chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented on 1/28 with worsening shortness of breath and malaise ongoing for 4 days. Septic by SIRS criteria. CXR evident for multifocal pneumonia and chronic lung disease. COVID +. Started on vancomycin, cefepime, dexamethasone and remdesivir.  Optimized respiratory status with flolan and diuresis.  2/1 stopped antibioitics and started baricitinib. Intubated on 2/8 with worsening acute hypoxic respiratory distress with increased work of breathing. Repeat CT showed right pumonary emboli and started on heparin drip.  Became more sptic reuquiring pressors and antibiotics restarted. Renal function worsening. During hospitalization code status was made intubate only. Condition continued to deteriorate and family decided to proceed with conmfort care only.
While receiving the flu shot on the right arm on Thursday October 11, 2007, patient was poked with the needle three to four times before the nurse was able to get the shot in.  The morning of Friday October 12th is when we first noticed patient's right arm starting to swell.  When we removed the band aid at 7:50 pm Friday October 12th, there were three visible little holes, in addition to a scratch that was probably caused when the needle was pulled away, as well as three little boils that were not there prior to the shot that was 15mm down from the three holes.  Saturday October 13th the boils were no longer there but instead a little open wound that is 5mm in length and 1mm in width.  Sunday October 14th the wound began to form a scab around the outer edge.  Saturday October 13th patient's arm continued to swell and it started to become very warm.  Patient complained of a lot of itching. Sunday October 14th patient's arm was swollen a past the elbow.  We called the Nurse the morning of Sunday October 14th.  She told us that based on his symptoms, it is protocol to bring him in especially considering the open wound.  Patient saw Dr. at the office for an 11:00 appointment Sunday October 14th.  Dr. said that she noticed the three places where the needle was and asked if he had other shots.  When we told her that it was only one shot, the flu shot, she said that next time patient needs to come with reinforcements to help hold him down.  She also noticed the place where the little wound was and said to put Neosporin or Bacitracin on it but, she preferred Bacitracin. Dr. said she did not believe that his arm was infected because patient did not change expressions when she touched it twice and he was able to pull and push with both arms and he was able to rotate the arm.  Dr. wrote a prescription for Augmentin to fill only if he started to not be able to move his arm.  Monday October 15th patient stayed home from school.  Patient's arm was still very swollen.  The swelling is now 200 mm from the site of the shot.   The bottom portion of the inner arm looks like a red blotch that is 90mm in length and 70mm wide.   This then increased to include the upper portion of the arm later Monday night.  Patient was experiencing extreme itching and discomfort the night of Monday October 15th.  He was restless and whining about how much it itched.  Also Monday night he started to get areas of large bumps on the lower arm.
THREE RED BUMPS ON HIS CHEST, LIKE MOSQUITO BITES. COMPLAINING OF PAIN IN CHEST UNDER WHERE THE BUMPS ARE LOCATED.
It was a big rash at the lower part of my leg, bubbly rash, puffy and sticky. Close to my ankle. A lot of puffy bumps, that's the first time I've ever had a rash like that. I?ve never had a rash like that before. I went to the Doctor and he gave me a gel. I also had a headache on my right side for a few days and took motrin 800mg for it and it went away.
My daugther received her 4month shots on 6/7/08 at the Health Department.  On Sunday, she developed what we thought was a heat rash, we treated it with a cool bath, kept it dry.  She spent a few days with my mother (was exposed to no new foods, detergents or environments) I picked her up on Wednesday 6/11/08.  Her face was slightly swollen and the "rash" had spread down her neck and covered 85% of her face.  On Saturday 6/14/08, when she woke up her "rash" had dispeared and in its please was a huge red, raise hive that covered most of her face.  Later in the day after spending a lot of itme trying to figure out what may have caused this it dawned on me that his may be a reaction to her shots.  We went straight to the emergency room where they diagnosed where with an allergic reaction and the red swollen skin were called "hives" They gave her 1 dose of prednizone (and sent us home with a script for 2ml's of predizone for 4 days), within hours the redness/hives had drecreased.  During the time prior to the emergency room trip she would scratch uncontrollably and become upset as it would hurt.  This affected her ability to sleep. Her face and eyelids were swollen and pink. She had a glassy look in her eyes. Her sleep was eradic but was never consistant prior to vaccination.
1 patient received doses from vial that went to 6.6 F; 1 patient received doses from vial that went to 6.6 F/ freezer excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received doses from vial that went to 6.6 F/ freezer excursion) and POOR QUALITY PRODUCT ADMINISTERED (1 patient received doses from vial that went to 6.6 F) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received doses from vial that went to 6.6 F/ freezer excursion). On 01-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (1 patient received doses from vial that went to 6.6 F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (1 patient received doses from vial that went to 6.6 F/ freezer excursion) and POOR QUALITY PRODUCT ADMINISTERED (1 patient received doses from vial that went to 6.6 F) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Freezer excursion was reported, and the data log said it happened on 12-May 2022. There was a loss of power close to midnight.  Maximum temperatures reached was 6.6 F with the excursion duration of 5 minutes. Vials were moved from freezer to refrigerator on 31-May-2022 and were stored in fridge, quarantined in a separate bag. Vaccine was still frozen upon visual inspection on 16-May-2022. Proposed desired use by date was reported as 03-Jun-2022 and 09-Jun-2022 to 10-Jun-2022. 8 vials were impacted in the excursion, three were used, there were 5 left. Remaining 5 vials were not punctured with no previous excursions.  It was also reported that patient received Spikevax on 01-Jun-2022. The vial was initially stored in the refrigerator on 31-May-2022 and the vial did not undergo any temperature excursions. No treatment medications were reported.
were administered after experiencing temperature excursion.; No additional AE details available.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 10-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032932, expiry date: 28-SEP-2022 (strength, dose number, route and anatomical location were not provided) for prophylaxis.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of 6°F to 14°F (8.5° F) for 0 hours 18 minutes 0 seconds; 6°F to 14°F (11.9F) for 1 hour 0 minutes 0 seconds with a cumulative Timeframe: 1 hour and 18 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint was involved.
feels sleepy/he's asleep; sleep paralysis; lucid dreaming; he wakes up; he cannot move; when he sleeps he has difficulty breathing; feels very tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up) and HYPOKINESIA (he cannot move) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up), HYPOKINESIA (he cannot move), SLEEP APNOEA SYNDROME (when he sleeps he has difficulty breathing) and FATIGUE (feels very tired/fatigued). At the time of the report, SOMNOLENCE (feels sleepy/he's asleep), SLEEP PARALYSIS (sleep paralysis), ABNORMAL DREAMS (lucid dreaming), POOR QUALITY SLEEP (he wakes up), HYPOKINESIA (he cannot move), SLEEP APNOEA SYNDROME (when he sleeps he has difficulty breathing) and FATIGUE (feels very tired/fatigued) outcome was unknown.            No Concomitant medications were provided. No Treatment medications were provided.   This case was linked to MOD-2021-297626 (Patient Link).
Fever, faintness, weakness, diffuse body aches, joint pain, chills, shortness of breath, eyes burning, cough.
Left arm sore. By 9pm felt nauseated, both shoulders and upper arm began to hurt as the night progressed pain moved down his back and hips. Nausea continued next day woke up by 6am walked only a bit but still felt nauseated, chills no fever, still feels malaise right now. Took Advil PM for symptoms. Spoke to doctor on 9/18 10:30 am who recommended also to use Ibuprofen. He doesn't feel like eating, getting better with medication not if it wears off. Lying around not moving much. Doctor recommended also water and benadryl. Not red on injectetion site, indicated that left arm was more painful than right.
Patient experienced fairly extensive swelling (she first notified me at ~4:30 PM on 10/31/14) that I would say ~ +2 edema (no pitting noted). She also noted the injection site to be red and slightly painful. She said it was worse the day(s) before, but it was much better.
Woke up with severe shakes, fever grew to 103, up every hour, freezing, headache, and Fibromialgia hurting everywhere.
Extreme flu-like symptoms of joints and full-body aching, light headache and fever. Sore arm area of shot and swelling, lasting two days, then intense itching in 3" x 3" area of shot, lessening in 5 days and gone in 1 1/2 weeks. I saw the pharmacist.
ADMINISTERED PRE-FILLED SYRINGE THAT WAS 10 MINUTES PAST ITS 6 HOUR MAXIMUM IN THE REFRIGERATOR; STORED PRE-FILLED SYRINGE THAT WAS 10 MINUTES PAST ITS 6 HOUR MAXIMUM IN THE REFRIGERATOR; This spontaneous report received from a physician concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 07-AUG-2021) dose was not reported, administered on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the subject experienced administered pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator. On 17-JUL-2021, the subject experienced stored pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator and stored pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator was not reported. This report was non-serious.
Patient did not get the full booster dose/couple of drops ran down her ar/some of it came back out of her arm; some of it came back out of her arm/couple of drops ran down her arm; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient did not get the full booster dose/couple of drops ran down her ar/some of it came back out of her arm) and INJECTION SITE EXTRAVASATION (some of it came back out of her arm/couple of drops ran down her arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 03-Jun-2021 and Pfizer on 24-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient did not get the full booster dose/couple of drops ran down her ar/some of it came back out of her arm) and INJECTION SITE EXTRAVASATION (some of it came back out of her arm/couple of drops ran down her arm). On 27-Dec-2021, INCORRECT DOSE ADMINISTERED (Patient did not get the full booster dose/couple of drops ran down her ar/some of it came back out of her arm) and INJECTION SITE EXTRAVASATION (some of it came back out of her arm/couple of drops ran down her arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
reported sore arm on 1/25 on 1/26. Reported "light" arm  pain, itching, and fatigue on 1/27 and 1/28/2021 Narrative:
Lymph node pain, fever, body aches, chills, taken tylenol extra strength. Fever will subside after several hours then return.
site bleed and has swelling. Appeared to be an acute hematoma.  Patient was instructed to monitor and ice at home.  Upon follow up on 9/18/2020, patient reported no pain or soreness or any issues.
Shortly after getting the vaccine (within 20 minutes)- headache, minor aches in muscles.   45 minutes after vaccine- more severe muscle soreness. 12 hours after vaccine- full body muscle aches (pain in all muscles like a post-run lactic acid build up), joint pain throughout entire body with radiating pain in joints from toes to fingers to neck.   Chills (no fever) Nausea Inability to sleep
Day after 2nd dose of shingles vaccine, has left me shivering and nauseous
pt recv vax;cont crying, inconsolable for > 3 hr;PC to hlth dept from mom, referred to MD;MD suggested apap & benadryl;local redness at site; pt ok 14mar95;
Client was observed for approximately 15 minutes after she received the vaccination when she told the observation nurse that she was feeling claustrophobic and wanted to step outside for air. She exited the vaccine hub against medical advice, then fainted.  Immediately afterwards, nurses from the observation team, including myself wheeled her inside using a wheelchair. Once inside, the client's legs were raised on a chair, an ice pack was held against the back of her neck, and she was given water and crackers to consume. Her vital signs were collected periodically until they were stable and she reported feeling better.
about 40 minutes after shot:  taste in mouth then swollen tingly warm lips, sinuses swollen, tingly and warm in nose and forehead, "shadowy" vision  I took 2 zyrtec a few minutes after symptoms started, lasted for 8 - 10 hours  Then I was fine
ACHINESS; DISCOMFORT; CHILLS; TIREDNESS; FEVER; This spontaneous report received from a vaccine facility via a company representative concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject started having symptoms around 8 pm achiness. On 10-MAR-2021, the subject experienced discomfort. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced tiredness. On 10-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient recovered from achiness, discomfort, and chills on 11-MAR-2021, was recovering from tiredness, and had not recovered from fever. This report was non-serious.
2nd dose after 43 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (2nd dose after 43 days from the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-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) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced OFF LABEL USE (2nd dose after 43 days from the first dose). On 26-Feb-2021, OFF LABEL USE (2nd dose after 43 days from the first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided  Treatment information was not provided
Fatigue; My energy level has not fully retuned.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the right arm on 19Apr2021 at 07:00 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization in hospital. Medical history included influenza from 2003 to an unknown date; Asthma (triggered by smoke) and congenital hearing loss; both from an unknown date and unknown if ongoing. Patient had past drug history or known allergies to Tree nuts, coconuts, palm oil. The patient previously took first dose of BNT162B2 (Batch/Lot Number: not reported) via an unspecified route of administration, administered in the right arm on 20Mar2021 at 07:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization and experienced no reaction on previous exposure to vaccine. Concomitant medications within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC); paracetamol (TYLENOL) (reported as 9 days before); benzocaine (ANBESOL); all taken for unspecified indication, start date and stop date were not provided. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. On 21Apr2021 at 08:00, after second vaccination, patient experienced fatigue for about 3 months and patient's energy level has not fully retuned. Further clarified that patient was normally active, and reports walks 3 miles/day, go to a dog park almost daily and walk an additional 3 miles, and pedal on an exercise bike with moderate resistance for 60 minutes. But after the 2nd dose, walking 1 mile exhausted her and she could only bike for 5 minutes. Patient was easily exhausted until 16Jul2021 and my energy became to come back. Her energy level still has not fully returned. Patient used to work 12 hour days and still felt energized at the end of the day. Now, after working 8 hours, She feel fatigued and unable to exercise. There is no hospitalization prolonged due to events. Patient did not receive any treatment for adverse events. The outcome of events was recovering at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
AFTER THE PATIENT RECEIVE THE PFIZER COVID-19 VACCINE, THE PATIENT AND MOTHER WERE WAITING NEAR THE PHARMACY AREA. APPROXIMATELY 5 MINUTES AFTER, THE MOTHER CALLED OUT FOR HELP SINCE THE PATIENT SEEMS TO BE DIZZY. THE PATIENT WAS IN AND OUT OF CONSCIOUSNESS WHILE SITTING ON THE FLOOR. THE PARAMEDIC CAME WITHIN 3-5 MINUTES AND TOOK THE PATIENT'S VITALS. THEY TOOK HER TO THE EMERGENCY ROOM.
COUGH, HIGH BLOOD PRESSURE (160/104), COLD AND HOT CHILLS, INCREASED JOINT PAIN, AND CHRONIC FATIGUE, OCCASIONAL DIZZINESS, MEMORY LOSS/CONFUSION  (BRAIN FOG), COUGH, AND HEAD COLD STARTED ON/AROUND DECEMBER 30, 2021.  THOSE SYMPTOMS STILL CONTINUES SINCE MY 2ND VACCINATION.   ALONG WITH ATYPICAL CHEST PAIN - MUSCULOSKELETAL CHEST PAIN; INFLAMED CHEST CARTILAGE STARTED ON JANUARY 5, 2022 AND GOT WORSE ON JANUARY 8, 2020. I SPOKE TO MY ADVICE NURSE AND SHE ADVISED ME TO SEEK MEDICAL ATTENTION AT URGENT CARE CLINIC. MY LUNGS WERE CLEAR AND THE EKG WAS NORMAL. I WAS TOLD TO CONTINUE IBUPROFEN, REST, DRINK PLENTY OF FLUIDS, AND USE WARM AND COLD COMPRESSES. I WAS PRESCRIBED ALBUTEROL. I CALLED BACK TODAY, JANUARY 21, 2022 BECAUSE THE INCREASED FATIGUE.  I WAS TOLD TO GET TESTED AND KEEP THEM INFORMED OF ANY WORSENING - IF SO, COME BACK TO THE URGENT CARE CLINIC. CALL 911 IF THERE IS AN EMERGENCY AND I CANNOT DRIVE (I LIVE AND CARE FOR MYSELF ALONE). ITS WAS ALSO ADVISED TO REST AS MUCH AS POSSIBLE.
Fever, Joint Pain, Fatigue - onset 3:30 PM same day as dosage  3/18 - joints locking up for periods of time, continued feeling feverish throughout day, very fatigued 3/19 - joints still locking up, fatigued, 1 mouth sore on tongue 3/20 - some joint pain, fatigued, 2nd mouth sore appeared on inside of left cheek
startling effect every 10-15 sec for about 30 minutes; temp approx 101 R; constant crying lasting through the noc;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose was not reported, administered on JUL-2021 for prophylactic vaccination. Dose series was 1. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient had no side effects after vaccination. But, on an unspecified date in NOV-2021, the patient got covid (suspected covid-19 infection, suspected clinical vaccination failure) with very little symptoms. The consumer reported as "The patient got Johnson and Johnson shot in July no side effects but got Covid in November with very little symptoms Thank (a higher power)". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000206658.; Sender's Comments: V0 20211227545-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Pfizer 3/30/21, 4/20/21. Positive on 2/7/22