chrisvoncsefalvay/vaers-outcomes huggingface dataset:
39-year-old participant enrolled into the study on 27 Jun 2022 (Sars COV-2 Negative, HIV positive) after meeting all inclusion criteria.  From her medical history she provided to the study team, she did not report any other chronic illness she was suffering from other than her positive HIV status.  She came back for her second vaccination on 25 Jul 2022 and on both vaccinations, she did not get any reactions to the study drug.   Since her enrollment, she was always called (active surveillance as per protocol) and was stable.  However, on her scheduled surveillance date of 22 Dec 2022, her p  She came back to site on 23 Aug 2022 for her scheduled visit 4.0 which was a non-vaccination visit and she was fine.  Since her enrollment, she was always called (active surveillance as per protocol) and was stable.  However, on her scheduled surveillance date of 22 Dec 2022, her phone was unreachable and her next of kin which she had provided to the site.  She was called again on 05 Jan 2023, 06 Jan 2023 09 Jan 2023 and 13 Jan 2023. In all these attempts, her contacts were unreachable aswell as the contacts of her next of kin.  0n 16 Jan 2023, the study team decided to do a home visit to check on her and its where the neighbors informed the team that the participant had actually died on 31 Dec 2022.  She died from her mother's home and exact cause of death is still being investigated. It will be updated in the follow up report.
One and a half hours after the  vaccine, I suddenly became very dizzy and had a hard time focusing. I was extremely happy that I was NOT driving.  I could not think straight and had sweat pouring down my face. My head was very heavy and as the day progressed, my neck also became sore. I took Advil and later Tylenol and they helped the head ache but not the dizziness. I lost appetite. I consulted the reading material about the vaccine and all of my symptoms were normal side effects, so I did not seek medical assistance. My daughter is a doctor and wanted me to report for statistical reasons.
Received a Moderna booster dose from a vial that has been open more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a Moderna booster dose from a vial that has been open more than 12 hours post puncture) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, LISINOPRIL and PHENTERMINE for an unknown indication.    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a Moderna booster dose from a vial that has been open more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a Moderna booster dose from a vial that has been open more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that first and second dose details were unknown. It was reported that patient did not have other vaccines. Symptoms and COVID-19 positive details were unknown. No treatment information details were reported.
This spontaneous report as received from a other health professional refers to a male patient of unknown age. Pertinent medical  history and drug reaction/allergies were not reported. The patient received unspecified dose of GARDASIL (lot number, dose and route were not reported) separated by approximately 1 year apart on unspecified dates. No adverse effect reported. This is one of two (1407US004333) reports from the same source. Additional information has been requested.
pt states about 6pm the night of the injection developed severe left buttock pain. then next morning, she woke up at 7am and notice a bruise on the outer portion of her left calf. Had video visit with provider.
Expired vaccine used A non-serious spontaneous report of administered expired FLUMIST was received from a health care worker in the USA concerning a four-year-old child. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history was provided. The reporter indicated that outdated FLUMIST was administered to two children on 24-Oct-2008 [expiration date 10-Jan-2008). The patient's were re-administered the flu shot. Upon follow up the reporter stated no adverse events were associated with this expired vaccine usage; therefore, treatment and causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 24-Mar-2009 included Product Complaint Investigation results.
Racing heart and burning scalp .Hives on right side of head . Feels like a headache on right side
Dizziness, numbness, palpitations, shortness of breathe, and headache.
Large hives on both legs seemingly spreading, redness and itching. I took a 50mg tablet of Diphenhydramine and was resolved the next day.
This spontaneous report as received from a physician via CDC refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # unknown). On an unknown date the patient experienced herpes zoster. Polymerase chain reaction (PCR) testing performed at the CDC was found to the OKA vaccine strain. The outcome of herpes zoster was unknown. Additional information has been requested.
Injection site red, warm, and swollen.  Not improving after 2 days. Antihistamines taken by patient without improvement.
Mother of the baby stated that the patient develop a rash through the body, fever and fast breathing.
VACCINE EXPOSED TO TEMP OUTSIDE OF REC RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
Pt c/o sudden onset of nausea, dizziness and "feel like I want to throw up". Injection site without redness or swelling. Denies cardiac or respiratory distress. Pt sent to nurse to call parent for pick up.
Information has been received from a registered nurse (R.N.) concerning a 48 year old male who on 21-Oct-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot# 660718/0551X), injection route and site not reported). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed redness and swelling of his arm that extended to his "lymph nodes". The location of the affected lymph nodes was unknown. It is unknown if the patient has received PNEUMOVAX 23 in the past. Follow up information was received from a nurse concerning a 48-year-old male patient with anemia and a family history of breast cancer and prostate cancer who on 21-OCT-2008 was vaccinated intramuscularly in the right deltoid with a dose of PNEUMOVAX 23 (lot# 660718/0551X). He was concomitantly vaccinated intramuscularly in the left deltoid with the first dose of ADACEL (lot# C3033AA) at the same time. The patient woke early next day and experienced chills, body aches and redness on his arm. A puffy Red lines above area where injection given. The patient was treatment with TYLENOL, ice to arm. Symptoms better next day. Redness gone by 3rd day. Patient had been hospitalized in Feb-2007, there is possibility (small) he may have had vaccine there. Additional information has been requested.
Itchy, tingling feeling going from injection site up the arm, over the neck and throat, stopping around the mouth. As time went on felt like chin, lips, tongue were coming off novicane. Had to take benadryl to stop symptoms from worsening.
2 1/2hr p/vax felt funny w/pain in arm;took APAP then APAP#3 on 8JUL98;has noted gen nausea since shot;
second dose vaccination record says  have 1ml per dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (second dose vaccination record says  have 1ml per dose) in a  patient of an unknown age and gender 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 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (second dose vaccination record says  have 1ml per dose). At the time of the report, ACCIDENTAL OVERDOSE (second dose vaccination record says  have 1ml per dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.   This case was linked to MOD-2021-399913 (Patient Link).
Pt came to clinic for office visit and requested booster shot of Covid vaccine. Pt initially received Moderna vaccine and was given Pfizer for booster dose in office. Pt was notified.
Report received from a nurse on 18-OCT-2010 (received via Merck WAES 1010UA01764). A 30 or 31 year old female patient (date of birth unknown) received flu vaccine (brand and batch unknown) on 12-OCT-2010. The patient had a medical history of pneumonia and a history of MA. The patient also received additional suspect drug PNEUMOVAX 23 (batch unknown) on the same day to prevent pneumonia. On 12-OCT-2010, the day of vaccination with the suspect drug, the patient said the injection really hurt. On 14-OCT-2010, the patient developed a high fever of 103 degrees. The patient went to the doctor on 14-OCT-2010. The nurse said the doctor stated this might be an infection; it is red and swollen with induration at the injection site. The patient required hospitalisation. Her white blood cell count was extremely elevated. The nurse reporter that the infectious disease doctor said it was the vaccine. The nurse also reported that she thought it was the pneumovax vaccine because that was the arm that was swollen. The patient had received the flu vaccine in the other arm at the same time. The event outcome was recovering. The case was reported as serious due to hospitalisation. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
red large itchy node (like a lump); large itchy node; headache; fatigue; threw up four times; red large itchy node; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (red large itchy node (like a lump)), INJECTION SITE PRURITUS (large itchy node), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (threw up four times) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE MASS (red large itchy node (like a lump)), INJECTION SITE PRURITUS (large itchy node), HEADACHE (headache), FATIGUE (fatigue), VOMITING (threw up four times) and INJECTION SITE ERYTHEMA (red large itchy node). At the time of the report, INJECTION SITE MASS (red large itchy node (like a lump)), INJECTION SITE PRURITUS (large itchy node), HEADACHE (headache), FATIGUE (fatigue), VOMITING (threw up four times) and INJECTION SITE ERYTHEMA (red large itchy node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided
08 6:30 p.m. Very rapid heart rate 115/min. lasted until 6 a.m. 11-14-08. Arm very sore shoulder to elbow in muscle. 4 days - minor soreness until 11-21-08.
5/5/06-Called felt like a reaction to vaccine, noticed Friday "felt swelling of R nostril. Saturday visibly swelling R nostril slight swelling, nostril not closed. 6/7/06-Talked with client, said swelling  R nostril resolved by 6/6/06. Client talked with doctor on Saturday, 6/3/06 re: swelling nostril. Doctor instructed client to apply ice pack to R nostril and take Benadryl as directed. 6/7/06-Client stated noted rash chest. By 6/6/06 PM covering small area only, several pink, raised areas noted Jap. Enc. vaccine. Held to talk doctor on Monday 6/12/06.
Soreness, redness, itching and swelling at injection site. Consider drawing a circle in pencil around redness on arm. Consider taking diphenhydramine 25mg orally if redness worsens or does not improve and to follow up with a visit to a health clinic.
chills; myalgia; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 ( product: COVID 19,  dose number: 1,  dose brand: Pfizer, dose lot unknown: True,  dose lot unknown reason: Not available/provided to reporter at the time of report completion.), when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 04Oct2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 04Oct2021, outcome "recovering", described as "myalgia"; FATIGUE (non-serious) with onset 04Oct2021, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of chills, myalgia, fatigue.  Additional Information: Lot unknown reason provided as not available/provided to reporter at the time of report completion. No other vaccine in four weeks reported. No other medications in two weeks. Adverse event reported as the patient, who is a pediatrician, received a booster dose of the Pfizer COVID vaccine and experienced chills, myalgia, fatigue, nausea and diarrhea. The symptoms lasted for two days. The patient stated that she had experienced similar symptoms after the second dose of the vaccine except for nausea and diarrhea. No covid prior and post vaccination. No known allergies and other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site redness; Whelps; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema, injection site wheal and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site wheal and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site wheal and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness, whelps and swelling at the injection site of her first dose.  The patient could not recall the date of the initial dose, but she added she never had issues with the Zostavax. The reporter consented to follow up. The case has been linked with the case US2019AMR170622, reported for the dose 2 of the same patient.
Fever for greater than or equal to 7 days. Crusted lesions on chin and roof of mouth. Localized induration and erythema of right leg (around 4 cm diameter) lasting 4 days.
DIZZINESS IS DEBILITATING; FEELING FLUEY; INCREASED HEART RATE; FEVER; RINGING IN EARS; HEAR HER HEART IN EARS LIKE STRONG PULSE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: runny nose, and concurrent conditions included: hashimoto's disease, and unspecified allergy, and other pre-existing medical conditions included: The patient reports no symptoms prior to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced hear her heart in ears like strong pulse. On 08-APR-2021, the patient experienced ringing in ears. On 09-APR-2021, the patient experienced increased heart rate. On 09-APR-2021, the patient experienced fever. Laboratory data included: Heart rate (NR: not provided) increased. On MAY-2021, the patient experienced feeling fluey. On an unspecified date, the patient experienced dizziness is debilitating. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No signs of infection, and COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and fever on 10-APR-2021, hear her heart in ears like strong pulse, and ringing in ears on 03-JUN-2021, had not recovered from dizziness is debilitating, and the outcome of feeling fluey was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Atrial fibrillation; Blacked out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) and ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included DVT. Concurrent medical conditions included Chronic pain and Spinal stenosis lumbar.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant). On 12-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out) and ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 12-Feb-2021, Chest X-ray: abnormal (abnormal) Abnormal. On 12-Feb-2021, Electrocardiogram: abnormal (abnormal) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication used was not provided. No Treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-194935 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pentacel was given without being reconstituted/diluent HIB portion not given/No AE; Based on information received on 06-Feb-2020, the report previously considered as non-valid became valid as patient identifier details were updated.  Initial information received on 24-Dec-2019 regarding an unsolicited non-valid non-serious case received from a consumer (office staff) in the United States.  This case involves a two years old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without being reconstituted with diluent HIB portion (lot UJ015AAA) via intramuscular route in an unknown administration site on 23-Dec-2019 for prophylactic vaccination.  Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  Patient was re-immunized one month later.  It was an actual medication error due to inappropriate reconstitution technique.  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 holders 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.  Follow up information received on 06-Feb-2020 from the Nurse (nursing supervisor).  Case validity, patient demographic, reporter, product and event details were updated.
Since the vaccine I have had extremely loud ringing in my ears, blood pressure has been dangerously high and somewhat uncontrollable, I am dizzy a lot, suffered loss of vision in right eye on two occasions for a few seconds, constantly tired. I also suffered 2 TIA's, and a heart attack. I was doing fine prior to the vaccine.
Patient stated her friend had the second Moderna vaccine and she was totally exhausted.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Patient stated her friend had the second Moderna vaccine and she was totally exhausted.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Patient stated her friend had the second Moderna vaccine and she was totally exhausted.). At the time of the report, FEELING ABNORMAL (Patient stated her friend had the second Moderna vaccine and she was totally exhausted.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-114278 (E2B Linked Report); Sender's Comments:  MODERNATX, INC.-MOD-2021-114278:
Acute muscle spasms to arm x 24hrs. Nickel sized area "bullseyes" at injection site. Unable to do prom because pain.