chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18 year old previously healthy male whom presented to ER today in setting of chest pain experienced 1 day s/p COVID vaccine with concern for post COVID vaccine myocarditis.    Patient had his Pfizer COVID booster shot on 5/10. He initially developed headaches the day after and severe back pain which persisted. He was unable to lay back due to the back pain and vomited x 1 after taking tylenol for the pain. On 5/13, day prior to presentation, he began to develop anterior substernal chest pain, 10/10 at its peak, currently 0/10, with no aggravating or alleviating factors. He does report occasional palpitations. No notable fevers, dyspnea, presyncope, syncope, abdominal pain, diarrhea, change in color, chills, cough, diaphoresis, edema, orthopnea.   He presented yesterday where he was noted to have elevated and up-trending troponin on high sensitivity testing (5/13 @ 1600 10,683, 5/14 @ 6am up to 14,925), with elevated creatinine kinase 338, and CRP 32.1. His chest pain had improved by the time he got to the ED waiting room but given the findings he was admitted to inpatient floors for one night, initially concerned for NSTEMI, and written for ASA, statin and Lovenox DVT PPX but ultimately did not get them. Cardiology was consulted for concern of COVID vaccine myocarditis. EKG notable for ST segment changes with mild ST elevation in V2, and depressions in V4-V6. ECHO with normal function, trivial TR/MR. Patient was accepted for transfer to inpatient cardiology. Patient was transferred to alternate hospital for evaluation for presumed post Covid vaccine myocarditis. He remained hemodynamically stable and without ectopy. He had no arrhythmia and ST segment abnormality on EKG was mild. He had an elevated troponin on admission to 0.84. Given his symptoms and troponin leak, he received IVIG (2g/kg) and steroids (Methylpred 30mg IV BID) per protocol. Troponin was down trending and 0.15 on day of discharge.  Echo was performed which revealed low normal LV function (see report below); cardiac MRI was performed on 5/16, report remains pending at the time of discharge.  Methylpred was transitioned to prednisone to complete a 5 day course.  Chest pain resolved and his EKG normalized  5/31 follow up visit: Patient has been doing well since discharge. He went back to work. At the end of the day, he had a bad headache, was tired and vomited. This was also the day after stopping the steroids. He has been back to work, and this did not occur again. He denies cardiac symptoms, specifically no chest pain, palpitations, shortness of breath or syncope.  Post vaccine myocarditis. Admitted 5/15 with chest pain, troponin leak and ECG changes post Pfizer vaccine. Echo with borderline LV function. Treated with IVIG + steroids. Normal cardiac MRI. Patient remains restricted from vigorous physical activity for 3-6 months. We will plan to do an exercise stress test around 3 months prior to clearance for sports participation.
Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it; Headache; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) (seriousness criterion medically significant), HEADACHE (Headache) and MYALGIA (Muscle aches). At the time of the report, MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) outcome was unknown and HEADACHE (Headache) and MYALGIA (Muscle aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included medicine for high blood pressure everyday (unspecified name).  The patient might go to emergency room  because her doctor was concerned if she was having a stroke.  No treatment information was provided.  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.; 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.
the booster put her away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "no problems"; COVID-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "no problems". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "the booster put her away".  Additional Information: The reporter stated that she felt depleted after her booster dose and had to drag herself out of bed the next day and that she knows someone who also had no problems with the first two doses, and then the booster put her away.  The lot number for BNT162B2 was not provided and will be requested during follow up.
6d ago received TDAP to (R) upper arm -> 3d later dev. redness & blister. (R) upper arm: quarter size bulla intact with erythema to (R) lat. No warmth. No papula. Drained bulla using 18ga. needle -> SILVADENE -> drsg. F/u 3d.
SkinRash METHYLPREDNISOLONE 125 MG ONCE 125 mg/1 VIAL INTRAMUSCULAR NOW, PREDNISOLONE 20 MG EVERY DAY TAKE FOUR TABLETS BY MOUTH EVERY DAY FOR 2 DAYS, THEN THREE TABLETS BY MOUTH EVERY DAY FOR 2 DAYS, THEN TWO TABLETS BY MOUTH EVERY DAY FOR 2 DAYS, THEN ONE TABLET BY MOUTH EVERY DAY FOR 2 DAYS, TAKE WITH FOOD
I21.4 ACUTE NON ST ELEVATION MI 4/28/2023 ACUTE NON ST ELEVATION MI
mom reports fever of 103-104.2 R which began about 2 hrs post vax; inconsolable crying, did not ear or sleep, & that pt's head would hang to one side & would stare; (lasting 1-2 mins);
GAVE BIVALENT BOOSTER AS INITIAL DOSE. THERE WAS A LANGUAGE BARRIER AND INITIALLY WHEN ASKED BY BOTH PHARMACIST AND TECHNICIAN THAT HE SAID YES WHEN ASKED IF WANTED BOOSTER. AFTER SHOT GIVEN, PATIENT ASKED WHEN NEXT SHOT WAS. PHARMACIST SAID NO EXTRA SHOT WAS NEEDED AFTER BOOSTER LIKE THE INITIAL SERIES.  PATIENT THEN SAID HAD NOT FIRST DOSE.
Mild Flu like; Headache; Cough; Fatigue; Sore Arm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTTS" (unspecified if ongoing), notes: POTTS. Concomitant medication(s) included: LOSARTAN. The following information was reported: COUGH (non-serious) with onset Jan2021, outcome "unknown"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown"; HEADACHE (non-serious) with onset Jan2021, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset Jan2021, outcome "unknown", described as "Mild Flu like"; PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "Sore Arm".  Additional Information: Patient Experienced 1st -5th doses mild flu like, HA, SL Cough, Fatigue, Sore Arm 48 Hrs.Other medications in two weeks was Multivit, losartan. Yes, other vaccine in four weeks, Other vaccine 4 weeks product was Pfizer. Yes, COVID tested post vaccination and no prior vaccination. Sender's Comments: Linked Report(s) : PFIZER INC-202201380992 same patient and different drug dose/events.;
92-year-old male with history of CHF presents emergency department by EMS from local residential facility.  He is complaining of difficulty breathing.  He was hypoxic at 86% on room air at the nursing home.  He arrived on a CPAP by basic EMS and is 96%.  He got an albuterol treatment in route.  He recently tested positive for COVID.  He denies chest pain.  No fever.  He is nontoxic in appearance.
pt recvd vax;exp a "nickel taste " in mouth & numbness in arm;could not move arm fully for 3 mo because lost sensory & motor control; no lab work done;
Headache; Diarrhea; Fatigue; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 36-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 left arm on 30May2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 31May2021 at 00:30, the patient experienced headache, diarrhea, fatigue and pain at injection site. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events headache, diarrhea, fatigue and pain at injection site was resolved on31May2021.   No follow-up attempts are needed. No further information is expected.
pt recv vax 20FEB96 & 45min later pt became flushed, achy, fatigued, devel a h/a & was perspiring profusely;went to bed 9PM that evening & slept until 2PM the following day;awoke did not have any energy;
No ADR, timing ERROR 2nd dose given 49 days after 1st one Narrative: No ADR, timing ERROR 2nd dose given 49 days after 1st
anxious; This is a spontaneous report from a contactable physician. A 9-decade-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on Jan2021 as SINGLE DOSE for covid-19 immunization. Medical history included cardiovascular disorder and cerebrovascular accident. The patient's concomitant medications were not reported. The patient reported, he came in for dental appointment. Had received first dose of Pfizer Covid-19 vaccine late last week. Has multiple underlying cardiovascular issues including previous stroke. Normally very calm. Patient was extremely anxious and unable to sit long enough for dental appointment. Seemed somewhat agitated as well. The outcome of event was unknown.  Information about lot/batch number has been requested.
Severe flu-like aches. Swollen vertebrae top of neck. Difficulty sitting up for extended periods of time. Movement of left shoulder, arm, and neck very limited and extremely painful. (Literally crying for 3 days due to pain).
There was no adverse reaction.  The patient had requested a Shingrix vaccine and was given the COVID vaccine instead.  The tech who entered the vaccine did not realize he wanted Shingrix and processed a COVID shot, as there were multiple COVID shots being given at one time.  The patient was made aware of the shot he was getting and gave verbal consent.  The wife came for her shot after him and verified what shot they were receiving, at which point the staff realized the mistake.  The couple actually did want to get the COVID vaccine series, but they did not fall within the eligible phase yet.
Patient states had facial redness when he work up the next morning and progressively got worse as the day went on. By Sunday symptoms were worse with Right Eye swelling shut, Right ear very swollen and rash and hives progressing down right side of body. Neck and Throat are red with rash. Hives progressed down the back side of  Right Leg--Hives behind Right Knee--Mother gave patient Benadryl OTC, Mother tried topical hydrocortisone and hydroxyzine 25 mg.
During monitoring period post Pfizer COVID-19 vaccine, pt experienced throat tightness and left arm itching. Patient reported she had a slight headache prior to administration of Covid vaccine. Patient denied allergic reaction symptoms prior to leaving the COVID vaccine clinic.
Patient stated to Lead RN that she was feeling "itchy" on her arms and legs and that scratching did not relieve the itchiness after receiving her second dose of Pfizer vaccine. She stated it was the same reaction she felt as the first dose.  EMT & Lead RN did not obverse any signs of distress or indication including hives or redness on skin. Patient stated she was not experiencing any SOB and upon observation by EMT Lead RN her breathing appeared unlabored and within normal limits.  Lead RN authorized EMT to give 50mL Diphenhydramine HCl oral solution per protocol and a water bottle at approximately 2:15pm. Patient stated at approximately 2:30pm she was no longer feeling itchy. Lead RN &EMT educated patient regarding s/sxs of adverse reaction and when to go to the ED/call MD.
MUSCLE PROBLEMS IN HER ARMS AND LEGS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; TONGUE NUMB; THROAT NOT RIGHT, IT FELT SCRATCHY AND STILL GRAVELLY; LIPS SWOLLEN; This spontaneous report received from a patient via other company (Pfizer Inc) concerned a 65 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to carvone which was in essential oils, and allergy to mint. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had developed muscle problems in her arms and legs after the vaccine (Dose number in series 1). The patient received non-company suspect Moderna covid-19 vaccine, (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient also received non-company suspect Moderna covid-19 vaccine, (elasomeran), (Dose number in series 3), (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). The patient also received non-company suspect drugs Nurtec ODT, (rimegepant sulfate), (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 30-APR-2023 for an unspecified indication.  On 30-APR-2023 at night, after the drug Nurtec patient experienced throat was not right, it felt scratchy and was still gravelly, lips was swollen, and tongue was numb (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose 2), and elasomeran (dose 3) was not applicable; and action taken with rimegepant sulfate was not reported. The patient had not recovered from throat not right, it felt scratchy and still gravelly, lips swollen, and tongue numb, and the outcome of muscle problems in her arms and legs and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
(R) upper arm with blanching/redness noted approx. 1/2 dollar size. Pt c/o itching- mild swelling which was improving remarkably. No evidence of cellulitis. Tx: Rest, ice and BENADRYL PRN. Pt declined and will continue to monitor.
Pt called 10-17-14 to ask if certain side-effects were common w/HIGH DOSE flu shot. Pt states pain bicep which radiates to her neck. No irritation or pain at actual injection site. Pt states pain subsided for few days then came back.
Noticeable lung tightening within 10 minutes of shot. Cleared within the next 10 minutes. Noticeable but slight shortness of breath for the next 2 days, followed by sharp lung pain in the right lung on day 3 which lasted for about 2 hours, then subsided and there were no more issues.
Patient reported hives on underside of the right arm from armpit to elbow. Patient has had rash for ~4 days, but was vaccinated 11 days ago. Patient was instructed to take benadryl at bedtime. She had been trying to use Aloe gel for relief with no improvement. Recommended to stop Aloe and use OTC Hydrocortisone cream.
PATIENT HAD A LUMP SINCE THE DAY OF INJECTION ON THE INJECTION SITE.
The area around the injection site turned white, and the area around the white turned red.  It became swollen, started burning/itching and there was heat in the red area.  The swelling and redness progressed to the elbow.  There was pain in the elbow joint once the swelling and redness hit there.  I was treated at an urgent care facility, was given a shot of antibiotics and then a prescription for a sulfa antibiotic.  On the 31st I went to emergency room because the swelling and redness was not abating.  I was given Augmentin.  Both emergency room and the urgent care facility said it was MRSA.  But there were no open wounds.  No blood work was done and no one reported the reaction.
Information has been received from a person at a physician's office concerning a 7-year-old female who on 23-SEP-1999 at 10:30am was vaccinated in the deltoid with a second dose of Varivax (lot# 628027/1257H). On 23-MAY-2006 at 15:47 pm the patient broke out all over in chickenpox. Unspecified medical attention was sought. At the time of this report the patient's chickenpox continued. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 26-FEB-2014 the patient was vaccinated with GARDASIL INJ via intramuscular injection (lot#, dose and dose# unknown) into the gluteal muscle in error. No known adverse effects. The outcome and action taken were not provided. Additional information has been requested.
Approximately 8 hours after receiving the second dose I experienced itching at the injection site on my arm, sore arm, nausea, body aches, chills, high temperature  up to around 103, fatigue and restlessness,  my heart was racing, and I was experiencing Pulsatile tinnitus in my ears where I could hear whooshing sounds that I assume were of my heartbeat.  This lasted for two days and started to get better around the 3rd day.
I woke up and looked in my mouth and my tongue is pebbly and grayish black.  No ulcers so far, as I saw under "Covid tongue" on the internet.
The patient had severe anxiety so mentally she was obviously freaking out but physically she was fine; When administering the vaccination, the needle came of the syringe so the patient did not get the entire dose; When administering the vaccination, the needle came of the syringe so the patient did not get the entire dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. Other Case identifier(s): US-PFIZER INC-202101835380 (Pfizer).  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 20Dec2021 (Lot number: FJ8757, Expiration Date: Feb2022) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codein, reaction(s): "Allergic to codein", notes: Allergic to codein. Vaccination history included: Covid-19 (DOSE 1; MANUFACTUERER UNKNOWN), when the patient was 44 years old, for Covid-19 immunization; Covid-19 (DOSE 2; MANUFACTUERER UNKNOWN), when the patient was 44 years old, for Covid-19 immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 20Dec2021, outcome "unknown" and all described as "When administering the vaccination, the needle came of the syringe so the patient did not get the entire dose"; ANXIETY (non-serious) with onset 20Dec2021 20:30, outcome "unknown", described as "The patient had severe anxiety so mentally she was obviously freaking out but physically she was fine".  Additional information: The patient did not receive any other medication prior to COVID-19 vaccine. Pharmacist reported that the patient probably received only half or less than half of the vaccine due to the needle that had came lose while she was given the vaccine. Some went in her arm and some didn't. The injury was the same as with a normal vaccination.   Follow-up attempts are completed. No further information is expected.
Began as fine red papular rash on right upper arm spread over the next three days to both arms and both legs. Also had slight upper lip swelling on day four. had intense itching. Began Benadryl intermittently on day four, regularly on day five and six. Rash was gone by day seven except slightly on legs. No trouble swallowing or breathing. No hives.
had blood spew out of the injection site; This is a spontaneous report from a contactable consumer. This consumer reported for 3 patients. This is 1 of the 3 reports.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: E19126), via an unspecified route of administration on 23Jan2021 (at the age of 73-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jan2021, after receiving the second dose of vaccine, the patient lost a lot of blood, there was excess bleeding at the injection site. He was the third patient that had blood spew out of the injection site. It was explained that the bleeding lasted about an hour, it was not a lot but shot right out of the puncture, where the jab was at the injection site. The clinical outcome of the event was resolved on 23Jan2021.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021760094 same reporter/product/event, different patient
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 20-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Development of chest pain and dyspnea. Large pleural and pericardial effusions requiring drainage.  No evidence of CHF by echo or BNP. Fluid was found to be exudative rather than transudative. No growth of infectious agents found to be causal. ESR and CPR extremely elevated. All self resolving after thoracentesis and pericardiocentesis.