chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed symptoms of MISC on 1/26/22; fevers began on 1/28/22 with a Tmax of 40.2 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, shock, sinus tachycardia, hypotension, cough, shortness of breath, pneumonia, chest pain, abdominal pain, vomiting, diarrhea, mucocutaneous lesions/conjunctivitis, headache, and near syncope. Abnormal labs included thrombocytopenia, elevated fibrinogen, elevated CRP, elevated ferritin, and elevated D-dimer. ECHO studies showed coronary artery dilatation, left ventricular dysfunction, trivial mitral regurgitation, mitral stenosis, severely dilated aortic annulus, and mildly dilated aorta. Patient was admitted to the hospital on 1/30/22 and treated with IVIG, infliximab, norepinephrine, and high flow nasal cannula. He was admitted to the ICU from 1/30/22 to 2/1/22. He was discharged on 2/4/22.
Patient received Moderna Covid-19 vaccine on 1/29/21. Patient was seen by provider on 2/2/21 and reported initial minor soreness in right shoulder that progressed to limited shoulder mobility. Patient stated that she is unable to lift her arm overhead without help from other arm. At time of visit, patient stated that she feels symptoms are improving and are managed with ibuprofen. Patient reported that she believed that the vaccine may have been given too posterior. Patient was diagnosed with SIRVA - Shoulder Injury Related to Vaccine Administration. Patient received referral for physical therapy if needed. Provider recommended supportive care and gave patient education/information regarding range of motion exercise.
No additional AE reported; the nurse was placing the safety lock on syringe the barrel where the needle screws into the syringe broke /There is 1 unit with an alleged defect; Poor quality device used; This spontaneous report was received from a medical assistant (also reported as a nurse) referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions and allergies, concurrent conditions, and concomitant drugs were not reported.   On 06-SEP-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (strength: 0.5 ml, 1 dose, product qty: 1, lot#: X005583, expiration date: 10-DEC-2024; route of administration was not reported) for prophylaxis. After the administration, when the nurse placed the safety lock on syringe, the barrel where the needle screwed into the syringe broke (also reported as "the part where the needle attached to broke off" and "broken syringe tip") (needle issue). There was 1 unit with an alleged defect. It was unsure whether the syringe had a broken component. The syringe tip cap was attached properly prior to use and intact, undamaged with seal on receipt. Complete vaccine was administered to the patient (poor quality device used). No dose was missed. No one was hurt, neither the nurse administering or the patient. It was "repeat user" who administered the vaccine. It was unsure whether the syringe had a broken component. No additional adverse event (AE) was reported (no adverse event). As of 07-SEP-2023, the product was being shipped back to manufacturer.
pt recvd vax & 24 hrs later exp SOB & fatigue; pt sx lasted 2 wks;
After vaccine I had a normal reaction of feeling fatigued, and there was a point within days of the vaccine that I felt like I was in a fog or daze, and has lasted up until a couple days ago. A week after my booster vaccine, when I would get up and get dizzy and I fell back twice. That is when I gave a call to 911, I went to the ER by ambulance, blood work, EKG. I was released the same day after about 8 hours. Since then I have felt in a daze and I can't really think straight or focus on anything in general. The daze is starting to go away. I have set up an appointment with a neurologist. I also had night sweats the first two nights post vaccine.
On day 2 after the 2nd dose vaccine, that evening I had sweats, chills and fever was 104. I took Tylenol and alternate with Motrin every 6 hours. I woke up the next day, I had severe flu-like symptoms-body aches, weakness, migraines, fever, chills, dizziness, nausea and loss of appetite. I stayed in bed to rest and sleep. I went to see the doctor on 7/1/2021 because I developed a urinary infection and pneumonia. I had shortness of breath, fatigued, low grade fever, urinary pressure and frequency and urgency. They did blood work, urine culture and CT scan which confirmed pneumonia and UTI. I was prescribed Levaquin which has resolved both my UTI and pneumonia. I am still suffering from symptoms and side effects from the vaccine. I have daily full body pains and aches, headaches, fatigue, chills, loss of appetite and unable to work or do normal daily activities.
Oral ulcers on my looking like Aphthous ulcers with similar ulcer on my urethral meatus 24h after taking my vaccine
Received flu shot 7pm 10/20, developed difficulty breathing at school after lunch (also peanut allergic, but no known exposure) and was found by school nurse to be be wheezing, pale, diaphoretic, tachycardic and to have a fine urticarial rash. Patient improved with 2 puffs of albuterol, an inhalation treatment with albuterol and pulmocort, and 25mg. of Benadryl.  He was essentially well when evaluated in office within the hour and was continued on medications.
4 hours following COVID vaccine administration to L shoulder, patients experienced moderate pain and restricted L arm range of motion.
This spontaneous report received from a parent concerned a 21 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced terrible body ache, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible body ache, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210439312, 20210439367 and 20210440719.
fever or chills,  cough,  sore throat, stuffy or runny nose, muscles that hurt.
Approximately 2 hours following vaccine administration, patient began to feel short of breath and had chest pain, so they returned to the vaccine clinic. From there, she was taken to the ED.  Was observed for 45 minutes following the vaccine without any signs or symptoms of reaction. On arrival to the ED, she had redness without hives on the anterior portion of her neck. At that time, patient denied shortness of breath or chest pain. Given 25 mg diphenhydramine po in the ED. Discharged home with instructions for use of Benadryl if needed.
chills; body aches; Fever 102.1; This is a spontaneous report received from a contactable other hcp (patient). A 22-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 04Feb2021 11:30 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Birth control medication was reported as concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 05Feb2021 21:00, the patient experienced chills, body aches and fever 102.1. The patient underwent lab tests and procedures which included body temperature: 102.1 on 05Feb2021. The outcome of events was recovering.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report was received from a certified medical assistant refers to an unspecified pediatric patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. ON 28-APR-2014, the patient was vaccinated with first dose of VAQTA vial 25/0.5 ml (lot #, dose, frequency and  route not provided) Then, subsequently, on 07-OCT-2014, the patient was vaccinated with the second dose of VAQTA (less than six months after which was outside there commendations in the VAQTA prescribing information). No adverse effect reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 59 year old female. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported,1 total, administered on 05-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  The patient received additional non-company suspect vaccine included: BNT 162 (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 05-NOV-2021 on right arm for prophylactic vaccination.  On 27-DEC-2021, the patient took nasal swab PCR (polymerase chain reaction) test. On 28-DEC-2021, the result came positive, hence had confirmed clinical vaccination failure and confirmed covid-19 infection (Dose number in series 1 and 2). The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209329. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as the only indication the patient had Covid but does refer to any symptoms) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20211263449-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. 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
Patient had significant swelling, redness, and pain at the injection site 2 days after vaccination. The injection site was firm to the touch and was still growing at the time.
After her first dose her injection arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After her first dose her injection arm was very sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that the patient had never been diagnosed with/tested positive for COVID-19.  Patient did not have chronic or long standing health conditions or acute illness at the time of vaccination month before. .  Concurrent medical conditions included Drug allergy (Aspirin).    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (After her first dose her injection arm was very sore). At the time of the report, VACCINATION SITE PAIN (After her first dose her injection arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided.  No treatment medication was provided.   This case was linked to MOD-2022-533243 (Patient Link).   Reporter did not allow further contact
Extreme headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9269) via an unspecified route of administration in the arm left on 20Feb2021 at 11:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and penicillin 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 medications included olmesartan medoxomil (BENICAR), venlafaxine hydrochloride (EFFEXOR), atorvastatin calcium (LIPITOR), trazodone hydrochloride (TRAZADONE), menthol, capsaicin (ALLEVE) and Motr all for unknown indication from an unknown date and unknown if ongoing. On 22Feb2021, the patient experienced extreme headache.  The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain 2 inches below injection, rash around 2 1/2 inches in diameter. After several days became itchy, almost unbearable. Still persists 16 days later. Reported to my PCP on 10/06/2023.
Narrative:  Pt is a 82y.o. male who died on 03/03/2021 w/ h/o DM, COPD, HTN, RA. Pt received Moderna Covid-19 Vaccination 2/2 on 02/10/2021. Unlikely that Moderna Covid-19 vaccine caused/contributed to pt death.
Less than one hour after shot - extreme sense of needing sleep. Took 30 minutes nap in car after stopping at convenience store.   Over the next 36 hours, loss of strength, extreme aches and joint pain, fever up to 101.2, fatigue,
I had the usual symptoms the first day after, fever/chills etc. It?s now a week later and I have had heart palpitations for 4-5 days, blurred vision and an urgency to urinate. I have felt faintish as well. I am hoping this passes soon.
vaccine was administered 4 day beyond use date. Contacted her to inform her and check on any adverse reactions. Patient states the she had a red hot arm where injection was given but that since has gone away.
Initial reaction was mild pain and swelling at the injection site.  That is normal for me; I took no medication.  However, by three days later pain and swelling had not subsided; I continued without medication.  By five days out, site remained swollen, red and was itching considerably; I used topical antihistamine.  Continues swollen and itching on sixth day; continue to use topical antihistamine.  This is totally abnormal for me.
Server chills, extremely high heart rate though out the night, muscle weakness, dry cough, swollen legs.
Pain in left arm shooting down arm. Tingling. Shoulder pain that hasn't resolved as of 10/09/2014.
I had the Moderna vaccine on the 08/20/2021,  the next day I got my period with some body pains headache and tiredness. Then in 2weeks time (4th sept,2021) I experienced vaginal bleeding with clots which lasted for 9 days during those days I also experienced  the following:  Heavy breathing  Headache  Tiredness Cold Irritated throat, all these lasted for a week.   During the course of these symptoms as I was waiting to c my PCM  I was only taking painkillers and vitamin c .
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concurrent conditions or medical history provided. In 2010, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU), subcutaneously (dose, lot # and expiration date were not reported). Concomitant therapies included COREG. On an unknown date, about two weeks later following ZOSTAVAX vaccination, the patient developed mild case of shingles. The patient received unspecified treatment for the event. The outcome of shingles was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
First symptom was sore injection site.  This occurred about 10 hours after the injection.  Body and joint soreness started at 14 hours after injection.  Also experienced chills but did not record a fever.    Also developed a persistent headache beginning at 14 hours post injection and lasting for about 48 hours depending on treatment.   Experienced fatigue for about 48 hours after injection.  Took Tylenol first to treat at 14 hours post injection.  Took Advil at 18 hours after injection to augment Tylenol performance.  Maintained this treatment  at appropriate dosage (2 pills/dose) and intervals for about 48 hours after injection.   Most symptoms subsided after 48 hours but injection site is still a bit sore even now which is almost 72 hours post injection.
Started feeling unwell the morning after the shot with a bad bad headache and chills. Had a fever of 101 degrees. Very sore injection site and lots of body aches. Vomited during the night. Second day after the shot still running a fever and upset stomach.
I'VE HAD BACK TROUBLE-BUT 2-1-21 MY LEGS SWELLED. TWICE AS BIG-THE VACCINE SEEMED TO SETTLE IN MY BACK - THE 2ND SHOT MADE WORSE @ THIS TIME I CAN'T WALK!!
As mother and child were leaving the clinic, the child became pale and passed out. She then vomited. Allowed her to sit quietly and observed.  Called 911 who observed but then she was allowed to go home with mother.
Patient initiated Pfizer COVID series in the 6 months through 4 years age group. Patient is required to complete series in that age group. Patient inadvertently received Pfizer 5-11 Bivalent vaccine as patient was 5 years old at time of vaccination. Patient will complete <5 COVID series with third dose being <5.
On 3/24/17 in the AM, patient experienced a red, itchy rash approximately 5 inches in diameter at the administration site. Patient also reported a slight fever (not measured).
PATIENT RECEIVED PFIZER DOSE OUT OF AN UNDILUTED PEDIATRIC VIAL.  PT DID GET CORRECT DOSE SINCE THE VIAL WAS NEVER DILUTED.  CALLED PATIENT TO LET HER KNOW HER DOSE WAS FROM PEDIATRIC VIAL, BUT WAS CORRECT DOSE SINCE IT WAS NOT DILUTED. NO INDICATION FROM HER OF ANY SYMPTOMS OR REACTIONS TO THE VACCINE.
This spontaneous report as received from an 81 year old female patient regarding herself. Concurrent conditions included hypertension and penicillin and sulfa allergy. The patient's medical history included lymphoma. On 03-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 single dose once intramuscularly (lot# and expiry date were not reported). Concomitant therapies included COUMADIN and CARDIZEM. On 03-FEB-2016, the patient experienced redness around the injection site. The same evening she felt horrendous pain, and the redness spread down her arm to her elbow and she came down with a headache and her legs shook. The patient stated she was very weak and had trouble walking. The patient also stated that the redness had now traveled underneath her left arm and it was "bright red and felt hot". Lab test included routine blood work (results unspecified) from her oncologist. The patient sought medical attention which included a call to the pharmacist. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Woke up about 1:00 am in delirium and feverish. No control over thought process or able to get up. Managed to get out of bed at 9:00 am but was so weak could barely make it up a flight of stairs. And when I did ended up in bathroom vomiting. Laid on floor to get some strength back. Went back to bed and slept restlessly until 4:00 pm.  Still feverish and weak but not as bad as earlier. Ate some cold grapes and went back to bed until the following morning. Tried to stay hydrated and took ibuprofen several times. My upper arm was red and blotchy for 3 days. Overall I?d say the severest part of the event lasted 48 hrs and another 24 hrs of tiredness and nausea but not vomiting.
arm became red & swollen shortly p/vax; had t103.2 that evening; day care provider was concerned but parents were not;
Mild chills overnight after receiving the vaccine (about 15 hours afterward). General fatigue and grogginess throughout the day after receiving vaccine. Symptoms improved as the day went on.
Patient stated that almost a week after receiving the vaccine she developed a rash and noticable bump at the injection site. She stated that before calling on 8/8/2018 the affected area had got noticably larger (she stated the rash extended about 2 inches around the injection site). The area is not painful unless presuure is applied. Pt has not experience any other adverse events.
I received my first dose SHINGRIX on the afternoon of April 2, at my local pharmacy. SHINGRIX 50 Mg/0.5 ml Inj Glax. Within 12 hours I awoke with chills and a low fever (0.5). Fever, chills, general aches and muscle pain persist, 24 hours since injection. I also experienced unusual bloating and explosive gas within 2 hours of the shot, that continued for about 6 hours. I am 61 years. I have taken TYLENOL to ease the chills and discomfort. I have reached out to report this to my doctors office, and wanted to report it here as well. This is not what the pharmacist told me to prepare for. Thank you.