chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild
Swollen painful lymph node in left armpit (size of a small orange), small painful nodes in left breast,  101.9 fever for 2 days. body aches, chills
Had the shot twice and has still gotten shingles after the shots/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot twice and has still gotten shingles after the shots/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient's friend via interactive digital media. The patient has had the shot twice and had still gotten shingles twice after the shots. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
He got his vaccine, everything was fine as far as he could tell.  He went back home and then he went about his day, worked in the garden.  He came in the evening about 4 hours later and then he started feeling weak, kind of shaky, in fact that he was shaking going to bed.  Eventually that settled down, and he was tired and went to bed around 9 or 10:00 PM.  Then when he woke up on Tuesday he was still a little weak feeling, but he went about his normal activities for the day and got to feeling better and better.  He is feeling better today.  He said it was having a dose of flu.    He also had a similar reaction to his flu shot last year.
Patient received 0.5ml dose of the booster of Moderna rather than 0.25ml.
12/20 - symptoms presented as possible right ear infection.   12/21 - began taking Amoxicillin 875MG 2xdaily 12/25 - presented in urgent care, for treatment of worsening ear infection.  In addition to Amoxicillin,  Prednisone was prescribed.  Did not fill or take the prednisone on 12/25 due to Christmas Holiday and no open Pharmacies. 12/26 Awoke with Bells Palsy on right side of face.  Went to ER. Was diagnosed with Bells Palsy and potential ear swimmers ear. Placed on and began taking the following medications on 12/26/2020. Prednisone 10MG Tablets taking 4 tablets every day for 2 days, 3 tablets every day for 2 days, 2 tablets every day for 2 days and 1 tablet every day for 2 days CIPR/DEXAMETH 0.3-0.0% OTIC SUSP - instill 2 drops into right ear twice daily for 7 days. AMOX-CLAV 875MG VALACYCLOVIR 500NG Bells Palsy impacting right side of the face.  Symptoms began 12/20, presenting as possible right ear infection.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication were not provided. On 03-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (expiration date: 06-AUG-2016) (dose, route of administration and lot # were not provided). Additional information is not expected as reporter declined to participate in follow-up collection process.
Pericarditits, mild chest pain, positional, pleurtic chest pain  reviewed ECG with cardiology who recommended treatment for mild pericarditis with ibuprofen tapered dosing  had abnormal ECG
pt recv vax 7SEP95 sl fever 9SEP; 10SEP 430PM gen tonic clonic sz w/t104+; taken to hosp ER-nl exam, CBC, UA, lytes, glucose, BUN, creatinine; 11SEP exam WNL; imp febrile convulsion prob unrelated to vax
After a week I have started to itch throughout my whole body. On my head neck back, chest arms, legs , feet. I feel like I have  head lice . Seems to be getting worse. Sometimes feels like needles pricking me or something biting me.   Changed my hormone pills at the same time so I?m not sure if it is this
I started having body ache, headaches, tiredness, soreness after the vaccine. The sever headaches continued for several weeks after the vaccine
After injections were given baby went limp and eyes rolled back. Baby recovered after a short time 30 sec to 1 minute.
5 RAISED PAPULES, SMALL, ABOUT 1CM IN DIAMETER, ON UPPER LIP, CHIN, AND NECK STARTING ABOUT 2 HOURS AFTER VACCINE ADMINISTRATION.  NO SOB, NO TONGUE SWELLING, NO SECONDARY ORGAN SYSTEM INVOVLEMENT.  RESOLVED AFTER 45 MINS OF OBSERVATION AND 50MG OF ORAL BENADRYL.  NO OTHER NEW EXPOSURES, FOOD OR OTHERWISE TODAY, THESE ARE BOTH OF HIS FIRST SHOT IN SERIES.  VERY SMALL LOCAL ERYTHEMA TO YF INJECTION SIDE ON LEFT UPPER ARM, ABOUT QUARTER SIZED ERYTHEMATOUS AREA, NOT RAISED, NO WHEAL, NOT WARM.
Next day following vaccine : morning headache, later afternoon fatigue, muscle aches and joint pain, evening slight  fever and chills
Patient started coughing and complained of difficulty breathing 15 minutes after getting the vaccine. Observation room nurse checked her vital signs immediately. BP 170/100; HR 75; O2 sat 99%; RA pain 0/10. No signs of allergic reaction noted at this time. No major medical problem, history or any type of allergic reaction per patient. Patient was instructed to remove the mask and try to inhale through the nose; exhale through the mouth (to help with breathing) and decrease anxiety level. Did not notify the paramedic since patient vitals were stable and stated she is feeling better. Patient was instructed to lay down and checked her BP again. BP was 150/97. Patient was monitored for 15 minutes in the observation room; educated on symptoms of allergic reaction and encouraged to follow up with her HCP regarding high BP.
Pt was in 15 minute waiting  period and suddenly collapse out of seat; she was immediately assisted by pharmacy staff who also alerted EMT based on patient's rapid breathing; No Epi was needed. Cold pack put to pt's head and nape of neck & oximeter placed on finger until EMT arrived about 10 minutes after call. Pt was not taken by EMT; Left with mother and brother
3:30 in the morning freezing cold chills/ dry heeves/ aching bones and body/ couldn"t keep food down /or take any meds/had to miss work/ disoreinted/ just kept sleeping all day and night felt better the next morning... went to work on Thursday 05/ 06/ 2021 felt about 95 % better in about 24 hours......no food and no meds and very week....feeling better now, besides tender stomach from dry heeving
Received the vaccine on 2/15/21 at 10:15 am in Left upper arm. Went to bed at approximately 11:00 pm. Started with body chills at approx. 11:00 pm. off and on during the night. Woke up the next morning with muscle and joint aches and feeling weak. Took an Arthritis Strength Tylenol at approx. 8:30 am. on 2/16/21. Felt better but still weak and some muscle aches. So took another Tylenol Arthritis Strength at appprox. 4:30pm. Improved that evening. The next morning symptoms of slight weakness only. Did not take any more medication other than regular daily meds.
weight loss, muscle weakness, abnormal crp level and liver test, loss of appetite, bed bound, falls, and unable to get up from floor. unable to make meals, dependent on care giver for food meals
This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date in July 2012, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot# and expiration date not reported). On 10-MAR-2015 the patient was in the physician's office to be vaccinated with the second dose of GARDASIL, which would be late. There were no symptoms reported. Additional information has been requested.
STORA IN REFRIGERATOR( 2-8)UP TO 30 DAYS .(VACCINE USED AFTER 10/16/2021.
Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The consumer stated that he received Shingrix and had 3 days of side effects. The reporter did not consent to follow up. The consumer refuses to provide any further details regarding this adverse event at the time of reporting.  The reporter stated that he might call back to update this case after speaking to his health care professional. The reporter stated that he would like his personal information to not be a part of this report. For the tolerances of 2nddose, refer case US2019AMR137275.
Wrong vaccine. I gave a booster 0.25mL dose of Moderna vaccine rather than the intended 0.2mL dose of Pfizer for 5-11 age group.  Patient tolerated the vaccine well during the observation period.
rapid onset of red, hot and bumpy rash on arm where shot was administered.  Size about 4 inches in diameter. Took benadryl and iced area. Area as of now still same and it itches. Today rubbed in some cortisone -10
Patient received her shot on 1/13/2021 at 11:20am.  12 minutes later she started getting very dizzy. Her face was very red. She was extremely hot. Patient first bp was 140/101 with a pulse of 75. We continued to monitor her for the next 1 hour and 20 minutes until family arrived because she refused for us to call 911 because she did not want a bill. Every time we sat her up she was extremely dizzy. BP was 160/107 when she sat up on the bed. Her husband ended up taking her to the ER because she was still very hot and dizzy. Dr. was here. He listened to her breathing multiple times. There was no signs of allergic reaction. Patient reported a history of panic attacks.
Swelling, redness, itching, soreness, and heat around injection site 8 days after injection. Still experiencing. Will be patient and wait for it to go away.
vomiting; head ache; shortness of breath; dizziness; cold; My wife fell a little chill after the vaccine; This is a spontaneous report received from a contactable consumer. A 66-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 at 01:30(at the age of 66-years-old) as SINGLE DOSE for covid-19 immunisation At Public health clinic/veterans administration facility. Medical history included Diabetic, covid-19 (all from an unknown date and unknown if ongoing). Concomitant medication(s) included carvedilol; atorvastatin calcium; amlodipine; canagliflozin (INVOKANA) (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient did not allergies to medications, food, or other products. On 26Mar2021 at 15:45PM, the patient experienced a little chill after the vaccine. At around 1am 27Mar2021. She experienced chilled, vomiting, headache, shortness of breath, dizziness. Until 9am she still cold and chill. No treatment was given for the events. The outcome of the events was recovered with sequel.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported some ankle swelling in the left leg the morning after vaccination. no other events were reported.  on seeing the ankle it was visually a little larger than the right ankle. pt was not too worried and had already contacted PCP with photo, I advised a follow up with a PCP and to go to urgent care if it got any worse.
I had the vaccination 07/18/2022. On 08/02/2022 I started to experience a visual aura again. It was similar to blurry horizontal line that increased in blurriness and waviness for about an hour. After that hour, it disappeared. I did a telephone consult and Dr. stated to monitor.
This case was reported by a nurse and described an 18 year old female subject who did no respond to vaccination with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On 10/14/2004 the subject received the first dose of Engerix B (lot ENG5586A).  11/15/2004 the subject received the 2nd dose of Engerix B (lot ENG5586D). On 6/27/2005, the subject received 3rd dose of Engerix B (lot AHBVB074BA). This is longer than the recommended interval of six months between the first and third dosed of Engerix B. Approximately six weeks after the third dose of Engerix B, on or before 8/15/2005, a hepatitis B surface antibody titer indicated that the subject, did not seroconvert.
Injection reaction.  Redness, itchiness, and leathery patch over injection location.
patient received both VAXELIS and Engerix-B yesterday and wants to know if the manufacturer has any recommendation; This non-serious spontaneous safety report, with reference number 2023SA282138 (Inquiry# 01767327), was received by the partner on 14-SEP-2023 and forwarded on 15-SEP-2023, from a health professional.     Due to the nature of the event, the causality between the event "patient received both VAXELIS and Engerix-B yesterday and wants to know if the manufacturer has any recommendation" Vaxelis was not applicable.  Further information is expected.
Pfizer vaccine was administered on 6/30/21. On 7/1/21 mother reported that the patient was feeling fine, just a sore arm. On 7/9/21 mother reported that the patient is experiencing malaise and a sore arm.
sore arm; pain moved to the back of the neck; headache; terrible toothache; ear pain; eye pain; pain was mostly left side; whole body felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NECK PAIN (pain moved to the back of the neck), HEADACHE (headache), TOOTHACHE (terrible toothache) and EAR PAIN (ear pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029az1a and 016bz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history. and concomitant drugs are provided.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (pain moved to the back of the neck), HEADACHE (headache), TOOTHACHE (terrible toothache), EAR PAIN (ear pain), EYE PAIN (eye pain), PAIN (pain was mostly left side) and FEELING ABNORMAL (whole body felt terrible). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache), TOOTHACHE (terrible toothache), EAR PAIN (ear pain), EYE PAIN (eye pain), PAIN (pain was mostly left side) and FEELING ABNORMAL (whole body felt terrible) had resolved and NECK PAIN (pain moved to the back of the neck) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information was not provided. Lab details were not provided.   This case was linked to MOD-2021-121822 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 Outcome of the events added. 2 nd dose information added. Concomitant product added. Patient demographics added(Height, Weight, Race)
Myalgia, Arthralgia, Fever, FATIGUE, SWEATS, CHILLS, Narrative:
Breakthrough case admission after 2 vaccines Moderna 2/26/21 Lot# 023M20A;  Moderna 3/26/21 Lot# 018B21A
Patient with intellectual disability received his vaccine on 1-7-2021 in his right deltoid.  On 1-11-2021 it was noted that he was developing a rash on his right ear/cheek area and a raised red rash near the sight of his vaccine by the attending nurse on 1-12-2021. is unable to verbalize his symptoms, an anatomical diagram was completed by his nurse on 1-12-2021, noting continued redness on the right side of his face and his right upper arm.  Photos were also taken to archive this.  His PCP was notified and an order was received to give a dose of diphenhydramine at approximately 1:30 PM on 1-12-2021. By 1-15-2021, the arm and facial redness had resolved per patients nursing notes.
Initial solicited report received on 08 March 2017 and follow up information received on 13 March 2017 from an investigator in a trial. A 22 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 04 August 2016. On 23 August 2016, 19 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified, and on 15 August 2016, 11 days post vaccination the subject was diagnosed with I40.9 Acute myocarditis, unspecified. The lab data included within 30 days post vaccination, the Troponin I, ECG, Echocardiogram were not available, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 22-year-old male who developed acute myocarditis and acute pericarditis with favorable temporal association post vaccination with ACAM2000. Myopericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be pulmonary edema, pulmonary embolism, aortic dissection, esophageal rupture and pneumothorax. History of allergies or trauma was not reported. Based on missing additional information on confirmation of diagnosis with CK-MB assays, myocardial biopsy, role of study vaccine can not be ruled out.
Low grade fever X 2 days. Muscle fatigue, muscle weakness, joint aches, body aches, headache, generalized fatigue X 5 to 7 days.
Case number PHEH2015US019563, is an initial spontaneous report received from a healthcare professional on 30 Sep 2015. This report refers to a 55 year old male patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that the FLUCELVAX vaccine was stored at room temperature for 24 hours and then it was administered to the patient. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
first dose of bnt162b2 on 01Dec2020, patient was due for their second dose 30Dec2020; first dose of bnt162b2 on 01Dec2020, patient was due for their second dose 30Dec2020; patient had a positive COVID test, contracted Sars-Cov-2; patient had a positive COVID test, contracted Sars-Cov-2; This is a spontaneous report from a contactable Nurse from a Pfizer-sponsored program. A 48-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 01Dec2020 at a single dose for COVID-19 immunization. There was none medical history or concomitant medications. The patient received the vaccine on 01Dec2020, and then on 15Dec2020, patient had a positive COVID test, contracted Sars-Cov-2, and was due for their second dose 30Dec2020.  She was supposed to get her second dose at the end of Dec2020, but she did not return. She stated they were caught in the middle. The patient did return for her second dose with her employer, but they turned her away. The patients second dose was supposed to be on 30Dec2020. Suspect product: Caller does not have the NDC, lot, or expiration date to provide from the first dose that the patient received. There was a Product Complaint. This is a non-serious report. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  and suspected LOE  due to temporal relationship.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  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.
For the past several weeks, my Blood Pressure has gone way up.  My Doctor had me do blood test, it came back - good. It sometimes went to 167/101 extremely high and I feel flushed in my face all the time. I see my Doctor on November 2nd, 2021. Doctor just prescribed Hydroxzyzine HCL 25 mg today for the anxiety I am experiencing worrying about this medical condition of high blood pressure.  I am not positive the problem I am experiencing is from the vaccinations (3) I received but it happened shortly afterwards.  Was hospitalized one day in early march because my BP went so high.
There was not an adverse event to the vaccine. The dose was given at 1 yr old which is 3-6 months earlier than recommended.
Headache after 4 hours, body and joint aches, fever of over 101 at 3 am and sharp bone pain on shins.  Day two fatigue, weakness of muscles and joint pain.
Was feeling lightheaded for one and a half hours and the next day I was feeling sluggish most of the day
local erythema, induration + tenderness approx 1.2-1.4 cm diameter-inc skin temp
First dose no pain with left arm injection, took 10 hours for my injection arm to hurt, soreness lasted 24 hours with no other sx's. Second dose,  left arm injection site hurt immediately, went to sit in observation room,  started to feel numbness/tingling in left arm, hand and fingers (like it was asleep).  No other sx's at this time,  Charge Nurse notified and observed me for an hour then released.  Pain noted into left arm pit 3 hours (rating pain a "9") after injection, numbness/tingling in left arm/hand/fingers lasted 6 hours.  Took 2 Tylenol at 2100 before bed.  Woke up at 0250 with chilling, nausea and aches all over. Tingling/numbness gone at 0250. Left arm extremely painful now at 0949 on 2.11.21 rating pain a "8".  Hard to lift left arm.  No temperature, chilling continues with nausea and generalized muscle aches.  Continuing with Tylenol 650mg every 6 hours