chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Sore arm; Headache; This is a spontaneous report from a contactable consumer (patient). A 16-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) in Arm Right via unspecified rout of administration as dose 2, single on 22May2021 03.30 PM (at age of vaccination 16-year-old) for covid-19 immunization in Pharmacy or Drug Store. The patient medical history included anemia and anorexia. The patient had no known allergies. The patient concomitant medications included Prozac (FLUOXETINE HYDROCHLORIDE), multi-vitamin, iron and vitamin d. Historical vaccination included BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) in left arm via unspecified rout of administration as dose 1, single on 01May2021 03.30 PM (at age of vaccination 16-years old) for covid-19 immunization in Pharmacy or Drug Store. The patient experienced sore arm with first shot. On 23May2021 06.00 AM, the patient experienced fever of 101.2 less than 24 hours after injection, headache and sore arm. The patient did not receive other vaccine in four weeks. The patient did not receive treatment for any adverse event. The patient had no covid prior vaccination. The patient had no covid test post vaccination. The outcome of events was reported as recovering.   This follow-up is being submitted to notify that the lot/Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Chest pains unlike any experienced before. Breathing was impaired. Heart rate and blood pressure were normal when taken using a home BP machine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 11:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:48 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 83.12 for dose administered on 27-Mar-2021 and 83.05 for dose administered on 27-Feb-2021. No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Batch number 014M20A administered on 27-FEB-2021 underwent temperature excursion with temperature range 33 to 35 degrees Fahrenheit from 09:00 Am to 05:00PM . This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
The callers wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized.; The callers wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized.; Caller states his wife is in the hospital she is that bad; Sick; Nauseous; This is a spontaneous report from a contactable consumer (spouse). A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported stated, his wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized. Reporter wanted to know what he should do about receiving the second Pfizer Covid 19 Vaccine. Again stated, his wife was in the hospital she was that bad. Stated he does not think that answering questions for a report would be helpful. Stated he got it because an unfortunate person had it and gave it to him and his wife. Reporter stated what he was concerned with now, she was in the hospital and he was at home and feels better and it has been at least 10-14 days, he figures he can he get the shot, but he wants to see what he should do about the second dose. Reporter stated the same thing happened with his wife and it hit. Stated it was not the next day but they felt nauseous and sick, not the day after but a few days after, probably a week or so before someone gave them a push. Stated he does not wish to complete any reports at this time, he does not feel that it would help anything. The events were assessed as serious and caused/prolonged hospitalization. The patient underwent lab tests and procedures which included diagnosed with Covid: positive on an unspecified date. The outcome of events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021881074 same reporter/drug/AE , different patient.
Client requested high dose flu vaccine stating his doctor said he needed the high dose formula because of his health. Nurse gave vaccine based on client's report, not realizing it was given out of age range until after dose was administered.
Patient was anxious before giving vaccine. Attempted to inject vaccine with Vanish point 1 inch needle. Needle was dull and would not insert with ease. Patient asked if needle had been inserted. I informed her it had not and I was going to use a different needle and syringe. Patient was then injected with the vaccine using Mckesson Prevent HT 1 inch 25 gauge needle. While sitting in the chair patient stated that she felt like she was going to pass out. Patient had a syncope episode while sitting in chair. Held patient up right. Patient came to after 5 seconds. Dr. and EMT at chair side. Vitals at (10:14) 94/51, pulse 60, and pulse ox 98%. Patient was continuing to be monitored. Vitals at (10:25) 99/54, Pulse 54 pulse ox 98%. Patient sitting the entire time. After the episode patient stated that she has a history of fainting with blood being drawn and injections. At (10:38) Patient pulse rate 60  Patient was monitored for an additional 40 minutes in observation before being cleared by Dr.
Pt described a film in throat, tightness in throat, mucus in throat, and reported nausea.  HR was 87, BP 142/90 RR 16, O2 sats on RA 99%.  Pt was reluctant to seek care but after nausea continued and pt became slightly SOB she agreed and went to the ER for treatment.  Pt was treated in ER and discharged home.
G40.901 EPILEPSY W STATUS EPILEPTICUS 10/14/2021 HYPERCHOLESTEROLEMIA G51.0 RIGHT BELLS PALSY 5/20/2021 HYPERCHOLESTEROLEMIA J96.00 ACUTE RESPIRATORY FAILURE 10/14/2021 HYPERCHOLESTEROLEMIA R29.810 RIGHT FACIAL MUSCLE WEAKNESS 5/20/2021 HYPERCHOLESTEROLEMIA
Given pneumovax right arm 10/17/03. Reports 12 hours later developed severe pain, redness and whelps. Seen in our office 10/20/03, right deltoid swollen, red with nodules x3 about 2cm.
MOST PROMINENT SYMPTOM OF NOTE:  HEART ISSUES AFTER VACCINATION   Day 1: Sore arm; gastrointestinal  Day 2: Sore arm; gastrointestinal Day 3: sore arm; tired muscles  Day 4: sore arm; heart palpitations, shortness of breath, chest pain, tight chest? temp:  100.3  (Resting heart rate is usually around 54 - 58BPM. Resting heart rate was 78 bpm) Day 5: period style bloating (May be unrelated or be kickstarting menstrual cycle early).  - Afternoon - nausea, cramps, stomach pain  - Evening - fever 99.1. Sore throat  Day 6: Tired; left arm numb and achy. Cramps  Day 7: Tired.  Fever 99.0  Day 8: Fever 99.0. Sneezy. White/yeast discharge  Day 9: temp normal. Sharp pain/shooting pain in chest. Major cramps. PAINFUL cramping. So painful. So painful cramping. Gassy. Stomach pain
Swelling and Erythema at site of injection - spreading daily to roughly 4"x4" circle by 7/8/2023.  Site is Painful and Itching.
Localized arm reaction at injection site: redness, swelling, warm to touch, "rash" appearance.  Patient is going to monitor reaction and apply cold compress to the area. Complaint of stomach pain that started Sunday evening.  No change in diet but did note that he had Celiac disease but has avoided gluten.
Pains in my heart/ sharp pain like in your lung like a growing pain/piercing pain; Headache; Arms numb in and off first couple days; one hive on my face; This is a spontaneous report from a non-contactable consumer (patient herself).  A female patient of unknown age received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route, on unknown date at single dose for COVID-19 immunization. No relevant medical history and concomitant medications were provided. The patient stated that when she went to get her first dose of BNT162B2 the pharmacist pinched her arm when inserting the needle, caller seeking information if is this the correct way to administer. The patient also reported that she sat for 15 minutes in the pharmacy after and then when she left she sat in her car for 10 minutes more and felt sharp pain like in your lung like a growing pain, but that it was low in her uterus, piercing pain happened several times over that day. Also at that time she experienced headache that lasted just a few seconds.  Other side effects reported were: arms numb in and off first couple days, pains in my heart, felt similar as when I may have had COVID mildly before, period felt like it was going to start but it never did. These all went away. Then on day 6 and 7 really bad headache 2 and a half hours headaches. Caller also reports one hive on my face last one day and went away. She is scheduled to get her second shot in about 4 days. The patient had recovered from the events on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/11/05 Swelling, bruising, tender to touch at injection site. Temp 100.6 on 10/12/05. Ice, Tylenol. 10/13/05 Right upper arm moderately swollen, slightly tender. Take Mobic; continue Tylenol.
Stroke; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), unknown dose via an unspecified route of administration, administered in Arm Left on 14Apr2021(at the age of 36-years-old), as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was other. Patient had taken Blood thinners and statin for reported events. Patient visited to emergency room/department or urgent care. On 30Jul2021 at 08:30 AM, the patient experienced stroke. The patient was hospitalized for stroke for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) was negative on 19Jul2021, sars-cov-2 test (Nasal Swab) was negative on 26Jul2021, and sars-cov-2 test (Nasal Swab) was negative on 31Jul2021. The outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Enlarged and weak heart. Shortness of breath. Very high heart rate 200 plus .all these affects started happening after 2nd shot . heart needed to be shocked to get correct heartbeat. Extreme fatigue. Very weak  and short of breath.
pt had vaccinia reaction to shot. Multiple raised and flat erythematous patches noted, as well as increased itching. Area diffuse over head, neck, ant and post truncal areas as well as abdomen, arms and legs. Tx: zyretec 10mg, prednisone 20mg 1 tab, calamine lotion, aveeno bath. Pt referred to Dermatology for  further eval.
Myocardial infarction RCA with immediate angioplasty. 100% occlusion. CFX and LAD totally clear. Initial troponin ~5.7 x ULN.
Narrative: Patient reported experiencing angina for ~6 weeks after receiving first dose of COVID vaccine. Patient received first dose at Facility- patient refused second dose. symptom first appeared day after receiving vaccine. Of note patient diagnosed with CAD and has previously experienced angina (2019) though follow up with cardiology since that time patient has been deemed stable.
TIA/ stroke; Migraines even worse; a lot problems like with her memory; Nausea; Confusion; It's almost like a headache right between her eyes; Left arm hurt like crazy; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 58-years-old female patient received bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: EN6106), via an unspecified route of administration on 18Mar2021 (at the age of 58-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included intervertebral disc degeneration, fracture cracked pelvic bone, Fibromyalgia, nerve compression. The patient's concomitant medications were not reported (patient takes unspecified blood pressure medications). The patient previously took BNT162B2 (lot/batch: EME198), via unspecified route of administration in left arm injection on 26Feb2021 as 1stdose, single for covid 19 immunisation. On an unspecified date, the patient experienced migraines even worse, a lot problems like with her memory, nausea, confusion, it's almost like a headache right between her eyes. On 18Mar2021, the patient experienced, left arm hurt like crazy. On 09Apr2021, the patient experienced tia/ stroke happened a couple of days after second vaccine. Hospitalized for 3 or 4 days. The patients was admitted on 09 Apr 2021. They have her on medications and stuff for it. The patient has not recovered and still having a lot problems like with her memory. She is still being treated for TIA.The patient states it has improved but it's going to be there and monitored and get tests and the doctor said it was ongoing and she has to be careful. On 18Mar2021 the patient went back to get her second dose, because things subsided. A couple days after her second shot she had a stoke. The patient had a TIA and went to hospital for that and went to her heart doctor and said that the vaccine caused the TIA and they recommend that not to take the vaccine again. The patient states she had no problems and had a heart check and everything before she had the injection and everything was normal. No medical problems. The patient states they put her on blood thinners on 24May2021. They ran all sorts of tests. MRI, X-rays, blood work and they said that it was due to the injection. And now she has to take blood thinners which she didn't have to take before. After all the tests the doctors decided the patient need to continue on a blood thinner. She was on a blood thinner when she was in the hospital. Therapeutic measures were taken as a result of nausea (nausea). Meclizine and anti- nausea prescribed on 12Apr2021. Meclizine 25mg, reports this puts her sleep, 30 count. Ondansetron 4mg, every 6 hours as needed,  230 count. The outcome of the event migraines even worse, a lot problems like with her memory, nausea, confusion was not recovered. The outcome of the event left arm hurt like crazy was recovered. The outcome of the event tia/ stroke was recovering. The outcome of the event it's almost like a headache right between her eyes was unknown.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Site: Pain at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Confusion-Mild, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium
Anaphylatic reaction. Coughing, Hives, Swelling on face. given shot of Epi .27cc subq.
Findings on clinical exam appear to be a zoster like rash. This is certainly possible in the setting of varicella vaccine and a varicella reaction. The chances of this occurring are in the order of 4-8 and 10,000. In my review it appears that no treatment is necessary. His symptoms are fairly mild and this should resolve on its own. We did discuss the importance of covering this and monitoring for signs of secondary infection with bacteria. He is also contagious, mildly so in contact with patient's that have not had chickenpox or are immunocompromised should be limited.
Pt recvd 2 doses of Hep B vax & w/2nd dose pt found to have liver function abnormalities w/SGOT & SGPT minimally elevated; The GTT was above 800, & alkaline phosphatase was also elevated; bilirubin was not done;
erythematous raised itchy maculopapular rash, some w/vesicular appearance;no fever
4cm(W)x 5cm(L) reddened elevated area left deltoid injection site - warm/tender to the touch Indurated/erythematous no drainage no SOB no Hives no generalized itching.
Had shots in AM.  Had seizure around 9pm - called 911.  Went to hospital - noted he had fever to 101.  Cousin also has hx of febrile seizures.
Reports tremors and pain to right arm and hand. Also reports joint pain, especially to right hip area. Reports generally "not feeling well".
Whole body tremors that affected ability to swallow, with fatigue and headache. Started about 12 hours after vaccine and lasted a total of 24 hours. No doctors visit was required.
No adverse events were reported. The patient received a 2nd booster despite not being eligible. She is under the age of 50 and reports she is not immunocompromised.
Left arm painful for two days. On February 15th woke with nausea, fatigue, lethargy, dizziness and vomiting.
BLOOD PRESSURE 30 POINTS HIGH 135/80; PAIN AT INJECTION SITE; HEADACHE; FEVER 100F; NAUSEA; BLOOD PRESSURE DROPPED; BODY ACHES; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on the Left Arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced blood pressure dropped. On 18-MAR-2021, the patient experienced body aches. On 18-MAR-2021, the patient experienced pain at injection site. On 18-MAR-2021, the patient experienced headache. On 18-MAR-2021, the patient experienced fever 100f. On 18-MAR-2021, the patient experienced nausea. On 03-APR-2021, the patient experienced blood pressure 30 points high 135/80. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure dropped on 01-APR-2021, body aches, headache, and nausea on 24-MAR-2021, pain at injection site on 03-APR-2021, and fever 100f on 22-MAR-2021, and had not recovered from blood pressure 30 points high 135/80. This report was non-serious.
12 year old patient received Moderna Booster inadvertently.  No adverse events (mother reported fatigue x 1 day and some arm soreness)
Headache, Myalgia, Chills, fatigue, injection site pain Narrative:
Body ache, muscle pain, stiffness.  All over.  Difficulty sleeping due to unable to get comfortable yet still tired.  Slight/minor headache.  Lasted just about one day. Felt fine after about 5:00 pm the day following the shot.
This spontaneous report was received from a medical assistant referring to a 29 year old female patient. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date in September 2016 and on an unspecified date in October 2016, the patient received the first and the second dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) both doses for prophylaxis. On 19-APR-2017, the patient was vaccinated with GARDASIL with lot # M014929 and an expiration date of 27-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
I felt kind of achy all over and I was running a fever of about 101 or so, it was enough that I did not feel like do anything other than sleeping it off. I woke up in the middle of the night with those sweats you feel when you have a fever and that went from hot to cold. This lasted a a few nights, the fever broke on April 13, 2021.
Hospital Course:    Patient is a 87 y.o. female patient of PRIVATE, MD with a history of 87-year-old female admitted with acute exacerbation of COPD chronic lung disease, patient received aggressive pulmonary care and responded including IV antibiotic steroid stable cardiopulmonary status type 2 diabetes mellitus blood sugars were running in the upper 100s range.  Patient remained stable during the hospital stay and discharged home in stable         Discharge Diagnoses: COPD acute exacerbation  Patient with 1.  COVID-19 infection 2.  Respiratory failure, 3.  Suspicion for pneumonitis  Patient currently on p.o. dexamethasone for a 10 day course. Status post DC IV remdesivir   Chronic lung disease acute exacerbation of COPD respiratory tract infection Type 2 diabetes mellitus Osteoarthritis
PATIENT DESCRIBED FEELING DIZZY AND NAUSEA ABOUT 30 MINUTES AFTER RECEIVING VACCINE. SHE WAS MONITORED FOR AN ADDITIONAL 15 MINUTES AFTER WHICH SHE DESCRBIED FEELING BETTER AND RETURNED TO WORK WITH NO FURTHER COMPLAINTS.