chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & 4hr later flat red ras resembling heat rash appeared @ site;then progressed up to trunk to chest, arms, face & head;didn't appear to itch;no local swelling;
Pt recvd flu vax 5NOV93 & presented to MD w/neck pain, & prescribed unspecified meds; devel tingling in hands & feet, terrible pain in the legs; c/o of pain, tingling, paralysis in legs & hands & numbness; dx GBS due to a viral infect;
Patient reports receiving Jansen vaccine around 5:30 pm at the pharmacy. The patient then went home and went to bed. She woke up around 1:00 am on 5/27/2021 with numbness/tingling/pain in the left arm and in both legs. She states "it hurts to even stand on my legs".  This has persisted all day and is not getting better. She has contacted her PCP and the pharmacy and they informed her to call us. Other symptoms include headache, jaw pain, dizziness body ache (mostly lower back) and cough. None of these symptoms are normal for her.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 77 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
I20.9 ANGINA, UNSPECIFIED 6/25/2022 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 6/25/2022 ACUTE NON ST ELEVATION MI I21.9 ACUTE MI 6/28/2022 ACUTE NON ST ELEVATION MI
"feeling faint, nauseas", episode of projectile vomiting, LOC-Informed EMS she has a history of N/V and LOC R/T injections and anxiety. Pt. discharged home at 13:50 on  . Recorded by RN.
She presented to the hospital today for weakness which has been getting worse progressively over the last few days..  She appeared to be ill during presentation and she was not a very great historian.  Associated symptoms include abdominal discomfort which has been occurring after eating right immediately and resulting in decreased p.o. intake.  She also had on and off diarrhea over the last 2 weeks up to 5 times a day, dark in color but not so foul-smelling.  Vitals in ED: T-max normal; HR max 102; nadir BP 84/38.   Temperature on arrival to ICU was 95.2.  Patient also tested positive for COVID.  She denies shortness of breath, cough or sore throat.  No fever at home.  She reported exposure to her son who had COVID as well but she does not recall when.  She is vaccinated.   Of note, patient follows with Dr. for cholecystitis and she was just seen 2 days ago and felt to be doing well.  Cholecystectomy was not offered due to her multiple medical issues.
I experienced shingles , I had itching and a rash on my right side. I also had a fever
Information has been received from a healthy professional concerning an approximately 21 month old female patient who on 10/27/00 was vaccinated with a dose of varicella virus vaccine live. concomitant therapy that day included a dose of MMRII and a dose of Prevnar. On approximately 06/29/01, the patient experienced more than 50 lesions. She has not yet been seen by a physician. It was noted that the patient's three cousin's (WAES #'s 01071354,01071705, 01071706) had a similar experiences after receiving varicella virus vaccine live. Unspecified medical attention was sought. Additional information has bee request.
Left deltoid hypersensitivity reaction, warmth, redness and swelling locally.  Patient reported hives bilaterally on arms, but not observed on examination.
Per vaccinator, while administering vaccine he pushed the dose and after the plunger reached the end of the syringe (full dose given) the needle broke off of the syringe at the hub. Vaccinator gently removed needle and hub from patient's arm and patient was unharmed. A replacement dose was not needed or administered as the patient received the full dose.
cold sore on lips; fever; 2 episodes of nose bleed, it is little bit but random; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (2 episodes of nose bleed, it is little bit but random), ORAL HERPES (cold sore on lips) and PYREXIA (fever) in a 37-year-old male patient 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 31-May-2021, the patient experienced EPISTAXIS (2 episodes of nose bleed, it is little bit but random). On an unknown date, the patient experienced ORAL HERPES (cold sore on lips) and PYREXIA (fever). At the time of the report, EPISTAXIS (2 episodes of nose bleed, it is little bit but random), ORAL HERPES (cold sore on lips) and PYREXIA (fever) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
Chest pain and shortness of breath overnight. Not able to sleep, anxious. Overall feeling that something is not right in my body. Following evening muscle aches, little pain at injection site. Sore throat and headache. Took benedryl at night hoping it would help me sleep. It did not. Also, having to use my inhaler a few times each day.
arm hurt; "felt tired"; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills) in a 41-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm hurt), FATIGUE ("felt tired") and CHILLS (chills) outcome was unknown.            No concomitant medication and treatment information were reported.
Fever; chills; muscle pain; body ache; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Dec2021 14:00 (Lot number: FD7220) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPRINTEC, start date: Jan2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical Location: Arm, Route of administration: Intramuscular, Lot: EL3247), administration date: 02Feb2021, when the patient was 31 years old, for COVID-19 immunization; Bnt162b2 (Dose; 2, Anatomical Location: Arm, Lot: EL3247), administration date: 15Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 03Dec2021, outcome "recovered" (04Dec2021), described as "Fever"; CHILLS (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "chills"; MYALGIA (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "muscle pain"; PAIN (non-serious) with onset 03Dec2021, outcome "recovered" (05Dec2021), described as "body ache"; HEADACHE (non-serious) with onset 03Dec2021, outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Therapeutic measures were not taken as a result of chills, myalgia, pain, headache.  No follow-up attempts are possible. No further information is expected.
watering  eyes; Heartburn; joint pain; soreness in eyes; This case was received via United States FDA (Reference number: 2020SA366865) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (soreness in eyes), LACRIMATION INCREASED (watering  eyes), DYSPEPSIA (Heartburn) and ARTHRALGIA (joint pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included Rash since an unknown date and Nasal disorder since an unknown date. Concomitant products included DUPILUMAB (DUPIXENT) from 17-Dec-2020 to 22-Jun-2021 for Atopic dermatitis.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2020, the patient experienced EYE PAIN (soreness in eyes). On an unknown date, the patient experienced LACRIMATION INCREASED (watering  eyes), DYSPEPSIA (Heartburn) and ARTHRALGIA (joint pain). At the time of the report, EYE PAIN (soreness in eyes), LACRIMATION INCREASED (watering  eyes), DYSPEPSIA (Heartburn) and ARTHRALGIA (joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Urine analysis: positive for bilirubin positive for bilirubin.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by reporter
Pt. was given an expired Tdap vaccine, no adverse reactions were noted, new non-expired vaccine was given.
Arm/shoulder pain; Arm/shoulder pain; Swelling at injection site; Numbness/tingling sensation radiating down arm; Numbness/tingling sensation radiating down arm; Mild headache; Nausea; Body aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021 at 20:00, the patient experienced arm/shoulder pain and swelling at injection site. Numbness/tingling sensation radiating down arm. Additionally, mild headache, nausea, body aches, chills and no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events arm/shoulder pain and swelling at injection site, numbness/tingling sensation radiating down arm, mild headache, nausea, body aches, chills and no fever were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
9/22 at 6p.m. started feeling full in my sinuses and heavy in the top of my head area. Felt immense pain in the back of my eyes and base of my neck and body fatigue that night and continuing 9/23 and 9/24. I took 500 mg quercetin split into 2 doses morning & afternoon. Adding ibuprofen to this regimen helped a lot. Quercetin began to relieve the pressure but ibuprofen helped with the pain levels. Took 1 dose of 300 mg of golden turmeric on 9/23. I had heard that it wasn't a good idea to take it so that the vaccine could work but felt this inflammation response warranted it. I am currently still doing 500 mg of quercetin as I still have sinus pressure upon waking. I am so much better at this point on 9/27!
Patient got the Johnson&Johnson vaccine in march, she came into the office we checked twice and she did not have antibodies. So the doctor decided to give her a pfizer vaccine aswell
Pain in right shoulder, body aches, low grade fever, headache, difficulty sleeping/ then slept most of the next day.  2O hrs discomfort  after injection
Muscle pain from top of buttox to behind the knee. So severe that moving causes extreme pain.  Once laying down cannot get up without extreme pain.  Cannot roll over when sleeping due to the pain. Tylenol helps a bit but only for about 2 hours.
36 hours after my vaccine I had severe vomiting.  For the next 18 hours I was vomiting every 2 to 3 hours.  Then could not eat for another 6 hours following due to extreme nausea.  I also had a painful headache for those 24 hours.  I felt feverish, but did not have a fever.
headache; 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 HEADACHE (headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.
mom reports that 2 days p/vax the palate of the mouth swelled & caused diff swallowing, face was covered w/red, raised areas, these sx lasted 4 days;took child to see MD;dx vax rxn;
had his 1st dose of the vaccine 3 weeks ago/due for 2nd shot that day but he developed symptoms of Covid19; had his 1st dose of the vaccine 3 weeks ago/due for 2nd shot that day but he developed symptoms of Covid19; he felt congested/congestion; Fever; cough; little bit of tiredness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient called regarding the Pfizer BioNTech Covid19 Vaccine. Per report, he had his 1st dose of the vaccine 3 weeks ago (on unspecified date) and is due for 2nd shot that day but he developed symptoms of Covid19 such as congestion, cough and a little bit of tiredness; all on unspecified date. He did COVID home test and the results were inconclusive. He was asking if he could still take the 2nd dose of the vaccine that day. Further reported that he felt congested on unspecified date. He already received his first dose of the Pfizer COVID vaccine and he felt congested and he also had a fever and he did take MOTRIN as treatment for his fever and then he also took the COVID home test and it was inconclusive and he wanted to know if its still okay to get the second dose. The patient underwent lab tests and procedures which included COVID-19 test: inconclusive on unspecified date. Therapeutic measures were taken as a result of he felt congested/congestion and fever. The outcome of the events was unknown.  Information about Lot/Batch has been requested.
Patient is 95 years.  Up until @2/12/2021 displayed no signs of "dementia" or confusion.  On or about 2/12/2021 she began to show signs of confusion, irritability and dissociation.  Her usual upbeat personal turned to sitting, looking down and choosing not to initiate conversation.  She responds to questions with minimal response.  Her memory seems to be mostly intact.  She occasionally makes negative comments about herself like "I'm so dirty", "I'm filthy".   I realize that my mother is 95 years old and that she is NOT in perfect health.  At this time she is not being treated for her condition and would likely refuse treatment.  IU offer this as information for your use.  Did the Vaccine trigger an episode?  Her doctor said :possibly".
On 01/01/21, I experienced a vaso vagal syncope episode and actually passed out and injured my upper back and right side of rib cage.  I am a nurse and was looking up the required reporting and saw this as a reportable event, and even though it indicates within 7 days, I thought it might be worth reporting.  I have never passed out like that before.
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 08-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Patient came back into the pharmacy the day after receiving the vaccine. He reported a mild rash and itching in the deltoid area and upper arm.  Recommend that he try Benadryl to relieve the itching/rash. Also recommended that he follow up with doctor if symptoms worse or do not improve.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-DEC-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, subcutaneous for prophylaxis, lot # M042504 and expiration date on 30-NOV-2017 (dose and anatomical location were not reported). The pharmacist reported that there were no adverse effects in the patient.
102 temp day after the booster shot; 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 PYREXIA (102 temp day after the booster shot) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 temp day after the booster shot). At the time of the report, PYREXIA (102 temp day after the booster shot) outcome was unknown.            No concomitant medication provided.  No treatment medication provided.
Initial unsolicited case received from a  nurse on 13 November 2014. The reporter stated that approximately 10 patients experienced "full blown" pneumonia within 24 to 48 hours after receiving FLUZONE HIGH DOSE or FLUZONE QIV; lot numbers, dates of administration, and other administration details were not reported. No identifying information was reported for the patients, and it was unknown how many patients received each vaccine. Treatment, diagnostic test results, and outcome were not reported. Documents held by sender: None.
reports that one of her staff had administered an expired daptacel with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient  and reporter reported that the one of her staff had administered an expired diphtheria-15/tetanus/5 AC Pertussis Vaccine [Daptacel] with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hib Vaccine (Hib) And Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for Prophylactic vaccination.  On 15-Aug-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 30-Mar-2023 and lot C5828AA) via intramuscular route in left vastus lateralis for immunization and on the same day her staff had administered an expired daptacel with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Someone gave expired dose of Moderna vaccine to a patient 2 days after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Someone gave expired dose of Moderna vaccine to a patient 2 days after expiration date) 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 12-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Someone gave expired dose of Moderna vaccine to a patient 2 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Someone gave expired dose of Moderna vaccine to a patient 2 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
SORENESS IN ARM; LEG PAIN; EDEMA OF LOWER EXTREMITIES; NAUSEA; HEADACHE; VOMITING; CHILLS; EXHAUSTION; 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: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced exhaustion. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced edema of lower extremities, soreness in arm, leg pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, soreness in arm, chills, exhaustion, and nausea on 17-MAR-2021, had not recovered from edema of lower extremities, and leg pain, and the outcome of headache was not reported. This report was non-serious.