chrisvoncsefalvay/vaers-outcomes huggingface dataset:
REDNESS AND WARMTH AT THE INJECTION SITE STARTED ONE WEEK AFTER THE INJECTION, MONDAY2/1.  ON TUESDAY, 2/2 THE SITE HAD INCREASED IN SIZE AND  APPEARED MORE INFLAMED.  I MARKED WITH A MARKER  TO MONITOR THE SIZE OF  INFLAMATION.  DURING THE DAY THE INFLAMMATION INCREASED OUT OF THE BORDER OF THE MARKER  MORE SO ON THE RIGHT SIDE. THIS  MORNING,2/3, NO CHANGES NOTED.   I AM AFEBRILE, NO SPECIFIC  PAIN IN THE AREA, JUST RED AND  WARM.
I had the 2nd dose of the Shingrix vaccine yesterday (05/07/2020) around 2 PM.  At 2 AM this morning (05/08/2020) I awoke with severe shivering and feeling cold.  The house was warm.  I was in pajamas and had a sheet and blanket.  I had to get out a comforter to get warm enough to go back to sleep.  Awoke at 6 AM this morning with a headache.  My left arm hurts baly when I try to lift it.  It's slightly red and swollen at the injection site.  I feel quite tired.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Dec2021 as dose 3 (booster), single (Lot number: 068H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications or other medications in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (04May2022) Positive; (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 08May2022 to 12May2022. The patient tested positive for COVID-19 and took Paxlovid after four days of testing positive unpacked of it she tested negative for COVID-19 on an antigen test on day five. She tested negative again on day six. She felt good and thought she was in the clear. Four days after the first negative test she had all symptoms back and tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 4 days ago, injection site started itching and progressed to red and hot; vaccination site erythema; muscle aches down legs, across back, shoulder blades; extreme tiredness; vaccination site pruritis; During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot), VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (muscle aches down legs, across back, shoulder blades) in a 78-year-old female 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.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN, LEVOTHYROXINE, Furosamide, RIVAROXABAN (XARELTO), LISINOPRIL and CARVEDILOL for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), MYALGIA (muscle aches down legs, across back, shoulder blades) and FATIGUE (extreme tiredness). On 26-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (About 4 days ago, injection site started itching and progressed to red and hot), VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE PAIN (During 1st 36 hours after receiving 1st dose,Patient experienced minimum soreness at injection site, muscle aches down legs, across back, shoulder blades, extreme tiredness.), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (muscle aches down legs, across back, shoulder blades) and FATIGUE (extreme tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a registered nurse refers to 68 years old patient of unknown gender. On 21-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K003600, expiration date verified as 10-MAR-2015(also reported as 19-MAR-2015) 0.65 ml dose once, subcutaneous(dose number was not reported), that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint(PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
noticed neck was tender on lt side more towards the front on 7AUg98;felt lump on neck about half way between shoulder & jaw;had sinus drainage & taking dimetapp & trimenie x 2 days;
Shingrix given after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-FEB-2023 Reporter's comment: A pharmacist requested information about the thermostability of Shingrix after being exposed to 31 degree Fahrenheit. After being told that Shingrix should not be exposed to 31 degree Fahrenheit, they stated that a many doses had been administered to many patients, without giving specific details.  When asked for information about patients and specific vaccine details, they stated that it would not be needed to create an adverse event report as their corporate team already did do.  They did not gave any specific information. The reporter did not consent to follow-up. Additional supportive information: The Shingrix vaccine was exposed to 31 degree Fahrenheit, which led to incorrect storage of drug.
This case was reported by a pharmacist and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown details). At an unspecified time after vaccination with TWINRIX, the subject experienced allergic reaction. The pharmacist stated that the subject had an "allergic reaction to TWINRIX a long time ago". She explained that the patient did not have an anaphylactic reaction, but the exact nature of the reaction was not known to the pharmacist. The pharmacist had learned of the information from a co-worker and did not have any additional detail to provide. At the time of reporting the outcome of the event was unspecified.
This report is being submitted following a periodic review of death certificates .    Death certificate for this individual indicates "recent COVID vaccine" in   "PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause"
Approximately 14 days after injection,  my left arm developed large hives all over shoulder and injection site.  Only hives are on area of my arm of  Covid injection. Some itching at injection site.  Some lupus like symptoms- Brain fog; fatigue-joint stiffness.
This is a spontaneous report form the contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, NDC number and Expiry Date: Unknown) via an unspecified route of administration in left arm on 16Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included autoimmune disorder (diagnosed 35 years ago) and has not been experiencing any symptoms from that just some very minor symptoms very recently. Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Patient had previously received first dose of vaccine (Lot no: EP7534) on 26Mar2021 and had left arm swelling (injection arm) and pain, along with migraines and fatigue which resolved after a week. Immediately the same day as the 2nd dose of the vaccine, the patient had pain in her left (injection) arm/hurting and restricted movement in her left arm. On an unspecified date (after the second dose), patient was extremely tired, very fatigued and had migraines along with pain and swelling in her left (injection) arm. The pain in her arm continued for about 6 weeks. Patient did not remember what got better and what got worse and forgot about it, but the pain never went away. The swelling got better but was not as bad. No treatment was received for the events. Events did not require visit to emergency room or physician office. The outcome of events pain in her left (injection) arm was swelling and hurting and restricted movement in this arm was not resolved while for other events fatigue and migraine was unknown.  Additional information has been requested.; Sender's Comments: Agent, caller is a consumer that reported her side effects after receipt of both doses of Pfizer COVID vaccine, however her question is if she can get further clarification if possible, regarding if she should go have quantitative antibody testing that will tell her if she is protected or not? caller was warm transferred by Agent and caller stated "I got information that I did not understand", caller asked: "How do I know if my second dose worked if I had this side effects?. E-transmitted duplicate AE, caller did not provide additional AE details Response: Responded per documents attached and referred for discussion. Offered to send PRD by email, but caller declined and stated her HCP will have that information. Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller stated from prior INT: "I got information that I did not understand" Caller stated she also did not understand information provided by Agent during this follow-up INT. Response: Referred back to her HCP for specific recommendations and medical advice regarding antibody testing, and offered to email the PRD from response provided in prior Request and Interaction, but caller declined and stated her HCP will have that information.
Student Under Age 18 Received a Dose of Heplisav-B; Initial Report Received on 03-Sep-2019 and 04-Sep-2019   A nurse reported that "two students" under the age of 18 received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. Of the two students, one was reported as a 17-year-old male, who received one dose of HEPLISAV-B.    Relevant medical history and allergies were reported as none.   Concomitant medications were not provided.   On 25-Oct-2018, the patient was administered with the first dose of HEPLISAV-B (lot # 1032912, expiration date: 15-Mar-2019, and NDC # unknown).    On 03-Sep-2019, the nurse reported via email that two students under the age of 18 received a dose of HEPLISAV-B.   On 04-Sep-2019, the nurse reported that of the two students, one was a 17-year-old  male, who received one dose of HEPLISAV-B. He did not return for a second dose. No other information was provided.  At the time of the report, no adverse events were reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B.; Sender's Comments: The company assessed the event of product administered to patient of inappropriate age as non-serious. The event of product administered to patient of inappropriate age is unlisted per HEPLISAV-B.
Difficulty breathing through her nose, feels like her nose is swelling, cheeks flushed.
Rash at vaccination site - redness, itching began on 1/28/21 Treatment: Allegra antihistamine 12-hour tablet taken at 10 a.m. on 1/29 and10 p.m. on 1/29; hydrocortison topical cream Outcome: 1/30/21 no itching, continued redness
2 months after vaccination, I started feeling body aches and loss of taste/smell. I started having a cough a week later. I began wheezing with any exertion and could not take a deep breath. I halted exercising to see if that would help. On March 1st, 2022, I went to the doctor and they prescribed Albuterol inhaler 2 puffs every 4 hours as needed. I then went back on 4-6-2022, and they prescribed an antibiotic (name unknown) and done lab work. I am still experiencing wheezing and shortness of breath at this time. I am still using the inhaler as well. I am reporting a case of breakthrough Covid.
High fever: 103 degrees for 2 days, only lowering to 101 with medicine. Swollen and very sore arm. Severe headache (just like a migraine); extreme fatigue; severe aching; dizziness, lightheaded-ness; chills.
patient did bot received second dose yet (for Hepatitis B); This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Jul-2022 Reporter's comment: The nurse wanted some guidance regarding a patient who received 1st dose of Twinrix and on the day of reporting received Hepatitis A vaccine from Merck. The patient did not receive the 2nd dose yet. The reporter was asking if they could administer Engerix as an alternative, because they did not use Twinrix.  The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose Twinrix (for Hepatitis B), which led to incomplete course of vaccination. This case was identified as duplicate of case US2022106125. All future correspondence would be added in case US2022106125, which stands as case of record for this patient and the case US2022106127 would be deleted.
Post vax the patient developed diarrhea and vomiting. The patient went to the doctor on 06/26/2001 and was told symptoms were viral and had nothing to do with the immunization.
Hives; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in arm right on 13Mar2021 11:30 (Batch/Lot Number: Ew6205, expiration date: not reported) as second dose, single for covid-19 immunisation (at the age of 76-years and was not pregnant). The patient medical history included known allergies (but have not had any of them). Concomitant medication(s) included apixaban (ELIQUIS),  metoprolol succinate taken for an unspecified indication, start and stop date were not reported and multivitamin (all as other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. Previously, the patient received BNT162B2 via an unspecified route of administration, administered in arm right on 20Feb2021 11:30 (Batch/Lot Number: Em9810, expiration date: not reported) as first dose, single for covid-19 immunisation. On 15Mar2021 05:00, the patient experienced hives. No treatment received for the adverse event. Outcome for the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sudden twitching of left foot, feeling idenical to electrical shock/tazer, numbness, tingling sensation from my feet going up my legs,lower back, spine, shoulders and neck .NEXT DAY severe aches all over same body parts, headaches,chills,dizziness, difficulty breathing, swollen left arm(injection site(
PATIENT WAS VACCINATED ON 01/21/2022. PATIENT WITH A SECOND DOSE ADMINISTERED ON 10/09/2021 AND THE REINFORCEMENT WAS ADMINISTERED BEFORE 5 MONTHS. A FAMILY MEMBER WAS CALLED TO VERIFY THE MINOR'S HEALTH STATUS.
Suspected vaccination failure; I got shingles from the shingles vaccine; Neck pain; rash; not able to work for days; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient's mother had shingles ).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles from the shingles vaccine), neck pain (Verbatim: Neck pain), pain (Verbatim: pain), rash (Verbatim: rash) and inability to work (Verbatim: not able to work for days). The outcome of the vaccination failure and shingles were unknown and the outcome of the neck pain, rash and inability to work were resolved and the outcome of the pain was resolved (duration 5 months).   The reporter considered the vaccination failure, shingles, neck pain, pain, rash and inability to work to be possibly related to Shingrix.  The company considered the vaccination failure, shingles, neck pain, pain, rash and inability to work to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 17-AUG-2023 This case was reported by a patient via interactive digital media. The patient got shingles from the shingles vaccine. The patient was not aware of getting it because of his/her active, healthy lifestyle but that was not the case at all. The reporter stated that little did she knew, shingles varies from person to person. For her, it stated with four days of neck pain. The pain kept getting worse. Then a rash developed and her doctor diagnosed her with shingles. The pain was so intense that she was not able to work for days. Even after the rash went away, she had pain that lasted for five months. She wish that she would not have waited to learn more about shingles. The reporter thought that the event might had been related to the drug. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pt recv vax in 1971; within 12-24 hr post vax pt exp stiff joints, tight chest, sore everywhere
Vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022; Booster dose administered to patients after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered to patients after use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Janssen COVID-19 Vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Janssen COVID-19 Vaccine. On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered to patients after use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered to patients after use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Patients had received their 1st booster dose of the Moderna COVID-19 vaccine after the use by date. The vial was initially stored in the refrigerator on 10-JUN-2022. The vial did not undergo any temperature excursions. BUD in refrigerator was on 10-Jul-2022 at 10am. Patients had not reported any adverse  reactions post vaccination. Treatment information was not provided.
tongue swelling with bumps on tongue (felt fuzzy) knot in throat  reported to firefighter on duty and they encouraged me to go see my doc where he gave me a steroid shot as well as a benadryl tongue swelling went down in 15-20 minutes but knot in throat still present as well as now a headache
8/15/07 Left injection site was red. 8-16-07 anterior of left thigh was red. Patient c/o some pain and itching. Not warm to touch. Patient was given Benadryl strips - 2 strips every 4-6.
Fatigue; not chills, rather I was FROZEN from my solar plexus to my feet. I could not get warm with the heater turned up and under piles of blankets for at least 10-12 hours. Fever 100.2; severe muscle pain down outside of both thighs and lower back. By 5 pm I could barely stand or walk. Very unstable. On 4/23, I had a milder version of side effects, profound fatigue and slight fever.
Chief Complaint: Cough, congestion, shortness of breath and weakness Additional Medical History:  Patient is a 66-year-old morbidly obese male.  He also has a history of HIV, arthritis and hypertension.  He is currently on antiviral therapies for HIV.  He presents to the emergency room by auto complaining of nasal congestion, worsening cough and congestion which is productive at times of a greenish tinged sputum as well as generalized weakness and shortness of breath.  Patient states he started with some nasal congestion and a sore throat 4 days ago which has gradually become worse.  He has been around relatives with similar symptoms however his is worse.  He also states he is very weak and is having a hard time getting around at home because he feels so weak.  He has not been taking his Lasix because he is afraid he cannot get to the bathroom because of his weakness.