chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 virus test positive; Suspected COVID-19/symptoms of Covid; This is a solicited report from the marketing program facilitated collect received from a contactable consumer (patient) based on the information received by Pfizer from AbbVie manufacture number (21K-163-4072617-00).  A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number and expiry date were not reported) intramuscular on 27Aug2021 (at the age of 43 years old) as dose 1, single for covid-19 vaccination; and adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from 16Jun2021 to 2021, at 40 mg, weekly for moderate to severe hidradenitis suppurativa. Medical history included moderate to severe hidradenitis suppurativa from an unknown date and unknown if ongoing. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's concomitant medications were not reported. In Sep2021, the patient experienced COVID test positive and suspected COVID-19. On 02Sep2021, the patient experienced symptoms of Covid.  The action taken in response to the events for bnt162b2 was not applicable, and for adalimumab was unknown. The outcome of the events was recovering.  Solicited report from the USA by a consumer of a 43 year old female with events of non-serious COVID POSITIVE and SYMPTOMS OF COVID with HUMIRA (ADALIMUMAB). There was no reported medical history. In Sep2021, the patient experienced COVID POSITIVE. On 02Sep2021, the patient experienced SYMPTOMS OF COVID. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 27Aug2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech, lot number unknown, expiration date unknown. Concomitant drugs and dates of administration (exclude those used to treat event): Concomitant drugs not reported. Other relevant history: Not reported. Relevant Laboratory & Other Diagnostic Tests. Sep2021 COVID TEST: Positive. Describe reactions (including relevant test/lab data): COVID-19 virus test positive (SARS-CoV-2 test positive) - Recovering/resolvingSuspected COVID-19 (Suspected COVID-19) - Recovering/resolving  The reporter's causality for the events of COVID test positive with BNT162B2 and adalimumab (HUMIRA) was no reasonable possibility. The reporter's causality for the event of suspected COVID-19/symptoms of Covid with BNT162B2 and adalimumab (HUMIRA) was not provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The reported COVID test positive and suspected COVID-19 is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. Case will be reassessed upon receipt of additional information.
Seizure, myoclonic jerking, turned blue face turned white, ran a fever, developed a rash.
Swelling and itching at injection site 7 days post injection. Skin warm/hot to touch in that area.
received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 26th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 2-MAY-2022 Reporter's Comment: Registered nurse reported that the patient received only liquid portion of Shingrix, without being reconstituted and wanted to know if they have to be revaccinated since it did not seem like a full dose and in case revaccination needed, which would be the recommended interval between doses. Healthcare professional did not have any demographic details from patient since she send them over to the manager. Healthcare professional was not sure if lot number was for liquid portion or lot number from the box. She was not sure and did not have any further details. The reporter consented to follow up. Additional Supportive Information: The patient received only liquid portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is one of 7 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter US-GLAXOSMITHKLINE-US2022AMR073093:Same reporter US-GLAXOSMITHKLINE-US2022AMR073094:Same reporter
Headache started 2-23, on 3-5 had MRI brain that showed central venus sinus thrombosis from transverse sinus to sigmoid sinus and jugular vein. Treated with SQ Lovenox followed by oral Coumadin. Headache has resolved and I am still alive.   I have not yet had repeat MRI to recheck thrombosis.
arm has been red, and warm ever since the injection at that Moderna site; arm has been red, and warm ever since the injection at that Moderna site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm has been red, and warm ever since the injection at that Moderna site) and VACCINATION SITE ERYTHEMA (arm has been red, and warm ever since the injection at that Moderna site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   In March 2020, the patient received dose of DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On 05-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 05-Nov-2021, the patient experienced VACCINATION SITE WARMTH (arm has been red, and warm ever since the injection at that Moderna site) and VACCINATION SITE ERYTHEMA (arm has been red, and warm ever since the injection at that Moderna site). At the time of the report, VACCINATION SITE WARMTH (arm has been red, and warm ever since the injection at that Moderna site) and VACCINATION SITE ERYTHEMA (arm has been red, and warm ever since the injection at that Moderna site) had not resolved.            No concomitant medications were reported No treatment medications were reported. Patient had taken dupilumab previously. The consumer also said that Dupixent has been a life saver for her, her skin has never been clear, and she is able to wear short sleeved clothes again, so she has had positive effects in using the Dupixent. At the time of the report, Dupixent was continued." It was not reported if the patient received a corrective treatment for the events.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
painful right wrist and right hard that limits movement started appropriately at 2200 on 12/31/2020
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 the patients were vaccinated with doses of VAQTA (strength, dosage, route, lot number and expiration date were not reported), that were exposed to a supported temperature excursion since 05-NOV-2014. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Diffuse macular papular rash face trunk (pruritic) approx 24 hr after fever (evening after vaccines)
The child received pediatric dose for 2nd Covid Shot. He turned 12 y.o between first and second dosing.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presented to emergency department (ED) in  painful sickle cell crisis. Patient receives monthly exchange transfusions, utilizes oxygen at home at night, and has been hospitalized frequently for painful sickle cell crises. Symptoms were managed with home pain medication regimen but pain intensified after vaccination and could no longer be managed at home. Patient admitted,  received analgesics and oxygen, infectious workup negative, and discharged to home medically stable.
Heavy Sweating; migraines through out the day and night.; Dry mouth; blurry vision; left arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 04Oct2021 11:00 (Lot number: 301458A) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERHIDROSIS (non-serious) with onset 04Oct2021 17:00, outcome "unknown", described as "Heavy Sweating"; MIGRAINE (non-serious) with onset 04Oct2021 17:00, outcome "unknown", described as "migraines through out the day and night."; DRY MOUTH (non-serious) with onset 04Oct2021 17:00, outcome "unknown", described as "Dry mouth"; VISION BLURRED (non-serious) with onset 04Oct2021 17:00, outcome "unknown", described as "blurry vision"; PAIN IN EXTREMITY (non-serious) with onset 04Oct2021 17:00, outcome "recovered" (06Oct2021), described as "left arm soreness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
set of twins came in for well child exams. twins were due to get same immunizations ( kinrix and proquad) two sets were brought into the room and the same vaccination was picked up by both individuals giving shots and given. RN supervisor was notified.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-SEP-2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness and weakness. Got home at around 1545hrs and  I continued to have diarrhea all night until Saturday -all day. Diarrhea settled at around 1800hrs.
Received Pneumonia vaccine right deltoid 10/29/02 @ health department, Developed warmth, redness and swelling @ injection site within 4-6 hours after injection, states was "size at egg", When examined on 10/30//02, had redness, increased warmth and slight swelling @ injection site. Redness was approx 2 inches diameter.
2&12 INCH RED RASH, FIRM TO THE TOUCH. RESOLVED WITH BENADRYL AND TOPICAL BENADRYL.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031721A and 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Soreness) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, PAIN (Soreness) and HEADACHE (Headache) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Treatment information was included acetaminophen. This case was linked to US-MODERNATX, INC.-MOD-2021-080370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080370:2nd dose case.
First day - resting heart rate 30 -35 beats above normal  and blood pressure was up  / aching in chest and shortness of breath / Second day - Chills and aching all over
A report has been received from a Health Professional concerning a 15 year old, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on 18-Dec-2013. MD reported that 8 people received expired FLUMIST. The outcome of the event of received expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.
About 5 minutes after patient left the consultation room she began seizing which lasted about 60-90 seconds. She then regained her senses and then had another episode about 3 minutes later. When questioned she mentioned she is terrified of shots and had not eaten this morning.
SORENESS, REDNESS (AREA MEASURED APPROXIMATELY 3 INCHES IN DIAMETER), SWELLING, ITCHING AT INJECTION SITE. ALL OF THE ABOVE LASTED FOR 4 DAYS. PATIENT HAD NEVER HAD AN ADVERSE REACTION TO INJECTIONS.
we have a large  group of long-covid patients and many of us; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (we have a large  group of long-covid patients and many of us) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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 POST-ACUTE COVID-19 SYNDROME (we have a large  group of long-covid patients and many of us). At the time of the report, POST-ACUTE COVID-19 SYNDROME (we have a large  group of long-covid patients and many of us) outcome was unknown. Not Provided          The patient reported we had a large group of long-covid patients and many of us, especially those in the neurological cohort, had experienced severe worsening and some new symptoms with the Moderna bivalent vaccine.  They believed that was due to the spike protein interacting with autoimmunity in their symptoms. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-748314 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748314:Same reporter
RN removed vial of what was thought to be a new box of COVID bivalent vaccines, which was in fact COVID monovalent box in the "COVID Bivalent" bright yellow bin. COVID box was not labeled "Monovalent" as it has been in the past when received from pharmacy, which indicated to RN that it was the bivalent, as it was also placed in the bivalent bin. RN pulled up all 6 doses up, and put them in the appropriate area for MA distribution. All COVID doses were distributed to patients. Alternate RN was notified that the clinic needed more bivalent doses, and went to the fridge to grab a vial of COVID bivalent vaccine to pull for distribution. Once at her desk, RN noticed that the vial stated "COVID Vaccine", Not "COVID Bivalent". RN went back to verify that the box was also monovalent placed in the wrong bin. RN discussed with Administrator, RN that it might have been monovalent distributed, RN confirmed that the vial used this morning for vaccines was pulled from the monovalent box that was labeled without "monovalent" and put in the COVID Bivalent bin.  Alternate RN and Administrator RN went to nursing supervisor to report the incident. PRIVATE was onsite who was the previous Nurse Supervisor. PRIVATE contacted IT in pharmacy to obtain a list of the patient's administered vaccines today. List retrieved. RN notified patients on 1/19 Per MD infectious disease head, 2 months until patients can receive bivalent dose.
swollen fingers and feet; This is a spontaneous report from a contactable consumer. A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Aug2021 as a single dose  for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient woke up with swollen fingers and feet next day after her first dose of vaccine.  The outcome of the events was unknown . The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient stated that the her arm has a rash the size of a tea cup (the redness has gotten better) and has experienced pain in the arm which has not gotten any better. Patient did state that she had the chicken pox really bad as child when administering vaccine. Advised patient to take pictures of arm and if it does not get any better within the next 24 hours to contact her doctor or go to ED. I did tell patient that a rash and pain is common but have not had anyone stress concern of large rash and severe pain. Patient said she would wait it out and see what happens. I told her to keep me posted and to call with any other questions.
This female subject was enrolled in a blind study. On 8/2/06, she received a booster of combined diphtheria, tetanus acellular pertussis containing small amount of diphtheria and pertussis (Boostrix) or tetanus toxoid, reduced diphtheria toxoid and acellular pertussis absorbed vaccine Adacel IM U deltoid. This subject received Boostrix. Medical conditions Since 1990, the subject is suffering from hiatal hernia. Since 2005, the subject is taking Nexium for gastroesophageal reflux disease. On 8/2/06, same day after the 1st dose of Blinded vaccine, this 43 year old subject developed pain in her stomach, syncope, tightness in jaw and chest and was pale. She collapsed, an ambulance was called and she was taken to the ER where she was admitted. Worked up for syncope was negative. On 8/3/06, the subject was discharged. At the time of the report, it was not know what caused the symptoms. The events were unresolved at time of reporting. Investigator causality was unknown at the time of reporting.
doses involved in possible excursion/missed 97 hours worth of temperature data logging; There was an issue with where they found out that they missed 97 hours worth of data logging; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (doses involved in possible excursion/missed 97 hours worth of temperature data logging), PRODUCT MONITORING ERROR (There was an issue with the where they found out that they missed 97 hours worth of data logging) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (doses involved in possible excursion/missed 97 hours worth of temperature data logging), PRODUCT MONITORING ERROR (There was an issue  where they found out that they missed 97 hours worth of data logging) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (doses involved in possible excursion/missed 97 hours worth of temperature data logging), PRODUCT MONITORING ERROR (There was an issue with where they found out that they missed 97 hours worth of data logging) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (doses involved in possible excursion/missed 97 hours worth of temperature data logging) and PRODUCT MONITORING ERROR (There was an issue where they found out that they missed 97 hours worth of data logging).    No concomitant medications were reported.  The reporter stated there might a possible excursion with the Moderna COVID-19 vaccines and was unable to confirm it as there were 97 hours missed for data logging.  On 08-Sep-2022, the vial was moved from freezer to refrigerator and was now stored in the fridge.  There was no change in the vaccine state upon visual inspection.  The vial did not undergo an excursion previously and was not punctured.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646284 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646284:same reporter
Child was immunized on 4/4/11 Mom noted increased redness/swelling, warmth to area (L) deltoid 4/5/11. Today area circular 6 1/2 cm., red, warm, slight tender to touch.