chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the first vaccination I got a severe UTI. I had never had a UTI before. The pain was so awful that I could not properly urinate. Two relatives (my aunt and uncle) also attained a UTI post 2 weeks after the first dose of the Covid vaccine.
Sudden onset tinnitus since day 2 of receiving vaccine. Continue to  experience tinnitus since 1/27/22. No tinnitus before receiving vaccine.
First one was pain in my jaw and chest - shortness of breath and elevated heart rate. I went to ER and I was hospitalized for four days and then discharged.  Was monitored while I was at the hospital but no procedures were done. I got IV fluids the first day of it.  They sent me home with what I had already been on before the vaccine. When I was discharged, I was not having those symptoms. I was wearing a 30 day event monitor when I was discharged.  Second health event: Afib episode - June 15 or 16. Went to ER at Hospital - they gave me some different meds this time - Heparin by injection in the abdomen; Increased Lopressor; no fluids or oxygen that time; I was released with new meds - stopped taking Lopressor and Plavix; started on Eliquis and Cardizem and Toprol.  #3 - I was in the hospital a third time - a couple of weeks later on July 14th - shortness of breath and that was the main symptom. They did a chest x-ray in the ER which showed fluids around my lungs and around my heart. They also did a CT scan which verified the same thing. They admitted me and gave me Lasix through the IV for three days. I was there for week that time. Medications stayed the same from after the second time in the hospital when I was sent home. I also had oxygen for a couple of days because my pulse OX rate was dropping and going up and down. They were trying to get rid of as much fluid as possible. They did another echo-cardiogram - was normal as far as heart function.  Doctor appts - have had - cardiologist, pulmonologist and family physician
Received smallpox vaccine 2/25/03.  Had the expected mild side effects such as fatigue and headache on day 5 - 8, and tender lymph nodes (under arms) day 6 - 9.  Had a normal take response.  Approximately 8 months later (when weather got cold) developed Raynaud's syndrome.  Approximately 2 years after vaccination developed malaise, myalgias, neuropathy, joint pain, and was diagnosed with systemic lupus erythematosis.  Because this is a multifactorial and progressive disease, and they are not sure of the cause, I thought I should report this in case others have had similar problems.
No additional AE; ROTATEQ was inadvertently administered to a patient after being improperly stored during a supported excursion; This spontaneous report was received from a medical assistant regarding to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in August 2022 (reported as "within past 4 days"), the patient was inadvertently vaccinated with an improper storage dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #W004503, expiration date 15-MAY-2023, taken orally (strength and dosage regimen were not provided) as prophylaxis (Product storage error).  The improper storage vaccine underwent a temperature excursion of 34 degrees Fahrenheit (F) for 19 hours and 15 minutes without previous excursions. No adverse events were reported.
Patient received a flu shot initially, then shortly after received a COVID Pfizer bivalent vaccine, then he fainted, fell off his chair, then regained conscious right after, seemed okay, left the facility walking,
Had URI SX of congestion coughing slight fever at beginning of cruise May 27-June 3,2022. Tested neg for Covid on May 26, 22. Ran out of cough syrup on June 2, 22 and was very sick especially fatigued by then. Called ship infirmary who sent personnel with meds and Covid kit to stateroom. Tested positive. Moved to isolation on ship and for 5 days later at relatives home. Flew home June 7,22 and still tested positive June 8,22. Called PCP Dr. who prescribed Paxlovid which I took for 5 days. Tested neg for Covid June 9,22. Was fatigued but without URI symptoms for 10 more days. It was a lousy honeymoon.
Narrative: 77 year old male with past medical history significant for CKD, HTN, CAD, CHR , PAD, DM c/b peripheral neuropathy, HLD, Depression/ Anxiety, and PTSD. Patient received first dose of the Moderna COVID-19 vaccination at a Pharmacy on 3/11/2021. The following day the patient was feeling extremely fatigued and difficulty moving around. He also had fevers and loss of appetite. Per the patients wife, the symptoms continued for around 5-6 days at which time the patient returned to his baseline health.
Baby had a convulsion 5 days after receiving MMR/V and Hepatitis A vaccines. No fever at home. Lasted 3 minutes.
Male patient, 23yo, had marked on screening form that he had fainted previously, so I asked him about that incident prior to the vaccination.  He said that 2 years ago he passed out after a flu shot, so I asked if he was feeling ok today and if he had eaten anything.  He said he had eaten a granola bar and was feeling fine.  I proceeded with the vaccination, watching him closely.  He immediately slumped in the chair and passed out.  I yelled for another pharmacy team member to come assist me with him.  By the time the 2nd team member was in the room, the patient had regained consciousness.  We propped his feet up on a box to elevate them some while he sat for a few more minutes.  I asked if he wanted me to call anyone, he said no that he was fine.  I let him sit in the consultation room another few minutes until he felt ok to walk.  After 10 minutes, he felt ok to walk and went to the waiting area to have a seat for another 25-30 minutes.  I continued to monitor him, and then asked him to walk around the store for a few minutes to make sure he was ok before leaving the store.  After 30 or so minutes, he felt ok to leave.  Called patient about 2 hours after leaving and he was still doing okay.
Anaphylaxis, trouble breathing occurred about 5 hours after vaccination. Treated in emergency room and hospitalized for 1 night.
Patient received 1st dose of moderna vaccine on Friday 1-22 from vial opened the day before.
Tingling throughout body still have this since 03/09/2021 Fast heartbeat still have this since  03/09/2021 Lost appetite this has got a little better over past two weeks Fatigue still have this since 03/09/2021 Tremors internally still have this since 03/09/2021
Developed a red, raised, itching rash at the injection site 7 days after injection. Rash spread in a circular pattern over the course of 2 days, then began to resolve, clearing up from the center of lesion outward.
Patient presented with Prednisone prescription and stated that she developed hives approximately 3 hours after attending a dinner (Pot luck). Not sure if it's vaccine related.
Information has been received from a physician concerning an 18 year old male patient who in approximately August 2006, was vaccinated with a  dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, the patient experienced pain in joints and developed low grade fever.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested. Follow up information has been received: the physician reported that the patient was recovered from his symptoms and stated "all it was was a one day flu". Additional information is expected.
Strong metallic  taste in mouth; This is a spontaneous report received from a contactable nurse (who is also patient). A 36-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in right arm, on 12Jan2021 11:00, at single dose, for COVID-19 immunization, in the hospital. There were no medical history and concomitant medications. The patient has no known allergies. The patient is not pregnant. The patient did not have COVID-19 prior to vaccination and did not receive other vaccines in four weeks. The patient experienced strong metallic taste in mouth on 12Jan2021 11:30. No treatment was given for the event. The patient was not tested for COVID-19 post vaccination. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Information has been received from a physician concerning a 17 year old male patient who on 26-JUL-1994 was vaccinated with a first dose of MMR II HSA (route, site, dose and lot number not reported). On 14-OCT-1994, the patient was vaccinated with a second dose of MMR II HSA (route, site, dose and lot number not reported). On 11-NOV-2009 the patient was diagnosed with mumps. The first set of blood test for IgM was negative. For IgG was 4.49 and for Serum Amylase was 184. On 10-NOV-2009 the patient experienced mumps (Though the date diagnosed was reported as 11-NOV-2009). The patient was afebrile and had parotitis. The outcome for mumps was not reported. No further information is available.
pt recvd vax; sz like activity about 4 hrs p/ vax; fever of 101;to er;given meds for fever
feel like going to pass out; difficulty breathing; dizziness; weakness; losing his balance; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (feel like going to pass out), DYSPNOEA (difficulty breathing), DIZZINESS (dizziness), ASTHENIA (weakness) and BALANCE DISORDER (losing his balance) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PRESYNCOPE (feel like going to pass out), DYSPNOEA (difficulty breathing), DIZZINESS (dizziness), ASTHENIA (weakness) and BALANCE DISORDER (losing his balance). At the time of the report, PRESYNCOPE (feel like going to pass out), DYSPNOEA (difficulty breathing), DIZZINESS (dizziness), ASTHENIA (weakness) and BALANCE DISORDER (losing his balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Aspirin
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the husband of the patient told that his wife (the patient) received SHINGRIX and she developed shingles. The pharmacist had little information and could not read the lot number and expiration date on the paperwork. The reporter wanted to speak to medical information and transferred her there.
ACUTE RESPIRATORY FAILURE 9/25/2022 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT  ACUTE RESPIRATORY FAILURE 9/25/2022 POSTPROCEDURAL DEEP INCISIONAL WOUND INFECTION, SUBSEQ
Pt had Anthrax #4 on 3/17/00 and within a few hours, developed localized redness and swelling. On 3/18/00, pain moved distally to above right elbow. On 3/19/00, had right forearm pain. On 3/20/00, right hand and fingers were tingling and had numbness (except for right thumb). Pt was prescribed Allegra and Naprosyn and a neurology consult. Do not administer future Anthrax vaccines.
This spontaneous report was received from a medical assistant refers to four patients of unknown age and gender. There was no information about the patients' concurrent conditions and medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M043581 with expiration date on 28-OCT-2018 (dose and route of administration were not reported). Properly stored doses of sterile diluent (MERCK) were used to reconstitute the doses of VARIVAX. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 1702 hours. Data logger was used to record the temperature excursion. There were no previous excursions reported. Additional information has been requested.
Rashes noted left forearm with slight itching self treat with 50mg Benadryl.
Both myself and my husband have atrial fibrillation (A-Fib).   Mine started two weeks after my first shot.  I was hospitalized and I am under doctor care.   My husband go A-Fib about two weeks after his shot.   He is also under medical care.   It seems very strange that both of us have the same heart issue after the shots.   First shots were 3/9/21 and second shots were 3/30/21.
12/11/2021 awake at 4:30 am with debilitating joint pain and discomfort in shoulders, elbows, wrists, hands, knees and ankles. Inability to sleep. Could not move arms without searing pain in every joint. Hands were swollen, needed to remove wedding ring.  Pain was reduced after six days, then 12/16 at 4 in the morning it got worse.   Put on a three day course of 50mg steroids 12/17/2021   Discomfort and joint pain subsided by 12/25/2021.  Every symptom returned 1/4/2022 lastingabout six days, with the pain diminishing each day.  Flare up agin 1/17/2021, 2/1/2021, and 2/5/2021.   No real relief at this point. Left arm and shoulder are in constant pain.
Patient says he began experiencing extreme body aches and fatigue the next day.  He also developed itchiness all over body.  He spent the next two days sleeping.
Progressively worsening hive type rash from head to toes. Generalized swelling and pain of all joints. Cannot walk due to pain.
I received the vaccine at 7:20 am.  At 12:30pm I started to notice discomfort in my left him and right arm. I also started to feel some fatigue and 'foggy'.  Within an hour I was very fatigued, the joint pain in my hip progressed and had a headache. I used Tylenol and rest to help the symptoms. I was not able to go to work the next day. By 7pm on Feb 24 I felt fine. I was able to go to work and I no longer need Tylenol. I noticed that on February 25 I had hives on my torso. The hives had persisted for the past two days. They are located only on my torso and I don't have any other symptoms at this time.
Experiencing contractions hours after vaccine administration, at regular intervals; Experiencing contractions hours after vaccine administration, at regular intervals; Arm twitching; Headache; This is a spontaneous report from a contactable consumer or other non HCP (patient herself).  A 35-years-old pregnant female patient (pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jun2021 11:30 (at the age of 35-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history included COVID-19 prior to vaccination. The patient had no known allergies. The patient had no other medical history. The patient's concomitant medication received within 2 weeks of vaccination included ascorbic acid, biotin, folic acid, iodine, nicotinic acid, omega-3 fatty acids, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine, vitamin b12 nos, vitamin e nos (PRENATAL + DHA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jun2021 at 11:30 the 30 weeks pregnant (as reported) patient received vaccine and at 16:30, the patient started experiencing contractions hours after vaccine administration, at regular intervals. Arm twitching also noted, headache but not bothersome as much as the contractions. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient's last menstrual period date was 06Nov2020 and the due date is 15Aug2021. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment for events. The outcome of the event vaccine exposure during pregnancy was unknown and the other events were resolving.  No follow up attempts are possible. No further information expected.
Within 90 minutes of vaccine administration patient experienced extreme at the injection site which continued to worsen over the next 15 hours.  On a pain scale 1-10 patient reported being a 10.  Patient lost conscientiousness for about 45 seconds.  Wife believes that her husband when into A-Fib.  Patient had nausea  and when to toilet to vomit and passed out for another 45 seconds.  Patient was sweating profusely.  Patient's wife assisted him up and after he lost consciousness after the third time.  Then wife tested his oxygen and blood pressure which were normal.   Spouse gave him a dose of Flecainide
One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip;  21 children received only half a dose.  No adverse effects were reported;  the event is considered resolved.
did not received 3rd dose; waited 5 months and get her second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 28th January 2021).   On 29th June 2021, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 3rd dose of Engerix B. On 29th June 2021, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional details were provided are as follows: Pharmacist reported that the patient waited 5 months to went back to the pharmacy and get her 2nd dose of Engerix-B later than recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting, the patient did not received 3rd dose of Engerix-B yet, which led to incomplete course of vaccination. The reporter would like to know if they could gave her 3rd dose of vaccine on 31st August 2021, or how did they need to proceed. No further details were provided at the time of the call. The reporter consented to follow-up via phone.
Per nurse on 10/25/17: Patient arrived with daughter for complaint of reaction to flu that was received on 10/11/17. Patient states on 10/11/17 his arm broke out in a rash and experienced chest tightness. States he took two BENADRYL and went to sleep. States the rash went away and he had not had any further chest pain since then. States he does have leg pain at night and has had for years. States he had to takes an ibuprofen at bedtime about 3 times a week. States he has had episodes of chest burning and times. Will obtain EKG.
Case number PHEH2013US026643 is an initial spontaneous report received from a pharmacist on 30 DEC 2013. This case refers to a 14-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 30 DEC 2013. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 30 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Pfizer / BioNTech / Treatment of COVID-19  Start date: 9Aug2022; Pfizer / BioNTech / Treatment of COVID-19  Start date: 9Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: other medical history: Heart disease; "in treatment for breast cancer" (unspecified if ongoing), notes: other medical history: in treatment for breast cancer. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19 Start date: 9Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Treatment of COVID-19; (Aug2022) Negative, notes: Had Covid rebound 3 days after negative test; (17Aug2022) Positive, notes: Had Covid rebound 3 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2 weeks reported. Patient was treated with anti viral drug for COVID 19 Paxlovid, treatment start date was 09Aug2022 and treatment stop date was 14Aug2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Guillain Barre Syndrome. Transverse myelitis. Pt. is still followed by urologist & neurologist.
fever 101.5; non responsive; no head control-limp; full of mucous in mouth; transported to local ER via ambulance approx MN 3DEC92;
Developed fever, malaise, and cough about 12-16 hours after administration of the vaccine; symptoms were present for about 2-3 days. Of note, tested positive for COVID-19 at an urgent care clinic the day after vaccination (unaware of COVID-positive status prior to vaccination).
Rash by the injection site with some swelling and irritation. Used cortisone and that helped.
Bladder irritation two days after first shot.  Some blood tinge.  Resolved in a few days.   Significant bladder pain, bleeding, incl clots  two days after second shot.  Resolved with cranberry pills after a few days. Thought maybe was due to eating jalapena peppers in my chicken nachoes. Both weekends. Then heard that women are reporting bizarre bleeding after vaccination so re evaluated and considered the bleeding could have been an adverse reaction to vaccine and decided to report my experience.
Patient had 1 tonic clonic (non febrile) seizure on 12/24/22 and 2 tonic clonic seizures on 12/25/2022.  Patient was diagnosed with epilepsy and placed on Keppra. He will remain on Keppra for at least 2 years at which time he can be weaned off if he remains seizure free.