chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid 19 on Aug 27, despite being vaccinated; Tested positive for Covid 19 on Aug 27, despite being vaccinated; This is a spontaneous report from a contactable consumer or other non-health care professional. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration (at the age of 72-years) on Jan2021 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an intramuscular route of administration (at the age of 72-years) on Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 27Aug2021, the patient experienced tested positive for covid 19 on 27Aug, despite being vaccinated. On unspecified date in Aug2021, experienced tested positive for covid 19 on aug 27, despite being vaccinated (drug ineffective). The treatment was not received for all the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
employee received an expired dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B adult) (batch number 39tz2, expiry date 07-SEP-2023) for prophylaxis.   In SEP-2023, the patient received Engerix B adult. In SEP-2023, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: employee received an expired dose of Engerix-B).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-SEP-2023 Regular pharmacist did not wish to share additional information as it was an employee  not a patient. Regular Pharmacist reported an employee received an expired dose of Engerix-B which expired 7 days before administration, which led to expired vaccine used. The reporter did not consent to follow-up.
Moderna COVID?19 Vaccine EUA 21 doses were inadvertently drawn up from the 20 dose Moderna vials and subsequently administered to patients.  No coring/leaking detected from vial at end of process.  Vaccine preparation was not batched in order to prevent contamination/growth.  Vaccines all drawn up within acceptable 12 hour time frame.  Vaccine stored in bags to protect from exposure to light.  Vaccines prepared using aseptic technique.  No adverse event reports from patient.
rash; red; sore arm; swollen; kind of hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), ERYTHEMA (red), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen) and INJECTION SITE PAIN (kind of hurt at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash), ERYTHEMA (red), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen) and INJECTION SITE PAIN (kind of hurt at the injection site). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, RASH (rash), ERYTHEMA (red), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen) and INJECTION SITE PAIN (kind of hurt at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified blood pressure pills.
Swollen lymph nodes under arm, pain at injection site, chills, fever, congestion, malaise, body aches, headache, leg pains, sensitivity to light.
Moderna COVID 19 vaccine was admitted to patients after 27.5 hours at room temperature.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID 19 vaccine was admitted to patients after 27.5 hours at room temperature.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID 19 vaccine was admitted to patients after 27.5 hours at room temperature.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID 19 vaccine was admitted to patients after 27.5 hours at room temperature.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Developed fever 102 degrees F - swelling, bump (hard to touch) & erythema to (L) arm where varicella was place - went to urgent care & "cellulitis" (vaccine) had been diagnosed - tx - BACTRIM DS 2xdAYX10 days.
started six days after vaccine, rash with itching on arms and back. Took benedryl and it helped. Got up on the seventh day and started again all over my body now, tried cortizone but it is not helping. I haven't changed anything so figured it had to be from the vaccine. I read where you can get it from the vaccine and it could last 2 to 12 days. Anything else I can use to stop the itching? Will I be okay or should I go to the hospital?
Headache, Diarrhea, nasal congestion, soreness at injection site, soreness of arm Narrative: Advised employee if symptoms worsen and /or  persist >48 hours seek medical attention Symptoms improving
My son ended up getting an extremely high fever untreatable by TYLENOL or ibuprofen. The site of the injection was flaming red, accompanied by a rash. He ended up being unable to eat or nurse and became generally unresponsive to us after screaming for many hours, and we had to take him to the ER. At the ER he ended up having to get fluids and was monitored. We were there maybe a day. There wasn't much they could do for him, and once his fever was lowered they released him home. It took him weeks to get back to the point of nursing and behaving somewhat normally. Maybe six months later he was diagnosed with a learning disability and later we found out it was Autism.
Pain in shoulder and radiating down arm, unable to raise arm more than shoulder height. Limited arm movement, knots in shoulder and arm muscles.
Recived both Pfizer doses, 4/9 and 4/30. Brain zaps, vertigo, extreme migraines, nausea, chills, muscles aches that last 4+ days
Nausea, head aches-various, sore throat, tiredness, long sleeps, no energy, lightheadedness, aching muscles. Tylenol & Benadryl. Both my wife & I had the vaccination at the same time, became ill at same time and we had the flu for 3 weeks as it tapered off to feel normal again. We both got our 2nd Moderna vaccination on March 9, 2021 at 10:30 A.M. and the next day flu set in the same as the first time but this tapered off in a week when we felt normal again. The first episode we almost went to the emergency room due to the flu effects.
After receiving the Anthrax vaccine I experienced lightheadedness, dizziness, faint, respiratory problems began immediately after first shot and stomach issues.  Respiratory problems persisted and worsened after each shot to the point of coughing until I threw up.  Now it feels as if there is something in the middle of my chest that interferes with breathing.  It feels like a fluttering which causes me to cough.  I had been given cough syrup with codeine in it and numerous other medicines to try to resolve the issues.  Nothing has worked up to this point.  I have also been referred to numerous specialists.  I have experience increased episodes of migraines since receiving the shot and they have gotten worse with each shot.  I have also experienced joint pain since being given the Anthrax vaccine.
Extreme fatigue, splitting headache, chills and sweats starting approx. 10 hours post-injection, lasting until 34 hours post-injection. More immediate arm pain than 1st dose. Also a big red blotchy patch on arm just below injection site, roughly 3 inches by 1.5 inches, warm to the touch. Noticed approx. 40 hours post-injection, but could have been there earlier. (Slept most of the day post-injection, so I didn't notice.) Red arm blotch continues as of 54 hours post-injection (current time).
Sweats Abdominal Cramps Body Aches Severe Fatigue Swelling and Redness and Induration and Warmth and Tenderness to Palpation at site of injection after the second shot All symptoms started about 8 hours after the second dose and have continued to today.  Today is the first day the symptoms seem to be decreasing in severity a little.   Symptoms are worse at the end of the day.
Patient is a 78 y.o. female patient of, MD with history of rheumatic heart disease s/p open mitral valve commissurotomy in 1982, pulmonary hypertension, mitral valve insufficiency, tricuspid regurgitation, mild aortic valve stenosis, paroxysmal atrial fibrillation on Coumadin, hypertension, hypothyroidism, sleep apnea presented to Hospital with complaint of abdominal pain but was found to be hypoxic while in the ER.  Patient had CT abdomen in the ER that was unremarkable other than mild pulmonary interstitial edema.  Patient also had elevated BNP, was hypoxic and needed oxygen.    Acute on chronic diastolic CHF exacerbation Acute hypoxic respiratory failure 2/2 above Rheumatic heart disease status post mitral valve commissurotomy in 1982 and mitral valve balloon valvuloplasty in 2021 Paroxysmal atrial fibrillation status post pulmonary vein isolation Hypertension  Nonobstructive CAD POA Likely diastolic, last echocardiogram showing EF 60% X-ray showed mild scattered haziness in middle and lower lung zones which may represent pneumonitis versus edema or developing atypical pneumonia. CT scan abdomen pelvis showed findings suggestive of pulmonary interstitial edema. Follow-up repeat echocardiogram Start patient on IV Lasix Continue losartan, Coreg, Tikosyn, Cardizem Warfarin dose per pharmacy Strict I's and O's and daily weight The patient improved and feels ready for discharge.  Discharge the patient on same home regimen.  She takes p.o. Lasix at home.   Covid-19 Virus Infection Date of onset of symptoms: Abdominal pain Symptoms present on admission: Hypoxia Date of covid positive test: 4/6/2023 Vaccination status: vaccinated Imaging: Chest x-ray as above. Oxygen requirements on admission: 2 L Current oxygen requirements: There Medical therapy: steroids  Consultants following: None Anticipated special isolation end date: 4/16   Hypokalemia Replete and monitor
Severe migraine and nausea. Vomiting. Sore arm.  Got my 1st shot about 15 hours ago and have had side affixes for about 13 hours.
Pain in arm, rash, fatigue & headache: began 8 PM date of injection and all that is left as of today is the slight rash and fatigue.
4/22/21- Cough, body aches, Sore throat- Drive up COVID test 4/27/21- Cough, increased SOB- Office visit, CBC, CMP. Given Augmentin, Azithromycin and Prednisone 4/30/21- Increased SOB- Office Visit, CBC, CMP, COVID CT and US
Myocarditis after COVID-19 vaccine (with only a single fatal case); This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (death, medically significant), outcome "fatal", described as "Myocarditis after COVID-19 vaccine (with only a single fatal case)". The patient date of death was unknown. The reported cause of death was myocarditis. It was not reported if an autopsy was performed.  Meta-analysis of studies reports on the occurrence of myocarditis after a full vaccination course with RNAbased SARS-CoV2 vaccines; pooled incidence of myocarditis after vaccine was 0.0035% over ~2 years of reporting, with only a single fatal case. Conclusion: Myocarditis after COVID-19 vaccine occurs, but occurrence is rare, which is often associated with complete recovery. Although rare, serious cases may persist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event fatal myocarditis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Myocarditis after COVID-19 vaccine (with only a single fatal case)
DID NOT HAVE ANY AS OF TODAY, 02/15/2021. TRIED TO USE VSAFE, BUT DON'T HAVE TEXT PHONE.  SO I REPORTED HERE. I WON'T USE AGAIN UNLESS I GET A BAD EFFCT.
+ redness and induration to posterior right upper arm, no lesions, no streaking. Swelling / pain at site.
Patient felt pain all over his arm starting a few days after he received the vaccine and it was painful to move his arm for one a half month and finally now the pain is less but it is still there as mild pain when he moves his arm. This happened after he received his second dose of SHINGRIX. He actually has Shingles infection a few months before he received the vaccine. He had the shingles infection between November 2017 and January 2018. He then received his first SHINGRIX vaccine dose on 04/26/2018 and had the second dose 06/25/2018. He did not experience any adverse effects after the first dose, only had it after the second vaccine was given in June and is still suffering mild pain in his arm till today
Itching with rash on face and neck, not observed by this reporter. I was notified by phone after leaving patient's worksite (where administered).  I recommended ER visit.
PT, A 23 Y.O, RECEIVED VACCINE IN LEFT DELTOID.  UPON STANDING AND WALKING AWAY, PT ALMOST IMMEDIATELY FELL FACE-FORWARD AND SMACKED HIS FACE/HEAD ON A TALL WOODEN STOOL IN OUR PHARMACY.  A FAMILY PHYSICIAN WHO WAS ACTUALLY PRESENT DURING THIS EVENT SAID THE FALL WAS MOST LIKELY DUE TO A VASOVAGAL RESPONSE (VASOVAGAL SYNCOPE).
This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored of VAQTA lot # m003011 with expiration date: 15-NOV-2017 and lot# M017982 with expiration date: 13-MAR-2017 (dose and route were not provided). No adverse event was reported. There was not product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected since as there is not consent to follow-up.
Left upper arm red, edematous and itchy. Ice to left upper arm, Benadryl 12-5 every 6 hours for itch.
felt achy; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received the second dose of Shingrix couple of weeks ago and since then felt achy.
temperature excursion that occurred several days ago in the Freezer; No adverse event; received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer).    Concomitant products were not provided.  It was reported that vaccine that underwent a temperature excursion in the freezer was just found out about the excursion today in an audit.  Treatment medication were not reported.
first dose on 2March2021 and did not get his second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose on 2March2021 and did not get his second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose on 2March2021 and did not get his second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose on 2March2021 and did not get his second dose) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product was not provided by the reporter.  Treatment information was not provided.
This spontaneous report was received from a nurse practitioner refers to a 23 year old female patient. The patient has no pertinent medical history, drug allergies or reactions. On 04-MAR-2013, the patient was vaccinated with a 0.5 ml (milliliter) dose of PNEUMOVAX23 (lot number reported as H012650, expiry date 27-FEB-2014, route was intramuscular in the left arm). The patient had no concomitant medications. On 04-MAR-2013, the patient developed pain and burning at the injection site 1 hour after administration of PNEUMOVAX23. The symptoms worsened overnight and the patient had redness and diffuse swelling at the injection site and pain radiating to left scapula. Laboratory tests were not performed. Treatment rendered for the events were BENADRYL and ice compresses. The outcome of the reported events were reported as not recovered. The patient sought medical attention (office visit). Additional information has been requested.
This is a spontaneous report from a contactable registered nurse (RN) through a Pfizer sales representative. A female patient received TRUMENBA at 0.5 ml single and FLUMIST, both on 08Nov2015. Medical history and concomitant medications were not provided. On 08Nov2015 the patient felt lightheaded, so the nurse let her lay down for 15 minutes, put her feet up and gave her something to drink and she was fine. The patient mother said that they had a family history of getting lightheaded when they receive injections. The patient recovered from the event on 08Nov2015. Follow-up (08JAN2016): Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL (lot # not reported). Subsequently the patient fainted. The outcome was unknown. Additional information has been requested.
left bicep site feels warm; left bicep, site is red.; Arm pain; radiating pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin warm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 09-MAR-2023, 6 days after receiving Shingrix, the patient experienced skin warm (Verbatim: left bicep site feels warm), erythema of extremities (Verbatim: left bicep, site is red.) and pain in arm (Verbatim: Arm pain). In MAR-2023, the patient experienced radiating pain (Verbatim: radiating pain). The outcome of the skin warm, erythema of extremities and pain in arm were not recovered/not resolved and the outcome of the radiating pain was not reported.   It was unknown if the reporter considered the skin warm, erythema of extremities, radiating pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the skin warm, erythema of extremities, radiating pain and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 10-Mar-2023 The paitent received her first dose of Shingirx vaccine and the area on her left bicep below the injection site feels warm and was red. The patient reported that she feels radiating pain that comes and goes. Less than a week after vaccination, the patient had arm pain. The patient did not gave permission to call the health care professional. The patient said she called the health care professional this morning and they told her to call the pharmacist that gave her the vaccine. The reporter did not consent to follow-up.
It had a red spot at injection site for about 4-5 days and then went away. The red spot came back about 2 weeks later and stayed for 4 or 5 more days.
Brief tonic/clonic generalized convuls not cohernt to speaking lasted several second to one or two min; feverish 101.3 @ MDs office; pt given meds;
Dizziness, fainting and pallor about <5 mins after vaccination IM. BP 105/58. Pt laid on exam table for about 30 mins and improved. BP 108/58, PR 60, RR 20.