chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neutropenia fever - polymicrobial bacteremia; Neutropenia fever - polymicrobial bacteremia; This is a spontaneous report from a contactable physician. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) (at the age of 55 years old) as a single dose for COVID-19 immunisation. Medical history included pancytopenia from an unknown date and unknown if ongoing and prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021, the patient experienced neutropenia fever - polymicrobial bacteremia, which required hospitalization for 5 days. The patient underwent lab tests and procedures which included SARS-COV-2 test (nasal swab): negative on 01May2021. Therapeutic measures taken as a result of neutropenia fever - polymicrobial bacteremia included IV antibiotics. The outcome of the events neutropenia fever - polymicrobial bacteremia was recovered on 05May2021.  Follow up needed, further information has been requested.; Sender's Comments: Based on available information and known drug profile the reported "neutropenia fever - polymicrobial bacteremia" are unlikely related to  BNT162B2.  These are probably intercurrent  medical conditions in a patient  with a history of pancytopenia and COVID-19 infection.  Case will be reassessed if additional information is received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
right arm pain radiating to thumb and thumb "locks" up.  Narrative:  After 1st vaccine - right arm felt sore within a couple of hours of her vaccination. She took tylenol after the injection. The pain in her arm wasn't too bad that first day (12/22). It continued to get worse over the following days to weeks. The pain in her arm continues and she can't lift her arm up without pain and her thumb locks up. The pain in her arm is "where the ball joint is for the shoulder" and it runs down her arm pulling into her thumb. The thumb is sore to the touch and locks up. She has not had this kind of problem before. 2nd vaccine - left arm felt sore but went away after a couple of days. 1/28 - employee was evaluated by the EOH doc at the MC on 1/27. He referred her to a worker's compensation physician for further evaluation and treatment. No diagnosis at this time. Differential includes C6 radiculopathy, frozen shoulder, or complex regional pain syndrome.
Fever of 100+, diarrhea, severe muscle aches and joint pain, severe fatigue
extreme soreness at point of injection, restricted movement of left arm above shoulder level, temperature - (for about 24 hours).  Highest temp reached was 99.6 degrees. elevated. all symptoms resolved in about 48 hours
2nd dose administered to patient from expired vial/Above vaccine given at 7:30am on 9/1/21 and vaccine expired on 8/31/21. no adverse reaction noted. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial/Above vaccine given at 7:30am on 9/1/21 and vaccine expired on 8/31/21. no adverse reaction noted.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 7:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial/Above vaccine given at 7:30am on 9/1/21 and vaccine expired on 8/31/21. no adverse reaction noted.). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial/Above vaccine given at 7:30am on 9/1/21 and vaccine expired on 8/31/21. no adverse reaction noted.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided.  No treatment information was mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 07-SEP-2021 contains No New Information
S/P anaphylactic RXN due to vaccines given (DTap-IPV, MMR, Var) - (currently pt ongoing daily desensitization oral Tx 9mo)- within 1minute cough/wheeze/pulse ox 91%- all S/Sx improved somewhat with albuterol & then S/Sx completely resolved & ASYX after EPI given (mom's pen)   pt asymptomatic after EPI given, then paramedics arrived onsite & brought pt to ER for further monitoring pt's allergist contacted after departure to inform re: anaphylactic episode, agreed with above Tx, was okay for vaccines given but informed in general, known increased risk of anaphylaxis at anytime due to many possible 'triggers' while ongoing daily oral desensitization Tx.
Vasovagal syncope VS BP:118/51, HR 71 bpm RA 98%
inject site was sore 2-3 days then became itchy and red 3-6 days now itchy red swollen warm with small infection site 6-8 days
Starting 06/18/2022, I had a low grade fever, cough, congestion, headache and body aches.  I tested positive with an at-home COVID-19 test the same day. On 06/19/2022, I started Paxlovid (prescribed by my husband) in the evening. I finished it as instructed. I would say the symptoms lasted a total of 2-3 days from when they started and began subsiding afterwards. I did have a lingering cough which lasted for about 2 weeks or more. I was exposed to someone on the weekend of 07/01/2022 who had COVID-19 (but they did not start having symptoms or test positive until 07/03/2022). I tested myself on 07/05/2022 and it was positive.  I basically quarantined for 5 days afterwards and did not take Paxlovid again. My symptoms were very mild compared to the first time.
10 days after vaccination, injection site is red and itchy and area is slightly sore and warm to the touch
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Aug2022 at 12:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid treatment start date=10Aug2022, lot number= GE1666. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe facial edema; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (Severe facial edema) 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 provided.     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 FACE OEDEMA (Severe facial edema) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE for Face edema, at an unspecified dose and frequency. At the time of the report, FACE OEDEMA (Severe facial edema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported . The patient reported that he was treated at an urgent care facility with epinephrine and wanted to confirm if this was a delayed reaction to the vaccine or not.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Feeling different--not feeling good; Sore arm--m Sensation on her left arm around the breas; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling different--not feeling good), PAIN IN EXTREMITY (Sore arm--m Sensation on her left arm around the breas), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included OLMESARTAN MEDOXOMIL, MOMETASONE FUROATE (NASONEX), VITAMIN D3 and PROBIOTICS NOS for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling different--not feeling good) and PAIN IN EXTREMITY (Sore arm--m Sensation on her left arm around the breas). In April 2021, the patient experienced CHILLS (chills) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (Feeling different--not feeling good), PAIN IN EXTREMITY (Sore arm--m Sensation on her left arm around the breas), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient also uses Neti pot flush, Premarin vaginal cream and high blood pressure pills.
had been itching since shot but started feeling like my throat was closing, had heart palpatations, and felt nauseated. Took 50mg of benedryll and symtoms started improving within 20 minutes but itched almost all of next day.
rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix. On 10th June 2019, 8 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced rash on thigh. The patient was asking if she need to see a physician.
This spontaneous report has been received from a license practical nurse concerning a 12 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
18OCT96 t100, both arm sore, swollen, nauseated & vomiting;19OCT96 330AM t102;took APAP & applied moist heat to lt arm;arm sore;20OCT96 lt arm sore, swollen w/red streaks present;went to ER dx staph cellulitis on ATB;21OCT96 feels better;
shingles/painful blisters across her abdomen and back and was diagnosed with shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 14-NOV-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date (reported as shortly after the vaccination), the patient suffered painful blisters across her abdomen and back and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), her symptoms have resulted in physical limitations not present prior to using the product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of shingles was considered as not recovered. The reporter considered the event to be disable and related to Zoster Vaccine Live(ZOSTAVAX).
I got COVID after getting the vaccine and booster; I got COVID after getting the vaccine and booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID after getting the vaccine and booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BRIEF OVERVIEW: Admission Date: 6/7/2023 Discharge Date: Jun 13, 2023 Discharge Disposition:  home or self care   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cavitary pneumonia [J18.9, J98.4] Multifocal pneumonia [J18.9]   HOSPITAL COURSE: 63 y.o. male with past medical history of COPD, HTN, Crohn's disease, and right lung mass s/p EBUS with biopsy negative for malignancy who presented to the ED with chief complaint of SOB, productive cough, and weakness.    Patient was recently evaluated last month for hemoptysis and found to have right sided lung lesion highly suspicious for malignancy. He has been following with the clinic and has a chest port placed on 5/17 for anticipation of starting chemotherapy. Patient underwent bronchoscopy on 5/25 for lung biopsy with fine needle aspiration negative for malignancy. Tissue pathology showed pulmonary parenchyma with reactive pneumocyte hyperplasia.  Tissue culture grew Streptococcus agalactiae and streptococcus intermedius. Patient was scheduled to follow up with office this month and have repeat chest imaging. In the interim patient reports he had worsening cough and dyspnea with malaise and loss of appetite. He presented to ED for further care.    In the emergency department, patient was afebrile, tachycardic with heart rate 108bpm, otherwise hemodynamically stable on room air.  Labs significant for leukocytosis with WBC 24.76, anemia with hemoglobin 10.1, and thrombocytosis with platelets 449.  EKG revealed sinus tachycardia without signs of ischemia.  CTA thorax was negative for PE but did show rapidly progressive RUL, RML, and RLL dense consolidative changes concerning for multifocal PNA. In addition COVID-19 PCR was positive. Patient was started on broad spectrum abx and admitted to hospitalist.    The patient slowly improved. COVID-19 was thought to be incidental and not contributing to PNA. ID was consulted. Sputum cx grew MSSA. ID recommended 4-6 weeks total of abx with IV unasyn while inpatient and discharge on cefadroxil 1000 mg bid x 4-6 weeks to treat GBS and strep intermedius seen on cultures from 5/25 bronch as well as MSSA in sputum cx.    Pulmonology was also consulted and recommended outpatient follow up in clinic with repeat imaging to document improvement.    SLP was consulted and evaluation negative for dysphagia.    PT/OT evaluated patient and recommended SAR, the patient declined and the was discharged home with assistance from his brother, with whom he will be staying.
Acute urticaria. Symptoms include itching and raised red wheals. Urticaria are located on the arms (upper back and abdomen) and trunk. Onset was sudden 2 day(s) ago. Onset followed none (except she did receive the Moderna vaccine #1 on 4/16/2021). Onset was associated with exposure to medication.
14 hours after shot - severe chills, fever of 101.7F 20 hours after shot - strong full body ache, high soreness at shot location, headache, fatigue 32 hours after shot - fever broke, fully body soreness, fatigue, no appetite 52 hours after shot - fever returned of 100.0F, fatigue and no appetite all day All these symptoms have been treated with consistent tylonol, Advil, fluids, food as tolerated Not fully recovered, but 2nd day after shot is better than 1st
Per patient, "Rash to left upper arm appeared 24 hours following flu shot. Rash warm to touch, and itchy. "Seen in Emp Health on 11/18/05; diffuse rash to abdomen, a febrile, with rash to left arm from shoulder to elbow. Denies other S/S.
Approximately 4 weeks I had a small rash develop on the lower portion of my rib cage, severe pain and muscle weakness in my hands, feet and lower extremities with shaking in my left arm. Treatment for the muscle weakness and was prescription of Oxycodone for pain. These pain meds were taken until from July 2016 through Sept 2016 until admitted to the Hospital for surgery to remove a large polyp and a 4 cm section of my large Colon on Sept 19th. After surgery in Oct I started to lose muscle control of my upper and lower extremities until finally paralyzed from the waist down. I am now confined to a wheelchair.
On morning of 2/12 reported she had h/a, body aches, arm hurt up to her neck, REPORTED FACIAL SWELLING THAT BEGAN 2/11 (DAY OF VACCINATION).  She states her face and lips were swollen as verified by family members.  She did not want to go to ER and stated she had no trouble breathing.   On evening of 2/12 she stated she was very sleepy, still had h/a, but thought facial swelling was beginning to resolve. On 2/13 she stated facial swelling was gone, but that she had chills and fever of 100.5. On 2/15 she was asymptomatic.
No additional AE reported; Patient was accidently administered an expired dose of PNEUMOVAX 23 on Oct 18, 2023. Product expired on Jul 30, 2023.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 18-OCT-2023, the patient was accidently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (lot#: U034712, expiration date: 30-JUL-2023, once; strength, dose, and route of administration were not reported) for prophylaxis (expired product administered). No additional adverse events (AE) were reported (no adverse event).
AFTER 12 HOURS OF INJECTION FELT HAZY; 20 HOURS AFTER THE INJECTION HAD  103 FEVER; This spontaneous report received from a patient via a company representative concerned a 39 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced after 12 hours of injection felt hazy. On MAR-2021, the subject experienced 20 hours after the injection had 103 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from 20 hours after the injection had 103 fever, and the outcome of after 12 hours of injection felt hazy was not reported. This report was non-serious.
WHILE WAITING HERE AT PHARMACY FOR 15 MINUTES AFTER VACCINATION, HE STARTED FEELING NAUSEOUS AND DIZZY. PATIENT TRIED TO SIT DOWN ON THE CHAIR BUT BEFORE HE COULD REACHCHAIR HE JUST PASSED OUT AND FELL DOWN ON FLOOR, DID NOT LOOSE COMPLETE CONSCIOUSNESS, WOKE UP HIS OWN IN 30-45 SECONDS AND SAT DOWN ON CHAIR BY HIS OWN. EMS WAS CALLED, BY THE TIME HE DRANK SOME WATER AND ESM ARRIVED THEY EXAMINED HIM AND ASKED IF HE WOULD LIKE TO GO TO HOSPITAL BUT PATIENT DENIED AND WAS GETTING BETTER.
Sore arm; Elevated blood sugar; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BLOOD GLUCOSE INCREASED (Elevated blood sugar) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M207J and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), BLOOD GLUCOSE INCREASED (Elevated blood sugar) and FATIGUE (Fatigue). On 20-Feb-2021, PAIN IN EXTREMITY (Sore arm), BLOOD GLUCOSE INCREASED (Elevated blood sugar) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: elevated (High) elevated.         No treatment information was provided  Action taken with mRNA-1273 in response to the event was not applicable.
fever for 5 days temp as high as 105.5; treated w/APAP & then Motrin; appetite & activity level dec; seen by MD; no etiology identified, doesn't feel its from immun; mom reports pt uncomfortable when lying down;
4/26 Dr's office visit notes: Left arm has 2x3 in. Erythematous, warm, slightly tender, clearly demarcated inflammation. Reaction: Swelling at site yesterday 4/26, worse last night. Temp today 4/26 = 99.2 F. Med. Plan: Ice on inflamed arm 10 minutes 3x/day for 2-3 days, Ibuprofen 300 mg. BID 3x/day for 2-3 days return in 48 hours if not better.
The patient woke up the night of the vaccine needing to use the restroom (around 9 PM) and was unable to keep her balance trying to get to the restroom. She had a headache as well. The next morning on 3/29/2022, she stated that she continued to have a headache and difficulty with balance but had no vertigo or dizziness. She had to hold on to stable surfaces in her home in order to move about because of her lack of balance. She had no shortness of breath either. She went to make a phone call and realized that she didn't know how to use her phone. She knew what her phone was but could not figure out how to use it. Upon hearing this, her husband decided to take her to the local emergency room where she was treated and released.