chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling on his underarm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose,manufacturer unknown), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 14Apr2021, outcome "unknown", described as "swelling on his underarm".  Additional information:Event Verbatim: Caller refused to provide last name. He mentioned that he received his 2nd dose of the Pfizer COVID Vaccine on Monday and last night he noticed that there was swelling on his underarm area on the arm he got the shot. On the papers he received, it does say something about injection swelling but nothing about underarm swelling. He mentioned that he searched the internet and saw that there was a possibility of lymph node swelling in the underarm. He is asking if this has been reported and for what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling of right side of throat, right face and eye, chest congestion. (Get same reaction with sulfites but reaction more severe.) Throat swelling started within 15 minutes. Not sure if reaction so drove home.  While driving, face and eye swelling. Took children's Benadryl (can't take adult Benadryl). Stopped symptoms. Wore off after 6 hours - swelling returned. Took generic 24-hour zrtek and symptoms stopped and didn't return.
03/30 pm developed redness and swelling LAT, Tylenol and Benadryl.
Soreness; Flu like symptoms; Fever; Chills; Tiredness; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas). At the time of the report, PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas) outcome was unknown.            No treatment medications were provided. No concomitant medications were provided.  Patient got sick following vaccination with the booster dose of the Moderna COVID-19 vaccine and experienced the following: fever, chills, tiredness, soreness, nauseas and flu like symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received with no new information.
I had a runny nose with a sore throat. I also had a headache and a cough. I tested positive on November 3, 2022. I went to the clinic and they performed a PCR test on November 4. The doctor prescribed Paxlovid. It took about 3 days for me to feel better. All of my symptoms pretty much subsided over the 3-day period except a runny nose and I am now testing negative.
PT called pharmacy complaining of light headed, dizziness, and trouble breathing and asking what to do. She had received the shot about 24 hours ago before experiencing any side effects. Informed pt to seek out her doctor.
Progress Notes  3/24/2021     Date:  3/24/2021                                                                                               Subjective Patient is a 51 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination.    He was given the Pfizer vaccination in the right deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience "funny feeling in his face" and difficulties breathing.  He denied rash, difficulty swallowing, wheezing, throat tightness, dizziness and facial swelling.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes.     ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches       Previous Reactions: Denies.    Objective    Vitals Vitals:   03/24/21 0825 BP: (!) 132/90 Pulse: 89 SpO2: 100%      Physical Exam Vitals reviewed.  Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash)    3/24/2021 9:12 AM
No additional AE reported; administration of improperly stored vaccines to patient; This spontaneous report was received from a vaccine coordinator  (Office Manager) and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date in 2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (dose: 1 (unit not reported),  lot #U017138, expiration date: 28-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of minus 14 degree Celsius for a time frame of 7 hours (occurred on 20-JAN-2022). There were no previous temperature excursions reported. No additional adverse event (AE) information was provided.   This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2205USA005084: US-009507513-2205USA005067: US-009507513-2205USA004997:
Patient received the Monovalent Pfizer 5-11yr vaccine and should have received the Pfizer 5-11yr Bivalent booster vaccine.  Patient contacted by clinic. No adverse outcomes noted.
Soreness at injection site night of vaccine. Headache and nausea the next morning (13 hours after injection). Fever of 101 degrees later that evening (20 hours after injection). Fever subsided during the night (~28 hours) and headache persisted into the next day.  Treatment with Tylenol helped somewhat.
Shivers, headache, body aches and low grade fever ( 100.5 ).  Also soreness at injection site.
Headache, Myalgia, Tachycardia, Chills without fever Narrative:
pain all the way down left leg; joint pain; hip pain; ankle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain all the way down left leg), ARTHRALGIA (joint pain), ARTHRALGIA (hip pain) and ARTHRALGIA (ankle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain all the way down left leg), ARTHRALGIA (joint pain), ARTHRALGIA (hip pain) and ARTHRALGIA (ankle pain). The patient was treated with TRAMADOL at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain all the way down left leg), ARTHRALGIA (joint pain), ARTHRALGIA (hip pain) and ARTHRALGIA (ankle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: the pain could possibly be (Inconclusive) the pain could possibly be arthritis.         This case was linked to MOD-2021-058614 (Patient Link).
Information has been received from a physician and a nurse concerning a female who on 17-JUL-2007 was vaccinated with her second SC dose of varicella virus vaccine life (Oka/Merck) (Lot# 656177/0675U). Subsequently the patient developed a nodule and experienced local injection site pain and swelling after vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
nausea 6hr p/vax;frontal lobe h/a w/inability to raise lt arm, shivering, freezing & chills 24-48hr p/vax;MD dx cellulitis & tetanus rxn 72hr p/vax;tx doxycycline & DPH;
coughing; fever; sick; flu like symptoms; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who experienced coughing (cough), fever (pyrexia), really sick (malaise) and flu like symptoms (influenza like illness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious really sick (malaise), coughing (cough), fever on and off (pyrexia), flu like symptoms (influenza like illness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.. It was reported that, patient could not get up for a month.   Final diagnosis was influenza like illness, pyrexia, malaise and cough.   The patient was treated with PREDNISONE,  antibiotics and CODEINE for Cough.  The patient outcome was reported as unknown all events.  Information on the batch number was requested.
Received pneumococcal vaccine on 12/25/10 by morning 12/27/10 arm was swollen, reddened and tender for approx 8 inches around injection site ((L) arm).
Chills, lower quadrant abdominal pain, fever - 102.4 degrees, weakness, disoriented, aching, soreness in Rt arm. Dx: cellulitis on RUE down to elbow.
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age. Current conditions and medical history were not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
36 hrs after shot I felt nauseous and dizzy. 20 minutes later I felt hot. 10 minutes later I felt cold. Took temperature. It was 65.2 Lasted about 30 minutes. Temp went back to about 90. Then dropped again, but not as bad. Repeated every 30 minutes for about 5 hours. Each episode getting less severe.
When we called him for his second vaccine in the series, he said his arm was still sore and bothering him. He said that he had an xray done and they said it was arthritis.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 16-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unspecified date in 2016, the patient was treated the same physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering (emotional distress), and other damages. The outcome of the events was unknown. Causality assessment was related.
Left Side of the face numbness; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, at age of vaccination 49 years), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EL9266) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took when she was younger, she had an allergic reaction to Erythromycin but later on in life she had product with Erythromycin and was fine with no problems, so she doesn't know. She had no Lot or Expiry for Erythromycin. Caller stated that she was calling about the Covid Vaccine, she just took it, and an half an hour later when she got into her car, she started feeling numbness as if like when going to the dentist and when they give Novocain or something. Her left cheek and eye lid were numb. She wanted to know if this was considered a normal side effect or if this was an allergic side effect. She was a Teacher. Her first dose was on 17Feb2021 at either 12:10 or 12:15 noon, the numbness was about a half hour later, close to 1PM. Caller stated that she hasn't seen anybody with this side effect. She was not worse; she was a little better, but it was still there. When queried for product details caller stated that just wanted to know if she should be taking Benadryl or if this is an allergic reaction, she would love to sit here on the phone all day, but she had already sat on the phone for an hour and a half waiting. She just wanted to know she was not getting paralyzed or something here. Caller wished to end safety report here and wanted to be transferred for her question. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Acute deep vein thrombosis (DVT) of axillary vein of right upper extremity Bilateral Pulmonary Embolism
Pt had pre screening for COVID prior to a scheduled procedure.  Her COVID testing was positive so the procedure was cancelled/rescheduled
No additional AE; temperature excursion. Caller states that GARDASIL 9 administered today 12 JAN 2021; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 12-JAN-2021, the patient was vaccinated with with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R025728 was confirmed to be valid, expiration date reported as 15-JUN-2021, but upon internal validation established as 18-JUN-2021 (exact dose, route of administration, anatomical location were not provided) for prophylaxis.  The multiple temperature excursion was 48.2 degrees Fahrenheit (F) (48.2 F) for 7 hours. Previous excursions was 48 F for 5 hours and 8 minutes. The digital data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025728; expirationdate: 18-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sweating, light headed, dizzy, nausea, emesis , pale in his car . After emesis he felt better and his color came back. Ambulance came to reassess. He felt fine. Parents came to pick him up and take his car home
Patient received a second Moderna booster and is not immunocompromised.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second Moderna booster and is not immunocompromised.) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second Moderna booster and is not immunocompromised.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second Moderna booster and is not immunocompromised.) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The patient received a second Moderna booster and later found out that they did not qualify for it. The patient was not immunocompromised.   No treatment medications were provided by the reporter.
Knots on extremities. Arms and legs. Denied any itching. Reported to me on 3/14/2013. Benadryl cream applied. Afebrile.
PATIENT WAS ADMINISTERED UNDILUTED COVID-19 VACCINE ON 08/24/2022.  SHE SHOULD HAVE RECEIVED 10 MCG BUT INSTEAD RECEIVED 20 MCG.  ERROR WAS REPORTED TO MOM ON 08/23/2022 @ 1700 BY DR. WHEN THE ERROR WAS REALIZED.  MOM STATED THAT PATIENT HAS A SORE ARM AND ARMPIT BUT NO OTHER SYMPTOMS.
This spontaneous report as received form a medical assistant refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were inadvertently administered doses of COMVAX (lot number J013884 and expiration date 19-AUG-2016, dose and route of administration were not reported) that had been improperly stored. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Info has been received from a pharmacist concerning a PT who was vax'd "many yrs ago" w/a dose of Hep B vax recombinant. Subsequently, the PT "reported a reaction". The PT's vax records were unavailable and the "exact reaction was never documented". Add'l info has been requested.
Initial unsolicited pregnancy report received from the literature on 10-AUG-2016. This case was linked to 2006-03101, 2016SA148766, 2016SA148776, 2007-00117, U2002-00204, 2016SA148885, 2016SA148897 AND 2016SA148892. (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves a female patient (unknown age) who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date while she was pregnant. The patients last menstrual period date and pregnancy trimester was not reported. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination during her pregnancy, the patient experienced syncope. It was a case of Vaccine exposure during pregnancy. Lab data and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
1/8/00, itchy palms bilaterally; > over body during day. Taking Benadryl for severe itching; Gold Bond. Red, raised, pin-head areas over body & discomfort. Temp 102.
Covid vaccine documentation: PT admitted 10/16/21 ? 10/19/21. POC SARS COV2 ANTIGEN POS 10/16/21. Pfizer dose 1 given 1/11/21 lot EL014. Pfizer dose 2 given 2/1/21 lot EL3302. Per documentation, PT respiratory status declined. PT was made DNR-CC with hospice, transfer to hospice 10/19/21.
Irritation, red, soreness and inflammation near and around the injection site commencing 8 days after date of vaccine until current.