chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he constant had salty taste and that his lips also had salty taste; change in taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, 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: DYSGEUSIA (non-serious), outcome "unknown", described as "he constant had salty taste and that his lips also had salty taste"; TASTE DISORDER (non-serious), outcome "unknown", described as "change in taste".  Additional information: Patient reported that he experienced a change in the ability to taste where he constant had salty taste and that his lips also had salty taste so he was unable to drink. Patient already went to the doctor to find a solution, however, was unable to receive any. Patient wanted to know how to get rid of the salty taste. He received the Comirnaty vaccine last 06Oct2023. Patient said he can drink and eat but everything is affected by the taste. Patient mentioned that the only difference before and after he experienced the change in taste was the Comirnaty vaccine so "it has to be related to that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
battling respiratory problems for 6 weeks; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (battling respiratory problems for 6 weeks) in a 70-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced RESPIRATORY DISORDER (battling respiratory problems for 6 weeks). At the time of the report, RESPIRATORY DISORDER (battling respiratory problems for 6 weeks) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Information has been received from a nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent condition and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K007264, expiration date 02-MAR-2017, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
12/28/17 Employee stated she had arm pain post at least 2 weeks from administration of vaccines; still has occasional pain upon various movements.
A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.).    No concomitant medications were reported.  No treatment medications were reported.
Information has been received from a certified medical assistant concerning a 10 year old female with no medical history or allergies who on 10-FEB-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. It was reported that on 03-MAY-2007 the patient developed chickenpox with 20 scattered papules and vesicles all over her body. The patient was not experiencing fever. It was unknown if the patient received a second dose of the vaccine because the patient was switched to another practice and her records were not all received. Unspecified medical attention was sought. No laboratory tests were performed. The patient's status was reported as recovering. No product quality complaint was involved. Follow-up information indicated that the patient was given a dose of varicella virus vaccine live (Oka/Merck) at another doctor's office. There was no illness at time of vaccination. The outcome was reported as recovered. No other information reported. Additional information has been requested.
Booster dose; arm sore; chills; feverish; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 12:00 (Lot number: FF2589) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 12:00, outcome "unknown", described as "Booster dose"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "arm sore"; CHILLS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "chills"; PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "feverish". It was unknown if therapeutic measures were taken as a result of pain in extremity, chills, pyrexia.  Additional information: Facility where most recent vaccine administered was Workplace clinic. The treatment received for the adverse event was reported as unknown. Covid prior vaccination and covid tested post vaccination was reported as unknown.  No follow-up attempts are possible. No further information is expected.
tested positive; tested positive; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional (patient) reported for self that: A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 27Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE, dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was an inpatient healthcare provider (SLP) and have been working with COVID-19 patients since the start of the pandemic, lived in an area with a low infection rate (withheld county in withheld country, currently at 2% positivity) and tested positive on 04Nov2021. Outcome of covid-19 and drug ineffective was unknown. The patient underwent lab tests and procedures included SARS-CoV-2 test showed positive on 04Nov2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
10:30am- 2nd dose received  1:30pm -fatigued/ headache (Advil taken, symptoms subside) 6pm - fatigue/ sore arm/ headache (Tylenol, symptoms worsen) 11:30pm- chills, body/ muscle aches, clammy  1:30pm- worsening chills, worsening aches, insomnia, restless legs, panic attack 5am- nausea, aches, chills, fever (Tylenol & Zofran- helped minimally) continued lack of appetite Symptoms subside Approx 48 hrs after 2nd dose.
Vasovagal without syncope; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 07Apr2021 at 10:45, the patient experienced vasovagal without syncope. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with just water and ice packs on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vasovagal without syncope was recovering 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.
High fever spiked on day 6 post vaccine administration. Fever didn't break till a week later. Was consequently high for 6 days straight with no aid. Rash on whole body from forehead to toes. Yellowing of the skin all over and black and blues under the eyes. Lethargic state.
12 year old male patient received Dapatcel instead of Adacel, no AE; 12 year old male patient received Dapatcel vaccine, no AE; Initial information received on 30-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 year old male patient who received a DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   On 27-Jul-2020, the patient received a sixth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot 2032420 and expiry date: 23-May-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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 Directive and Module VI of the 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.  There will be no information available on the batch number of Adacel for this case (it was not administered).
Potential AE due to doses administered from vials that may have been compromised; Administered vaccine from vials that may have been compromised.; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion.; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion.). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, vaccines administered at pharmacies that were stored in an unapproved freezer and thus might have been compromised. At pharmacy, digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.   Moderna  date order was provided as 01 Nov 2021 and 15 Nov.The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.   No treatment details were reported.
@1035 Pt felt mildly dizzy and nauseated. Gave pt some alcohol pad to smell to relieve the nausea. Effective. Dizziness is still present. Started fluids. Tol well.    @1045 Pt ambulated. Unsteady gait. Escorted back to her chair. Instructed to drink more water. Pt complied. Lifted feet to chair.    @1100 Pt is feeling better but still mildy dizzy. VS 141/76 (101) 64HR  16RR 98%   @1115 Pt stood up, ambulated. Pt did well. Gait stable. Tol well. Pt is looking better. Pt stated that she is ready to go home. Husband at bedside. Asymptomatic. ED precautions discussed with pt. Instructed to follow up with PMD. Made MD aware and agreed to the plan.
blisters in her hands; rash on hand; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters in her hands) and RASH (rash on hand) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (blisters in her hands) and RASH (rash on hand). At the time of the report, BLISTER (blisters in her hands) and RASH (rash on hand) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contains non significant information. Address updated.
pt ate fell asleep 530AM in sleep-over a 3 hrs period of intermittant high pitched screaming, arching back, arms & legs moved, tonic clonic movements-pt did not wake up;
Skin irritation, inflammation on site of vaccination administration earlier today when she woke up (7/27). Recommended BENADRYL OTC and MD visit if unresolved.
Weakness; Aches and pains; Low grade temperature; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN (Aches and pains), PYREXIA (Low grade temperature) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ASTHENIA (Weakness), PAIN (Aches and pains), PYREXIA (Low grade temperature) and CHILLS (Chills). At the time of the report, ASTHENIA (Weakness), PAIN (Aches and pains), PYREXIA (Low grade temperature) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed to update case level seriousness.; Reporter's Comments: This serious case concerns a 68 Y/O female with an unexpected event of asthenia along with expected events of pain, pyrexia, chills. Event onset on Day 2 after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), HYPERHIDROSIS (sweating) and TREMOR (uncontrollable shaking) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 0081321-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL, AMLODIPINE and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, METFORMIN HYDROCHLORIDE (XIGDUO XR).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). On 03-Mar-2021, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweating) and TREMOR (uncontrollable shaking). On an unknown date, the patient experienced CYSTITIS (Bladder infection). At the time of the report, FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), HYPERHIDROSIS (sweating), TREMOR (uncontrollable shaking) and CYSTITIS (Bladder infection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Treatment medication included Alot of water and two tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: New event: Bladder infection added,2nd dose information added.
Rash developed 2 days after shot - first on arm where shot was given then all over body. Headache today - 4-28-09.
Fever 102, Fatigue, Sweats, Diarrhea, low pulse ox Possible groundglass opacity within the bilateral lower lobes which may represent inflammatory/ifectious process.  Prescribed azithromycin
I was diagnosed with vertigo and sinus infection I was prescribed Meclizine; Zyrtec for the sinus infection
Soreness in left arm lasting about 24-28 hours (started around 8PM 4/15/2021) and fading around 10PM 4/16/2021 Fever peaking at 100.3 starting at 4PM 4/16/2021 and lasting until around 12AM 4/16/2021, mild chills Mild body aches during fever in both shoulders, back and neck, gone by 10PM as fever started to recede.
Patient got second dose Pfizer vaccine 5/10/21. First dose Pfizer 4/8/21. Janssen vaccine 3/8/21. Pt fully aware Jassen is single dose but signed up and omit to inform about Janssen to get Pfizer due to concern for Janssen efficacy
very tired; still can't function; My urine stream became half of what it normally is; severe stomach pains/ pains around outside of stomach; Pain in right kidney; Chills/hot; Hands shaky; Slight confusion; Couldn't eat; Couldn't sleep or sit for more than 10 minutes at a time due to pain; Couldn't sleep or sit for more than 10 minutes at a time due to pain; bloat; This is a spontaneous report from a contactable consumer(patient). A 68-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no: EN6199) via unspecified route of administration in left arm, as single dose on an 06Mar2021 16:45 for COVID-19 immunization (at the age of 68-years). The patient medical history and concomitant medications were not reported. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no known allergies. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 06Mar2021 22:00, patient started to get severe stomach pains, couple hours after, patient got pains outside of stomach, pain in right kidney, chills/hot, handy shaky, slight confusion, could not eat, drank water and could not sleep or sit for more than 10 minutes at a time due to pain. Patient started to bloat. Less severe on Monday 08Mar2021 and finally slept a full night from 7 pm to 3 am Monday into Tuesday. Patient stated that symptoms have decreased but still could not function and was very tired yet at 10 am Tuesday (09Mar2021). Patient stated that urine stream became half of what it normally was. Patient had been drinking lots of water, had some crackers, had five teaspoons of broth last night and finally ate a bowl of oatmeal. The events resulted to visit doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of, my urine stream became half of what it normally is. The outcome of all the events was recovering except urine stream became half of what it normally was, which was recovered on 08Mar2021.  No follow-up attempts are possible. No further information is expected.
Within 1-2 mins of administrating vaccine, child began to cough with small amt of vomit. Paleness & weakness noted. Began to regain color & alertness within 5- 7 mins. No SOB, wheezing or unconsciousness. Monitored in office & referred to private physician.
Vaccine given 8/4/2010, developed Bell's Palsy 9/1/2010 - seen/eval in ED 9/2/10 given Prednisone x 7 days.