chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptoms were very mild with Covid infection of 12-27-21.(Fever, chills, cough, muscle aches, Nasal congestion/ runny nose)) and DRUG INEFFECTIVE (shots 1-31-21, 2-28-21 and booster on 11-11-21. Symptoms were very mild with Covid infection of 12-27-21) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced COVID-19 (Symptoms were very mild with Covid infection of 12-27-21.(Fever, chills, cough, muscle aches, Nasal congestion/ runny nose)) and DRUG INEFFECTIVE (shots 1-31-21, 2-28-21 and booster on 11-11-21.  Symptoms were very mild with Covid infection of 12-27-21). At the time of the report, COVID-19 (Symptoms were very mild with Covid infection of 12-27-21.(Fever, chills, cough, muscle aches, Nasal congestion/ runny nose)) and DRUG INEFFECTIVE (shots 1-31-21, 2-28-21 and booster on 11-11-21.  Symptoms were very mild with Covid infection of 12-27-21.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: 34.097 (Positive) Positive. Source of sample for RT PCR test was nasal. No concomitant medications was provided by the reporter. No treatment was provided by the reporter. Duration of fever, chills, muscle aches, nasal congestion/runny nose was for 2 days and cough was for 7 days. Company comment: This case of drug ineffective concerns a 68-year-old male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 1.5 months after the booster dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the booster dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case of drug ineffective concerns a 68-year-old male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 1.5 months after the booster dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the booster dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I began having chest pains about 24 hours after the vaccine. It felt like extreme heart burn that lasted for about two hours. It was not calmed by Tums but did alleviate after being elevated.
I reviewed patient's child profiled and noticed after shot was given that patient was not due until 10/2016 for the vaccine since she had the first dose in April and second dose was on Oct 2016. Second dose was given too soon.
administered the diluent only; administered the diluent only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-OCT-2023, the patient received Shingrix. On 23-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered the diluent only) and inappropriate dose of vaccine administered (Verbatim: administered the diluent only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2023 The pharmacist reported that she administered the diluent only to an elderly female patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
I had stomach pain about 2 hours after the injection. I went to sleep at 10 pm and woke up at 2 am to go to the bathroom. My legs felt like I could barely move them but I was able to go the bathroom. Once I got up and walked toward the bathroom door I hit my head into the door. I ended up on the floor. I sat up and my husband came in. He said I was mumbling incoherently and then passed out for about 28 seconds. He said my arms were moving up and down while passed out. I woke up covered in sweat and he put me in bed. I slept until 8 am and then woke up with a headache, nausea, body aches and dizziness. The headache and dizziness lasted until 3/18/21.
Information has been received from a physician concerning a 6 month old patient who in December 2006, was vaccinated with rotavirus vaccine (human-bovine) (2 nd dose). The patient received her second dose four months after she had received her first dose of rotavirus vaccine (human-bovine). No problems were reported. Additional information is not expected.
Raised, itchy rash at the vaccination site - erupting six days after administration of vaccine.
About 1:15 pm (an hour after shot), I was driving and noticed my face on both sides of my temples started to swell. I removed my sunglasses and noticed the swelling for about 20 minutes then it subsided.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 09-NOV-2015 the patient was vaccinated with MMRII (lot # L012479, expiration date 10-APR-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
27 JUL- T 103.4 10 day post vaccine.  Runny nose, red/macular circular spots on chest, very irritable.  Fever, rhinitis, rash mac-pap, agitation.
Tiredness; Muscle pain; Chills; Joint pain; Fever; Feeling ill; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient received of unknown gender the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 29Jun2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient underwent lab tests and procedures, which included nasal swab test on 04Aug2020 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 30Jun2021 the patient experienced tiredness, muscle pain, chills, joint pain, fever and feeling ill. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures, which included COVID-19 test on an unknown date in 2021 and the result was negative. The clinical outcome of the events tiredness, muscle pain, chills, joint pain, fever and feeling ill was unknown at the time of this report.
This spontaneous report as received from a physician refers to a 67 year old male patient with diabetes and shingles attacks since 1965. The patient's medical history included high blood pressure and high cholesterol. The patient had no drug reactions or allergies. On 11-JUL-2012, the patient was vaccinated with ZOSTAVAX (lot # 0564AE, expiration date unspecified) (dose not reported) subcutaneous. Concomitant therapies included JANUVIA, glyburide (manufacturer unspecified), AMLODIPINE, Ramipril (manufacturer unspecified), metformin (manufacturer unspecified), CRESTOR, thyroid (manufacturer unspecified), ATROVENT, alprazolam (manufacturer unspecified) and hydrocodone (manufacturer unspecified). The physician reported that the patient experienced an increase in shingles frequency since the patient was administered ZOSTAVAX. The physician reported that the patient got shingles once a year since 1965. The physician also reported that the patient had a shingles attack in the beginning of February of 2013 (date unspecified) and again in 01-APR-2013 (two attacks) since the patient was vaccinated with ZOSTAVAX. The physician described the recent shingles attacks as similar to the shingles attacks the patient has been getting since 1965, with the exception of the frequency. The patient sought medical attention and was treated with VALTREX. The outcome of the events was reported as not recovered. Additional information has been requested.
Injection site, left deltoid, red, swollen. Swelling did not pass shoulder nor elbow.
intense itching in left ear; throat and scalp began itching; throat and scalp began itching; cough; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 04Aug2021 09:15 (Batch/Lot number was not reported) as single dose (at the age of 59-years-old) for COVID-19 immunization. Medical history included multiple sclerosis (MS), asthma and known allergies: slight to shellfish, dust mites, roaches, feathers, box elder. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); levothyroxine sodium (SYNTHROID); spironolactone (SPIROLACTONE); and montelukast sodium (SINGULAIR); all taken for an unspecified indication, start and stop date were not reported. The patient also took an unspecified vitamin concomitantly. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Aug2021 09:30 (also reported as after 20 minutes), the patient experienced intense itching in left ear, throat and scalp began itching, and cough. The events were further described as: an intense itching in left ear began, itching intensified and throat and scalp began itching. The patient took liquid BENADRYL but itching in throat continued as well as an urge to cough. The patient took another dose of liquid BENADRYL and two puffs of albuterol inhaler. Itching continued until 10:45. The patient received treatments of 2 ZYRTEC, liquid BENADRYL and albuterol inhaler. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient was recovering from the events. The events were considered non-serious by the reporter.   Information on the lot/batch number has been requested.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 6/2/2022 Discharge Date: Jul 15, 2022  PRESENTING PROBLEM: Weakness generalized Weakness Spinal stenosis  Spinal stenosis at L4-L5 level    HOSPITAL COURSE:   Patient is a 68 y.o. female with past medical history significant for CKD stage 3, DM type 2 with peripheral neuropathy and retinopathy, coronary artery disease, hypertension, dyslipidemia, TIA, iron deficiency anemia, urinary tract infection, urinary incontinence, GERD presented with generalized weakness.  Labs mostly unremarkable apart from chronic anemia, CKD stage 3. Did have hgb drop less than 7 on 6/11 and given 1 unit PRBC; no signs/symptoms of bleeding; did get CT scan of leg due to hip pain and was negative for hematoma.  PT and OT recommended skilled nursing facility, awaiting placement.  While awaiting for placement, patient was noted to have further decline in her  generalized weakness, was only able to tolerate brief standing. Upon further chart review, patient had a MRI of the lumbar spine in April at which time she was noted to have severe L4-5 spinal canal stenosis.  She did see Ortho Spine at that time but surgery was not pursued.  Due to progressive weakness and risk of becoming bed-bound/wheelchair-bound, I did request to repeat Ortho input.  Upon evaluation, it was decided that patient will be a suitable candidate for surgery given her degree of spinal canal stenosis.  Orthopedics requested patient be transferred to hospital for possible surgery on 06/21.   She underwent a  L4-L5, L5-S1 laminectomy, instrumentation, arthrodesis on  06/21. Postop acute blood loss anemia requiring 1 unit of PRBC. Her Hemoglobin stabilized above 8 and JP drain was removed.    PT/OT recommended SAR. Patient remained in the hospital for extended period of time due to difficulty in finding accepting SAR. She was finally able to discharge to subacute rehabilitation in stable condition on 7/15.  Patient contracted Covid during hospital stay, testing positive on 7/4/2022.  COVID-19 positive - screened for placement, tested positive on 7/4, last tested on 6/15 and was negative but was positive on 5/12/22 - patient asymptomatic, not hypoxic - she is s/p 2 doses of Janssen vaccine in 7/31/21 and 2/26/22 - in severe respiratory precautions - daughter updated
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
pt reports nausea, fatigue, diarrhea, abdominal cramping since 4/8/21, continuing at time of visit
RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.
Heart rate increased to 150  BPM in middle o night. Woke me up. Took 1 propanolol ,20 mg. HR decreased WNL within 45 minutes   Had flu like symptoms for next 3 days.  Vomited in middle of night, 2  nights later.
Severe pain at injection site persisting for well over a week resulting in limitation of movement. General fatigue for 2 days
Information has been received from a consumer concerning her nephew who was vaccinated with MMR II (therapy date, dose, route and lot# not reported). Subsequently the patient experienced autism.  Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
elevated blood pressure to 156/92 following injections.  Experienced dizziness.   BP checked 5 hours after vaccine: 143/88.
Swollen left side of face, severe headache & nausea for two days no appetite for four days.
Information has been received from a consumer concerning her 85 year old husband with a history of myocardial infarction and no allergies who in February 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  In February 2007, 3 weeks after vaccination the patient developed a headache then began to develop numbness and paralysis of the right side of his face.  The patient was diagnosed with Bell's Palsy and then diagnosed with RAMSAY-HUNT Syndrome.  The patient lost the hearing in his right ear.  Multiple unspecified diagnostic laboratory tests were undertaken.  It was reported that various MRI's and CT scans were also undertaken.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Upon internal review, lost the hearing in right ear was determined to be an other important medical event.  This was one of several reports received from the same source.  Follow-up information has been received from a physician concerning an 85 year old male with a history of myocardial infarction who on 12-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 656608/0032U).  In approximately March 2007 about 1 month after vaccination, the patient developed shingles in his ear.  The patient also had BELL's PALSY and was droopy on the right and developed RAMSAY HUNT syndrome.  The physician thought the patient was treated with prednisone and acyclovir.  It was also reported that the patient's wife developed BELLS's PALSY (WAES# 0802USA02705).  Subsequently, the patient recovered was noted to be "done fine."  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain.  Additional information has been requested.  5/9/08 Received CT & MRI reports only. 5/13/08 Reviewed PCP medical records of 2/12/2007-1/24/208. FINAL PCP DX: BELL's PALSY, right; RAMSAY HUNT syndrome; post viral symptoms. On 2/12/07 pt w/DJD of hands, cough & congestion.  Returned on 3/19/07 w/pain on the right side of his head, scalp & ear for a few days.  Exam revealed slight inflamed right TM & no tenderness/no rash of scalp.  Returned 3/21 w/right eye & facial droop, HA & right ear pain w/decreased hearing.  Tx w/steroids, antiviral meds & eye ointment/patch.  Referred to ENT & seen 4/4/2007.  Exam revealed patient has bilateral hearing loss w/right increased, dizziness, right ear pain.  Patient had herpetic ulcers w/crusting of right inner & outer ear.  Audiology test revealed sensorineural hearing loss, right worse than left. Referred to neuro & seen 5/1/2007.  Continued w/extreme fatigue, hearing loss & intermittent vertigo but BELL's PALSY had resolved.  Tx w/PT for post viral symptoms & vertigo. To this day, my equilibrium is "off" when I walk. I equate this problem at about 20% vetigo. Also, thru examination I have lost about 60% of my hearing in my right ear. Since my encouter with RAMSAY-HUNT I am extremely tired most of the time.
First few days just a little sore to be expected. Day 3 thru 5 pain continues to gain in intensity. Day 14 pain centrally located at injection site and has spread to lower part of the next and down to elbow. Pain is intense like a pulled mussel. Now head and neck movement also experience some pain when moved. Arm is constantly hurting,  even when sleeping and at rest. I have not got e in for any additional evaluation at this point thinking this would go away after a few days. Now two weeks it is not getting any better. I will be seeking some assistance from Eagle Family medicine soon if relief does not occur soon.
STORAGE IN REFRIGERATOR (2 GRADE C - 8 GRADE C) UP TO 30 DAYS (VACCINE USED AFTER 10/16/2021).
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
got vaccinated. got out of the hospital because of shingles\ suspected vaccination failure; got out of the hospital because of shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization) and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and just got out of the hospital because of shingles. The patient stated he/she did support getting vaxed, because the pain was quite manageable after less than a week, which seems to be due to the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.