chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved.            No concomitant medication information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna  were missed to be booked-in. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.   This spontaneous case concerns an adult, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant Rheumatoid arthritis flare up after receiving a dose of mRNA-1273 vaccine. Outcome of the event was reported as not resolved. Patient received a 2-dose primary series of mRNA-1273 vaccine, given 26 days apart, followed by a 3rd dose on an unknown date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying condition of rheumatoid arthritis remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an adult, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, medically significant Rheumatoid arthritis flare up after receiving a dose of mRNA-1273 vaccine. Outcome of the event was reported as not resolved. Patient received a 2-dose primary series of mRNA-1273 vaccine, given 26 days apart, followed by a 3rd dose on an unknown date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying condition of rheumatoid arthritis remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
Fatigue; dizziness; headache; fever 101.1; some body aches.
Patient's arm is red and hot. Redness extends about 4 inches on upper arm in a circle. I called the patient's doctor, but it is Sunday and the receptionist gave me a nurse's line to call to report this. Once I contacted the nurse's line, patient spoke with nurse who instructed her to apply cold packs and contact her prescriber on Monday.
Had COVID vaccine and had reaction. Large welts at site of injection, warm to touch, very swollen and tender. Itchy around that area.
Home tested positive for Covid 19 on 4/238/2022, no symptoms felt like I had a slight cold, never posted a fever. Self guaranteed until testing negative 5/7/2022. Home tested negative for Covid 19 on 5/7/2022.   July 12, 2022  at approximately 11:15 experienced chest pain Checked in to Emergency room at approximately 1:45 pm same day. Multiple tests were conducted in was diagnosed with Pulmonary Embolism. Transported to Hospital in same day for further observation, tests, etc. July 13, 2022 released from hospital to personal care physician Prescribed Eliquis
headache, chills, severe muscle aches.  Muscle aches in legs so strong they woke me in the night. Very uncomfortable. Chills and general sickness (feeling feverish. but did not. register fever) for 48 hours.  Muscle pain and swelling in legs still  present  four days post  vaccine.   Injection site  also sore, but just for the. first. few days
During monitoring period post Pfizer COVID-19 vaccine, pt experienced headache. VS: 132/84, P-64, O2 98%, Resp 16. Patient states normal blood pressure is 120s/70s. Repeat VS 15 minutes later during extended observation: 126/80, P-65, O2 98%.
In the middle of the night he woke up to a very painful knee; This case was reported by a pharmacist via call center representative and described the occurrence of knee pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was unknown.   It was unknown if the reporter considered the knee pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The patient received Shingrix and in the middle of the night he woke up to a very painful knee.  The reporter consented to follow up. The caller stated it was unknown if it was related and was asking about potential side effects.  The reporter did not have further information to provide at reporting time.
Information has been received from a pharmacist referring to a female patient of unknown age. No pertinent medical history or drug allergies were reported. A few months ago (date unspecified), the patient was vaccinated with ZOSTAVAX (strength, dose and route unknown). There was no concomitant medication reported. On an unknown date, the patient developed reoccurring rashes on unspecified body sites. The patient sought medical attention from her unspecified primary physician. The outcome of rash was reported as not recovered. The causality between rash and ZOSTAVAX was unknown. Additional information has been requested.
CHIEF COMPLAINT AKI   HISTORY OF PRESENT ILLNESS Patient is an 85 y.o. female with HTN/HLD, CAD s/p DES x2 (12/2020), atrial fibrillation (not on anticoagulation due to prior GI bleed), HFrEF (EF 32%) carotid artery stenosis, PAD, polycystic kidney disease s/p renal transplant 1998 on cyclosporine/cellcept/prednisone, bilateral renal artery stenosis, cerebral aneurysm s/p repair 2003, who is transferred from a facility for worsening kidney function and potential need for dialysis.   Patient was initially admitted to a facility for fatigue/weakness and reported hallucinations, and was found to have AKI and UTI. Creatinine was 0.9-1.2 at baseline, 2.23 on admission, and 2.74 today. Lytes today showed Na 129 and K 5.1. CT abdomen without contrast showed no acute abdominal pathology. US kidneys showed right iliac fossa renal transplant with suggestion of mild hydronephrosis and mild diffuse increased parenchymal echotexture suspicious for sequela of AKI. Foley catheter was placed. Patient was given iv bumex 1mg, but urine output remained poor, and patient was transferred to a different hospital for possible dialysis. Patient was also started on ceftriaxone for possible UTI, and urine culture is still pending. Patient also has increased leukocytosis to 31.7.   Note patient had been on bactrim since spring 2021 for UTI prophylaxis. She denies NSAID use or herbal supplementation. Patient is somnolent with decreased attention when she arrived. She is alert and oriented x3. She uses 1L NC at night at baseline. Patient's bumex dose had been recently increased to 2mg PO in the morning and 1mg at noon.
Our daughter cried inconsolably for over 12 hours straight starting within an hour after her vaccines. Nothing helped calm her down. Infant acetaminophen was given after 12 hours of her crying and this seemed to help a little as she was finally able to sleep for a short period of time but then was up crying again. After 24 hours she seemed to be back to her normal state.
Less than 15 minutes after administration the patient felt clammy, sweaty, dizzy, became pale, nauseated, vomited and had chills after vomiting. I called the parent later that day and he stated she was doing ok  but was fatigued and would let us know if there were any future problems
WARMTH, REDNESS AND TENDERNESS SURROUNDING INJECTION SITE R DELTOID. THE FOLLOWING DAY DEVELOPED WARM RED SWOLLEN AREAS INNER SURFACE OF R UPPER ARM. TOOK BENADRYL OTC NEXT DAY AREA WAS FADED AND LESS TENDER.
24 hours after vaccine, she had a fever of 106.  A week after, she began having breathing problems (no history) and chest pain.  Symptoms have continued still, and not getting better.  We have been to urgent care, ED, pediatrician, and going to cardiologist soon.  Now has 2 inhalers and OTC pain meds.  I firmly believe the problems are connected to covid vaccine.
Received vaccine at 6:30 pm.  itching at site began within first 15 minutes and lasted 2 days. Improved with antihistamine.  Within 4-6 hours I began having vertigo causing waking through out the night.   symptoms of vertigo were intermittent, non positional, and accompanied by blurred vision and persistent nausea throughout following day.. Also, chest tightness/wheezing/asthma symptoms acutely wise for 1-2 days after vaccine. Expected reactions included Fever of 101.2 after motrin, leg pain, headache but with  loud pulsatile tinnitus. As a healthcare provider I can honestly say that this was out of the expected ?normal response? and definitely the vertigo was not anxiety provoked as some articles suggest (not immediate and not syncopal).
Palsy; Mild and not obvious distortion; Tingles or neuropathy like sensation in lips in chin.; Tingles or neuropathy like sensation in lips in chin.; Weakness noted; Occasion drooling since October; numbness left side of face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Oct2021 15:00 (Lot number: FF2593) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy; "Known allergies: Wheat" (unspecified if ongoing), notes: Known allergies: Wheat; "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 01Apr2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: PALSY (medically significant) with onset 25Oct2021 10:00, outcome "not recovered", described as "Palsy; Mild and not obvious distortion"; NEUROPATHY PERIPHERAL (medically significant), PARAESTHESIA (non-serious) all with onset 25Oct2021 10:00, outcome "not recovered" and all described as "Tingles or neuropathy like sensation in lips in chin."; ASTHENIA (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "Weakness noted"; DROOLING (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "Occasion drooling since October"; HYPOAESTHESIA (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "numbness left side of face". The events "palsy; Mild and not obvious distortion", "tingles or neuropathy like sensation in lips in chin.", "weakness noted", "occasion drooling since october" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) negative, notes: Nasal Swab; (03Feb2021) negative, notes: Nasal Swab. It also reported that since the vaccination, the patient had been tested positive for COVID-19. Therapeutic measures were not taken as a result of bell's palsy, neuropathy peripheral, paraesthesia, asthenia, drooling, hypoaesthesia.
Patient is fully vaccinated. Hospitalized due to COVID-19. Patient fell on 8/11/2021 due to weakness and was seen in the ER where he was tested positive by PCR. States he has since been hospitalized on 8/16/2021 and was discharged. He is still pretty weak and has not fully recovered from the illness.
Grade 4 (above 104F) fever; severe chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in right arm, on 21Sep2021 at 16:30 (at the age of 21-years-old) at dose 2, single for COVID-19 immunisation. Medical history included gastric ulcer and COVID prior vaccination. COVID had not tested post vaccination. The patient had not known allergies. Concomitant medication included omeprazole taken for gastric ulcer, reported as other medication taken in two weeks. The patient received the first dose of BNT162B2 on 17Aug2021 at 16:00 (at the age of 21-years-old) administered in right arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Patient had been experiencing severe chills, fatigue, and had been having a grade 4 (above 104F) fever since approximately 07:00 of 22Sep2021, so about 14 hours after he was vaccinated with the second dose. With fever reducing medication (TYLENOL), he had been able to reduce the fever to 101.3F, in Sep2021, but it kept creeping back up towards 104+F, in Sep2021. The patient had not recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
The Moderna vaccine was administered to a 17 year old male. The vaccine is not approved or authorized under EUA for anyone under the age of 18 years-of-age. No symptoms were reported by the individual.
Presented to the ED in full body tonic clonic seizure activity. Convulsions noted to cease at 2225 IV administration of midazolam. Then transferred to another hospital.
Acute Cerebellitis Patient is currently critically ill, admitted to the Hospital with severe life-threatening neurologic failure due to acute cerebellitis of unknown etiology.
Slight dizziness and mild nausea occurring the day following the immunization (3/5) and continuing through present.  No treatment as of yet has been administered.
getting more sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 7-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 1 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "getting more sick". Additional information: Patient got her first dose in the primary series with the monovalent orange cap 5-11 formulation of the Pfizer BioNTech Covid 19 vaccine last year. Since then she's been sick various things, she has been getting more sick especially after having the second shot of the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300003701 same patient, different dose vaccine and event;US-PFIZER INC-202300004133 same patient, different dose vaccine and event;
I can't breath, My lungs swell up and then I would start wheezing and couldn't get any oxygen, I went to the hospital last week because I am not handling this asthma very well, I was prescribed Albuterol 90MCG as needed, Alvesco 160MCG 2 a day.
no adverse reaction        Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The reporter stated that her daughter experienced a sore arm from longer than one week but it eventually go away. This case has been linked with case US2018GSK164861, reported by the same reporter.
6 cm area of induration & swellling (R) upper arm, non-tender. 4 cm area of non-tender swelling (L) arm no erythema noted but darker pigmented skin.
approximately 2 and 1/2 weeks after patient received shot had a rash on her left upper arm, shoulder and back.  She said a week later it became very itchy.  The md prescribed some triamcinolone cream to help with the itchiness.  Also she has been very fatigued starting about two weeks after the vaccine
On 6-7-2022, I had a headache and runny nose. I used my allergy medication, TYLENOl and  EMERGEN-C orange packets for symptoms. On 6-10, I began having a sore throat and chest congestion with a cough. I went to a walk in clinic and they performed a Covid test with positive results. They ordered POLY-TUSSIN DM, albuterol sulfate inhaler 2 puffs every 4-6 hrs. as needed and a Z-PAK dose pack. I did not take the Z-PAK but I did take the cough syrup and inhaler. I still have a lingering cough. I am reporting a breakthrough case of Covid.
Vasovagal fainting spell.  Patient fainted walking down the hall after having vaccine.  He hit his chin on the floor.  He had a laceration on the chin, that was repaired in the office. He was sent to an ENT who diagnosed with jaw fracture.
Chest pain.  Pain from front right through to the back just under shoulder blade.  Lasted 4 days.
Vaccinated 8am 5/24 with pneumovax. 1 hour later, had quarter sized redness. 5 hours later, systemic symptoms (achiness, malaise), 3 inch redness by that night. Fever next day 104.2 despite Motrin. 48 hours later, WBC count 27K. Subsequently admitted due to progressive site of lesion; raised margins and systemic symptoms. Admitted for 4 days for parenternal antibiotics.
Sharp chest pain; "Extremely painful that it woke me up and made it impossible to sleep"; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 24May2021 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergy and sulfonamide allergy. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (NORLESTRIN FE) and levocabastine hydrochloride (ZYRTEC); from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on the left arm on 05May2021 at 12:00 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 vaccination. On 25May2021 at 00:00, the patient experienced sharp chest pain on left side only. Extremely painful that it woke the patient up and made it impossible to sleep. Began 12 hours after second dose and lasted 24 hours. It did hurt to take in a deep breath. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sharp chest pain and "extremely painful that it woke the patient up and made it impossible to sleep" were recovered on 26May2021.  The batch/lot number for BNT162b2, was not provided and will be requested during follow up.
Started itching at extremities, no visible rash; felt feverish and achy the following night.
PROQUAD given to a 14 years old.; This spontaneous report was received from a consumer and refers to a 14-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, at age of 14-year-old, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml (lot #, expiration date, route and site of administration were not provided) for prophylaxis (Inappropriate age at vaccine administration).
Tested Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested Positive for Covid-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse effect (No information was reported.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced COVID-19 (Tested Positive for Covid-19). At the time of the report, COVID-19 (Tested Positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information about any concomitant and treatment medications.
Following the first booster in Aug, 2021, Patient began experiencing mobility issues and memory issues which worsened in the weeks following the first booster.    After the second booster, his  mobility issues worsened greatly to the point that he was unable to walk without assistance and had trouble with his cognitive skills and incontinence.  Over the following months, the symptoms continued to worsen and he developed neuropathy in his lower extremities.   Prior to taking the vaccines, he was an active, vibrant person with a sharp mind.  He ran 30 miles a week before the vaccines and was an active hiker and golfer.  He climbed mt. Kilimanjaro a few years earlier.   He is no longer capable of walking, much less running.   Minor symptoms began in the weeks following the original two vaccines in Feb. of 2021 but got much worse after the boosters.