chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient discharged after (7) day inpatient stay from 11/16-11/23/2021. 87-year-old female presenting to our institution with 1 week of shortness of breath and productive cough.  She also had progressive fatigue and weakness.  She was identified to be febrile at the urgent care, and directed to the emergency department for further evaluation.  Patient is vaccinated for COVID-19, but had not had her booster.  In the ER she was found to have a COVID-19 positive test and a hemoglobin of 6.7.  She received 1 unit packed red blood cells and was admitted to the hospitalist service.   In regards to her anemia, she was seen in consultation with Hematology who recommended that the patient received as needed transfusions, and follow-up as an outpatient for possible bone marrow biopsy after she recovers from COVID-19.   In regards to her COVID-19, she initially was on room air not requiring oxygen.  She received monoclonal antibody infusion.  Chest x-ray did show developing infiltrates, and the patient rapidly deteriorated, requiring high-flow nasal cannula.  She was placed on remdesivir and dexamethasone.  CT angiogram thorax was obtained, which ruled out pulmonary embolism but showed evidence of COVID-19 pneumonia and suspected CHF with pulmonary edema and small bilateral pleural effusions.  Patient was noted to have progressing left-sided infiltrates, with a significant rise in procalcitonin.  There is concern for bacterial superinfection, and the patient was started on cefepime and vancomycin.  Patient continued to have increased oxygen needs, and ultimately elected to discharge home with hospice goals of care.  She would like to be with her family.  She will complete 5 additional days of dexamethasone at discharge.   Given the finding of new congestive heart failure, the patient was started on intravenous diuretic therapy.  She diuresed well.  Echocardiogram was obtained, showing a ejection fraction of 40% with moderate dysfunction and minor regional variations.  She was noted to have an echodensity in the right atrium measuring 1.1 x 1.3 cm.  She was started on losartan as well as Coreg.  She was seen in consultation with Cardiology, they recommended anticoagulation, and repeat echocardiogram however the patient elected for hospice goals of care.     Patient also identified to have uncomplicated urinary tract infection, with E coli likely CAUTI. This was treated to completion during hospital course.   She signed up with Hospice was discharged home in stable condition with hospice
Had this sise effect where a scab came over the top of where the shot was/fall off but then come back again; This spontaneous case was reported by a consumer and describes the occurrence of SCAB (Had this sise effect where a scab came over the top of where the shot was/fall off but then come back again) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A, 022M20A and 939903) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (MULTIVITAMINUM), VITAMIN C [ASCORBIC ACID], METFORMIN, LETROZOLE, EZETIMIBE (ZETIA), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), CARVEDILOL (COREG), ACETYLSALICYLIC ACID (ASPIRIN 81) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCAB (Had this sise effect where a scab came over the top of where the shot was/fall off but then come back again). At the time of the report, SCAB (Had this sise effect where a scab came over the top of where the shot was/fall off but then come back again) outcome was unknown.            No medical history information was provided by the reporter. No treatment medications were reported.
Hemodialysis Patient receiving hemodialysis at approx 0934 pre BP 143/70, pulse 65. At approx 1204 BP 102/43, pulse 65. Patient was administered first dose of MIRCERA 100mcg IVP at 1158, Pneumococcal vaccine 23 IM 0.5ml at 1200, RECOMBIVAX 40mcg IM at 1201. At approx 1205 patient reported tingling in his ears and complained of shortness of breath, and then became unresponsive. CPR was initiated at 1205, 911 called, EMS arrived and transported patient at approx 1245 to hospital ER. Patient expired in ER.
immed p/inject area surrounding inject site became reddened, warm to touch, sl edema; no resp distress, pt crying; pt seen by MD & DPH given;
Multiple episodes of vomiting with a shrill cry, bloody diarrhea, pale, and lethargic. Firmness felt on right abdomen. Suspected intussusception. Transferred to hospital from E.R. given IV fluids. Abdomen ultrasound confirmed DX. Procedure: Air enema fluoro intussusception reduction.
Administer expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that it was unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non-significant information.
Redness and tenderness to injection site. Onset day of injection within 4 hours. Antibiotics given.
Initial misuse report received from a healthcare professional on 20 September 2013. The cases were received on 21 March 2014 at GPV.  A 19-month-old patient received FLUZONE give a 0.5 ml dose. It was reported that, limited studies have bene done using 0.5 ml for this age group and there were no significant adverse effects. However, two doses 1 month apart are still needed for complete immunization. No adverse event ws reported. List of documents held by sender: none
never received the second one- it's been 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never received the second one- it's been 42 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (never received the second one- it's been 42 days). On 17-Feb-2021, PRODUCT DOSE OMISSION ISSUE (never received the second one- it's been 42 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications were not reported.  No treatment information was reported.   Reporter did not allow further contact
Massive Right lower extremity DVT requiring placement of iliac vein stent. DVT extended from right common iliac and superficial femoral v into inferior vena cava and L common iliac vein.
12OCT93 itch, redness, hives, hot for 1 day; improved for 1 day, returned 13OCT93 PM; pt is pregnant 10 wks called obstetrician;
multiple unspecified patients were admnistered a dose of improperly stored PEDVAX HIB; No adverse symptoms were reported; This non-valid, spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On unknown dates, the patients were vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S021456, expiration date 25-FEB-2022 (dose, frequency, route of administration were not provided) for prophylaxis.   Administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion below 36 Fahrenheit degrees (F) (35.2F) for 15 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse symptoms were reported.  The case is non-valid due to lack of the patients' identifiers.
Patient had 4 vaccines on 4-3-12 & later that afternoon both arms were red, swollen & warm to touch. She was started on oral BACTRIM & BENADRYL on 4-5-12 w/ improvement in sx by 4-6-12.
Information has been received from a physician concerning a female patient with type 1 diabetes and spinal disc problem who in approximately March, 1997 ("about 15 months of age") and in 2008, was vaccinated with the first and second dose of VARIVAX (Merck), respectively. Concomitant therapy included corticosteroids (unspecified). The physician reported that since vaccination with VARIVAX (Merck) the patient had had 3-4 cases of shingles. The most recent case was in approximately 22-JUN-2012 ("about 1 week ago"). At that time she had a steroid injection for a spinal disc problem and then developed shingles. The lesions were on her lower back and upper buttocks. The patient had bee seen by physician for medical attention. ZOVIRAX was given for most recent case of shingles. At the time of the report, the patient's shingles persisted. HCP was interested in VZV Analysis by PCR (Polymerase Chain Reaction) and wanted to send viral isolates. VZID packet faxed. Additional information has been requested.
Pfizer COVID vaccine was stored in regular freezer for longer than 2 weeks and patient received.
Was a little sick after the 2nd Pfizer dose, but not a huge problem.  About a month after the 2nd dose I've had fairly severe joint pain in my hands.  I have never had joint pain or arthritis in either of my hands (other than a single injury).  This is a new phenomenon and I'm attributing it to the vaccine, as I've had no change in diet, medications or lifestyle.  It has affected my left hand greatly (left arm injection site).
Insomnia really bad last for 3 weeks.  Only slept once I was so exhausted that I slept for 2 days then it started over again.  Getting better now...I would call it mild
Hives, SOB, throat closing 3 hours after vaccine, used inhaler with some relief, following AM had chills, fever to 104 and sore throat. + strep test in ED. She rarely uses inhaler.
Dizziness/Vertigo for 5 days after shot; then 5 days again 6 weeks later starting 5/13/2021;then 2 weeks again 2 months  after that starting 7/21/2021.
pt recv vax; pain across chest like glass in lungs; chills followed by shaking; fever, sweating; n; weakness for 2-3 days;
Second vaccine was chickenpox and he now has the chickenpoxs in his mouth and on his legs very badly
Flu shot was received on 11/25/16 around 7 PM.  The following morning around 4 AM pt woke up with sharp pain in her lower back, below the waist. Pain was very sensitive to the touch. The next day pt also had back pain in the middle upper back. 11/28/16.  Back pain is still present, and has varying degrees of severity. Sometimes sitting or laying makes it worse. At around 9:30 PM pt said her left arm (the one where the shot was received) felt a little numb, and her upper back felt tingly. Pt then went to the emergency room. The doctor there was not concerned and said she has a slightly herniated disk. The pt's husband does not believe this and thinks the back pain and weird sensations are because of the flu shot. 11/29/16 (today). Pt still has back pain.
About 15 min after injection ,pt c/o dizziness and blurry vision. He was escorted back to exam room to lay on exam table and given water (which he requested). He denied HA, abdominal pain, nausea, SOB, chest pain, or palpitations. At about 2:00 he indicated that his sxs had resolved and he was released to care of his brother at 2:34 PM.
Swelling in the lymph nodes under her arm; Where she got the shot is itching, red and sore; Where she got the shot is itching, red and sore; Where she got the shot is itching, red and sore; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Nov2021 (Lot number: FH8030) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2000 (ongoing), notes: Verbatim: Diabetes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First vaccine: , NDC/expiration: unknown/31Jul2021, Lot: ER8727, Site: unknown), administration date: 01Apr2021, when the patient was 62 years old, for COVID-19 Immunization; Covid-19 vaccine (Second vaccine: , NDC/expiration: 31Aug2021, Lot: EW0170, Site: unknown), administration date: 22Apr2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Swelling in the lymph nodes under her arm"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Where she got the shot is itching, red and sore"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Nov2021, outcome "not recovered".  The patient didn't taken prior vaccinations list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine  Follow-up attempts are completed. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 14-MAR-2011, a healthcare provider at the county health department administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 03-FEB-2017 and 13-JUN-2017, the patient was treated by a physician at a primary care office for shingles and post herpetic neuralgia. The patient was diagnosed with shingles, post herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
lt arm swelling-itching, red, indurated area circumscribed around shot;seen same day as DTAP given 3-5 days;
1/24/12 - 6 mo well check with sinusitis/ear infection - shots given including Rotavirus. Vomiting next day significant. X-Ray nl. 1/26 worse ear infection see in office - not drinking well. ROCEPHIN shot given. 1/26 - 5pm bloody stool. 1/27 3am bilious vomit. 1/27 - U/S, X-Ray positive intussusception. Required ileocolectomy.
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 05-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:
I got the shingles shot and then two weeks later I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in apatient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date,the patient received Shingles vaccine.On an unknown date,weeks after receiving Shingles vaccine,the patient experienced shingles.On an unknown date, the outcome of the shingles was unknown.  It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received shingles vaccines and experienced shingles.
While waiting, my throat felt a little funny - but I chalked it up to nerves.  After 15 minutes, I was excused - felt fine, and went home.  While driving home, my neck started to itch and I had a few hives pop up on my neck/chin.  Also while driving home (within an hour of the shot) the roof of my mouth started getting itchy.  Upon arriving home, my mouth continued to itch, my throat had a tickle and my chest felt tight.  By 8 pm, my chest was still tight and I had developed more hives as well as the continued mouth/throat itchy feeling.    I took 2 benadryl around 9:30 pm and went to sleep.  I woke up around 6:30 AM and my mouth was still itchy/chest was still mildly tight.  By 9:30 AM, everything had resolved.
10 mins p/vax pt c/o pain in arm then vomited mom said pt's eyes rolled back & face turned blue; pt was taken to exam table initial pulse 50 & BP 50/P but was consious & whining for dad; placed on 100% 02 mask & color improved quickly;
Information has been received from an nurse practitioner concerning a female pt in her seventies with coronary disease, diabetes, hypertension and thyroid problems who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the pt was vaccinated at another physician's office. concomitant therapy included Micadis, Lipitor, aspirin, Evista, Synthroid, metoprolol, Glyburide and Exelon. The pt developed a rash about three weeks after vaccination The rash started on her chest and primarily on her trunk. She visited her general practitioner and a dermatologist for treatment which included a topical steroid. A product quality complaint was not involved. Additional information has been requested.
Arm was sore; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore). At the time of the report, VACCINATION SITE PAIN (Arm was sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Pt devel fever up to 104, vomiting, refused fluids, lethargy
I had frozen shoulder. It was extremely painful to raise my arm to shoulder level. I had constant pain even while sleeping. It lasted 2-3 months. The shot was given too high in my shoulder. My doctor said it went into my burfa instead of muscle. S.I.R.V.A I was treated with steroid injection.
pt. vax w/ Hep B vac had unspecified amount of vac splashed into eye.Later,pt. exp. eye irritation.
The day after the vaccine I broke out in hives, around 10 spots, and daily getting a few more hives. (The early ones fade away). Then one week after the vaccination I had an irritation at the injection site on my arm (itchy raised bump covering about 2 square inches).
Patient had his 1st  Moderna vaccine on 11/3/2021 and gave patient 2nd dose of Pfizer vaccine 9/21/22. No adverse outcomes or symptoms after having patient wait 15 minutes.
There was actually NO adverse event, but rather an administration error that we did not realize until recently.  There was a new RN on board that day and it was the first time she diluted/prepared vaccine. This was the pediatric orange cap Pfizer covid 19 vaccine, that is supposed to be mixed with 0.9% sodium chloride. She did NOT dilute the vaccine with 0.9% sodium chloride. And since the error was discovered later, it has been difficult for her to remember the details. However, we have narrowed it down to 2 possibilities: 1) that the vaccine was mixed with sterile water diluent instead, or 2) that the vaccine was not mixed with a diluent.
Had vaccine years ago, still got shingles; shingles on face; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media The patient had vaccine years ago and still got shingles on his/ her face was the worse pain he/ she ever experienced. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.