chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 days post vaccination,  PT awoke with left calf pain, swelling, warmth, and redness. She was evaluated at the Emergency Department. She was diagnosed with : Thrombophlebitis of superficial veins of left lower extremity  I80.02. She was instructed to
Day 1 - Within 30 minutes of injection I felt dizzy and my vision was unfocused (almost blurry).   Day 2 -  The ocular disturbances continued and I had a huge headache.  Almost felt as if my eyes were dilated. Day 3 - The back of my head and neck ached like whiplash from a car crash if I moved my head up  and down; head felt stiff and heavy; ocular disturbances continue Day 4 - Same symptoms as Day 3 continue
Discharge Provider: MD Primary Care Provider:  MD Admission Date: 10/16/2022 Discharge Date: 10/20/2022 Presenting Problem: Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure (HCC)  HOSPITAL COURSE: Patient is a 43 y.o. male with past and current medical history of severe biventricular heart failure NICM EF 15%, severe VHD; severe MR and mod/severe TR, persistent afib and hx LAA thrombus on Eliquis, chronic pericardial effusion, and social history of medication noncompliance, homelessness, marijuana use, tobacco use and hx ETOH abuse who presented to the ED on 10/16 with complaints of dyspnea, orthopnea, leg swelling, weight gain and viral syndrome. He was found to be in decompensated  heart failure massively fluid overloaded due to non compliance with his medications. He was admitted for diuresis.    He was diuresed to a weight of 79.2 kg from an admit weight of 96.2 kg. Diuresed a total of net negative 19 liters during admission and symptoms significantly improved. Patient was transitioned to Torsemide 40 mg PO daily.   Upon admission, he also was diagnosed with COVID. He was treated with remdesivir 10/17-10/20 and did very well from a covid perspective. Patient on RA and lungs clear, therefore felt ok to discontinue COVID treatment at this time.   Patient w/ hx of noncompliance and not taking medications for various reasons. In an attempt to streamline and reduce burden of medications to hopefully improve compliance, ARB was discontinued and Eliquis was changed to Xarelto for once daily dosing.    The patient is homeless with issues making it to his appointments. Social work was consulted for assistance. Patient discharged with plans to stay at shelter at least 1 day with cab voucher given. Unfortunately, patient not wanting to live in shelter and has no family/friends available. Resources given by care management. Patient discharged in stable condition on 10/20/22.
Pt was seen in office on 06/10/2004 and diagnosed with C-pox. Pt was vaccinated on 1/13/1997.
Rec'd vaccine 12/18 2:30 pm. That evening at 6 pm had sore (L) post lateral shoulder. 12/19 Fever to 101.5. Fever, felt achy, left work. Upper arm noted 12/19 am to be red with induration. Pt still feels achy. Took ibuprofen last night.
weakness; second dose of the vaccine has been delayed until day 42; Fatigue; flu-like symptoms persisted; cough; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INFLUENZA LIKE ILLNESS (flu-like symptoms persisted), COUGH (cough), ASTHENIA (weakness) and PRODUCT DOSE OMISSION ISSUE (second dose of the vaccine has been delayed until day 42) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 07-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms persisted) and COUGH (cough). On an unknown date, the patient experienced ASTHENIA (weakness), PRODUCT DOSE OMISSION ISSUE (second dose of the vaccine has been delayed until day 42) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), INFLUENZA LIKE ILLNESS (flu-like symptoms persisted), COUGH (cough) and FATIGUE (Fatigue) was resolving, ASTHENIA (weakness) had not resolved and PRODUCT DOSE OMISSION ISSUE (second dose of the vaccine has been delayed until day 42) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information include Steroids, Anti-biotics, Prednisone.  The patient's doctor evaluated the patient during a Teladoc appointment and prescribed steroids and antibiotics. The patient's cough continued and the caller reported that the patient was also experiencing weakness and fatigue. During a second in-person visit, the doctor prescribed prednisone and another antibiotic. The patient's symptoms are resolving with the exception of the weakness. The patient had to delay the second dose of their vaccine and will not be getting it until the 42nd day.   Reporter did not allow further contact
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 05-NOV-2015, a healthcare provider at an internal medicine office 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 29-SEP-2016, the patient was treated by a physician at the internal medicine office for post herpetic neuralgia. The patient was diagnosed with shingles 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.
Seen in ER on 2/17/17 at 930AM. Sx's began on 2/16/17 at 600PM. W/headache, confusion, vomiting, diarrhea, incontinence of U/A 3 stool. Rx: IV fluids, ZOFRAN for nausea, TYLENOL for H/A. Returned to ER at 12:00 noon on 2/17 w/ same Sx's. Rx: IV fluids. Dx: Vaccine adverse event. Seen by local physician on 2/20/17. Dx: Same. Instructed - no  more vaccines.
ER Triage Note   Patient a 27 year old MALE presents to Emergency   Department on 01/25/22 08:53.       Tetanus status: Last Tdap: Oct 05, 2020      LMP:    Chief Complaint: Visit CC: productive cough, hypoxic.  Patient is a 27 year old MALE who is being admitted  to the Hospital. This patient meets inpatient level of care because he  has hypoxia from COVID 19.  Still ongoing
Oth complications following immunization, NEC, init on 2016-10-19.
12 hours after injection, I began to have chills and rigors with elevated temp to 101.9 and dull headache.  Approximately 16 hours after injection, I began to forcefully vomit, fever/chills/ rigors continued, and pounding headache developed.  For the next 24 hours the fever, headache, nausea any myalgia continued.
2/5 Pain over entire right arm, body aches, chills, sporadic shooting pain in other parts of body (collarbone, back, arm pits, thighs), headache, fatigue 2/6 Much better than 2/5 but still pain in right arm near injection site, small rash near injection site, overall body aches, slight chills
Within hours of routine 4 months immunization (DTaP, HIB, Prevnar, IPV) pt became limp and extremely irritable. This lasted 30 hours, then resolved completely.
Swelling of left knee and limping. Vaccine was administered in the left leg. She did have a cold at the onset of this as well.
DAY OF VACCINATION: SHARP PAIN AT INJECTION SITE WITH SENSITIVITY TO HOT/COLD. TWO DAYS AFTER VACCINATION, REDNESS AT INJECTION SITE.  10 DAYS POST VACCINATION, ROUND RASH AROUND INJECTION SITE.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-APR-2013, a healthcare provider administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On or about 24-OCT-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, 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 (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
got  a head ache with in 5 minutes of the vaccine that required Medical attention that cause me to miss two days of work from Vaccine 1 Vaccine two: Tuesday had hives from head to toe all over body  ran fever for two days , missed a day of work  went to the doctor gave me a double steriod shot on Friday  and told me I had hive internally and externally then on Monday went back to the doctor gave me two weeks of steriods and a topical cream  and  confirmed that I had an allergic reaction to the shot.  Still is currently under doctors care.
RED BUMP; BRUISED; INJECTION SITE SWELLING; PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced red bump. On MAR-2021, the subject experienced bruised. On MAR-2021, the subject experienced injection site swelling. On MAR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site swelling, red bump, pain and bruised was not reported. This report was non-serious.
sore arm the next day; weren't feeling well; got what they expected; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected). At the time of the report, PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected) outcome was unknown.            No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Pt. received vaccine at approximately 1:10pm on 7-26-12. Pt. reacted to the vaccine 5 minutes later and was feeling dazed, pale, weak. Treatment with epinephrine .2mL. Pt. recovered 20 minutes after injection of epinephrine. Site was the deltoid of the left arm.
This case is linked to case 2021SA394804 (same reporter). This case involves a two-month-old female patient who accidentally received only part of a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and not the HiB portion (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID ACPERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (0.5ml, lot UJ504AAA, expiry date: 29-May-2022) via an unknown route at an unknown administration site for prophylactic vaccination. It was a potential medication error due to Inappropriate reconstitution technique (latency: same day). It was reported "Caller says that a nurse accidentally gave only part of a dose of Pentacel and not the Hib portion. Caller wants to know about next steps and side effects to look for." At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Severely depressed left ventricular systolic function with LVEF 25-30% Mildly dilated left ventricle Mitral valve is moderately thickened with stenosis
Shingles Vaccine given at 5pm.  Painful arm and shoulder complex after admin and teeth hurt ( who knows??) 5 am next day low grade fever (99.8), severe body aches, headaches, joint pain, general fatigue which was consistent all day.  Not helped by advil every 4 hours. Could not lift my vaccine arm above my head due to pain 2nd day after returned to near normal with the exception of teeth pain...
This spontaneous report as received from a registered nurse via a company representative refers to an unspecified number of unspecified patients. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (lot#, route and dose were not reported). The nurse reported that an unspecified number of ZOSTAVAX diluent vials might have gone through an unsupported temperature excursion and could had been used to reconstitute ZOSTAVAX and administered to an unspecified number of patients. This occurred over a 13 year period. No adverse effects reported. It was unspecified if the patient sough medical attention. Additional information has been requested.
Patient called to report 24 hours after receiving flu shot in left deltoid, pain in injection site radiating down to elbow - back up to shoulder area - unable to lift arm.  Reports 11-10-08 that she had ball and socket replacement of left shoulder 4-08 - No aches or problems till after flu shot - doing ice; Ibuprofen - will consult with doctor if pain doesn't stop.
1.5 inch round circle swelling next to injection site; raised; firm; tender; mildly itchy; noticed on afternoon after shot
Rash at injection site, Swelling and pain. Slight fever and chills on morning following vaccination. Extreme exhaustion also on day following vaccine.
Approximately 1 day after receiving vaccination patient noticed a small red rash around the injection site.  Patient said it was not overly itchy or painful but has kept growing.  She came to the pharmacy today 6 days post vaccination and the area is the size of her upper arm muscle.  Patient states no itching, difficulty breathing, or any other issues.  I advised the patient to take Benadryl and the area should stop growing and/or shrink in size and to call and let me know in the next day or 2.
Headache; Tired; During the night, around 1 or 2 am, she couldn't lift her arm.; Arm, achy and sore, struggle to reach with her arm; Dry cough in the evening, not normal; Injection site pain, left arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at 09:40 on 09Apr2021 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history reported as none. The patient's concomitant medications were not reported. The patient previously took BNT162B2, dose 1 via an unspecified route of administration, administered in right upper arm at 11:30 am on 19Mar2021 (Batch/Lot Number: ER2613) for COVID-19 immunization and experienced slightly sore right arm. The patient experienced dry cough in the evening, not normal on 09Apr2021, injection site pain, left arm on 09Apr2021, arm, achy and sore, struggle to reach with her arm at 09:55 on 09Apr2021, headache at 02:00 on 10Apr2021, tired at 02:00 on 10Apr2021, during the night, around 1 or 2 am, she couldn't lift her arm on 10Apr2021. Therapeutic measures were taken as a result of events injection site pain, left arm and arm, achy and sore, struggle to reach with her arm and headache. The outcome of event injection site pain, left arm was recovering; of event couldn't lift her arm was unknown; of event headache was recovered on 10Apr2021; of event tired was recovered on 14Apr2021; of rest events was not recovered.   No follow-up attempts are needed. No further information is expected.
Soreness about an hour after the injection. Next day woke up very tired, body aches, slight headache, body chills and soreness. By the end of the day on 5/5, a whole day after my first shot, I was completely exhausted. I had a mild fever, body chills and was completely fatigued. This morning 5/6, slight headache but feel way better than previous day. I took ibuprofen the morning and night of 5/5. This helped with symptoms I was feeling.
Patient presents to emergency department with allergic reaction including hives, redness over face, urticaria, and swelling since 3/23/21. Patient has taken occasional Bendaryl doses. Patient given Benadryl, Pepcid, and Solu-Medrol.
No additional AEs reported.; Caller is an nurse reporting an AE on behalf of a consumer. The caller stated that expired GARDASIL 9 was administered to a patient on (25-MAY-2022). The caller noted that this was within thirty days of the GARDASIL 9's expiration date. Permission t; This spontaneous report was received from a nurse and refers to an 18-year-old female patient.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 25-MAY-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #T007035, expiration date: 01-MAY-2022, administered for prophylaxis (dose, strength, site, and route of administration were not provided) (expired product administered). No additional adverse events details or product quality complaints were reported (no adverse event).
multiple unspecified patients were vaccinated with improperly stored VARIVAX; No adverse effects reported.; This spontaneous report was received from a nurse, concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.   On an unknown date, unspecified patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # N021318 and lot # R009409 (strength, dose, route of administration, and anatomical location were not reported) both for prophylaxis; which were previously reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects reported.  Regarding varicella virus vaccine live (oka/merck) (VARIVAX) temperature excursions: The lot # N021318 with an expiration date on 07-AUG-2019 had a storage temperature from -9 to 8 degrees Celsius (°C) (-8 C) for a total time frame of 1 hour 20minutes. There was a previous temperature excursion at -50 °C to -15 °C (-14.7C) for 1 hour 15 minutes and -14 C to -10 C (-9.8 C) for y hours 45 minutes. The call was placed because of a Digital Data logger report.  The lot # R009409 with an expiration date on 29-MAR-2020 had a storage temperature from -9 C to 8 C (-8 C) for a total time frame of 1 hour 20 minutes. There was a previous temperature excursion at -50 °C to -15 °C (-14.7 C) for 1 hour 15 minutes. The call was placed because of a Digital Data logger report.
Initial soreness at injection site after injection. Then, about 1 day later, he developed redness and swelling that was very hot to touch roughly 4 inches away from injection site. Patient's doctor prescribed an antibiotic in case of secondary infection.
Cellulitis like reaction. Area where injected started with a red like rash and spreading  down arm.  Very painful, hard and red. Took Benadryl and Motrin. Will keep monitoring. If it becomes worse will go to ER. About 2 hours after injection I noticed the redness and throughout the day it was spreading. The This same thing happened the last 2 times I had the flu shot and they gave me antibiotics before. I was able to catch I t early this time.
Fever 101.8, after Tylenol, lethargy, AM report no other symptoms. 1705 fever 102.8 30 min after Tylenol, child not wanting to eat, diarrhea, red around injection site. 1720, fever broke, eating, cancelled ER.
The vaccine that was administered was expired. I, , RN, failed to waste/discard of the unused vaccines from Monday 08/23/21.
Several hours after PCV-7, Fever, Hives, Limp, Lethargic.  Recovered by next day.
Nose started slowly bleeding from left nostril.  Patient lay down and went to sleep and it found that it stopped.  Did not plug nose.
4/1/2023 I woke up with a bad headache on top of my head and just did not feel well. Other people in the home had tested positive for COVID. I had a little bit of a runny nose and a cough.  I went to an urgent care and tested positive for COVID. I had a chest x-ray which was normal. I was prescribed Paxlovid, an Albuterol Inhaler and cough syrup. I began the Paxlovid that day. I am still testing positive for COVID, but all my symptoms are gone.