chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 05Oct2023 at 13:00 as dose 1, single at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Advil, reaction(s): "known allergies: Advil". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
After a few months of getting my first dose of Pfizer's COVID vaccine, I started to have VERY heavy period bleedings...fibroids have now developed....and now I'm currently being treated for the condition of Menorrhagia. My period bleeding is so heavy each month that my gyno has warned me that I run the risks of being admitted to the ER if I'm loosing too much blood. It's very scary...has never been this heavy and I've also become anemic (now am taking Iron pills to counter the symptoms). As I've spoken to other females (in their later 30's to mid 40's) who have also experienced heavy period bleedings (but my situation is probably one of the worst considering I need medical treatment), I kindly implore the medical community to research and look into this as the adverse affect it's having on some of us females suffering from very heavy menstrual cycles (and mine which I probably will need surgery for). It's made me question getting the 2nd booster since I'm nervous about the amount of continuing blood loss.
received the first dose of Moderna on 21JAN 2021, not received the 2nd dose yet; aneurysm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of Moderna on 21JAN 2021, not received the 2nd dose yet) and ANEURYSM (aneurysm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Aneurysm (dialysis) since an unknown date.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of Moderna on 21JAN 2021, not received the 2nd dose yet) and ANEURYSM (aneurysm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of Moderna on 21JAN 2021, not received the 2nd dose yet) outcome was unknown and ANEURYSM (aneurysm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported , NO treatment medication was reported. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR: outcome of AE, Dose 2 completed
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 18-MAY-2018, it was reported that the patient inadvertently received an expired dose of sterile diluent (MERCK) lot # L025374 and expiry date 27-MAR-2018 (strength, dose, route and frequency were not reported) it was used to reconstitute MMR II lot # R002930 and expiry date 31-JAN-2019, also reported as 30-JAN-2019 (strength, dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was filed.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 06-MAY-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot #0628AE, expiration 26-JAN-2015 and a dose of RECOMBIVAX HB lot # reported as 0231AA, expiration 02-NOV-2014 (dose and route unknown for both vaccines). The Healthcare worker reported that VAQTA and RECOMIVAX HB had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursion was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Shot given at 625pm . 650pm patient reported feeling tightness in throat and single episode of dizziness immediately following vaccination. No other symptoms noted. No rash, difficulty breathing, or wheezing reported. Patient given 50mg of chewable Benadryl at 650pm. Blood pressure checked via wrist monitor at 705pm, reading was 106/67, rechecked with arm cuff at 720pm, reading was 116/80. Patient stated feeling better at 725pm
patient experienced nasal congestion within 12 hours. Next day in afternoon patient had fever of 100.4. Did go to emergency room and got I.V. steroids for inflammation around lungs per wife via phone.
patient received vaccine which was expired by 16 days, Pfizer was contacted and they approved the dosage as okay and not needing any more intervention
Negative antibody (test); A spontaneous report was received from a nurse concerning a 56 years-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had negative antibody test/Drug ineffective.   The patient's medical history as reported by the reporter was that the patient has had cancer with stem cells. Concomitant medications were not provided.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route at unspecified site for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient received their second dose of mRNA-1273 (Lot number: unknown) through an unknown route at unspecified site for prophylaxis of COVID-19 infection.  On 19 Feb 2021 the reporter reported that the patient had a negative antibody (test). Laboratory test included antibody test on an unspecified date in 2021. Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of event, negative antibody test was unknown.; Reporter's Comments: This report refers to a case of a 56-year old patient who received mRNA-1273 (lot # not provided) and experienced drug ineffective with no associated AEs. The causality for the event drug ineffective is assessed to be Not Applicable
15 month old healthy child seen for well visit in clinic. They were due for a booster dose of COVID-19 vaccine and the chart flagged in record as being due for a booster. Pfizer bivalent vaccine for 6mo-4y old children was ordered and given. After it was given, the team realized that the child had received the Moderna primary series of two doses at an outside facility. Because of this, they should have been given the Moderna bivalent booster and not the Pfizer booster.
At approximately 2100, Pt complained of pain to his left arm where he stated he received a Pneumonia Vaccination during the previous shift.  His nurse examined his arm and found edema, erythema, warmth, and induration at his L Deltoid. The sitting Charge Nurse was notified, and patient's physician was notified. Md ordered Ibuprofen 600mg, and Codeine 1 tab together with a cold compress to affected area.
Day 1:  headache and chills, no fever.     Day 2: fatigue and chills, no fever    Day 3-4 :  fatigue and chills, no fever   Day 5: Strong heart palpitations, chills and fatigue .     Day 6-7  Heart pain, palpitations, chills and fatigue/  Had to rest constantly.  Began taking ibuprofen to calm the inflammation.    Day  8:  Heart pain, pressure & palpitations worsening, fatigue.   Primary and Cardiologist recommended going to ER.   Diagnosed with mild pericarditis.    Day 9-10:  Home on bedrest taking ibuprofen 3x day with continued heart palpitations, pain,  chils and fatigue.
Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient was administered the first dose of GARDASIL 9 on 12-OCT-2015, the second dose of GARDASIL 9 on 16-DEC-2015 (lot number and expiration date, dose, route and vaccination site were unspecified for both doses) and the third dose of GARDASIL 9 (lot# L045711, expiration date 08-MAY-2017) on 16-FEB-2016 (inappropriate schedule of drug administration). This was outside the recommendations per the GARDASIL 9 prescribing information. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's relevant medical history and concurrent condition were not reported. On 02-MAY-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K005574, expiry date 17-APR-2016, (dose, route and anatomical site were not reported). Concomitant medications were not provided. No adverse effect was reported. No product quality complain (PQC) was involved. Additional information has been requested.
4 days p/vax pt became irritable & listless;devel sz that were severe & difficult to control;hosp & sent home on med;outcome is unk but concerned about poss of long term sx;
Bloating, acid reflux, nausea, vomiting, diarrhea, constipation, poop mucus but no poop, unable to eat without feeling awful, stomach making loud noises. I thought it was something I ate/what I was eating and not the vaccination but the symptoms continued and went to had GI map done in 11/2021. I take 30 plus supplements, pro and prebiotics, which help but when I don't take them the symptoms return. I spoke with my GP about the issues and was told not to take the COVIFd boosters or vaccine again.
Breakthrough case admission after 2 vaccines Pfizer 3/3/21 Lot# EN6202;  Pfizer 3/24/21 Lot# ER8732
ever (100), nasal congestion, runny nose, coughing, headaches, body aches, sore throat, SOB with activity, mild SOB at rest, difficulty speaking/swallowing with SOB, starting 1/1/22
COUGH; CHILLS; FEVER; HEADACHE; BODY ACHE; COULD NOT SLEEP; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart failure, and concurrent conditions included defibrillator implanted. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced could not sleep. On 13-APR-2021, the subject experienced body ache. On 13-APR-2021, the subject experienced cough. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, headache, chills, fever, cough, and could not sleep. This report was non-serious.
1st Vaccine Administered: 9/19/2021 Pfizer  2nd Vaccine Administered: 10/14/2021 Pfizer After the vaccine, very little physical symptoms. Including very little arm soreness. However, one week later, extremely odd behavior began to develop. He began to speak to himself, develop visual hallucinations, and become spaced out for long periods of time. It would not become uncommon for him to stand by himself for over 30 minutes in the same position. He showed many stroke symptom signs. He then proceeded to lose his ability to eat, sleep, or even take showers. He became extremely catatonic. He went to the Emergency Room three times. First, they ruled out strokes. Second and third times were run arounds. We had extremely tough time getting in contact with any psychiatrist. He was then eventually ruled incapacitated by a social worker and she urged him to involuntarily check himself into the psych ward. There he stayed for over two weeks and a half weeks in the psych ward. He was put on high dose of medications and was eventually discharged with and diagnosed with catatonic psychosis. He has recovered 60% percent since then. But he still is on medication. He is not in the condition to work and has lost employment. He is unable to look at phone, TV, or computer screens for any extended period of time. He does not like to hear loud noises or music anymore. He previously had no prior condition and the event coincided with the second dose of the Pfizer vaccine. He is now receiving job disability insurance checks for being disabled with psychiatric condition.  He is still recovering at this time.   1st ER VISIT: 11/12/21     2nd ER VISIT: 11/17/21   3rd ER VISIT: 11/21/21  PSYCH WARD STAY: November 22nd 2021- December 6th 2021   PSYCHIATRY DISCHARGE SUMMARY AND POST DISCHARGE CONTINUING CARE PLAN   Date/Time: 12/6/2021 5:39 PM  Age: 23 y.o.        Date of Admission:   11/22/2021 Date of Discharge:     12/6/2021    Event leading to hospitalization / Reason for Hospitalization Chief Complaint or Reason for Admission Significant functional decline and overall slowing of speech and motor the past 3 weeks
Information has been received from a registered nurse concerning an 18 year old female with a history of mole excision who on 12-NOV-2007 was vaccinated with her first dose of GARDASIL (Lot #659437/1266U). Concomitant therapy included birth control. On 12-NOV-2007, immediately after the vaccination, the patient did not feel well. She experienced a syncopal episode and fainted. The patient collapsed, became unconscious for three to four minutes and started shaking. The patient also experienced pallor. Her blood pressure was normal. Ammonia was held under her nose. She recovered shortly after. The patient was not hospitalized. The nurse did not consider the event to be disabling, an other important event, or life threatening. The registered nurse also noted the patient had a similar experience after a mole was removed. She went home that day with her mother and her vital signs were stable (Pulse=160, blood pressure=112/68). The patient recovered. The patient refused to come back for a second shot of GARDASIL. it was recommended the patient see a neurologist. The patient has not been back to the office since 12-NOV-2007. The nurse reported that she did not feel this adverse experienced was from GARDASIL vaccination. This was all the information the nurse could provide. No additional information is available. Follow up information was received on 5-MAR-2008 from the registered nurse. At approximately 1:33 pm on 12-NOV-2007 the patient  fell back on to the table with mild shaking, foaming at the mouth, and loss of bladder control. It took 3-4 minutes for the patient to come around, she was immediately alert and denied feeling tired. At 4:00 pm the patient's blood pressure was 96/56 and her pulse and 68 beats per minute. The patient was held in the office for 20 minutes. The patient felt well and her mother drove her home. The patient had a follow up with a neurologist (date unspecified) since her last dose. The patient had recovered on an unspecified date. The mother reported that the daughter had a similar episode after node removal. No additional information is available.
a 74 y.o. male resident who was sent here for above problems. He contracted Covid-19 infection after he was sent there on 2/12 for rehab. He tested (+) on 2/21. He was severely hypotensive on arrival here and confused. He has been started on pressor agent. UA show signs of infection. D dimer 1139, lactate 9.5, procalcitonin 1.8. He is confused.  Later same day, his conditioned worsened and the outcome was clear, patient was made DNR and was provided comfort care until his passing,
This spontaneous report was received from a Medical assistant reporting to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The primary reporter stated that on unspecified dates, the patients received an improperly stored dose of (Oka/Merck) VARIVAX Injection (Concentration, dose, lot number, expiration dates were not provided). Concomitant therapy was not reported. No adverse events were reported and no product quality complain was involved. Additional information has been requested.
Second dose which is scheduled on 07Apr2021; Sore arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose which is scheduled on 07Apr2021) and INJECTION SITE PAIN (Sore arm at the site of injection) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose which is scheduled on 07Apr2021) and INJECTION SITE PAIN (Sore arm at the site of injection). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose which is scheduled on 07Apr2021) and INJECTION SITE PAIN (Sore arm at the site of injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       no concomitants and treatments medications was reported   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow-up information received on 17 Jul 2021 contains significant information. updated event outcomes to recovered.
Acute metabolic encephalopathy. Presented to our clinic day after vaccination only oriented to self and shortly before not even oriented to self. Reportedly at baseline very sharp w/o evidence of cognitive decline. Febrile at 102.4, pulse 102, meeting SIRS criteria. No other obvious source, therefore likely systemic inflammatory reaction from vaccine. No-focal deficits that would indicate stroke, but recommended going to ER for further evaluation. At ER, septic workup performed as well as laboratory studies. Lactate elevated but otherwise labs pretty unremarkable. CT head and CT angio head/neck performed w/o acute findings. Patient's mental status reportedly began to spontaneously improve in ER, and discharged.
Information has been received from a physician concerning a 4-year-old female with allergy to nuts who on 10-SEP-2007 was vaccinated subcutaneous in her left arm with a second dose of Varivax at 16:00 hours (Lot # 658413/1025U). Concomitant vaccine included a second dose of MMR II (Lot# 6554200279U) administered on 10-SEP-2007 at 16:00 hours, subcutaneous in the right arm. There was no illness/adverse events at the time of vaccination or following prior vaccinations. On 10-SEP-2007 at 16:05 the patient experienced anaphylactic reaction 5 minutes after vaccination that included the following symptoms: scratchy throat, hives, vomiting, difficulty breathing (decreased O2 saturation, bradycardia, hypotension and greater than five second capillary refill. On the same day the patient developed left arm edematous. Patient sought medical attention via an office exam and hospitalization. The patient was treated with dexamethasone (MSD) 10 mg intramuscularly once, diphenhydramine oral (BENADRYL) 25 mg PO once and epinephrine injection (EPIPEN JR) administered intramuscularly once. On 11-SEP-2007 the patient recovered from all adverse events. A product quality complaint was not involved. Anaphylactic reaction and left arm edematous were considered immediately life-threatening, required one day hospitalization, and was an other important medical event. Additional information is not expected.
Information has been received from a physician assistant concerning a 25 year old female patient with penicillin allergy, no pertinent medical history, who on 27-OCT-2009, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot#: 0040Z). On 31-JUL-2010, the patient was vaccinated in the left deltoid with the second dose of GARDASIL (Lot#: not reported). There was no concomitant medication. No lab diagnostics studies were performed. The physician assistant stated that on 01-AUG-2010, the day after the patient received her second of GARDASIL, the patient developed muscle weakness of the left arm. The patient also complained of neck pain. Since the patient lives one hour away from the office, the physician assistant directed the patient to report to a local emergency room if the symptoms got worse. The patient contacted the physician assistant by phone. At the time of the report, the patient's muscle weakness of the left arm and neck pain persisted. Additional information has been requested.
No additional AE reported; HCP reported that 3rd dose of RECOMBIVAX HB was given too soon to an adult patient; This spontaneous report was received from a nurse and refers to a 24-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.  On 19-NOV-2021, the patient received the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) Vial. Then, on 17-DEC-2021, the second dose was given and on 05-JAN-2022, the third dose was given too soon (Inappropriate schedule of product administration). All doses were administered as an intramuscular injection, 1 milliliter, with a lot #T025374, expiration date: 25-JAN-2023, for prophylaxis (strength, and route of administration were not provided).  No additional Adverse Event (AE) was reported.
Dizziness, Arthralgia, feels hot, achy sore all over Narrative:  Other Relevant History:
Face swelling, eyes swollen, mouth and tongue swollen. Severe redness over entire body, child screaming and clawing at head and ears.
Hives on arms, face, upper back occurred about 24 hr after influenza vaccine was given. No respiratory symptoms.
pt recvd vax & 1 min later states "I feel funny" started going pale, layed pt down, eyes rolled back, arms & legs became stiff & locked as if in sz activity;
Pt said upon asking for immunization that she was a"scaredy cat".  After I gave the AFLURIA she asked to stay seated so she could calm down for a little bit.  I asked her if she was ok, she just said she needed a minute.  I checked on her every couple of minutes because she got more upset if I hovered.  She said she was sweaty and anxious, but it was what happened every time she got a shot.  I offered her a bottle of water after a few minutes which she accepted.  She sat for about 15 minutes until she calmed down.  She said that it was a better experience than normal, but i thought it should be reported.
Several incidents of intense vomiting and diarrhea between 9:00 PM and 7:00 AM accompanied by mild chllls. Weakness and mild dizziness in the morning. Another 3 hours of deep sleep required to re stabilize, followed by acute thirstiness.
Fever 101.6 by 5pm as well as large raised deep red hives or spots. Hot to the touch.  He won't stand or let anyone touch his legs Especially tge right one. Hip to ankle in red spots
Day of injection started having pain in right  armpit like a bruise. It has spread and very sore. It is swollen also