chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart racing often; shortness of breath; lethargic; extreme brain fog; weight gain; muscle fatigue; headaches; body aches; This is a spontaneous report from a contactable consumer(patient) reported that. A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 11:00 (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 34 years). The patient past Medical history included known allergies: Penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. on 29Apr2021 18:00, the patient experienced Heart racing often, shortness of breath, lethargic, extreme brain fog to the point where I couldn't do my work, weight gain, muscle fatigue, headaches and body aches. The seriousness criteria are disability. The events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received. The event outcome was recovered with sequelae on an unspecified date in 2021.
p/vax pt had sz & taken to hosp; hosp rpt a sudden onset of stiff neck w/nausea;pt rpt stomach hurting;released
Patient reported dizziness and trouble breathing following first dose of COVID-19 vaccine. The patient was  tachypneic with respiratory rate of 30s (trach in place) on room air with HR 102, BP 175/85, and satting 100%. A code was called, and the patient was given IM epinephrine and transported to the emergency department for monitoring for possible allergic reaction versus trach issue.  Workup in the ED was negative, and the patient was discharged.
dizzy; migraine; fatigued; This is a spontaneous report from a Non-contactable consumer (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jun2021 15:00 (21-years-old at the time of vaccination), as dose 1, single for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that, on 09Jun2021 (24 hours after 1st dose), felt very dizzy and fatigued. Had to leave work and go home early due to feelings that I might pass out. Thankfully, I did not pass out. Patient had a migraine for the rest of the day, was fine 36 hours after dose. Patient did not take any treatment for the event. The clinical outcome of the events was recovered on 10Jun2021.  No follow-up attempts are needed. No further information is expected.
LEFT Shoulder where kinrix vaccine given erythema, induration vessicles 10.5cm X 11cm.On 6/20 only few crusts from vessicles, otherwise completely resolved.
listlessness; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (listlessness) and PAIN IN EXTREMITY (very sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN CALCIUM (LIPITOR) and WARFARIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced LISTLESS (listlessness) and PAIN IN EXTREMITY (very sore arm). At the time of the report, LISTLESS (listlessness) and PAIN IN EXTREMITY (very sore arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.   This case was linked to MOD-2021-015944 (Patient Link).
Mother was dx with zoster 2 weeks before onset of child's symptoms. 3 siblings also have symptoms.
103.9 temp after Tylenol doses and then bloody urine leaked and have had blood/mucus with each urination since.  Tylenol, hydration and rest only treatments
FLUZONE HD and PNEUMOVAX 23 were administered on the same day, but in different arms. Patients left arm started swelling the day after administration and a rash was present. Swelling and rash went from upper arm past the elbow.
Within 6 hours I had overwhelming headache with injection site pain that radiated up to my ear and down to my elbow. I had lymph node pain and swelling. The next 36 hours I felt general malaise with a bad headache which continued to linger throughout the week.  A few days later on Feb 4 at 3am I woke up with extreme chest pain and trouble breathing. I was rushed to the hospital where I had an NSTEMI event resulting in a cardiac cath/thrombectomy  removing a rope-like blood clot in an otherwise healthy heart.
Local skin reaction - mild redness. Patient instructed: BENADRYL, TYLENOL, warm compresses.
vertigo 2 weeks after covid vaccine.  has continued for 2 weeks after it started (4 weeks post dose). vertigo severe enough to potentially cause fall. patient had to sit on ground until the symptoms alleviated.
RECEIVED A SECOND BIVALENT DOSE.  FIRST DOSE OF MODERNA BIVALENT 50 MCG/0.5MLS WAS GIVEN 11-12-22.  SECOND DOSE OF PFIZER BIVALENT 30MCG/0.3MLS WAS GIVEN 4-1-23.
Fever 101, heart palpitation, onset approximately 90 minutes after receiving MMR.
Patient stated that she had the normal symptoms the first couple of days. On day 10 patient received a sudden onset of joint and muscle pain. Pain made it uncomfortable to walk.
Pt c/o heart palpitations, head pressure, and feeling hot. Reports relief of symptoms at time of arrival to med obs #1. Pt offered water, accepted. Declined snack. Pt refused w/c. Escorted to exit by staff with spouse. No s/s of distress noted. Pt ambulatory independently at time of d/c to home. VSS. VS are as follows: 1316: BP 149/87, HR 71, RR 18, O2 sat 98% on RA 1322: BP 166/90, HR 78 ,RR 18, O2 sat 99% on RA 1325: BP 150/94, HR 76, RR 16, O2 sat 100% on RA
Got H1N1 injection 11/17/09 in arm. Noon today,11/18/09, developed hives on butt, went to Dr., stated adverse reaction to H1N1. Rx BENADRYL.
pt received bivalent Pfizer booster on 9/11/2022.  she presented to pharmacy for another booster today and we administered bivalent Pfizer today
Information has been received from a licensed practical nurse concerning a 15 year old female patient who on 25-AUG-2009 was vaccinated intramuscularly with a dose of 0.5 ml of GARDASIL (Lot #659184/0843Y). There was no concomitant medication. According to the nurse on 27-AUG-2009 the patient fainted and fractured her jaw. Since then, the patient had had irregular heartbeats and was seeing an unspecified specialist. Additionally, the nurse mentioned that the office was notified by the patient's mother until 28-SEP-2009. The patient's mother continued to call the office and reported that her daughter continued to be very sore and tired. According to the reporter, the patient was previously very athletic and healthy and at the time of the report she got tired easily. The patient was sent  for evaluation by an unspecified family physician. The patient had an abnormal EKG with Holter monitor. At the time of the report the patient had not recovered. Follow up information has been received from the licensed practical nurse who indicated that the patient was a female student with no known allergies/reactions and no pertinent medical history who on 25-AUG-2009 was vaccinated with her first dose of GARDASIL (Lot #659184/0843Y) in her left upper arm at 11:30. There was no illnesses reported at time of vaccination. According to the nurse, at the time of the report the patient had not recovered. The nurse also mentioned that the patient saw a family doctor and was referred to the another facility. Follow up information has been received from the licensed practical nurse who stated that she had not heard any more and that the patient went to another facility. No further information is available.
Later that day I became dizzy, severe migraine, rash at site, redness at site, extreme arm pain, neck stiffness and pain, jaw pain, nausea.
Left upper eyelid spasming several times an hour day and night for about 10 days, then starting to lessen to every couple of hours day and night
Pt found down and pulseless in home by husband. EMS called, Pt found to be in PEA arrest. Pt achieved ROSC with CPR and Epinephrin. Pt Passed away on 09/07/2021 at 1330. Pt was in multisystem organ failure.
Sudden onset of seizure activity while at a student volleyball game on 4/25- I have no seizure history with myself or anyone in my family.
On Friday, 4/9, I experienced a fever of 103.3, sore throat, earache on the left side, swelling on the neck and face, swollen tonsils, white stains on my tonsils, headache, toothache, and terrible muscle pain.  When I went to the emergency room on 4/10, I received a dose of dexamethasone  15ml and was instructed to take Tylenol.   On 4/11, I had no further symptoms after taking the dexamethasone.   On 4/12 in the AM, my fever (101.4 F), sore throat, earache on the left side, toothache, headache, more swelling on the neck started to occur. I took Tylenol for the symptoms.;   I was feeling very tired and weak the entire time and experienced severe dizziness.   On 4/13, my body started to bruise up on the left side of my body (foot). Then, I developed a bruise on my left shin and left hand. I had severe tremors and shakes. I went back to the emergency room on 4/13 and lost consciousness in the waiting room.   My left tonsil started to develop black spots on it. My doctors at the emergency room did not know what this was. I was given dexamethasone via IV and clindamycin 150MG X3/day X 6 days.   On 4/13, my left buttocks developed shingles.   On 4/16, I had a visit at my doctor's. I still had swelling on the face and neck, my bruises grew in size. My doctor prescribed me Valacyclovir 1gm X1 tablet X 3/day X 1 week.   From 4./16, these symptoms persisted for about 10 days before I began to feel better.
Immediate (within 15 seconds) tracheal/ chest heaviness and tightness with dyspnea. Mostly resolved within 30 minutes although lingering chest tightness over the next few hours. No wheezing. Approximately 9 hours later, severe myalgias and rigors. Abated with ALEVE. Back to baseline by the next morning.
No known adverse effects; on 19/08/19 a 20 year old patient received a dose of PROQUAD; This spontaneous report was received from a health professional and refers to a 20-year-old patient of unknown gender. No information regarding patient's concurrent conditions, medical history and concomitant medications was reported. On 19-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot #S003861, expiration date 08-AUG-2020 (dose, route of administration, anatomical site of injection were not provided) for prophylaxis. No adverse effects were reported.
Severe Brain Fog and dissociation to the point where I could not go to the bathroom or feed myself at its worst. I was hospitalized for 3 days.
Patient came in on 10/16/17 complaining of redness and swelling at injection site. Affected area was large and hot to touch. Suggested patient go see her doctor. She came back a few hours later with a prescription for KEFLEX and stated the doctor diagnosed her with an under the skin infection.
Faint rash all over body, mainly near belly button on waist--clusters of red dots red dots all over chest, back, arms, thighs Itches a little but not really. Mainly you can see it.  Also having some muscle pain and pain at the injection site.
Unknown number of patients received doses from 9 vials that had went through a temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Unknown number of patients received doses from 9 vials that had went through a temperature excursion) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Unknown number of patients received doses from 9 vials that had went through a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Unknown number of patients received doses from 9 vials that had went through a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
This is a 92y.o. female with significant past medical history of HTN and COPD that presented to the hospital with chief complaint of chest and abdominal pain. Chest pain began 4-5 days ago and did resolve temporarily with Tums. Chest pain is described as achy pressure and is located underneath her ribcage and epigastric area with radiation to midsternal area. She admits to nausea, vomiting, and shortness of breath. Denies any fever, chills, chest pain, abdominal pain, constipation, diarrhea, or urinary symptoms.    In the ED, patient hypertensive, afebrile, tachycardic, tachypneic, stable SPO2 on room air. COVID detected on swab. LFTs elevated. Troponin elevated. CXR negative. She has been admitted for further evaluation and management with GI and cardiology evaluations.    Patient seen and examined only by the attending physician. NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.
Within 24 hours of me second Modena shot I started having massive headache. pain at injection start 1 hour after injection. At 24 hours I became to have aches and going between chills and sweat w/ low grade fever. It is now three say out and no adverse results present except are at injection site has started to increase in redness and itching.
negative COVID Spike IgG antibodies protein/failed to achieve immunity/patient had no response to the vaccine/vaccine did not work for her; relationship between Ocrevus and lack of response to the vaccine; This is a spontaneous report from a contactable physician (rheumatologist) reporting for his wife and a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1284/expiration date: 30Apr2021), via intramuscular route of administration, on 16Jan2021 12:00 (at the age of 62 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number:EH9899/expiration date: 30Mar2021), via intramuscular route of administration, on 26Dec2020 (at the age of 62 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Co-suspect medication included ocrelizumab (OCREVUS) from an unknown date with her last dose on 11Jun2020, (7 months prior to first dose of vaccination) via intravenous route of administration for multiple sclerosis. Relevant medical history included multiple sclerosis, sulfa allergy. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021, the patient had a COVID Spike IgG antibodies protein drawn to assess response. The results were negative on two occasions, even after sending the test to a different lab. The patient seems to have failed to achieve immunity. The patient reported that she had no response to the vaccine, as she had no antibody so the vaccine did not work for her. Action taken in response to the event with ocrelizumab was unknown. Treatment was not received for the event. The outcome of the event negative COVID Spike IgG antibodies protein/failed to achieve immunity/patient had no response to the vaccine/vaccine did not work for her was unknown. Since the vaccination, the patient had not been tested for COVID-19. The physician reported that he thinks there is a relationship between Ocrevus and lack of response to the vaccine.
SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial solicited report received on 12DEC2017 from an investigator in a trial. This is a 27 year old male who received immunization with ACAM2000 on 27SEP2017. The patient had no prior cardiac or other relevant medical history. No concomitant medications or vaccines were reported. On 08OCT2017 (12 days after smallpox vaccine) the patient had an abnormal electrocardiogram and troponin I (5.69ng/mL) and a normal echocardiogram. On 17OCT2017, he was diagnosed with myocarditis, unspecified. At the time of the report the outcome was unknown. No further information was provided.
After each vaccine I received 2/28/2021, 3/21/2021 and 10/23/2021. I experienced severe chest pain in heart area, lung pain in both lungs and dyspnea. It went away after 2 days so I did not seek medical help. After each vaccine the adverse reaction was worse. After the 10/2022 vaccine I experienced repeated symptoms on and off until the beginning of May, 2022 at which time these symptoms did not go away. The became so severe that I went the the ER feeling like I was having a heart attack. I was given IV morphine, had a CT of the chest, a chest x-ray and multiple echocardiograms. Diagnosis - pericarditis. I had surgery on 5/9/2022 at which time a pigtail drain was inserted. This did not resolve the problem. On 5/13/2022 I had surgical subxiphoid pericardial drainage by a cardio vascular surgeon. I have now been hospitalized from 5/8/2022 through today 5/14/2022. I was told I will continue to stay inpatient for 2-3 may 4 more days.
Received Flu vaccine 9/30/19. Pain at site of injection (L) shoulder immediately. Pain (L) shoulder has continued since 9/30/19. Saw NP at Clinic for evaluation + treatment. Physical Therapy PT two times a week for 4 (four) weeks.
I was given the Zoster vaccine on Feb 24, 16 and ended up with intussusception. I suffer for 5 months and two days and I told my doctor I believe that vaccine hurt me and he call it stress well 8-3-16 I was operated on. I still have staple. Went to hospital they only took blood and urine. Set one in hall way then said can't find anything.
Pt was inadvertently administered an expired PNEUMOVAX 23 on 10/20/2017 (NDC 0006-04943-01 lot # L029073, expired on 04/19/2017). Spoke to staff/state immunization program, she states vaccine viability is a concern and pt will need to be revaccinated at next visit. Pt has appt scheduled for 12/20/2017. Pt will be advised at appointment as we need Translator to communicate with pt. Provider aware and ok with this plan.
nausea, headache, dry cough, armpits very soar, tiredness, ache body, sore arm at the injection site- symptoms started very mild on April 2 worst April 3 and started to get better April 4 this is on the first shot scheduled for second shot on April 22
Fever, myalgias, arthralgias, tinnitus, headache, dizziness
This case was reported by a nurse via other manufacturer and described the occurrence of passed out in a female patient who received MENVEO. Co-suspect products included TRUMENBA. In June 2016, the patient received the 1st dose of MENVEO (intramuscular) and the 1st dose of TRUMENBA (intramuscular). In June 2016, several hours after receiving MENVEO, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. In June 2016, the outcome of the passed out and dizziness were recovered/resolved. It was unknown if the reporter considered the passed out and dizziness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a Pfizer Territory Manager and was not provided product information by the reporter. The patient's medical history was unknown. Concomitant medication were unknown by the reporter. On 17th June 2016, the non-GlaxoSmithKline sales representative stated that he was on luncheon at a pediatric office and a nurse and a physician shared adverse events for 4 separate patients who received MENVEO and standard 1st dose of TRUMENBA (non-GSK vaccine). They stated that at least 3 patients also received MENVEO on the same day. The reporting sales representative had limited information regarding patient's details (initials, date of birth, age, height, weight and ethnicity was unknown) and adverse events. In June 2016, few hours after vaccination with MENVEO and TRUMENBA on the same day, the patient experienced dizziness, lightheadedness and passed out. The patient went to the emergency department. The date of visit to emergency department and the duration of the visit was unknown. In June 2016, the patient underwent blood test and the blood work was fine. Other investigation was unknown. The reporting sales representative did not have reporting nurse's last name. The reporter email and prescribing email was unknown. The National Drug Code (NDC), lot number and expiration date was unknown for both TRUMENBA and MENVEO. The nurse did not have time to provide that product information at the time of reporting. The patient had not received another vaccine due to the 2nd dose was not due at the time of reporting. This case was not associated with product complaint and there was no medical information request. This case has been linked to cases US2016GSK116036, US2016GSK116037 and US2016GSK116038, reported by the same reporter.