chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suddenly became dizzy, My family who consists of 3 nurses were with me at the time. Had a witnessed vasovagal syncope episode . Turned white, lost consciousness for about 90 seconds. No pulse was felt by my daughter who is APN. 3 chest compressions were done, then color in my skin began to return (per my family). I was then transported to the emergency room. Cardiac work up for heart attack was negative, vital signs were stable after initial episode. Was admitted to hospital for 18 hours for observation. I have no medical history and had no changes in my daily routine
A week after flu shot increased urination started, very painful leg pain, swelling, tightness   Was seen at the ER 10/27/20 and they sent her home. Also spoke to MD and he told her to take a diuretic.
Dx red and swollen and warm. Tx: cold compress and Zyrtec and Motrin.
Faint did not hit head. EMS eval. P60 O298% 96/50Stayed for 30minutes. BP 122/64. Home w family
This spontaneous report as received from a registered nurse refers to a 6 month old patient (gender unspecified). On 12-JUN-2014, the patient was vaccinated with expired dose of RECOMBIVAX HB vial SD IM 2.5y (strength, dose, frequency, route of administration and anatomical location: not reported) (lot # 1625AA, exp date: 06-JUN-2014). No adverse effects were reported by the reporter. Additional information has been requested.
On January 10, 2023, I started having palpitations and a flutter in my throat. I felt very anxious. It was mild to begin with, but, several days to a week later, they became more numerous. After a while, they felt like they were almost constant. I could feel my pulse skip a beat on my wrist. On January 25, 2022, I got frightened and called my husband to come home. He took me to a walk-in cardiac clinic that afternoon. They took my blood pressure and administered an ECG. The ECG was abnormal. She suggested I wear a 24-hour Holter monitor. I received it today and will wear it until tomorrow. I have a follow-up appointment in March.
vaccine was administered 20 hours after the vial was initially punctured.  it should be administered within 12 hours.
Approximately 36 hours after the vaccine, I was very tired and felt warm (no flu like symptoms though). I noticed a small amount of acne starting on my face at that time. I went to sleep, and the next morning, my face was covered in acne. I wasn't tired or warm anymore and have felt fine since. The acne persists.
Case number PHEH2013US019150 is an initial spontaneous report received from a pharmacist on 10 Sep 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. It was reported that the patient was vaccinated with MENVEO (batch number: M11042) intramuscularly on an unknown date. It was reported that the patient only received MenA lyophilized conjugate reconstituted with sterile water and did not receive MenCYW-135 liquid conjugate. No adverse event was reported following the maladministration. No further information was provided.
patient complained of back pain unlike he's ever had before.  Started about 30 hours after he got the flu shot.  He had the typically sore arm for a day which went away, then he started having the back pain
patient was hospitalized a few days after receiving vaccine due to fever, cellulitis, requiring over night hospital stay with IV antibiotics
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 09-FEB-2017, the patient was vaccinated with an improperly stored dose of M-M-R II subcutaneously, lot # M025607 with expiration date 18-MAY-2018, for prophylaxis (dose was not reported). The vaccine was exposed to a temperature between 5 and 25 Celsius degrees in 4 cycles. The cumulative time was 1.5 hours. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005482:
No adverse effects were reported; improperly stored dose of were administered to a patient on 24 OCT 2022; This spontaneous report was received from the vaccine coordinator, and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 24-OCT-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U034522, expiration date: 22-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). No additional adverse event was reported.
icky feeling; fever; headache; chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EK9231) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Caller states her first dose of the vaccine had lot EJ1685 and was not involved in the temperature excursion), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "recovered" (2021), described as "icky feeling"; PYREXIA (non-serious), outcome "recovered" (2021), described as "fever"; CHILLS (non-serious), outcome "recovered" (2021), described as "chills"; HEADACHE (non-serious), outcome "recovered" (2021), described as "headache".  Additional information: She is calling about the Pfizer COVID Vaccine and is not sure how to pronounce the name of Comirnaty and asked if anyone can pronounce the name. She is calling because she works at a local public health agency and had a temperature excursion for the Pfizer COVID Vaccine and it has been ongoing and they realized the freezer was set a little too low for the last couple of months and were keeping it at negative 28 degrees Celsius and had raised the temperature to negative 25 to negative 15 degrees Celsius about a day ago; the freezer never went below negative 30 degrees Celsius and kept it the standard frozen temperature between negative 30 to negative 15 degrees Celsius and the vaccine was administered to patients for their 1st, 2nd and booster doses. She is seeking stability information. She does not know the number of patients that received the vaccine after the temperature excursion and has no patient information to provide. She also received her booster dose of the Pfizer COVID Vaccine and that was involved in the temperature excursion; states for herself and the other patients involved the lot number involved in the temperature excursion is FF8841 and it has expiry date 31Mar2022 and she does not have the NDC to provide. She has no HCP information to provide. Her first dose of the vaccine had lot EJ1685 and was not involved in the temperature excursion, her 2nd dose has lot EK9231 and was not involved in the temperature excursion and her 3rd booster dose was administered on 06Oct2021. States for seriousness criteria for the temperature excursion she would say it is a near miss potential and medically significant and she also had the same reaction for the booster dose as she had for her 2nd dose of the vaccine and that was fever, chills for a day, icky feeling and headache and those symptoms have resolved but began on 07Oct2021 and resolved that evening.  Verbatim event relatedness: Pfizer COVID Vaccine: icky feeling - Related   Follow-up attempts are completed. No further information is expected.
Loose motions; This is a spontaneous report from a contactable consumer reporting for himself. A 57-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration, administered in left arm on 26Feb2021 at 18:15, at 57 years of age, (Batch/Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included proteinuria from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Feb2021 08:00 the patient experienced loose motions, for which no treatment was received. The event was resolving at the time of the report.  Follow-up attempts are completed. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Additional Details: Approximately five minutes after administering vaccines patient reported sweating, dizziness and faintenss. emergency was called to the pharmacy and patient was taken for further evaluation by EMS personnel
chronic adrenal insufficiency,  acromegaly and gigantism, chronic diastolic heart failure, previous CABG, remote history of PE, chronic dyspnea, type 2 diabetes, and history of stroke. He presents with symptoms, signs, and test results concerning for acute infection due to COVID-19 with systemic inflammatory response syndrome probably due to viral infection.  He does have cough and is mildly hypoxic at rest intermittently raising concern for pneumonia, but no radiographic infiltrates were evident on chest CT performed yesterday.  In addition to risk of pneumonia with hypoxic respiratory failure, he is also at risk for acute on chronic adrenal insufficiency, acute heart disease, and recurrence of venous thromboembolism, and he has had severe acute functional decline with generalized weakness and disequilibrium, so hospitalization is considered medically necessary.
Pfizer-BioNTech COVID-19 Vaccine EUA ; On 5/11/21, Patient experienced tingling in left arm minutes after the vaccine was injected (4:07pm). Patient became nauseous. While in the vehicle to go home, patient's breathing quickened. After this, patient's vision became blurry and he was unable to see. Patient also experienced hearing loss with ringing in ears. The father of the patient pulled the car over in case medical attention was needed. Patient eventually passed out for about 30 seconds (about 4:22). Patient recovered, but complained about fogginess (thinking was unclear and unfocused). The next day, on 5/12/21, the patient experienced chills and nausea without a fever. Currently, the patient is doing fine with no further symptoms.
Pt developed a skin lesion on his upper abdomen/lower chest approximately 3 days after his second dose of COVID vaccine.  Lesion did not heal, pt presented to ER on 5/3/21.  Wound continues to heal as of 5/10/21.  Of note, patient experienced a similar lesion after his first dose of COVID vaccine.  The first lesion was treated with doxycycline and had resolved prior to receipt of second dose.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain (serious criteria other: serious as per reporter), injection site blisters (serious criteria other: serious as per reporter), injection site rash (serious criteria other: serious as per reporter) and injection site redness (serious criteria other: serious as per reporter). On an unknown date, the outcome of the injection site pain, injection site blisters, injection site rash and injection site redness were unknown. It was unknown if the reporter considered the injection site pain, injection site blisters, injection site rash and injection site redness to be related to BEXSERO. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA). The patient experienced pain, redness and blistering red spots at injection site (unknown deltoid) of the vaccine. The responsible physician and the person administering vaccine to the patient were unknown. The patient information was not available. No vaccine date was available.
Patient experienced several episodes of anxiety with feelings of doom. Patient had elevated BP and heart rate during these episodes. The episodes persisted for approx. 1 1/2 - 2 hours. 50 mg of BENADRYL given PO to alleviate symptoms (assuming allergic response).
Pt had rash over entire body and swelling/ turning blue of her legs and hands.  Also headache and slight fever.
lesions on my spinal cord which may result in permanent nerve damage; lesions on my spinal cord which may result in permanent nerve damage; numbness which is increasing day by day; This is a spontaneous report from a contactable consumer (patient).  A 40-year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in the left arm on 25Mar2021 11:00 (at the age of 40 years-old) as single dose for covid-19 immunisation.  Medical history included penicillin allergy and shingles outbreak. Patient previously received bnt162b2 (lot number: EN6200) on 01Mar2021 at 09:00 in the left arm for covid-19 immunization and experienced shingles outbreak. Concomitant medication included doxycycline monohydrate taken for an unspecified indication, start and stop date were not reported.  The patient was now (Mar2021) experiencing numbness which was increasing day by day. She had an MRI scan last week (Mar2021) and it's showing lesions on her spinal cord which may result in permanent nerve damage. She will be speaking with a neurologist this week and doing additional test/scans. The patient underwent other lab tests and procedures on 07Apr2021 which included Nasal Swab (for sars-cov-2 test) with negative result.  the outcome of events was reported as not recovered. It was unknown whether treatment was received. The events were considered as serious,involving persistent or significant disability or incapacity.   No follow-up attempts possible. No further information expected.
Pt became shaky, throat felt itchy. Complained of chest feeling tight. Benadryl 25mg IM given at 1045. Complained of spotty vision. Pt reported having filler in lips a few days ago. Wheezing in left lung, Epi given at 1101. Pt left with EMS 1125.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a female patient of an unknown age 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 VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
I have arthritis which normally flares up in one joint at a time every now and again. After I got the third dose of the vaccine, I was achy for a few days after the shot but I started to have joint pain in multiple joints. It feels like it is much worse than normal. I have had a hard time sleeping. Even my toe joints hurt and my back has been very painful. My back, hips and my wrist have been the worst. I was prescribed Celebrex and it has improved over the last three weeks.
Rash starting at injestion site spreading to chest and scalp as well as back.  Was seen by clinic physician.  Given Benadryl 50 MG PO.
Patient reported a sensation of numbness in the vaccine arm for about 3 days after 1st dose. Received 2nd dose today and reported the same sensation starting immediately upon administration. no other symptoms present. Opposite arm from 1st dose.  patient walked away before observation period ended.
Info has been received from a heath professional concerning a 30 year old female (White and Hispanic) with a history of idiopathic thrombocytopenic purpura that resulted in a splenectomy who on 7/21/05, at 13:00, was vaccinated, SC, in the left upper arm with a 1st dose of varicella virus vaccine live (lot 044P). There was no concomitant medication that day and no illness at the time of vaccination. Concomitant vaccinations on 7/1/05, at 13:00, included a 3rd dose, IM in the left deltoid of Engerix-B (lot 650454/0751P). On 8/11/05, the pt experienced breakthrough after vaccination with 10 lesions that were vesicular, papular and crusted over. The pt had no systemic symptoms. It was noted that on 5/18/05, a Zoster IGG was negative and 1 done on 9/12/05 was positive. No product quality complaint was involved. Follow-up info indicated that the pt began to have vesicular lesions about 8/11/05. She thought they were insect bites but more developed. At the time, the pt was seen on 8/16/05, there were about 10 lesions which the pt thought were not insect bites since they were in areas where she was always clothed. She had no constitutional symptoms. It was noted that the pt believes she had a reaction to the varicella vaccine. There were about 6 visible lesions, one of the earliest is noted on the lower leg and appears as an impetigo lesion. There are small non-purulent papules about 3mm in diameter on the hands and feet. The 6 lesions are in various stages of healing. The 2 on the calf and arm are crusted with an "erythematous" base. The two on the palm and sole of the foot are papular and without serious fluid present as are the others on the neck and arm. One lesion on the chest has a small amount of serous fluid. The assessment was "a possible reaction to varicella beginning 21 days after the administration of the vaccine. "See lab section for relevant lab results. The pt recovered on an unknown date. Additional info is not expected.
Heart palpitations. Fast heart beat. 99-120. 95 when at rest.  Up to 130 when stabding or moving from laying position.  Chest pain heart area.
Pt vaccinated with Heptavax-B  w/allergy to sulfa drugs, two hrs after vaccination  began experiencing chills, hot flashes, lt-sided jaw pain, ringing in the lt ear, tearing of the lt eye, lack of taste, & drowsiness. See WORM
Arm became red, slightly swollen and hot and itchy near injection site. The reaction slowly went down the arm and cleared near the site over the course of about 2 weeks.
Since I got my vaccine I have been diagnosed with Idiopathic Intracranial Hypertensions. I started having infrequent dizzy spells that were happening. They lasted under a minute and I felt like I had to hold on to something. It was happening for three months and I started to get headaches and visual disturbances on 08/18/2021. I was feeling very unwell. I went to the ER and they identified a problem with my Spinal Fluid pressure. There is a risk of loss of vision. I have Venous-Sinus Stenosis. I have been to the ER 3 times and I have been hospitalized from 09/1//2021-09/07/2021. I have had medications added and they drained some fluid with a Lumbar puncture.
The day after my vaccination I had soreness in the armpit of my left arm. It was pretty uncomfortable the first three days, but continues the pain is subsiding.
Pt has received FLUMIST in previous years. Received FLUMIST 1/15/09. Seen in ER 1/17/09 for presumed viral illness. Admitted to PICU 1/19/09 with encephalomyelitis.   3/25/09 Received hospital medical records of 1/19-2/9/2009. FINAL DX: viral meningeal encephalitis Records reveal patient experienced pharyngitis before Christmas, tx w/oral antibiotics, improved then relapsed & tx w/second round of oral antibiotics.  Improved & given flu shot.  Developed sore throat, cough, fever, runny nose& URI s/s again.  Seen in ER 1/17 & dx w/viral syndrome.  D/C to home then developed dizziness, falls, HA, emesis, eye deviation to right, sudden onset of inability to walk or talk.  Episodes of unresponsiveness thought to be seizures.  Neuro & ID consults done.  Admitted PICU.  Tx w/IV antibiotics, antivirals, steroids, antiseizure meds w/limited improvement.  Feeding tube inserted.  Labs & clinical status improved slowly but remained nonverbal w/very limited movement & unable to walk unassisted w/unsteady gait.  Transferred to rehab. Follow-up: Pt still with residual speech problem, difficulty with ambulation secondary to lower ext. weakness.
Brainfog; depression; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brainfog) and DEPRESSION (depression) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Depression.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Brainfog) and DEPRESSION (depression). At the time of the report, FEELING ABNORMAL (Brainfog) and DEPRESSION (depression) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified medication for depression and anxiety. Treatment detail was not reported by the reporter.
Pt noticed red papules around smallpox site and macules on trunk of body and back that itched.
Patient received second Pfizer dose on 4/9 at 9:15 am. That evening she developed fever of 102.5 F with body aches and chills. On 4/10 at about noon, she developed squeezing chest tightness for about 20-30 minutes. 7/10 with back and neck tightness as well. she developed an urgent need to have diarrhea and had a momentarily loss of consciousness consistent with presyncope. Afterwards,the chest tightness went away and she felt better. All other symptoms resolved. The patient came to the clinic. Vitals: BP 97/63, P90, T36.6C, D-dimer 7140 ng/ml EKG- NSR, rate 83 bpm, no acute ST-T changes, Troponins negative, CBC - normal Chest CT with contrast negative for PE B/L LE Venous ultrasound- Right posterior tibial thrombus
Patient was wheeled to observation area at 1415. States she started to feel a lump in her throat. VS at 1418 168/102 100% O2 Sat HR 80 bpm. 20 RR. Denies SOB, chest pain, and or difficulty breathing. Lung sounds are clear. States she took her own 25 mg Benadryl prior to coming in due to typically feeling in lump of throat after vaccines. VS at 1425 156/102, 98% O2 sat, HR 68, RR 18. Patient decides to take an additional 25 mg of Benadryl while in observation. Patient states she is having mild anxiety. Talks in full complete sentences. 10 mins after 2md dose of Benadryl patient states the lump is going away and feels much better. Pt was advised to seek medical care if she starts having  SOB, difficulty breathing or throat swelling to seek medical care.
Friday  4/9 Shortness of breath  Hard to breathe Sore arm   Saturday 4/10  Bad headache  Sound wheezy   MONDAY 4/12 Shortness of breath Left shoulder/chest pain