chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Staff notified RN that Pt was in the triage room and she needed help. Patient ID x 2, on assessment, Pt stated her throat feels dried up and she cannot breath appropriately. V/S was done and Pt's BP was 116/69, Pulse 81, R 22, Oxygen saturation 100%. Pt stated she had just recently gotten her second shot of the COVID-19 vaccine, Pfizer. She stated she had a rxn to the first dose. Pt was placed on 2liters of oxygen and Provider was informed. Provider, NP ordered Solumedrol and benadryl. Medications were given at 0835am IM. Pt was continued to be monitored. BP at 0840 was 113/58, oxygen 100%, pulse 79, R 20. Pt was informed she is having a rxn to the vaccine and would be monitored before she could go home. After 0910, Pt's BP was taken manually and BP was 110/72,  Pulse 78, R 18, and Oxygen saturation 100%. Pt was observed for about an hour before been discharged. Provider asked RN to schedule Pt for a telehealth appointment for tomorrow. Pt was scheduled for the appointment. Pt stated she feels much more better and alright and she can breath well. Pt's husband at bedside. Patient aware and verbalized understanding of all instructions and patient to return PRN to the clinic. BSN, RN/PHN
Patient called after getting home that she has pain at the injection site, and a golfball sized amount of fluid collecting at her elbow.
Cold sweat, headache, nausea, stomach ache, pain and itching at injection site x3 days. Rest and fluids.
Client stated got Pfizer Vaccine dose 1 on 2/24/21 and reported diffused itching and rash over body 1.5hrs after receiving vaccine. Did not take any medication or report to provider. Symptoms resolved after 3 days.
1:30pm: diarrhea episode, no treatment. 4:30pm: diarrhea episode, no treatment; felt nausea until about 5:30pm. 12:30am (2/6/21): woke up from sleep with moderate-to-severe body aches and moderate chills (temperature was 98.7, slightly higher than my normal); took 600mg ibuprofen and laid on icepacks; no further debilitating body ache episodes. All day (2/6/21): body fatigue, no treatment. During sleep on 2/6, 2/7, 2/8, and 2/9, I've woken from my sleep multiple times per night due to vivid, stressful dreams.
Dark red circle with swelling the size of a nickel, red ring around it the size of a half dollar. Hot to touch, swollen, hard lump the width of a golf ball underneath the skin still there. Low grade temperature even with alternating Tylenol and ibuprofen.
patient received, in his left arm, a dose of Menactra which was beyond its expiration date/no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in his left arm after its expiration date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5835AB, Feb-2019.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred.  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.
waited the standard 15 minutes.   then left on way home started to wheeze.  Got home and wheezing getting worse.  Used my inhaler help and feeling more comfortable.  But wheezing continued thru to the next day.  Using my inhaler as prescribed for my allergy conditions
lt deltoid firm & hot to touch; pt c/o some pains & itching; tx: Triamcinalone arm, dressing & wrap-hydramine/Elix; RTC/4 days if s/s cont
One week and 2 days after receiving the second dose of the Moderna COVID-19 vaccine, I had series of seizures that resulted in my hospitalization for roughly 24 hours. I have been visiting several doctors since. The Neurologist I saw described what happened as convulsions and I believe this was a direct result of the COVID vaccine.
Janssen COVID-19 Vaccine EUA: patient hospitalized with acute neurologic symptoms (slurred speech, syncope, and lower left leg weakness), aspiration pneumonia, pan-sinusitis, and hypoxemic respiratory failure after running out of home oxygen. Administered supplemental oxygen and antimicrobials. Discharged to home medically stable.
headache; fever; Did not feel good; A spontaneous report was received from a health care provider concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed headache, pyrexia and did not feel good.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot #011L20A) on 04 Jan 2021 in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021 the patient didn't feel good and experienced headache and pyrexia. She took her temperature while at work and two separate readings,  104. 8 degrees and 102 degrees.   Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, headache and pyrexia, was considered unknown  The reporter did not provide an assessment of the event, headache and pyrexia.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient with penicillin allergy and no pertinent medical history. On 03-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000494, exp date 14-APR-2014). Concomitant therapies included CELEBREX. The pharmacist reported tat on 04-JUN-2013, the patient presented to pharmacy with a red rash the "size of a softball" around the injection site with a small blistered area within the rash. The pharmacist stated the blistered area looked like a water blister the size of a "half dollar"; the area was inflamed, "hot to the touch" and itchy. Topical cortisone was given for the events. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Patient received a 3rd does of the shingrix vaccine.  No adverse events were reported by the patient.
with the second dose the chills and aches were very brief; with the second dose the chills and aches were very brief; vitreous detachment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Smallpox shot for immunisation, reaction(s): "high fever", notes: states that she thinks it was the Smallpox shot that she got when she was very young, but is uncertain if it was the Smallpox shot. States that it caused her to have a very high fever. ; Smallpox shot for immunisation, reaction(s): "One of her adult teeth then grew in half thickness with a brown stain on it", notes: One of her adult teeth then grew in half thickness with a brown stain on it and she was told that was probably because of the high fever she had as a child. . Vaccination history included: Bnt162b2 (Dose:1, lot# EM9809, Anatomical location: left arm), administration date: 11Feb2021, for COVID-19 Immunization. The following information was reported: VITREOUS DETACHMENT (medically significant) with onset Apr2021, outcome "recovering", described as "vitreous detachment"; CHILLS (non-serious), PAIN (non-serious) all with onset May2021, outcome "recovered" (May2021) and all described as "with the second dose the chills and aches were very brief". The event "vitreous detachment" was evaluated at the physician office visit and emergency room visit. Clinical course: States that she had the first dose in Feb, the second in Mar. Then in early Apr she was travelling and got diagnosed with Vitreous Detachment. States she does not know if she had it before, and she had been on a plane, but it was about 6 weeks after her second shot. She said that it was starting to resolved by itself. Patient states that it had seemed to be subsiding. Patient states that with the second dose the chills and aches were very brief; may be like an hour. Denies any other medications, medical conditions, labs, testing, or treatments relevant to these events. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient states that she went to the Emergency Room in (name) and was diagnosed with the vitreous detachment. States that the doctor wanted to make sure it was not a detached retina. When she returned to the states her doctor agreed with the diagnosis that she received in (name).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101741009 same patient/drug, different AE, different dose of vaccine
#1 Pfizer 12/24/20 w/ chest tightness, DOE starting 4 hrs post vaccine. DOE resolved after 24hrs. Employee contacted company, who in consult with CDC recommended #2 Pfizer 1/14/21 administered at an allergist's office. Instructed to take Claritin 10mg 1hr prior to appt. At 2hrs post vaccine, patient developed similar sxs of chest tightness, DOE, palpitations, O2 sat 87%. Given Albuterol via nebulizer, additional dose of Claritin10mg. Patient felt better 5-10min after neb. D/c'd home after total 3hr observation. Had mild DOE 1/15 that resolved w/in 24hrs. Also severe HA, BA, fatigue, injx site pain. Felt much better on1/16. Denies hx asthma or atopic dermatitis.
mom noted rash around vaccine site 24MAR98;beginning to fade @ time of exam 26MAR98;330PM no fever, no apparent LOM;
20 mins after inj. pt complained of headaches and leg pain. Fever began and arm turned purple/red and was swollen 3-4 inches long and 3 inches wide. Pt given TYLENOL and BENADRYL and today 9/30/09 arm is the same w/ head pain and leg pain.
47 year old - headache, body aches and fatigue starting 24 hours after receiving yellow fever, typhoid, tetanus, hep A-going on 5 days.  Red, swollen at site of yellow fever.
rash; Headache, dizziness, nausea; Headache, dizziness, nausea; Headache, dizziness, nausea; diarrhea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache, dizziness, nausea) and NAUSEA (Headache, dizziness, nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), HEADACHE (Headache, dizziness, nausea), NAUSEA (Headache, dizziness, nausea) and DIARRHOEA (diarrhea). At the time of the report, VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache, dizziness, nausea), NAUSEA (Headache, dizziness, nausea) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No specific follow-up information recorded.
Patient contacted 911 complaining of not feeling well and difficulty breathing. Upon arrival patient was found by EMS in cardiac arrest. EMS was unable to get return of spontaneous circulation.
Patient received Pfizer COVID vaccine on 1/18/21 and 2/8/21. On 10/14/21, patient is admitted to our facility for ureteral stone, pyelonephritis, and COVID-19 infection with possible acute respiratory failure with hypoxia. Patient underwent cystoscopy, left ureteral stent placement on 10/15/21. As of today (10/15/21), patient is still admitted in our med/surg unit.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 55-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The reporter was an internal medicine manager. It was reported that, there had been no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that, no adverse reactions were reported by the patient. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment medication was reported.
Pt was given PNEUMOVAX and TDap vaccine on 7/24/13. Pt called office c/o pain in his R arm, rash and redness on 7/30/13. Pt was seen in the office on 7/30/13. Dx:  pain in joint: upper arm and rash. Tx- Prednisone (Medrol Pak) and Hydrocodone were prescribed and will f/u 8/2/13.
she didn't realize they were given the booster before it was "approved".; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (she didn't realize they were given the booster before it was "approved".) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack. Concurrent medical conditions included Sepsis.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced OFF LABEL USE (she didn't realize they were given the booster before it was "approved".). On 30-Aug-2021, OFF LABEL USE (she didn't realize they were given the booster before it was "approved".) had resolved.            No Concomitant medications were reported. No Treatment medications were reported. reoporter said she took the flu shot  and so far so good.   This case was linked to MOD-2021-355780 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: FU received on 20 oct 2021,mentioning  patient has taken flu shot
Pt recvd measles vax on 12FEB91; On 4MAR91 pt devel congestion & and inc temp; Pt presented to MD & was dx w/OM in rt ear; pt given Septra; 7MAR91 pt devel measles; Lab eval reveales Rubeola IgG-0.29 & rubeola IgM greater than 1:80;
Started having redness and puffiness around injection site. Area is about 7.5 cm in diameter. Advised her to take BENADRYL as directed.
noticed cut on my head, stopped bleeding with gentle pressure; noticed cut on my head, stopped bleeding with gentle pressure; Fell in my bedroom; felt dizzy for a few seconds; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EL3302) via Intramuscular in deltoid muscle on 18Jan2021 at 10 AM as single dose for COVID-19 immunisation in nursing home/senior living facility. Patient's medical history included high cholesterol, acid reflux, both ongoing. Concomitant medications included ongoing simvastatin oral for high cholesterol (for years), oral generic acid reducer for acid reflux (for years). On Wednesday 20Jan2021 at 11 AM he fell in bedroom in narrow area between bed, bookcase, and file cabinet. Did not lose consciousness but felt dizzy for a few seconds. Got up quickly; noticed cut on his head; stopped bleeding with gentle pressure. The patient underwent lab test which included Covid 19 test on 07Jul2020: Negative. Initiation of new medication / other treatment / procedure was not required for event. The outcome of event cut on his head was unknown, for other events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
administration of improperly stored PROQUAD and VARlVAX; No additional adverse events reported; administration of improperly stored PROQUAD and VARlVAX; This spontaneous report was received from a consumer, referring to patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 30-AUG-2021, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T028137, expiration date reported and validated as 15-FEB-2022) as prophylaxis (product storage error).  On an unknown date, the patients were vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T025945, expiration date reported and validated as 30-JUL-2022) as prophylaxis (product storage error). No additional adverse events reported.  The vaccines underwent a temperature excursion between minus (-) 14 degrees Celsius (C) to -10C (-12.5C) for 1 hour, 28 minutes and 0 seconds. There was a previous temperature excursion between 6 degrees Fahrenheit (F) to 14F (10F) for 5 hours, 4 minutes and 0 seconds.
Headache fatigue Narrative: missed one day of work due to headache and fatigue following second dose
48 hr. after immunizations, Breathing monitor used daily when sleeping - alarm sounded at 0200am. Picked up child - limp, appeared not to be breathing. Rubbed stomach and back and child took big breath after few seconds and cried. Kept awake for awhile and put back to bed after 20 min did fine after that.
COUGH, Fatigue, Congestion or runny nose, and Nausea or vomiting
HPI: 4 year old autistic male here for area of swelling and erythema following injection 2 days ago. Pt received IPV and DTaP in left thigh on 12/12 and mom reported he moved during the injection. He immediately began scratching the site and picking at it. It turned red and swollen last night. He has had no fevers, normal po intake, and normal activity level. No previous reactions of vaccinations. WDWN non toxic, fighting during exam. Left lateral thigh with 12cm x 9cm area of induration, erythema and warmth. Central area with break in skin, dry/yellow crusted discharge. Assessment/Plan: Cellulitis following vaccine Keflex 250mg/5cc, 15 cc po tid x 10 days (=75 mg/kg/day). Area marked on skin - patient to follow up in 2 days or sooner for fevers, increasing area of erythema, new concerns.
Developed flushing, diaphoresis, nausea, and eventually syncope about 18 hours after vaccine injection.  Got up in the night to check on my kids, had been standing for about 2-3 minutes when symptoms started, and passed out in the hallway about 60 seconds after symptom onset.  Recovered consciousness within a few seconds, had to lay on the floor for about 5 minutes due to nausea, then got back in bed and went back to sleep.  Woke up 3 hours later and felt completely fine except a little fatigue - all other symptoms had resolved.
Patient called Sunday 8/15/21 to ask about some side effects he thought may be a result of the Pfizer 2nd dose (lot fa7485 exp 10/31/21) he received on Tuesday 8/10/21 (he received his first dose in April). He stated a few days after the shot, he had no energy, was nauseas, vomited once (Friday 8/13/21), was sleepy all the time, had no appetite, and felt bad overall (malaise). What prompted his call on Sunday was that he noticed "red freckles" all over his arm of the arm he was given the vaccine in. They were not raised, not itchy, and stayed red with pressure (non-blanching, although I'm not sure if this was accurate as he may not have understood what I was describing exactly). He stated his fingertips and fingers hurt, and that his arm overall felt somewhat tingly.   I explained that while some of these symptoms sound vaccine-related, several seem very atypical from my understanding. I recommended he call his doctor or seek urgent care that day so that he could be evaluated. He understood.   He did have a recent COVID exposure from his adult child's family that he was living with. In addition, while he was living with them temporarily, his child has told us in the past that he is homeless. He did say on the phone with me that he is currently living in his truck. That being said, he did not act like access to healthcare would be a barrier to getting this looked at and said he would do so right away.   I called him today, Thursday 8/19/21 to follow up to make sure he was doing okay and to see what the doctor said, but I could not reach him and he did not have a voicemail that had been set up. I will attempt to reach out again tomorrow.