chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've now tested COVID positive again; I've now tested COVID positive again; Sinus congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FINASTERIDE. Past drug history included: None. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "not recovered" and all described as "I've now tested COVID positive again"; SINUS CONGESTION (non-serious) with onset 28May2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: COVID-19: (23May2022) Negative; (27May2022) Negative; (28May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, sinus congestion.  Clinical information : Other medication in 2 weeks of vaccination : Finasteride. There were no Known allergies. It was reported that after taking Paxlovid for 5 days, I started to test Covid negative on Mon 23May22 (my fifth day) and my symptoms mostly stopped. I then tested negative every day through Fri 27May. But today I started to develop a cough and some sinus congestion, and I've now tested Covid positive again.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Information was received on 16-AUG-2017 from a lawyer regarding a female patient of unknown age. On 18-AUG-2015, the patient received a dose of ZOSTAVAX vaccine for its intended purpose: the prevention of shingles. On or about 29-AUG-2015, the patient developed an itchy rash on her trunk and upper extremities. The patient's condition got so bad that she had to be hospitalized on 03-SEP-2015. Subsequently, the patient required various treatments and medications for her condition. In late 2016, the patient was again hospitalized for this condition. The patient continues to experience a recurrent rash. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct use of ZOSTAVAX. The patient paid for the ZOSTAVAX for the purpose of preventing shingles and the patient has not received the safe and effective vaccine for which she paid. Itchy rash on her trunk and upper extremities and recurrent rash were disabling. Additional information has been requested.
Patient experienced weakness, tingling , pain in legs for about 15 minutes 20 days after first shot, then experienced the same thing again and could not physically walk for 15 minutes and continued experiencing pain, then it subsided. and has not recurred. patient does not have a primary care provider to report to.
Pt had nosebleed less than 1 hour after receiving  Moderna COVID vaccine booster lasting 10-15 minutes.  Pt reported a copious amount of blood out of nose and down throat.  Pt reported to have never had a nosebleed before.  Occurred at pt's home.
ST-elevation myocardial infarction secondary to coronary thrombus. Patient reported chest pain, midsternal w/ radiating to back and arm, onset 1130 on 10/27.
I received a flu shot Friday afternoon, Dec. 10, 2021, at 1450. The shot itself felt different than previous years, in that it burned a little when it was administered (typically I hardly feel it). And when the medical technician went to put the bandaid on it, stated she couldn't see where it was because there was no blood, which I didn't really think anything of at the time. When I got home, my upper arm was sorer than it's ever been after any vaccination. Usually I hardly feel any soreness, and it remained very sore in my upper arm the next couple of days. I was also concerned about the tingling which I started getting right after I got home from the clinic. My arm where I got the shot was feeling sore then numb and I started to feel tingles in the opposite hand, which was odd to me since that wasn't the side I had gotten the injection. I wasn't sure what this was so I googled and have not googled since so I don't stress myself out because it showed flu shot reactions that could lead to paralysis and certain conditions. I called the clinic to tell them what I was experiencing. The person on the phone told me she would ask the provider and then informed me the provider said to monitor my symptoms and gave me the number of the after hours clinic.  I woke up in the middle of the night and my arm was feeling numb and the opposite arm was feeling tingles. I called my parents very anxious about these symptoms who prayed with me about it and I finally went to sleep. The next morning (Sat-Dec 11), as I went on with my day, I felt very fatigued, sore, headache and I was getting little needle-like tingles every so often in my legs, spine, neck, arms, hands. I would also feel a seldom quick warmth in an area and have been experiencing minor numbness. These tingles and some numbness with warmth in areas have continued since then lasting only a short duration but every so often in various places in my body throughout the day, even in my face, brain area, spine, legs, hands, arms, everywhere for the tingles.
I have never had bladder problems in my life until the 2nd dose of Moderna. 8 days after this injection, I began having severe bladder pain with no clear cause. I am on a social media support site for people with bladder pain and many other sufferers report that their bladder problems also began with receiving the COVID-19 vaccine.
PATIENT CLAIMS ENTIRE LEFT UPPER ARM RED AND SWOLLEN, FEVER/CHILLS, NAUSEA, HEADACHE, AND NUMBNESS IN HER LEFT THIGH
CHEST (RIBCAGE) PAIN; KIDNEY PAIN; HURTS TO BREATHE; ABDOMEN PAIN; SEVERE BACK PAIN; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced chest (ribcage) pain. On APR-2021, the subject experienced kidney pain. On APR-2021, the subject experienced hurts to breathe. On APR-2021, the subject experienced abdomen pain. On APR-2021, the subject experienced severe back pain. On APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe back pain, hurts to breathe, severe headache, abdomen pain, chest (ribcage) pain and kidney pain was not reported. This report was non-serious.; Sender's Comments: V0: As per standard protocol ,MAC comment is not required for non-serious cases
Pt in office today (01/05/2022) to report that she has had an adverse reaction. Vaccine was given during a mass vaccination clinic on 11/03/2022. Pt was given a handout on possible allergic reactions after vaccine was administered and then stated that she has had all of them but unconsciousness. The list is as follows: swelling of the face, eyes, or tongue, difficultly swallowing, difficulty breathing, wheezing, abdominal cramping or pain, tightness in the chest, nausea or vomiting, and itchy skin. While assessing patient, patient did not appear in any distress. Face did no appear swollen, respiratory rate within normal parameters and patient had steady gait while being observed during the 15 minutes. Pt was asked when these symptoms started and never could tell a specific day of when they started.  She did state that all of these symptoms had been going on before receiving the injection but made staff aware after receiving vaccination. Stated that if this was received before vaccination then she would not have received booster. Pt stated that she can not physically get self in and out of bath tub or turn herself over in her own bed.  Stated that both legs swell and that she has been to the hospital and had "30,000" dollars worth of test ran. Pt was asked if she was diagnosed with blood clots and pt stated that there has been no diagnosis. Pt states that she is to go to a Internist doctor for follow-up care.  Pt wanted to make sure that her reaction has been documented and that no other person will have to experience what she has.
patient received his first dose of covid-19 vaccine and tested positive.; patient received his first dose of covid-19 vaccine and tested positive.; This is a spontaneous report from a contactable nurse (patient himself).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date were not reported) , via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, patient received his first dose of covid-19 vaccine and tested positive.  He will be getting the 2nd dose due today and wanted to know if it's still recommended. The outcome of the events was unknown.   Information of lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Within 10 minutes of receiving vaccine, patient c/o itching and tingling in throat. Patient received Benadryl 25 gm l IM - EMS transported patient to hospital. Patient states she received Solumedrol IV in ER. She was discharged from ER with Medrol dose pack. Patient states she ran a fever for a week following vaccine and continues to have trunk rash.
Patient started feeling really bad around 6pm with a fever over 102, headache, and chills. His blood pressure became elevated (170/90). He took some TYLENOL or MOTRIN and the symptoms decreased some. He was still fevered the next day, but felt better towards that evening. He did not go to the doctor. He had a small site reaction with his arm being "a little sore".
Patient experienced feeling lightheaded and then fainted. Provider came to assess and confirmed patient experienced a vasovagal attack. Patient given apple juice and two sets of vital signs taken. Patient verbalized feeling better and walked out of clinic accompanied by mother.
Patient waited in the pharmacy with no apparent issues but upon going home about 45 minutes to a hour after the shot, she started itching. She stated hives were presenting around 1.5-2 hours after the vaccine. The hives presented from arms to chest, stomach and thigh. She applied benadryl cream and contacted her primary doctor for a visit today. Patient stated the hives were fading this morning before her appointment.
lightheadedness; Mood is anxious (slight); This is a spontaneous report from a non-contactable other health care professional. A 42-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration on 24Mar2021 (age at vaccination of 42-year-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced light-headedness on 24Mar2021 and anxious mood (slight) on an unknown date in Mar2021. It was further reported that during her 15-minute waiting period after the injection, the patient began to experience light-headedness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Mood was anxious (slight). The patient received treatment for the reported events as water and close monitoring. Follow-up response to treatment was excellent. Patient was discharged and was stable to go home and follow-up with. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient information, patient tab and narrative were amended.
Fever; Nausea; Body Aches; Headache; Not able to remember things; sweating; chills; dizzy; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101440905 (Pfizer).  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Aug2021 10:00 (Lot number: FC3180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "scoliosis in her back and metal pins in her back." (unspecified if ongoing), notes: That was placed when she was 18.; "She still has back issues." (ongoing). There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Diarrhea"; PYREXIA (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Nausea"; PAIN (non-serious) with onset 07Aug2021, outcome "unknown", described as "Body Aches"; HEADACHE (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Headache"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "Not able to remember things"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "not recovered", described as "sweating"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizzy".  Additional information: Events diarrhoea, fever, nausea, headache, unable to remember things, dizziness, sweating, were reported as worsened. The patient's symptoms were coming and going. She had diarrhoea. The frequency was more. The Fever was worsened and she had headache all the time. Body aches were off and on. She may get pain in her shoulder. She had headache from being lightheaded. The night sweats have been going on for a couple of weeks. They happened mostly at night. No emergency room and physician office visit. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse event prior vaccinations, she was really healthy.     No follow-up attempts are possible. No further information is expected.
Information has been received from a Registered Nurse concerning a current 20 year old male patient who on 27-JAN-1992 and on 14-SEP-1995 was vaccinated SQ with 0.5 ml first and second dose of MMR II respectively (lot number not reported). It was reported that it was recently found to have a negative antibody titer to mumps (date unspecified). The patient was administered an additional dose of MMR II on 20-JUL-2010. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Red, hot to touch & pruritis, HA 2" x 4.5" swelling started developing next day (Thursday) (1" x 1"). Tx: Applied cold compresses, triamcinolone cream.
Bell's palsy on right side of face; This serious case was reported by a other health professional via sales rep and described the occurrence of bell's palsy in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (previous history of bell's palsy on the left side of her face).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's palsy on right side of face) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     It was unknown if the company considered the bell's palsy to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2023 The patient reported that 10 days after she was vaccinated with the Shingrix, she developed bell's palsy on the right side of her face. The reporter agreed to follow up from GlaxoSmithKline.
Got sick with both doses; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Got sick with both doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick with both doses). At the time of the report, ILLNESS (Got sick with both doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment details were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment   This case was linked to MOD-2021-213305 (Patient Link).
Very weak; Patient received 2nd dose day 42 after the 1st; Diagnosed with Colon cancer after the 1st dose; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of COLON CANCER (Diagnosed with Colon cancer after the 1st dose) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood transfusion on 11-Feb-2021 and Surgery on 19-Feb-2021. Concurrent medical conditions included Colon cancer on 13-Feb-2021.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced COLON CANCER (Diagnosed with Colon cancer after the 1st dose) (seriousness criterion medically significant). On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose day 42 after the 1st). On 18-Mar-2021, the patient experienced ASTHENIA (Very weak). The patient was treated with Surgery (Transfusion on 11 Feb 2021 and surgery on 19 Feb 2021) for Colon cancer. On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose day 42 after the 1st) had resolved. At the time of the report, COLON CANCER (Diagnosed with Colon cancer after the 1st dose) and ASTHENIA (Very weak) outcome was unknown.            The patient's medical history was not included. Concomitant products were not listed. This report refers to a case of a 96-year-old female patient who experienced non-serious event received 2nd dose received day 42 after the 1st (inappropriate schedule of vaccine administered) for mRNA-1273 (lot # -unknown) and very weak and serious event of colon cancer.  Based on temporality, the event of very weak cannot be excluded with product use. Colon cancer is assessed as unlikely due to latency to diagnosis and inappropriate schedule of vaccine is assessed as not applicable.; Sender's Comments: This report refers to a case of a 96-year-old female patient who experienced non-serious event received 2nd dose received day 42 after the 1st (inappropriate schedule of vaccine administered) for mRNA-1273 (lot # -unknown) and very weak and serious event of colon cancer.  Based on temporality, the event of very weak cannot be excluded with product use. Colon cancer is assessed as unlikely due to latency to diagnosis and inappropriate schedule of vaccine is assessed as not applicable.
chills, diaphoresis, fatigue, congestion, rhinorrhea, cough, chest pain
Left thigh swollen red. Child remained, very irritable with fever x 24 hours. Dtap left thigh. right thigh with fine MP rash only area where MMRV was given.
Edema. Blisters. Erythema. Fever. Treated in ER 48 hours after injection. Diagnosis - cellulitis Rx Prednisone, KEFLEX.
COVID+ 12/1/2022.  Vaccination Status - pfizer x3 + Pfizer BIVALENT BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: NP Admission Date: 12/1/2022 Discharge Date: Dec 4, 2022   Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus 12/01/2022 Unknown ? Community acquired bacterial pneumonia 12/01/2022 Unknown  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Renal insufficiency Pneumonia due to COVID-19 virus  Sepsis due to pneumonia   HOSPITAL COURSE: The patient is a 92 yo woman with PMH of DM2 on insulin, COPD, stroke, HTN, CKD3b, and GERD who presented to the emergency department 12/1 after her daughter found her very lethargic at home with generalized weakness. The patient was admitted with COVID 19 pneumonia with superimposed RML of treated pneumonia.  She was placed on empiric IV ceftriaxone and azithromycin.  Sputum culture, urine strep antigen & Legionella.  Strep antigen came back positive. Since she improved significantly , she was sent home with 7 day prescription for amoxicillin.  She was evaluated by PT/OT who recommended home with home health, PT and OT. She also had AKI this admission due to poor PO intake  which improved with IV fluids . Lisinopril dose decreased to 20 mg dose from 40 mg daily dose due to AKI and soft BPs.  Patient was discharged in stable condition. CONSULTS / RECOMMENDATION: None