chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart rate randomly increased to 180 BPM. 200-300 BPM in the ambulance; SVT; light-headedness; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 17:45 (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included premature menopause from an unknown date and unknown if ongoing. Patient previously received the first dose via an unspecified route of administration, administered in the left arm on 15Apr2021 08:00 (Batch/Lot Number: EW0169), for covid-19 immunization. The patient's concomitant medications were unspecified (there are medications that the patient received within 2 weeks of vaccination). On 07May2021 18:45, the day after the second shot, patient's heart rate randomly increased to 180 BPM. 200-300 BPM in the ambulance. The ER cardiologist thought it was a SVT. She also had light-headedness. Events resulted in Emergency room/department or urgent care visit. Outcome of events was unknown.  No follow-up attempts are needed. No further information expected.
Pt reports that 36 hours after he received his vaccine he developed vertigo and went into a cardiac arrhythmia. He took an ambulance to the ER, he was given IV fluids and had lab work done. He reports he is now starting to feel better (5 days later)
About 12 days after the first dose on Jan. 13, I experienced Vertigo  which resolved after 2 days but was left with lingering dizziness for three more days. THEN, after the second doxe on Feb 10, about 12 days later, I once again experienced vertigo which lasted 4 days and experienced dizziness for days afterwards including today as I write this report. The dizziness does decrease daily but is worse in the morning and diminishes as the day proceeds.
I haven't had a period since 2018 (hysterectomy)/I came on my period today; bleeding; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I haven't had a period since 2018 (hysterectomy)/I came on my period today), VAGINAL HAEMORRHAGE (bleeding) and MYALGIA (pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy (she haven't had a period since 2018) in 2018.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (I haven't had a period since 2018 (hysterectomy)/I came on my period today), VAGINAL HAEMORRHAGE (bleeding) and MYALGIA (pain). At the time of the report, MENSTRUAL DISORDER (I haven't had a period since 2018 (hysterectomy)/I came on my period today), VAGINAL HAEMORRHAGE (bleeding) and MYALGIA (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Approximately 24 hours following administration of DTaP, parent reported gross swelling and inflammation of left arm from just above elbow to and including shoulder.
High resting heart rate for 12+ hours. Resting heart rate up to 163 in my sleep.  Heart rate was in 85-95 range the hour of the shot then began rising after I went to sleep. stayed in 117 -136 range from 1 am Dec 12 to 11 am Dec 12.  This is the most severe of the other side effects I experienced -  body aches, head aches, short fever (99.3 F - 101 F) & cold sweats, fatigue, dizziness, nausea, diarrhea.
First 24 hours: highly fatigued, headache and lower back ache, loss of appetite and constantly thirsty. Brief period of high heart rate and cold chills. Started to develop itchy bumps on upper torso after 48 hours. Previous adverse effects no longer present.
Received vaccine on 1/10/21 and 2/21/2021. Tested positive for covid on 3/02/2021. Admitted to hospital on 3/23/21 for difficulty in breathing.
nausea; passed out; seizure; enlarged heart; hurt knee; sore mouth; This is a spontaneous report from a contactable other HCP (patient). A 19-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration, in the left arm on 20Apr2021 at 11:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient has no history of COVID-19 prior to vaccination. The patient had received other vaccines within 4 weeks prior to the COVID-19 vaccine: 2nd dose of Human papilloma virus (HPV) vaccine on 06Apr2021 in the right arm. On 20Apr2021 22:30, the patient experienced passed out, seizure, hurt knee, sore mouth, enlarged heart, and nausea.  The patient reported, "I was fine all day until around 10:30 pm I went into my mothers room and she was asking me how my arm feels I told her it was fine and right after saying that she said I passed out in front of her and then I began to have a seizure for about 50 seconds and then I woke up. After waking up from the event I had a hurt knee and sore mouth as well as an enlarged heart. I have no history of seizures in the past so it was definitely scary." The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 20Apr2021. Therapeutic measures taken included anti seizure meds, fentanyl, and paracetamol (TYLENOL). The patient recovered with sequelae from the events, passed out, seizure, hurt knee, sore mouth, and enlarged heart. Outcome of nausea was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a 14 year old female who on 01-MAY-2008 was vaccinated with the third dose of GARDASIL (lot # 0152X) and 3 weeks later (approximately 22-may-2008) was diagnosed with pericardial effusion.  At the time of reporting the patient was not recovered.  Lab diagnostics studies performed included echocardiogram.
Once I gave shot, his arm immediately swelled up, local irritation + redness w/ minimal bleeding.  Pt. did not feel dizzy or have any other adverse effects.  Pt. upon follow up 4 hours later stated swelling was down and he felt great.
Patient age 11 years was given the purple cap Pfizer vaccine instead of the orange cap Pfizer vaccine. According to patient's stepmother, patient did not complain of any adverse events, nor did the stepmother notice anything out of the ordinary with her following the vaccination.
That night my arm swelled up, and it was swollen for 24 hours. The next day on 5/5 my knee locked up and I was limping, my leg became more and more painful and inflamed over the next 3 days. Then it suddenly subsided.
Pt started having a fever, muscle aches, joint pain, diarrhea and poor appetite on 10/3/20. Fever "broke" 10/6/20  with onset of "itchy"  rash on torso, head, arms and hands. Pt states there is a cluster of spots around the injection site of MMR. Highest temp was 101.4. Pt was screened for covid prior to onset of rash and was negative.  Pt plans to go to walk-in clinic today (10/7/20) for further evaluation. Pt does not have PCP. Pt plans to call HD back after visit.
Injection site and whole arm felt like it was on fire for several minutes. Tech said this was normal but it lasted much longer that Tech stated. This should not be a "known" adverse effect as this vaccine should not be given with the knowledge that this level of pain is a cause.
Patient complained of left arm pain. Father reported that the patient spoke to the administering pharmacist and discussed the location of the vaccination and potentially given to high on the arm and possibly hitting the bone during administration. By 12/26/22 patients father reported that she was having difficulty moving her harm. They were unable to make contact with the family physician due to the holiday. Informed them if necessary to go to the emergency room for the increasing discomfort she was having with loss of range of motion.
Crabby, screaming on & off x 1wk unless held, diarrhea x 1wk; Given APAP & pedialyte per MD, lump 2 inject site; No temp, no sz; normal hlth p/2wks;
Pain in injection point which is typical. However, I developed a severe headache, and fever after the injection. The headache continues.
POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, with reference number 2023SA240518 (Inquiry #) was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, from a nurse.  Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis was not applicable.   This case is linked to other temperature excursion cases: MCM-005121, MCM-005126, MCM-005127, MCM-005128. MCM--005136, MCM-005135, and MCM-005140 (patient's twin).   Further information is expected.
very sore left arm; body aches; mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient herself) of 42-years-old female received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number: EL3247) via an unspecified route in left arm on 26Jan2021 10:45 am and second dose on 16Feb2021 13:45 pm via unspecified route in left arm both as single dose for covid-19 immunisation. Patient medical history included overactive bladder, premature ovarian insufficiency and known allergies were reported as yes. Concomitant medications were not reported. Patient took other medications within two weeks before vaccination and had not received other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to the vaccination. On 16Feb2021 23:30 the patient experienced very sore left arm, body aches, mild headache, and fatigue. The patient was not tested for covid-19 post vaccination. The outcome of the events is recovering.
Had fever the evening of the shot, had chills and shoulder where shot was given was sore, has ongoing pain in right shoulder, has been diagnosed with frozen shoulder and been going to PT.
Received shot on a Thursday afternoon and felt fine that evening.  The minute I stood up from bed Friday morning, it hit me like a ton of bricks- instantly:  Fever, chills, joint and muscle pain, lightheadedness, increased heart rate, exhaustion, migraine-like headache...all severe.  I don't recall the last time I was so ill and in pain.  Did not lessen at all throughout the day.  Took Advil 3 times that day.  I tried to go to work but couldn't stay.  Had to take a sick day.  Went to bed at 9:00pm and slept until 9:30am.  I usually sleep 6-7 hours.  I broke out into a sweat multiple times through the night.  The following day, I woke up much better but still weak.  By the end of that day, I was probably back to 75%.  I was back to normal on Sunday.  It was horrible experience and will unfortunately prevent me  from getting the vaccine annually.
Body and joint pain, headache, severe tiredness, lingual ulcer.  Body and joint pain started within hours after 2nd dose and the worst was over within 36hrs.  Headache morning after vaccine and resolved after taking ibuprofen.  Sleepiness started the day after vaccination and was particularly bad in the morning- kept having sleep attacks where I would fall asleep when trying to stay awake.  Improved as long as I was moving around.  Tongue ulcer appeared about 36hrs after vaccination and is still present and painful to a small degree.  I haven't been to the doctor for any of the symptoms as most were self limiting.  If the ulcer changes, doesn't resolve it becomes more painful will inform my Dr.
Originally, I went to my primary doctor, and I had abdominal issues.  He sent me to the ER and they ran some test and labs.  They found a mass on my adrenal gland.  They gave me some medications for the pain I was experiencing.  I thought it was Appendicitis.  Which it did not end of being that.  About a few days of rest, the abdominal issues subsided.  That was the end of that.  I did go back to my primary to follow-up on the mass.  He sent me to the endocrinologist about the mass.  They are monitoring my labs and my hypothyroidism.  So far it has not changed or worsen.  They have prescribed weight loss medication.  They have also prescribed me Topamax for the migraines that I always have.  Around September I started having more migraines that I have had to miss work more.  I have been seeing a neurologist.  They have changed medications.  I have stopped the Topamax.  I have also done recent labs which show increased levels of cortisol.  I am unsure if it has anything to do with tumor they found.  Then on October 16th I got my 4th COVID shot.
Directly after receiving the shot he became pale, dizzy and faint almost passing out. They explained it as Vasovagal syncope reaction. The nurse sad. After some water and the nurse checking vitals he was sitting up and communicating normally so the nurse left to get his discharge entered and shut the door. What happened next happened within seconds then minutes. He was talking about wanting to go to a store and drinking water then said he was nauseous. I asked if he needrd the waste basket and out his water down. By the time I turned back around he was as white as a sheet and going to fall off the exam table. I grabbed him to hold him up and his legs and arms began bending oddly then went limp, his eyes rolled back and began fluttering, his head flopped back and he turned completely blue and making gargling sounds. I held his head up with my thumb in his mouth because I thought he might be seizing abd he wasn't breathing. I was screaming his name and trying to keep him from falling off the table while rubbing his chest roughly to keep him from completely loosing conciousness. I had to keep screaming Hello!!!!  stay awake! Hello! Hello! Help stay awake!!!! They all came in and got him laid back and he stopped gargling and looking around. They took his blood pressure and checked his sugar. His color started coming back and they had him stay about another 30 minutes. They had him walk around before we could leave.  We live a 25 minute drive from the office and I was terrified the entire way that it was going to happen again on the highway in snow. No child should experience anything like that to prevent later illness. No parent should have to witness their child in that state. I thought he was dying. My baby boy was blue...blue! Drilling and gasping. I'm supposed to accept that is a side effect? That is something that happens? No! I  stopped vaccines with my 3 children as babies for this exact reason. This was proof of my fear and my choice as 100% correct. I only chose to get him the HPV Vaccine because Cancer Runs heavily in my family and I let my fear choose. Never again.
ended up with high blood pressure , diabetes , cellulitis of scrotum. Had to be transported by ambulance to hospital and spent eight days there. Currently on antibiotics , blood pressure medication , insulin and have had a catheter for 5 and 1/2 weeks.
This spontaneous report was received from a Registered Nurse (R.N.) concerning 5 month old patient (gender not provide). The patient's pertinent medical history and concurrent conditions were not reported. On 01-JUN-2016, the patient was vaccinated with the first dose of ROTATEQ, per oral route (Lot # and dose were not provided). Concomitant therapies were not reported. There was no product quality complaint involved. No adverse symptoms were reported. Additional information has been requested.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program Pfizer First Connect. A 64-years-old female patient  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899, expiry date Mar2021, NDC 59267-1000-1), intramuscular in right arm on 18Dec2020 11:45 at a single dose as prevention. The vaccine was administered in the hospital. Medical history included ongoing cardiomyopathy diagnosed about 32 years ago  and had pacemaker defibrillator Placed about 12 years ago. There were no concomitant medications. She was supposed to get the second dose of the Covid vaccine but she was positive for Covid. She found out she was positive for covid on Monday 04Jan2021 after she had a nasal swab test on 02Jan2020.  The outcome of the event was unknown.
On March 31, 2021 in early morning I developed shingles on the right side of my torso after a couple days of headache and chills.  Additionally as of today, 4/10/21 my left arm muscle is still hard and achy at the injection site, which bled about a 1/2 teaspoon amount at the time of the injection.
CHIEF COMPLAINT Chief Complaint Patient presents with ? Abdominal Pain ? Headache    a 79 y.o. female who presents with chief complaint of not feeling well.  Patient is unable to be any more specific about what it is that is wrong.  She denies fever chills nausea vomiting abdominal pain diarrhea constipation or urinary tract symptoms.  She does state that she has been feeling somewhat weak.  Her appetite has been fine.
About 30 minutes after vaccination baby was inconsolable crying, leg was really red and she threw up. This continued for a few days and then severe diarrhea and fever started about 36 hours after vaccination. Child was going about 16 times a day. Taken to medical center they could not figure out what was wrong said maybe pneumonia. They said they were not equipped to treat baby in such medical condition so they transferred is to another hospital where they ruled out pneumonia and all other possible causes. They gave her an IV. And said people have reactions to vaccinations but it is highly unlikely.
Fever; Headache; Arm pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced fever, headache and pain in arm. On an unknown date, the outcome of the fever, headache and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received her dose of the Shingrix vaccine in her left arm and she had a fever, a headache, and was experiencing arm pain. The reporter asked if she could take Tylenol for treatment. The reporter was referred caller to health care professional. The reporter did not consent to follow-up. No additional details provided by the reporter
Pt was given pediatric dose (0.2mL) instead of adult dose (0.3mL) for the booster (3rd) dose.
Cardiac Arrythmias/Heart issues; Accelerated Palpitations/ Heart issues; Lack Of Oxygen; Throat Pain; Ear Pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 at 12:30 as dose 4 (booster), single (Lot number: GL2042) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination; "Caffeine allergy" (unspecified if ongoing); "Antihistamines allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Accelerated Palpitations/ Heart issues"; ARRHYTHMIA (medically significant) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Cardiac Arrythmias/Heart issues"; EAR PAIN (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered"; HEADACHE (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered"; OXYGEN SATURATION DECREASED (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Lack Of Oxygen"; OROPHARYNGEAL PAIN (non-serious) with onset 22Nov2022 at 04:30, outcome "not recovered", described as "Throat Pain". The events "cardiac arrythmias/heart issues", "accelerated palpitations/ heart issues", "lack of oxygen", "throat pain", "ear pain" and "headache" required physician office visit. Therapeutic measures were taken as a result of arrhythmia, palpitations which included Nebivolol. Since the vaccination, the patient has not been tested for COVID-19.
This case was reported by a pharmacist and described the occurrence of radiating pain in the arm in a 39-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Levothyroxine, Spironolactone, Desonide cream, Clindamycin lotion, LEXAPRO, AMBIEN, XANAX, FINACEA and METROGEL. On 17 November 2008 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. After receiving FLULAVAL, the subject began to experience radiating pain in the same arm where the injection was given (the left arm). The pain reportedly radiated up and down the left arm and was not just at the injection site. The subject stated that the radiating pain started 1 to 2 days (November 2008) following FLULAVAL administration, but a specific date was not provided. The subject had described the pain as nerve-related pain. She treated herself with ibuprofen 800 mg as needed. The ibuprofen dulled the pain, but did not make it go away. At the time of reporting, the events had improved over the 2 to 3 weeks prior. The subject was still uncomfortable. The subject denied any recent change in activity level or heavy lifting that might have contributed to these events. The pharmacist considered the events were possibly related to vaccination with FLULAVAL. Follow-up information received on 05 January 2009 indicated that the events began on 19 November 2008. At the time of follow-up, the events were improved and still considered to be possibly related to treatment with FLULAVAL.
Abdominal pain happened on 14th April, i.e. 3rd day of vaccine injection and prolonged till today.
Hospital admission AC Arterial Occlusion, Atypical Pneumonia. COVID-19 suspected, however three tests since admission result COVID-19 negative.