chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; 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 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Oct2023 at 11:45 as dose 1, single (Lot number: PHZERHG9497) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PAXLOVID from 08Nov2023 to 13Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the ED and was subsequently hospitalized for Bacteremia gram + cocci, severe sepsis, likely from line infection within 6 weeks of receiving COVID vaccination.
Tinnitus started periodically in left ear, became permanent, then right ear began and six months later both are constant at low volume
Started w/small red itchy bump at the injection site that I thought was a bug bite. Hot to the touch and with slight discomfort. Redness and raised area spread down my arm and stopped about halfway between injection site and elbow. Continued to be itchy, red, hot and sore. It looks like the typical allergic reaction hive. Redness, itching and raised area is slowly reducing, but still present.
her face turned red; had itch around her lips and nose; had itch around her lips and nose; allergic reaction; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced allergic reaction, lip pruritus and nasal itching. On an unknown date, the patient experienced red face. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction, red face, lip pruritus and nasal itching were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, red face, lip pruritus and nasal itching to be related to Shingrix.  Additional details were provided are as follows: Registered nurse reported that a patient received a dose of Shingrix on Saturday and had an allergic reaction, her face turned red, had itch around her lips and nose. The patient to pharmacist and after taking Benadryl, the reaction were gone. The reporter consented to follow-up and requested to call the physician.
Fever to 106 10-12 hrs p/#4 DTP- no seizure activity noted. Seen in ER & followed up at FMD. No residual problems.
bad case of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad case of diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.  No Medical History information was reported.On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced DIARRHOEA (bad case of diarrhea). At the time of the report, DIARRHOEA (bad case of diarrhea) outcome was unknown.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No Concomitant medications were provided by the reporter. No Treatment information was reported. Patient received the first dose of the Moderna COVID-19 vaccine on 21Feb2021 (Lot 007M20A), the second dose on 21Mar2021 (Lot  007B21A) and the booster dose on 04Nov2021 (Lot # 007B219), all 3 as injections into left arm. Two days after her first dose patient had a bad case of diarrhea. Then with the second shot she had no problems. Two days after the booster shot she had a bad case of diarrhea again   This case was linked to MOD-2021-381361 (Patient Link).
This spontaneous report was received from a medical assistant regarding an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an adult dose of RECOMBIVAX HB injection 10/1 microgram/ml (dose, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
I have Covid19 now; I have Covid19 now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 62-year-old patient received BNT162b2 (BNT162B2, solution for injection), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Jun2022, outcome "unknown" and all described as "I have Covid19 now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (04Jun2022) Positive, notes: now my doctor prescribed me Paxlovid because I have Covid19 now. I just got it today, it was tested,. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Consumer stated, "I was wondering , you know the Paxlovid, for Covid19. I had two Pfizer shots in the beginning and two booster. I am 62 but I take different Medicine. I want to know this could be interact, If I take Oxycodone. What will happen if I take Paxlovid with Oxycodone. Can it hurt my liver or anything like that". Consumer stated, "No, not all together, I have taken two vaccines, Pfizer, then I took 2 Pfizer boosters. Okay, now my doctor prescribed me Paxlovid because I have Covid19 now. I just got it today, it was tested, the doctor prescribed now. I want to make sure because I read few things that, if I took Paxlovid with my Oxycodone, it might get me more high or it might get me more or can hurt my liver. I want to find out about that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, chills, abdominal pain, swollen lips night of 3/14/21. - Took OTC Benadryl with relief  She also c/o burning sensation in her vaginal area.
Approximately one week after receipt of the 1st Moderna Covid vaccine, I experienced sudden severe itching at the vaccination site...nowhere else.  I scratched minimally.  The skin around the site was reddened and raised even hours and a couple days after itching abated.  When I googled it, it sounded precisely like the phenomenon called 'Covid arm', although my particular case seemed relatively mild compared with some of the pictures/reportage. article I read.
mental breakdown; depression; This spontaneous case was reported by an other health care professional and describes the occurrence of MENTAL DISORDER (mental breakdown) and DEPRESSION (depression) 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 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 MENTAL DISORDER (mental breakdown) and DEPRESSION (depression). At the time of the report, MENTAL DISORDER (mental breakdown) and DEPRESSION (depression) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Reporter did not allow further contact
Had sore arm to touch for about 7 days.  The day after the vaccination about 8:30 am started to get chills, body aches, went to bed.  Took my temperature a while later it got to 100.0 F.   I basically stayed in bed.  When I woke up Monday morning fever was gone and felt much better with the exception of some minor aches.  By Tuesday felt 100% back to myself again.
11MAR 8AM h/a, nausea, vomit 6x, dry heaves
This spontaneous report as received from a certified medical assistant refers to a 11 years old female patient. On 16-AUG-2013 the patient was vaccinated with first dose of GARDASIL (lot # J006236 exp. date: 25-FEB-2016, dose, strength, site and route of administration not reported). On an unknown date in 2013 the patient experienced swelling, soreness, and tenderness at the injection site. When the patient informed the healthcare  worker that she had the injection site reaction, she had already recovered (date not reported0. There was no treatment of the events. On 22-OCT-2013 the patient was vaccinated with second dose of GARDASIL (lot # J007354 exp. date: 20-FEB-2016, dose, strength, site and route of administration not reported). There were no adverse events reported after second dose of GARDASIL. The relatedness between GARDASIL and the events was not reported. Additional information has been requested.
Arnpit was warm; hard; felt like shooting pain; Lymph node swelling; swelling under her left armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling under her left armpit), FEELING HOT (Arnpit was warm), INDURATION (hard), AXILLARY PAIN (felt like shooting pain) and LYMPHADENOPATHY (Lymph node swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Dry cough on 14-Dec-2020, Fatigue on 14-Dec-2020, Exhaustion on 14-Dec-2020 and COVID-19 on 14-Dec-2020. Concurrent medical conditions included Loss of taste since 14-Dec-2020, Loss of smell since 14-Dec-2020, Migraine, Anxiety, Sleep disorder and GERD. Concomitant products included ALPRAZOLAM (XANAX) from 10-Oct-2005 to an unknown date for Anxiety, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for GERD, VERAPAMIL from 05-Oct-1999 to an unknown date for Migraine, TRAZODONE for Sleep disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING (swelling under her left armpit). On 01-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling). On an unknown date, the patient experienced FEELING HOT (Arnpit was warm), INDURATION (hard) and AXILLARY PAIN (felt like shooting pain). On 08-Apr-2021, LYMPHADENOPATHY (Lymph node swelling) had resolved. At the time of the report, SWELLING (swelling under her left armpit), FEELING HOT (Arnpit was warm) and INDURATION (hard) outcome was unknown and AXILLARY PAIN (felt like shooting pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication was reported.   This case was linked to MOD-2021-152264 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographic details updated. Updated Lab data, Relevant history, Concomitant medication, Action taken change from unknown to Not applicable as 2nd dose information updated, Swollen lymph nodes event added.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 50 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that on 22-Apr-2021, patient took an antibody test (semi-quantitative spike protein test) post vaccination which came negative. On 10-May-2021, patient repeated antibody test which was also negative. On 22-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On 10-MAY-2021, Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210524105-COVID-19 VACCINE AD26.COV2.S- Confirmed Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
pt recv vax 29AUG96 & 30AUG96 & 31AUG96 pt exp a fever;1SEP96 pt devel approx 30 varicella-like lesions, t101, eventually 45 lesions;
Swollen limpnode that is full of fluid on collarbone tender and skin is red with irritation
1-3 days after the vaccination, I had the typical sore arm, but no major reaction.  On the morning of the 8th day after vaccination, I noticed a quarter-sized very itchy red hive at the injection site.  Today is the 9th days after vaccination, and the red hive is no longer itchy, but it has grown to a diameter of 4 centimeters.  I take Claritin daily for allergies, and have continued taking it daily throughout this event.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna vaccine at 17 years old.) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna vaccine at 17 years old.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna vaccine at 17 years old.) had resolved.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Dizziness, Headache, Myalgia, NauseaVomiting, CHILLS, FATIGUE
point of injection on his left arm aches; left arm is a bit swollen and hurts if lifted; A spontaneous report was received from a Consumer concerning a 85-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain and swelling at the vaccination site.  The patient's medical history was not provided. Concomitant medications reported were Vitamins, Losartan, Amlodipine Besylate, Glipizide, Simvastatin, Aspirin, fenofibrate, meclizine.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) in the left arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the left arm ache and a bit swollen and hurts if lifted.  Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were considered unknown.; Reporter'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.
Information has been received from a nurse referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The nurse reported that since 09-MAR_2016 the patients were vaccinated with doses of ROTATEQ (dose not reported, lot number K019370 with expiration date 16-JUL-2016 and lot number L027070 with expiration date 30-APR-2017, orally) that had been improperly stored (temperature: 47.1F and time frame: 30 minutes). It was reported that there was a previous temperature excursion with 48.7F for 30 minutes. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
excessive saliva; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY HYPERSECRETION (excessive saliva) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced SALIVARY HYPERSECRETION (excessive saliva). At the time of the report, SALIVARY HYPERSECRETION (excessive saliva) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Patient presented to the ED on 9/14/2021 with an acute stroke and PE.
had the first dose  on 25Feb2021, did not get second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had the first dose  on 25Feb2021, did not get second dose yet) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included ENOXAPARIN SODIUM (ALEXA [ENOXAPARIN SODIUM]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had the first dose  on 25Feb2021, did not get second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had the first dose  on 25Feb2021, did not get second dose yet) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Patient had an allergic reaction. Onsite EMS was called vitals HR 96 BP 130/90.  Patient refused evaluation or care. Released against medical advise.
Vomiting, edema noted to area of injection, feeling weak. Fever. Gave prednisone 5 mg po to take x 7 days.
Large swollen, itchy, red splotch at injection site; Large swollen, itchy, red splotch at injection site; Large swollen, itchy, red splotch at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Jul2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient and concomitant medication were not reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient also 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 26Jun2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jul2021, at 09:00, the patient experienced large swollen, itchy, red splotch at injection site. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event large swollen, itchy, red splotch at injection site was ongoing at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started with sores on my left foot. I thought it was athlete  feet . My eye started with white bumps at the lash line in both eyes. My right eye was worse. Lower inside right eye had a red pimple. Treated with warm soaks and Ciprofloxacin according to the prescription. It seem to help with the pain and pustules and they started to drain. I would soak my foot in Epsom salt bath  and used Keteonazole cream 2% as prescribed. It made it worse. I stopped using it and used Clotrimazole and that seemed to work well enough to dry the sores out and bring back a dark pink color to the skin on  my large toe and under my foot. It stopped working the week of July 8th 2019. I called Podiatrist  to set up an appointment. I went to this office  July 15th for a visit. He looked at my foot and I informed him of everything. He stated I had shingles cause by the Shingrix SDV/INJ. I should only use Clotrimazole if I still had itching after my shower. He advised me not to receive the second vaccine.
Erythema and pruritus at injection site, area affected increasing in diameter over 2 days, now the size "of a baseball".