chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness and agitation; Tiredness and agitation; nausea, chills with no fever and shortness of breath for a day; nausea, chills with no fever and shortness of breath for a day; nausea, chills with no fever and shortness of breath for a day; soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Tiredness and agitation), PAIN IN EXTREMITY (soreness in his arm), DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), FATIGUE (Tiredness and agitation) and NAUSEA (nausea, chills with no fever and shortness of breath for a day) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy NOS.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 25-Feb-2021, the patient experienced DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), NAUSEA (nausea, chills with no fever and shortness of breath for a day) and CHILLS (nausea, chills with no fever and shortness of breath for a day). On 08-Mar-2021, the patient experienced AGITATION (Tiredness and agitation) and FATIGUE (Tiredness and agitation). The patient was treated with SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) at a dose of 1 dosage form; LORATADINE (CLARITINE) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. On 15-Feb-2021, PAIN IN EXTREMITY (soreness in his arm) had resolved. On 26-Feb-2021, DYSPNOEA (nausea, chills with no fever and shortness of breath for a day), NAUSEA (nausea, chills with no fever and shortness of breath for a day) and CHILLS (nausea, chills with no fever and shortness of breath for a day) had resolved. At the time of the report, AGITATION (Tiredness and agitation) and FATIGUE (Tiredness and agitation) 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.
Left shoulder pain with decreased active ROM, tenderness but no erythema. Apprehension with passive ROM.
Upper arm red and swollen, some pain, no treatment, 3 days. Right shin and ankle pink and itchy on 4th day, became a rash on shin. Treated with Clobetasol, moisturizing cream. Itch stopped in one day, rash gradually disappeared. About 4 days.
12yoM with history of asthma who presented 10/4/21 with respiratory failure and newly diagnosed cardiac dysfunction. Per outside report, he initially presented Wednesday September 29th with fever, cough, shortness of breath, and malaise. He was seen in local ED and diagnosed with strep throat. He was started on augmentin. He was sent home but returned to ER several times for similar symptoms over the next few days. He also developed rash and conjunctivitis. He continued to have daily fevers up to 105F. Today he presented to outside ED with similar symptoms and respiratory distress. He was initially treated as an asthma exacerbation and received steroids, albuterol and duonebs. He also received unasyn and azithromycin for possible pneumonia on CXR. He was admitted to PICU. Due to increased respiratory distress he was placed on BiPAP. However, he continued to have sats in 80's so was intubated after receiving roc/ketamine. He was sedated with fentanyl, precedex, and received vec. He had 4 beat run of VT. Echo was obtained which showed decreased biventricular dysfunction with LVEF ~ 25%. COVID swab negative. RIJ was placed. Art line attempted but was unsuccessful. He was noted to have lower blood pressures with systolics in 80's so was started on epi at 0.01. Stable on transport with sats in 90's. He received COVID vaccine on 8/30/21 and 9/21/21 (do not have lot number available, not found in our database). Of note his sister had COVID 9/9/21 so likely he was infected and primed for MISC before he was fully vaccinated. On admission +paraflu/rsv/covid, Cn 38. Our multidisc MISC team agreed upon confirmed MISC, reported to agency. We sent nucleocapsid IgG to facility,  which was pos. He received IVIG, methylprednisolone, LMWH, ASA. He is still being followed by nephrology for his AKI, cardiology, and rheum. Last EF 59% on 10/19/21.
felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) intramuscular, on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 75 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 02Jan2021 at single dose. Relevant medical history included COVID-19 last Mar2020 and knee replacement on 12Jan2021. The patient received no concomitant medications. The patient reported she had the 2 shots. After both shots, her arm hurt, she felt wiped out, and she had joint pain. After the second shot, she did run a fever as high as 100. She said that she had the second shot on Friday 22Jan2021 and on Saturday she was wiped out. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The event wiped out had resolved in Jan2021, while outcome of other events was unknown.
I occasionally get migraines.   At the most 2-3 days a month but most months I don't get any.  I probably have less than 12 migraine days per year.  Since my second shot, I had 18/25 days with a migraine.
Pt returned home after 3rd Hep B vax and at approx 20 minutes after injection started developing symptoms of throat tightness, wheezing, congestion, shakiness and dizziness, without hives or rash. Pt treated this herself with Azmacort inhaler with relief. Pt has own epinephrine injection pack (not used) and so didn't report to her MD. Symptoms completely abated over 2 days.
4wk p/vax devel pain & swelling lt knee;DXT in lt calf MAY97;rx w/NSAIDS & pred;dx oligoarthritis  w/knee effusion;still has pain & swelling in joints;MD now recommended course of methotresate;
4 Patients given a dose from a punctured vial stored at room temperature for 34 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 Patients given a dose from a punctured vial stored at room temperature for 34 hours) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 Patients given a dose from a punctured vial stored at room temperature for 34 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 Patients given a dose from a punctured vial stored at room temperature for 34 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  Between July 21 & 23 punctured a Moderna vial in the morning and 34 hours later dosed 4 patients.
Period changes- Thick cup (1.5 cup clear gelly) of cervical mucus released a few days after vx #1- this has never happened to me before;  period stopped mid period after vx 2.  Pain in arm at site; headache; fatigue; muscle pain; body soreness; cramping menstrual cramps
Red face cheeks; Red face cheeks, slightly swollen, notcaused by sun exposure; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female 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 27Mar2021 at 09:00(at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four 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 been tested for COVID-19. On 28Mar2021, the patient experienced red face cheeks, slightly swollen, not caused by sun exposure. The patient did not receive any treatment for the reported 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 red face and swelling of face was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Breakthrough COVID case: On 04/15/2022 I took a Rapid COVID test and it came back negative. I took the test because my wife wasn't feeling well. The next evening I started to have cold like symptoms. I had severe post nasal drainage and coughing. I took some Nyquil so I could sleep. Two days later 04/18/2022 I decided to take another rapid COVID test and it came back positive. I started to experience headaches as well which I don't usually have. I contacted my doctor to advise of the positive test. Up until yesterday my symptoms had stayed consistent. I am starting to feel a little better. The dry cough has subsided and the hoarseness isn't as bad.
Localized reaction.  Reports tremors to upper ext.  Neurologist does not feel tremors r/t pneumo vaccine.  Appt pending for evaluation.
At first my arm was sore at the sight. I was very tired. Then three days later I noticed a rash on my right under arm. It was red and itchy. Then it went to my right right under arm red and itchy. Now its on my legs small spots red rounded from the top of my leg all the way down to my foot on both legs
Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ (date, route and dose unspecified). The physician reported that after the patient was given the ROTATEQ tested positive for rotavirus. It was reported that the patient sought medical attention, unspecified. The outcome is unknown. Additional information has been requested.
Severe pain and redness/heat at site, fever, nausea, headache, body aches.
75-year-old male patient received the FLUZONE QIV instead of the FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; 75-year-old male patient received the FLUZONE QIV instead of the FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75-year-old male patient who received the influenza quadrival A-B vaccine [Fluzone Quadrivalent] instead of the fluzone high dose quadrivalent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza quadrival A-B vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  On an unknown date the 75-year-old male patient received the fluzone qiv instead of the fluzone high dose quadrivalent with no reported adverse event (wrong product administered, product administered to patient of inappropriate age) (same day latency).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
sore arm; Rash and redness; Rash and redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (Rash and redness) and ERYTHEMA (Rash and redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), RASH (Rash and redness) and ERYTHEMA (Rash and redness). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), RASH (Rash and redness) and ERYTHEMA (Rash and redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported .
Chills, fever, cough, headache, joint pain throughout body, soreness and redness at injection site. Overall feeling of sickness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2021 as dose 1, single (Lot number: 037K201), on 31Jan2021 as dose 2, single (Lot number: 043L20A), on 19Aug2021 as dose 3 (booster), single (Lot number: 059E21A) and on 23Feb2022 as dose 4 (booster), single (Lot number: 037K20A) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Essential thrombocytosis" (unspecified if ongoing). Concomitant medication(s) included: AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANIC ACID], start date: 05Jul2022. Past drug history included: Known allergies: levaquin for Drug allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound 4 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 05Jul2022 to 09Jul2022 for Covid-19 treatment.   No follow-up attempts are possible. No further information is expected.
Patient was accompanied by older sister for annual physical exam with physician.  Older sister was assumed to be patient's legal guardian  by healthcare team and gave consent for patient to receive vaccinations. After vaccinations were administered,  it was determined that the sister was not the legal guardian and outreach was made to legal guardians.
Rash, ErythemaMultiform, UrticariaPruritis, cellulitis Narrative:
son has a side affecst for the last week, feels dizzy; This is a spontaneous report received from Pfizer sponsor program. A contactable consumer reported for  female patient that: A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer and son both got final vaccine last week, son has a side effects for the last week, feels dizzy, on a roller costar. consumer wants to know if its normal for side effect to last that long. There were no unaddressed medical questions referred or for-warded to Medical Information. The outcome of the vent was unknown.   No Follow-up attempts are needed. No further information expected. Information about lot/batch number cannot be obtained.
Patient administered MMR II and PROQUAD concurrently; This spontaneous report was received from a Nurse and refers to a 11 years old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 10-NOV-2020,  the patient was vaccinated concurrently  with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter for prophylaxis and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter for prophylaxis  (route of administration, lot number and expiration date were not reported for any suspect therapy).
Extreme fatigue; I was sick in bed for 3 days; headache; slight fever; This is a spontaneous report received from a contactable consumer(patient). A 44-Year-old non-pregnant female (Patient) reported herself. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 15:00 (at the age of 44-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced drug hypersensitivity. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:00 (at the age of 44-years-old) as a single dose for covid-19 immunization and experienced lymphadenopathy. The patient had no other vaccine within four weeks. On 14May2021 03:00, the patient was sick in bed for 3 days and have been sick with headache, slight fever, extreme fatigue. She went to urgent care. Tested for Covid, mono, UTI, etc. The adverse event resulted in emergency room department or urgent care visit. The patient received treatment with antibiotics. No hospitalization prolonged. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative- nasal swab on 26May2021, sars-cov-2 test: negative on 28May2021. The seriousness of the event was considered as non-serious. Outcome of the event was not recovered, at the time of this report. Device Date was 01Jun2021 Follow-up attempts are completed. No further information is expected.
The RPh didn't realize we were supposed to be moving on to giving bivalent boosters and mistakingly administered the monovalent shot in its stead.  The bivalent shots were not in stock at the time.
getting a slight headache.; Arm pain and fatigue starting 8 hours after vaccine.; Arm pain and fatigue starting 8 hours after vaccine.; General feeling of being unwell; Swelling and redness at injection site starting 12 hours after vaccine.; Swelling and redness at injection site starting 12 hours after vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 11:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: All except obesity are control by medication; "Obesity" (unspecified if ongoing), notes: All except obesity are control by medication; "High cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Supreventricular tachycardia" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; CRESTOR; ZETIA; DILTIAZEM. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan". Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200), administration date: 05Mar2021, when the patient was 40-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: ER2613), administration date: 06Apr2021, when the patient was 40-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: 320308D), administration date: 01Nov2021, when the patient was 40-year-old, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 4, Batch/Lot No: GJ6665), administration date: 16Nov2022, when the patient was 41-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 25Sep2023, outcome "recovering" and all described as "Swelling and redness at injection site starting 12 hours after vaccine."; PAIN IN EXTREMITY (non-serious) with onset 25Sep2023 at 20:30, outcome "recovering", FATIGUE (non-serious) with onset 25Sep2023 at 20:30, outcome "not recovered" and all described as "Arm pain and fatigue starting 8 hours after vaccine."; MALAISE (non-serious) with onset 25Sep2023 at 20:30, outcome "not recovered", described as "General feeling of being unwell"; HEADACHE (non-serious) with onset 25Sep2023 at 20:30, outcome "not recovered", described as "getting a slight headache.". Therapeutic measures were not taken as a result of headache, pain in extremity, fatigue, vaccination site swelling, vaccination site erythema, malaise. Additional information: Concomitant medication also included "vit d k2 coq10".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Within a few hours developed pain, swelling, redness and limited range of motion. Pain 5-6/10.   Symptoms slowly resolving.  Presents today with firmness and tenderness in the deltoid area.  Redness and swelling noted in the inner arm to above the elbow. She has pain when she tries to lift her arm above her head.   She has been using ice/heat compresses and Tylenol.    An appointment was made for tomorrow to see a physician  as she felt she could not go today and her symptoms are improving.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium