today with complaints of generalized weakness that began about 5 days ago.  The patient  tested positive for COVID-19  yesterday.   the patient is vaccinated for COVID-19.  Patient's accompanying symptoms include decreased appetite, productive cough, mild shortness of breath.  Patient denies any fever, chills, body aches, nausea /vomiting, diarrhea.  Patient also has sustained falls over the last couple of days with no injuries except for abrasions on his bilateral shins.  Patient is currently taking PO Levaquin for UTI.  Patient has a past medical history significant for atrial fibrillation, BPH, CAD, hypertension, OSA, Parkinson's disease, neuropathy.   Upon arrival to ED patient's temperature is 98.1, heart rate 100, respirations 24, pulse ox 96% on room air, blood pressure 124/60. Patient had a chest x-ray completed yesterday that shows stable cardiomegaly without acute cardiopulmonary process.   patient had laboratory studies drawn yesterday which reveals WBC 4.21,  INR 1.8, CRP 4.10, glucose 157, creatinine 0.52, total bili 1.5, albumin 3.2, calcium 8.0, lactic acid 2.8, proBNP 794.   Patient was seen and examined at the bedside on the medical pulmonary unit.  The patient is currently resting, in no acute distress.  Patient continues to complain of significant weakness, fatigue, body aches.  Patient denies any chest pain, shortness of breath, nausea/vomiting. Patient states his son was taking care of him, however, he tested positive for COVID-19 today making it difficult for him to take care of him with his excessive weakness at this time.  10/5/21: Patient is an 84-year-old male who was admitted on 10/01/2021 with chief complaint of generalized weakness. Patient was found to be COVID-19 positive on 09/30/2021. He was vaccinated.  He did not require supplemental oxygen, but his family was unable to take care of him at home due to the amount of weakness and fatigue he was experiencing. He was continued on his previous home medicines and received antibiotics as he was recently diagnosed with the urinary tract infection in the outpatient setting.  On 10/05/2021, the patient was discharged to a skilled nursing facility can not to continue his previous home medication regimen.
Fatigue, low grade fever 99.3, chills, muscle and joint pain ,and nausea. At vaccine site bruise and right arm pain
Pfizer Covid Vaccine made her sick; She is not feeling well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), dose 1 via an unspecified route of administration on 23Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced pfizer covid vaccine made her sick and she is not feeling well in Jun2021, she is not going to get her second dose of pfizer covid vaccine on an unspecified date. She reported the Pfizer Covid Vaccine caused her to have some reactions behind it. She just wanted to let Pfizer know that the Pfizer Covid Vaccine made her sick and she is not going to get her second dose of Pfizer Covid Vaccine. She is not feeling well, she has got to go lay down. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Within a few hours, area of injection became very swollen, hot. Erythema/swelling extended from mid-thigh to knee. No fever.
Pfizer vaccine was administered outside of hospital - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  I24.8 DEMAND ISCHEMIA 6/3/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 ATHEROSCLEROSIS OF AORTA I24.8 DEMAND ISCHEMIA 6/3/2022 ARTERIAL INSUFFICIENCY OF POSTERIOR TIBIAL ARTERY, UNSPECIFIED TYPE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 ARTERIAL INSUFFICIENCY OF POSTERIOR TIBIAL ARTERY, UNSPECIFIED TYPE I24.8 DEMAND ISCHEMIA 6/3/2022 CHOLELITHIASIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 CHOLELITHIASIS I24.8 DEMAND ISCHEMIA 6/3/2022 ATELECTASIS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 ATELECTASIS I24.8 DEMAND ISCHEMIA 6/3/2022 DM 2 W PERIPHERAL VASCULAR DISEASE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/26/2021 DM 2 W PERIPHERAL VASCULAR DISEASE
Pt developed 4x4 rash at injection site. Rash very itchy and red. It disappeared on Sat (6/22/12). Pt is doing ok no other symptoms.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JAN-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Cried for more than 3 hours.  Hyper-reactive.  Temp 100.9 R.
EMS providers approached by 17 y/o pt complaining of rash local to injection site. Pt stated that he received the first dose of the Pfizer COVID vaccine at 17:21hrs today. Pt denied feeling any itching or pain at the site, and only noticed the rash upon visual inspection of the site. Pt denied chest pain, shortness of breath, nausea, womiting or diarrhea. Upon inspection, (R) upper arm found to have slight, non-raised rash, warm to the touch. Full assessment performed and vital signs obtained. GCS 15, P 76 regular, RR 18 non-labored, B/P 146/P, PERRL, SpO2 99% RA. No other associated symptoms found. Pt administered Diphenhydramine 25mg IM in RA. Pt monitored and denied any worsening of condition. (See Attached)
Patient was given children's vaccine dose rather than Adult dose Pfizer. No adverse reaction noted or reported
The pharmacist discovered that the Johnson and Johnson vaccine had been left out longer that the 2 hours allowed after puncture at room temperature.  The vaccine had been out for approximately 2 hours and 15 minutes.  The manufacturer was contacted, and the pharmacist was told that the literature does not state that this is a reason for revaccination.  The patient has not reported any adverse effects.
tired; Patient reports feeling achy; chills; third dose of the COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE, start date: 23Jul2021. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "tired"; PAIN (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Patient reports feeling achy"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "chills".  Additional information: Patient reports feeling achy, tired, and chills yesterday, likely due to the third dose of the COVID-19 vaccine administered 23Sep. Patient states he has no side effects today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
30mar90 pt vax hepta B.  pt ex right upper quad abdo pain for 1 day. 30apr90 2nd vax. same sx.
Patient reported fever greater than 100, arm pain, swelling and dizziness approx 24 hours after vaccine. Vaccine given on 10/11/2016 in office on 10/14/2016 with complaints called office on 10/13/16 to report.
Patient received both fluzone HD and pneumovax on 9/21.  He came into pharmacy 9/23 showing me his arm.  Most of his upper arm was red and slightly swollen.  It was itching the night the shots were given but that has ceased.  Patient also said his skin and muscle was very sore.
Client was administered a Pfizer 12+ monovalent vaccine that had been in the refrigerator for over the 10wk use by date once moved into the 2c-8c  temperature range.   Patient had not adverse reaction or events from this
Pediarix, Pedvax, Hib, and Prevnar, administered on 04/14/2005.  Approximately 30 seconds after given, child became listless, although he seemed to recover here in office, Mom states he remained listless for about 40 minutes.
Information has been received from a nurse referring to an unknown gender patient of unknown age. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 28-FEB-2019, the patient was vaccinated with ROTATEQ orally (lot # R016271, expiration date: 25-APR-2020, dose and frequency were not reported) for prophylaxis. The ROTATEQ vial split open, causing spillage of an unknown amount of the dose; the vial leaked while the dose was being administered (product leakage and product container issue), and the patient received very little of the dose (incorrect dose administered). No adverse effects were reported in the patient. The outcome of product vial split open and vial leaked was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment was not provided.
THE INJECTIONS WERE GIVEN ON 10/23/17 AT APPROX. 5:00PM. ON 10/25/17 AT APPROX: 10:00AM THE PT DEVELOPED A FEVER. FEVER STARTED AT 101.4 AND UP TO 103.5. PATIENT'S MOTHER WAS INSTRUCTED TO USE TYLENOL AND IBUPROFEN AND PUSH FLUIDS. MOTHER WAS TOLD TO BRING PT IN TO BE SEEN IF HAVING FURTHER/ONGOING CONCERNS.
Vial was initially stored in the refrigerator on 14Jun2022 and dose administered on 15-Jul-2022; Administered a Moderna Covid-19 vaccine two days after 30 day expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine two days after 30 day expiration) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14Jun2022 and dose administered on 15-Jul-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine two days after 30 day expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14Jun2022 and dose administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine two days after 30 day expiration) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14Jun2022 and dose administered on 15-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was initially stored in the refrigerator on 14-Jun-2022. Vial did not undergo any temperature excursions.  No treatment information was provided.
This was 2nd shot. First one, felt a little flu like but not serious, no fever. After 2nd shot, in addition to expected sore arm, started feeling chilled the night after shot. Felt okay in the morning, so went for morning jog. After the run, chills came on pretty quick and fever went to 102 by lunch time where it stayed all day. Finally took an ALKA SELTZER to sleep that night and fever broke about 1am. No fever the next day, some muscle soreness. Next day, felt fine. Suspended daily runs until that next Tuesday.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "DDD" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "PCN" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid (anti-viral) for COVID-19 treatment from 05Jan2023 to 09Jan2023. She was taking any other medications/products within 2 weeks of starting COVID-19 treatment.
did not eat for 2 days; feverish; she had a severe headache; chills; body aches; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-RA-000000150 (RA).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown"; PYREXIA (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "feverish"; NAUSEA (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown"; HEADACHE (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "she had a severe headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "did not eat for 2 days". Additional information: the patient started treatment on 19Mar2021, 08Apr2021 and 11Oct2021 with Pfizer BioNTech Covid-19 Vaccine dose 1, dose 2 and dose 3 (reported as booster) respectively for COVID-19 immunisation. It was reported that on 19Mar2021, after the first dose of Pfizer, the individual was feverish and at 1am that morning, she had a severe headache, chills, body aches and nausea. She also did not eat for 2 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered after 31 day refridgerated beyond use date but before 45 day excursion time.
In Sept - I had a really sore throat that started on one side and migrated to whole throat; really bad congestion. Sinus pressure; ear congestion; and kind of cloudy feeling and lethargy. I did go and get tested for COVID and they also did a Strep test on throat but everything was negative. They thought it was some other viral thing going on. No treatment except for home remedies. Lasted about five days. Also, I had a ridiculous amount of snot.
I had extreme body aches, tiredness, headache, and was nauseous and threw up many times.
Erratic heart beat (palpitations) began a few weeks after injection, especially and consistently upon lying down. HOWEVER, I was exposed to Covid one week after receiving vaccine and developed very mild symptoms a few days later, which only lasted a few days.. I did 2 home tests, but neither was conclusive. (One showed what could have been a faint line, but I wasn't sure.) I'm not sure if palpitations were caused by Covid itself or the bivalent vaccine, but my doctor seemed to think it was the vaccine because he had read about similar cases in the literature.  Palpitations continue, but much less frequently and severely, but no longer when lying down.
Two days after the vaccination, and one day after he was brought home, my husband could not breathe. A nurse measured his oxygen saturation at 75%.  He was taken by ambulance to the local Emergency Room. He went into a coma and was put on a ventilator.
Hands and feet extremely cold, cold sweat, dizziness, chills, hard to breathe
Baseball size swelling noted under injection site on (R) upper arm. Warm to touch. Hurts to touch.
This spontaneous report as received from a non-medical healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On an unknown date the patient was vaccinated with improperly stored dose of VARIVAX (Merck) (dose, route of administration, anatomical location and lot number was unspecified by reporter). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further adverse event information was provided. Additional information has been requested.
Chest discomfort. Difficulty breathing. Still have dyspnea. Went to Urgent Care clinic and had neg. chest X-Ray. Wake up frequently at night due to shortness of breath.
Syncope; This is a spontaneous report from contactable other HCP via Pfizer Sales Representative. This other HCP reported similar event for 3 patients. This is a 3rd of 3 reports.   A patient of unspecified age and gender started to receive meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration at single dose on an unspecified date for immunisation.   The patient medical history and concomitant medications were not reported.  The patient experienced syncope on an unspecified date with outcome of unknown.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019341772 same drug/event/reporter, different patient;US-PFIZER INC-2019341787 same drug/event/reporter, different patient
Itching, hot rash developed around site of injection one week after receiving vaccine , remained and spread out over 4 days
Patient received Tdap (ADACEL) vaccine at visit 9/15/14, patient called in 9/17/14 complaining of red, swollen, hot to touch and painful injection site.
Patient contracted COVID after being fully vaccinated Shortness of breath, Cough, Sore throat, congestion and hypoxic.
Large blood clot in jugular vein. It's unclear how long it was forming, but required hospitalization in August 2021. On anticoagulant medicine. Results are indeterminate so far but looks like the meds are working.
Pt had previously received first dose in series on 5/12/2021.  Second dose would not have been due until 6/9/2021.  The home was notified when I realized this - approximately 2 hours after administration, and they increased the monitoring of the patient for adverse events/side effects.  Patient was observed with no issues as of 1130 on 5/22/2021 (18 hours after administration)
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 15-SEP-2012 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-DEC-2015, the patient was treated at a medical group center for a painful rash that was diagnosed as shingles. The patient has been prescribed valacyclovir (VALTREX) and tramadol to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.