chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sores; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart stent" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sores".  Additional information: The patient reported that patient just got my 2nd vaccine dose and patient is fine. Patient just got some sores but patient is ok. Patient have had a heart stint in the past. Do you have a trial for people with pre-existing conditions such as Heart conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe chills, Fatigue, headache, Muscle Aches, Fever.
No additional AE provided; Nurse calling states she inadvertently administered expired VAQTA to a patient.; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The medical history, concurrent conditions, drug reactions or allergies and concomitants therapies were not mentioned.  On 20-JUN-2022, the patient was vaccinated inadvertently with an expired dose of Hepatitis A Vaccine, inactivated (VAQTA) (Expired vaccine used), formulation: intramuscular injection, dose: 0.5 milliliter, batch # U003450 expiration date: 02-MAY-2022, (strength, vaccination schedule, and anatomical site of administration  were not reported).   It was stated that the vaccine had been stored at the appropriate storage condition, specified in the product label, through the date of administration. No additional adverse event details provided.
Red, burning raised welts, rash on both inner thighs and buttocks. Worsened during the day today.
Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult male patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Shingrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius on 7th August 2022 (for 48 minutes).   This case is for 9 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118614:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118572:Same reporter US-GSK-US2022118612:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118616:Same reporter.
10 Minutes after revieving the covid vaccine, the  Patient became warm, BP190/106 pulse 68, pulse oxcimitry 100%.Rest and juice, the patient felt better, BP 155/78 Pulse 68, puulse oxcimitry 100%. The patient has a history of anxiety. No complaints of chest pain of SOB. No rash.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L033548 with expiration date 14-MAY-2017 (strength and dose number were not provided). The patient's concomitant medications were not reported. The office manager stated that, the vaccine temperature excursion had a time frame of 72 hours at 34 degrees F. Data logger was involved. However, no side effects were noted. ROTATEQ was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
About 6 hours after I received the vaccine at my doctor's office, the site became red.  It then became hot.  By the next morning, the arm had a circle of 4 inches of bright red, swollen flesh.  It was very hot.  I had a terrible headache.  It is not Thursday the 7th, and the red circle is hot and red as ever.  I have taken tylenol and put ice on it.   No more flu shots for me!!
Developed a fever of 104.8 1 week after the MMR, Chickenpox, Hepatitis A vaccines. Treated him at home.  Fever went down.
Dull HA(headache); Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via unspecified route of administration on an unspecified anatomical site and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), in the right arm on 23Mar2021 at 08:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included as HTN (Hypertension), poly Mal, obesity and age. The patient had a history of allergies to NSAIDS. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 10:00, 9-10 days post last vaccination the patient experienced dull HA (headache) and fatigue. The patient reported that little or no reaction day of or one week from last injection.  The patient thought that was interesting and hoped for some reaction post injection to show bodies reaction to immune response and the patient was surprised that they were latent symptoms. No therapeutic measures were taken for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of dull HA(headache) and fatigue was ongoing at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial and follow up information has been received from a physician via a wholesaler concerning an 85 yr old pt (previously reported as 4 pt's) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649111/0287P). Subsequently the pt developed the shakes and swelling around the injection site. The pt did not undergo a work up or hospitalization. No other information was available. In follow up information it was reported that 4 other pt's developed the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot 649111/0287P) (WAES 0411USA02514, 0412USA01843, 0412USA01845, 0412USA01844). Additional information has been requested.
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 34 years old female patient who experienced difficulty with range of motion of the left arm and had pain in shoulder, while she received vaccine  FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine, lot number not reported via unknown route in the left shoulder joint instead of left deltoid. On an unknown date, the patient developed a non-serious difficulty with range of motion of the left arm (Injected limb mobility decreased) and had pain in shoulder (shoulder pain) following the administration of Influenza Quadrival A-B Vaccine. It was a case of actual medication error due to vaccine administered at inappropriate site. (Other relevant tests included No lab data). Final diagnosis was difficulty with range of motion of the left arm and pain in shoulder. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for difficulty with range of motion of the left arm and pain in shoulder. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
fainting; Hair loss; This is a spontaneous report received from contactable reporter, nurse. The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm right, administration date 03Jul2021 10:30 (Lot number: EW0198) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took unspecified concomitant medications. Vaccination history included: Bnt162b2 (lot# EW0181, administration time: 10:30 AM, first dose, location: Left arm), administration date: 12Jun2021, when the patient was 40 years old, for covid 19 immunization. The following information was reported: syncope (medically significant) with onset 17Jul2021 20:00, outcome recovering", alopecia (non-serious) with onset 17Jul2021 20:00, outcome recovering. Therapeutic measures were not taken as a result of syncope, alopecia. No other vaccine in four weeks, no covid prior vaccination. No covid tested post vaccination.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported event syncope and other reported events and the suspect drug BNT162B2 cannot be excluded.       The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Ulcers in my mouth that I?ve never had before. Severe pain swallowing, eating.
At approximately 24 hours from the time I received the flu shot this season, I developed a rapid and irregular heartrate/beat with overall feeling of "wooziness" and weakness, which resolved about 3 hours later.
On 05/01 I started having tingling in toe just after I went to bed, but I ignored this. On 5/20/01 I went to hospital for tongue tingling, woke me from sleep and the symptoms still prominent on hospital arrival, but gone by the time I got to see the Dr. On 5/29/01 I began seeing my Dr as soon as possible after visit to the hospital. Other strange experiences was tenseness/tightness in back of neck/head, both left and right. Tenseness in both jaws, numbness in top left lip and numbness in left cheek of face. When laying down at bed time, my heart flutters/ and shallow beating. On 5/30/01 there was a tightness down breastbone one that lasted for at least an hour. I have prickling around left eye socket, left eye visual disturbance. the same evening the back of my head perspired enough to wet hair thoroughly, and significant sweating occurred at other times to-all while sleeping. I awoke some nights feeling hot and had tingling in scalp at site of cut. I have difficulty enunciating and slight hesitation during speaking. I have hoarseness and could not talk loud with numbness in upper throat. I have also experienced occasional bumps that itch which do not look like bug bites, they have been on my face, hand, ankles, knee, and soreness between middle and index fingers on both hands with the left being more dominant. I am experiencing fatigue. Some of the symptoms occurred simultaneously and all lasted from a half hour to 24 hours. Various symptoms occurred everyday day from just before my hospital visit on 5/20/01 until 07/31/01. Was symptom free for about 10 straight days then experienced tingling in right eye which traveled to left eye. All symptoms were more prominent on left side than right. Most disturbances were chest and up.
10-24-07 - teeth cleaned - 2000 mg amoxicillin. 10-25-07 - Headache - fever - tired - weak - cough - temp 103.5. 10-26-07 Above plus hurt - chills - sweats - thrush lasts 10-14 days except cough which lasted about 30 days - no one catches it from me - exact same scenario last year. Amoxicillin 500mg - 3x - 20 days.
Slept a lot; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot) and HEADACHE (Headache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced HYPERSOMNIA (Slept a lot) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HYPERSOMNIA (Slept a lot) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product was not provided by the reporter.  Treatment information was not provided after first dose.  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.  Further information has been requested.   This case was linked to MOD-2021-231690 (Patient Link).; Sender'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.  Further information has been requested.
She got her vaccine, they had her wait an additional 15 minutes.  She had  tingling sensation the entire time and she went home.  Around 5:27 she looked at her arm, it was bruised, it felt like alligator skin, rough to touch when she touched it and started to get little blisters around it.  It looks like her skin is burnt like she had been in a fire.  She went to the Medical Center and they told her that it was a local reaction and outlined it with a marker, and gave her an ice pack, which seemed to make it worse.  They gave her Naproxen and then she decided to leave as they didn't do anything, and said that she said it was a local reaction and that was going to get the second vaccine.     She went home so on 5/20/21 she went to Hospital. She saw DO in the ER.  She had chest pain, shortness of breath and two very large blisters on her arm with fluid in it when she was seen there.  She was informed that whoever gave her the vaccine did not go in far enough and that they gave her the vaccine in the tissue and not the muscle.  They did EKG, and they did blood work to see that it was no blood clots or in her lymph nodes, and said that it was a severe reaction from the vaccination, and that they had never seen anything like that before.    0n 5/21/21 she went to her PCP, she drained the numerous blisters that she had on her arm, she prescribed her Clindamycin, Motrin 600 mg, a skin cream Kenalog, she also gave her some aquaphor cream as well.  She does not feel that this has helped much.   Even after she drained the blisters, which the fluid was clear.  She has been taking numerous pictures.  The blisters came back, not as large but came back.  The blisters would drain when she would take a shower and it was tannish in color and she called her PCP who told her to continue to take the antibiotics.  She also bought some OTC cream, and an aloe vera plant which seems to be helping.  She says that the dark skin has peeled off and the skin is pinkish and raw looking, which is a large area on her arm where every bump was.  She said that the area is really really bad and is embarrassed to show her arm.
Patient's arm swelled at the injection site following the injection and she complained of tingling in her abdomen and legs following injection.
On 4/21/21 11 days after shot developed rash/hives at injection site on right arm approximately 4-5 inches across, along with elevated blood pressure around 150/95. Next evening at 7:30 went to ER with mild chest pains and blood pressure peaking at 225/104, with a resting heart rate of 100 bpm. EKGs, chest X-ray, and heart enzyme tests confirmed no emergent heart condition. Was released after 3 hours observation when blood pressure dropped to 170/100 without medication. On 4/24/21 my blood pressure was 160/100, so physician prescribed 0.1mg of clonidine to take as needed. Before now I was never prescribed blood pressure medication. Will record my blood pressure for two weeks with a follow up visit on 5/07/21.
Patient reports swelling at injection site that has not gone away since vaccine was administered. Patient reports no pain or discomfort, but wanted pharmacists to be aware of adverse effect.
Asymptomatic positive COVID-19 PCR; presented to ED with concern for melena and hematemesis.
Patient came in for a scheduled COVID booster appointment. Upon arrival, he presented his COVID card which showed only one dose on Janssen given 5/29/21.  He was then given the vaccine and he left shortly after.  Upon running the claim through insurance, it was discovered that the patient has gotten multiple vaccines from different facilities (Pfizer 5/13/21 and 1/11/22; Moderna 10/30/21).  The patient was immediately contacted and he confirmed that this was true.  He stated that he wanted to get the multiple vaccine based on "research" he found that showed changing the vaccine would be more effect against fight COVID.  He was then counseled that the protocol for the vaccine does not allow for multiple vaccines to be given as he had done.
OBSTRUCTIVE SLEEP APNEA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Information has been received from a consumer concerning her now 5 year old daughter with no drug reactions/allergies who on 22-MAR-2004 at the age of 12 months was vaccinated with MMR II. Concomitant therapy included VARIVAX, but the patient's mother did not know if the VARIVAX was (MSD) or not (manufacturer not reported). "Around when the patient turned 24 months old" in approximately March 2005, the patient developed autism. The patient had sought unspecified medical attention. The mother reported her son followed an autism program. At the time of reporting the patient was recovering from the autism. Upon internal review, the patient's autism was considered to be other important medical event. Additional information has been requested.
Approximately 15 min after receiving the vaccine receipiant started to complain of itching in the right arm where vaccine was given. She also developed a rash that quickly spread to bilateral upper arms, abdomen, upper back and bilateral thighs. At no point did she complain of SOB or feeling like her throat was closing up. She was given oral benadryl 25mg and Pepcid 10mg from which she reported no relief from the pruritus. She was sent to Occupational health for further evaluation and treatment. She was prescribed Pepcid 20mg once daily, Medrol (Pak) 4mg in a dose pack, Zyrtec 10mg daily, and hydroxyzine HCI 25mg every 4-6 hrs as needed. She followed up 3 days later and continued to complain of itching. She was adviced to contniue the above medications and try cool milk compresses, colloidial oatmeal bath soaks & topical anti itch meds for the contniued pruritus.
This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out), PAIN (pain ranges between 2-10), EAR DISCOMFORT (pounding in my ear,feels like a pulsing), NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.) and NERVE BLOCK (On 04Aug2021, she got another block) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache,never went away, nonstop,headaches haven't gone away). On 29-Apr-2021, the patient experienced EAR DISCOMFORT (pounding in my ear,feels like a pulsing). On 02-Jun-2021, the patient experienced NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.). On 04-Aug-2021, the patient experienced NERVE BLOCK (On 04Aug2021, she got another block). On an unknown date, the patient experienced OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out) and PAIN (pain ranges between 2-10). The patient was treated with DOXYCYCLINE from 22-Apr-2021 to 04-May-2021 at a dose of 40 milligram. At the time of the report, OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out), PAIN (pain ranges between 2-10), EAR DISCOMFORT (pounding in my ear,feels like a pulsing) and NERVE BLOCK (On 04Aug2021, she got another block) outcome was unknown, NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.) had resolved and HEADACHE (headache,never went away, nonstop,headaches haven't gone away) had not resolved.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Magnetic resonance imaging: normal (Inconclusive) completely normal.Patient had close to 10 doctor visits between specialists and her primary care but they can't figure out what's wrong.Patient stopped taking it because her doctor told her it could cause headache. Patient stated that the pain ranges between 2-10 on any given day.This case was linked to MOD-2021-295321 (Patient Link).
vomitting, swelling of leg, mild shaking, irritability, slight fever,sleepy,non-stop crying for more than an hour.
On the second day, I was super tired, I had anxiety nauseas. On Wednesday I went to see my ENT doctor he sent me to do a hearing test. I passed the hearing test and he did not know what to do about it. I did one week of steroids. After 2 weeks I was able to hear, beside that pain I had pain in my jaw line.