chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site for 3rd dose; 3rd dose given to patient who is not immunocompromised; 3rd dose interchanged with Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site for 3rd dose), OFF LABEL USE (3rd dose given to patient who is not immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (3rd dose interchanged with Pfizer vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.   Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History Information was reported.  Concomitant products included LISINOPRIL, CLOPIDOGREL BISULFATE (PLAVIX) and ATORVASTATIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site for 3rd dose), OFF LABEL USE (3rd dose given to patient who is not immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (3rd dose interchanged with Pfizer vaccine). On 21-Aug-2021, OFF LABEL USE (3rd dose given to patient who is not immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (3rd dose interchanged with Pfizer vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site for 3rd dose) outcome was unknown.            No treatment medications were reported.  Symptoms: It was reported that patient received first two doses Pfizer vaccine and experienced events, patient was not immunocompromised and received 3rd dose of vaccine as Moderna Vaccine.
Temperature steady at 101, body aches, severe headache, fatigue, body chills, sweats, feeling hot, and feeling dehydrated.
Syncopal episode with diffuse sweating and dizziness. transferred to facility. Per mom, patient has hx of fainting with shots.
Loud non-pulsatile tinnitus in left ear only; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Apr2021 at 11:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included adenoidectomy (adenoid removal), scoliosis surgery and myringotomy (tubes in ears as child) and sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 15:00, the patient experienced loud non-pulsatile tinnitus in left ear only. The patient had not had this before. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event loud non-pulsatile tinnitus in left ear only was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Pt. became unconscious and lost bladder control-she had shallow, infrequent respirations with an exp. stridor noted-pulse faint and slow.  Epinephrine given IM per clinic standing order and pt. became conscious within 15 seconds-could not remember losing consciousness.  Taken to the hospital for further evaluation.
Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 09Aug2021 at 11:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications was not reported. On 09Aug2021 at 11:15, the patient experienced dizziness within 5 minutes and lasting. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event dizziness was unknown.
Patient awakened from sleep at 3:00am on Thursday, April 17, 2003 with "heaviness in chest and shortness of breath".  Patient, a nurse, walked around house hoping symptoms would abate.  After an hour was able to return to bed and slept.  Later that morning, while driving to work at 8:00am, symptoms returned and worsened.  "I was so short of breath and had intense chest pressure".  "I had a sense of impending doom." She presented to the ED.  Oxygen and nitroglycerin were given.  ECG and cardiac enzymes were obtained.  Symptoms did not respond to NTG.  On examination by cardiologist, new Grade I systolic murmur auscultated.  Pt. admitted to hospital for further workup.  All cardiac enzymes normal.  2D ECHO normal.  Stress test normal.  Pt. discharged morning of 4/18/03. Will follow-up with cardiologist in 1 month.
Numb tongue; Tongue , cheeks and forehead are "on fire"; Sore mouth; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb tongue), BURNING SENSATION (Tongue , cheeks and forehead are "on fire") and ORAL PAIN (Sore mouth) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numb tongue), BURNING SENSATION (Tongue , cheeks and forehead are "on fire") and ORAL PAIN (Sore mouth). At the time of the report, HYPOAESTHESIA ORAL (Numb tongue), BURNING SENSATION (Tongue , cheeks and forehead are "on fire") and ORAL PAIN (Sore mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
devel varicella as did his brother both of whom recvd same lot of vaccine w/o resulting protection
Localized swelling (3x3.5"), pain, redness at site of varicella vaccination. May have had fever @ 24+ hours. Vomited x 1 at 36 hours. No rash, respiratory symptoms or lesions. Parent trested with ice, Tylenol & Benadryl.
5ml syringes that had been provided by Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/21/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Approximately 7-10 days or so after receiving the first dose of the pfizer Covid vaccine I started to develop this red, nodule-like, painful "rash" on both of my forearms. Not only the left arm where the vaccine was administered. This did not go away after a couple of days, and I was instructed by a physician to being taking Benadryl. This appeared to alleviate the symptoms (no visible red nodules anymore)  4-5 days prior to my second dose, so I stopped the medication and presumed it was done. Then, within 4-5 hours of receiving my second Pfizer covid vaccine, I broke out into the same red, painful, nodule-like "rash" along both of my forearms. This time was worse than the previous reaction. I was instructed to take Allegra at the time by a physician, which I did for approximately 4 weeks. This seemed to get rid of the symptoms I was experiencing, and I could not visualize the nodules on my forearms anymore. However, after approximately 2 weeks, I noticed a painful and swollen vein in my right forearm, opposite arm to the one I received the vaccine in. I did not think much of it at the time, since I had no other associated symptoms. Then, over the next couple of weeks, it appeared to become more swollen and painful. Also, I saw another swollen vein near my knee. On April 6, I had labs drawn and CBC, CMP, TSH, and ESR came back normal, but the CRP was elevated. Thus, I was instructed to begin aspirin 325mg, which I took for 4 days beginning April 8th and ending April 12th. On April 13th, an official ultrasound confirmed a DVT in my right popliteal vein, a superficial thrombus in my proximal great saphenous vein, and a superficial thrombus in my right forearm where the pain originated from weeks prior. The initial presumption at this time is that the clots are vaccine-related, but could be linked to an underlying blood disorder that was triggered by the vaccine. Blood hyper coagulation labs have not yet come back. I was initiated on Eliquis starting April 12th for the DVT.
A report has been received from a Health Professional concerning 49 year old, male subject, who had been receiving FLUMIST QUADRIVALENT.  FLUMIST QUADRIVALENT started on an unknown date. The patient was inadvertently administered with FLUMIST QUADRIVALENT at the age over 49 years which started on 01-OCT-2014. The outcome of the event inadvertent administration of FLUMIST QUADRIVALENT to a patient over 49 years of age is unknown. The report was considered to be non-serious.
Late 3rd dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first two doses around 1996).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Late 3rd dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-JUN-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 3rd dose of Engerix-B, which led to incomplete course of vaccination.
Low grade fever (100.0), nausea and fogginess around 7 pm.  Patient admits to donating blood around 5 pm on the same day.  She was not treated with medication and the next day her symptoms subsided
patient had no adverse reaction, but he was under 18 at time of administration.  He had an incorrect birthdate on vaccine consent form.
Burning, itching on leg with vaccine injection on first day, resulting in a red rash the following evening and developing into blisters.  Dr. diagnosed with Shingles on Saturday Nov. 21, 2009 at 11AM and prescribed Acyclovir to be taken for 5 days.
Migraine, chills, whole body aches, nausea, itching at injection site.
Just 3 hours after vaccination administration my son starting hysterically screaming non stop for 3.5 hours. His cry I would describe as high pitched so hard that he'd be out of breath choking. I could not calm my son down with anything I did. I was never so scared in my life. The doctor would not even recommend an alternative to help if this happens. Had I not asked, she would not even recommend to get infant Tylenol. Because she did not even described a needed dosage for an infant I had to call her home that night while baby screaming on my arms to tell me allowed dosage according to his weight. When baby finally calm down after 4 -5 hours I held him in my arms all night just to make sure he was breathing.
Initial report was received on 30 August 2012 from a non-health care professional. A female patient (age not reported) with a history of migraines had received on 29 August 2012 an intradermal right deltoid injection of FLUZONE Intradermal, lot number UT4470AA (invalid) and an intramuscular left deltoid injection of Hepatitis B, lot number AHBVC111AA and "within one hour" after vaccination, experienced a one inch in diameter red, swollen area at the right deltoid. The patient also reported that her mouth and throat felt like they were swelling. The patient reported no difficulty breathing or swallowing, but stated her swallowing felt "different". According to the reporter, the tongue appeared slightly swollen and had a white coating on it. The was to be evaluated by a physician. No treatments or concomitant medications were reported. The patient had no illness at the time of vaccination. No other information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
On Wednesday 5-23-07 symptoms were puffiness, soreness, heat at the injection site.
Caller reported an improperly stored administered PROQUAD; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-SEP-2020, it was administered to the patient an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) as prophylaxis. The vaccine administered experienced a temperature of 6 degrees Fahrenheit (F) to 14F (11.7F), for 25 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
pt recvd vax 21APR93 & exp a local react manifested by redness, swelling, heat & soreness; subsequently pt recovered; No further details were provided;
At approx. 3:30 pm 12/14/10 pt developed sudden onset of body aches, headache, fatigue, rash on neck - face flushed. Rash gone by next day. Facial flushing eased up late morning 12/15/10. Headache eased up some 12/15/10 after taking 4 ADVIL - but still had sl. h/a. Pt denied local reaction - also denied SOB, dizziness, chills or nausea.
four days after receiving the Moderna vaccine I began feeling painful lumps under my right armpit which is the arm that was vaccinated. I am currently experiencing these painful lumps under my arm pit, along pain breathing throughout the day.
Patient experianced red and soreness at site of injection and realized big red mark on her back and it was hurting. On 06/29/2016 she had rash on her back, around her stomach, on her arms and shoulders. Patient was seen by her dermatologist 07/08/2016 and they had prescribed her triamcinolone cream, Dove soap/lotion and Benadryl.
Palpitations palpitations/flutter lasted approx 1 week intermittently  Narrative:
Patient reports no side effects or issues.  It was discovered during vaccine documentation that the patient had received another Covid shot 3 days prior.  Error occured when pharmacy clerk wrote Moderna on the paper vs RSV (the intended vaccine).  Doctor informed of error.
Sore throat; head cold; This is a spontaneous report from a contactable consumer, the patient. A 71-years-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration on 09Mar2021 at 10:30 (at the age of 71 years old) as a single dose for COVID-19 immunisation. Medical history included COPD, depression, anxiety and panic disorders. The patient was allergic to sulphas, alpha blockers and effexor. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), bupropion XL (MANUFACTURER UNKNOWN) and mirtazapine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 06:30, the patient experienced sore throat and felt like head cold symptoms. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore throat and head cold symptoms were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
vision disturbances; inflammation on the brain; my brain just did not want to function at all; having problems with inflammation that has gotten worse; having problems with inflammation that has gotten worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 immunization. The following information was reported: NONINFECTIVE ENCEPHALITIS (medically significant) with onset 2021, outcome "unknown", described as "inflammation on the brain"; MENTAL IMPAIRMENT (medically significant) with onset 2021, outcome "unknown", described as "my brain just did not want to function at all"; INFLAMMATION (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "unknown" and all described as "having problems with inflammation that has gotten worse"; VISUAL IMPAIRMENT (non-serious) with onset Mar2021, outcome "unknown", described as "vision disturbances". The events "inflammation on the brain", "my brain just did not want to function at all", "having problems with inflammation that has gotten worse", "having problems with inflammation that has gotten worse" and "vision disturbances" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: elevated, notes: I had was showing elevated information; magnetic resonance imaging: unknown results. clinical course:Consumer stated, "I am in curious over if there has been any reporting of inflammation from the Pfizer vaccine itself? I started having problems with inflammation that has gotten worse and it started like a week or so after I had the second shot. So I was wondering if there is any report that has been reported about inflammation and last week I was told I have, probably they are going to be doing a biopsy but they think there is inflammation on the brain." While paraphrasing the concern: Consumer stated, "Yes well it is shortly after about, I have to look at, it is probably was about 2 weeks, maybe a week after second shot, I have some symptoms. When I had the second shot, the day of it, where my brain just did not want to function at all and I just went and rested. About a week, week and a half, like two weeks later, I started noticing vision disturbances and they have stayed. That was in March so I have these vision disturbances from quite a long time that. Since second shot and then it is been progressing. because of the eye symptoms, they thought maybe the brain has inflammation."
at first she had left arm ached and tingling such as when you hit funny bone and went down to finger tips und lasted through the night and prevented her from sleeping. then had low grade fever for a couple days. nothing extreme.  diarrhea 3 days after shot. hives and rash still present. still sore. now itches.
Bad pain at injection site and swelling starting 1 hr later, and lasting over 1 week. Decr over time but lasting at least 10 days. bad rash all over body, worse on both arms, rash on upper legs as well with rash lasting at least 10 days.  Peeling skin both arms, legs, moderate, lasting through day 6. Swelling in face, arms, legs, torso - Severe. Lasting at least 10 days.  Dizziness,  starting  2 hr, lasting at least 10 d. Weakness - start 2  hr. last at least 9 d
Mother states high pitch dry for 2 days, very fussy, and never happened before according to mother. Dr diagnosed patient on 01/18/06 with abdominal colic, Dr didn't find any other abnormal findings on office visit.
I am a physician who received Covid vaccine on Thursday morning 12/17.  Over the proceeding 24-48 hours, I developed mild headache and fatigue to extent napped Saturday.  Tuesday 12/22 developed muscle soreness right buttock radiating behind left knee and intermittently down to left heal, and a sensitivity to touch behind that leg.  I thought I was developing sciatica. Muscle aches and sensitivity worsened and was having aching with intermittent shooting pains in pelvis and both legs to extent worked standing up.  No weakness, change in bowel or bladder. Christmas eve late afternoon, developed severe headache, body aches limited to pelvis and below, and extreme sensitivity to skin (painful to sit on toilet).  Headache was so severe I vomited sick times and contemplated going to ER as concerned about meningitis.  Also with fever. I have a history of csf leak repaired via laminectomy in 2015 and have never been as sick as I was Christmas even overnight.  By Friday afternoon able to get out of bed and alternate ibuprofen/tylenol. Headache became less severe with mild body aches limited to lower body and symptoms persisted days. Sunday, temp still elevated at 101.5, the Monday 100.2, Tuesday 99.4, and Weds 12/30 97.4 and finally back to baseline.  I had a negative Covid rapid antigen test Sat 12/26 at 4pm and another neg Covid pcr test Monday afternoon 12/28.  Other than fatigue, I am back to baseline.  I would like guidance regarding whether to proceed with 2nd dose as I am very concerned I experienced aseptic meningitis.
pt recv vax & exp burning sensation across back, sore arm, pain in neck & shoulder, disorientation, forgetfulness & hallucinations; devel a fever & flu-like sx;
Involuntary muscle twitches, jerks, movement in various places and sometimes multiple ones at once - two weeks following shot: fever, lethargy.
A couple of weeks after my 2nd dose of the Moderna vaccine, my legs started hurting. At some times, the pain was quite bad. It was like really bad body aches but only in my legs. It would last for a couple of days and then come back randomly. My doctor recommended using compression socks, but that only made the pain worse after removing the socks at the end of the day.
Fever of 105.8 spiked at around 5am the day after the shot. I was already alternating Tylenol and ibuprofen to keep the fever down. I began taking ibuprofen at about 6pm  the day of the shot.
Approximately 24 hours after second dose, dizziness, nausea, headache, fever.  Duration of approximately 18 hours.
Was asleep, sat up jerking and trembling. Unresponsive to touch or grandparents voice. Lasted 3-5 minutes. Very lethargic afterwards.