chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a positive result / covid test result = Positive; received a positive result / covid test result = Positive; the patient began "feeling off"; mild body aches; 100 degree fever; slight cough; minor sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jan2021 (Lot number: EK9262) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231), administration date: 06Jan2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Dec2021, outcome "not recovered" and all described as "received a positive result / covid test result = Positive"; FEELING ABNORMAL (non-serious) with onset 30Nov2021, outcome "not recovered", described as "the patient began "feeling off""; PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "mild body aches"; PYREXIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "100 degree fever"; COUGH (non-serious) with onset 30Nov2021, outcome "not recovered", described as "slight cough"; OROPHARYNGEAL PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "minor sore throat". The patient underwent the following laboratory tests and procedures: body temperature: (30Nov2021) 100 degrees, notes: fever; sars-cov-2 test: (01Dec2021) positive, notes: The patient submitted to a PCR test on the morning of 01Dec2021 and received a positive result later that day. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, feeling abnormal, pain, pyrexia, cough, oropharyngeal pain. The patient is a healthy (Age Withheld) y/o male working as a physician assistant, who received two doses of Pfizer COVID vaccine in Jan2021. After attending a 250-person indoor wedding reception on 27Nov021 (at which there was at least one attendee who tested positive for COVID-19 within 48 hours after the event), the patient began AE on 11/30/2021. Patient reports only mild symptoms thus far and was scheduled to receive his booster on 03Dec2021.Covid prior vaccination was reported as no and covid tested post vaccination was reported as yes. It was unknown whether patient received any other vaccine in four weeks. Ae resulted in: None of the above.
Low-grade fever about 3 hours after injection. Body aches about 20 hours after injection Sore arm at injection site starting about 3 hours after injection
I have a lingering and its getting worse, total fatigue; I feel half dead, in another week  I wont be able to get out of bed and I have no other health problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number:1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I have a lingering and its getting worse, total fatigue"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "I feel half dead, in another week  I wont be able to get out of bed and I have no other health problems".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu -given L/DM-/IM. C/O of L arm hurting. Red area at site of inject. Sleeplessness. LDM red, feveral, 57cm & 75 cm.
Rhythmic Head twitch to the left. Accompanied by hand twitching. Patient was still alert and responding however VERY fussy. The event lasted nearly an hour.
No symptoms, or reaction but vaccine was given without being mixed with the ACTHIB component can you please let me know if this should have been reported on VAERS.
Chills, 99.2 temperature, fatigue 24 hours later. Sore arm and swollen lymph node
On August 25th, the patient began to develop hives on his arms, legs, and neck. With benadryl the hives went away but came back once the medication wore off. From the 25th to the 29th the hives began to get worse and became painful, spreading to his face back, hands, feet, legs, and arms. On the 29th, he was taken to the Clinic and was prescribed prednisone for five days. After three days of taking the prednisone, the hives finally stop coming back. The five days of doses was complete on September 2.
I have been feeling abnormal heart beats 3 times (like my heart skipped a beat). Every time I had the episodes, the symptoms included: dizziness and short of breath. I was not doing any physical activity when I had the episodes.
c/o light headache after taking her 2nd dose of vaccine.  denies PMH, no allergies, VS BP 120/74, R 20, P64, O2 Sat 97%.   Pt denies other symptoms of covid reaction post vaccination.   Pt. monitored for another 15 mins and she stated that her symptoms have resolved.  Pt. drove home by husband.. in no distress.
Large red welt at injection site, warm to the touch. On 3/29 arms broke out in rash.
weakness, decreased appetite, cough 77 yo male with PMH of CAD, mild cognitive impairment, critical stenosis of aortic valve, cough, hypoxemia, prostate cancer, T2DM, ESRD, IDA, OSA, compression fracture, depression, HTN, dyslipidemia reported having a cough, feeling weak with decreased appetite 2 days after his COVID19 vaccine on 1/4/2021. Patient saw primary care note on 1/11/2021 and reported on 1/13/2021 that he was started to feel better. PCP did not think it was pneumonia. No tx was prescribed. On 1/4/2021, vaccine administered without complications. The patient was advised to remain in the facility for 15 minutes post vaccination. He did not have any reaction at that time. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy.
Initial report received on 20 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 6-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 02 December 2011, 03 February 2012 and 04 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 22 April 2012, approximately 18 days after the last dose. On 25 April 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 26 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 10 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Mom states "daughter had shots on Friday, fever Sunday 101.5-102, 103.5 yesterday and vomited last night seen ER last night and given antinausea medication, they tried to collect urine unable to giving her Motrin and Tylenol every 3 hours no rash, no redness to shot site."
5 years old patient received Flublok in the left deltoid; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received 0.5 mL dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by mistake (lot QFAA1912, expiry date 28-Jun-2020) via unknown route in the left deltoid on 12-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse event.  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.
Pt. nervous and anxious upon arrival for vaccine. pt. reported in 250's for blood sugar upon arrival and past 2 wks few uk blood sugar had been spiking. After vaccine approx 5 min. pt. c/o flushed face, HA on (R) side, and BS of 343. pt c/o confusion and was extremely anxious.
Patient arrived to the pharmacy whit a second dose appointment for the Moderna Covid19 and it was revealed that the patient was 17 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient arrived to the pharmacy whit a second dose appointment for the Moderna Covid19 and it was revealed that the patient was 17 years of age) in a 17-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient arrived to the pharmacy whit a second dose appointment for the Moderna Covid19 and it was revealed that the patient was 17 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient arrived to the pharmacy whit a second dose appointment for the Moderna Covid19 and it was revealed that the patient was 17 years of age) outcome was unknown. Not Provided      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.   Concomitant Medications were not provided by the reporter. Treatment information was  not provided
Six days after receiving the vaccine, on 01/19/2021, I got a red itchy rash below the injection site which was about 2 1/2 - 3 inches in diameter.
Pain during injection, reported immediately. Ongoing pain in left arm w/ weakness  and inability to lift and hold objects, very difficult to roll over in bed.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-AUG-2017, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, frequency, route and indication not reported, lot # M037015 with expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # M035268 with expiration date 19-APR-2019). Temperature that the vaccine exposed to was 40.2 F, the time frame was unknown. There was a previous temperature excursion of 15 F to 46 F for 18 hours and 34 minutes.  No adverse effects were reported. This is one of three reports received from the same reporter. ; Sender's Comments: US-009507513-1709USA007622: US-009507513-1709USA007623:
SYNCOPE LASTING 2 MINUTES FOLLOWED BY GAG REFLEX.  NO VOMITING. NO DIFFICULTY BREATHING.  NO RASH.  RESTED 20 MIN AND HOME WITH DAD.
Initial unsolicited report received from an other non-healthcare professional (office staff) on 29-Sep-2017. This case involves a two patients (age and gender not reported) who were vaccinated with FLUZONE HIGH DOSE (batch number, expiry date, route and site of administration were not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the two patients showed extreme swelling, redness, and itching. The patient's laboratory data and corrective treatment were not reported. The events outcome was not reported. List of documents held by sender: none.
viral rebound; viral rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "viral rebound". Clinical course: The office reported at least 3 cases of viral rebound. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-PV202200025379 same drug /event, different patient.;
Fever, chills, body aches for <12 hours Headache and dizziness for ~36 hours
Immediately after being given the shot, the patient fainted. She woke up about 10 seconds later and I got her to sit back up in her chair. I gave her some ammonia to help with the fainting. About a minute or so after she woke up, she started to faint again, and had a small seizure that lasted about 5 seconds.
BUMPS ALONG THE SIDE OF THE  TONGUE; STRANGE MARKINGS UNDER FINGERNAILS; HEADACHE; DIZZY SPELLS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy individual at the time of reporting. 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 02-APR-2021, the subject experienced dizzy spells. On 02-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced bumps along the side of the tongue. On 04-APR-2021, the subject experienced strange markings under fingernails. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy spells, bumps along the side of the tongue, and strange markings under fingernails, and the outcome of headache was not reported. This report was non-serious.
LEFT SIDE OF FACE SWOLLEN, EXTREME LEFT EAR PAIN. SAW MD ON 10/12/15 - NO EAR INFECTION, HAD CAROTID ULTRASOUND- NO ISSUES OR TUMOR.
Dizziness then syncope (passed out twice).  Out for about 15 seconds first time then a few minutes later for 30 seconds or so.
Pt died in hospital on 3/3/22. He was admitted on high-flow oxygen with high velocity therapy secondary to respiratory failure complicated by pneumonia.  He was slowly making some improvements with nutritional status but his respiratory status remained difficult to improve in terms of ability to wean his oxygen demands.  On March 3rd he developed increased respiratory distress and quickly developed bradycardia with hemodynamic instability.  He was a do not resuscitate.  He received medications for comfort as he was not making any recovery is with conservative interventions.
Ringing in my ears/head. A loud high pitched ring. Making me crazy. Started around March 10th. Is not getting better.
Child received vaccine 10/16/03 and had outbreak of chickenpox 4/07 had mild case reports parent, no fever or treatment given
pt recvd vax; waking up w/ sweating & shakes between 1am & 4am;episodes daily in DEC;1 episode in JAN;apap & advil given alternately
Pt received first dose of Pfizer vaccine around 1843.  Pt and father report that after about 30 seconds post vaccination, patient felt dizzy, became diaphoretic and pale.  At 18:45 a RRT was called.  B/P 80/50 and heart rate 60.  Patient moved to stretcher and given ice pack applied to posterior neck.  Patient transported to ED via stretcher with father and Nursing Supervisor.
Presented to PCP on 2/8/2021 with Cellulitis at injection site
11NOV92 9AM pt reported to clinic w/mom; had 7 small papular lesions on lt arm close to elbow;11NOV92 1130AM had rash;
patient received ADACEL vaccine which was exposed to 52.6 degree Fahrenheit for seven days, no AE; A pregnant female received a dose of Adacel, no AE; Initial information was received on 20-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA189059, 2020SA189085, 2020SA189112 and 2020SA189132 (same reporter).  This case involves a 34 year old female patient who received a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6638AA, expiry date 04-Dec-2022) via an intramuscular route at the left arm for prophylactic vaccination on 15-Jul-2020, while she was pregnant and which was exposed to 52.6 degree Fahrenheit for seven days from 08-Jul-2020 to 15-Jul-2020.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period and estimated due date was not reported.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to incorrect product storage and vaccine exposure during pregnancy.  A medical assistant reporting having Adacel exposed to 52.6 degrees F from 08Ju2020to 15 Jul2020 that was administered to pregnant patient.  at time of reporting, the outcome of the pregnancy is unknown.  At the time of reporting, 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 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.
Immediately leaving room and entering waiting area to check out she became hot and sweating, turned pale, shakey and felt like she was going to pass out with extreme thirst and a rash on arm.  Twenty minutes later she became cold and shivering.
Patient stated that a few hours after getting her Moderna booster she started to have severe muscle cramping and pain in both of her legs, and she was unable to walk for 3 days. She denied any other symptoms until approximately 6 days after her vaccine when she developed an itchy rash all over her body. She did not seek any medical attention during this time, but she rested, drank fluids and put anti itch cream on the rash. She called because she wants to know if she should get another booster if needed in the future due to these reactions. She had no issues after her 1st and 2nd doses.
(R) deltoid warm to touch, swollen. Experienced SOB on 8/13 returned to office on 8/14. Pt states SOB.
High fever (103 degrees), headache, body aches, fatigue, soreness and swelling at injection site.
Injection sight pain, spiked a fever after going to bed. Forehead fever 101.7. Fever would go up and down through out the night.  She was experiencing extreme lethargy the next morning and all day, loss of appetite all day on the 30th and continuing to the 31st. Complaining of throat hurting. Extreme lethargy on the 31st. Only treatment is giving fluids and comfort so far.
Feel warn out and tired. Not certain that it's really from the shot but it might be . It's been kinda low level and pretty much all day I think. Sore arm at injection site. And muscles might be tight . That maybe just in my head or from my life style
Second dose is past day 35; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is past day 35) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is past day 35). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is past day 35) had resolved.            No concomitant medications reported. No treatment information was provided.    This case was linked to MOD21-054176, MOD21-115401  (Patient Link).
Vaccine expired on 01-Apr-2022 and stored in refrigerator on 13-Apr-2022; Received expired booster dose beyond MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in refrigerator on 13-Apr-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in refrigerator on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in refrigerator on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials were initially stored in the refrigerator on 13 Apr 2022 around 8pm. The vial did not undergo any temperature excursions. Patient received 1st booster dose.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.