chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clinical Summary Patient is a 82 y.o. male patient with history of bladder cancer, HTN, HLD, CKD II, TIA. Presents with shortness of breath and weakness. COVID positive, s/p 10d isolation.  S/p remdesivir, CAP coverage, and steroid treatment. Weaned to RA from initial 5L requirement. Course complicated by recurrent c.diff infection, treating with vancomycin taper per ID. Palliative followed, patient qualifies for hospice and is s/p hospice informational visit this admission. Patient opts to pursue SNF. Discharged to facility.     Problem List Acute Hypoxic Respiratory Failure, resolved Covid-19 Virus Infection, improved  Secondary to COVID-19 viral infection with superimposed bacterial CAP, possible underlying pulmonary fibrosis Covid test (+) 9/6/22, isolation ended 9/13/22 Fully vaccinated   5L O2 via NC -- > SORA  S/p Remdesivir, Decadron, Rocephin, Zithromax  IS, pulm toilet, Duo-nebs Q6H PRN  Per Pulm: outpatient PFTs, repeat CT to follow up pulm infiltrates Discharged to SNF    Recurrent C.difficile Colitis Initial infection 6/3/22 without confirmed treatment  Again positive on 7/13/22 and s/p 14d PO vancomycin This admission, C. dif positive on 9/13/22 ID consulted: NAP-B1 PCR (+). Ongoing Vancomycin Taper.    Goals of Care Patient and family met with Palliative Care this admission  Patient does qualify for Hospice (pulm disease, dementia) Current goals of care: FULL code and SNF placment Discharged SNF placement    Severe malnutrition, POA Generalized weakness In the setting of bladder cancer 105 lb weight loss since 1/2021 Boost supplementation TID, regular diet Nutrition followed  Dementia Delerium Waxing and waning orientation to place, situation Likely delirium on underlying dementia  SLUMS score 10, FAST stage 7B; ambulation is lost   Recurrent Falls Prior admissions for presyncopal, syncopal events Likely due to poor PO intake at home PT following; AMPAC 13 SNF placement    Dysphagia Suspected Chronic Aspiration  CTPA demonstrates debris within distal esophagus Speech Pathology consulted: ground solids, thin liquids, small bites   Chronic Normocytic Anemia History of GIB Multifactorial: iron deficiency, anemia of chronic disease Admission Hgb 9.6, near b/l 10-11 in setting of IVF Daily CBC stable, no evidence of GIB this admit    Elevated troponin without evidence of cardiac ischemia Chronically elevated, flat on admission In setting of AKI, hypovolemia Asymptomatic, EKG without ischemia Okay to discontinue telemetry    Hyponatremia, resolved  Likely secondary to poor PO intake Na nadir 127, Na 135 wnl 9/19 BMP MWF    Bladder Cancer Oncologist: S/p transurethral resection Cystoscopy 05/22 negative 2 years of pembrolizumab (Keytruda) per Oncology Hypertension Hyperlipidemia Continue home atorvastatin Home lisinopril continued   Mediastinal and right hilar adenopathy Grossly stable from previous CTs, including June 2022  Suspected due to immunotherapy  Recent PET scan - no significant uptake Oncology considering referral to pulmonology if pt continues to have progressive cough and respiratory symptoms Recommend outpatient follow-up and monitoring
The day after pt received shot she got a sore arm, muscle issues in her buttocks and thighs. She stated butt and thighs were stiff and difficult to move without there being pain. Pt stated these symptoms lasted for two days.
convulsive seizure, lasting 2 minutes, unable to awaken, lowered consciousness for several days after event
Patient said she was fine, then a couple weeks after the vaccine, her arm became sore. She said there is no redness, swelling, bruising, or anything and the pain comes and goes but did not start until a couple weeks after receiving the vaccine.
Post herpetic neuralgia; diagnosed with herpes zoster/shingles; Information has been received from a lawyer and the patient regarding a case in litigation, concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   In or around 19-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (reported as "shortly after receiving the vaccine"), the patient suffered painful rash to her left flank. She was diagnosed with herpes zoster/shingles and postherpetic neuralgia, as the nerve pain and burning continued in the area of her shingles outbreak. The reporter stated that the patient's symptoms resulted in physical limitations not present prior to vaccination, and that she was experiencing mental and emotional distress due to resulting physical limitations and seriousness of her condition. Moreover, the patient suffered sustained severe and permanent personal injuries and serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   By the time of this report, the patient had not recovered from shingles and postherpetic neuralgia. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   The reporter considered shingles and postherpetic neuralgia were considered to be disabling events.
Patient developed localized swelling and hive immediately after MMR injection Pt did not have any respiratory distress, She was playful after vaccination. Ice was applied, Swelling was noticeable but hive got smaller. Mom was advised to call if any shortness of breath, wheezing, color change.
Site: Pain at Injection Site-Medium, Systemic: Nerve pain from injection site down arm stopping below elbow-Medium, Additional Details: Patient had shingles back in 1997 with the type of nerve pain described above. Patient also had a dose of Zostavax when it was on the market, but date given was unknown. The first of the series of Shingrix on 10-12-2022 produced no side effects like she described here on the second of the series. Patient was given a 7 day course of Valacyclovir by her primary care doctor on 5-11-2023
Pt had low-grade (99-100 degrees) fever & cellulitis-like (red, hot to touch, painful & inflamed) spot on arm with bruise. Went to walk in clinic on Saturday morning but wasn't given anything until Sunday when he noticed a new red spot. They gave him antibiotics d/t worry of possible infection.
Local reaction- Macular greater than 3 X 3 inches with color and induration  @ left upper extremity, Tylenol
This spontaneous report as received from a healthcare worker refers to unspecified number of patients (age and gender unknown). The healthcare worker reported that GARDASIL which was exposed to 34F for 28.5 hours, may had been administered to unspecified number of patients on an unspecified dates (dose, route and lot# not reported). No adverse effects reported. Additional information has been requested.
Itching, redness and swelling at injection site and surrounding arm. Pt is going to take antihistamine for itching and swelling and use ice prn for swelling. Will monitor circumference of affected area and seek physician if condition worsens.  Not warm to the touch or other signs of infection.
Information has been requested from a PA concerning her 5 year old healthy son who on 08/12/04 was vaccinated with a dose of MMR vaccine. The PA reported that she tried to vaccinate her son with the MMR in her home. She had difficulty witht the vaccination process and sprayed the vaccine over the sink in her home. The vaccine was then refrigerated in a syringe for 3 days, the PA then transported the MMR vaccine in her car for 2.5 hours at temps possibly above 77 F. Her son was then vaccinated by another health care professional in the office where she works. The pt developed GI problems which began on 08/23/2004. Unspecified medical attention was sought. The PA also reported that she develped GI problems after exposure to the MMR vaccine live. ( WAES0501USA01399) Additional information has been requested.
Pregnant and just got the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and just got the Moderna vaccine) in a 33-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D27L20A and O24M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Delivered  live full term baby) on Aug-2018. Concurrent medical conditions included Chemical sensitivity (paraben) and Alcohol use (2-3 glasses of wine per week through pregnancy and now in post-partum).   On 11-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-May-2020 and the estimated date of delivery was 06-Feb-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and just got the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy. The delivery occurred  on 15-Feb-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth w/o Complications. Estimated date of conception was 16 May 2020. On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and just got the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Prenatal screening test: 12 week genetic test for fetus normal (normal) 12 week genetic test for fetus normal. On an unknown date, Ultrasound abdomen: 8 weeks, 20 weeks, and 41 weeks (normal) 8 weeks, 20 weeks, and 41 weeks.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: initial pregnancy report form: Reporter address, doctor information, Second dose vaccine information, patient initials changed, Allergy to paraben, LMP date, date positive pregnancy test, estimated date of conception provided. Number of fetuses ,investigations during pregnancy, number of previous pregnancies with end date and outcome. in medical history current condition: Alcohol use.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Left arm began to become firm at the injection site, itchiness, redness and area started to become hot to the touch. No pain or soreness indicated at this time.
Pink eye; This spontaneous case was reported by a pharmacist and describes the occurrence of CONJUNCTIVITIS (Pink eye) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CONJUNCTIVITIS (Pink eye). At the time of the report, CONJUNCTIVITIS (Pink eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
36 weeks pregnant (G3P1) at time of 2nd injection Headache that started 8 hours post injection Debilitating fatigue 20 hours post injection lasting all throughout the day after injection (with headache needing a total of 2g of Tylenol for the day). Symptoms resolved the next day.  Estimated due date 2/8/2021 No pregnancy-related adverse events as of time of VAERS report
Pt came back from receiving flu shot, states feels funny. When asked states throat feels "weird", feels dizzy, and unsteady on feet. Pt also c/o withdrawal symptoms from narcotics. VSS, pulse and heart rate regular. Spoke to provider, gave 25 mg of PO benadryl. Pt remained stable and observed for 30 minutes and improved. Ambulated independently out of office. Provider aware
Sudden nausea/vomiting within 30 minutes of injection, patient ultimately felt better 15-30 minutes after vomiting and went home
Patient developed COVID-19 symptom 1/5 -1/6/2022. After his first treatment with monoclonal antibodies on 1/14/22. He presented to ED with a re action to the infusion and ended up being admitted to the hospital. He was admitted for about 2 days. Patient was discharged home. Patient returned to ED on 1/25/22. Patient stated worsening of symptoms. He had worsening shortness of breath at home. He also has body aches. He has overall malaise and cannot walk anymore.  No fever. No chest pain or current shortness of breath. No nausea vomiting or diarrhea. history of lymphoma with peritoneal involvement- in remission for the past 2 years. Hospital web report with diagnosis of COVID-pneumonia -Not hypoxic and with marked elevation in acute phase reactants -Patient was given dexamethasone in ED, and continued per protocol. Patient had a mildly elevated troponin with record stating may be an indicator of some demand ischemia versus myocarditis related to COVID-19. Next Web report received from Hospice. Patient died 1/29/22 at 10:49. Patient received COVID-19 PRESERVATIVE FREE .3ML PFIZER PURPLE CAP on 10/1 9/2021. Patient received COVID-19 PRESERVATIVE FREE .3ML PFIZER PURPLE CAP on 2/10/ 2021. Patient received COVID-19 PRESERVATIVE FREE .3ML PFIZER PURPLE CAP on 1/21/ 2021.
Severe loss of appetite. I simply stopped feeling hungry/hunger. It seemed I did not lose my sense of smell, however. Loss of appetite resulted in 15lb weight loss within a few months, so I forced myself to eat at least one complete meal per day, began taking a multivitamin, and ate high-calorie foods.  The loss of appetite lasted until recently - for about 18 months - and my weight is currently at normal. I still experience short periods of appetite loss when I simply do not experience hunger for 1 to 3 days.
bad reaction / Chills; Fever; Aches; Skin was on fire; This case was reported by a consumer via media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, fever, pain and burning sensation skin. On an unknown date, the outcome of the chills, fever, pain and burning sensation skin were recovered/resolved.   It was unknown if the reporter considered the chills, fever, pain and burning sensation skin to be related to Shingles vaccine.  Additional details were provided as follow: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd dose of Shingles and had a pretty bad reaction included chills, fever, aches and his/her skin was on fire which lasted for couple of days. The follow-up would not possible as no contact details were available.
TRANSIENT CEREBRAL ISCHEMIA 11/27/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient complaints of itching, some swelling, redness on arm by the injection site. Pt. decided to take couple of Aspirin 325mg.
Pt developed MIS-A with a significant hospitalization (6 days) from 2/8-14, 2021. However, this was felt much more likely to be due to her antecedent SARS-2 infection, which preceded her vaccination.  She was dx'd w/COVID w/onset of URI/sinus sx onset 12/31/20, dx'd w/pos PCR on 1/2/21.  Experienced fairly modest sxs and did well w/conservative tx (cough suppressants, rest, no steroids), returned to work subsequently.  Then took 1st COVID vaccine )Moderna, 1/22/21) uneventfully.  Developed MIS-A in early Feb, within 6 wks of her SARS-2 infection--GI sxs, rash, conjunctival injxn, encephalopathy, elevated BNP though LVEF intact, tx'd w/IVIG x 1, steroids, aspirin, w/extensive inpt ID, Rheum eval and good response.  Received 2nd mRNA vax completely uneventfully on 2/19/21.  Largely recovered from her MIS-A currently.  MIS-A form completed and submitted.
patient received Tennivac which was expired two days before/no AE; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 18 years old male patient who was vaccinated with 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which was already expired two days ago (batch number U6021AA and expiry date 27-JUL-2020) via intramuscular route in the left deltoid for prophylactic vaccination(expired product administered).  Vaccination(s) included TENIVAC (7 years ago). Medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) and MENZO for Immunisation.  It was an actual medication error case due to expired vaccine used.  At the time of report 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 Directive and Module VI of the Practices. 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.
Patient received 1st dose of Covid Pfizer on 07/02/2021. Patient  is 11 years old and per CDC guidelines and regulations Pfizer vaccine is only for 12 years and older. Patient was scheduled for 2nd dose on 07/23/2021. No issues or concerns were reported at the time of the second visit on 07/23/2021. Patient was not given 2nd dose as it was noticed he is not age appropriate for have received Covid vaccine according to CDC guidelines.  Have been trying to contact father via telephone to explain further, unable to contact.
Pt seen 9/25/08 in clinic, LF thigh with erythema 15 1/2 cm length 5cm width. Advised home care measures with Benadryl for itching. 9-29-08pt seen urgent care, tx: antibiotic.
He got the vaccine yesterday, 2/10/21, and at 8:00 PM started getting chills.  About 10:30 was getting joint aching with pain.    Went to bed at 8:00 due to fatigue.  Felt nauseated.   Was hurting really bad with the joint pain that lasted until about 2:30 AM.   He woke up this morning and is feeling much better.   He did not take anything for the pain.  It attacked his joints mainly his ankles and knees and was not able to move.  His knees felt hot to the touch.
Pharmacist failed to mix adjuvant with antigen. Adjuvant component alone injected.
Patient sent to emergency department from nearby vaccine clinic with tachycardia (HR 138). She received her second dose of the Pfizer vaccine approximately 45 minutes prior to arrival to ED.  On arrival to ED she also had abnormal sensation in the back of her throat, change in her voice, and a new rash which developed few minutes prior to arrival. At this point, with signs and symptoms c/w anaphylaxis, she was given IM epinephrine, solumedrol, Benadryl, and famotidine. Symptoms improved entirely after 3-hour observation period and she was discharged home on EpiPen, prednisone, Benadryl, and famotidine.
This spontaneous report was received from a consumer concerning her daughter of unknown age. On an unknown date in March 2013 the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On an unknown date in June 2013, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Since an unknown date, the patient experienced severe menstrual cramps. The patient did not seek any medical attention. The outcome of severe menstrual cramps was reported as not resolved as the patient was experiencing severe menstrual cramps at the time of report. The relatedness for severe menstrual cramps was unknown for GARDASIL. Additional information has been requested.
Pt recvd Engerix-B & several days p/had malaise, flu-like sx, dehydration & elevated temp; was seen by MD; hospitalized 4-5 days p/onset of sx; still hospitalized;
Brother had jerking movement with inj. Patient had his approx 10 min before. After seeing brother he felt nausea, crying, white in color. He sit in chair BP 102/60 after cool compress and seeing brother was OK. Patient walked to car.
Patient had radiating nerve pain up her arm (from injection site) to the base of her neck. Woke up in the middle of the night with a stabbing pain. Has occurred off and on throughout the past 8 days.
Pt states "I am afraid of needles". Hep B given in RD without problem. When pt getting up to leave became dizzy and fainted. Was lowered to floor without injury. B/P 96/50, P-92. After 10 minutes B/P 112/60, P-68. Watched pt for another 10 minutes. B/P 110/72, P-82. Sent home with mother who is an EMT.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 38 year-old male patient. On 26-Sep-2015, the patient received AFLURIA (batch number: U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
1st noticed pain in ears (both)(sharp, shooting).  2nd had slight swelling of mucous membranes in mouth (puffy feeling), nose started dripping.  Had sinus pressure.  3rd arm pain, swelling, redness developed 24 hours later and lasted 5 days.  Took Aleve.  By 7pm-symptoms persisting, by 8:30pm-all symptoms gone.