chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient reported that after recieving VARIVAX her "titer exam came back inconclusive"; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) reconstituted with a sterile diluent (strength, dose, batch/lot# and expiry date were not reported for all the suspects) via subcutaneous route for prophylaxis. On an unknown date, the patient had titer examination performed which came back inconclusive (antibody test abnormal). The outcome of antibody test abnormal was unknown. The causality assessment was not provided. There was no product quality complaint (PQC).
On March 24, 2021, the day of the shot, I only felt soreness in my left arm. The next morning, March 25, 2021, I began to feel body aches, chills, and I was in a cold sweat. I took ibuprofen throughout the day to combat the symptoms. The evening of March 25, 2021, the pain was much more severe (body aches all over my body, including my face, teeth, my hands were sore and stiff, etc.). I did not sleep much of the night because the symptoms were very uncomfortable due to the chills and cold sweats. The morning of March 26, 2021, my left armpit began to swell. By the afternoon, my left armpit (the arm where I received the vaccine) was swollen, tender, and soft. There is some redness and the swelling and tenderness are more pervasive. It is difficult to hang my arm at my side due to the pain and swelling. I understand, after calling the nurse hotline, that this is a common side effect but I also have a skin condition (Hidradenitis Supparativa) and it is difficult to know whether flare-ups are triggered by environmental factors.
PATIENT EXPERIENCED REDNESS DOWN ENTIRE ARM, ITCHING AND BURNING IN FACE WITHIN 5 MINUTES OF INJECTION.
About 3 hours or so after receiving my second COVID (Pfizer) vaccine, I started experiencing facial flushing, some facial swelling, redness on my chest and some mild swelling of my tongue.  The flushing and redness and facial swelling lasted until Satudray May 8th and the swelling of my tongue took about 7 days to completely go away.
Patient had nausea, dizziness, shivering, trembling, and sweating, BP 101/51, HR76, RR12, T99.1. Symptoms did not resolve after 25 minutes, ED was called and patient taken to ED. Upon arrival to ED, was hyperventilating and had anxiety. ED BP 121/74 HR77 RR20, T98.2F. EKG normal. Monitored in ED, then discharged once stable.
This case was initially received via Regulatory Authority (Reference number: US-irms-MOD21-127586) on 24-Mar-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, and HYPERSENSITIVITY (allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE REACTION (COVID arm). On an unknown date, the patient experienced VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, HYPERSENSITIVITY, NEUROLOGICAL SYMPTOM, and PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna COVID-19 vaccine). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, HYPERSENSITIVITY, NEUROLOGICAL SYMPTOM, and VACCINATION SITE REACTION (COVID arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  On an unknown date patient saw dermatologist and had a biopsy done, at the time of the report results were unknown.  Patient also reported having pictured available.  Treatment information also included seven days of an antibiotic, 2 topical creams, and an antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information received on 6-AUG-2021 and included new events added and medication information changed. On 06-Aug-2021: TCR was received on 7-AUG-2021 and new event added.
She wasn't less thirsty than before; She is dehydrated; Started having bladder infections; Really sleepy; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Started having bladder infections), DEHYDRATION (She is dehydrated), THIRST DECREASED (She wasn't less thirsty than before) and SOMNOLENCE (Really sleepy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Eye pain (Chronic eye pain.) and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, LISINOPRIL for Diabetes, PARACETAMOL (TYLENOL [PARACETAMOL]) for Eye pain, PIOGLITAZONE HYDROCHLORIDE (ACTOS) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced SOMNOLENCE (Really sleepy). In July 2021, the patient experienced CYSTITIS (Started having bladder infections). On 12-Nov-2021, the patient experienced DEHYDRATION (She is dehydrated). On an unknown date, the patient experienced THIRST DECREASED (She wasn't less thirsty than before). The patient was treated with CEFATRIZINE PROPYLENEGLYCOLATE (CEFTIN [CEFATRIZINE PROPYLENEGLYCOLATE]) for Adverse event, at an unspecified dose and frequency. On 14-May-2021, SOMNOLENCE (Really sleepy) had resolved. At the time of the report, CYSTITIS (Started having bladder infections), DEHYDRATION (She is dehydrated) and THIRST DECREASED (She wasn't less thirsty than before) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, Renal function test: abnormal (abnormal) Dehydrated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant product use included steroid shot occasionally for joints. The patient was really sleepy for ten days, but was ok with that and wasn't less thirsty than before, it wasn't progressing.   This case was linked to MOD-2021-385712 (Patient Link).
My daughter felt significant pain at the innoculation site.  After a couple of minutes she became dizzy and passed out.  Her eyes were open and her arms were tense and bent at the elbows while she was unconscienous.  This lasted for about a minute.  Afterward, she was perspired and felt weak. We were kept in the doctor's office for about one hour and 15 minutes afterwards.
Evening of vaccine date, experienced chills, fatigue.  on Day 2 she developed fever 99.4 & sweats, and chills continued. Day 3 developed pain under arm pit &, headache. Day 4 woke up tired, restless sleep due to chills, stuffy nose and cough. Self treating: Tylenol, rest, fluids. Tested on 2/22/21 for COVID due to cough and stuffy nose. Results pending.
Pt. describes pain in her shoulder and muscles of her Lt. arm.  Has some bruising and finds it hard to move her arm up and down due to soreness.  Denies any swelling at this time. She only takes one ASA 325 mg per day.  No other pain medication. Pain started on Wed. 3/5/08.
Employee reported left sided numbness entire body & face the evening following vaccination. Presently experiencing numbness.
Syncope with posterior head trauma (closed) secondary fall. Low BP. Observation x 15 min, then vomiting ensued. Blood sugar 108 after juice/cookie. Obs. x 45 min, symptoms resolved.
p/vax pt devel difficulty breathing; fever; and dec appetite; findings on exam include: pos posterior cervical adenopathy  to corner of mandibular ramus; lt testes mildly tender to palpation; dx: probable mumps; pt given ibuprofen & APAP
Approx 15 minutes after receiving the shot the area just above injection site began to itch and form a bumpy rash. The nurse who gave the injection had me take Benadryl and she rubbed some cream similar to hydrocortisone cream on the site and asked me to remain under observation. Over the next 15 minutes I developed itching/hives  on the bottom right portion of my back and both sides of my neck. Nurse applied cream to these areas also. The rash at the I next ion site began to spread up my arm so they advised I go to my doctor?s office (located in the same building). When I got there I was experiencing itching in my throat, mucus in my throat (similar to the feeling when I?m getting an allergic asthma attack), the rash was very itchy, very red and had spread up to the shoulder area and around my neck. My doctor looked me over closely, had a nurse give me a cortisone shot, stayed I had an ?immediate reaction? to the vaccine and gave instructions for me to take Benadryl, Xyzal and Pepcid every 4 hours and if symptoms worsened to go to the hospital. She then had me wait in her office for observation while I waited fir my husband to pick me up. Within approx 20-30 minutes of the cortisone injection the redness has gone away and the rash was lessening.
PATIENT NOTED DIZZINESS AND TINGLING AND FAINTNESS MINUTES UPON RECEIVING VACCINE.
SERIOUS INFECTION AROUND HEART; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received Covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced serious infection around heart, she was taken to the hospital. It was reported she might need an open heart surgery. The action taken with Covid-19 vaccine was not applicable. The outcome of serious infection around heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210700618-Covid-19 vaccine -serious infection around heart. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Extreme itching - hives, urticaria. Acute angioedema - Urgent Care Sep. 12. ER - Sept. 15, Sept. 16. Epinephrine shots etc. Both ER visits.
He recieved the H1N1 vaccine around 9:00 am. At he at 12:00 Complaining of chest pain. No Diagnosis, then released from hospital. He Died at midnight (12:00 am) from a ruptured aorta.
Just felt like right arm was punched super hard but it was about 6 hours later. I put heat on it and it's helped alot; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Pfizer en 6199) via an unspecified route of administration in the right arm on 02Mar2021 at 16:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included knees replaced, both hips one 2xs 1 ,3xs both shoulders, rod in lower back for scoliosis and latex allergy. The patient previously received acetyl salicylic acid (ASPIRIN) for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication multi vitamin (C, d3, E, Iron, B12, potassium) (MANUFACTURER UNKNOWN) and vitamin B complex (SUPER B COMPLEX) both  for unknown indication from an unknown dates and unknown if ongoing. On 03Mar2021 at 00:00, the patient just felt like her right arm was punched super hard but it was about 6 hours later and she had put heat on it and it helped a lot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right arm was punched super hard was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Stated he felt achy the day after the shot was given. Today 8/2/07, he states he stayed home from work - had temp of 99 and feels achy all over still. The Tetanus shot was given on 7/31/07.
BEATS PER MINUTE HAD DROPPED BELOW 40; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other company (Pfizer) concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, 1 total administered on 16-MAR-2021 at 14:30 on right arm for prophylactic vaccination. Age at time of vaccination 59 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194 and expiry: UNKNOWN) dose was not reported, 1 total administered on 28-OCT-2021 at 15:45 on right arm for prophylactic vaccination. No concomitant medications were reported. The patient received paxlovid (form of admin, route of admin not reported, batch number: GA8854 and expiry: unknown) dose was not reported, administered from 08-JUN-2022 to 12-JUN-2022 for treatment of COVID-19. On an unspecified date in 2022, the patient experienced suspected covid-19 infection which was suspected clinical vaccination failure (dose number in series 2). On 11-JUN-2022, the patient lwatch started giving her alerts in the middle of the night that her blood pressure per minute (blood pressure per minute) had dropped below 40 bpm (dose number in series 2). This happened while she was on the drug, Patient took all five days, when she stopped the drug it went away. Patient believe it only dropped her BPM about five points. Patient do not believe she was in any danger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from beats per minute had dropped below 40 on 12-JUN-2022, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0:20220647189-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related. 20220647189-COVID-19 VACCINE AD26.COV2.S-Beats per minute had dropped below 40. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event(s) is considered not related.
Information has been received from a licensed practical nurse concerning a 4 month old male, with no relevant medical history, who on 02-JAN-2009 was accidentally vaccinated with VARIVAX (Merck). Concomitant medications and past drug history were unknown. It was reported that on 02-JAN-2009, the infant was given the wrong vaccine while in the pediatrician's office. The licensed practical nurse reported that the patient was doing fine. It was unknown if there was any relevant laboratory data. As of 02-JAN-2009, it was unknown if he would continue to get VARIVAX (Merck) and he was doing fine. Additional information has been requested.
Patient had Sanofi rabies vaccine 4-dose series that was a mixed series with Novartis product, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via regulatory agency (Reference number- 00877948) and transmitted to Sanofi on 30-Nov-2021.   This case involves male patient (unknown age) who was vaccinated with RABIES (HDC) VACCINE [INACTIVATED HUMAN RABIES VACCINE] Sanofi rabies vaccine 4-dose series that was a mixed series with Novartis product, RABIES VACCINE INACT (VERO) (RABIES VACCINE (VERO CELL) FOR HUMAN USE) (Off label use)  The patient's medical history, medical treatment(s), concomitant medications and family history were not provided.  Past vaccination included RABIES VACCINE for an unknown indication  On an unknown date in 2013, the patient received a first dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for post exposure immunization  On unknown dates in 2013, the patient received a second, third and fourth dose of suspect RABIES VACCINE (VERO CELL) FOR HUMAN USE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for post exposure immunization  It was a case of an actual medication error due to Off label use (latency same day)  No adverse event was reported  It was reported "A medical information pharmacist with the manufacturer for RabAvert (Bavarian Nordic) learned of adverse event (AE) information when speaking with a retired optometrist (patient) yesterday. The patient is recently received a 2-dose series of RabAvert for post-exposure prophylaxis. He discussed with the Bavarian Nordic pharmacist that he is experiencing tinnitus 10 days after receiving RabAvert. Through that conversation, the patient mentioned his history of receipt of other rabies vaccination. When he was a middle school child, he received a rabies vaccine series. Then in 2013, he had an exposure and was given a 4-dose series of human rabies vaccine, as prescribed by an infectious disease physician. For this 4-dose series, he reports that he received one dose that was from a Sanofi product and three doses of Novartis product"  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 guidelines. 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.  There will be no information available on the batch number for this case.
At an unspecified time, the pt received an injection of Lymerix. Sometime thereafter, the pt experienced neck pain.
Dull pain in area where shot was administered. Not always present, but comes back every week or so for about a day. Is more noticeable with physical exertion.
pt recvd vax; 1nov95 devel migratory maculopapular rash beginning on ankles which was pruritic;to epidemiologist who determined rash was probably allergic rather than measles;tx w/ hydroxyzine;
CTEPH; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY HYPERTENSION (medically significant), outcome "unknown", described as "CTEPH". The patient underwent the following laboratory tests and procedures: scans/tests: CTEPH, notes: diagnosed with CTEPH after many scans and tests.  Clinical course: Reporter stated that she believed her husband reacted to the Pfizer vaccine they received in Jan/Feb2021. He had now been diagnosed with CTEPH after many scans and tests that started with breathing problems the week after receiving the vaccine. She believed his case needs to be documented, because up until he received the vaccine, none of these problems were on the radar.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Red rash started on stomach and has moved around the body for the last two weeks.  Mostly on the torso. Also palms of hands are really itchy.   Went to allergist who suggested an antihistamine which is turns out I can't tolerate so I'm waiting for further instructions from him on an alternative treatment..   Said it should correct itself hopefully within the next two weeks. said he had seen this with the first booster.    Two weeks in I'm still itchy.
Pt started having Chest pain and palpitations within days after the booster.  After 2 months and noting worsening of the symptoms. the pt followed up with PCP.  Exam and labs led to diagnosis of acute hyperthyroidism.
His preschool noticed he was not acting like his normal self, he started to look warm so they took his temperature and he had a 101 degree fever. For the next 2 days he was lethargic, red cheeked and had a fever between 101-103. He got a "cold" symptoms, stuffy/runny nose, sneezing, a few coughs for the week following.
Urticarial/skin hypersensitivity- on antihistamine and cortisone cream.