chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Headache; Vomiting; Diarrhea; Third (booster) dose administered; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Oct2021 at 14:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 08Mar2021 at 14:00 (at the age of 69-years-old) and also a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 29Mar2021 at 12:00 (at the age of 69-years-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 07Oct2021 at 00:00, the patient experienced fever, chills, headache, vomiting and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, headache, vomiting and diarrhea were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
The patient experienced redness, swelling and a demarcation-hive appearance (6 inches out from the elbow); The patient experienced redness, swelling and a demarcation-hive appearance (6 inches out from the elbow); the patient reported muscle soreness; The patient experienced redness, swelling and a demarcation-hive appearance (6 inches out from the elbow); This spontaneous report was received from a pharmacist regarding a 68-year-old female patient. The patient did not have any medical history, concurrent conditions, concomitant medications and drug allergies/reactions. On 05-NOV-2019, the patient was vaccinated with a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S018405, expiration date: 23-MAR-2021 (dose number and anatomical location were unknown) intramuscularly for prophylaxis (reported as "vaccination"). On 06-NOV-2019, in the morning the patient reported muscle soreness (myalgia). In the evening of the same day, the patient experienced redness, swelling and a demarcation hive appearance (6 inches out from the elbow) (erythema, swelling and urticaria). The patient returned to the pharmacy on 06-NOV-2019 and the pharmacist instructed her to take diphenhydramine (BENADRYL) (unspecified dose). On 07-NOV-2019, the pharmacist was followed up with the patient and the rash was mildly improved (recovering) but the patient did not take the diphenhydramine (BENADRYL). The pharmacist instructed her to take diphenhydramine (BENADRYL) again. The patient sought medical attention. There were no lab diagnostics/study performed. The outcome of events erythema, swelling and myalgia was reported as not recovered at the time of report. The reporter's causality assessment was not provided. No product quality complaints (PQC) involved.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1911USA003496:01393890: case #
COVID+ 12/28/22.  Vaccination status - J&J x1 Discharge Summary  SHMG HOSPITALIST                                              Discharge Information: Discharge Provider: MD  Primary Care Provider : DO  Procedures to be scheduled by PCP: None Results/Procedures requiring PCP followup: None Admission Date: 12/28/2022 Discharge Date: 01/03/2023 Admitting Diagnoses: COVID-19 Details of Hospital Stay PRESENTING PROBLEM:  Hypokalemia  Lightheadedness  Generalized weakness AKI (acute kidney injury) (HCC)  COVID  COVID-19    HOSPITAL COURSE: Patient is a 66-year-old female with multiple medical problems including urostomy, and colostomy.  She also has a history of PEs in the past but is not currently on anticoagulation.  She has had 3 weeks of intermittent dizziness usually whenever she stands with a feeling like she is going to pass out. She has apparently only passed out once and it was yesterday briefly.  She has had no loss of consciousness today.  Her only activity has been going to the bathroom, and returning immediately to her chair.  This has been going on for at least 3 weeks.  She has apparently started a workup with her primary care physician which included a stress test, and a CT angiogram thorax to re-evaluate for further PE.  She denies fevers however, her son at the bedside notes that she has had a pretty significant cough the last week or so.  She reports that she has not had any further increase in output of her colostomy until today and now she has had a lot of output more than usual, consistent with diarrhea.  She denies blood in the stool.   she initially reported that she has been eating and drinking adequately, however her son at the bedside disagrees and when pressed she agrees that her intake has been poor.  Son at the bedside also reports that he was up visiting for the holidays and when he came in the house yesterday she appeared so ill that he told her he was going to bring her to the hospital today.  She was admitted and we struggled with hyponatremia and hypomagnesemia.  We also worked to try and slow down the output from her colostomy.  We added Questran and Lomotil with some success.  She stabilized and we overshot the potassium and she actually had to have some reduction so we held her potassium supplementation treated with Lokelma.  Enteric pathogens and C difficile were negative.  Discussed at length the need for controlling her colostomy output.  Her renal function stabilized, potassium levels normalized.  Her respiratory status was stable and she was at her functional baseline.  It was felt she could return home with continued outpatient care.  She was discharged in stable condition./
Eye pain; Headache came back; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eye pain), HEADACHE (Headache) and HEADACHE (Headache came back) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Eye pain.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (Headache). On 31-Jan-2021, the patient experienced EYE PAIN (Eye pain) and HEADACHE (Headache came back). On 29-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, EYE PAIN (Eye pain) outcome was unknown and HEADACHE (Headache came back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported by the reporter. Treatment was not provided. Patient suffers from Migraine and eye pain but has never been diagnosed with Migraine. The patient visited eye doctor and the eyes are fine.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Significant Follow up received in mail and outcome of Event (headache) was resolved
Red swelling past elbow warm to the touch -left arm- where PNEUMOVAX was given.
Patient reported to pharmacy today, 34 days after injection, stating he has had a very abnormally sore arm, cannot lift his arm above his head and assumed that was not normal to still have. He was encouraged to be checked out by his physician as soon as possible.
Pain and tingling of rt arm, swelling of rt arm and hand, pain on right side of the body, rt sided jaw pain within a few hours of vaccine administration.
pinched nerve; pain with lifting; fast heart beat/3-4 times/made me jump up from the sofa; He recently had been to the dentist and was prescribed pain medications; extreme fatigue/feels tired after 1/4 mile; wakes him up at night/cannot stay up late enough to watch the soccer games in europe/going to bed at 8:30/Went to sleep at 5:30 last saturday; secretions from my nose; Left arm pain/bad pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games in europe/going to bed at 8:30/Went to sleep at 5:30 last saturday), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting) and PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced RHINORRHOEA (secretions from my nose), VACCINATION SITE PAIN (Left arm pain/bad pain) and NAUSEA (nausea). On 04-Sep-2021, the patient experienced SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games in europe/going to bed at 8:30/Went to sleep at 5:30 last saturday). On an unknown date, the patient experienced TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting), PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) and FATIGUE (extreme fatigue/feels tired after 1/4 mile). On 13-Apr-2021, RHINORRHOEA (secretions from my nose), VACCINATION SITE PAIN (Left arm pain/bad pain) and NAUSEA (nausea) had resolved. At the time of the report, TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games in europe/going to bed at 8:30/Went to sleep at 5:30 last saturday), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting), PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) and FATIGUE (extreme fatigue/feels tired after 1/4 mile) outcome was unknown.            Concomitant products included ANTIBIOTICS. No treatment medications were provided.   This case was linked to MOD-2021-317246 (Patient Link).
pt recv vax & 48 hr later devel a fever & rash; No further details were provided;
On 11/14/02, patient was administered 5th DTaP right thigh IM .5cc, 4th IPV left thigh upper, 2nd MMR left thigh lower SC. Patient presented to our office iwth redness, warm to touch, swollen on 11/15/02.
This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding of the scratching) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (Hard breathing), Allergy to animal dander (horse hair, rash/swelling) and Allergy to antibiotic (tetracycline. Rash). On 05-May-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bleeding of the scratching) (seriousness criterion medically significant) and HYPERSENSITIVITY (Hypersensitive to vaccine). The patient was treated with TRIAMCINOLONE for Rash, at a dose of UNK, bid and HYDROXYZINE for Rash, at an unspecified dose and frequency. At the time of the report, HAEMORRHAGE (Bleeding of the scratching) and HYPERSENSITIVITY (Hypersensitive to vaccine) had not resolved.            No concomitant medications was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine (Unknown), the reporter assessed the causality as possible.  It was reported that patient received the second dose on 5th May. On 23rd July patient met with a allergy specialist because the rash still persists. Patient reported that it was more severe on the chest rather than back. Patient also reported symptoms did not change after the second vaccine.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-101848 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
covid vaccine breakthrough case  dose 1 Pfizer 2/5/21 EL9269 dose 2 Pfizer 2/26/21 EN6198
A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a female patient. The patient's medical history, concomitant diseases and concomitant medications were not reported. On an unknown date, the patient received FLUMIST (intranasal) while she was pregnant. The patient had spontaneous abortion. The outcome of the event of drug exposure during pregnancy as well as of spontaneous abortion was unknown. The report was considered to serious due to important medical event and hospitalization criteria. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of spontaneous abortion to be not related to FLUMIST. The company causality was implied no for drug exposure during pregnancy.
Irregular menstrual bleeding.  My regular period came very early, lasted much longer and was harder than a typical period.  A week after that period ended I started bleeding again for 4 full days (still hasn't stopped), again harder than a typical period.  I track my periods using a fitness tracker so I am certain that my regular period was atypical and I've never experienced mid-cycle bleeding before now.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Lot number: 330268BD) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergy: shellfish. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown".
Pt got Varivax 12/6/02. Pt had 20 lesions break out, probably represents varicella disease from vaccine. Pt started on Acyclovir since unknown if exposure to wild type.
3RD DOSE OF MODERNA COVID VACCINE #3 GIVEN 11/8/21, LOT #077C21B; pt resides in a nursing home; recent UTI and was on ABX; 7/24/22 she had a positive COVID test; given Albuterol, Vitamins C&D, Zinc, ABX, Decadron; DNR with comfort measures; the pt passed away in the facility 4 days later
I have had hives since Monday may 17th. They get really itch but then some of the bumps stay for a day or two after it pops up.
No adverse effects reported; a patient was given an expired dose of VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 30-SEP-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (expired product administered) 1 injection, subcutaneously, lot  # N024566 with expiration date 07-SEP-2019, for prophylaxis. No adverse effects reported.
01/10/22 presents to EC ED for "Sepsis, right groin pain s/p liposuction". PMHx of "HLD"
My face had broken out a little bit by my cheek and at the base of one of the sides of my nose; my platelet count is down; white count is down; my T-cell count is down; This is a spontaneous report from a contactable consumer or other non hcp. A 8-decade-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cardiac failure congestive from an unknown date and unknown if ongoing, chronic kidney disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced my t-cell count is down on 2021, my face had broken out a little bit by my cheek and at the base of one of the sides of my nose on Aug2021, my platelet count is down on 2021, white count is down on 2021. The patient underwent lab tests and procedures which included platelet count: down on 2021 my platelet count is down, t-lymphocyte count decreased: down on 2021 my T-cell count, white blood cell count: down on 2021 My white count is down. Therapeutic measures were taken as a result of my face had broken out a little bit by my cheek and at the base of one of the sides of my nose was Amoxicillin 500mg three times daily and bacitracin and cortisone via topical route of administration. The outcome of the events t-lymphocyte count decreased, rash, platelet count decreased, white blood cell count decreased was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are needed. No further information is expected.
Received SHINGRIX in right deltoid on 10/20/18. On 10/23 began to have pain in right wrist. Over next few days symptoms progressed to pain at an 8/10 level, swelling, inability to actively move fingers, pain on movement of wrist, pain touching wrist, and heat in joint. Pain was a constant ache with sharp pains with movement or contact. CBC normal, uric acid at upper level of normal (6.2). NP (urgent care) called with diagnosis of gout. I am just now beginning to be able to use my right hand. Splinting, NSAIDs, heat have helped with pain. Have follow up appt with PCP tomorrow for plan of care.
Noticed some soreness in her right axilla and swelling and tenderness at the injection site on her arm. Some increased axillary tenderness today. Right upper arm with 8cm or moderate welling. Very mild erythema and warmth. Right axilla with no palpable swelling or nodule. No warmth or erythema but there is ttp. Right hand with normal sensation and cap refill.
The initial case was missing the following minimum criteria (unspecified adverse event). Upon receipt of follow-up information on 13Aug2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. An 18-year-old male patient received the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose; and GARDASIL, via an unspecified route of administration on an unspecified date at an unspecified dose, both for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was given the first dose of meningococcal group b rlp2086 along with another vaccine HPV (Non-Pfizer product) on the same date and had a severe reaction. The patient experienced high fever of 103, chills, severe headaches, and shaking on an unspecified date. Outcome of the events was unknown. The physician wanted to know if she can give the vaccine again as she would hate to compromise the dosing and stop giving the GARDASIL. The reporter presumed that meningococcal group b rlp2086 was causing the reaction since GARDASIL was given at the office. He had to be sent to another office location on the same day to receive meningococcal group b rlp2086 at least 15-20 minutes later. He started to have the reaction about an hour after the initial GARDASIL vaccine was administered which is why she was presuming meningococcal group b rlp2086 caused the reaction. Information on the batch number has been requested.
Dizzy; Hot and cold flashes; Tingling and buzzing in finger tips of both hands; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), PARAESTHESIA (Tingling and buzzing in finger tips of both hands) and NAUSEA (Nausea) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), PARAESTHESIA (Tingling and buzzing in finger tips of both hands) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), PARAESTHESIA (Tingling and buzzing in finger tips of both hands) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
PATIENT GOT THE VACCINE AT THE ADMINISTRATION SIRE AND WALKED TO THE WAITING AREA BUT INSTEAD OF REACHING THE CHAIR CAME BACK HALF THE WAY MAY BE TO WALK WITH HIS MOM AND FELL DOWN AND ALMOST FAINTED FOR FEW SECONDS AND THEN CAME TO SENSE AND ACTED NORMAL BUT COMPLAINED A LOT ABOUT HEAD AND EARS HURTING( PROBABLY DUE TO FALL). 911 CAME IN FEW MINUTES AND TOOK PATIENT TO HOSPITAL
Urinating blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 13:30 (Lot number: FC 3184) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "If Covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; LEXAPRO; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Omnicef, reaction(s): "Known allergies: Omnicef". The following information was reported: BLOOD URINE PRESENT (non-serious) with onset 31Aug2021 07:30, outcome "unknown", described as "Urinating blood". The event "urinating blood" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood urine present.  Additional information: Report about Covid vaccine: Yes. Reporting type: AE. Reporter type: Patient. Age group: Adult (18-64 Years). Patient occupation: None of the above. If other vaccine in four weeks: No. Other medications in two weeks: Lexapro, Singular, Flonase, Spironolactone. Adverse event: Urinating blood. Adverse event country:. AE resulted in: Doctor or other healthcare professional office/clinic visit. If patient recovered: Unknown. If treatment AE: Yes. AE treatment: Antibiotics. If Covid prior vaccination: Yes. If Covid tested post vaccination: No. Known allergies: Omnicef. Other medical history: None.  Follow-up attempts are completed. No further information is expected.