chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On day 6 after vaccination, patient first experienced nausea; on day 7 abdominal pain started; and on day 8, diarrhea commenced.  Diarrhea was initially non-bloody.  Other symptoms included headache, fatigue, and axillary lymphadenopathy at about the same time.  Vaccination site progressed normally with a normal 'take' recorded on day 7.  Anorexia occurred about day 13-14.  Over the course of illness, the patient lost 10 pounds.  On day 13, the patient went to a local emergency room where abdominal exam and abdominal X-rays were performed.  She was given IV fluids.  Blood was taken for CBC, lipase, and results were apparently normal. Stool specimen for O&P and Salmonella, shigella, campy and E coli were negative.  On day 14, patient commenced having bloody diarrhea.  Patient is now following up with a gastroenterologist with a working diagnosis of ulcerative colitis flare.  At this writing, patient's weight has stabilized and appetite has returned.  At no time was any specific therapy given for the patient's condition.   In the emergency room, the patient was given phenergan, bentyl and metronidazole.  She did not take the metronidazole because the culture (and O&P) had not yet been completed.
Narrative:  Patient received Moderna booster yesterday. She developed chills, fever, weakness, and AMS overnight. She was transported to the ED via 911 and was dx with dehydration. She was treated with fluids and sent home. Patient felt back to her baseline within 3 days. Patient has 1st vaccine, also J&J on 3.31.21 and did not have any adverse effects.
dizziness, extreme increase in blood pressure/hypertension, upset stomach, swelling  on left cheek, feel flush, lot and cold flashes
Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued tinnitus and migraine symptoms (photo sensitivity and sound sensitivity, sinus pressure, intermittent headaches)
Swelling at and around injection site.  Began a few hours after injection. Patient went to her doctor.  She stated that doctor said she would be sore for a few days and to apply ice.
Beginning the morning after the vaccination (November 23rd), the patient experienced extreme nausea and a very swollen left arm. These symptoms resolved about 24 hours after onset. The patient stated that she did not feel completely  "like herself" until November 25th.
Fever  2 days  Body aches for 2 days Chills for 2 days Headache 3 days  Runny nose 2 days Weakness /fatigue2 days
1-2 days following 2nd Moderna vaccination, patient developed decreased appetite, nausea, fatigue, headache, and abdominal pain. These symptoms progressed and she came for admission on 4/15/21.  She had fevers of unknown origin despite very comprehensive workup. She also was found to have autoimmune hemolytic anemia (COOMBS Test+) requiring blood transfusion. Because she was having headaches, we obtained MRI brain which showed several small punctate strokes. Distribution possibly was scattered. A thorough workup to exclude Endocarditis was performed including transesophageal which all resulted negative. Her fever curve worsened as did her hemolysis until she needed blood transfusions. A CT Scan of Chest/abdomen/pelvis revealed lymphadenopathy of neck and chest up 1.7cm. Biopsy was performed which showed epithelioid granulomas. Stain for infection was negative. She received broad spectrum empiric antibiotics with seemingly no response. Her fevers seemed to start to decrease on 4/24/21 in PM. Once patient had TEE and Biopsy completed, she was started on Corticosteroids on 4/25/21.  This resulted in rapid improvement in fevers, inflammatory markers, and reduction in hemolysis. Symptoms rapidly improved. She was monitored for several more days and then discharged on 5/1/21.
felt like I had covid again.  then had swelling in my face and hands,  and then got a bloody nose for a few days
Pt. stated adverse event onset 24 hrs post vaccination.  Pt seen for unrealated medical follow-up on 11/18/09 @ 13:30.  No signs or symptoms of adverse reaction noted by PA. Pt did not report any adverse reactions.  Pt also seen by in-house phlebotomist on 11/20/09 at 08:00.  No signs or symptoms seen by phlebotomist or reported by Pt during venipuncture. Pt was seen by PA on 11/25/09 at 09:30 for vaccination reaction. Symptoms included flushing, itchy, rash spreading from upper chest to neck and lower face, jaw.  Pt states this presentation was improved from earlier. Exact date referred to is unknown. Pt stated onset was 24 hours after injection. Treated w/ Vistaril, 50mg, IM.  Advised to use OTC Benadryl 25 to 50mg and return to clinic or ED if symptoms worsen.
Injection site swollen and red. As big around as a baseball. I got a fever that started around 6pm on 5/8/2023 and then a migraine and body aches and pains. Migraine lasted 12 hours. Fever broke around 24 hours. Still have body aches and a swollen arm today 5/10/2023
8-29-09 (Mild Fever). 8-30-09 & 8-31-09-(Chills & Fever of 102.5 on & off). 9-01-09-Redness on arm covered all of arm above elbow-9-1-09 saw Dr & was given a pers. For Amox-Clav.
- 1/26/2021: headache and fatigue all day (1/27 all better), worsening around 3-6 pm, right upper arm pain, left arm pit node swelling and pain (recovered within a few days) - 1.5-2 weeks after vaccine: rashes on toe tips looks like chilblains (might be from cold? Might be from vaccine?)
20 minutes after the injection my face around my right eye and down ward started to swell and tingle.  within the hour it went away.
Patient fainted.   When he became responsive his head hurt and it took him an extended period of time to be able to get up and leave office.  Vital signs were good.  He developed a migraine necessitating treatment at emergency room.
A report has been received from a Health Professional concerning a 50 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 15-Oct-2014. It was reported that the patient FLUMIST QUADRIVALENT was administered to a 50 year old which started 15-Oct-2014. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a 50 year old is unknown. The report was considered to be non-serious.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received vaccine 6 days post expiry dose of the Moderna.  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-395985.
Patient received a vaccine that under went a temperature excursion; No adverse event; Patient received a vaccine that underwent a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion).    Patients weight was reported as 33.6. Vaccine  site was reported as RQ. Concomitant medication list was not provided. It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other.  vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that under went one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion. The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion. Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08Aug2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18-Aug-2022. Number of vials/ per doses impacted was 1 vial. The excursion occurred on 07-Aug-2022. The vials were not punctured until they were used for a patient and then discarded. No side effects were reported. Treatment information was not provided.
Fever, NauseaVomiting, GastricBleeding, Hemoptsis Narrative:  Required a visit to the er, was given zofran and released
Moderna COVID-19 Vaccine EUA Deep bruise around the injections site (upper right arm), the bruise has remained as of today 4/1/21.  Bruising started immediately after vaccination given 3/25/21.  (currently one week)
cold throughout body, increased HR, Numbness in hands and feet, dry throat.  Evaluated by EMS-Cleared
Pt developed approximately 20 - 30 skin lesions. Physician diagnosed mild chickenpox. Pt was afebrile. Pt was treated with calamine lotion and Benadryl.
stuffy/runny nose; stuffy/runny nose; headaches; fever; congestion; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a 42-year-old male consumer patient (reporter's father) that, A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing blood pressure measurement, ongoing diabetes mellitus, ongoing hypersensitivity. It was reported that patient took medication for blood pressure, diabetes, and allergies. She does not have information with her. No further information provided. There is unknown Other Products and Patient History ware reported. No Investigation Assessment. It was reported that patient received his first Pfizer Covid vaccine dose on 20May2021. He has been experiencing a stuffy/runny nose, headaches, fever, and congestion. It was reported that patient got Pfizer vaccine first one 4 days ago on Thursday, 20 May2021. Patient having some side effects, stuffy runny nose, almost always clear liquid. Having headaches. Fever. Wants to know if there is something he can take or recommend. Having congestion as well. Going on for 4 days. Events started day of vaccination. Patient took Pfizer Covid Vaccine because he Wanted to be safe from virus, other family members got it. It was reported that patient has not done anything Treatment for event. Reporter seriousness for Stuffy runny nose, almost always clear liquid was unspecified. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
C/O "migraine and exhausted - went home and slept" after vaccination. Not first flu shot.
Significant pain felt in the upper-left abdomin or lower-left chest region. This pain was not accompanied by other symptoms such as coughing or sneezing. The pain made movement difficult. This pain was minor in the same for one to two days prior. Was given antibiotics when admitted to the ER.
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Pain in shoulder with limited range of motion continuing over 3 months beyond admin date. Has visited chiropractor/orthopedics due to event which remains unresolved
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; FLUID OVERLOAD; NOT FELT WELL; This spontaneous report received from a health care professional concerned a 57 year old adult male, ethnicity not reported. The patient's weight was 110.9 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient received Uptravi (selexipag) (tablet, oral, batch number: 031541502 expiry: 31-JUL-2022) 1000 ug, 2 times every 1 day, therapy dates were not reported for primary pulmonary hypertension. Concomitant medications included amlodipine, Opsumit (macitentan), and Adempas (riociguat). On an unspecified date, patient received covid-19 vaccine and had not felt well since then. He was diagnosed with covid-19 infection and was advised by primary care physician to go to the emergency room for worsening shortness of breath and decreased oxygen levels. The patient went to emergency room and fluid overload has also been determined. The patient had suspected clinical vaccination failure.  Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Not reported, and Oxygen saturation (NR: not provided) Decreased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The patient had not recovered from covid-19 infection, not felt well, and fluid overload, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number 90000182758.  Additional information received from Product Quality Vigilance on 14-JUN-2021.   .; Sender's Comments: V0 20210624724-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. V0 20210624724-UPTRAVI-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.
3 days after rec. injectable flu vaccine the pt broke out in a rash and itching small papular rash, blances, no other symptoms.
Concerns seen on 11/1 for severe back pain/burning and numbness in legs. Dad sts provider cracked her back and she was rx'd a muscle relaxer. Back pain resolved, but still w/ weakness in right leg and numbness in left leg. Had a f/u appt at ortho on 11/7 and they did xray, labs, and MRI. Notes from visit in patient does. Thought it could potentially be Guillain Barre syndrome. Has been getting stronger w/ more feeling in legs. No known recent falls or injuries. Afebrile, no other cold sx's. Received FLUMIST on 10/25/13. Here w/dad.
This spontaneous report received from a pharmacist and refers to a patient of unknown age and gender. The information about patient's pertinent medical history and drug reaction and allergy, and concomitant medications were not reported. On 28-DEC-2021, the patient was vaccinated with expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter lot# S036662 and expiration date 14-NOV-2021 (frequency, route of administration and anatomical site of vaccination,) as prophylaxis (Expired product administered). The reporter stated that, the vaccine did not experience temperature excursion. No additional AE reported. No PQC reported.
Information has been received from a registered nurse concerning an unknown number of female patients who were vaccinated with a dose of Gardasil.  It was reported that the girls felt light headed afterwards.  It was also reported that it seemed quite painful to the girls.  At the time of this report, the patient's outcomes were unknown.  No product quality complaint was involved.  This is one of two reports from the same source.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Patient given PEDIARIX which contains Polio. Also received dose of Polio. No symptoms noted.
R arm became red and very warm to touch. Also painful to touch. Swelling of injection began 12 hours later. Pain and swelling gone after 48 hours.  Still a little red but subsiding. Cool compress and TYLENOL given.
Within 10 hours of vaccination, fever of 102.6, chills, body aches, pain at injection sight.  Following day, fever of 100.7 in the morning, then 101.6 in the evening.  Continued body aches and extreme fatigue.  Second day, pain at injection sight, fever of 99.7.  Third day, no fever or symptoms.  Took Tylenol to reduce fever.
PT BECAME NAUSEATED AND DIZZY SHORTLY AFTER SHE RECIEVED HER J&J VACCINATION
Site manager of Housing reported pt had a sore arm and observed the site that was red the size of a grapefruit and swollen. Called 9/17/15, site manager reported arm feeling better.
Body aches/fever 101.5 at 11 PM/cough/bad headache/chills. Took one Tylenol PM to get to sleep.  Woke without fever or other symptoms after 9 hours.  (this was only the 2nd vaccine I received since 1968 - received vaccine in Nov 2012 and had no reaction.)
Had the shot and got Shingles/Suspected vaccination failure; Had the shot and got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comments: The case was received from the patient via interactive digital media. The patient had the Shingles shot and got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pt had arm all swollen and ran fever. Saw ER doctor and said had gotten injection site infected. Not reaction to shot.
Initial health care professional report received on 01 Dec 2009: This child was inadvertently received 0.25 mL IM dose of FLUVIRIN (batch no: unknown) on an unknown date. No adverse event was reported. No more information was available.
Narrative:  Patient presented to outside facility on 3/28/2021 after receiving second dose of covid vaccine on 3/19. Patient was found to have COVID pneumonia, upgraded to medical ICU with hypoxia and shock. Patient rapidly progressed to ARDS and MODS. Required intubation and mechanical ventilation, sedation and paralytic and proning protocol. Developed shock and acute kidney injury and required vasopressors, start of CVVH and bicarb for metabolic acidosis. Patient continued to decline despite aggressive measures. Developed refractory acidosis and up-trending need for vasopressors. He required cardioversion for afib with rvr. Abx for bactermia. Hep gtt for presumed PE. Family aware of poor prognosis and DNR decision made. He continued to decline and escalated vasopressors 2/2 refractory acidosis. Family made decision for comfort care. Patient expired 4/2 @ 1224 am.
Mom states client broke out with a red, bumpy rash the same day immunizations given. Rash lasted 3 weeks and mom states she took client to the doctor 4 times, because rash kept reoccurring. Client doesn't have rash at present time.
fever, chills, body aches, decreased spO2 with ambulation, tachycardia
passed away one week after her shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by reporter for his or her mother. The patient passed away one week after her shingles shot. The reporter stated it was sad but it happened. This case had been linked with case US2021AMR127094, as reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR127094:Same reporter; Reported Cause(s) of Death: unknown cause of death