chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had headache; sore throat; and weak. Took a home COVID-19 test; called doctor and was prescribed PAXLOVID; still felt weak and congested a week later decided to go to urgent care and was told that it was sinus infection; went to primary care doctor and was given a blood test, showed antibodies were high.
Fever of 102, chills (indicated by goosebumps), headache (assumed by child not wanting to lift head at times & crying), loss of appetite, fussy/crying, listless/cranky/not as active as usual.
Information has been received from a pharmacist concerning a 70 year old female who on 23-DEC-2008 was vaccinated with a 0.65 ml dose of ZOSTER vaccine live (Oka/Merck) (lot # 663199/1557X).  The patient's relevant medical history and relevant past drug history are unknown.  The patient's relevant concomitant therapy included CIPRO that was started on 29-DEC-2008 for an unknown indication.  On 17-JAN-2009 this consumer reported to the pharmacist that she experienced redness and itching around the injection site.  The pharmacist described the ZOSTER vaccine live (Oka/Merck) injection as a slightly reddened, circular area without any bumps, which is kind of "patchy" looking.  The consumer did not see her doctor regarding the ZOSTER vaccine live (Oka/Merck) injection site.  It was unknown if any laboratory testing had been performed.  As of 17-JAN-2009, it was unknown if the patient continued to use the ZOSTER vaccine live (Oka/Merck) and the outcomes of the redness and itchiness around the ZOSTER vaccine live (Oka/Merck) injection site were unknown.  Additional information has been requested.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A female patient of an unspecified age and ethnicity received TRUMENBA (Lot # WAL-R9416, Exp. Date: 01Jan2019), at single dose via an unspecified route of administration in one arm on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included booster shot of MENACTRA, administered in the other arm, with a small quarter sized local reaction. The patient previously took meningococcal vaccine a/c/y/w conj (dip tox) for immunisation at the age of 11 years, and she did not had a reaction. Patient had also a known allergy to sulphur. The patient experienced a reaction that night that covered entire arm and rash on the stomach. The outcome of both events was unknown.
No additional AE; Caller stated that the medical assistant mixed up the vaccines that were meant to be given to her 2-year-old daughter and instead gave them to her 2-month-old. The 2 year old daughter dd not receive any incorrect vaccines as the mistake was caught be; This spontaneous report was received from a consumer and refers to a 2-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 19-OCT-2023, caller stated that the medical assistant mixed up the vaccines that were meant to be given to her 2-year-old daughter and instead gave them to her 2-month-old. The 2-year-old daughter did not receive any incorrect vaccines that included hepatitis a vaccine, inactivated (VAQTA) lot # 1971534 and expiration date 06-OCT-2024, for prophylaxis (exact dose and dose number were not reported) and influenza a(h1n1) pdm09 vaccine (INFLUENZA A(H1N1) PDM09 VACCINE), as the mistake was caught before that (intercepted medication error and no adverse event).
Broke out in hives around both arms and the thigh/upper legs. None on the body/neck/face/lower legs. Appeared as if it was an allergic reaction, but this would be a first.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 46 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ030AA, expiration date: May-2019, route and site of administration was not reported) on 26-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to overdose and inappropriate age at vaccine administration (FLUZONE HIGH-DOSE accidentally administered to a 46 year old female/No AE). The patient did not experience any side effects so no medical treatment was needed. 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 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. List of documents held by sender: none.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to 3 patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored MMR II (lot# K022285, expiration date 22-NOV-2016, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Myalgia, Arthralgia, Diarrhea, Injection site pain, fatigue Narrative:
Racing heart, dizziness, chills, headache, fatigue, muscle pain, joint pain, arm soreness
Severe pain at site of injection, muscle aches, fever, chills, nausea and fatigue.
A report was received from a health professional on 1/7/02 concerning a 64 year old female patient who experienced an inadvertent administration of Fluvirin, most of the vaccine accidentally spilling out onto the patient's arm when the syringe plunger was pulled by the medical assistant. The patient did not complain of any adverse event at the time of administration.
looked like the old red measles all over my body; Initial information received on 11-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional.  This case involves an adult patient (exact age and gender unknown) who experienced red measles all over his/her body (Morbilliform rash), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza vaccine for prophylactic vaccination and no adverse event reported (patient had taken the regular flu shot for years with no problems). The patient's concomitant therapy, medical treatment(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  Vaccination details and reason for taking the vaccine: Dose: unknown; Frequency: unknown.  On an unknown date, the patient developed serious red measles all over my body which hurt so bad (Morbilliform rash) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported that patient would never take the flu shot ever again. It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns an adult patient (exact age and gender unknown) who experienced Morbilliform rash after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding concurrent condition during vaccination and laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
CONFIRMED COVID-19 INFECTION; BURNING EYES; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JAN-2022, the patient experienced confirmed covid-19 infection, and burning eyes. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and burning eyes was not reported. This report was non-serious. This case, from the same reporter is linked to 20220112654, 20220112293 and 20220112632.
For 4 straight days patient, who walked over well prior, dragged his entire right side while attempting to get around.
Called health center on 4/29./21 to report tinnitus after recieving dose 1 of pfizer vaccine.  Pt was made an urgent care visit.
Next day within 24 hours following pt receiving bivalent moderna covid booster pt had bilateral leg weakness/neuropathy.
TINNITUS; HOT FLASHES; SEVERE CHILLS; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced tinnitus. On 08-APR-2021, the subject experienced hot flashes. On 08-APR-2021, the subject experienced severe chills. On 22-APR-2021, Laboratory data included: Hearing test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, and the outcome of sore arm, severe chills and hot flashes was not reported. This report was non-serious.
Patient presented to office with vesicular rash on face, trunk that was causing itching and discomfort. Patient did not have fever. There were less than 50 lesions present at the time of visit.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "Mild bronchial asthma" (unspecified if ongoing); "Known allergies: drugs with opiates" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: moderna covid-19 vaccine (Dose 1, Batch/Lot No: 031M20A, Location of injection: Arm Left), administration date: 09Feb2021, when the patient was 67-year-old, for COVID-19 Immunization; moderna covid-19 vaccine (Dose 2, Batch/Lot No: 012A21A, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 67-year-old, for COVID-19 Immunization; moderna covid-19 vaccine (Dose 3, Batch/Lot No: 039F21A, Location of injection: Arm Left), administration date: 04Nov2021, when the patient was 68-year-old, for COVID-19 Immunization; moderna covid-19 vaccine (Dose 4, Batch/Lot No: 001M21A, Location of injection: Arm Left), administration date: 14Apr2022, when the patient was 68-year-old, for COVID-19 Immunization; covid-19 vaccine (Dose 5, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 28Sep2022, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Patient first developed COVID symptoms on 21Oct2023 which worsened the next day and she tested positive on 22Oct2023. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 22Oct2023 to 26Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 30-SEP-2010, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  01-JUN-2011, the patient was treated for a painful, blistering rash which was then diagnosed with shingles. It was reported although shingles is an incurable viral condition, the physician prescribed acyclovir for management of his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Thursday- shot.  Feel great.    Friday- Day after- headache and  sore arm  Saturday- woke up with hives on face and skin feels like it's on fire.
Pfizer vaccine was administered outside of the clinic - reported by patient   COAGULOPATHY, UNSPECIFIED TYPE 1/26/2022 BACK PAIN  COAGULOPATHY, UNSPECIFIED TYPE 1/26/2022 ACUTE PULMONARY EMBOLISM
Chills, fever, soreness at site, headache, nausea, muscle aches
Patient felt dizzy, lightheaded and fell. She reported that she could have "passed out" she lives alone. She remembers getting up off the floor.
Narrative:  74yo male patient died on 12/20/21. Cause of death is unknown. pt had history of E55.9 Vitamin D deficiency (SCT 34713006) I10. Hypertension (SCT 38341003) E11.9 Type 2 diabetes mellitus (SCT 44054006) I25.10 Coronary atherosclerosis (SCT 443502000) J44.9 Chronic obstructive lung disease (SCT 13645005) M19.91 Osteoarthritis (SCT 396275006) E78.00 Hyperlipidemia (SCT 55822004) Pt had received covid vaccines on 2/26/21 & 3/26/21. Likely pt's death is not related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
Narrative:  75yo male  Pt died on 1/6/2021 inpatient on ICU unit. Death was caused by:Acute hypoxic respiratory failure secondary Covid pneumonia, complicated by immunosuppresion in the setting of Small B cell lymphoma, H/o hairy cell leukemia s/p splenectomy due to agent orange exposure. Pt had received 3 covid full doses due to immunocomprised on 1/8/21, 2/5/21, and on 9/14/2021. Pt's covid positive test 12/25/2021. Per admitting MD H&P note 12/25/2021:" CC: Pt is a pleasant 75 yo male, who comes to ED after being discharged on 12/19- Covid PNA. He was not sent home on supplemental o2 . Today he returns with progressively increasing shortness of air, and dry cough for the last couple of days. He also presented fevers, up to 102F. Denies headaches, dizziness, chest pains, hemoptysis, abdominal tenderness, hematuria, or hematochezia. In ED patient O2 saturation was around 70s on non-rebreather mask. Evaluated and updated to Bipap 100%, 16/10, and saturation around low 90s Medical Hx: Hairy cell leukemia in 09 s/p splenectomy on allopurinol,  acyclovir, and Bactrim, Small B cell lymphoma on Ibrutinib and vit b12, allopurinol , Essential HTN on amlodipine and carvedilol, Hyperlipidemia on atorvastatin, T2DM on metformin, Obesity, Glaucoma R eye, and bilat knee and Covid PNA 12/19 OA" Appears to be a covid vaccine failure leading to pt's  death. Pt was immune compromised from cancer treatment but had received all 3 full doses of covid vaccine.
No additional adverse event; the 17-year-old patient received an adult dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 03-MAR-2020, the patient was vaccinated with and adult dose of hepatitis a vaccine, inactivated (VAQTA) strength 50/0.1 units per milliliter (U/mL) (number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number S025258 has been verified to be a valid, expiration date reported and validated as 05-NOV-2020) as prophylaxis (product administered to patient of inappropriate age). No adverse events were reported for the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Severe chills, headache, joints aching, fever, nausea. Lasted for about 24 hours.
On January 4th i was sitting down eating my lunch and when I was done and went to get up I couldn't put weight on my left foot. Felt like i sprained it. The pain was there for two and a half days and suddenly it went away and i was ok. Now this past sunday January 10th my period came, 15 days earlier, and is really bad. I have to change pads like every two hours because of the amount of blood coming down and is still going on today. It has never lasted this long and I have not bleed this much for this long either.
A 13 year old female reported that she received Cholera vaccine on 4/19/99 and immediately developed an injection site reaction characterized by pain and swelling. The next day, the injection site was indurated, red and painful.
Headache, Fever,  low grade temp 99.8, chills, HA Narrative:
This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 12:40 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017) dose 2, intramuscularly in the left arm (left deltoid). No concomitant medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Shooting and throbbing pain in the occipital lobe area that started 6 days after vaccine was administered and persists until today. Patient received the vaccine at doctor's office (02/07/18) and reported the reaction to the pharmacy today (03/05/18).
COVID 19 Treatment; COVID 19 Treatment; Covid rebound 6 days after completing Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Covid rebound 6 days after completing Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (25Aug2022) Negative, notes: Covid rebound 6 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if therapeutic measures were taken as a result of disease recurrence.  Clinical course: Anti-viral details: Product: COVID 19 Treatment Brand: Paxlovid, Treatment received from 15Aug2022 to 19Aug2022, No Known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt had stem cell transplant June 2022. Needed to re-start his COVID 19 vaccinations. 1st dose given 11/1/2022 with no adverse effects, 2nd dose given 12/1/2022 with no adverse effects, and 3rd dose given 1/3/2023 with no adverse effects.
I give 3 shot to patient by parent request states need for school entry Tdap, HPV, MCV-4 patient was anxious and crying she wait 10 minutes in the room I was printing shots records and after parents and pt walk to the front desk to finish paperwork, patient start telling sick was assisted by RN. Triage for pt found sitting on floor, c/o nausea and syncope observed very pale. Pt's father reports pt assisted to sitting position secondary onset syncope. VS: BP 116/67 T 97.4 HR 46. Pt assisted to triage exam rm, pt cont. c/o dizziness speech clear, not slurred, but answers vague. Started O2 2L mask, pt cont. pale, increased syncope w/near fainting. Pt assisted to prone position w/LE's elevated, O2 increased 6L mask O2 Sat 100%, PCP notified, 911 called. EMT's arrived < 10 min while pt examined by PCP. VSS, HR 107.
For 9 days following the vaccination : strong body aches, night sweats, insomnia, dizziness, disorientation. For about 2 months following the vaccination : extreme fatigue, paleness.
First day...sore arm...2nd day...body aches began, by evening body and muscle aches/headache were severe. Took 1,000 mg of Tylenol. 3rd day-body aches continued.. still   taking 1,000 mg of Tylenol as needed.