chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Insomnia; flushed face; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: Pfizerew0162) in left arm on 09Apr2021 for COVID-19 immunization. Medical history included endometriosis, hypothyroidism, mitral valve prolapse. Patient was not pregnant, not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included levothyroxine sodium (TIROSINT) and lisdexamfetamine mesilate (VYVANSE). Patient previously received metoclopramide hydrochloride (REGLAN) and morphine and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Apr2021, patient experienced insomnia for three consecutive days after vaccine and flushed face. No treatment received for the adverse events. Since the vaccination, patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 at time- 21:39, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
June 16, 2021 Heart Ablation - because I had been in A-Fib and in order to get me off the medicine, I had to have the ablation. So that it would get me to stay out of A-Fib. Also  I gained a bunch of weight very fast - after the second vaccine. I had been on a bunch of steroids from January hospitalization when I had COVID pneumonia. I waited until March to have the COVID vaccine - on the 10th (the first one). I got the second one on the 9th of April. I had tiredness and flu like symptoms - body aches and slight fever (99.1) the first day after the 2nd vaccine and all the other symptoms went on another day. I felt good enough to try to play 9 holes of golf on the Saturday after - although I was pretty wiped out after. So I was fine - until lately when I had shortness of breath after the ablation. The weight gain had been coming on - I was  pretty active until that Ablation of time - I go to the gym and was getting rehab for my shoulder. But now with  having the Ablation and then after having shortness of breath after the Ablation, I haven't been able to do that. I just tried to start a little walking again yesterday for the first time. I think the shortness of breath is getting better - it's better today than it was last week.  Note: I got a Pneumonia vaccine at doctor's office in February; I got a 1st Shingles shot after I had both COVID vaccines - in the latter part of May probably; I haven't had the second shingles shot yet - should probably get that next month.
Initial report received from healthcare professional on 3 November 2014. This case is linked to case 2014SA152268 (same reporter, same vaccine FLUZONE QIV). A female patient, whose date of birth, age at the time of event, medical history and concomitant medications were not reported, had received intramuscular first dose of FLUZONE QIV (batch number and anatomical site of administration were unknown) on an unspecified date of September 2014 to October 2014. It was reported that on an unspecified date of September 2014 to October 2014, after receiving FLUZONE QIV vaccine, the patient experienced fever and chills. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from healthcare professional on 13 Jan 2015. It was reported that the patient experienced fever and chills for 24 to 48 hours. The outcome of the event was resolved. Follow up information received from healthcare professional on 26 Jan 2015. A 50 year-old female patient, whose medical history included celiac disease and being prone to getting high (103 degree) fever, received a first dose of FLUZONE QIV (Batch number UI200AC, expiry date 30Jun2015) in right arm intramuscularly at 11: am on 31-Oct-2014. Corrective treatment included 1000mg TYLENOL. No diagnostic or lab tests were done. No medications routinely taken. The outcome of the event was unknown. Documents held by sender: none.
Patient experienced redness (splotches) on cheeks of face, neck, chest, back, and around injection site starting 1-2 days after both vaccinations. This redness lasted approximately 1 week and went away on its own. The redness had a warmth to it, but it did not itch. She did not experience and swelling in throat. The patient went to see her dermatologist Dr. for a routine office visit after her second dose where she was told to take CLARITIN in the morning and 1/2 of a levocetirizine tablet in the evening. She stated she did this for a couple days.
No additional AE; A Healthcare Worker called to report that expired RECOMBIVAX HB was administered to a patient on 11/23/2022. No additional AE reported. No PQC reported.  No further information was provided.; This spontaneous report was received from other health care professional referring to a 7-week-old female patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 23-NOV-2022, the patient was vaccinated with an expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # T032918, expiration date 12-NOV-2022; dose, strength and route of administration were not reported) for prophylaxis (expired product administered). No further information was available (no adverse event). No product quality complaint (PQC) was reported.
Began feeling tightness of eyes, drowsiness and head swimming. Laid head down on desk and became unresponsive. Could hear co-workers around her, but could not move or speak. Incontrollable sobbing alerted co-workers who tried to obtain response. Taken to ER. Continued intermittent inability to speak or move or grasp. Hands and arms tingled and cold. Legs shaking uncontrollably. Some nausea, but no vomiting. Labs WNL, MRI unremarkable, EKG unremarkable.
Four days after receiving the second dose, I broke out in a rash from my neck to my ankles. I visited my dermatologist, 03/01 and I was prescribed triamcinolone acetonide cream 0.1%. I used the cream and within less than a week, I was feeling better and the rash started to go away. I have had this rash occur two more times after the original breakout. I used the cream that was prescribed to me and it helped. I recently had it refilled in case of another breakout. The doctor was going to treat me with prednisone, but they didn't want it to mix with the vaccine since it was only four days after receiving it.
Preventricular contractions up to 20%, required a visit to the ER, and a new prescription for beta blockers.
Approximately 3.5 years post vax, this pt developed a rash all over and a fever. At the time of this report she was still being treated for event. Follow up provided no additional data.
On 10/23 in the eVening, I developed  chest pain which became severe, had very elevated blood pressure.  Called the squad.  Was given aspirin to chew.  They started  an IV and game me nitroglycerin under my tongue and fentanyl in my IV.  Chest pain improved after nitroglycerin.  I did not have EKG changes. My troponin was 48 upon arrival and increased to 150, then 860. I was on a heparin drip.  I was taken for a heart cath and possible stint placement.  My heart cath showed no blockage, despite my presentation and elevated cardiac enzymes.
Pregnancy: (10 weeks; first trimester). Symptoms: extreme fever and dehydration, fatigue, vomiting (likely a form of extreme morning sickness due to dehydration and empty stomach due to lack of appetite). Unable to sleep due to waking every 2 hours to use restroom.
Intussusception, reduced by diagnostic enema. Presented with vomiting and bloody stools on 12/7/07. 1/7/08-records received for DOS 12/7-12/8/07-DC DX: Intussusception status post reduction. HX of emesis, not tolerating foods and bloody diarrhea. Vomiting. Air contrast enema with successful and uncomplicated reduction of ileocolic intussusception which had originally progressed nearly to the splenic flexture.
Chills the first night as well as drowsiness and a sore arm. The following two days, I had nosebleeds each morning. The third day after, I had a nosebleed in the evening accompanied with nausea and headache (pressure)
Patient was administered the Vaccine via intramuscular injection in the Right Thigh. Patient was checked back with in ten min and patient had localized swelling and redness to the right of injection site. Patient was looked at by the ordering Physician and stated the patient should be okay and advised the patients parents to give correct dosage of Benadryl.
DEATH AFTER A MONTH OF RECEIVING VACCINE; This spontaneous report received from a consumer via social media via a company representative concerned two male patients of unspecified age, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, two patients died after a month of receiving vaccine due to unknown cause. The reporter stated that, "Our church has, had two young men. Die after a month of receiving the VAX. Mandatory to attend local college". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220220610-covid-19 vaccine ad26.cov2.s- Died after a month of receiving vaccine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
A few days after the vaccine I developed a rash on my torso including my stomach and back.  It has been approximately 4 weeks and I am still experiencing the rash.  Dermatologist suggested it might be due to the vaccine.
Pain at injection sight (upper arm) has spread from up and down the left side of my body.  My left hand is cramping, and gripping anything is painful.  My left shoulder and neck are cramping (up to my ear) and raising my arm is painful.  Even my left knee is bothering me.  The amount of discomfort is surprising.  I had none of these symptoms prior to the injection.
Patient did state he had his 2nd dose of Moderna, but it is not documented where this reporter can find the date (would have been sometime in April). He told this reporter he started to not feel well about 3 weeks after his 2nd dose. He eventually felt so bad he sought treatment in July. He was admitted 8/6/2021 with group B streptococcus agalactiae bacteremia, sepsis resulting in fever, encephalopathy and AKI (likely due to SBP).  TTE 8/17 showed severe AR and possible vegetation. TEE 8/18 confirmed infective endocarditis c/b AoV insufficiency. Patient is not an IV drug user.  Hospital course also complicated by Afib w RVR and was started on dilt drip, now off as patient's HR improved and he has had low BP in setting of likely worsening AoV insufficiency. Patient also with pulmonary edema periodically requiring 1-2L O2 . Furthermore, 8/22 patient had short run of torsades treated with Mag  Over the past several days, patient has developed hepatocardiorenal syndrome with worsening AKI. Transfer to ICU for consideration of CRRT initiation. Structural and CT surgery following due to severe AI. Tentative plan for TAVR. Patient with slowly worsening AMS as well, acute-subacutely worsening today. Thought to be due to hypoperfusion v acute illness. Cosyntropin stim test for hypothermia negative.  Patient arrived to ICU somnolent but arousable. HD catheter, PICC and A-line were placed for CRRT initiation, pressor initiation and hemodynamic monitoring respectively. Patient's hemodynamics continued to worsen evening after ICU transfer and temporary pacemaker was inserted and patient was paced with HR 90-110. Despite pressor support and temporary pacemaker, patient continued to worsen and was persistent in stating he no longer wished for current cares to continue. It was felt patient would not tolerate TAVR or liver transplant at this state as patient was not improving with pressor, CRRT, temporary pacemaker and hemodynamic support and as a result decision was made with family to transition patient to comfort cares. He ultimately succumbed into death on 8/26/2021
Initial report received from a physician assistant on 27 October 2010. A 31-year-old female patient had received a 0.5 mL left deltoid injection of ADACEL (lot number C3490AA, expiration date 16 July 2012) on 21 September 2010. Within 15 minutes of receiving the vaccination, the patient returned to the urgent care area complaining of numbness and tingling that was involving the entire shoulder and spreading upward and posteriorly to the scapula and base of skull on left, and downward, distally, to hand. There was some reduction of sharp and soft sensation in the arm, although there was no motor dysfunction. The sensation involved three dermatomal areas and followed a unilateral nerve distribution pattern of entire aspect of left arm, not just a localized area, and it was thought by the clinic to be unusual, and had not been observed by the clinic before. The patient's vital signs were stable and she was kept in urgent care area for extended time. The patient was seen back the following day and had improvement in symptoms but no resolution. As of 12 October 2010, the patient still had tingling in fingertips and scapular area in the neck, but she had continuing overall improvement. Documents held by sender: None.
Information has been received from a physician concerning an 8 year old male pt who in approximately 1997, at one year of age, was vaccinated with a dose of varicella virus vaccine live. On 05/24/2004, the reporter stated that the pt now has shingles on his right arm. Medical attention was sought, but hospitalization was not required. The pt was treated with Acyclovir and naproxen. At the time of the report, the pt was getting better. A quality complaint was not involved.  Additional information has been requested.
Information has been received from a licensed practical nurse (L.P.N.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 26-JAN-2016, the patient was vaccinated with a dose of expired PNEUMOVAX 23, lot # K009105, expiration date 21-JAN-2016, 0.5 ml, intramuscularly in the right deltoid (expired vaccine used). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Within one minute of receiving immunization, patient reported feeling closing of airway, itchy throat, and difficulty breathing. 911 was immediately called. Patient was instructed to lie down flat on her back. At the patient's request, EPIPEN was not administered, but diphenhydramine 50mg was administered. Paramedics arrived on scene. By this time, patient reported improvement in symptoms. Paramedics evaluated patient for blood pressure and blood oxygen levels. Patient declined being transported to the emergency room. Patient's parents arrived on scene and signed a release from the paramedics and went home.
gave two doses of an expired vaccine to two patients for their Booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave two doses of an expired vaccine to two patients for their Booster) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059h21a, 048b21a and 039b21a) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy and Drug allergy (Allergy to Nesporin).   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (gave two doses of an expired vaccine to two patients for their Booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave two doses of an expired vaccine to two patients for their Booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported.  Concomitant medication were reported as tyrod medication and asthma medication.  No treatment medications was provided.
No adverse reaction noted; per system Risk Management guidance this form was entered due to the Td vaccine being expired on 6/6/22.
08/30/2021, within the 1st hour that I had the vaccine, I threw up. I had extreme fatigue, 6 hours after the shot, I passed out, hurry-up and-get-to-your-bed fatigue. I slept for 3 days, I went to sleep and did not wake up. I slept 42 hours. It was bizarre. I woke up dehydrated. 09/26/2021 at midnight, the shingles breaking out, little blisters on my face. I started my valacyclovir immediately, I have rescue medications because I can't wait to start them. And I called my doctor on 09/29/2021 to report the shingles and by then I was doing better. I was supposed to get 2nd vaccine on 09/27/2021. The doctor would not let me get my 2nd vaccine because I had the shingles virus. I was not able to get my vaccine until 10/13/2021, when the shingles virus was out of my system. After the 2nd vaccine, I just had fatigue, no shingles. I stopped taking my antibiotics when I had the shingles and just took the valacyclovir. 10/07- 10/10/2021, I got bad infection, lower pelvic, double over excruciating pain on my lower pelvic. On 10/10/2021, I started my antibiotics, and the infection went away. That was not an AE. It was because I stopped taking my antibiotics.
This spontaneous report as received from a licensed practical nurse (LPN) referred to approximate 5 patients. The reporter stated that there had been approx 5 cases of syncope in patient receiving GARDASIL (lot # not reported) in the last 10 days and it may be lot related. At the time of reporting, the outcome of the patients was unknown. It was unknown if the patient sought medical attention. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
IT IS BELIEVED GUARDIAN CHANGED PATIENTS DOB TO 9/18/2008 ON 6/9/21 VACCINATION DAY TO MAKE PATIENT APPEAR 12YO AND RECEIVED ADULT PFIZER DOSE 0F 0.3ML.  PATIENT'S CHILDHOOD IMMUNIZATIONS AREIN IMMTRAC UNDER A DIFFERENT DOB 9/18/2012 WHICH WOULD HAVE MADE PATIENT 10YO AT TIME OF VACCINATION.
A little over 12 hours after receiving my 2nd Pfizer vaccine I began experiencing significant menstrual cramps. Menstrual bleeding began about 24 hours after receiving the vaccine. I am not due to have my period for over a week - I have a predictable cycle so this is extremely out of the ordinary.
Pt had left the clinic after meningococcal vaccination and went to the local store 2 blocks from the clinic.  The father states while they were in the store the pt become pale, sweaty and passed out.  The father brought the pt back to the clinic where he was noted to be alert, pale sweaty.  He was placed in a treatment room, placed in Trendelenburg position and monitored.  His color improved, sweating improved, he was more interactive.  Vital signs and oxygen saturation was normal.
Information has been received from a registered nurse concerning a 41 year old unemployed Hispanic male patient with an allergy to penicillin who's 4 year old son was vaccinated on 03DEC2003 with a dose of varicella virus vaccine live. The son had no reaction or rash post vaccination. The 41 year old male patient was not sick at the time of his son's vaccination. On 05JAN2004, the 41 year old male patient developed chickenpox. On 05JAN2004, the patient was seen at a health center when he only had a fever. On 06JAN2004, the patient had a doctor's visit at a different health center and was diagnosed. Laboratory tests were not performed. The patient's chickenpox included fever from 05JAN2004 to 06JAN2004, "achy bones" from 05JAN2004 to 06JAN2004 and blisters from 06JAN2004 to 16JAN2004. The patient recovered after two weeks. A product quality complaint was not involved. The reporter also mentioned that the son's mother developed chickenpox after the son was vaccinated with varicella virus vaccine live. It was noted that the family recently immigrated from Cuba on 17NOV2003. Additional information is not expected.
PRODUCT STORAGE ERROR; This spontaneous report received from a pharmacist concerned multiple patients. 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 not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product storage error was not reported. This report was non-serious.
Systemic: pneumonia-Mild, Additional Details: Per pt's wife, pt started feeling bad on 8/1/21 and ran a fever of 102. Pt went to doctor on 8/3/21 and was diagnosised with pneumonia. Pt is asymptomatic per wife and received antibiotics.
Fever, cough wheeze and cxr showing RML pneumonia, insufficient response? Amoxicilin/clavulanate 1000 mg QID, Prednisone 20 mg every day, albuterol 180 mcg PRN.
injection site redness, swelling, soreness, onset 7 days after vaccination, progressing 3 days after onset