chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out in shingles on the right side of lower trunk and lower back and right groin area in front; Breaking out in hives all over  trunk, neck and in hair; This is a spontaneous report from a contactable consumer, the patient. A 56-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 left arm on 18Mar2021 at 00:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included caisson disease, peripheral neuropathy, joint replacement, generalised arthritis, headache, sciatica, drug allergy to Morphene, DHE for migraine. The patient received unspecified other medications 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 28Mar2021 the patient experienced breaking out in hives all over trunk, neck and in hair. On 30Mar2021 the patient experienced broke out in shingles on the right side of lower trunk, lower back and right groin area in front. Roughly on 28Mar2021 began noticing that she was breaking out in hives all over her trunk, neck and in her hair. On the 30mar2021 she also broke out in shingles on the right side of her lower trunk, lower back and right groin area in front. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with medications for pain, steroid salve, steroid pills. The clinical outcome of the event breaking out in hives all over trunk, neck and in hair and broke out in shingles on the right side of lower trunk, lower back and right groin area in front was resolving.   No follow-up attempts are needed; information about lot number cannot be obtained.
On December 5, 2022, I woke up not feeling good. I began to feel weak and tired. I began to feel worse before the night. Within two days I was congested. I tested positive for COVID-19 at home on December 6, 2022. I started to run a fever. I was prescribed PAXLOVID and began to take it Tuesday and was back to work on Thursday.
Tuesday night, January 4th 2022 around 930 I went to bed and laid down and started getting sharp pains in my chest. It lasted about an hour until I went to sleep. The next 2 nights it did the same thing when I went to bed. Thursday night I started to get anxiety when I went to bed because I knew it would hurt when I laid down. I started taking 800 mg of ibuprophen 3 times a day at this point. Nothing was wrong during the day. Saturday I went to the grocery store and had to come home and take a nap and that really scared me. I decided it was time to go to the doctor. Monday the 10th I went to the doctor and they ran an EKG and bloodwork. They saw something in the EKG and sent me to get a chest x-ray of my heart. I asked if I could work out like I normally do and they said I could until it hurt. Wednesday the 12th I went to the gym and had to stop 30 minutes into class and take a break. They following day I made it 40 minutes before my heart started to hurt. The doctor said that I didn't have a heart attack or anything. They said that one of my heart markers was high in my blood and made me come back in on the 17th to check the marker. I went back to the doctor on Friday the 24th to discuss the blood work and check on my heart. The heart marker in the blood is back to normal and my heart doesn't really hurt anymore. I do feel it from time to time, I never really paid attention to my heart before. I do now.
ONE OF TWO PTS WHO 30 HRS AFTER INJECTION COMPLAINED OF HEADACHE, MALAISE, FATIGUE AND FEELING WARM.  ALSO EXPERIENCED LOCAL REACTION:  SWOLLEN, RED AND HOT TO THE TOUCH.
Patient called on 11/10/11 and stated that she had bruising after the vaccine was given which resolved but that her upper arm was hurting. She denied any erythema, swelling, redness, warmth, or fevers. She had not seen a physician yet and was instructed to follow up with a physician.
a slight sore throat and cough with a slight fatigue; a slight sore throat and cough with a slight fatigue; body aches; chills; fatigue; mild fever; diarrhea; nausea; This a spontaneous report from a contactable nurse (patient).  A 26-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EJI685, unspecified route of administration on 30Dec2020 15:45 (at the age of 26-years-old) as 1 single dose in the right arm  for COVID-19 immunization.  Medical history included Polycystic ovarian syndrome (PCOS) and anxiety. Concomitant medication included ascorbic acid (VITAMIN C) colecalciferol (VITAMIN D), zinc and birth control. The patient was allergic to sulfamethoxazole and trimethoprim (BACTRIM) antibiotics. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The next morning after receiving the vaccine the patient had full body aches, chills, fatigue, mild fever, diarrhea, and nausea. These all resolved within 24 hours as the next day (2nd day after vaccination). The patient felt much better, and only had a slight sore throat and cough with very slight fatigue.The full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events full body aches, chills, fatigue, mild fever, diarrhea, nausea, a slight sore throat and cough with a slight fatigue. Outcome of the events full body aches, chills, fatigue, mild fever, diarrhea, and nausea was recovered. Outcome of the events a slight sore throat and cough with a slight fatigue was recovering. Since the vaccination, the patient has not been tested for COVID-19.
? 10/15 Fever 101.2, body aches, sore throat, headache, jaw ache, earache ? 10/16 Severe and sudden stabbing pain on right side below Brest, centered.  Lasted 30-60 seconds at 114 pm ? 10/16 3 sharp pains in the left side of my neck too at 635 pm ? 10/17 Feels like costochondritis now ? 10/17 eve rapid onset of diarrhea and low fever 99.7 ? 10/18 Extreme abdominal pain extending into lower back.  Low grade fever 99.9.   Legs feel heavy
Fever and chills: Night of 6May thru mid day 8 May Body Aches: 7May thru 8May Headache: 7May thru 8May Chest tightness: 9May -  still ongoing)
Pt. is MD at our facility.  Was walking to his office 20 min after vaccine and had onset of lightheadedness and diaphoresis.  Walked to ED and was evaluated.  No chest pain, sob, wheezing,   NO rash/hives/  no facial or oral swelling. Initial BP 158/46;  P 130  Po2 100%;  Exam otherwise normal Given IV fluids and IV solumedrol in ED;   all sx resolved and he returned to work approx one hour later I saw him 4 hours later - no further sx;  vital signs stable
Received a Dose of HEPLISAV-B Subcutaneously; Initial report received on 28-Jul-2023 and 01-Aug-2023  A lab supervisor reported that a male in his early 50's (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization subcutaneously.  No medical history, allergies, or concomitant medications were reported.   On 26-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot # 943241, expiration date 06 Sep 2025, and NDC # unknown) subcutaneously in the left bicep using a 25-guage needle, which "did not go deep enough." The lab services supervisor administered the dose. No adverse reactions were reported.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient received dose #2 of Pfizer vaccine from ATC Vaccination Services LLC. in and was notified by email that vial was left in freezer past recommended time frame. Medication was expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/12/2021 as recommended. No adverse reactions identified on site.
Headache, Myalgia, Fever, headache, lack of appetite, fatigue, chills Narrative:
severe body aches; chills; fatigue; cervical and left axillary lymphadenopathy; left axillary lymphadenopathy; muscle weakness; This is a spontaneous report from a contactable physician reported for herself.  A 48-year-old female patient received first dose of BNT162B2 (Pfizer product), intramuscular on 21Dec2020 10:15 at single dose on left arm for COVID-19 immunization.  Medical history included High cholesterol, insomnia, ongoing penicillin allergy, covid-19 from 13Nov2020 to an unknown date and pneumonia from an unknown date (the patient was tested positive for covid on 13Nov2020 and was hospitalized on 23Nov2020 with pneumonia).  Concomitant medication included atorvastatin calcium (LIPITOR), zolpidem tartrate (AMBIEN), escitalopram oxalate (LEXAPRO), colecalciferol (VITAMIN D), fish oil (FISH OIL OMEGA 3) , zinc (ZINC), ascorbic acid, dexpanthenol, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopheryl acetate (MVI) and bifidobacterium lactis (PROBIOTIC).  The patient previously took niacin and experienced drug allergy.  The patient received injection at 1015 am at 0300 am on the following day (22Dec2020) she experienced chills, severe body aches, fatigue, cervical and left axillary lymphadenopathy and muscle weakness, woke up the next day and was asymptomatic except the left axillary lymphadenopathy which is still present today on 24Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid tested post vaccination. No treatment was received for the events. The outcome of the event left axillary lymphadenopathy was not resolved while of other events was resolving. The reporter assessed the events as non-serious. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event severe body aches cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.
Covid19 breakthrough.  1st vaccine received on  02/15/2021.  63 y/o PmHx anxiety, arthritis, Fempop bypass, CKD, Bladder/ureteral/Kidney CA, pyelonephritis, COPD, Transitional cell CA of Right Kidney s/p Right Nephrectomy, cystoprostatectomy and Ileoconduit, smoker presents to ED with increased Left flank pain, decreased urine output after recent stent to ileoconduit.  Pt afebrile, Room air sat 99%. Per MD asymptomatic to Covid.  Placed on IV abx.
Patient has had numbness and tingling both arms, weakness of legs and fatigue since 2 days after his Covid Vaccine Jan 6th. Has had 2 syncopal episodes since then. Had a syncopal episode Feb 15 and again 2/26/21
fever; chills, rigors; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) and CHILLS (chills, rigors) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (chills, rigors). At the time of the report, PYREXIA (fever) and CHILLS (chills, rigors) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Hives to arms, legs and torso.  No change since onset. No medication taken.
Initial information received on 06-Nov-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a female patient (age not reported) who experienced flu shot with the chemicals took out her heart and she almost died, while she received vaccine FLUZONE HIGH DOSE. The patients past vaccination(s) included pneumonia vaccine and got bronchitis. The patients past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and Exp. Date not reported via unknown route in unknown administration site. On an unknown date, the patient experienced flu shot with the chemicals took out her heart and she almost died (cardiac disorder) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as life-threatening. Reporter stated that the flu shot has aluminum, formaldehyde, and mercury in the shot. She had a defibrillator now. She had given the flu shot herself. Details of lab data not provided. Final diagnosis was (Life-threatening) cardiac disorder. It was not reported whether the patient received a corrective treatment. The event outcome was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a female of unknown of age who presented with cardiac disorder (unspecified) after vaccination with FLUZONE HIGH DOSE and reported that she almost died due to the event. The time to onset is unknown. Moreover, there is no information regarding patient's age, past history, medical condition at time of vaccination, details of the event and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Pt recvd 3 doses of Engerix-B on 25JUL90, 20AUG90, & 16JAN91 & was found to be a non-responder;
Patient stated she had the Pfizer #2 vaccination end of April (unsure of date) and 1 week later became symptomatic with SOB.  For 3 weeks she felt SOB with CP.  She presented to hospital and found to have bilateral pulmonary embolisms.  Please contact patient for further details.  She states she is very healthy and does not have risk factors for clots.  She requested I fill out this form for her.  I spoke to our pharmacy and they directed me here.  I do not know all of the details therefore more investigation should be performed.
Bruise covering left arm, muscle pain, fever 100 degrees, headache, and extreme fatigue.
5 inch by 3 inch red raised tear drop burning, itching rash at the injection site
Daughter phoned to say dad experiencing dizziness . Headache, hoarseness shortly after immunization, but didn't say anything at past history
Sharp painful continuing headache, dizziness, hot/cold body  sweats, joint aches, extreme tiredness
About 10 days after the shot in my left arm Developed a red itchy rash that was very hot to the touch it was probably 6 inches across and 4 inches wide.
Pt has vertigo with lightheadedness, pressure on back of head, and no appetite for 3 days following FLUBLOK IM shot.
No adverse effects were reported; MMR II was inadvertently administered to a patient today 8/23/2023, and it expired on 8/4/2023; This spontaneous report was received from a physician referring to a 34 year old patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 23-AUG-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, lot # U024229, expiration date: 04-AUG-2023 (strength, route, dose number, anatomical location and indication were not provided) for prophylaxis (expired product administered).  The healt care professional also asked about the need for revaccination.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 29-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Within 1 min of vaccine administration, patient said he did not feel well and started convulsing briefly (5-10 second), he then started blacking out and lost control of his speech and his body. Pt sweated profusely and said he felt a burning sensation in his urethra. Called 911 for paramedics. They checked his BP, pulse and BG . All came back normal . Did not follow paramedics to ER
Patient fainted, hit the floor, and began to seize. His mother was present.  We called 911 and attended to patient. He came back to consciousness after 3-5 minutes, sat up and began to vomit. We got him sitting up and talking. First responders arrived and assessed patient. He and his mother left walking out the door with first responders to their car.
had  knot at injection site which got bigger and she had pain up to her shoulder and continued to the top of her shoulder to her back to her spine. Pain got so bad she couldn't turn her head without it hurting. Stiffness in her neck and pain subsided to her ears. Blisters erupted in the top of head under her hair it was itchy and painful.
31 year-old female got the first Pfizer vaccine around 11AM. She started getting hives and flush and then started to feel like her eyes and bottom of tongue were swelling. No difficulty breathing or swallowing. Bottom lip feels swollen. She feels a little tight in her chest but this can be baseline for her. She took Zyrtec at 12:30PM and hives have started to improve. She has never had an allergy to a vaccine in the past.
Still having a temperature of 101; vaccination site erythema; Fever; Chills; Soreness in injection site; Warm to touch; Muscle aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PAIN (Soreness in injection site), INJECTION SITE WARMTH (Warm to touch) and MYALGIA (Muscle aches) 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 No adverse reaction.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PAIN (Soreness in injection site), INJECTION SITE WARMTH (Warm to touch), MYALGIA (Muscle aches) and ERYTHEMA (Red). On an unknown date, the patient experienced PYREXIA (Still having a temperature of 101). At the time of the report, PYREXIA (Fever), CHILLS (Chills), INJECTION SITE WARMTH (Warm to touch), MYALGIA (Muscle aches), PYREXIA (Still having a temperature of 101) and ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
At first he was sick and had fever , migraines, body aches. The next morning he was dizzy and kept following against the wall and couldn't swallow. Finds out he had 3 different strokes.
Immediate nausea, followed by extreme diarrhea for next 36 hours along with sever chills.  No fever.  Same thing happened with first shot on 3/8/2021 but this time was much worse.  Have had similar reactions to other vaccines and boosters.  Believe allergic to polysorbate which has given me food issues before.  Did not know this was in the vaccine or I would have better prepared for the reaction.
fever, chills, body aches, nasal congestion, loss of taste, chest congestion. starting 10/3/21
Pt came in to clinic for second dose of COVID vaccine. Patient stated after the first dose around 9 PM she noticed she had hives in her body. She went to the ER and was given a steroid shot and then returned home, Pt denies other s/s.
This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were administered with an unspecified number of improperly stored dose of RECOMBIVAX HB injection (lot # K021444 with expiration date 17-SEP-2016 and lot# K008986 with expiration date 01-APR-2016; dose and route were not provided). There was no concomitant medication reported. It was unknown if the patients sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports receive from the same reporter. Additional information has been requested.