chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive for COVID on 11/17/2021. Fully vaccinated and also vaccinated with a booster. 52-year-old female presents complaining of cough and fatigue.Admits to some chest aching but denies any chest pain with exertion. Denies any leg pain, leg swelling, shortness of breath.She was given IVF, Toradol, Tylenol, and Decadron. CXR negative for acute process. Labs reviewed, no significant abnormalities. Pt agreed to giving Dr. clinic her information for monoclonal antibody infusion.Told to return to ED for any new, worsening, changing or persistent symptoms.
Pt recvd 1st dose of Engerix-B vax 26NOV91 & 29NOV91 pt exp nausea (no vomiting & a rash w/itching; flu
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 08-AUG-2016, the patient was subcutaneously vaccinated with expired dose of ZOSTAVAX (dose was not reported, lot # L003218 expiration date: 30-APR-2016). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Very high fever (104) with extreme chills (teeth chattering so badly my jaw was sore) for 2 hours at symptom onset (12am-2am) followed by low grade fever (100.4), body aches, and extreme fatigue for 36 hours (ending on the 11th at 6pm).  Low grade (110.4) fever every day from 2pm-10pm since the 11th.  Body aches continue all day.  Right lymph node under armpit very swollen.
High dose flu vaccine was administered to a person 62 years old. Wrong dose-over dosage.
My arm was sore at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site.). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported. No treatment related information was reported.   This case was linked to MOD-2021-278957 (Patient Link).
Redness and swelling around the injection site in the a.m., by noon, having some chills, fever of 99.9, headache and some body aches. Took two acetaminophen this morning, some better now (3 pm).
SLIGHT SORENESS AT INJECTION SITE; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had covid or side effects. The patient previously received three doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with three doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient received fourth dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2). The patient additionally received fifth dose of covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis which was associated with off label dosing frequency (Off label use) and revaccination with different covid-19 vaccine (Dose number in series 3). The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight soreness at injection site (Dose number in series 3). It was reported that "I got 5 vaccines. Never got covid or side effects beyond slight soreness at injection site". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight soreness at injection site, off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
w/in 5 mins of vax pt reported feeling light-headed rapid hear rate (pulse 120) BP 198/94, BS 134 monitored BP to dec 184/84, P100 became very thristy & flushed 1/2 hr p/vax; taken to MD;
Patient felt dizzy and nauseous after receiving the vaccination. Patient vomitted about 15 minutes after receiving the shot. Patient appeared sweaty and was monitored for 30 minutes after her symptoms. After 30 minutes and after drinking water patient and her mother stated she was feeling better and she went home with her mother. She denied any shortness of breath, itching or swelling. Patient received the pfizer and flu shot before with no issues. Patient had not eaten that morning and was nervous about needles and patient's mother is attributing her vomiting and dizziness to nerves and not eating.
Another rash; EXHAUSTION; This is a spontaneous report. This report is regarding the second dose of bnt162b2. A contactable 52 years old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The medical history was not reported. Concomitant medication(s) included montelukast sodium (SINGULAIR), Metoprolol Succinate, Diltiazem Hcl, unspecified Multivitamin, pregabalin (LYRICA), levothyroxine sodium (SYNTHROID), Cyclobenzaprine Hcl, cyanocobalamin (VITAMIN B-12), Duloxetine Hcl, fluticasone propionate (FLOVENT), omeprazole (PROTONIX), cetirizine hydrochloride (ZYRTEC), calcium carbonate (TUMS), Meclizine hcl, fluticasone propionate (FLONASE ALLERGY RELIEF), salbutamol sulfate (ALBUTEROL SULFATE HFA), diclofenac sodium (VOLTAREN). Historical vaccine included the first dose of BNT162B2 for covid-19 immunization, and she had a rash on her face and scalp and had no energy. After the second vaccine dose, patient had another rash and felt extreme exhaustion on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Redness/swelling/sl. tenderness at R thigh approx 5-6"
Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness; Anaphylaxis-swelling of eyes, tongue, and injection site.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 05Apr2021 16:00 as single dose for COVID-19 immunization.  Medical history included known allergies: yes and hypertension. The patient was not pregnant. Concomitant medications included metoprolol succinate (TOPROL XL), lisinopril dihydrate (LISINOPRIL), and cetirizine hydrochloride (ZYRTEC). The patient had no other vaccine in 4 weeks. On 05Apr2021 16:15, the patient experienced anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness. The events resulted in emergency room/ department or urgent care. Therapy for the events included prednisone, antihistamine, and intravenous (IV) fluid. The patient did not have covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.
Information has been received concerning now a 4 year old female who on 11/03/1998 was vaccinated with one dose of varicella vaccine. On 11/20/2000 the pt experienced breakthrough varicella. On 11/23/2000 the pt recovered. No further info is available.
invalid dose administered to two patients; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (invalid dose administered to two patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (invalid dose administered to two patients). At the time of the report, INCORRECT DOSE ADMINISTERED (invalid dose administered to two patients) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (invalid dose administered to two patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (invalid dose administered to two patients). At the time of the report, INCORRECT DOSE ADMINISTERED (invalid dose administered to two patients) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-052032 (E2B Linked Report).   This case was linked to US-MODERNATX, INC.-MOD-2021-052032 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052032:Crosslinked case
Excessive sweaty but no fever  Blurred vision Extreme pain in right eye when looking left or right
Agressive cold sore; herpes simplex; Covid arm; Chills; Nausea; Headache; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 05Jan2022 at 17:45 (Lot number: 33036BD)at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Cold sores" (unspecified if ongoing), notes: History of cold dore (last one 1 year ago). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number:EN6201, Anatomical Location: Right arm, Administration Time: 13:00, Route of Administration: Unspecified), administration date: 19Mar2021, when the patient was 48 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8734, Anatomical Location: Right arm, Administration Time: 14:00, Route of Administration: Unspecified), administration date: 09Apr2021, when the patient was 48 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 17:45, outcome "unknown", described as "Dose received: 3"; ORAL HERPES (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Agressive cold sore"; HERPES SIMPLEX (non-serious) with onset 07Jan2022 , outcome "not recovered", described as "herpes simplex"; HYPERSENSITIVITY (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Covid arm"; CHILLS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Chills"; NAUSEA (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of oral herpes, herpes simplex, hypersensitivity, chills, nausea and headache.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received Valacyclovir as the treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 06Oct2021 as dose 3, (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FENOFIBRATE, start date: 01Apr2020, stop date: 04Oct2022; AMLODIPINE BESILATE, start date: 01Jan2019, stop date: 04Oct2022; DICLOFENAC, start date: 01Apr2018, stop date: 04Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Paxlovid from 23Sep2022 to 27Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
During night, some body aches and headache.  Woke up on 3/24/21 and got out of bed and had extreme nausea, dizziness, weakness, 2 bouts of diarrhea, and fainted once.  Also some body aches and headache still.  I am now taking it super easy as I don't want to fall again.
Woke Saturday morning around 12:00am with patient and bed sweated wet and patient had chills.  Extremely tired to point could barely move.  Sunday morning still extremely tired, red rash around injection area about three inches around, large knot under armpit of injection site the size of a softball.  Monday morning still tired but not as extreme.  Still had rash at injection site and entire upper arm swollen.  Still had knot below armpit.
None. Pt. had pregnancy test preformed on Nov. 9, 2012. Had FLUMIST on 10/15/2012.
After receiving a GARDASIL 9 dose, within 3 days the warts started to disapear and became less painfull; no additional AE reported; This spontaneous report was received from an employee and refers to a 11-year-old female patient. The patient's concurrent condition included warts. The patient's medical history, concomitant medications, drugs reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis. A female patient had horrible warts on both her hands, about 40 warts. After receiving ahpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose, within 3 days the warts started to disappear and became less painful. Within 10 days of receiving thehpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the warts were all gone. No additional adverse events were reported. The outcome of adverse event was not reported.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
injection site swelling up a little, pt had vaccine before though, asked pt to stay back for 10 minutes to make sure pt is ok. Pt was fine the whole time. Swelling when down after 5 min. Pt left store with advices on what to do with allergic rxn
No Adverse event occured, but patient in retrospective review of NJIIS data was discovered to have incorrectly been given Moderna vaccine while under 18 year old as approved in the EUA. The manufacturer was contacted and they provided information about an ongoing clinical trial in patients 12-18 years old receiving the same (100mcg) 2 dose series of Moderna COVID-19 vaccine, however this age group is not currently approved. This is being reported as an error having occurred with the Moderna COVID-19 vaccine. Patient/Guardian will be contacted by a prescriber to inform the patient of the historical event and explain when a 2nd dose can be given.
Big red patch around injection site, around 3 plus inches in diameter, swollen,  hot to touch.  It is now 4 full days since vaccination and still like this.  I looked online and it's called  "covid arm."  So it's not unexpected, although I am wondering when it will go away.  Also the day after I received the vaccine, I had a LOT of muscle soreness, aches, etc., to the point it was hard to get up and down, so I just wrapped up in a blanket and sat around.  That issue was all gone the next day.  I don't want to waste your time, but thought I should share info about my "covid arm."  Thank you.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L004754 with expiration date 10-NOV-2016 and lot# L010595 with expiration date 12-NOV-2016, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
worried because she can't work; feeling feverish; Body pain; Headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (worried because she can't work), PYREXIA (feeling feverish), MYALGIA (Body pain), HEADACHE (Headaches) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (worried because she can't work), PYREXIA (feeling feverish), MYALGIA (Body pain), HEADACHE (Headaches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (worried because she can't work), PYREXIA (feeling feverish), MYALGIA (Body pain), HEADACHE (Headaches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes antidepressant.    This case was linked to MOD-2021-337515 (Patient Link).
Dose 1 given 1/20/2021 Lot #029K20A Moderna  Pt admitted to hospital for covid 19, discharged to hospice on 10/7/2021
After receiving shots for travel purposes, I was told my left arm would be sore for a few days.  It has been 28 days and my arm still hurts.  No swelling or redness was ever visable, however the pain for the first two weeks was excruciating.  It is not as bad now but it is still very much present.
This spontaneous report was received from a Licensed Practical Nurse refers to a 14 year old male patient. On an unknown date in May 2013, the patient was vaccinated with GARDASIL (lot#, expiry not reported) dose 1, 0.5 ml, intramuscular route. On 13-MAR-2014, the patient was supposed to received his second dose of GARDASIL but was inadvertently administered CERVARIX. No adverse effects reported. No PQC involved. Additional information has been requested.
I was awoken by chest pain at 5:45AM on 5/20/21. This pain lasted 1-2 minutes and recurred every 1-2 hours. Went to ER and received ECG, chest x-ray, and blood tests. EKG results were abnormal. Referred to cardiologist for appointment on 6/16/21. Pain continued to appear every few days, though less severe.
BODY ACHES; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, headache, and fatigue on APR-2021. This report was non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX, is intended to prevent. On or about 01-MAR-2016, the patient was treated by a physician for a vesicular outbreak, 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, and other damages. Additional information has been requested.
Redness, swelling. Cellulitis. Treated with Keflex, Motrin.
18 year old male, is presenting with RECURRENT , NON-EXERTIONAL CHEST DISCOMFORT. PATIENT RECEIVED 2ND PFIZER VACCINE 5/17/21, ON 5/18/21 HE DEVELOPED FEVER, ON 5/20/21 HE DEVELOPED NON EXERTIONAL, RECURRENT  CHEST DISCOMFORT. UP TO 7/10 IN SEVERITY AND LASTING A FEW HOURS AT A TIME AND THEN RESOLVING.  Discharged home on 5/23/21 with Indomethacin 25 mg Cap Commonly known as: INDOCIN Take 1 capsule by mouth 2 times a day
IRREGULAR HEART RATE; NAUSEA Narrative:  Irregular heart rate and nausea