chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinator pulling doses from an uncapped vial to administer Moderna vaccine/ think this was in error; This spontaneous case was reported by an other health care professional and describes the occurrence of MEDICATION ERROR (Vaccinator pulling doses from an uncapped vial to administer Moderna vaccine/ think this was in error) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced MEDICATION ERROR (Vaccinator pulling doses from an uncapped vial to administer Moderna vaccine/ think this was in error). At the time of the report, MEDICATION ERROR (Vaccinator pulling doses from an uncapped vial to administer Moderna vaccine/ think this was in error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2022: Follow Up contains Patient Gender added
Achy; Sleepy; Second COVID shot kicked the butt for a day / knocked out for the day; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy), SOMNOLENCE (Sleepy) and FEELING ABNORMAL (Second COVID shot kicked the butt for a day / knocked out for the day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product FESOTERODINE FUMARATE (TOVIAZ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and FESOTERODINE FUMARATE (TOVIAZ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Achy), SOMNOLENCE (Sleepy) and FEELING ABNORMAL (Second COVID shot kicked the butt for a day / knocked out for the day). At the time of the report, PAIN (Achy) and SOMNOLENCE (Sleepy) outcome was unknown and FEELING ABNORMAL (Second COVID shot kicked the butt for a day / knocked out for the day) had resolved.            No concomitant medications were reported.  The patient stated that the second COVID shot kicked the butt for a day and was not bad. It just knocked the patient out for the day, so the patient just hung around the house and took it easy. Patient experienced the same reaction with Shingrix vaccine that the patient got recently and had a rough half a day but then it was fine.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I had prepped for a colonoscopy the day before; the next day on 01/24/2023, I went in for a colonoscopy and noticed my blood pressure was high with speeding heart rate. They performed an EKG on me and determined I was suffering from atrial fibrillation. They rescheduled my colonoscopy and informed me to contact my primary care provider or go to the emergency room. The next day, I went to my PCP who performed another EKG and saw I was in a-fib. He then referred me to a cardiologist who I saw on 01/27/20223 and prescribed me ELIQUIS and metoprolol. I have an echocardiogram and nuclear stress test scheduled on 02/20/2023 with another nuclear stress on 02/22/2023 and a follow-up appointment with my cardiologist on 03/01/2023 to analyze the results.
Pt slept 630-830PM, awoke irritable & became pale & limp; staring of eyes & unusual "balling" of his tongue, but had no gross jerking. Receiving Tempra every 4 hrs p/vax but still had fever when seen by reporter at ER at 11:40pm
This spontaneous prospective pregnancy report as received from nurse practitioner refers to a female patient of unknown age. No concurrent condition or medical history reported. On 04-JUN-2015, the patient was vaccinated with the third dose of three series (first and second dose administration dates were not confirmed by the reporter) GARDASIL lot # K023432; expiry date: 18-JUN-2016, intramuscular. On the same day, the patient had a positive pregnancy test confirmed by urine based pregnancy test. The patient's last menstrual period, gestation and estimated date of delivery was unknown. No medical attention was sought by the patient. Action taken with the suspect drug was not applicable. The outcome of the event was unknown. No product quality complaint was reported. Additional information has been requested.
The evening of 3/17/21, I noticed a small red rash on my left arm, opposite side to the injection site.  Slightly tender to touch.  By the next morning, the rash had grown, and grew slowly throughout the day.  By about 5PM, I developed a slight fever, but felt ok.  I still have the rash as of this morning (3/19).  I have drawn an outline around the edges so I can tell if the size changes.  I don't feel feverish now, but a little achy and rundown.
This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly store. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13, 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1410USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 0/25/2013(MARRS# 1401USA000278). RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013(MARRS# 1401USA000277). PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013(MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
Headache persisting and worsening despite meds.; This is a spontaneous report from a contactable healthcare professional, the physician. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an intramuscular route of administration in the left arm on 16Mar2021 at 14:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and thyroid disease. The patient had no known allergies. Concomitant medication included losartan (MANUFACTURER UNKNOWN) and levothyroxine sodium (UNITHROID) for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021, the patient experienced headache, which was persisting and had worsened despite the medications. The event had resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken for the event included nabumetone. The clinical outcome of the event persistent headache was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Discharge Provider: DO Primary Care Provider at Discharge: DO   Admission Date: 9/8/2022 Discharge Date: 9/10/2022 PRESENTING PROBLEM: Acute metabolic encephalopathy HOSPITAL COURSE: 54 yo with HTN, DMTII, seizures, CKD, CVA, COPD on oxygen, chronic pain brought to ED 9/7 for AMS. She was found to be hypercapnic with low GCS for which she was intubated. COVID positive without infiltrates on CXR. Drug screen neg for drugs of abuse and alcohol level was negative. She had post intubation shock for which she required norepi. 9/8 pm, she self extubated. She did require precedex overnight for agitation which was only transient and with appropriate behavior.    Recently prescribed baclofen, Lyrica, and Flagyl for back/vaginal pain. Negative head CT - history of CVA November of 2021 - managed with aspirin and statin therapy. Seen by Neurology exam without focal deficits, defer further neuroimaging. EEG with encephalopathy. Stop baclofen and lyrica.   Patient transferred out of the intensive care unit to the general medical floor.  She is breathing at her baseline oxygen level and requesting to go home as soon as possible.  Mobilizing without difficulty in the room.  Labs unremarkable this morning.  Sputum did return with MRSA and due to severe episode will elect to treat for 5 days.  Allergy to sulfa therefore prescribed doxycycline.   At time of discharge, patient is hemodynamically stable and insistent on leaving asap.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer (neighbour) concerned a male patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total, administered in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had laboratory test on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antibody test which showed negative result (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210843278 and 20210853492. This case is associated with product quality complaint: 90000191321.; Sender's Comments: V0:20210857119-Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure- This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest and neck. arrived to obs, 1830 bp 140/69 hr 95 rr 18 sats 96%, feeling hot. water and apple juice given, started feeling relief and blotchy neck and chest improving. 1838 bp 112/66 hr 97 rr 18 sats 95% on ra. 1847 bp 118/67 hr 67 rr 20 sats 99% on ra, blotchty areas resolved, and facial/mouth tingling resolved as well as throat tightness. escorted to exit with no further issues. instructed on benadryl once home.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: swelling left arm to elbow. pt states itches and warm to touch-Mild
Body aches, back aches, join pain beginning 9 hours after shot. Severe chills, nausea, vomiting. Migraine and fever.
Soreness in area of injection lasting for 3 months, and continuing (left arm following PREVNAR 13 immunization).
4/8/21: "Six and a half hours after my J&J vaccine I had started shaking with severe chills. By 8 hours after my vaccine I had impaired coordination, extreme fatigue, and it was laborious to walk. Muscle aches and a blinding headache overnight added to my misery. This morning the headache was painful not blinding and the muscle aches not as intense. Had to return to bed right after eating soup, due to weakness. Chills abated by this morning. Speech slowed this morning while talking on the phone. Have spent the day in bed resting"  4/9/21: "Voice was back to normal by 8:30 pm last night. Slept well overnight - no chills or headache. Feeling stronger this morning - no headache!!! Arm still aches, but that is nothing c
Quadriplegic Cerebral Palsy, Microcephaly, Toxoplasmosis, Cortical Blindness, and Viral Herpes.
no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 21-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007192: US-009507513-2109USA007193: US-009507513-2109USA007194: US-009507513-2109USA007195: US-009507513-2109USA007196: US-009507513-2109USA007197: US-009507513-2109USA007198: US-009507513-2109USA007199:
After vaccination, menstrual periods increased in duration, flow and unpredictability. Period started early a few days after vaccination and continued for a longer time than usual. Menstrual cycle continues to be unpredictable.
Fever 101, shaking, chills that began around 11:00 pm and lasted through night.  Fever resolved after approximately 36 hours, headache lasted 72 hours, sporadic hot flashes 24-48 hours after shot.
April 4, 2009 pt received a FLUMIST around 1115. He felt fine prior and immediately afterwards (the pt had eaten breakfast and was well hydrated). One hour later while he was eating his lunch he began to feel faint. According to his friends the pt suffered a seizure which lasted 1-2 minutes. According to the pt he was not incontinent of bowel or urine and he did not bite his tongue. He was transported to the ER by ambulance (during transport the pt was only oriented to person/self; not time or place). According to the pt the workup was normal. The pt was instructed to f/u with his PCM and get and MRI and EEG which the pt did not do. On Nov 14, 2009 the pt received a flu shot around 1900. He pt felt fine prior to and immediately after vaccination. He had eaten dinner at 1730 and was well hydrated. At 0700 on Nov 15, 2009 while in the chow hall getting his breakfast the pt began to feel faint and shaky. According to his friend, his eyes rolled back and his arms began to move so he lowered the patient to the floor. According to witnesses the pt had a seizure lasting 1-3 minutes. The pt did bite his tongue; he had no bowel or bladder incontinence. The pt was taken by ambulance to the ER where according to the pt he had labs done which were normal; x-rays were deferred because the pt had an MRI of the brain scheduled in 3 weeks (the pt did not keep his appt). On Nov 23, 2009 while driving home from work the pt begin to feel a "fluttering in his chest", difficulty focusing, and a "pins and needles sensation" in his legs. The pt pulled off the road. The episode lasted 2-3 minutes. To date, the pt has not had any further episodes or seizures. He has not driven since Nov 23, 2009. Pt was evaluated by neurology on 3/25/10: Neuro exam: non focal. See below for MRI and EEG results. Referred to Cardiology to r/o convulsive syncope. Workup included EKG, Echo, Holter Monitor. Evaluation did not reveal "any significant structural or electrical abnormality that likely explains his presentation. 5/21/10 pt placed P3 profile until Nov 2010. Continue "spell" precautions: (no driving, no operating heavy machinery, no carrying a weapon, no swimming alone, no walking at heights, no deployments. Pt to f/u with neurology Nov 2010. Temporary medical exemption to all vaccinations. Symptoms: Palpitations (785.1), Disturbance of skin sensation (782.0), Symptom, nervous/muscskltl systems NEC (781.99), Syncope and collapse (780.2), Abnormal involuntary movement NEC (781.0), Syncope and collapse (780.2).
Fever 102.2 within 4 hours of medication; This spontaneous safety report, with reference number 2612749 (ID 2612749-1), was received by the partner on 24-MAY-2023 and forwarded on 26-MAY-2023, from a non-health professional.  The reporter did not assess the causal relationship between Vaxelis and the reported event of "Fever 102.2 within 4 hours of medication".  Further information is not expected.
Both arms ache not able to reach to my back also get feverish headache  chills and gastro pains
Muscle aches; joint pain; injection site pain; This is a spontaneous report from a non-contactable nurse reported for herself. A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date unknown), via an unspecified route of administration on left arm 05:30 PM on 04Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications include escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN). The patient previously took the first dose of bnt162b2 (lot number: EH9899) via an unspecified route of administration on arm left on 14Dec2020 at single dose for covid-19 immunisation. The patient experienced muscle aches, joint pain, injection site pain on 05Jan2021 04:00 AM after the second vaccine administrated, with outcome recovered. The patient received treatment for the events with Ibuprofen.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K009192 with an expiration date on 27-JUN-2016; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Mild reaction but not mentioned anywhere. The first shot GAVE me a temporary latex allergy. I have never had one before, I use band-aids or latex gloves and have had latex paint on me many times. The effect lasted the second week, about. I got the shot 3/17  and that week and the next was doing yard work and there are a number of thorny roses. I know I used a few band-aids that week and nothing happened but then in the second week I used just one and it made me itch and turned just a little red. Mild reaction but clear and plain, no doubt of cause and effect. I took a photo. I subsequently tested myself with more band-aids in the third and fourth week to make sure I was safe for the second shot and nothing happened. A bit strange and I have not heard anything of this happening to anyone else.
The pt received the 1st dose on 11/13/01 and had a fever of 103.2F, slept for 28 hours, had staring, was pale and had twitching. The 2nd dose was received on 1/22/02 and the pt had difficulty breathing. Rate of respiration was 84 per minute (panting, nostrils flaring) and pale skin. Both incidents were within 3-6 hours.
patient , CALLED THE PHARMACY ON 02/04/2022 AT 1:01 PM , REPORTING THAT SHE HAS ADVERSE REACTION AFTER THE SECOND DOSE OF THE PFIZER BIONTECH SERIES .  LOT FK9729 , REPORTING  RASH IN THE SITE OF THE INJECTION ( LEFT  ARM) , ALONG WITH HEADACHE  AND ADMITTED TO HOSPITAL FOR IMMEDIATE CARE ON 02/02/2022 3:00 PM
hypereuia, pain, induration & warmth injected site; pt started on po ATB;
Physician Discharge Summary     Patient: MRN:025222 Age:60 y.o. DOB:11/11/1961 Admit Date:  7/11/2022 Discharge Date:  7/13/2022      Principal Diagnoses:  Active Problems:   Acute renal failure   CKD (chronic kidney disease) stage 2, GFR 60-89 ml/min   Obstructive uropathy   Acute cystitis without hematuria   Type 2 diabetes mellitus, without long-term current use of insulin     Discharge Diagnosis: Bilateral ureteral stones, UTI, Acute on chronic stage 2 CKD, Dm2, COVID 19,    Hospital Course:  The patient was admitted with the above. He was treate for the UTI with levaquin. He had a lazer lithotrypsy done on the left with stent placement. He had basket extraction done on the right with stent placemeent. Nothing grew on cultuers. He was placed on levaquin to complete 7 days. His ace was held do to acute renal failure and his cr improved iwht IVF. He was not hypoxic so no active tx was initaiated for COVID 19. He was asked to follow up outpatinet.    Consults to: Urology.    Significant Diagnostic Studies:  CT abdomen and pelivs.    Procedure(s): Cystoscopy and stone extraction with bilateral stents as mentioned above.    Disposition:  home   Discharge Condition:  fair
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that her husband of unspecified age received PREVNAR 13 on an unspecified date, at 0.5 ml single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine shot and then 2 months later he had to go to the hospital for pneumonia. Event outcome was unknown at time of report. No follow up attempts are possible. No further information expected.
Co-located at Vaccine Clinic, who is administering COVID vaccine. Our Health Center is administering Covid Vaccine. Agency is administering vaccines on Health Center behalf. Patient who was supposed to be vaccinated for second dose of one vaccine, received first other vaccine. Patient made aware. Followed guidance and will not give patient another vaccine. Family made aware.
The pt experienced a light red rash appearing on torso and head approximately 30 minutes post vax.