chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized;  COVID-19 positive (8.21.21) - hospitalized on 8.28.21 due to COVID (fully vaccinated)  Discharge Information: Admission Date: 8/27/2021 Discharge Date: 09/02/2021 Admitting Diagnoses: Pneumonia due to COVID-19 virus PRESENTING PROBLEM:  Hypoxia  Acute on chronic congestive heart failure, unspecified heart failure type Pneumonia due to COVID-19 virus COVID-19    HOSPITAL COURSE: Patient is a 71 y.o. male who presented to the emergency department with complaints of shortness of breath.  He has a past medical history of chronic obstructive pulmonary disease, hypertension, GERD, gout, non-Hodgkin's lymphoma, CKD stage 3, type 2 diabetes, and lymphedema. Patient states that on 08/18/2021, he started having symptoms of COVID-19 including shortness of breath, fatigue, chills, fever, congestion, rhinorrhea, nausea, dizziness and weakness.  On 08/21/2021, he presented to the emergency department and COVID-19 was confirmed.  He states that since then he has had increasing shortness of breath.  Yesterday afternoon, a home health nurse checked his oxygen saturation and found it to be 87% on room air.  He presented to the emergency department after realizing he was hypoxic on room air.  In the emergency department, patient was febrile, tachypneic, and required 2 liters/minute supplemental oxygen via nasal cannula to maintain a saturation greater than 90%.  Complete blood count was unremarkable.  BMP was remarkable for chronic kidney disease.   BNP was 2261 in the emergency department, and increase from 1296 last week. EKG showed V paced rhythm.  Chest x-ray showed few patchy opacities in the right perihilar region and left lower lung along with small bilateral pleural effusions. Echocardiogram from 08/16/2020 shows LVEF of 45% with mild septal hypokinesis.  Additionally, it shows diastolic dysfunction stage I.  Suspect hypoxia related to COVID-19 pneumonia.  Patient has been admitted for further evaluation management of COVID-19 pneumonia and acute on chronic combined systolic and diastolic congestive heart failure.   Patient was admitted and diuresed with Lasix.  Had echocardiogram done recently on 08/16 was obtained from outpatient and found to have a stable ejection fraction of 40-45%.  He diuresed well with improvement of his renal function to his baseline.  He was treated with steroids and remdesivir.  He was able to be weaned off of oxygen but continued to have persistent dyspnea and exertional shortness of breath with cough.  With continued treatment the symptoms eventually improved and was felt he was stable to be discharged home for continued care.  He will follow salt and fluid restrictions, and his Lasix was increased to twice daily.  He will have a BMP drawn within 1 week and will follow up with tip in the latter more within the next week.  He is greater than 10 days from onset of symptoms so he no longer needs to self isolate.
12-16 hours after vaccine developed chills, hip / sacrum pain, fever of 100.4, headache, fatigue, nausea. Waxes and wanes. Improving over the course of day with Tylenol.  Unable to work. Again, improving since mid morning but still feel poorly.
Patient presented to the ED and was subsequently hospitalized for acute respiratory failure with hypoxia and pneumonia within 6 weeks of receiving first dose of covid vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Result Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Anti viral details COVID 19 Treatment, Paxlovid, Treatment start date 19Jul2022, Treatment stop date 23Jul2022. Admitted for chest pain for first booster. Had rebound covid from paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
My reaction is not life-threatening, but I thought I should report it.  About an hour after the shot, my arm and muscle began being very sore.  Around 7:00 my lower back was feeling a little uncomfortable and my shoulder and arm were hurting.  So, I used a moist heating pad to no avail and finally fell asleep.  I awoke at 10:50ish on Friday night after having the vaccine, and found that all the joints that are affected with arthritis were on fire - hot to the touch and REALLY hurting:  knees, shoulders and muscles in both arms, and lower back.    I could hardly get out of bed, I was so uncomfortable.   I looked at the Extra - Strength Tylenol, the Aleve and an anti-inflamatory - for which I would have had to take some food.  I decided to try one Aleve,  which I use only once in awhile for the Arthritis.  Hadn't used it in at least a month.  I sat and watched TV and within 35 minutes the fire and hurting had subsided.  That's the fastest Aleve has ever worked for me.  I went back to sleep and the next day felt like I was recovering from the flu - no energy.  I ate a little, watched a bit of TV and mostly slept the day away.  This is now the next day, Sunday, and I am back to normal.  I'm happy to not have had the bad headaches some report.   I send a "Thank you" to those who have given us these vaccines.
Patient developed COVID infection after vaccination. Symptoms started on same day of vaccination. 11/4 booster, 11/4 symptoms in PM, 11/6 tested positive, 11/7 treated with paxlovid.  Our facility didn't administer this vaccine. We are the pt's primary care. Clinician prescribed paxlovid. We called pfizer to ask if there was a minimum time between immunization and paxlovid. We were informed that this is a reportable event for Pfizer, so we decided to file a VAERS as well.  The state immunization database, doesn't reflect site of vaccine administration. It was administered at her place of business, per pt.
Flublok inadvertently given to a 14 year old when it is indicated for 18 and up
Received vaccine on 1/10/00, returned to office on 1/11/00 at 9:30 am w/erythema from L/elbow extending up and under arm. Area tender, warm, with good range of motion. Erythema extends 14 cm. Pt afebrile, non-toxic.
Extreme Headache, worst than when i got covid. I have no been able to eat, sleep, or shower.  I have had a fever of 101.2 on the 8th at around 1230, when i awoke at 2 am and checked it was at 101.3. I did not check any further after, but do not feel very hot right now. I had body sweats, and were soaking through sheets. The headache makes my daily life unbearable, a constant level 10 pain. I cannot move my neck, look down, left or right. My neck is very stiff as is the top of my shoulders. I have missed 3 days of work. I sleep for 30-45 min intervals and when i awake the pain seems to be worse every time.
Sore at injection site for 48 hours, slight headache for 12 hours, mild body aches for 12 hours, nausea for 12 hours, fatigue for 12 hours.
Left arm pain -myalgia -worse with arm lift /activity Gradually got better and finally resolved after 6 weeks with no treatment Past hx of arm radiclupathy but on Right arm
This spontaneous report as received form a pharmacist refers to a 61 year old female patient. The patient's concurrent condition and medical history was not reported. On 22-FEB-2015 at 15:00hr, the patient was vaccinated wit ZOSTAVAX (dose and site of administration not reported) Lot # K016322, subcutaneously. The patient also reported of soreness as recovered/resolved on 24-FEB-2015. The causality assessment was not provided. Additional information has been requested.
When patient was receiving the injection she said she experienced a "shock-like pain" that radiated from the injection site to her neck. She said it was very, very painful.  She was shaken up so stayed in the injection room for 25 minutes. She stated that she was afraid to leave in case something happened to her. She was given an ice pack and after 15 minutes she said she wasn't in pain put needed to calm down.
pt recvd vax; immed p/ vax exp local soreness;14nov94 to er w/ hx of malaise & fever blisters;c/o hurting all over,inc pulse,n, chills & dec nutritional status;chest x-ray taken & dx as resp infect; AKA pneumonia;
Sometime late May around the 31st, I was having severe upper left abdominal pain that radiated to my back.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient seemed to have a faiting spell about 10 minutes after vaccine was given, patient came too and felt "sick to his stomach", patient stated he felt okay, but once paramedics came, mom wanted him to go to with them to the hospital.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot # L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt has a PMH of obesity, prediabetes, and presented to the ED with strokelike symptoms. She had a COVID test done on 12/1 due to requirement for inpatient rehab and was found to be positive however asymptomtic.
itchiness; raised bubbles in their rash; A spontaneous report was received from a consumer concerning an unknown age of male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchiness, raised bubbles in their rash.  The patient's medical history was not reported.   No Relevant concomitant medications were reported like  On 15-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch - unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, after vaccination the patient experienced itchiness, raised bubbles in their rash.  Laboratory details not provided. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event were unknown for all events.; Reporter's Comments: This case concerns a male patient of unknown age who experienced a NS unexpected event of pruritus and NS expected event of dermatitis bullous.  The events occurred unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-014532:same reporter, different patient
PLEASE NOTE RECEIVED BOTH FLU VAC AND 2ND  COVID BOOSTER AT LOCAL PHARMACY  LEFT ISCHEMC STROKE SYMPTOMS OF R LEG WEAKNESS ON WEDNESDAY 11/16- TOTAL WEAKNESS SYMPTOM RT LEG ON FRIDAY THE 18TH WITH R ARM WEAKNESS WENT TO ER AT 6AM   ADMITTED FOR STROKE INPTAIENT DMISSION FOR 7 DAYS AT MEDICAL CENTER. DO NOT KNOW IF RELATED TO BOOSTER SHOT / FLU SHOT
Case number PHEH2014US019142, is an initial spontaneous report from a consumer received on 23 SEP 2014. This report refers to patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2013/2014 (batch number: 1308501, expiration date: Mar 2014) on an unknown date. On an unknown date after vaccination, the patient experienced burning at the injection site and then blistering. The outcome, seriousness and causality were not reported.
3DEC96 pt mom stated pt was jerking all over & felt very warm;instructed to take pt to PMD or ER immed;pt recv vax 11AM 3DEC96;adm to hosp dx FUO;
Influenza virus (FLUVIRIN) 2008-2009 formula expiration date 630/2009 given instead of 2009-2010 formula.  Vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.
no adverse event; 3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.) and NO ADVERSE EVENT (no adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.   On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Nov-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.).    No concomitant medications were reported. No treatment medications were reported.
Pt complained of lightheadedness, dizziness, nausea almost immediately after YF vaccination (it was the 3rd and last one administered). Pt put head down on desk, continued to complain of above symptoms. Then she loss consciousness for about 2 min. In these 2 min her head was put between her knees, and when she did not regain consciousness she was eased to the floor with out any injury. As soon as she was prone she regained consciouness without any confusion. She knew what had happened and remembered everything up to the moment she passed out. She had not eaten for almost 5 hr, she was offered and was able, after a few minutes, drink juice and eat crackers. Approximately 40 minutes after regaining consciousness she left. Contacted by phone 4 hrs later, Pt stated she had gone home and slept for almost 3 hrs and was feeling well.
Severe joint and muscle paralysis.  Fever for 24 hours.  Remained in bed for 2 days.
Patient reported back to the pharmacy on 10/7/2019 after receiving and Adacel vaccine on 10/1/2019 with complaints of a torn muscle with pain up his arm and across his chest. Patient had been seen by a doctor that day for symptoms. The doctor gave the patient a prescription for lidocaine patches.
This spontaneous report as received from a male consumer refers to his wife of unknown age. In the morning of 17-MAY-2013 the patient's daughter was vaccinated with a dose of ROTATEQ (dose, route, lot# not reported). A few hours later, the patient thought she came in contact with her daughters from a shared cookie and that there may have been transmission of the ROTATEQ. The patient's lip was swollen and it tingled at the suspected site of the ROTATEQ transmission. At the time of reporting, the patient's outcome was not recovered.
Very itchy hives; She broke out in hives all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy hives) and URTICARIA (She broke out in hives all over body) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced PRURITUS (Very itchy hives) and URTICARIA (She broke out in hives all over body). At the time of the report, PRURITUS (Very itchy hives) and URTICARIA (She broke out in hives all over body) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-405051, MOD-2021-405853 (Patient Link).
Post, smallpox vaccination on day 23, had itchy, erythematous, vesicular, umbilicated rash on UE's, LE's and feet for 2 days.
Low grade fever on the onset Sun 8/7. Low grade continued thru Monday and intestinal pain started 8/8. Joint pain started 8/11 along with eye inflammation causing the white area to bleed. By 8/13 I couldn't walk as my legs were weak. Now at one month after Zoster vac I am still having fever spells, severe joint pain and swelling, diarrhea, extreme low energy.
Marked swelling of left thigh with lump and erythema entire thigh. +1 induration
Fever, chills, nausea, vomiting, diarrhea approx. 10 hours post vaccine.
Approximately 2 and a half weeks after my first vaccine dose I developed shingles. It was/is a mild case on my left side abdomen. It was a mild case, so I didn't go to get medical care.  My husband and sister are both board certified Emergency Medicine physicians and they agree that I had shingles. I thought this could be useful information as you study side effects of the vaccine.  I am a healthy, in good shape 42 year old.  It seems like this effect is rare and typically seen in immunocompromised patients, but that is not the case with me.
Patient was given vaccine 7-26-17. Returned to pharmacy and stated arm had swelled from elbow to shoulder, but had since resolves. Arm on 8-2-17 was warm to touch redness was roughly in size of a palm. Patient was going to continue to monitor and use ice packs.
Event occurred after 2nd vaccination. Patient was diagnosed of COVID 19 Tylenol In-patient
Yesterday in the evening, some hours after receiving the booster for the Pfizer Covid vaccine, family heard the patient scream and complained of sudden and severe onset headache and hearing loss in the right ear, followed by a seizure and cardiac arrest.  She was brought to hospital where she was resuscitated and found to have a large subarachnoid hemorrhage.  She was transferred to hospital, a stroke center but it was determined that that she was already brain-dead.  Family denied any family history of brain aneurysm or subarachnoid hemorrhage and also denied the patient have any history of high blood pressure or any other significant medical problems.
Anxiety; weakness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (Dizziness) and ANXIETY (Anxiety) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012N20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included PROPRANOLOL, SIMVASTATIN and VITAMINS NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced ASTHENIA (weakness) and DIZZINESS (Dizziness). On an unknown date, the patient experienced ANXIETY (Anxiety). At the time of the report, ASTHENIA (weakness) and DIZZINESS (Dizziness) had not resolved and ANXIETY (Anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) They had an MRI on the brain and neck..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant followup added to include AE contact info, outcome of the events and lab test. On 15-Jul-2021: Significant Follow-up added-New event "Anxiety" added, new reporter details added.
Patient complained of severe fatigue, fever of 100.9 to 101.9 most elevated in evenings, lasted 2.5 days. Patient stated she also had a nagging headache and rash, itchy to back and shoulder areas. Symptoms resolved on 3rd day.
Patient developed headache the day he received vaccines. A red, shiny, circular rash approx. 9cm appeared on (R) arm. Pt had mild tenderness at this area.
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified number of patients of unknown ages and genders. No information received regarding medical history and concurrent conditions. The nurse reported that since 01-JUL-2014, unspecified patients might have been administered with (Oka/Merck) VARIVAX (dose, lot # and route were not reported) that were not stored properly. No adverse effects reported. All telephone attempts to obtain follow-up information have been unsuccessful.  This is one of several (1407USA004083, 1407USA004727, 1407USA004728, 1407USA004725, 1407USA004726) report received from the same reporter. Additional information has been requested.
Pt fainted & fell to floor after walking away from getting flu vaccination with parents. Came to right away saying "I just got dizzy".  Per w/c to school nurse office & had lunch.  No lump noted on head or c/o headache. Monitored for 1 hr & went back to class.     No adverse reactions known.