chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm is still swollen; Her arm is still hard; arm is still warm; arm is still itchy; 2 more bruises appeared above her waist line, with purple in the middle; she found 3 bruises across her stomach almost in a line; old-fashioned kid stomachache; not wanting to eat anything; chills; feverish; achy; her stomach feels tight, very uncomfortable; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (old-fashioned kid stomachache), PERIPHERAL SWELLING (Her arm is still swollen), INDURATION (Her arm is still hard), FEELING HOT (arm is still warm) and PRURITUS (arm is still itchy) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (old-fashioned kid stomachache), ABDOMINAL DISCOMFORT (her stomach feels tight, very uncomfortable), DECREASED APPETITE (not wanting to eat anything), CHILLS (chills), PYREXIA (feverish) and MYALGIA (achy). On 15-Apr-2021, the patient experienced CONTUSION (she found 3 bruises across her stomach almost in a line). On 16-Apr-2021, the patient experienced SKIN DISCOLOURATION (2 more bruises appeared above her waist line, with purple in the middle). On an unknown date, the patient experienced PERIPHERAL SWELLING (Her arm is still swollen), INDURATION (Her arm is still hard), FEELING HOT (arm is still warm) and PRURITUS (arm is still itchy). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (old-fashioned kid stomachache), PERIPHERAL SWELLING (Her arm is still swollen), INDURATION (Her arm is still hard), FEELING HOT (arm is still warm), PRURITUS (arm is still itchy), ABDOMINAL DISCOMFORT (her stomach feels tight, very uncomfortable), CONTUSION (she found 3 bruises across her stomach almost in a line), SKIN DISCOLOURATION (2 more bruises appeared above her waist line, with purple in the middle), DECREASED APPETITE (not wanting to eat anything), CHILLS (chills), PYREXIA (feverish) and MYALGIA (achy) outcome was unknown.            No concomitant medicine   Reporter did not allow further contact
Covid rebound after 3 day of completion of Paxlovid course; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 23Sep2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shell fish" (unspecified if ongoing). There were no concomitant medications. Patient did not take other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 19Aug2022, outcome "recovering", described as "Covid rebound after 3 day of completion of Paxlovid course". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 12Aug2022 to 16Aug2022.
DIZZINES, SYNCOPE WHILE SEATED, FELL INTO COFFE TABLE, RANDOM ABNORMAL BRUISING ON ABDOMINAL WALL AND LEGS.
CHILLS; NOT FEELING GOOD; NAUSEA; FEVER; TIREDNESS IN MORNING; This spontaneous report received from a parent concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pleurisy, issue with lack of cartilage in knee, and sensitive to medication, and other pre-existing medical conditions included the patient was using oral contraceptive. weight was approx 90 lbs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for fever. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced not feeling good. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced tiredness in morning. Laboratory data included: Body temperature (NR: not provided) 102.7 F, 98 F, jumped higher to the mid 103's teetering 104 F, between 99.5 to under 101, between 97.8 to 99 F, remained in 97-98 range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, nausea, fever, not feeling good, and tiredness in morning. This report was non-serious.
Patient stated she had headache, fever, redness and swellen of left arm.  Arm was still warm to the touch today.
Fever. Severe hip, back and neck pain. Headache. Nausea.
broke out in shingles rash a couple of days after. Also gynecomastia started forming with a lump on right side of chest.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported the 26 patients received doses of VAIRVAX (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Interstitial cystitis (frequent/painful urination, bladder discomfort, abdominal pain) treated with Elmiron and UTA.
Shot felt like it was given high in my left arm.  To this day my left arm is not working properly and hurts still in injection site. Goes to my shoulder and all the way to my middle of my crease in my elbow and my grip in my left hand is diminished day by day and now really bad.Immediately after I did not feel well. I sat in the wait room for about 20-30 minutes after. Then I went home and got on the couch and was down about 4 days not feeling well. My body felt like a truck ran over me.
Ataxia, mild developed this morning. 4PM has improved gait will follow next 24 hours.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.    On or about 12-OCT-2012 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength. batch/lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively on or about 12-OCT-2012, the patient's healthcare providers relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects.  On an unknown date, reported as subsequent to the vaccination, the patient experienced shingles and was treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).     The event shingles was serious due to hospitalization and life threatening.   Additional information has been requested.
pediatric male patient / received / an adult dose from Engerix-B; pediatric male patient / received / an adult dose from Engerix-B; This case was reported by a pharmacist and described the occurrence of adult product administered to child in a adolescent male patient who received HBV (Engerix B adult) (batch number 2793Z, expiry date 5th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Pediatric patient received a maladministration of Engerix-B, as the pharmacist gave to him  an adult dose from Engerix-B vaccine, which led to adult product administered to child and overdose. Health care provider would provide the data after callback. Pharmacist did not have the data when the communication was ongoing. The reporter consent to follow up.
This spontaneous report was received from a consumer refers to herself as a 66 year old female patient with penicillin allergy. On 29-FEB-2008, the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported), subcutaneous. On an unknown date in 2011, the patient experienced first shingles outbreak. On 20-JUN-2014, 2304 days after onset of therapy, the patient experienced second shingles outbreak. The patient sought medical attention and visited the office. The patient stated that the symptoms began vague and have now become full down. The patient was treated with high dose of antiviral medications with valacyclovir HCL at that time. The patient was controlling the pain ALEVE and which on scale of 1 to 10 addresses the pain at a 3-4 level. The patient was resistant to taking narcotic pain medications due to her own personal feelings about narcotics and therefore chooses not to taken them. The outcome of second shingles outbreak was reported as not recovered/not resolved. The outcome of first shingles outbreak was unknown. Additional information has been requested.
No adverse effect; Improperly stored dose of VARIVAX administered; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 24-JUN-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S000133 and expiry date: 02-JAN-2021 (product storage error) subcutaneously for prophylaxis (strength, dose, unit and anatomical location were not reported). The diluent was stored appropriately. No adverse effects were reported. The administered dose of vaccine experienced temperature excursion from 6ºF to 14ºF for a time frame of 2 hours and 40 minutes and 15ºF to 46ºF for a time frame of 7 hours and 40 minutes. There were no previous temperature excursions. The call was due to digital data logger. The outcome of the events was unknown. No product quality complaint (PQC) was involved.  This is one of the five reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA009882:1250974 US-009507513-1906USA010076:1251186 US-009507513-1906USA009880:1251149 US-009507513-1906USA009914:1251178
Headache; Nausea; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 22Mar2021 at 16:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 11:00, the patient experienced headache, nausea, chills and fatigue. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events, headache, nausea, fatigue and chills was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
pt recvd vax; 18aug94-21aug94 t ranged from 100-105;seen in er on 21aug94 w/ t of 105;
Vomited that evening, followed by a day-long period of heavy fatigue, fever, body aches, nausea, diarrhea. Diarrhea has continued for three days.
a darkening area of skin on her chin/it was the skin around the area lightening giving the appearance that skin was darkening; Vitiligo; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the parent.  A 14-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Lot number: unknown) at the age of 14 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN. Vaccination history included: BNT162b2 (Dose Number: 1, single, Prev dose lot unknown reason=Unable to locate or read the details.), administration date: 13May2021, when the patient was 14-year-old, for COVID-19 Immunization. The following information was reported: VITILIGO (non-serious) with onset 28Jun2021, outcome "not recovered"; SKIN DISCOLOURATION (non-serious) with onset 28Jun2021, outcome "not recovered", described as "a darkening area of skin on her chin/it was the skin around the area lightening giving the appearance that skin was darkening". The events "a darkening area of skin on her chin/it was the skin around the area lightening giving the appearance that skin was darkening" and "vitiligo" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin discolouration, vitiligo.  Additional Information: Patient also received BNT162B2 dose 3 (booster), single on 14Jan2022 for covid-19 immunization. It was reported by female (parent), that her 15-year-old daughter first noticed a darkening area of skin on her chin about 2 weeks after her 2nd covid vaccine. it became noticeably bigger around over the next few months.they thought it was melasma. They were able to see a dermatologist on 06Jul2022 and was told she had Vitiligo. She had very fair skin they weren't seeing darkening; it was the skin around the area lightening giving the appearance that skin was darkening. She(parent) believed this was related to the vaccine. AE treatment was reported as topical tacrolimus and triamcinolone. Wellbutrin was reported as other medications patient had in two weeks. Patient did not have covid Prior vaccination. patient did not have any other vaccine in four weeks. covid tested post vaccination was reported as Yes. Known allergies reported as None. there was no history of autoimmune disorders in her or the family. she had no other symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
temperature excursion of unknown cause, Max/low temperature reached: 32.7F Duration out of labelled range: 1 hour with no reported adverse event; 2 patients were administered menquadfi post excursion with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves 2 patients who received vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] and had temperature excursion of unknown cause, max/low temperature reached: 32.7f duration out of labelled range: 1 hour with no reported adverse event and 2 patients were administered menquadfi post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date there was temperature excursion of unknown cause, max/low temperature reached: 32.7f duration out of labelled range: 1 hour with no reported adverse event (product storage error).  On 05-Oct-2022, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation, strength: unknown) lot U7449AB, expiration date: 23-Sep-2024 via unknown route in unknown administration site as Immunization.  On 05-OCT-2022 the 2 patients were administered menquadfi post excursion with no reported adverse event (poor quality product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.A mini refrigerator was used and it experienced a low excursion.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (temperature excursion of unknown cause, Max/low temperature reached: 32.7F Duration out of labelled range: 1 hour with no reported adverse event, 2 patients were administered menquadfi post excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown date, multiple patients were vaccinated with a dose of improperly stored MMR II lot # K002528, expiry date: 18-FEB-2016, lot # K016153, expiry date: 24-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Started with fever that lasted 7 days (peak fever was 101.5). Vomiting morning of 11/22. Stomach pain on and off throughout. Loss of appetite throughout. Hives and paleness developed evening 11/22/09 - face, head, back, stomach, legs, genital area, ears, feet. Hives continued and got worse (patient tore off clothes and was screaming) resulting in an ER visit evening 11/24/09. Hives still continue currently (11/28/09). Fever continues as well... 99.6 right now (9pm 11/28). Patient reported her left leg hurt from he foot to hip tonight. Symptoms are worse in the evenings. Benadryl seems to make itching and fever worse. Hydrocortis/Eucerin creme helps a bit, but itching persists. Skin feels like permanent gooseflesh. Slightly clammy and bumpy.  Patient is understandably moody/irritable.
Pt. reports 48 hours after receiving vaccine she developed Left deltoid pain with subsequent weakness. Has diminished ROM.
At 3:00 AM on the day after I woke up with my right eyelid swollen and producing goop.  Other than that I had fatigue, sore injection site, and a headache.
pt recv vax & pt exp skin rash on face only, w/bumps & red marks on side of cheek & nose;no further details were provided;
APPROX 4.5 HOURS AFTER ADMINISTRATION OF VACC. I DEVELOPED SUDDEN ONSET OF CHEST PAIN,WITHIN 30MIN-LUNG PAIN/PRESSURE/BURNING,WITHIN 30MIN TIGHTENING/BURNING OF THROAT AND THICKENING OF THE TONGUE/TINGLING LIPS AND BRIGHT RED BURNING OF EYES
Child was given Kinrix. After administering the shot and the child had left the clinic, the nurse found a note that the doctor had recommended that the child only have DT.  Primary pediatric doctor was notified as well as parent of child.
Headache, Myalgia, Fever, Chills, Fatigue, Injection site soreness Narrative:
began with nausea, vomiting at 11pm'ish throughout night chills and fever, continued through the next day and a half, fever 102.5 resolved by 10pm day after vaccine but headache like my head was in a vise, nausea and vomiting and lethargy, remained for that and the next day.
27Mar2021, he tested positive for 2 covid test; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Mar2021 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that everything was fine, but on Saturday 27Mar2021, he tested positive for 2 covid test. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 27Mar2021. Patient was advised by his doctor to delay his 2nd dose for 90 days. The 2nd dose was originally scheduled on 07Apr2021. Patient was asking for general guidance regarding this. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hospitalized covid (+); This is an 87-year-old very pleasant male who presented to the ER today (7/24/21)  with a 3-day history of a cough which he reports to be dry and Hakki.  He also reported feeling some postnasal drainage.  Also the cough he had no other symptoms until today when he reported feeling feverish as well as having chills.  This patient is vaccinated with the Pfizer Covid vaccine.  First dose in January 2 dose in February.  They have just traveled back from another state where they attended a very large memorial gathering.  In the emergency room rapid Covid test was found to be negative.  Repeat came back (+). We are asked to admit him because he was mildly hypoxic.
Extreme fatigue.   Rapid heart beat.  Ache all over.  Joint pain   Pressure in chest   Can?t get breathe