chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer. Caller stated that the "varicella vaccine" (manufacturer unknown) was causing an epidemic of Shingles, and she knows 7 people under the age of 50 who have Shingles, including herself, and that is was caused by an unspecified varicella vaccine (manufacturer unknown) being given to children. She stated she knows of a child who got Shingles, but didn't say the child had received this vaccine. She also didn't state that she knew whether these people, or herself, had actually received the vaccine at all. This report concerns a child patient (age and gender unknown) who got shingles on an unspecified date. Patient's outcome was unknown. Additional information is not expected. This report is linked with MARRS cases 1304USA000279 and 1304USA001476, same reporter.
Dizziness, Headache, fatigue, achy , pain radiating from injection site down arm; head, ears, arms,eyes, felt as if swollen or with lots of pressure and hot. This is now resolved, eyes felt strained, described feeling in chest as 'weird' but now reolved, feels today - fatig Narrative:
He received the second dose of the vaccine on 6/4. 6/6 he developed neck pain that developed into chest pain as well. He additionally had some shortness of breath. He was seen on 6/7 by his pediatrician. An electrocardiogram was obtained which showed ST elevation in the lateral precordial leads(image below). Additionally a chest x-ray was obtained demonstrating clear lungs and no notable findings. A troponin T was obtained and measured 232 ng/L(normal range 0-22). CRP 39 mg/L(normal 0-7). His chest pain resolved within 3 days of developing. He has not noted any palpitations. He has not had any syncope. He has been doing light activities without having any issues.
DULL HEADACHE; This spontaneous report received from a patient concerned a male 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 10-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 dull headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dull headache was not reported. This report was non-serious.
Client is a 9 yr old female here with her mother for her first covid vaccine. She was very nervous at the time of her vaccine administration at 1645. She was given crackers to eat. At 1648, a loud thud was heard from outside her exam room. PNP entered the room and saw patient face down on the floor. Family member picked her up and laid her on the exam table. She was noted to be pale and crying loudly. HR in the 80s. She was monitored for several minutes attempting to get her to slow her breathing. As she stopped crying, she complained of headache all over and felt like her "stomach was bleeding." As she calmed down more, she also complained of right eye pain, left hip pain. She stated her abdomen did not feel strange any longer. She began twitching of her arms and legs intermittently. SHe was offered water, which she was able to drink some of. She did not like the ginger ale so would not drink that. Her Vitals remained stable with HR 89, BP 100/70, O2 SAT 98 on room air. She was rechecked frequently without significant change in her mental status or exam. She was answering questions appropriately.
He received booster dose COVID-19 Vaccine manufactured by Pfizer; patient received 1st dose COVID-19 Vaccine manufactured by Johnson and Johnson. He received booster dose COVID-19 Vaccine manufactured by Pfizer; He received booster dose COVID-19 Vaccine manufactured by Pfizer.; felt about to have ulcerative colitis flare up; sore arm; This is a non-interventional study report received from a contactable consumer or other non hcp.    A 42-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 intramuscularly on 2021 as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for colitis ulcerative. The patient medical history and concomitant medications were not reported.  It was reported that, on unknown dates, the patient experienced felt about to have ulcerative colitis flare up and sore arm. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Johnson and Johnson. He received booster dose COVID-19 Vaccine manufactured by Pfizer with outcome of unknown.  The reporter's causality for the event(s) of felt about to have ulcerative colitis flare up with Humira  (Adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of sore arm with Humira (Adalimumab) was no reasonable possibility The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  ; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events  and the suspect drug BNT162B2  cannot be ruled out.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.
Went outside smoked, came back in with fatigue, numbness to right side of face had some anxiety. Approximately 5 minutes passed from immunization. Patient vitals obtained and layed down 163/103, pulse 111 ice compresses to left arm where immunization administered. Face numbness went away after 20 minutes
Fingers 2-5 on my right hand went numb, very cold, turned white and painful. Loss of feeling in my fingers during this time. My fingers looked like a dead persons fingers. This still happens.
I tested positive for Covid on 28Mar 2021.; I tested positive for Covid on 28 Mar 2021.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient took the first dose of the Pfizer Covid 19 vaccine and scheduled to the second dose on 7Apr2021. patient tested positive for Covid on 28Mar2021. Patient questioned can he still take the second dose even though he tested positive. Patient also questioned can he receive the vaccine if he have a current or past diagnosis of covid-19 infection. It was reported that pfizer-biontech covid-19 vaccine does not contain sars-cov-2 and cannot give you covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021. Outcome of the events was unknown.   Information on the lot/batch number has been requested.  These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation.
On  5/20/2020  in the morning, we noticed one side of his lymph nodes under his jaw had become majorly swollen.  (Unilateral Lymphadenitis).  A few days later, there was a defined large lump in his swollen lymph nodes (Dr.s think it became bacterially infected, but this is unknown).  We gave him antibiotics orally, then were admitted inpatient at Hospital for IV antibiotics, which he took for about a week, then we continued for another week or so with oral antibiotics.  His lymph nodes under one side remain very swollen to this day.
A 54yr old male patient had an appt at 4pm.  4:00 pm  The patient decided not to get vaccine after he arrived.          His wife received hers and told him it was fine to get the shot. The patient agreed.  4:50 the patient received the vaccine. the patient kept stating he was nervous and appeared very anxious.  4:55 patient was sitting in booth with wife and daughter and employee heard the family yell "Daddy"         Employee saw the patient slumped over in booth.          Employee alerted some one who was in the observation area who then called the Emergency Dept. STAT to the Observation area.  4:56 RN and  RN responded to the area.  See RN statement below.         I was called to the cafeteria by RN for a possible reaction to a vaccine. When I arrived in the cafeteria patient was sitting in the seat with his head leaned on the back with his eyes closed. I asked him how he was feeling and he responded "I feel ok". He stated he hadn't eaten or drank anything that morning so he was given a Diet Coke and picked out a snack from the basket. He ate some crackers and drank some Diet Coke and stated he felt fine. His wife then stated that every time he is around needles he passes out. He said he felt better and was fine now. I told them when he got up if he felt weak or dizzy to call me back and I returned to the emergency room.  Emergency Nurses stayed with patient until they were sure he was fine and able to leave under his own power with his wife and daughter.  2/9/2021-  09:30 Follow up call made to patient by Emergency Dept. Manager. Patient stated he was fine and hadn't experienced any other symptoms. ED manager instructed patient the come to the ED or seek medical care if he experienced any other symptoms. Patient stated he understood and will comply. 02/10/21 08:30 call and spoke with patient . Patient states he feels fine , no other symptoms.
Got 11 yo vaccines on Tuesday. Noticed Wednesday that arm was swollen.  Not sure if it has been progressing or not.   Painful/tender with pressure. Some redness. Mildly uncomfortable when he raises arm - has some axillary soreness. No fever. Not interfering with ADLs
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 3 years old patient (also reported as 3 year 8 month old) who received a does of 0.25ml instead of the correct dose of 0.5ml, no adverse event, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2018, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259NA, expiry date- 30-Jun-2019 via intramuscular route in the right arm. It was also a case of actual medication error due to vaccine underdose. The patient had not experienced any side effects at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme soreness at injection site - could not raise arm, elevated temp (101.4 - took ibuprofen at that point), body aches, extreme fatigue, chills, headache, loss of appetite. Symptoms began approximately 12 hours after injection and lasted approximately 36 hours. At that point all symptoms were gone.
she hasn't been well since she took the vaccine/don't feel like myself; forget things/have a hard time remembering things when I talk; not talking normal/speech problems; she has the internal shakes/ shakiness/I have the shakes; she's not herself /nervousness in her system/have the jitters all the time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she hasn't been well since she took the vaccine/don't feel like myself), MEMORY IMPAIRMENT (forget things/have a hard time remembering things when I talk), SPEECH DISORDER (not talking normal/speech problems), TREMOR (she has the internal shakes/ shakiness/I have the shakes) and NERVOUSNESS (she's not herself /nervousness in her system/have the jitters all the time) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced VACCINATION COMPLICATION (she hasn't been well since she took the vaccine/don't feel like myself), MEMORY IMPAIRMENT (forget things/have a hard time remembering things when I talk), SPEECH DISORDER (not talking normal/speech problems), TREMOR (she has the internal shakes/ shakiness/I have the shakes) and NERVOUSNESS (she's not herself /nervousness in her system/have the jitters all the time). At the time of the report, VACCINATION COMPLICATION (she hasn't been well since she took the vaccine/don't feel like myself), MEMORY IMPAIRMENT (forget things/have a hard time remembering things when I talk), SPEECH DISORDER (not talking normal/speech problems), TREMOR (she has the internal shakes/ shakiness/I have the shakes) and NERVOUSNESS (she's not herself /nervousness in her system/have the jitters all the time) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-306606 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received on  02-SEP-2021 contains non-significant information.
No adverse effects were reported; the patient was inadvertently administered an expired dose of GARDASIL 9 (lot: M037770; Exp: 06/01/2019) on 06/14/2019; Information has been received from a pharmacist referring to a 24 year old patient of unknown gender. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.     On 14-JUN-2019, the patient was inadvertently administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M037770, expiration date 01-JUN-2019; strength and dose were unknown) intramuscularly for prophylaxis. No adverse effects was reported.
The patient reported fever, blister at the site of administration which lasted a week, the site of administration felt hard and hot to the touch, pain in the arm where the vaccine was administered, nausea, vomit, headache and a rash through the body. The patient was prescribed Cefadroxil 500mg.
Started with normal sore arm, ache, tired the day after.  These symptoms went on for a week.  Called Dr and they said they last longer in some people. By the week of the 11th my wife and I were both getting worse.  By Sunday morning, 1/10 we couldn?t get out of bed.  We tested positive for Covid around the 18th  My question is we are supposed to get our second vaccination on 2/3/21, a week from tomorrow.  Given the first vaccine, then testing positive for Covid, should we get the second shot as planned or should we try to delay a week or so to get more strength.  This report is identical for both my wife and myself.  Also, we mask, social distance, no restaurants, etc.  Thank you
Chills, sweats, myalgia, headache, gastrointestinal upset, fatigue.
Left side of arm (shoulder) is swollen and has large rash area covering a 4 x 6 inch area about 30hrs after vaccination.
tested positive for the Covid-19; tested positive for the Covid-19; This is a spontaneous report from a Pfizer-Sponsored program, . A contactable consumer (patient's wife) reported that 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration on 13Mar2021 (Batch/Lot number not reported) (at the age of 64-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient tested positive for the Covid-19 virus and he now in the hospital. The patient's second dose would be on Saturday, 03Apr2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
chest pains first on 3/20/2021 night, and next morning at 3/21/2021 8am; then recurring a few more times: 4/9/2021, 7/12/2021, and 8/9/2021.
Narrative: 85yo male patient with NSCLC (lung cancer) in home hospice care died at home on 1/3/2022. Pt had received covid vaccines on 2/4/21 & 3/8/21. This death is not related to covid vaccines.
Pt took flu shot at 08:50; 15" later, developed throat fullness. Pt given BENADRYL 25 mg PO. Vital signs stable.
3/18/11 Client's husband contacted Health Dept. Client began having chills/body aches 3/17/11 in evening before going to bed. 3/18 continued to have body aches, chills & headache but feeling better. Husband called ER but they would not give advise over phone. Advised to call PCP. Client stated to her husband, she felt like she had the flu.
Lightheaded, dizzy, clammy to touch @ 12:25PM.  BP 100/60 Left arm while having symptoms.  BP 110/80 left arm after symptoms.  Pt ate snacks and drink water.  He felt better and stated he was ready to go home after 30' monitoring
STARTED VOMITING, EXPERIENCED STOMACH PAIN, DIAGNOSES WITH ACUTE PANCREATITUS FULLY RECOVERED, HOSPITALIZED FOR 6 DAYS  PROBLEM FILLING OUT #21 HOSPITALIZED FOR 6 DAYS ---------------------------------------------------------------->>
Chest pains 4hours with shot. No other symptoms. Taken to ER- chest pain lasted 10 min. in ER and was discharged. No EKG or medication taken. OK symptoms to receive dose of vaccine and to wait 48 hours after vaccine before to ER again.
My son has died from a Pfizer vaccine; I have a dead child in my arms; I have a dead 6 years old in my arms; Vaccine doesn't work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "My son has died from a Pfizer vaccine; I have a dead child in my arms; I have a dead 6 years old in my arms"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Vaccine doesn't work". The patient date of death was unknown. The reported cause of death was "My son has died from a Pfizer vaccine; I have a dead child in my arms; I have a dead 6 years old in my arms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: My son has died from a Pfizer vaccine; I have a dead child in my arms; I have a dead 6 years old in my arms
Side effects about two months after The last dose/delayed symptoms of side effects months after the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects about two months after The last dose/delayed symptoms of side effects months after the second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects about two months after The last dose/delayed symptoms of side effects months after the second dose). At the time of the report, VACCINATION COMPLICATION (Side effects about two months after The last dose/delayed symptoms of side effects months after the second dose) outcome was unknown.            No relevant concomitant medications were reported.   Patient experienced side effects about two months after vaccination.  No treatment information was provided.
Patient with 2 COVID vaccines who admitted to hospital with positive COVID test and complications r/t COVID.  Provider d/c note:  " Patient with Late onset Alzheimer's disease with behavioral disturbance was noted to have an altered mental status, a Delirium.  When evaluated she had evidence of Acute respiratory failure with hypoxia.  The respiratory failure may be due to a  COVID-19 virus infection. Computed tomography angiogram of the chest reported: 1.  No central pulmonary embolism. There are a few tiny eccentric filling defects within segmental branches of the left lower lobe and lingula which are consistent with nonocclusive pulmonary emboli which may be acute or chronic. 2.  Dense consolidation of the right lower lobe and mild consolidation within the left lower lobe may represent pneumonia and/or atelectasis. 3.  Poorly defined groundglass and solid nodular densities throughout the right lung may be due to pneumonia or pneumonitis. Follow-up CT in 3 months recommended to demonstrate resolution. 4.  Trace bilateral pleural effusions. As the pulmonary consolidations seem more significant than other findings and procalcitonin was elevated so she was started on treatment for possible bacterial pneumonia with CEFTRIAXONE and AZITHROMYCIN.  The pulmonary emboli are questionable, small, likely of little clinical significance so she was not be anticoagulated.   Updated chest film with vascular congestion. Had some rales on exam. Was positive two liters since admit. Started FUROSEMIDE, Potassium, follow basic metabolic panel. She was then able to be weaned off supplemental oxygen.   She completed her course of antibiotics in the hospital.   Pancytopenia, part of which includes a chronic Normocytic anemia, likely due to COIVID, continue to monitor. White blood cell count now normal and platelets improving.   Bradycardia sinus bradycardia down as low as the thirties when asleep.  Maintains blood pressure. Dementia limits assessment for symptoms. No current medications contributing. Continue to monitor.   Patient's mental status appears to have returned to baseline with fairly profound cognitive impairment. Continued DIVALPROEX, DONEPEZIL, LORAZEPAM, MEMANTINE, RISPERIDONE.   Depression SERTRALINE  Issues Requiring Follow Up: none. "