chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/6/21: Received Vaccine around approx. 3:15pm.  10/6/21: Approx. 11pm woke up with a severe headache, cold sweats, chills, very sore elbow and knee pain, joint pain, shallow breathing, and dizziness when standing up. Lasted roughly 8 hours.  10/9/21: Approx. around 6:15am, noticed a slight pressure in the chest area. My heart beat felt off, very rapid, then hard heart beats, shallow breathing continued. Could not conduct my usual work pace. Could not go on my usual jogs. Heart beat seemed very off and very concerning.  10/10/21 - 10/24/21 = I continued to feel the same sensation as stated above on 10/9/21 during this time period. I tried to tough it out and hoped everything would go back to normal during this time period of 10/10/21 to 10/24/21. Chest pressure, shortness of breath and this feeling as if my heart would drop, then catch back up and start beating fast which would throw off my bodily actions/movement.  10/25/21 = At 1:13am I had woke up due to chest pains. Same area where I have had the pressure. I was scheduled to see my oncologist on 10/26/21. At 1:23am on 10/25/21 I had messaged my oncologist doctors office to make my condition known and if they could test for any blood clots, chest issues, blood issues, or anything else that could possibly be causing this. The only change made to my body was getting the vaccine on 10/6/21. I have never experienced these feeling I have been feeling. I jog 3 times a week, exercise 3 times a week and maintain a good diet. I do not do drugs, I do not smoke, and I occasionally have a few seltzers/cocktails on the weekend to relax.  Evening of 10/25/21 to 10/26/21: My hands and feet became numb, followed by my face and tongue. I woke up my roommate to take me to the ER. On the ride My hands began cramping beyond control along with my feet. This moved into my forearms and legs. I could not move my arms, legs, or neck. I could not open my eyes and my body felt as if it were shrinking and becoming  suffocated. I did all I could to breath to what I felt was, to just stay alive! It was traumatizing to myself and my friend.  10/26/21 till present: I still have the same chest pressure and experience the heart drop, off timing heart beat. I have to take it easy and really watch my heart rate. I have never had to do this in my life.
Generalized exanthem with onset 24-30 hours after receipt of 12 month vaccines (IIV SKB lot #UT5691NA), MMR (MO15930) PREVNAR (Wyeth R41774), varicella (Merck M039905) on 22 FEB 2017. She states at about 30 hours post vaccine, she was notified by the day care when she picked him up to inspect a dermatitis that had been noted during the day. She states it was generalized including abdomen, legs, hands and neck, erythematous, flat macular. She denies vesicles, papules or pustules. She denies observing pruritus. He has no systemic symptoms and seemed otherwise well. She states she took him to ER and they thought it was hives and he was treated with 7 days of prednisone and ZYRTEC. There was no oral/facial/throat or tongue swelling, flushing, conjunctivitis, wheezing, cough, SOB, nausea or emesis. The dermatitis cleared at 7 days except the abdomen which cleared at 8 days.
Adult patient received a pediatric dose; Adult patient received a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 36-year-old male patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date unknown) for prophylaxis.   On 27th April 2022, the patient received Engerix B pediatric. On 27th April 2022, unknown after receiving Engerix B pediatric, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt date: 28-APR-2022 Reporters comment: Immunization coordinator reported an adult patient received a pediatric dose of Engerix-B. The reporter did not consent to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix-B, which led to adult use of a child product and underdose. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071347:Same Reporter US-GLAXOSMITHKLINE-US2022071352:Same Reporter
Pertussis; Very sick; This case was reported by a consumer via interactive digital media and described the occurrence of pertussis in a 3-month-old male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced pertussis (serious criteria hospitalization, GSK medically significant and life threatening) and sickness (serious criteria hospitalization). On an unknown date, the outcome of the pertussis and sickness were unknown.   It was unknown if the reporter considered the pertussis and sickness to be related to DTPa vaccine.  Additional details were provided as follows: The patient was exposed to a 5 year old who they said had bronchitis.  The patient was very sick.  The patient was diagnosed with pertussis in emergency room after swan test. The patient was not old enough to receive the 2nd dose of DTP vaccine, thus immunity was not good. The patient almost died and was 10 days in intensive care unit (ICU). At the age of 6 months the patient was with suction machine. It was reported that,the 5 year old tested for pertussis and had no bronchitis. The patient's parents did not believe in vaccinations.      Lab Comments: on an unknown date patient underwent swan test.
I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 05/10/2023. I contacted a provider and got a prescription for an antibiotic but on the advice of my pharmacist I didn't get it. I did get a prescription for PAXLOVID. I tolerated the medication without any complications. As of today, I do not have any lingering symptoms.
Vaccine given to the patient as she was 16 years old; A spontaneous report was received from a nurse, concerning a 16-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273)/product administered to patient of inappropriate age.   The patient's medical history as provided included COVID positive on 09 Feb 2021. Products known to have been used by the patient, within two weeks prior to the event included benzoyl peroxide 5% topical cleanser.  On 18 Feb 2021 at 03:30 pm, the patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection considered as product administered to patient of inappropriate age.   It was reported that the patient was doing well with no signs and symptoms.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event Moderna vaccine given to the patient when she was 16 years old/ product administered to patient of inappropriate age was considered as resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age, for mRNA-1273, lot #: 016M20A, with no associated AEs.
Left neck and collar bone stiffness and pain; left lower back pain. Continued throughout night, helped minimally with ibuprofen.
10/08/03 9am noted 1/2 dollar size red swelling at injection site. This increased to a red hardened area the size of a baseball. Mother was advised by pediatrician to apply hot compresses and administer Tylenol. Size and reddness dissipated over the course of the following day. Mother denied fever. Observed unual fussiness.
Dizziness; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 15:00 (Lot number: EN6207) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "rheumatoid disease" (unspecified if ongoing); "vitaligo" (unspecified if ongoing), notes: too many to fit here; "Known allergies: Yes" (unspecified if ongoing), notes: allergic to many, many things. Concomitant medication(s) included: ACETAMINOPHEN; COENZYME Q10 [UBIDECARENONE]; CALCIUM. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, nausea.  Additional information: No Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient called RN 11/9/09 and reported feeling some pain/discomfort in her shoulder which she thought might be as a result of her Flu shot administered on 10/22/09. Patient saw her Dr. on 11/13/09. Patient stated her Dr. was treating her for tendonitis.
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a 20-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). In 1993, the subject had completed the hepatitis B series. Concurrent medical conditions included exposure via blood. On 18 September 2013 the subject received booster dose of ENGERIX B vaccine (unknown route and injection site) after a blood exposure. 2 days after vaccination with ENGERIX B vaccine, the subject experienced hepatitis B surface antigen positive. At the time of reporting, the outcome of the event was unspecified. This is one of the 2 cases reported by the same reporter.
client arrived to observation tent. After recieving vaccine c/o of dizzines . Client was placed on grass. EMS and doctor paged to observation site. VS taken at 2:10. 97%02 HR -68 116/81. Client is then placed to chair and states he stills feels dizzy. Client was then placed back to supine position. Then reassed to see if he was stable to sit. Client states he dont feel confident driving home. Wife was called and picked client wife picked up at 3:13. AOX4.
Rectal Bleeding; cytokine response; inflammatiory response; inflammatory wheezing; can't eat; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal Bleeding) and CYTOKINE STORM (cytokine response) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder (no longer have). Concurrent medical conditions included Immunocompromised (Immunocompromised/Primary immune deficient).   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal Bleeding) (seriousness criterion medically significant), CYTOKINE STORM (cytokine response) (seriousness criterion medically significant), INFLAMMATION (inflammatiory response), WHEEZING (inflammatory wheezing) and FEEDING DISORDER (can't eat). At the time of the report, RECTAL HAEMORRHAGE (Rectal Bleeding), CYTOKINE STORM (cytokine response), INFLAMMATION (inflammatiory response), WHEEZING (inflammatory wheezing) and FEEDING DISORDER (can't eat) outcome was unknown.            Patient had antibiotics which did not work initially.  Patient received steroids.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Concomitant products were not provided.  Patient was immunocompromised, primary immunodeficient and received a IGG replacement therapy and also auto-immune.  The action taken for m-RNA-1273 COVID-19 Moderna Vaccine was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Woke up with nerve/throbbing pain in right side of face including, ear, eye and back of head,jaw and inside of mouth. Has continued for 3 days now.
covid vaccine breakthrough   dose 1 Moderna 2/18/21 013M20A dose 2 Moderna 3/18/21 030A21A
Rec'd vaccine on June 27, 2017 - as soon as the injection was administered - it pained and burned terribly as it went into my arm. I mentioned it to the nurse immediately. It immediately became swollen and redness after that. and was hot - gave me weakness in my right side and dizzy. Dr. sent me to Radiology for complete 3D mamogram - Following week or so Dr. sent me to emergency room - Aug 26, 2020 three years later my right bust and right arm are still large than the left. Records and photos included. Thank you for taking the time to review my report. HPI: 18:40 This 76 yrs old female presents to ED via Walk-in with complaints of right arm swelling. 18:40 Patient presents with right arm swelling which started 9 days ago after she received the pneumococcal vaccine for the first time. She states that the vaccine burned initially when it went into her arm and since then she has been having intermittent itching, dizzy episodes, fatigue. She has right arm swelling, pain which radiates into the bilateral breasts. She told her PCP about the symptoms and he sent her for a mammogram and breast ultrasound 1 week ago at radiology. The results were unremarkable. She states she continues to have persistent symptoms and cannot take Benadryl because it makes her agitated. She was taking Motrin 800 mg which did not help. She called her PCP again today and he told her to come to the emergency room. She denies fever, chills, headache, cough, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, numbness/weakness in the extremities. She had surgery on her veins in February 2017 and has had bilateral leg edema since then which is unchanged. History obtained from patient.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Global Medical Information (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA277871, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised. It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949996, 20210949974, 20210949322, 20210950120, 20210949808 and 20210950006.
the patient died after getting the Pfizer BioNtech Covid vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reporting same event under the same suspect product for 6 patients. This is one of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253281 same reporter,same vaccine, same adverse event, different patient; Reported Cause(s) of Death: unknown cause of death
I was preparing doses for the day for a vaccination and was preparing to pull a dose for a patient. The patient and I started to talk and I got distracted, did not pull the dose and injected him IM with no dose but pull the syringe back and pushed in alittle, upon realization, I pulled the syringe out, wasted it and apologized that I stuck him with no dose in the syringe, and promptly administered the vaccination in the other arm so patient would receive his second dose
Received vaccine between 2:01 PM & 2:07 PM. 2:30 PM breathing difficulties, coughing, squeezing in chest. Wife took him to clinic at 4:00PM - given epinephrine & cortisone - started n/v, shaking of (L) hand, garbled speech. Was sent from clinic w/i by ambulance to hosp. Admitted.
Symptoms:  Fever, congestion, nasal discharge, sore throat, cough, myalgia in the last 1-2 days.  Slowly worsening.  Possible exposure at school.
(This was booster, Pfizer. prior had been moderna) 1 day post vacation : tired 2 days post vacation : severe daytime headache that required bedrest. Unable to function. Severity and headache type Not typical for me. Analgesics not effective. Subsided evening. 7 days post vacation : severe daytime headache that required bedrest. Unable to function. Identical to prior.. Analgesics not effective. Subsided evening.  Ongoing thru ~20 days post vacation ; Extreme exhaustion/fatigue : eg  - needed to pull over and close eyes during 20m daytime drive home for driving safety.  - need for daytime naps (atypical for me) - brain fog, brain mush, inability to think things through. (Atypical, I am a database developer and IT Support tech, was unable to function adequately in my job, to the point I thought something was wrong with my brain and wondered  if I was getting  early dementia!   Symptoms faded out by about 20+ days
Vaginal spotting/bleeding; Abdominal cramping; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 08Sep2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), the patient have an intrauterine device (IUD) and did not have a menstruation cycle in three years, prior to IUD, the patient had oral contraceptives without menstruation for 25 years, and COVID-19 on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and azithromycin (ZPAK); both from unknown dates for unknown indications and experienced allergy to antibiotic. On 10Sep2021 at 09:00, (also reported as three days after vaccination), the patient experienced abdominal cramping and had vaginal spotting/bleeding. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 09Sep2021, the patient underwent a binax test (COVID test) via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vaginal spotting/bleeding and abdominal cramping were recovering at the time of this report.
The pt experienced head to toes red bruised lesions. Almost chicken pox like in appearance. Onset was within 15 hours of administration. This was accompanied by a low grade fever.
Reports woke up with rash 10-09-2020 10-10-2020 Woke up with swelling to her face and reports her left eye was swollen shut. Sought medical treatment, was given steroids. States she is fine today. 10-16-2020
This spontaneous report as received from a registered nurse refers to a patient of an unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot# L023587, expiration date: 26-JUN-2017 (dose and route of administration were not reported). There was no adverse reaction reported. Additional information has been requested.
Patient contracted COVID after being fully vaccinated.  No booster fever, fatigue, anorexia, abdominal pain.
He presented to my office 04/14/21 with chest pain. Seen subsequently by cardiology and diagnosed with early pericarditis on 04/15/21.
No other AEs reported.; an expired dose of VARlVAX was administered to a patient; This spontaneous report as received from a vaccine coordinator referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.         On 26-JUL-2021, the patient was vaccinated with expired varicella virus vaccine live (oka/merck)(VARIVAX) 1 injection (dose, strength, route of administration and anatomical site of vaccination were not reported, lot # S022757, expiration date reported as 22-JUL-2021) for prophylaxis (expired product administered). The outcome of expired product administered was unknown. No other adverse events reported.