chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a 84y.o. female with a PMH significant for hypertension, CKD stage II, neurogenic bladder and osteoperosis presented to hospital on 10/3/2022 after a mechanical fall. Was found to be hyponatremic. Imaging showed nondisplaced fracture of right sacrum and comminuted right fracture. Patient was seen and evaluated by ortho and no intervention was indicated beside PT/OT. Fall was attributed to hyponatremia, excess fluid intake  escitalopram  and dehydration from recent illness . Pt was put on fluid restriction with improvement in Sodium. She was also given one dose of tolvaptan to bring sodium to higher normal level. Sodium was normal Upon discharge and she will f/u with nephrology.  She also had covid and completed 5 days of paxlovid op that was started 9/30. Urology saw pt due to urinary retention. Pt had 3 days of urinary cath for decompression of the bladder after which TOV was attempted with success. She will follow up with urology for further eval of possible neurogenic bladder  Pt was discharged to sar. She was encouraged to f/u with colorectal surgery for evaluation of fecal incontinence although not observed during admission. Her gabapentin frequency was increased to 4 times daily for pelvic pain. She will follow up with neurosurgery for further eval. She has an mri that she will get outpatient. Patient was discharged in stable condition.
Vaccine was checked in  by Pharmacist to be administered by Immunizing Tech. Tech did not realize the vial that was out was labeled and timed from the day prior and expired and new vial needed to be pulled out of fridge. Tech drew a dose out of expired vial and administered to patient.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 22-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 22-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Pt recvd MMR 930AM 9OCT93; 945AM pt jumped to feet clutching throat; fell to floor; jerking & rigidity noted in arms & legs; became extremely strong; skin cold & clammy; ?sz; to MD p/stabilized;
Nausea, headache, migraine. Extreme pain and swelling of lymph nodes. Lymph nodes under the armpits swelling with extreme pain. Swelling of lymph nodes was greater and more painful near site of injection.
Nurse administered too much vaccine. Per mother- states that he has fever, headache, soreness in arm, and no appetite. Informed mother that  if symptoms become worse such as chest pain, SOB, high fever; they needed to present to the ER.
patient received his first 11/12 year old routine vaccination dose of MENACTRA when it was not due until 23May2021 with no reported adverse event; Initial information received on 28-Apr-2021 regarding an unsolicited valid  non-serious case from a other health professional.  This case involves a 10 years old male patient who received his first 11/12 year old routine vaccination dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiration date not reported) via intramuscular route in right arm for prophylactic vaccination on 28-Apr-2021, when it was not due until 23-May-2021.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on 28-Apr-2021.  It was a case of an actual medication error due to inappropriate age at vaccine administration (same day latency).   It was reported that how to proceed and declined to provide email address. Also reporter did not have lot information available at the time of the call.   At time of reporting, no adverse event was reported.  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 the 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 on the batch number for this case.
Patient had two chicken pox blisters bath at came up around 2/28 or a bit before. They are not yet open or scabbed over, but they are quite itchy.
Information has been received from a pharmacist referring to a 78 year old female patient with allergy to scallops. Her medical history included prior case of shingles (date unknown) and diarrhea caused by macrolides. On 23-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L046295 with expired date 17-FEB-2017, 0.65 ml, subcutaneous). Concomitant therapy included an unspecified blood pressure medication. On 28-JUN-2016, the patient experienced discomfort in right buttocks and anterior portion of right thigh. The reporter saw the patient on 29-JUN-2016 and noted that she had a red raised area "like a hive" on the anterior right thigh, with itching and 4 to 5 areas "like mosquito bites, in close proximity" on the right buttock. Then the patient was seen by an unspecified dermatologist who diagnosed as "shingles" and prescribed a topical "steroid" cream. The patient was currently experiencing "pain shooting down her right leg". The outcome of the event was reported as not recovered. Causality was not provided. The reporter accepted varicella zoster virus identification program (VZVIP) packet which was faxed. Additional information has been requested.
hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6208) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "scoliosis" (ongoing), notes: scoliosis was diagnosed at least 10 years or 7-8 years ago; "Osteoporosis" (ongoing); "Arthritis" (ongoing); "spinal stenosis" (ongoing); "she had polio as a child" (unspecified if ongoing); "two little fractures in her lower bones in her back" (unspecified if ongoing); "she also has a walker she uses" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (medically significant) with onset Mar2021, outcome "not recovered", described as "hives". The event "hives" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results, notes: Had a lot of blood tests and they were trying to figure out why the hives and apparently the doctor figured it was the Pfizer vaccine; Body height: 5 feet 5 inches. Therapeutic measures were taken as a result of urticaria. Additional information: For her Pfizer Covid vaccine, the 1st was administered on 10Mar2021 with lot EN6208; the 2nd dose was administered on 31Mar2021 with ER8737 at the same facility; the booster dose was on 04Oct2021 with lot FF8811. Since she had the injections she has been dealing with severe outbreak of hives just on the right side and so she has gone to her primary care physician and dermatologist over and over these three years and they do not know what to do. She was sent to an allergist and they did an extreme amount of blood tests and checked her and the hives and came to the conclusion that the hives were caused by the Pfizer Injection. She was age 81 when the hives began as it was Mar2021 and after two vaccines and then the booster. As of Dec2022 she was started on injections in each arm called Xlara (also reported as Explar, Xlair) and carries an epi-pen with it and her last injection of Xlara was Friday and her hives were unbelievable at time of reporting and she can't believe nothing was working. When she first started going to the provider, she thought back in October or November of last year, she had the Xlair injections and had two of them one in each arm and the first three times she did that she would sit in the waiting room for 2 hours and was then ready to go and had to be alert in case she went into whatever and has not had to use her epi-pen; the Xlair injections began Dec2022 or so about in October or Nov2022 was when she started seeing him because her primary care and dermatologist gave up; they were putting her on prednisone all the time and that's not safe.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232978 same patient, different dose;US-PFIZER INC-202300233529 same patient, different dose;
Approximately 9 days after vaccination, child developed an erythematous papillar rash over entire body.  Mother reported fever of 103.  In MD office, temperature was 100.2.
Moderna COVID-19 Vaccine   Extreme fatigue, headache, sore arm, and intense dizzy spells.  This all occurred the afternoon / evening I received the vaccine.  All side effects subsided by the next morning less a sore arm.
Pt stated that he vomitted 0.5 hr after receipt of FLUMIST. Pt stated that he had abdominal pain this morning and vomitted last evening. Pt came to clinic and said he was better.
I first was having a runny nose and my sinuses did not feel normal. It just didn't feel right. I tested positive and contacted my doctor and he prescribed PAXLOVID. I developed a temperature for 12 hours and chill for half an hour. This was on the 20th, the highest temperature I had was 101.5, a stuffy nose and congestion followed that. I noticed a difference in my symptoms and tested negative on 02/28/2023. I still had nasal congestion. On March 03/03/2022, I tested positive again. The nasal congestion came back and elevated temperature on 03/04/2023, it lasted again for about 12 hours. The congestion developed and a shallow cough on 03/06/2023. When I developed the cough, I was advised to use the albuterol three times a day. The cough is now occasional with no nasal congestion on 03/08/2023 I did test negative again.
Dad reported lethargy, decreased appetite, and fever up to 102.7 began on the evening of the 10th and swelling in the jaw and face began after noon on the 11th.
Patient presents to the pharmacy very anxious to receive the vaccine. Her mom had filled out the vaccination form without any problems (NKDA, no ill day of vaccination, etc). Quickly after administering the vaccination (about 1-2 minutes), patient said she felt like she needed to 'vomit.' She threw up, was sweating, lost consciousness for 30 seconds, urinated, and then woke up. She was unaware of the event (did not know she lost consciousness or urinated). She was provided some water and began to feel better. She sat until she felt better. Patient and her parent left without letting me know. Unknown if patient improved, called the following morning to follow up but no answer.
Patient had the usual sore arm for several days after injection but then she said she got a faint rash around injection site and it itched quite a bit.
On 10/29/21 I noted blood/small clots in my urine.  Also experienced some urinary urgency.  Urine sample provided to lab at primary care MD's office.  Seen for virtual visit that afternoon.  Started on Bactrim x 3 days.  Symptoms all resolved by the time medication finished.
Vaccine given at a health fair at the community school large multi-purpose room.  After rec'd immunization nurse reports "slight seizure activity,breathing shallow and decreased."  In and out of consciousness for ? minutes.  Fire Department paramedics called.  Mother of child states child revived in ambulance.
30SEP93 fussy, pharyngitis; 7OCT rash groin/legs/trunk/face; 8OCT rash ince; adm to hosp;
Dizziness & HA. Started 10 min. after vaccine. Went away & then returned. Went to ER & had a normal EKG & bloodwork & was released.
The evening after my second injection around 9 p.m the pain in my left arm was so severe that I could hardly lift it above my head.  I started having a burning sensation in my lower back along with painful cramping in lower abdomen.  At 1 a.m I woke up freezing and the pain was throughout my entire body, I was nauseous, very weak, and I couldn't stand up right and could hardly walk to the bathroom.  The pain in my hips and legs was excruciating.  I had a slight headache.  I got up again at 6 a.m and I wasn't feeling any different.  Throughout the day I ate light foods and drank a lot of fluids and didn't feel better until that night around 8 p.m. I slept good that night and have had night sweats and hot flashes since.
Information has been received from a physician concerning a 13 week, 1 day old patient who was vaccinated with the first dose of ROTATEQ.  No adverse experience was reported. There was no product quality complaint.  Additional information has been requested.
Following visit and vaccine administration, patient reportedly was standing at the front desk while mother was checking out, having calmed from the vigorous screaming during vaccines. Patient reportedly fell to the side, striking his head against a counter and then fell to the floor, losing consciousness for possibly 5 to most 10 seconds according to mother. Fine tremor/shaking occurred briefly according to mother, but no tonic-clonic activity. Aroused spontaneously with no evident postictal phase reported. No loss of bowel or bladder. Was subsequently returned to an exam room where he remained clingy to mother, continued to resist exam, but consolable.  Mother states he had not eaten in several hours, patient acknowledging he is hungry. Cardiovascular exam repeated, no abnormalities. Mild soft tissue edema occipital region corresponding to contact during fall, but no crepitus or other concerning features. Area measuring approximately 1.5 cm. Good muscle tone. Alert and responsive with no other concerning features. Discussed vasovagal episode, which certainly seems most likely here. Reviewed concerning symptoms in general for seizures or other concerning problems. Call if unexpected other issues. Mother acknowledges understanding.
fainted/fell, BP 117/71, pulse 80. Resolved within minutes following monitoring
64 yr old female admitted on 3/4/2022 from Hospital. Pt had a past medical history of HTN, Hyperlipidemia, COPD, Follicular Lymphoma (pt was on chemotherapy for), Asthma, Chronic back pain, DM, GERD, Hypogeusia, Pneumatosis, and left Heart Catheterization.  Pt was diagnosed with COVID-19, prior to hospitalization. Due to the patients continued hypoxia and acute kidney injury the patient was transferred to hospital on 2/23/2022.  Cardiology did see the patient due to an NSTEMI, which was felt due to demand ischemia. While at Select the patients oxygen needs increased.  Family made the decision to go Comfort Cares on 3/26, pt expired on 3/27/2022 at 1405.
Large swelling in and around my left armpit with soreness. Appears to look like a lump under my left armpit with veins visible with the eye.  Swelling appeared after within 36 hours of receiving the 2nd Pfizer Covid-19 vaccination shot.
The vaccinator thought there was vaccine in the syringe when in fact there was nothing in the syringe being used. The Patient received less than 0.5cc of air.  Patient could not come back that day and stated they would reschedule with the health district to receive first dose.
after each one of the vaccines caller experienced an exacerbated rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (after each one of the vaccines caller experienced an exacerbated rash) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 016M20A, 012F21A and 057M21A) for COVID-19 prophylaxis.     Patient had very long medical history.  The patient's past medical history included Transient global amnesia (patient already experienced 2 previous TGA episodes before getting any of the COVID-19 shots. 1st episode between 2011 and 2014 (he did not remember the exact year).), Transient global amnesia (patient already experienced 2 previous TGA episodes before getting any of the COVID-19 shots. 2nd episode happened on SEP2019.) in September 2019 and Rash.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (after each one of the vaccines caller experienced an exacerbated rash). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, RASH (after each one of the vaccines caller experienced an exacerbated rash) had resolved.            Concomitant product use was not provided by the reporter.  It was reported that after each one of the vaccines patient experienced an exacerbated rash that he had before because he was a veteran and was exposed to orange agent, the rash lasted approximately from a couple days to 1 week after each vaccine, and it was treated with Triamcinolone which is a steroid cream to treat topical rashes.   This case was linked to US-MODERNATX, INC.-MOD-2023-748572 (E2B Linked Report). This case was linked to MOD-2023-748572 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748572:Spikevax PFS case
Ten minutes after the vaccine was administered the patient started with a persistent nonproductive cough, hoarseness, chest tightness, shortness of breath. Vital Signs BP 128/77: P=96: R=19: O2 sat=100% Oxygen was administered by nasal cannula, Solumedrol 125mg IV and nebulizer therapy with Atrovent 0.2 x 1. Was kept under observation and after one hour the patient had recovered.  Per the patient.
Wheezing in my chest and bad cough started on 5/5. Pain in my left calf began on 5/14. I went to the Emergency Room  on 5/16 and was diagnosed pulmonary embolism in both lungs and deep vein thrombosis in my left leg.
My wife and son and I all got the seasonal flu shot at a clinic right around Labor Day, not sure of the exact date. All three shots seemed normal and almost painless, and they did not have any reactions. However my injection site, left upper arm, quickly became very sore and stiff. It hurt all the time to varying degrees. I saw my doctor at about 5 weeks but he didn't seem concerned. He did give me the nasal version of the H1N1 vaccination, even though I was a few months over age 50. Around that time I gradually began to get better, but it was 4-5 months before I could sleep on my left side. 8 months after the injection my arm is still not completely pain free or mobile. I have been getting flu shots regularly for about 10 years without any unusual side effects (e.g. 1-2 days of mild soreness). I would like to know 1) if there is any possible treatment, and 2) if there is a nasal version of the seasonal flu vaccination, since I obviously don't plan on getting any more injections.
SORE ARM FOR 2 DAYS AND FATIGUE FOR 1 DAY AFTER THAT I WAS FINE TILL I STARTED HAVE SEVERE JOINT PAINS EARLY MARCH.
Shortly after vaccines, mother noticed severe irritability.   She wouldn't breastfeed.   She had 2 episodes of vomiting approximately EMS hours after vaccines.  Tactile fever.  Mother saw she was crying then turned red, no cyanosis.  Called ambulance, went to local ER, was evaluated and sent home, no testing done.
Cellulitis of 2/3 of left thigh and rash present. Low grade temp.
SEIZURES; This spontaneous report received from a pharmacist concerned a 49-year-old of unspecified sex, race and ethnicity. 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 (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, pharmacist called for a follow up on a precious case, from which one of the patient had experienced seizures.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629430- covid-19 vaccine ad26.cov2. s-seizures. This event(s) is considered un-assessable. 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).
At the time of vaccination things were fine. The onset of the symptoms started approximay 2 hr later.  The order of symptoms and event are as following: * First was a headache not the same usual headaches I am accostume to around 3pm as well as  body ache. Later on on my first day ( evening) I felt really tired and was ready to go to bed. That night  I felt  feverish so I took 500 mg of Naprosyn and went to bed. Around 5 am i woke up to get my day going, but I was feeling terrible, fatigue, body/joint pain i went back to bed and took another 500mg of naprosyn and woke up around 7 am sweating. Woke up took a shower and some how went to work. I haven't been felling well at all Thursday afternoon i started to decline again  took my temp and it was 100.5 i took 600mg of Ibuprofen.  That erst of the daay and night the symptoms have gotten worse. Last night 1/14/21 it was a terrible night. My left Ipsilateral Axillary  lymph node swell up to the point it feel like I have  a softball ball there. I have a cough that comes and goes my  body is hurts, I feels swollen, I feel like  my body is swelling up, my back hurts. My lymph node it is not going down. I don't know what to do because i had a fever again today.
pt recv vax & devel an inj site rxn characterized by warmth, redness & swelling;this is 1 of 4 pt from this site & lot# to report these adverse rxn;
09/12/22 presents to EC ED for "GI Bleeding". PMHx of "breast ca, HTN, SBO, CAD"