chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not eat anything; extremely nauseas/Nausea was reported as worsened; feeling really bad/ feels like she got hit by a car/head feel like going to explode was reported as worsened; feeling really bad/ feels like she got hit by a car/head feel like going to explode was reported as worsened; body aches/progressively aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: Reporter stated her mother has had this for 30 plus years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Reporter stated her mother had received the first dose with no issues.), for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: NAUSEA (non-serious) with onset 13Apr2021, outcome "unknown", described as "extremely nauseas/Nausea was reported as worsened"; FEELING ABNORMAL (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 13Apr2021, outcome "unknown" and all described as "feeling really bad/ feels like she got hit by a car/head feel like going to explode was reported as worsened"; PAIN (non-serious) with onset 13Apr2021, outcome "unknown", described as "body aches/progressively aches"; FEEDING DISORDER (non-serious), outcome "unknown", described as "not eat anything". Therapeutic measures were not taken as a result of nausea, feeling abnormal, condition aggravated, pain, feeding disorder.  Additional Context: . Reporter stated her mother got the second shot yesterday and has increasingly had feelings of nausea, head feel like it is going to explode, and feels like she got hit by a car because her body aches. Reporter stated the symptoms started yesterday within a few hours of receiving the vaccine. Nausea: Reporter stated she spoke with her mother a little while ago and she can not eat anything because she is so nauseous.  feels like she got hit by a car because her body aches: Reporter stated her mother has a lot of aches that are progressively aches. Reporter stated her dad had to help her mother get out of bed. Treatment: Reporter stated no because she is not sure if she is able to take anything. Time the Vaccination Was Given: Reporter stated her mother received the second dose around 12:00 and the first dose was received sometime in the morning. The patient did not had prior Vaccinations within 4 weeks. The patient had no AE(s) following prior vaccinations. No family medical history relevant to AE.Reporter stated her dad is high risk.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
was caused to suffer pain as a result of  Shingles, including any and all of its sequelae.; Information has been received regarding a case in litigation and refers to a 76 years old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-JAN-2018, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis. Subsequently, in August 2018, the pt was caused to suffer shingles, including any and all of its sequelae. As a result of the foregoing acts and omissions, the pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The outcome of the event shingles was considered to be not recovered. The causality was related.
Severe pain and heat at injection site and sore muscle of arm and shoulder, numbness of fingers and poor grip, unable to use right arm.
VARIVAX vaccine given in (R) subcutaneous tissue on 5/5/14 and employee reported redness, pain, swelling at site on 5/6/14. She followed up on 5/7/14 with PA at office and was given BENADRYL PO, ibuprofen, and steroid cream (topical). T-98.6 orally. Measures 70x40 mm.
Patient received HPV vaccine (3rd dose) in series on 7/22/09. A few minutes after receiving vaccine she felt dizzy and drop in BP to 81/46 from 106/73 noted.
No additional AE/PQC reported; expired PROQUAD was administered to a patient yesterday 3/22/2022; This spontaneous report was received from a certified medical assistant (C.M.A.), referring to a 4-year-old patient of unknown gender. Information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 22-MAR-2022, the patient was administered expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) lot number: T031825, expiry date: 16-MAR-2022 (dose, strength, frequency, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event (AE)/product quality complaint (PQC) reported (no adverse event). The reporter confirmed Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) had no prior temperature excursions.
it has been same but different of course they are little black and blue but not the same, the circles are round are still as dark; I have a very strange circles that goes around injection site; like a inner circle that the medium circle; looks like galaxies it looks like a moon and then around it there's a circle; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old female patient received BNT162B2(COMIRNATY, Formulation: solution for injection, Lot number: was not reported), via an unspecified route of administration on 27May2021 14:30, as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced it has been same but different of course they are little black and blue but not the same, the circles are round are still as dark and she have a very strange circles that goes around injection site; like a inner circle that the medium circle; looks like galaxies it looks like a moon and then around it there's a circle. It was reported as, she have a very strange circles that goes around injection site, it's not like the black and blue that's been happened, the needle went in very very fast and that was painful but she had circles around the injection site like a inner circle that the medium circle and it's still the same as of now almost 2 weeks. The consumer stated, she didn't receive treatment, because there's no pain it doesn't hurt. The outcome of the events were not recovered.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Pt has redness, swelling and tenderness to injection site. Pt went to ER the day after administration, dx with cellulitis, given ABX, seen here the following day (2 days later).
Tachycardia/Heart rate was 105 thru the night; Have fever 99.7deg F, myalgia, chills; myalgia, neck muscles hurt; Have fever 99.7deg F, myalgia, chills; a bad headache; slight dizziness; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced tachycardia, fever, myalgia, chills, headache and dizziness. On an unknown date, the outcome of the tachycardia, fever, myalgia, chills, headache and dizziness were unknown.   It was unknown if the reporter considered the tachycardia, fever, myalgia, chills, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine the night before reporting. The patient's heart rate was 105 through the night, at the time of reporting it was 97.  The patient had fever 99.7 degree F, myalgia, chills and neck muscles hurt. The patient had a bad headache and slight dizziness when the patient got out of bed in the morning of reporting day. The patient inquired if there was a situation down the road when they would need to get a booster. The patient also stated that a search revealed that tachycardia was a form of severe allergic reaction and their doctor would likely to advocate Tylenol.  The patient was resting in the bed at the time of reporting. The patient provided the consent to follow up.
experienced a metallic taste; This case was reported by a pharmacist via call center representative and described the occurrence of taste metallic in a 32-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 2BB77, expiry date 30th June 2021) for prophylaxis.   On 19th August 2020, the patient received FluLaval Tetra 2019-2020 season. On 19th August 2020, 30 min after receiving FluLaval Tetra 2019-2020 season, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was unknown.   It was unknown if the reporter considered the taste metallic to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient experienced a strong metallic taste approximately thirty minutes after receiving a dose of Flulaval.  The reporter consented to follow up.
Sore L arm at injection site alone with--Headache, body aches, chills, burning eyes, stinging in my joints,fatigue--all similar to when I had covid 19 in April of 2020.  Symptoms started approx. 20 hrs after the vaccine and lasted 24 hrs.  I took acetaminophen 650mg x 2 tabs every 6 hrs
Appears to be spreading down the arm. Raised red rash on front and back, right, shoulder.
fever; severe shaking; This case was reported by a consumer via call center representative and described the occurrence of fever in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and tremor. On an unknown date, the outcome of the fever and tremor were unknown.   It was unknown if the reporter considered the fever and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had severe bad reaction of fever and tremor. The reporter asked if she should get the second dose of Shingrix and if she would experience the adverse events again.
Pt recvd 3 engerix-B doses & was determiend to be a non-converter;
Discharge Provider:  Primary Care Provider:  Admission Date: 12/18/2022 Discharge Date: Dec 31, 2022 COVID positive date: 12/18/2022 PRESENTING PROBLEM: Weakness [R53.1]   HOSPITAL COURSE: Pt. is an 84 year old male, past medical history of prior CVA with residual left sided weakness, expressive aphasia attributed to CVA and possible chronic progressive aphasia, dementia and BPH who presented to the ED for evaluation of multiple falls in the recent weeks and generalized weakness. He was admitted due to need for rehab placement. CT head/CT cervical through lumbar spine/bilateral tib-fib x-ray were grossly unremarkable. He was found to be COVID-19 positive and mildly symptomatic with low grade fever and cough. Chest xray was unremarkable and he was treated supportively. Other work-up for etiology of fall was unremarkable including basic labs, blood cultures, urine culture, orthostatic vitals and recent TSH. He had unwitnessed  while inpatient but CT head was negative and sustained no injuries. His mental status fluctuated but overall remained at baseline per family. DPOA was activated this admission via two physician signature.   PT/OT consulted and recommended SAR. Patient remained in hospital to complete COVID isolation which ended on 12/29. Discharged to SAR in stable condition on 12/31   Patient did have 3mm pulmonary nodule noted on routine imaging. Advised follow up with PCP for outpatient CT scan in 12 months for further eval
Was seen in ER with 102.2 fever, shaking, nausea increase, heart rate head ache and neck pain.
This consumer spontaneous report (intial receipt 29-Jul-2014) concerns a female patient. On an unknown date, the patient received AFLURIA (batch number not provided). On an unknown date, the patient developed the flu the day after receiving AFLURIA. It occurred on two separate occasions (specific dates unknown). Outcome was reported as unknown.
Large reddened round area about 3 inches in diameter at injection site appeared 8 days after vaccination
My arm at the site of the vaccination has been sore for almost one year now. I will feel it sporadically throughout the day. There are times when it pulses. I put a heating pad on it and it was rapidly pulsing. Feels much different than the other arm and it is noticeably near the vaccine location in the upper arm. I have noticed that the more I feel it, the more unwell/sick I feel. I have considered getting leeches or doing something to counteract this problem.
Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches, slight tingling on the tongue, and eventual loss of voice over the subsequent two days. The on duty nurse who had administered the shot, strongly suggest that I drink lots of water and take Tylenol. March 6 and 7, my voice was to a whisper; however, the body aches and tingling of the tongue had subsided. I was extremely exhausted and unable to speak above a whisper on March 8, but did not experience any of the aforementioned side affects. Today, March 9, my voice is back above a whisper, with intermittent hoarseness.  I will continue regiments of rest, Tylenol, hot tea with crushed ginger. It is important to note that my breathing had not been affected since having taken the 2nd shot on March 5, 2021.
left arm swelled, turned red and progressively spread around arm from just below shoulder all the way down to just above elbow and underarm to side of breast
child developed urticarial rash consisting of red wheals on face to neck occurring 10-12 hrs /p immun. given. Child had no other sx or abnormalities on exam & rash subsided immediately /p giving oral diphenhydramine
Bruise where he got the shot; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK9231, expiry date: unknown), via an unspecified route of administration on 07Jan2021 at single dose (left arm) for COVID-19 immunization (Over 65 years old; 2nd group to receive in state). The patient medical history was not reported. There were no concomitant medications. Patient got the COVID Vaccine last Thursday (07Jan2021). He had soreness in his arm, which is fine, but when he took the Band-Aid off he had a bruise where he got the shot (13Jan2021). His wife told him he should call and report this. About the arm soreness, it was really sore the first couple of days. The nurse said if he moves his arm and works it, it would help. It was sore for about 2-3 days. Sore to the touch, but not painful. There were no treatment given. They were asking if they should contact his physician, if this is normal. He has had vaccines before, but never had a bruise. The outcome of the event Bruise where he got the shot was not recovered, while for other event was unknown.
I had a severe headache that was unbearable with so much pressure. I thought it was sinus related and took medication and it wasn't helping. I went to work and was sent home. I took a at home COVID-19 test. I had a really bad runny nose and sneezed a lot. On a scale of 1-10 my symptoms were about an 8. They started June 29th to around July 12th.
"Local" 8-10cm cellulitis area day post immunization on R thigh (+) induration, warmth, pain, and fever.
Patient came in to observation complains of itching of chin, and both arms after vaccination at 3:35pm, initial vitals were taken, and kep monitored, no signs and symptoms of distress or trouble breathing. Advised patient to switch his kn95 to surgical mask. 10 mins after monitoring, patient complains of itchiness of both legs and face. Second set of vitals were taken, no signs of distress and continuous monitoring. Then the patient complains itchy sensation of the tongue and have no difficulty breathing and vital signs are stable and within normal limits. The itchiness did not got better and benadryl IM was administered on his left deltoid , patient was continuously monitored. Patient was informed that for his second dose he may need to go to a medical equipped setting to get his vaccine. No EMS were called. Patient was escorted to take the taxi home. Vital signs remained stable. Nurses informed patient to monitor his condition, and go to seek urgent care if condition get worse. Patient stated he felt stable, comfortable  and better when he left the vaccine center.
After both shingrix doses still got shingles/Suspected vaccination failure; shingles in both thighs and groin area; Shingles not as painful as others; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-JUN-2022  Reporter's Comments: This case was received from the patient's wife via interactive digital media. The patient had the original shingles vaccine and both Shingrix doses a few years later.  The patient still got shingles on both thighs and groin area.  Fortunately for him it only lasted a couple months and not as painful as what others experience       Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were.
Urticaria on arms and trunk developed 2 days after injection, not near site of injection.
pain and stiffness in joints of hands, feet, legs, and arms inflammation and swelling, diagnosed by physician as rheumatoid arthritis
Information has been received from a licensed practical nurse concerning a 69 year old white female patient with a history of uterine cancer and hysterectomy who on 07-NOV-2007, was vaccinated IM  with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot #658075/0962U). Concomitant therapy included simvastatin (MSD) and DIOVAN. On 08-NOV-2007, the patient experienced swelling and inflammation of the right arm. There was a ring around the whole arm. It was hot to the touch at the area toward the middle of the arm and elbow. The physician prescribed NAPROSYN 375 mg, twice a day. The area was really red and raised. The whole arm was wrapped in bandage and the patient had been applying ice to the arm. No laboratory diagnostic studies were performed. At the time of this report, the patient had recovered. It was reported that this was a non-serious event and that the patient was not hospitalized. No product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information is not expected.
Patient received Hepatitis A on 6/5/17, on 6/7/17 patient came hoe from daycare clingy & with fever up to 39.3C. Fever continued for 6 days.
Patient was given vaccine after completing consent and Prevaccination Checklist for COVID-19 vaccines. Provider was in room with patient after vaccine. Provider reports patient stood from bed and moved to chair. Provider reports patient had a seizure that lasted 4 minutes per provider and a 10 minute postical phase. Provider palpated heart rate and reported patient went in to afibrilation. EKG was performed and ambulance called. Patient transported to ED.
This spontaneous report as received from a medical assistant refers to a 4 years and 9 months old male patient. The patient's pertinent medical history included allergic rhinitis. Concomitant therapies included cetirizine hydrochloride and ibuprofen. The patient did not have any drug reactions or allergies. On 20-NOV-2015, while attempting to administer a dose of VARIVAX (dose and route were not reported, lot # reported as L023549, expiration date: 26-JUN-2017), the child "pulled away" causing the needle to scratch their skin and resulting in a partial dose administered. It was unspecified how much vaccine, if any, was administered. The outcome of scratch was reported as recovering. There was no treatment given for the events. No laboratory tests were performed. The relatedness between scratch and VARIVAX was not reported. Additional information has been requested.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a four-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
PATIENT RECEIVED COMIRNATY VACCINE ON 9/26/23, WHEN THE PATIENT RETURNED ON 10/3/23 FOR HIS FLU AND PNEUMONIA VACCINATIONS THEY RECEIVED AN ADDITIONAL COMIRNATY  0.3ML DOSE INSTEAD WITH THEIR fluzone HD VACCINATION
I awakened this morning after a good nights sleep but feel very tired and exhausted.  All else seems normal.
Patient stated she had a sore deltoid for about 2 weeks and was counseled that is a common side effect. After several days the pain transitioned to her elbow. She has weakness in her elbow since the time of vaccination (~2 months). She has taken ibuprofen and TYLENOL to help treat.