chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL9265), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN, start date: 09Nov2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Arm red; Arm itch; Arm rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm red), PRURITUS (Arm itch) and RASH (Arm rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ERYTHEMA (Arm red), PRURITUS (Arm itch) and RASH (Arm rash). At the time of the report, ERYTHEMA (Arm red), PRURITUS (Arm itch) and RASH (Arm rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included none
a patient received improper stored vaccine; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported.      On 17-APR-2019, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R021078, expiration date 12-JUN-2021; one dose; route and dose number were unknown) for prophylaxis.        The storage temperature of the vaccine was reported as 52.5 degrees Fahrenheit (F) for a time frame of 4 hours and 40 minutes. There was no previous temperature excursion. No product quality complaint (PQC) was involved. The call was due to a data logger.
On January 21, 2021 participant had a high pitch constant ringing in her left ear. Went to her doctor about the ringing in April to check it out and found out she had a mild hearing lost in her left ear.
Injection site allergic reaction.  Red, swollen, hot area 4 inches in circumference.  Resolved without medication after 1 week.
Instant allergic reaction to injection; itchy; arm is numb where they injected the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Ew0162, first dose) solution for injection intramuscular in the left arm on 10Apr2021 at 11:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included sulfa allergy. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had an instant allergic reaction to injection, it's still very itchy, also my arm was numb where they injected the vaccine on 10Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included diphenhydramine (BENADRYL). The outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a female patient in her middle to late forties who, on an unspecified date, was vaccinated with a first dose of hepatitis B virus vaccine. Subsequently, on an unspecified date, the patient experienced some itching around the injection site which she described as very mild. On approximately 5/27/04, the patient then received her second dose of hepatitis B virus vaccine and shortly after the injection, she experienced itching again and her lips felt numb. The nurse administered diphenhydramine hydrochloride and the patient went home to nap. When the patient woke about six hours later, she felt chest tightness and shortness of breath. She went to the emergency room where she received more diphenhydramine hydrochloride IV and a corticosteroid (not further specified). THe patient did not immediately improve and began to feel worse. The emergency room physician told the patient that he thought she was having an anaphylactic reaction and administered epinephrine. The patient's condition then improved. She was admitted to the hospital for additional observation. Various other tests (not further specified) were performed to rule out other possible conditions. The patient still has periodic fatigue, right calf pain, and shortness of breath. The patient had a cardiac work up in the hospital and her cardiac enzymes were elevated. It was noted that the adverse events abated. A product quality complaint was not involved. Additional information has been requested.
Numerous vesicles on red bases -4 1/2 yrs post Varivax. clinical chicken poc, symptomatic treatment
Received expired vaccine/ Expired vaccine doses administered to unknown # of patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/ Expired vaccine doses administered to unknown # of patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/ Expired vaccine doses administered to unknown # of patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/ Expired vaccine doses administered to unknown # of patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the moderna vaccine was received on 03 Sep 2021 and was received as frozen. Date(s) of administration of vaccine: November 1st, 2nd and 3rd of 2021 No Concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received with No new information
They started on the 4th and have continued since. I have had fever (99-100.1), headache, dizziness, fatigue, brain fog, intensely dark urine. Even while being hydrated the urine color remains the same.
Headache, Rash & UrticartiaPruritis Narrative:  Developed dime-sized rash over injection site within 3-4 hours of the  vaccination, which persisted for 4 days. Rash described as pruritic and erythematous. Affected skin area became dry and flakey. He also experienced an intense headache the day after vaccination, that was relieved with acetaminophen. No other adverse effects noted.
Full body hives (both aroma, both legs and torso) took benedryl every 6 hours for the first 15 hours. Hives get slightly smaller with each dosage/treatment, but come back fully begore next dosage.  Added zyrtec (twice a day) and predinisone (20 mg.  Twice daily). Still current toy bei g treated
extreme hives with itching, redness swelling, generalized throughout entire body for 2+ days
fever low grade lasted 48hr;pain, tenderness & erythema @ inj site;
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender (encounter key # 437840). The patient's concurrent conditions and medical history were not provided. On 29-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, PNEUMOVAX had a temperature excursion for 696 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
experiencing swelling; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for male patient (husband) that:  A male patient of unspecified age had received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration, on 29JAN2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. (Reporter name) called on behalf of her husband (Name) who got his 1st dose last 29Jan2021. 2nd dose was cancelled due to the snowstorm. New appointment for the 2nd dose will be 27Feb2021. On an unspecified date, patient had experienced swelling. The took patient to the Emergency room and took 40 shots of Kenalog. At the time of reporting, the outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
At around 6:00 in the evening on 11MAY2021, the Pt noticed redness and swelling at the vaccination site. Pt also states she had swelling on R wrist on her vein and it subsided after 5 minutes. Pt had hot flashes and chills on 12MAY2021. Pt came to Clinic on 14MAY2021 at 9:00 AM and spoke to Dr. about the swelling, redness, pruritis, soreness and pain at the site. Dr. states it is a local site reaction and it needs to be documented in VAERS.
On 11/23/11 patient woke up with red rash on right arm with faint rash on left arm. Seen by physician 11/23/11 AM: temp 97.3 oral, no allergies prior to this; hives right upper arm diffusely erythematous up to the top of the shoulder to mid-forearm. There is a raised ring area injection. Left arm has 2 faint areas of erythema, no other signs/symptoms of any other illness, treatment continue TYLENOL & loratadine.
PATIENTS ARM DEVELOPED QUARTER SIZE RAISED RED MARK AT INJECTION SITE WITH APPROXIMATELY A 1" RING OF ERYTHEMA ENCIRCLING MARK. ARM IS WARM TO TOUCH AND PATIENT STATES IS ALSO PAINFUL
Diffusely weak on his legs.  Progressed to the point that he had complete loss of strength in the legs. Speech became dysarthic and hoarse, unable to swallow well. (Patient surgery right total hip arthroplasty. On Post op day 2 & 3 he started noticing he was having difficulty getting out of bed but still able to ambulate.  On POD 4 received the vaccines. Neurologist consulting thinks incident not due to vaccines but other issues related to admission diagnosis and condition).
Patient complaining of symptoms starting 6/5/19 in the evening.  He could not breath out of his nose.  Today he developed itchy, red bumps on his body, itchy eyes and his left arm hurt.
Nurse administered vaccine got poked with this patient used needle. Nurse was sent for testing, prophylaxis med if needed, follow up w md on 11/14/2022. Pt stated that she was not aware if she has any Blood related issue that transmissible.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (frozen in a temperature of 8.8 degrees Fahrenheit for 20 minutes; no previous excursion was reported) doses of PROQUAD (Merck) Lot # L002421 and expiration date: 23-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient felt shaky after receiving two vaccines and fainted. No loss of consciousness, vitals stable.
Pityriasis rosea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 13Feb2021 at 12:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. The patient had no known allergies to medication food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient took unspecified medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 23Jan2021 at 12:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 16Feb2021, the patient experienced pityriasis rosea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pityriasis rosea was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
2 to 10 hrs post vax pt exp onset of pain in rt arm, should & head; Pt had swelling, induration, redness, & warmth @ inject site 5x8 cm macular rash @ inject site, h/a, nausea, vomiting, violent neck & back pain, fever 103 to 104, achiness;
For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so  after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and  having pain at site of vaccine/upper arm. Dose 2:  administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still,  no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not.  Thank you.
Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 01May2021 as dose 2, single (Lot number: EW0173), in left arm and on 06Nov2021 as dose 3 (booster), single (Lot number: EW0217), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hemoglobin H disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: test was possibly positive; Positive, notes: it was definitely positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Other medication in 2weeks: No. The patient received Paxlovid as treatment for COVID-19 from 22Feb2023 to 27Feb2023. Known allergies: no; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300102662 same patient, different product/event;
Developed exercised induced asthma. After running 2 laps at relaxed pace (about 4 minutes depending on air quality and temperature) start experiencing shortness of breath, tightness of chest, fatigue, excess phlegm in lungs, and audible wheezing upon exhale. Never had asthma before, methacholine test concluded I am asthmatic now.
Adacel administered to person > 65 years tenderness in neck and neck joints, sacroiliac joint pain 3 weeks following vaccination.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 40 years old female patient who received a dose of ADACEL (prefilled syringe) that was shipped greater than 2 days. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was there. On 22-Feb-2019, the patient received a second 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB (expiry date: 15-Dec-2020) via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that no adverse event was noted. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Patient is 15 years old and have received Pfizer vaccine and does not meet Pfizer age group (which is 16 and older). Patient returned for second dose on 5/6/2021 and had no side effects on the first dose, other than a sore arm.
Fevor,chills,Stomach pain, headache, redness and swelling by injection site.  These symptoms started apptoximately 24 hours after shot.  The intense stomach pains lessened after 8 hours, then the headache started and lasted approximately 8-10 hours. The day after the stomach ache I was extremely tired and had chills.  Redness below the injection site was noticed 2 days later. The injection site is sore 3 days after the shot and the redness is also still there after 3 days.
patient was administered the first dose of ROTATEQ (Lot: 1660148 Exp: 09/16/2020) in the series today, 02/04/2020, and the patient is 6 months old; This spontaneous report was received from a physician referring to a 6 month old patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 04-FEB-2020, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dosage form of lot # 1660148 with expiry date 16-SEP-2020 (route unknown) for prophylaxis (product administered to patient of inappropriate age). No product quality complaint was involved.
Case number PHEH2016US002218, is an initial spontaneous report received from a healthcare professional on 27 Jan 2016. This report refers to a 51 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 158102) intramuscularly on 22 Jan 2016. On the same day 20 to 25 minutes after vaccination, she experienced heart palpitations and discomfort in throat. Outcome of the events was reported as complete recovery on 22 Jan 2016. Seriousness and causality of the events were not reported. seriousness of the events palpitations and discomfort was upgraded to medically significant based on the information available in the source document.
During the 15 minute post immunization observation period, the patient complained of difficulty breathing. The pharmacy called 911 immediately. EMS arrived and assessed the patient and determined that she didn't need an Epipen to be administered. The patient's lungs and breathing were determined to be good and clear upon further assessment by EMS. The patient refused to leave with EMS. Her breathing returned to normal before leaving the pharmacy.
Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achiness, soreness at injection site
noticed significant improvement in my vision; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (noticed significant improvement in my vision) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Retinitis pigmentosa (x-link), Peripheral vision defective and Night blindness.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (noticed significant improvement in my vision). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (noticed significant improvement in my vision) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Patient have noticed a lot of changes after vaccination.
Fatigue,  pain, swelling, warm to touch at injection site, nausea Woke up with fatigue, nausea started about 10AM, did not eat anything d/t nausea, feverish but temp was 98.8. Left work early and went home to bed early.  Woke up next day still fatigued but better and nausea gone.
Patient received 2nd COVID-19 vaccination on 06/27/2021. Vaccination administered was 1 day past BUD. BUD was set for 06/26/2021. Spoke with patient 06/28/2021, patient was experiencing normal side effects expected with mounting ample immune response. Symptoms for patient included, but may not be limited to: body aches, chills, mild headache and scratchy throat. These symptoms began around 9:10 am the morning of 06/28/2021, according to patient statement. Patient expressed understanding of what occurred and will wait for further instructions regarding efficacy of dose administered from Moderna once the pharmacy is made aware.
Approximately 24 hours after receiving the vaccine, I had a fever and headache; it lasted for 5 days. The headaches continued for 4 days after the fever went away.
Woke up with severe vertigo. Could barely walk to the bathroom, loss of bladder control, vomiting.
pt recv vax & exp pain, radiating 6 inches below rt deltoid which persists as of the date of this report;the pt was dx w/mononeuropathy