chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and NASAL CONGESTION (Stuffy nose feeling like I have a cold) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Feb-2021, the patient experienced NASAL CONGESTION (Stuffy nose feeling like I have a cold). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 02-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, NASAL CONGESTION (Stuffy nose feeling like I have a cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not provided.
Pt has blisters on his trunk and one arm developed 6/28/13. Pt received vaccine (ZOSTAVAX) on 6/18/2013.
Pt vax on 20MAR92 & on 23MAr92 pt had extremely inc temp, & was lethargic; hospitalized x 3 days;
HOSPITALIZATION FOR ADVERSE  EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date patient got Unspecified adverse event due to covid-19 vaccine shot which resulted to hospitalization. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization for adverse event was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210556296-covid-19 vaccine ad26.cov2.s-Hospitalization for adverse event. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Disoriented; Couldn't walk; Had difficulty breathing; Fever of 102; Heart problem got worse; Put on 10lbs; Fell once on the floor; chills; Fatigue; Muscle aches; A spontaneous report was received from a consumer concerning a 89-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced disoriented, couldn't walk, fell once on the floor, heart problem got worse, fever of 102, chills, fatigue, muscle aches, difficulty breathing, and put on 10lbs.   The patient's medical history, as provided by the reporter, included heart problems. Concomitant medications reported included blood thinners and diuretic.  On 08 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient was disoriented and couldn't find his way to the bathroom, couldn't walk and fell on the floor, had a fever of 102 degrees, chills, fatigue, and muscle aches. Per the patient's wife, his heart problem got worse after receiving the vaccine as he also experienced difficulty breathing and gained 10 pounds. On 09 Jan 2021, the patient was taken to the hospital and remains hospitalized. Treatment for the event included antibiotics and diuretic.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, disoriented, couldn't walk, heart problem got worse, fever of 102, chills, fatigue, muscle aches, difficulty breathing, and put on 10lbs, was not resolved. The outcome of the event, fell once on the floor, was resolved on 09 Jan 2021.; Reporter's Comments: This case concerns a 89-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the serious listed event of fever, the serious unlisted events of Disorientation, Gait disturbance, and Dyspnoea, the non-serious listed events of chills, fatigue, and muscle aches, and the non-serious unlisted events of Cardiac disorder, Weight increased, and Fall.  Very limited information regarding the events has been provided at this time. Based on the current available information and temporal association between the use of the vaccine and the onset of events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
After my son received these specific vaccines, which I had expressed concern before vaccinating because of previous fevers/reactions, and I was told they were all "just boosters".  He immediately felt unwell.  By the time we got home, he had a fever.  I did call in and was advised to give Tylenol.  Shortly after my son complained that he couldn't stand or get up to go to the restroom.  I attempted to help him and he collapsed to the ground.  For the next couple of days, he could not stand or walk and screamed in pain.  I called the office several times regarding my concern and was advised on the last day if he did not improve to take him to the ER.  He got up shortly after that and started walking assisted.  During this time he had a high fever that I was not able to break and was losing cognitive and speech function.  Over the course of months following this, he cognitively regressed as well as his speech.  He has been a mystery of diagnosis.  He is not as severe as Autism and is on the spectrum with SPD.  He has brain damage but what exactly is unknown.  He did have chronic ear and strep infections following this set of shots as well.
Headache, fatigue, chills, fever - started within about 3 hours of shot and lasted about 40 hours. Itchy rash at injection site and spreading in blotchy pattern down arm started about 36 hours after shot and continues
No adverse events occurred. The patient was administered a Pfizer Covid vaccine that was stored in the refrigerator for 10 days beyond what is approved by the manufactuer.
Patient received vaccines 4/4/2011. Left shoulder with swelling and redness, increase discomfort starting 4/6/2011 A.M.
ZOSTAVAX was given into the deltoid muscle and resulted in a raised area where the injection was given. Vaccine was given by a nurse at a clinic and not known if IM or SQ.
Hives appeared all over trunk of body and some on arms and legs several days after shot with no other causes of an allergy leading up to the event. Hives resolved with two days taking Zyrtec.
She received immunizations on 5/14/2021.  Parent reported noticing redness and swelling that started the same evening that has been increasing in size. Denies pain, denies limping, denies fever, denies any drainage.  Seen in clinic on 5/17/2021 for evaluation.  10 x 12 cm area of erythema and warmth with minimal swelling to the area.  Consulted with Infectious Disease attending on call who advised that you can see significant redness after getting immunizations.  Watchful waiting advised with close follow-up and recommendations for elevating the area.  Plan to see her back on 5/19/2021 for a recheck. Advised parent if increased swelling, redness, or fever , or she has difficulty walking develops before then to seek care in the Emergency Department or Urgent care.  Mom verbalized understanding.  If no improvement at follow-up plan for further workup as recommended by infectious Disease.
PT RECEIVED VACCINE AT 3 PM, BY 6 PM PT WAS HAVING SEIZURES THAT RESULTED GOING OT HOSPITAL. PT WAS IN HOSPITAL FOR 6 DAYS AND ON THE VENT FOR 4 DAYS. MD AT HOSPITAL STATED THAT IT WAS FROM THE COVID VACCINE AND ADVISED TO MAKE A REPORT.
Three days after vaccination I developed a red, itchy rash which was hot to touch on my upper left arm.  It proceeded to increase in size and intensity for three more days before I started taking Benadryl.  At its peak it covered almost my total upper arm and extended laterally about 2-3 inches.
24 hr after vaccination-local reaction with erythema, edema, tender. 3 days after vaccination-papular and vesicular eruption of submental, neck, chest region.
dull headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (dull headache). At the time of the report, HEADACHE (dull headache) outcome was unknown.            No Concomitant medication was available. No Treatment Medication was available.  Action taken with mRNA-1273 in response to events were Not Applicable.
gastric problems; anxiety; Tiredness; Dizziness; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A two contactable consumers (patient's husband and patient) reported that a 71-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 05Feb2021 10:15 (Batch/Lot Number: EL9269) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient did not received any other vaccine within 4 weeks prior to the vaccine. It was reported that the customer was calling on behalf of his wife and was asking if it was okay for her to take Tylenol for the pain and take TUMS for acid. His wife had the first shot of the vaccine and wants to take Tylenol for anticipated pain. The agent confirmed the wife had the first shot already. Upon transfer, the caller clarifies the TUMS is for tummy pain, ya know like acidic pain. The patient had gastric problems. He clarified its not COVID related or any pains with that. He was just trying to determine the safety of her taking the usual stuff. The patient explained her gastric problems has nothing to do with the COVID-19 vaccine. She mentions she was shrinking because she was getting older. Caller explained her and her husband got their first COVID-19 Vaccine on Friday, 05Feb2021. She had a little tiredness (05Feb2021) right after 3 or 4 hours and a little dizziness (05Feb2021) afterwards, nothing serious. She confirmed she recovered completely. She was a very anxious person and she gets nervous and worried, so she contributed the symptoms to her anxiety to get the shot and all the anticipation. She stated it could have been the vaccine though, she doesnot know. The patient did not visited emergency room or physician office. The outcome of the events tiredness, dizziness were recovered on 05Feb2021 and unknown for other events.
Pruritis and rash at site of injection, spread to entire upper Rt arm, started 2 days after injection.
On 7/24/21 Pt. noted painful left ankle with swelling. Progressively worsening causing pt. to develop limp. 8/5/21 throbbing painful sensation with redness noted, seen at PCP 8/5/21 ultrasound done and diagnosed with blood clot of right ankle. RX Eliquis.
PSORIASIS CLEARING ON FACE; AXILLA BUT PRESENT ON COCCYX; ACHE ALL OVER; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS CLEARING ON FACE), MYALGIA (AXILLA BUT PRESENT ON COCCYX) and PAIN (ACHE ALL OVER) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) CF. On 01-Nov-2021, the patient experienced MYALGIA (AXILLA BUT PRESENT ON COCCYX) and PAIN (ACHE ALL OVER). On an unknown date, the patient experienced PSORIASIS (PSORIASIS CLEARING ON FACE). On 02-Nov-2021, MYALGIA (AXILLA BUT PRESENT ON COCCYX) and PAIN (ACHE ALL OVER) had resolved. At the time of the report, PSORIASIS (PSORIASIS CLEARING ON FACE) was resolving.            No concomitant products were reported.  On an unknown date, the patient experienced psoriasis clearing on face, axilla but present on coccyx, back. On 01-Nov-2021, the patient experienced muscle pain and ache all over. On 02-Nov-2021, the muscle pain and ache all over resolved. Moderna covid-19 vaccine (elasomeran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 01-Mar-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 01-Apr-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna. On 01-Nov-2021, patient received 3rd dose covid-19 vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event(s) of psoriasis clearing on face, axilla but present on coccyx, back,  muscle pain and ache all over was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
On Saturday I had pain in my legs. Every day I got up my feet were experiencing pain of 8 or 9 out of 10. I went to the ER. X-Rays were completed as well as bloodwork. They gave me Vicodin in the pill form. I was then admitted and transported to the hospital for 6-7 days. I was told at that time there is an issue with my kidneys (Acute non traumatic kidney injury) which is why I was admitted to the hospital.
11/2 Nausea, vomiting, fever <102 degrees, swollen arm to elbow, redness, itching and hives in arm, hot to touch, painful. 11/3 swollen arm, redness, warm to touch, painful
Pt felt very sick at 10pm that night flu like symptoms.  next day could not move arm. Arm was red and it was a hard ball. Pt went to the ER. Given clindamycin and ibuprofen for cellulitis and pain. Pt still in pain 10/7/20
acute severe autoimmune hepatitis; This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HEPATITIS (acute severe autoimmune hepatitis) in a 47-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 an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (acute severe autoimmune hepatitis) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HEPATITIS (acute severe autoimmune hepatitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AUTOIMMUNE HEPATITIS (acute severe autoimmune hepatitis) to be possibly related.    Patient experienced vaccine-induced immune-mediated hepatitis with a rapid onset of liver injury after the first Moderna dose, which on re-exposure led to acute severe autoimmune hepatitis.  This is case concerns a 47-year-old male patient with no relevant medical history reported, who experienced serious, AESI, unexpected event of Autoimmune hepatitis. The event occurred unknown days after the second dose of mRNA-1273 vaccine. Patient experienced vaccine-induced immune-mediated hepatitis with a rapid onset of liver injury after the first Moderna dose, which on re-exposure led to acute severe autoimmune hepatitis. Very limited information is avaliable at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-380217 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is case concerns a 47-year-old male patient with no relevant medical history reported, who experienced serious, AESI, unexpected event of Autoimmune hepatitis. The event occurred unknown days after the second dose of mRNA-1273 vaccine. Patient experienced vaccine-induced immune-mediated hepatitis with a rapid onset of liver injury after the first Moderna dose, which on re-exposure led to acute severe autoimmune hepatitis. Very limited information is avaliable at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Date Time PM symptom 1-28-22 4:45 Dizziness/Headache 5:45 Fever -> 101.5 degrees F 6:45 Nausea & vomiting  8:45 Left chest pain w difficulty breathing. 10:45 Sinuses totally bloodied 10:45 BP 190/120/98 11:45 Fever 102.5, lasted till noon 1-31-2022 99.8 12:00 Pulse Oximeter to 90% 12:30  (for my wife)
Symptoms: not eating/drinking, lethargic, vomiting, blood in stool. Infant was evaluated in ER & admitted (3/20/19).
Immediately after shot she had numbness in her left arm from upper arm down to hand. Then later that night developed a headache, stiffness in her neck down to her left arm & body aches. Persisted for several days.
Patient complained of dizziness within 10 minutes of dose while sitting in her car. Asked her to deep breath, drink water, and set car air conditioning to max. Assessed vital signs which were within normal parameters during dizziness and 25 minutes after. Symptoms resolved within 5 minutes. Patient left facility feeling returned to her baseline.
Pt developed a temperature, aching all over and severe headache. She was treated in an urgent care clinic. The symptoms persisted for 5 days.
Patient was seated during her mandatory 30 minute wait, where she stated she began to feel light headed and had a headache. Stated that she has a history of pseudo seizures and that she had one with her first vaccine. Patient then became unresponsive, slumped back in her chair and began to seize. She was lowered to the floor while she was seizing and monitored by paramedics who were on site until the seizure was over. The seizure lasted approximately 4 minutes. Patient was postictal and elected to be transported to the ED for further evaluation. ED discharged her home.
I started to experience a head to toe rash/itch/swelling on 12/17/21.  It got worse in the overnight hours. I went to Urgent Care on 12/18/21 to be tested for Covid (negative) and then examined by a facility doctor.  I was discharged with a diagnosis of atopic dermatitis and prescribed Prednisone, Benadryl, and Triamcinolone Acetonide.  I contacted my PCP on 12/20/21 who took over my care and said it was probably a food allergy.  I was prescribed Prednisone, Allegra, Scalpicin, Triamcinolone Acetonide. As the cause was still undetermined and my symptoms continued, I search for an Allergist in my plan.  I saw Dr. on 1/19/22.  After presenting timeline and symptoms, she told me I had Dermatographism resulting from the Moderna Booster.  The office was seeing patients like me presenting same. I was told to continue with Allegra an topical creams/ointments.  As of today, still not resolved.
Received Varivax on 1/28/00. Now has chicken pox disease.
Swelling in right arm 12 days , started on the 23rd of January at 8pm. The swelling is warm and itchy. I also had night sweats the night of January 23rd.
PATIENT REPORTS SWELLING, REDNESS, SORENESS, AND HOT TO TOUCH IN LEFT ARM THAT ENCOMPASSES THE ARM FROM THE SHOULDER TO THE MIDDLE OF THE FOREARM.  SHE HAS TRIED ICE, BUT NO ANTIHISTAMINE AND NO RELIEF.  ON 10/25 SHE WAS PRESCRIBED AN ANTIBIOTIC AND STEROID CREAM.
Chest pain for 2 weeks with fatigue, found to have Perimyocarditis, admitted to the Pediatric ICU.  Seen by pediatric cardiology, Started on ibuprofen, IV Immunoglobulin, IV steroids. Troponin continuing to rise.    Serial EKGs with ST Elevations(v2-v6) and PR depressions (lead I), which normalized then developed lateral T wave inversions (v3-v6) Admitted on 6/16 Patient is still admitted at time of filing.
on 3/26 I had the first vaccine shot followed by the second shot on 4/2; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (on 3/26 I had the first vaccine shot followed by the second shot on 4/2) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since 25-Mar-2021.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (on 3/26 I had the first vaccine shot followed by the second shot on 4/2). On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (on 3/26 I had the first vaccine shot followed by the second shot on 4/2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Biopsy: her2 positive (Positive) HER2 positive.         It was reported that after the second shot of vaccine, another prognostic test was done and one of the markers which previously was HER2 positive was now HER2 negative.  No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
30 minutes after receiving his vaccine, this patient became pale and fainted. His temperature was 102. No evident seizure activity. He had "fever" right prior to the well-check (temp not taken).
Itchy rash. Patient developed a large, itchy rash two days after his first dose of Anthrax vaccine.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a 21 year old female patient with unconfirmed lupus in July 2013. The patient presented to her facility on 29-APR-2014 for Sexual Transmitted Disease (STD) testing and treatment, reporting that she was pregnant. During the patient's physical exam, her blood pressure was 76/53 on two attempts. The patient reported feeling "dizzy and faint" and she was instructed to go to her primary care physician for examination and to consult an obstetrician for management of her pregnancy. On 22-MAY-2014, the patient returned to the facility reporting that she was required to receive VARIVAX and TDAP for an employment requirement. On that date, the patient denied being pregnant, and she received VARIVAX, 0.5 ml, subcutaneous in the right arm for routine vaccination (was not reported if the patient received TDAP). Concomitant medication included "prenatal vitamins". On 29-MAY-2014, the patient returned to facility reporting that she was pregnant. The patient became pregnant on an unknown date. The LMP and EDD were not known. On 29-MAY-2014, the patient experienced discomfort in her abdominal region. Patient was examined, and the nurse reported that the patient had copious vaginal discharge and multiple macerated lesions in the genital area. The nurse could not determine from the exam if the lesions were vesicular or pustular, due to the amount of discharge that the patient was experiencing. The nurse did not confirm pregnancy during the examination. The outcome of the events was reported as not recovered. The pregnancy outcome was unknown. Additional information has been requested.