chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Chills; Throat Pain; Bubbles on face and whole body in worse condition; Bubbles on face and whole body in worse condition; Tiredness; Fever; Cough; Eye Watery; Bad food taste; Eyes pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0183) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 ([{product=COVID 19, brand=Pfizer,, brand unknown=False,, lot number=EW0183,, lot unknown=False, dose number=1,, vaccine location=Left arm}]), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Chills"; OROPHARYNGEAL PAIN (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Throat Pain"; BLISTER (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 09Oct2021, outcome "not recovered" and all described as "Bubbles on face and whole body in worse condition"; FATIGUE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Tiredness"; PYREXIA (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Fever"; COUGH (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Cough"; LACRIMATION INCREASED (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Eye Watery"; TASTE DISORDER (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Bad food taste"; EYE PAIN (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Eyes pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills, oropharyngeal pain, blister, condition aggravated, fatigue, pyrexia, cough, lacrimation increased, taste disorder, eye pain.  Additional information: Patient did not receive any other vaccines within 4 weeks and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Medium, Additional Details: Pain and swollen in armpit area.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of VAQTA (lot# reported as L002717, expiration date 02-JUN-2017, dose, frequency and route of administration were not reported). Concomitant medication was not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 21-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist via a sales representative. Sales representative stated the pharmacist reported that 2 anonymous patients developed a varicella like rash around their eyes within a day after receiving ZOSTAVAX vial (19400 PFU) (dose #, lot # and route of administration not reported) approximately one year ago. The patients sought medical attention. Sales representative stated the pharmacist mentioned both patients were approximately 70 years of age and both patients may have been treated with acyclovir or VALTREX. On an unspecified date, the patients recovered from varicella like rash around their eyes. VZVID packet was faxed to the pharmacist. Additional information has been requested.
pain in both thighs/occurs in the mornings and kind of fades away as he gets active during the day/kind of painful/Comes back everyday in the morning; strangest feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in both thighs/occurs in the mornings and kind of fades away as he gets active during the day/kind of painful/Comes back everyday in the morning) and FEELING ABNORMAL (strangest feeling) in a 70-year-old male patient 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 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in both thighs/occurs in the mornings and kind of fades away as he gets active during the day/kind of painful/Comes back everyday in the morning) and FEELING ABNORMAL (strangest feeling). At the time of the report, PAIN IN EXTREMITY (pain in both thighs/occurs in the mornings and kind of fades away as he gets active during the day/kind of painful/Comes back everyday in the morning) and FEELING ABNORMAL (strangest feeling) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
PATIENT EXPERIENCED SORENESS AT THE INJECTION SITE FOR 2-3 DAYS, AS EXPECTED.  TODAY (ONE WEEK LATER) SHE AWOKE WITH HER ARM BEING SORE ON THE BACK SIDE FROM TRICEP TO ELBOW, AND THE INJECTION SITE BEING HOT (NO SWELLING)
Abscess formation at immunization site right deltoid, status post incision and drainage due to cellulitis to right arm.  Treated with antibiotics and daily dressing changes.
Guillain-Barre disease; myocarditis; blood clots; This spontaneous case was reported by an other health care professional and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre disease), MYOCARDITIS (myocarditis) and THROMBOSIS (blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre disease) (seriousness criteria hospitalization and medically significant), MYOCARDITIS (myocarditis) (seriousness criterion medically significant) and THROMBOSIS (blood clots) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre disease), MYOCARDITIS (myocarditis) and THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected serious (medically significant) AESI events of Myocarditis  and Thrombosis  and unexpected serious (hospitalization and medically significant) AESI event of  Guillain-Barre syndrome which occurred on an unknown date in context to a  dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the events outcome was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected serious (medically significant) AESI events of Myocarditis  and Thrombosis  and unexpected serious (hospitalization and medically significant) AESI event of  Guillain-Barre syndrome which occurred on an unknown date in context to a  dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the events outcome was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Patient was administered the COVID19 (Pfizer-BioNTech Bivalent) vaccine as the first dose of her primary series.
red, raised, swollen area lt upper arm, oval shaped measures 3" x 2";area feels warm to touch;grandma reports no other sx distress;slept all noc;pt playful no motrin deficits noted;grandma reports redness noted this morning;
Metalic taste in mouth immediately following vaccine administration . Patient reports tingling around the mouth . No facial paralysis or gross motor defects . Patient without cardiopulmonary symptoms . Patient advised regarding COVID testing . ER precautions.
Patient received first dose of Moderna COVID series at 0905. Patient was provided a red card to wait 30 minutes post vaccine due to medical history. At 0927, patient reported itchiness and tightness in her throat accompanied by shakiness. BP 116/88, HR 99, O2 99% RA, R 19. Patient on cardiac monitor in normal sinus rhythm.  Lungs clear on auscultation, no swelling in airway or on tongue noted. Denies CP, SOB, respirations were easy and unlabored. 0930 Patient given 50mg Benadryl PO.  0940 Patient verbalized that tightness was still present but verbalized  ease of swallowing and no difficulty breathing. Further assessment of airway was still clear with no swelling present. Continued to assess patient with no remarkable change in condition. Patient decided to receive additional medical treatment due to throat tightness and itchiness still present. EMS transported patient  to hospital at 0957. BP 146/82, HR 90, O2 99%. Airway assessment still remained unobstructed and no swelling present.
I have no idea if this is connected to the vaccine.  Approximately 2 months after the second dose I started getting extremely short of breath on exertion. Walking uphill, walking upstairs, or carrying something left me really short of breath and weak.  In mid-May I went to my local hospital thinking I was having a heart attack as I walked up stairs and got short of breath, weak and sweaty.  They referred me to a Pulmonologist thinking it was a lung problem.
Patient was given Fluzone Quad PF injection 10/5/19. She stated she is allergic to latex. I used latex free gloves and latex free bandaid. After giving the injection, I asked her to stay in the store for 15-20 minutes. Patient came back to the pharmacy stating she did not feel well. She said she almost felt drunk/kind of out of it. She said she was feeling better now. I asked her to take her blood pressure at the machine and it was 160 something over 110. Patient stated she does have high blood pressure and is on medication. She stated she did take her medication today but had recently ate a high sodium meal at restaurant. She attributed the high blood pressure to the high sodium meal plus the combination of the flu shot. I asked her if she thought she needed to be seen by a doctor and she said she thought she needed to drink some water. Her husband was with her and they were headed home. I told her she needed to monitor her blood pressure closely and she assured me she felt fine and has a monitor. I asked if there was anything I could do and she said no. Patient said she was feeling better, shook my hand, and left the pharmacy around 6:13 pm 10/5/19.
On 10/11 I had a thinking spell and dizziness. I had rectal bleeding. Went to the PCP on 10/13. Went to ER from Dr's office. I was provided pain medication. Did f/u appt w/ PCP who suspected I had an ear issue. Was referred to physical therapists. I took a fall in November. Experienced severe headache on 12/21 and took over-the-counter pain meds. Saw Dr on 1/3 who thought I had a sinus infection and prescribed an antibiotic. Had adverse reaction to antibiotic and got prescription for diff antibiotic. Saw Dr again on 1/10 and was prescribed a diff antibiotic. Saw Dr again on 2/3 and was referred to ENT.
Pt re-evaluated 30 min s/p COVID vaccine administration, pt noted to be working on her cell phone looking down during entire observation period.    Upon discharge when pt asked how she was feeling reported that she was feeling dizzy and about 10 minutes prior had blurry vision while looking at her phone but didn't report to RN. Employee called to bedside.  Pt reports she did eat around 0900 this am.    RN checked pt VS and B/P: 108/58, P: 63, SPO2: 97% on room air, RR: 16. After Vitals were checked, pt reports her throat felt strange and was gesturing under her mandible. Pt was drinking water without issue. No swelling noted to pt nose, mouth, lips, tongue, no rash, redness, itching noted to body or injections site. Pt awake, alert, conversation is appropriate and speech is clear. NP called to bedside and advised to call 911 and pt in agreement.    While awaiting for the ambulance to arrive pt RR: remained between 16 - 18, SPO2: 98 - 100% on room air, P: remained in the 70's and regular. Throughout pt denied chest pain, shortness of breath, difficulty breathing, A&0 x person, place, time, situation, no respiratory distress noted. Pt did report felt like she drank 2 beers, dizziness, and feeling she really couldn't explained remained to the back of her throat/mandible.    EMS arrived and assumed care, report called to RN, pt transported to Emergency Department
pt recvd measles vax on 20MAR92; 5 mins p/inject pt devel a localized reaction w/pruritus, redness & a 3 cm induration; pt was treated w/ice packs & prescribed Seldane;
Doesn't feel good; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Doesn't feel good) and FATIGUE (Tired) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Doesn't feel good) and FATIGUE (Tired). At the time of the report, MALAISE (Doesn't feel good) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Felt far worse the next day; Arm had a big raised red lump where I got the shot; Arm had a big raised red lump where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt far worse the next day), VACCINATION SITE MASS (Arm had a big raised red lump where I got the shot) and VACCINATION SITE ERYTHEMA (Arm had a big raised red lump where I got the shot) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt far worse the next day), VACCINATION SITE MASS (Arm had a big raised red lump where I got the shot) and VACCINATION SITE ERYTHEMA (Arm had a big raised red lump where I got the shot). At the time of the report, FEELING ABNORMAL (Felt far worse the next day), VACCINATION SITE MASS (Arm had a big raised red lump where I got the shot) and VACCINATION SITE ERYTHEMA (Arm had a big raised red lump where I got the shot) outcome was unknown.            No Concomitant medication were provided. Patient felt far worse the next day than the patient did with any of the other Moderna COVID shots. No Treatment Medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2022: Live Follow-up received with No New Information
Extreme drop in blood pressure: Vaccine at 3:30 PM first drop @ 5:15 Pm to 84/51 HR 93;  @ 5:50 PM 80/41 HR95; 7:00 PM 128/60 HR 50; 3:40 AM 85/46 HR 58-Irregular.  This continued -the up 7 down till this writing (2/24 @ 9:30 AM).  Also body aches, chills, barely able to move. No headache this time.  Almost forgot - vomiting from 8:00 PM (2/23) till midnight (approx).  I have vision difficulty  from time of vaccination till now.  I think that is all.  General not feel goods!
when they were administering ADACEL to a patient, it did not go through needle and medication got onto patient's skin with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 31 years old female patient and reporter reported that Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] administering to her, it did not go through needle and medication got onto patient's skin with no reported adverse event.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jun-2023, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 18-Mar-2025, lot U7671AA) via intramuscular route in the right deltoid for immunization and on the same day they were administering adacel to a patient, it did not go through needle and medication got onto patient's skin with no reported adverse event (accidental exposure to product).  It was unknown if there were lab data/results available.  Reportedly: when they attempted to inject the medication, all of the medication shot out above the needle; states it came from where they attach the needle to the syringe; the serum shot through the side and did not go through the needle. The medication got onto the patient's skin on their arm. The caller states that they had the patient immediately rinse off the affected area and made her wait while they monitored her for any potential reactions; states that the patient was fine and did not experience any reactions afterwards. There was no Broke or cracked during preparation or use and received broken or cracked in the carton. There were not any signs of damage to any other vial in the carton.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Patient was given shot, was sitting in chair to relax afterwards. Found patient minutes later unresponsive, unable to wake for a minute. She was sweaty and asleep. Took several attempts to wake the patient. She appeared confused of her location and was unable at first to identify her location. Breathing was fine, first blood pressure reading was at 12:30pm 86/54 pulse:53. patient had also lost control of her bowels and light headed. Gave patient mountain dew and water, she had sat for a few more minutes and next blood pressure reading was at 12:39pm 109/69 pulse:53, finally at 12:50pm patient was having a reading of 114/90 pulse:64 and was feeling better.
Mild rash/itching on neck after first COVID vaccine - not sure if this is related to the vaccine Rash on arm starting one week following
Patient called the office stating that his arm is red and hot and his arm is swollen  all the way around. He has been feeling dizzy and nausea and has fallen. He was having a fever of 100.0.  Patient was also having arm pain. Patient was advised to go into UC.
migrane headaces to the forehead; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wrote her concern of the first dose of the Pfizer covid vaccination. She asked for an explanation in full detail why, after 29 days of taking the Pfizer shot to the left arm, she was having migraine headaches to the forehead (side effects). She tried aspirins and over the counter medications, with having no affect. She added that this was one of the reason why she and others were debating on taking covid vaccinations, now she was deciding if she still wanted to take the second Dose. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
This spontaneous report as received from a physician refers to an unspecified number of unspecified patients. The Physician called to report that an unspecified number of unspecified patients may have been administered ZOSTAVAX (Lot#, dose/frequency, route unspecified) that were improperly stored on unspecified dates from May 2012 to December 2012 at an unspecified healthcare facility. No adverse effects reported. This was one of several reports that received from the same source. Additional information is not expected.
Reported fever, pain & nausea/vomiting immediately after receiving HIGH DOSE INFLUENZA vaccine. Pt left msg on 1-18-12 that she had these symptoms after HD INFLUENZA. Attempted follow-up to obtain additional info. but pt. did not respond to phone msgs.
I had an itching, red, warm rash that spread from injection site down my arm about 4 inches.    It  showed up 8 days after my first shot and 1 day after the second shot.   Both times it subsided after about 5 days.    The rash was larger and had a 'demarcation line' at the bottom of the rash area after the second shot that did not show up after the first shot.   The demarcation line was between a slightly swollen red area and the non-rash part of my arm
Attempted to contact patient several times unable to reach attempted x2 on 7/23 and 7/26 and 7/27