chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to the ED on 12/31/21 Patient is a 52-year-old Caucasian female who presents to the emergency room with chief complaint of nausea and vomiting. She states that her whole body hurts. She states generalized weakness and fatigue. For the past 2-3 days she's had several episodes of nonbloody emesis to the point that she is not even able to keep down her usual home medications. She states that she has abdominal pain with shortness of breath. No chest pain. She has a reactive cough. She is fully vaccinated for coronavirus and received her second shot in April. Has not received a booster shot. She doesn't smoke. No alcohol or illicit drug use. Denies history of previous heart attacks...Pain in her stomach as an aching sensation in the periumbilical region. Constant nonradiating with no worsening or relieving factors. No sick contacts or recent travel. She's not home oxygen dependent and denies any chronic issues with her lungs.
PATIENT WAS GIVEN A 65+ VACCINE AND SHE IS ONLY 3 - WATCHED FOR 20 MINUTES AFTER VACCINE WAS GIVEN AND CONTACTED HEATLH DEPARTMENT - ADVISED MOTHER TO WATCH FOR SWELLING / PAIN / REDNESS - WILL FOLLOW UP WITH MOTHER ON 10.8.19 TO SEE HOW PATIENT IS DOING
Fever, headache, nausea., and of course soreness at site. Started about 1000 pm on day of vaccination.
Associate started having arm aches and pressure. She also had right ear pressure. The associate started having generalize aches (myalga). The associate denied to be seen in the ER. The patient left @ 19:50.
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of not responding to therapy in an adult subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). About three years prior to the date of reporting (06 April 2009), the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). After these initial three doses were given, two additional doses of Hepatitis B vaccine were given on unspecified dates. It was reported that the subject did not respond to vaccination with Hepatitis B vaccine. The subject, who was a nurse, received the Hepatitis B series about three years ago. The subject did not respond to the initial three dose series. Two additional doses were given and still titers were not indicative of sero-protection. Limited data was available since this occurrence took place three years ago. The reporter also indicated that two additional subjects, who were also nurses, did not respond to initial three dose series of Hepatitis B vaccine series administered about three years ago and additional two doses were given and still titers were not indicative of sero-protection (please see case id's A0778492A and A0778562A for more details on these subjects).
My arm hasn't hurt, only if I lift it a lot; under my eye it's so swollen that it is oozing water / it was a build of water from a sore from her face and not water coming from her eye; Today I woke up with a swollen face/very evident; hives; under my eye it's so swollen that it is oozing water; small blood vessels in my left eyes that burst/some blood vessels in her right eye burst; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date, NDC number: unknown), via an unspecified route of administration, administered in left arm on 25Aug2021 (age at vaccination was 48 years) as DOSE 1, SINGLE for covid-19 immunisation. No medical history reported. Concomitant medication was not reported, but patient stated that she was only taking her menopause pill. It was a vitamin that patient has been taking for years. Does not wish to add at this time. Does not think that it is related to this. On an unspecified date the patient was experienced my arm hasn't hurt, only if I lift it a lot and under my eye it's so swollen that it is oozing water / it was a build of water from a sore from her face and not water coming from her eye; On 25Aug2021, experienced some blood vessels in her right eye burst; On 26Aug2021, experienced face is swollen, hives, under my eye it's so swollen that it is oozing water. The report received as, yesterday, the patient received the Pfizer Covid 19 vaccine and today patient has a reaction to it. Today, patient woke up with a swollen face and small blood vessels in eyes that burst. What worries patient most are the hives and the swollen face, it was very evident. The patient was little worried, this hadn't happened to patient before. The patient arm hasn't hurt, only if patient lift it a lot, but patient face was swollen and under patient eye it's so swollen that it was oozing water. The patient washing the face normally and patient going to put on sunscreen. Later confirmation got that it was a build of water from a sore from her face and not water coming from her eye. Clarified that beneath both eyes are swollen. Treatment was reported as none. No investigation assessment was done. Outcome of the events pain in arm and facial pain was unknown and remaining events were not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Large, hot, raised welt 2" x 3" on right deltoid.  Hot on back of right arm, 2" x 2" area.  Right shoulder sore.
Arrhythmia indications appeared in a routing stress test given on 3/12/2021. Patient also had subsequent symptoms of arrhythmia, rapid heartbeat, elevated blood pressure and minor chest pain, peaking some time after this exam and gradually diminishing. Subsequent other exams, including a Cardiac MRI, revealed evidence of scar tissue in interior heart wall. Myocarditis was not initially considered, nor was a relation to the administration of the Covid vaccine.
Patient given Pfizer monovalent instead of Pfizer BiValent  no adverse event reported by patient
Hospitalized Weakness, fever, and required 2 L of O2.  MAB in the am when diagnosed and Remdesivir upon admission to the hospital.  Immunosuppressed mantle cell lymphoma on rituximab
Patient stated he experienced numbness feeling immediately after flu vaccine, but resolved. Then after 24 hours itching occurred and 48 hours later blisters appeared scattered all over body including legs, back, arms , stomach. Pt stated he had gone to his Primary physician and was taken off of all his meds at different times to try to figure out what might be the cause of his symptoms. He also went to a Dermatologist on many occasions, does not have specific dates at this time. Biopsy was done with inconclusive results. He also went to his Pulmonologist but was sent back to Dermotologist. Pt still has rash on legs, back, arms and stomach that continue sto itch, but not as bad as it did. Red/pinkish colored spots measuring approx 1/4 to 1/2 inch in diameter.
Very tired; Fatigue; Headache; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 13Mar2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any medications within 2 weeks of vaccination: The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 17Mar2021 (5 days after the vaccine), the patient felt very tired, fatigue, headache and joint pain. Therapeutic measures were not taken for the events. The clinical outcome of the very tired, fatigue, headache and joint pain was not resolved.   No follow-up attempts are possible; information about lot number cannot be obtained.
This spontaneous report was received from a physician referring to his significant other, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unspecified date in 2008, reported as " in approximately 2008", the patient was vaccinated with ZOSTAVAX (lot number, expiration date and route of administration were not reported). Approximately in 2013, reported as "within 5 to 6 years of receiving vaccine", the patient developed a severe case of shingles. The patient was treated by an unspecified dermatologist and received a course of acyclovir. The Herpes zoster lasted approximately 6 weeks. At the time of the report, the patient was recovered. The causal relationship between Herpes zoster and vaccination with ZOSTAVAX was not provided. This is one of the several reports received from the same source. Additional information has been requested.
Inappropriate Schedule of SHINGRIX/received the first dose on 2019 but not the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The VAERS details reported for 1st dose of Shingrix. The reporter consented to follow up.
Patient died on 01/24/2021.  Began exhibiting symptoms similar to Covid 1 day after vaccination.
The patient was accidently given an "undiluted" dose of COVID vaccine. She was contacted on the day following the error and states that "I feel great"
expired TENIVAC was administered to a patient with no reported adverse event; Initial information received on 18-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 36 years old male patient for whom expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Jul-2023, the patient received an expired dose of 0.5 ml (1x) (Frequency = once) of standard strength suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult suspension for injection (lot: U6922AA, Expiry date:  31-Jan-2023) via intramuscular route in the right deltoid for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient developed a erythematous, edematous upper arm around the site of the injection.  Patient treated herself with Benadryl (25 mg each dose 3 times over 2 days), hydrocortisome cream, and a cool compress applied to the site.  Mother marked a circle around the area of erythema which was initially 5cm diameter on 5/20 in the morning, by the evening the measurement increased to 10cm.  In the office the afternoon of 5/21/2014 the diameter of erythema measured 12cm.  There was a firm area in the center measuring 5cm in diameter at the time of the examination.
bleeding gums; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration at left arm on 16Dec2020 at 02:00 at a single dose for COVID-19 immunization. The patient did not have covid prior vaccination, and no covid test done post vaccination. The patient has no known allergies to medications, food, or other products. The patient has no other medical history. The patient did not receive any other vaccine in four weeks. Concomitant medication included marijuana (MARIJUANA CANDY).  The patient noted bleeding gums 2 days later on 18Dec2020 at 06:30. It was not usual for her. It was just blood streaked spit with brushing teeth. The patient did not receive treatment for the reported event. The outcome of the event was unknown. The event was not considered serious.  No follow-up attempts are possible; information about lot/batch number has been requested. No further information is expected.
Pt reported itchy face at 2:24.  Given PO Benadryl.  Reported having similar reaction but delayed with first dose.  2:46 reported dizziness.   3:09 reported feeling flushed in face but itching in face subsiding.
Rt thigh look red; edematous & warm at area of vax inject on 23JUL91; pt rx'd w/Bicellin 600,000 & ampicillin PO; 29JUL91 area of rxn vs cellulitis appear normal: no area of redness, inc warm or edema;
1) severe chills but no accompanying fever; covered with blankets to provide warmth; chills began to subside about 8 am on 4/10 and ended by 5 pm on 4/10 2) headache leading to cluster headache event; no other usual triggers present; symptoms included visual aura/tunnel vision, intense ringing in ears, and pressure/throbbing pain in head; treated with ibuprofen and acetaminophen, rest, fluids; symptoms began about 630pm on 4/9 and finally ended about 7pm on 4/10.
Local swelling, erythema thigh and knee, warm to touch, onset 6/4, significant improvement 6/5/03.
Back of brain got really hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101418174 (Pfizer).  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 10:30 (Lot number: FF8841) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE (ongoing); CBD OIL (ongoing). The following information was reported: FEELING HOT (non-serious) with onset 13Oct2021, outcome "not recovered", described as "Back of brain got really hot".  Additional information: Prior Vaccinations (within 4 weeks) was none. Patient enquired about any deaths and also he want to know about fluid in the brain. Patient received response about the information pertaining to side effects in the head were headaches. She Referred to HCP. Patient enquired about second dose and she was worried about it that she was supposed to got on 03Nov.Patient also took Vitamins as Concomitant medication(s).  No follow-up attempts are possible. No further information is expected.
Within 4-5 hours after receiving Prevnar vax, the patient developed a rash everywhere except her face. There were no other symptoms. The patient was treated with Benadryl.
Could not raise arm; Arm soreness; Body malaise; Chills; Low grade fever 99.3F; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise), MUSCULAR WEAKNESS (Could not raise arm), PYREXIA (Low grade fever 99.3F) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (developed positive antibodies) in September 2020.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (Low grade fever 99.3F). On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise) and CHILLS (Chills). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Could not raise arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 24-Apr-2021, PAIN IN EXTREMITY (Arm soreness), MALAISE (Body malaise), PYREXIA (Low grade fever 99.3F) and CHILLS (Chills) had resolved. At the time of the report, MUSCULAR WEAKNESS (Could not raise arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99.3 degree f (Low) Low grade fever 99.3 degree F On 24-MAR-2021 recovered.. On 28-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient Quest diagnostics re-ran sample and confirmed it was negative for viral load and therefore the PCR test was false positive. he put off the colonoscopy due to false positive . Terrible arm pain/severe arm pain ,AE Preferred Contact Updated, AE details updated were given as events   This case was linked to MOD-2021-100770 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-Up received on 14-JUN-2021 and new AE event updated On 27-Jul-2021: Follow up received on 27 JUL 2021 included no new information.
tingling in her arm at the injection site; hand turned red; soon after had tingling up and down her entire arm; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 24Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tingling in her arm at the injection site, hand turned red, and soon after had tingling up and down her entire arm. Therapeutic measures were taken as a result of the events, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of tingling in her arm at the injection site, hand turned red, and tingling up and down her entire arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-325994 (Patient Link).
Stratchy throat (immediate), swollen throat (couldn't swallow, could eat), congestion, couldn't breathe, eyes -very red and swollen, yellow mucus,  cough, shortness of breathe . On steroids, Benadryl, antibiotic eye drop.
Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; pain and swelling in a axilla area of left arm; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration in left arm on 12Jan2021 at 07:00 at single dose for COVID-19 immunization. Medical history included hypertension and ventricular septal defect. The patient was not pregnant. Patient has no COVID-19 prior to vaccination. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]), docusate sodium (COLACE), losartan, omeprazole and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), via an unspecified route of administration in left arm on 22Dec2020 at 2PM for COVID-19 immunization. On 12Jan2021 at 11:30 PM, the patient experienced intermittent fever and chills, body aches, tiredness, and pain and swelling in the axilla area of left arm. Patient has not tested for COVID-19 post vaccination. The outcome of the events was recovering.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications, and past drug history were unknown. On 19-MAR-2016 the patient was vaccinated with 1 vial of ZOSTAVAX, lot # L021609, expiration date: 10-SEP-2016 (dose and route were not reported). The vaccine administered had undergone an excursion; the vial had been refrigerated at 6 degrees Celsius for about 48 hours prior to reconstitution and administration. It is unknown if there was any relevant lab work. The event was considered to be medically significant by the reporter as it required intervention to prevent permanent impairment/damage. Additional information has been requested.
PSA went up; This is a spontaneous report received from a contactable reporter(s) (Consumer).  A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 02Mar2021 (Lot number: EN6205) at the age of 71 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious) with onset 08Mar2021, outcome "unknown", described as "PSA went up". Relevant laboratory tests and procedures are available in the appropriate section. The patient had a PSA test done 6 days after receiving the first shot and the PSA went up. The reporter would like to know if that was possibly due to the inflammatory process caused by the vaccine that caused that rise.  No follow-up attempts are possible. No further information is expected.
Patient admitted with myopericarditis to Hospital 11 days after vaccination. Started having pleuritic chest pains the day after vaccination.