chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 68 y.o. female patient of DO with history of DVT/PE, Hypertension, CVA, Afib who presented to hospital in trasnsfer from different Hospital for further management of COVID 19, acute HFrEF, recurrent PE, acute respiratory failure   Acute Hypoxemic Respiratory Failure Etiology: covid-19, CHF, PE Baseline O2 requirements: room air Current O2 requirements: room air Continue pulmonary hygiene- IS q 1hr Wean O2 to baseline oxygen requirements as able Continue treatment of underlying etiologies as outlined Resolved 1/1   COVID-19 Virus Infection  Date of onset of symptoms: 12/23/2022 Symptoms present on admission: fatigue and generalized weakness  Date of covid positive test: 12/29/2022 Vaccination status: vaccinated Imaging: CTPA 12/28 motion artifact/no evidence of PNA  Oxygen requirements on admission: RA  Current oxygen requirements: 2L/intermittent Medical therapy: decadron, remdesivir Consultants following: None  Anticipated special isolation end date: ~ 01/02/2022   Acute on Chronic HFrEF  TTE 12/2022 with EF 30% Suspect tachycardia mediated > ischemic Continue carvedilol 25mg BID Further GDMT as able, noting cost limitations BN elevated but euvolemic on exam Start lisinopril 10mg daily  Monitor renal function   Paroxysmal AFib with RVR   Intermittent with home Coreg 25 mg BID Cardizem gtt initially, converted to dilt 120mg PO daily  Cardio cs'd Cardizem CD dose increased HR and BP stable Acute pulmonary embolism, recurrent   (12/28) intermittent RVR, tachypnea, and borderline normal SpO2 at rest D dimer 7.44  CT PE thrombus distal right main pulmonary artery extending into the right upper, right middle lobe and right lower lobe pulmonary arterial branches Due to decreased mobility and non compliance with warfarin  Continue Lovenox bridge to theraputic warfarin  Verified with patient's daughter no rx coverage discussed charitable pharmacy and if approved patient can transition to Eliquis at no cost  Family to pick up information and establish telephone appointment to determine eligibility  Per cardio- no indication for thrombectomy INR therapeutic on coumadin 1/1   AKI Resolved   H/o CVA  Residual left sided deficits  Discontinued simvastatin due to risk of rhabdomyolysis with Cardizem  Continue atorvastatin  AC as above    Essential hypertension  Holding home amlodipine and lisinopril  Resume carvedilol  Titrate as able BP stable   Frost bite Blisters noted to left thumb and right index finger  Monitor    Generalized weakness  2 day history PTA  Prior CVA with residual left sided deficits, no new focal deficits  Prior plan of home with home health PT/OT - 2-3 days   Morbid obesity BMI 41.27 kg, adult  Recommend lifestyle modifications    Lung nodule 12 mo follow up CT recommended
Chills, fever, redness, swelling, heartburn, nausea, wheezing, weak, aching, fever, thick skin on arm, drowsiness.
13 year old patient came in with father for second dose Covid vaccine. Father was getting his booster vaccine. The nurse gave the 13 year old the fathers Pfizer 0.25 booster vaccine. We contacted the pharmacist who spoke to the father and answered all his questions. the patient was monitored for 20 minutes and left with no adverse reactions.
Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (dose, strength and route were unknown, lot # L013193, expiry date: 20-JAN-2017). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
RASH BIG RED BLOTCHES ON BODY, ITCH, THROAT FELT LIKE CLOSING UP, INJECTION SITE RED & BULDGING.
There were two occasions of reaction, but I didn't figure out the cause until the second shot in the series. Symptoms are hives and itching all over the body, which lasted for several weeks during the first reaction; and swelling and welts on the back of my neck. Symptoms are being treated with prednisone, cetirizine, ranitidine, and Bnadryl.
pt recv vax & c/o arm pain on lt deltoid;pain from flu shot;exam of area did not reveal extreme erythema & edema;cool to touch w/palpation;c/o pain in one area w/deep compression;area a little swollen;
After five days developed lymphadenopathy, on day 7 right deltoid red, swollen, itchy. delayed reaction
Noticed 4/5 days later that my face had swollen, and broken out a bit but not serious to go to ER. Days later, swelling is all over my body; hands, face, legs, knees, feet, arms. I feel extremely heavy and in much pain from the gain on my legs. I weighed 143 day of shot...4/5 days later 10 pounds happened, but not from eating...its swelling.
No adverse side effects from vaccine administration error. This is an error only report for expired vaccine given. Moderna was contacted in efforts to conclude if the vaccines administered on January 19th were efficacious or not. "The vaccine administered on January 19, 2022 from lot number 077C21B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. " No known sequela from the event.
The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.; No adverse event; Dose administered after manufacturer date of expiry to 12 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients) and PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 2-Jun-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.).    No concomitant medications were reported.  A Moderna vaccine that expired on 24April2022, was given past the expiration date through the month of June to 12 patients.  Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator.The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-619547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-619547:Same reporter/event
A non-serious, spontaneous report of sneezing and runny nose has been received from a nurse practitioner concerning a 37-year-old female patient who works in the reporter's practice subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 23-Sep-2009. Eight hours after receiving FLUMIST, the patient experienced sneezing and runny nose. As of 25-Sep-2009, the adverse events of sneezing and runny nose are still present.
Sick; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient's brother) via social media.  This case is linked to case ID 2020SA304070 (same reporter).  This case involves an unknown age female patient who got sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) after getting it for years (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. She put 2 plus 2 together and stop getting the shot, from then no problems (outcome: resolved).  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  There will be no information on the batch number for this case.
itching to bilateral axilla and neck, itching to injection site (left deltoid), light headed, itching to head, back, and bilateral legs. Reports flushed to face. Bumps to forehead.
Left armpit swollen and painful; Left armpit swollen and painful; Chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 13:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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.  The patient previously received cefaclor (CECLOR) and sulfamethoxazole/trimethoprim (SEPTRA) on an unspecified date, for an unknown indication and experienced drug allergy.. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 15:00, the patient experienced left armpit swollen and painful, beginning hours after injection and lasted at least 4 days (it was 4 days since injection and both pain and swelling had  persisted). On 15Apr2021, 8-9 hours after injection, the patient experienced chest pain and difficulty breathing that lasted for 36 hours. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain and difficulty breathing was recovered on 17Apr2021 after the duration of 36 hours while the events left armpit swollen and painful was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
He had a vasovagal reaction few minutes after receiving the vaccine.  Recovered after being placed in supine position with feet elevated.    Initial systolic bp of 80, HR of 40, O2 sat 97%.  No CP / Neuro Sxs / breathing difficulties / skin changes.    He was fasting for religious reason; also has h/o fainting when he tried to donate blood.   SBP came up to 100 after about 10mins.    He felt better after several bottles of water and a banana and was symptom free when he left the clinic about 30-40 minutes later.
Started having pulsing in arm and leg with heart palpitations. I was advised by my doctor to stop caffeine/exercise and alcohol. it took about 1 month for the palpitation feeling to go away. pulsating spread all over body after 1-2 weeks. Pulsating was strong initially and would be consistently happening all day for the first couple of months, now happens/ felt at different times throughout the day, felt mostly when in bed.
This spontaneous report was received from a registered nurse and refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-AUG-2016. On 03-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD, lot # M019233 with expiration date of 17-OCT-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 6 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
I had the sot and still got the shingles/Suspected vaccination failure; I had the sot and still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter itself. The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient received Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting
02/18/2021   I felt fine in the morning, but at about 11:30 a.m., I became extremely weak, nauseous.  for the rest of the afternoon, I suffered diarrhea, dry heaves, and extreme weakness.  I began feeling somewhat better at about 5:30 p.m. but still had diarrhea.  By bedtime, I was able to go to bed, and I slept as usual with no interruptions.  Today, I am feeling normal, had a normal breakfast at 9 a.m. I am still a little weak, but I feel like I am no longer ill.
Rash and Urticaria Pruritus. Treatment: Diphenhydramine 25 MG PRN, Prednisone as directed.
Child noticed pain and swelling in right arm beginning the evening of the vaccination, 08/01/2018. It wasn't until today, 8/03/18, that he expressed the pain and swelling to his father who became concerned and brought him to the health department around 3:30 this afternoon to be evaluated. Reaction appears to only be local. R deltoid is swollen tight, with redness and warmth to the touch.  Child still has full ROM of arm and swelling/redness does not extend past the anterior/medial deltoid region. Primary Care MD Dr. was called in the room to assess the child's arm as well, and concurred it was a local reaction and the MCV4 booster should not be given, since the child hasn't ever had a reaction with the DTaP series, it was more than likely the MCV4 that caused the reaction. Father was told to give Ibuprofen for pain and to alternate warm and cold compresses to help with the swelling. Was also told if the redness/swelling worsens by moving into the elbow joint or encircles  the whole upper arm, to seek medical attention immediately. No other concerns were voiced by the father and he states he understands the instructions and will follow up with the PCP if needed. Child denies any other pain at this visit. Left arm is normal in appearance and free from any local vaccine reaction.
*Pain (feels like a bruise), swelling ~one inch below injection site and about one inch in diameter and red *Fatigue *Headache *Shivering *Fever 101.1 *Unexplained belly pain *Unexplained all-over muscle pain in back At this writing, at 7:15 p.m., June 10, 2023, patient is no longer experiencing headache, shivering, belly pain.
A red "cold sore" like rash with some "blister like areas"  appeared on the back of his left arm where he received a varicella vaccination. Area covered a 3x2 inch patch. Pt c/o itching at the site. Client was seen by own MD Monday 4/25/11 afternoon.  Area was reportedly much improved and not as red.  MD dx area as an infection and gave antibiotic.  Parents of client are not convinced that rash was due to an infection, however, they still plan to give antibiotic, but wanted public health to know about reaction.
Feeling stuffy; Congestion; Headache; He's been feeling like he's got a cold in his chest; Throat feels congested; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Aug2021 (Lot number: EW0168) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: diagnosed when he was little, he can't remember exactly when, he was probably young. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Feeling stuffy"; NASAL CONGESTION (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Congestion"; HEADACHE (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Headache"; LOWER RESPIRATORY TRACT INFECTION (non-serious) with onset 29Aug2021, outcome "not recovered", described as "He's been feeling like he's got a cold in his chest"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Throat feels congested".  Additional Information: The patient did not visited to the Emergency Room and Physician Office due to events.  Follow-up attempts are completed. No further information is expected.
@ 11:45 pt recv vax & had burning & pain immed then had back pain & lt shoulder pain;around 1PM felt funny & had SOB but didn't require any intervention;also had some warm & cold feeling;no rxn to prev doses of flu vax in prev years;
pt woke @ 4AM w/T103 given juice & APAP-woke in morning w/low grade temp;
Patient received vaccine, felt faint, smelling salts used. Patient then had seizure for 10-15 seconds.  EMT / 911 called.  Patient went to hospital for follow-up.  Spoke with Patient the next day.  No adverse affects with full recovery.
Patient stated he had a local reaction  right after the vaccination that swollen ,red  and pain at the site of reaction that lasted at least 2 weeks then once that went away the pain persisted. To this day,  he states his arm is still sore and he  went to Dr. for advice but Dr. sent him to as since he got the shot here.
chills, h/a, fatigue, nausea, achiness x 4 days;
Pain at time of administration, right upper arm, continued throughout day. Nauseated appprox, 0100 29 December. Still Nauseated at 0815,  Pain in upper arm increased.
Body aches, chills, fatigue, and sore arm for two days; watery diarrhea, abdominal pain and bloating, loss of appetite, (ongoing)
very huge reaction in that injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (very huge reaction in that injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20H, 028L20A and 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergy injections for almost 35 years).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-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 VACCINATION SITE REACTION (very huge reaction in that injection site). At the time of the report, VACCINATION SITE REACTION (very huge reaction in that injection site) outcome was unknown.            She got the flu shot about 2 weeks prior to the booster, she takes the higher dose for that because of her age.  No concomitant medication was reported. No treatment medication use was reported.   This case was linked to MOD-2021-009697, MOD-2021-363249 (Patient Link).
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-MAY-2014, the patient was inoculated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAY-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed PERCOCET and VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
No energy, tired, redness @injection site, bruised 3 days later @ injection site. No appetite, just wanted to sleep, slight temp Lasted 3 days
A 12-year-old male patient received Pfizer (for 5 through 11 years of age, batch/lot# FL8094) at 16:34. He should have received Pfizer for 12 years of age and older. LVN stated she confirmed DOB but did not verify age prior to administration. Lead RN reinforced administration rights with LVN to prevent future errors. LVN verbalized understanding. Lead RN informed guardian, patient will receive Pfizer for 12 years of age and older for the second dose. Guardian of patient verbalized understanding.
Brain fog and difficult recalling words or names. Difficulty completing a sentence as I couldn't remember basic words or the names of places or people that I see every day.
Pt reported onset of severe pain 10/10 in (L) deltoid muscle (injection site) beginning 1 day after vaccination. Took 1000 mg ibuprofen per pt. When she presented for 2nd vaccine dose 12/9/15, she reports still having muscle pain and limited range of motion. Encouraged to see PCP, apply heat, continue to take ibuprofen. She describes pain as "deep", not in joint/bone. Improved but still present 12/9/15.