chrisvoncsefalvay/vaers-outcomes huggingface dataset:
induration near the spots; This case was reported by a other health professional via call center representative and described the occurrence of injection site induration in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of injection site discolouration (The patient received 1st dose on 31st Mar 2022 for tolerance to the 1st dose refer case US2022177893.).   On 26th May 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, several months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site induration. On an unknown date, the outcome of the injection site induration was not recovered/not resolved.   It was unknown if the reporter considered the injection site induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022177893   Additional Information: GSK Receipt Date: 28-Nov-2022. Reporter's Comment:  The reporter wasthe patient's mother and also an unspecified healthcare provider.  On 26-MAY-2022 she received her second Bexsero dose and a few months after the second dose the dark spots became scaly and lighter in color (AE: scaly skin).  The reporter stated that some induration was now noted near the spots of discoloration. Nothing else was reported. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022177893:Same reporter
2 days p/vax pt exp h/a & unspecified flu-like sx;sx progressed to blurred vision;pt saw internist who rx ATB & Ibuprofen;dx diplopia & referred to neurologist;MRI showed slowing of inferior rectus muscles & proptosis;
FEVER, HEADACHE, CHILLS, BODY ACHES, FATIGUE, SWEATS. THE FATIGUE STARTED A FEW HOURS AFTER THE SHOT. THE OTHER SYMPTOMS STARTED WITHIN 12 HOURS OF THE SHOT AND LASTED 48 HOURS. IT TOOK AN ADDITIONAL 36 HOURS BEFORE I FELT BACK TO NORMAL. NIGHT SWEATS ARE STILL (AS OF ABOUT 108 HOURS AFTER THE SHOT) OCCURRING .
chills, hot flashes, feeling flushed, fatigue, mind fog, pain at injection site, extremely sore muscles
Narrative: 75 year-old male patient reported injection site pain following his COVID-19 Moderna. No treatment needed.
Pt reported body aches and sore arm on Sat with egg size swelling, heat, redness to site on Sun and itching. Today swelling less but s/s persists. Denies n/v/d, dizziness, weakness, fever, sob, cp, or paresthesia. Did have episode of tunnel vision and weakness x 1 hr post vaccine attributed to fear of needles. Had white light in periphery as if going to faint, felt like was "sweating ice", but not diaphoretic, no airway obstruct or distress, no dysphagia. Onset about 5 min post vac lasting 1 hour then resolved. Was alone in office.  Had never had reaction to vac/injection like this before.  Denied any anaphylactic reactions.  Works with newborns and is a nurse. Will come to HC for documentation purposes.  Has allergy to chicken feathers, down pillows, all feathers (tested as child by pediatrician- pt never had skin testing), cats, long haired dogs...eyes swell and can't breathe. Can eat eggs w/o problems.  Did note this felt like Versed reaction when BP dropped out 66/42, sweating, distant hearing.
Initial symptoms of URI sneezing, post nasal drip sore throat.  Progressed to cough with sputum production going from clear to yellow/green to brown by Friday morning.  ER visit occurred on9/27/13 Dx RLL pneumonia.  Antibiotic and prednisone and albuterol ordered.
Body aches; Sore throat; Fever; Headache; Nausea; Cough; chills; Swollen lymph nodes; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via unspecified route of administration in left arm on 10Mar2021 at 15:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Medical history included gastroparesis. The patient was allergic to penicillin, Bactrim and Cipro. Concomitant medications included Estradial (MANUFACTURE UNKNOWN), Topamax (MANUFACTURE UNKNOWN), Imitrex ( MANUFACTURE UNKNOWN) and Wellbutrin (MANUFACTURE UNKNOWN), from an unknown date. On 12Mar2021 at 18:45 patient experienced body aches, sore throat, fever, headache, nausea, cough, chills, swollen lymph nodes and feeling tired. The patient did not receive treatment for the reported events. The clinical outcome of the body aches, sore throat, fever, headache, nausea, cough, chills, swollen lymph nodes and feeling tired was recovering.   No follow-up attempts are needed. No further information is expected.
Mild deltoid pain with arm movement and muscle contraction persisting to more than 5 weeks post-vaccination.
11/25/21 at 2300-Patient in usual health.  11/26/21 at 0900- Patient was awakened with major CVA Patient had arterial fibrillation on admission. (Arterial fibrillation also seen on ECG  of 6/10/2019) Patient not on anticoagulation.
5-18-04: approx 8 hrs after injection, began with redness and tenderness at site. Also felt fatigue. 5-19-04: started with transient nausea, felt feverish although no temp taken. Arm soreness with redness continues. Will see primary doctor today for evaluation. All symptoms remain today.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date in October 2018 (reported as between 08-OCT-2018 and 15-OCT-2018), the patient received unspecified doses of GARDASIL 9 (lot # R003557 with expiration date 20-NOV-2020; strength, dose and route were not reported) for prophylaxis, which was improperly stored. Current temperature excursion was 7.7 Fahrenheit degrees for 1 hours and 6 minutes. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter (linked case # 1810USA008298; case # 1810USA008299). Sender's Comments: US-009507513-1810USA008298: US-009507513-1810USA008299.
had under her under armpit  a sac that felt like it was full of water, and lasted for a couple of days.; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (had under her under armpit  a sac that felt like it was full of water, and lasted for a couple of days.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011f21a, 045a21a and 010a21a) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long-standing health conditions. Patient neither diagnosed with COVID-19 nor tested positive.  Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO), METFORMIN, CHLORTALIDONE (CHLORTHALIDONE), POTASSIUM (POTASIUM M), OMEPRAZOLE, AMITRIPTYLINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and LACTULOSE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AXILLARY MASS (had under her under armpit  a sac that felt like it was full of water, and lasted for a couple of days.). At the time of the report, AXILLARY MASS (had under her under armpit  a sac that felt like it was full of water, and lasted for a couple of days.) had resolved.            Other concomitant medications was reported are tyrod medicine, hormone pill, doco stool softer. Patient did not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was reported that patient did not seek medical care and patient did not experienced any similar event in the past. Treatment medications were not reported.   This case was linked to MOD-2022-565150 (Patient Link).
supper achy, like getting the flu; Diarrhea; constipation; lost his appetite; bad headache across the back of his head; chills  he was hot and cold all day; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (supper achy, like getting the flu), DIARRHOEA (Diarrhea), CONSTIPATION (constipation), DECREASED APPETITE (lost his appetite) and HEADACHE (bad headache across the back of his head) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (supper achy, like getting the flu), DIARRHOEA (Diarrhea), CONSTIPATION (constipation), DECREASED APPETITE (lost his appetite), HEADACHE (bad headache across the back of his head) and CHILLS (chills  he was hot and cold all day). At the time of the report, INFLUENZA LIKE ILLNESS (supper achy, like getting the flu), DIARRHOEA (Diarrhea), CONSTIPATION (constipation), DECREASED APPETITE (lost his appetite), HEADACHE (bad headache across the back of his head) and CHILLS (chills  he was hot and cold all day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.  One week after vaccination, the patient had bad headache across the back of head, super achy like getting the flu and lost appetite. Next day morning, the patient also had chills- hot and cold all day. On day 3 headache continued and by day 4 patient was better. On an unknown date, the patient experienced constipation and diarrhea.   This case was linked to MOD-2021-115907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Follow-up received on 08-05-2021:Significant information received, Added constipation and diarrhea as events.
Missed his scheduled second dose and is past the 42 day mark; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed his scheduled second dose and is past the 42 day mark) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his scheduled second dose and is past the 42 day mark). On 04-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed his scheduled second dose and is past the 42 day mark) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
On 6/30/2022 a Hep A (Vaqta) vaccination was adminestered to pt. during her 1 month Well Child Check up  by MA. The wrong vaccination was given as opposed to the right one which was Hep B ( Recombivax HB) series 2. The mistake was found when the chart went to billing and there was a discrepancy between orders and vaccine entered into the chart. The lot number on the chart was that of a Hep A (Vaqta) vaccine instead of the Hep B (Recombivax HB).
at 6 00 pm the same day I had a fever and headache felt week. was extremely thirstyI took tylennol and put eye pack on my forehead. I was ill until the next day around 9pm
Stiff neck base of skull limited backward motion; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and depression. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 09Mar2021 at 12:00, the patient experienced stiff neck base of skull limited backward motion. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event stiff neck base of skull and limited backward motion was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Right leg went numb right after injection, same happened with the first dose. Arm and shoulder pain that goes up to neck on right side, and wraps around to armpit. No swelling at this time. 24 hours after injection I felt extremely sick with a fever, chills, nausea, migraine, excessive thirst, and extreme fatigue. Slightly elevated blood pressure occurred as well.
Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 01-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 VACCINATION SITE PAIN (Soreness in the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Muscle soreness, tenderness, and nerve pain from neck, injection site and arm. Soreness has subsided, however nerve pain from neck to arm after 6 days persists.
Acute on chronic heart failure with preserved EF, related acute hypoxic respiratory failure. diuresis with torsemide, continue 20 mg daily with potassium, follow-up BMP, regular weights.  Echo completed shows EF 60%, moderate TR.  Symptomatic improvement in addition to successful titration of oxygen. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Fever (around 100 F), chills, arm soreness, fatigue, and severe headache for entire duration. I passed out/loss consciousness around 11:45 am and I threw up at around 4:30 pm.
The evening after receiving the vaccine, pt began having headache, lightheadedness, shortness of breath, nausea, loss of appetite. Th next day (6/10)  she notedmyalgias in lower back and hips with shooting pains in her knees and vomiting. She also noted mild fever and chills, nasal congestion and discharge with mild sore throat, and substernal chest discomfort. She described it as tightness with radiation to her throat and jaw, and right arm, witout radiation to her back, not associated with nausea, but is associated with shortness of breath and diaphoresis. Chest discomfort worse with lying down. Rapid COVID test negative. Upon arrival to ED on 6/11, her troponin was mildly elevated (0.039ug/L), D-dimer elevated at 348ng/mL, CRP also elevated at 5.96 mg/dL. ED physician diagnoses acute myopericarditis and patient was admitted to Critical Care Unit. On 6/13/2021 patient was discharged stable (limited bedside echo showed small pericardial effusion). Pt denies pleuritic chest pain on day of discharge.
Patient came in with (B) arms red and hot no fevers but blisters on (B) arms.
On Monday 12/6 she developed shortness of breath and tachycardia to 140 with chest pain on inspiration with headache while at school in class. ER eval done with negative findings. Symptoms continued with f/u with pcp and cardio consult with no acute findings. We are now a week out and symptoms improving but still with mild shortness of breath with exertion and slight tachycardia
Information has been received from a consumer concerning her 10 year old daughter who on an unspecified date was vaccinated with a dose of GARDASIL.  On the same day, the patient was vaccinated with a dose of VARIVAX in the same arm.  Subsequently, the patient experienced swelling at the injection site, fever and lethargy.  Subsequently, the patient recovered.  The patient's mother called the physician to seek unspecified medical attention.  Additional information has been requested.
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:   A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Patient was prescribed 2 types of antibiotics (unspecified) by a physician for the UTI but not known if patient has begun taking them.
This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 18:00 as dose 1, single (Lot number: EK5730), in left arm, on 08Jan2021 at 20:30 as dose 2, single (Lot number: EL3246), in left arm, on 25Aug2021 at 09:00 as dose 3 (booster), single (Lot number: EW0182), in left arm and on 30Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FL3198) at the age of 70 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "LBP" (unspecified if ongoing), notes: LBP; "insomnia" (unspecified if ongoing). Concomitant medication(s) included: Trazodone; Famotidine; Montelukast; Atorvastatin; Cyclobenzaprine; APAP; Vitamin D [Colecalciferol]; Calcium Antacid; B12 [Cyanocobalamin]. Past drug history included: Nickel, reaction(s): "Known allergies: Nickel". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient took Paxlovid from May2022 to May2022 for Treatment of COVID-19. Other Medication In 2 weeks Product included: Trazodone 150 Mg, Famotidine 40 Mg, Montelukast10 Mg, Atorvastatin 10 Mg, Cyclobenzaprine 10 Mg, Acetaminophen(APAP) 1000 Mg, Vitamin D 2000 unit (IU), Calcium Chew 600 Mg, B12 1000 MCGM. Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure/COVID-19 cannot be ruled out
Vaccinations given on a Wednesday. Patient began vomiting on Sunday through Thursday. Was taken to the hospital on Monday for dehydration. Released Tuesday; doing fine now. Discharge summary states gastroenteritis, hypokalemia. msv
OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE AT FLUCTUATED TEMPERATURE BETWEEN 19 TO 43 FAHRENHEIT; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced out of specification product use, and incorrect product storage at fluctuated temperature between 19 to 43 fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage at fluctuated temperature between 19 to 43 fahrenheit and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220534309.