chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She began not to be able to walk; She would scream whenever I touched her; she does not even know who I am right now; This is a spontaneous report from a contactable consumer via medical information team. An 80-year-old female patient received bnt162b2 (COMIRNATY, Solution for Injection) via an unspecified route of administration on 28May2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 05May2021 as dose 1, single for COVID-19 immunisation. It was reported that, patient did very well with the 1st dose, but after the second dose reporter began to notice a change in patient. On an unspecified date in 2021, patient was not able to walk and then patient would scream whenever reporter touched patient. It was reported that patient was hospitalized. They did tests at the hospital, and the CT showed nothing was wrong. Patient was currently in a withheld facility because patient did not even know who reporter was right now. The patient underwent lab tests which included computerised tomogram: nothing was wrong in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Information on the lot/batch number has been requested.
Case number PHEH2013US007864 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This report refers to a female patient. Her medical history and concomitant medications were not reported. She was vaccianted with MENVEO (batch number: A12009, expiry date: Feb 2014) at a dose of 0.5 ml intramuscualrly on 07 mar 2013. it was reported that the MENVEO she had received had been at 34 F for 12 hours and the vaccine was reported as not frozen. No adverse events were reported.
Date of Evaluation: 2/11/2022                                  Date of Injury: 2/11/22 Time of Trauma page: 735                                       Time of Evaluation: 735 Trauma Code: Level 2   Chief Complaint:  Trauma, MVC   Source of Information:  Patient   Mechanism of Injury/Details of Event:  This is a 74y.o. male presented to Hospital via EMS after multicar accident. Patient was restrained driver going 30-35 miles prior when he collided with another car. Patient was confused and perseverating at the scene however appears alert and oriented at this time he has past history of diabetes mellitus chronic obstructive pulmonary disease hypertension and tobacco abuse
This spontaneous report as received from a pharmacist refers to a 82 year old female patient with allergy to ampicillin. The patient's medical history included infections of the bladder. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX (dose, strength, site of administration not reported) (lot #J001700, exp: 08-MAY-2014). On an unknown date the patient developed a rash. The rash was itchy, hurt and felt like sunburn when touched. No treatment was given. No lab diagnostic studies were performed. The outcome of events was reported as unknown. The relatedness between ZOSTAVAX and the events was not reported. The patient sought medical attention via contacting with pharmacist. Additional information has been requested.
A 64 years old patient was administered Fluzone high-dose quadrivalent, no AE; A 64 years old patient was administered Fluzone high-dose quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (GMI) (Reference number- 00303444) and transmitted to Sanofi on 06-Oct-2020.  This case involves a 64 year old female patient who was administered a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ46AB, expiry date: 30-Jun-2021) once via intramuscular route in the left arm for prophylactic vaccination on 01-Oct-2020 (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was also a case of an overdose (latency same day).  At the time of report, the patient had no symptoms.  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 2001/83/EC 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.
Large 10 cm of induration of arm with another 6 cm surrounding erythema.
PATIENT WAS ONLY 16 AT TIME OF IMMUNIZATION AND VACCINE IS APPROVED FOR 18 & OLDER
I do have arthritis. But since the injections I am experiencing it in my shoulders and very severely in my elbows.; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 09:00 (at the age of 78-years-old) as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 08:45 (Batch/Lot Number: EL9266) as dose 2, single for covid-19 immunisation.  Medical history included hypertension, ongoing arthritis. Patient had no Known allergies. Patient received no other vaccine in four weeks. Concomitant medication included valsartan; spironolactone. The patient experienced "i do have arthritis. but since the injections i am experiencing it in my shoulders and very severely in my elbows" on 29Jan2021.  The patient thought shoulder pain was injection site pain but lingering. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative. Treatment was given for the event. Patient received Tylenol for arthritis. Prior to vaccination, the patient was not diagnosed with COVID. Patient tested for COVID post vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Covid breakthrough case. Patient presented to ER on 6/22/22 with c/o of sore throat, runny nose, headache, fever, body aches and exposure to covid. Hx of Pfizer vaccine x 3. DC home.
Infant found lifeless at 08-830 2/15/04 by pm. Infant fed at around 230 am. Reported to be doing fine except feel warm that afternoon after shot. Autopsy report received on 6/14/2004 states COD was SIDS.
Swollen lymph node in left arm, light to moderate swelling Sweating, no fever Chills during the night Lack of energy
expired Bexsero was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-222 Reporter's comment: The registered pharmacist called to inquired that the patient should need to revaccinated. The reporter reported that an expired Bexsero was administered to a patient. No additional details were provided. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Patient has thin skin already. The first shot did NOT cause this extensive bruising/bleeding like this 2nd shot did.  The bruising extends from below her shoulder down to her elbow, almost encircling the entire upper arm.  She said it was definitely subsiding and she didn't feel like she needed to go to the doctor.  She had more pain with this injection and couldn't sleep on that side.
After the shot, had the usual injection site pain/swelling.  Over the next couple of days however, pretty much everything swelled up.  Starting about 3 or 4 days after the shot, I was sore, achey, and started getting migraine headaches which I had not occurred for years.  They progressively got worse with serious vertigo, dizziness, nausea, ...
fever; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer (Patient) reported two reports for herself and her son. This is one of the two reports. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the 2nd dose of the Pfizer covid vaccine yesterday on 28Apr2021. She and her son have a fever in Apr2021. Caller also stated 'Tylenol' didn't really work for her. The outcome of the event was unknown.                                  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481479 same reporter, product and AE, different patient
Within 30 min I had sharp chest pains .very intense sweating high blood pressure high heart rate and an abnormal ekg a week later..2 weeks later was placed on an anti inflammation med for suspected myocarditis
flu-like symptoms; lost of appetite; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, lost of appetite on an unspecified date. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
wegener's granulomatosis or granulomatous with polyangiitis; acute kidney failure; respiratory failure; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 79 years as dose 2 (booster), single for covid-19 immunisation. The patient's concomitant medications were not reported. Vaccination history included: Johnson and Johnson vaccine (1st dose), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: GRANULOMATOSIS WITH POLYANGIITIS (hospitalization, medically significant, life threatening) with onset 26Dec2021, outcome "not recovered", described as "wegener's granulomatosis or granulomatous with polyangiitis"; ACUTE KIDNEY INJURY (hospitalization, medically significant, life threatening) with onset 26Dec2021, outcome "not recovered", described as "acute kidney failure"; RESPIRATORY FAILURE (hospitalization, medically significant, life threatening) with onset 26Dec2021, outcome "not recovered", described as "respiratory failure". The patient was hospitalized for granulomatosis with polyangiitis, acute kidney injury, respiratory failure (hospitalization duration: 10 day(s)). The events "wegener's granulomatosis or granulomatous with polyangiitis", "acute kidney failure" and "respiratory failure" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: covid-19: (08Feb2022) negative, notes: Nasal swab. Therapeutic measures were taken as a result of granulomatosis with polyangiitis, acute kidney injury, respiratory failure (IV steroids, hemodialysis and may need a biologic). The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
very mild slide effects remain (headache, aches, random chills or warmth feeling); very mild slide effects remain (headache, aches, random chills or warmth feeling); woke up with a 100.5 fever; sweating; aches, and soreness; chills; fatigue; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration, administered in left arm on 03Feb2021 09:00 (at the age of 31-years-old) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto's (thyroid). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. No known allergies. Concomitant medication included levothyroxine taken for an unspecified indication, start and stop date were not reported.The patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, lot number EL3249) via an unspecified route of administration, administrated in left arm on 13Jan2021 (at the age of 30-years-old) as 1st dose, single for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 the patient experienced fatigue (21:30), muscle aches (21:30), chills (23:30) while on 04Feb2021 patient woke up with a 100.5 fever, sweating, aches, and soreness at 01:30 AM and took Zinc quercetin and Advil, fever started going down. Finally fell asleep by 4:00AM. Again at 8:30AM patient woke up feeling much better, but still a bit weak with slight muscle aches. no more fever or chills. Patient had very mild slide effects remain (headache, aches, random chills or warmth feeling) on 04Feb2021 at 20:30 PM. With a good night's rest, patient predicted she will be back to normal tomorrow (05Feb2021). The patient underwent lab tests and procedures which included body temperature was 100.5 on 04Feb2021. Therapeutic measures were taken as a result of woke up with a 100.5 fever, sweating, aches, and soreness includes zinc quercetin and advil. However, no treatment was given for other events. The outcome of the event woke up with a 100.5 fever was recovered on 04Feb2021 while outcome of the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Severe reaction, swelling and pain, at injection site lasting about 7 days. Starting at about ten days, severe joint pain leaving pt. unable to walk or move her legs. This joint pain moved to her thighs, pelvic area, buttocks, calves, feet, shoulders, hands, then back to her hips. This reaction leaves her with severe pain and very limited mobility. She is currently using a walker to get to the bathroom and doesn't move much more that that. I have to help her change cloths.
Two days after injection a small circle of redness below the skin developed at the injection site.  The circle continued to expand over the next 12 days.  It is now about the size of a grapefruit.  The area is slightly warm to the touch and tends to be a little itchy at times.  It does  not seem to be healing.  Should I seek medical attention?
covid test Nasal Swab Positive; covid test Nasal Swab Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Aug2021, outcome "unknown" and all described as "covid test Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Aug2021) positive. 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 information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Vaccination failure ,COVID-19cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202101814804 same reporter and patient, different AE
soft tissue swelling at site of injection, moderate, without cold abscess; superficial cellulitis at site; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 8-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 20May2022, outcome "unknown", described as "soft tissue swelling at site of injection, moderate, without cold abscess"; VACCINATION SITE CELLULITIS (non-serious) with onset 20May2022, outcome "unknown", described as "superficial cellulitis at site". The events "soft tissue swelling at site of injection, moderate, without cold abscess" and "superficial cellulitis at site" required physician office visit. Therapeutic measures were taken as a result of vaccination site swelling, vaccination site cellulitis.  Additional information: It was unknown if the patient received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient was tested for COVID-19 post vaccination. Treatment for vaccination site swelling and vaccination site cellulitis included antibiotic and NSAID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My feet were swollen last week; Headache; Bell's palsy; Could not open an eye on left side; Can't talk great; Can't blink; Mouth was crooked.; Feeling  something wrong; Mouth still numb and twisted; Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 62-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.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling  something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted) and INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping). On an unknown date, the patient experienced PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache). At the time of the report, FACIAL PARALYSIS (Bell's palsy), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling  something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted), INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping), PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Lab details were not provided. Treatment medication for the symptoms included. prednisone 20 mg for 7 days valacyclovir 500 mg for 7 days white petrolatum to lubricate under the patch muscle relaxant for sleep - described as effective  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 7MAR97 or 11MAR97 & 14MAR97 pt devel bumps on knees & scattered papules;the rash progressed over body;that same day pt devel a cold, cough & itching & dx w/viral urticaria;17MAR97 & 19MAR97 seen by MD;dx erythema multiform;
Administration Error - bivalent booster administered less than 2 months after last monovalent dose
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "recovering", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "recovering", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.