chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to a 48 year old female patient. No medical history was reported. On 12-NOV-2014 the patient was vaccinated with RECOMBIVAX HB in the left deltoid (strength, dose, frequency). Other suspect therapies included HAVRIX given on left arm, TDAP and FLUMIST given on right arm. On 13-NOV-2014, the patient complained of body aches and general malaise. On 14-NOV-2014 the patient experienced fever of 101.4 F, and brushing at site of injection with continuing aches. The fever had subsided. Patient sought medical attention-she was seen in the physician's office on 17-NOV-2014 and complained of shoulder/joint pain in the shoulder region, redness with petechiae around and below the injection site, which was going toward the inner arm. The arm was not edematous or hot to the touch. No treatment was provided for the events. The outcome of fever was reported as 'subsided' (recovering), while patient had not recovered from the other events. The reporter did not provided the causality between the events and the suspect therapy. Additional information has been requested.
This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from an unknown cause of death. The reporter stated the youngest daughter's best friends mother died right in front of my daughter and her friend after getting the same one I got by J&J that's the main reason she refused and still refuses to be vaxxed. It was unknown if an autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220350556. Sender's Comments: V0. 20220350892-Covid-19 vaccine ad26.cov2.s -Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Palpitations and mild chest discomfort  Palpitations have been intermittent throughout the day but occur all day long - few beats stop and then recur  Some midsternal chest discomfort non radiating at rest   The only change that would have occurred is the vaccine
pt recvd vax;low grade fever thru 11march;high fever 12mar;relief w/ fever meds;became blue when getting a bath,main areas were cheeks,chin,lips & extremities;neck gland involvement,gen rash,still present;would only take liquids per mom;
Rapid heart rate almost immediately after injection. Weakness, fatigue and breathlessness  Was sent to the ER and treated with a beta blocker.
When I got the vaccine on the 1st day there were no side effects, pain, or symptoms. On day 2, that Friday, I started having pain in my upper shoulder located around the side of my neck. Through out the day that area was causing me pain. I was feeling extremely fatigued. When I got home I looked in the mirror, and I noticed that my shoulder was swollen to the size of a walnut in that same location. I called the nurse advise hotline to see if I could see a doctor off base, but due to my location they said I had to be seen on base. I went to the ER at Hospital that following Saturday and the swelling was bigger and extremely painful to touch. I also had abdominal pain. When I was able to see the physician, he told me the swelling was my lymph nodes. He told me he thought it was normal because my body was trying to fight the vaccine. He said it wasn't an issue, but I disagreed because I have never had a reaction from a vaccine before. Before I was discharged the doctor still prescribed me with Cephalexin 1 capsule 4xday for a 9 day supply. At the location of the vaccination site on my arm a magnet stuck to it. I also have been having diarrhea a little bit more than normal.  The consistency of my bowels looks as if I took a stool softener but I haven't. When I looked at my paperwork from leaving the doctor, I had a low grade fever of 99.1.
He had black stool on the night of 5/22/21 and on 5/23/21 starting having copious bloody diarrhea, passed out. Went to the ER on 5/23/21 was given blood transfusion and IV because hemoglobin dropped from 9.1 to 7.1 after one bowel movement. He had endoscopy and colonoscopy on 5/25/21 and was diagnosed with a colon ulcer which they cauterized and he was discharged in the afternoon due to hemoglobin being stable at 8. The next morning on 5/26/21 he woke up to use the restroom, defecated brownish-black-red stool and almost fainted and couldn?t get up from the floor. I called Dr. (gastroenterologist) who told me to take him to the ER immediately. My husband, is currently back at hospital getting evaluated.
ended up with CDIFF; flu like symptoms; She got mono due to low immune system; She was diagnosed with POTS; Now has chronic nerve damage; a really bad tremor to her right hand; feeling bad kinda like after a flu shot; fatigued; cold; Upper respiratory infection; Pneumonia; This spontaneous report has been received from a consumer referring to her daughter, a female patient of unknown age. The patient's medical history included postural orthostatic tachycardia syndrome. Information regarding the patient's drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unspecified date in 2007, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.  It was reported that after the first shot, on an unknown date, the patient had some adverse reactions, feeling bad like after a flu shot (feeling abnormal), fatigued. The patient had cold, then upper respiratory infection and then pneumonia.  On an unknown date, the patient was vaccinated with the second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.  By the time the patient got the third dose she had to see the doctor 14 times in 1 year due to colds, pneumonia, and flu like symptoms. It was mentioned that because of the administration of antibiotics, the patient ended up with CDIFF (clostridium difficile colitis) putting her in emergency room.   On an unknown date, the patient developed "mono" due to low immune system (infectious mononucleosis). On an unknown date, the patient had blood work done one day and she called home crying and saying she could not breathe, her  heart was pounding out of chest, so she was sent to ER, then, in March 2020, the patient was diagnosed with POTS (postural orthostatic tachycardia syndrome) and was sent to a cardiologist. It was also reported that the patient used to be vivacious and now has chronic nerve damage (nerve injury), a really bad tremor to her right hand (tremor), and flare ups all the time. The reporter also asked if there was any type of compensation that can be given at this point, because her daughter was 25 now and she can not hold down a job, "she spends a lot of time too tired to do anything and this is going to be the way it is for the rest other life. I am frustrated and hurt that I did not do more research and did not know that this might happen". At the reporting time, the outcome of pneumonia, tremor, nerve injury, postural orthostatic tachycardia syndrome, infectious mononucleosis, influenza like illness, upper respiratory tract infection, nasopharyngitis, fatigue, feeling abnormal and clostridium difficile colitis was reported as not resolved.  Upon internal review, pneumonia and clostridium difficile colitis were determined to be medically significant.
Swelling of left jaw and possible exacerbation of his chronic stable Immune thrombocytopenia causing acute thrombocytopenia. He started bleeding from the gun and was evaluated in specialized Care clinic on 10/31/2021 and admitted to hospital which due to acute drop in platelet count to 7 from previous platelet counts of 359, 337, 433 from 7/21/2021, 1/19/2021, 8/21/2020 respectively. He started taking prednisone which helped with the bleeding. Currently hospitalized and platelets are recovering.
Headache, aching muscles (flu-like symptoms), fatigue and a sore upper arm the flu-like symptoms began several hours after the vaccination and by later that evening i felt terrible. The next day the symptoms continued all day and night. The second morning after the vaccination i woke up feeling normal. I did not sense that this reaction was anything but normal adverse reaction. I'm reporting it because it is the socially responsible thing to do.
Information has been received from a physician concerning a male patient who on 23-SEP-2010 went to physician's office to receive an injection of ZOSTAVAX (Merck), and was given VARIVAX (Merck) instead. There were no adverse reactions to the injection of VARIVAX (Merck). It was unspecified if the patient sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available. This is one of several reports received from the same source.
patient got dizzy after vaccine administration vitals signs assessed BP=68/40  HR=87 T=97.7 Second set BP=97/65 HR=82 Ox=97% RR=16  patient were hydrated with a 240ml of water and after 15 min Resident verbalized feeling better and vitals' stable; patient walk out of the office accompanied by mother
Pain in her chest area and a severe pain under the left chest bone; chest pressure/tightening in the throat and chest; tightening in the throat and chest; choking or tightening sensation; This is a spontaneous report from a contactable consumer (parent) or other non HCP via Medical Information Team.   A 21-year-old female patient received bnt162b2 (Comirnaty, solution for injection, Lot number and Expiry was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication was not reported. On an unspecified date, the patient experienced pain in her chest area and a severe pain under the left chest bone, chest pressure/tightening in the throat and chest, choking or tightening sensation. Patient was also reporting a tightening in the throat and chest which is worse when she eats. Patient has been uncomfortable. The patient was having a little discomfort in the chest area underneath, it was started a few hours later. The pain was a severe pain under the left chest bone and the caller was told to take the patient to the emergency room. In the emergency room they did an EKG, checked the patient's blood pressure and oxygen. This was all perfect and they couldn't find anything wrong with the patient.  All events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement resulted unknown results (this was all perfect), electrocardiogram unknown results (everything was perfect), investigation unknown results (this was all perfect) all on unspecified date. Reporter stated patient has been uncomfortable. The clinical outcome of the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
little dots and tiny blisters; can't sleep at night; hands feel swollen; Hands feel warmth; contact dermatitis; some numbness; tingling; rash on right hand / rash then went to right arm; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling), RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night) and DERMATITIS CONTACT (contact dermatitis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ESCITALOPRAM OXALATE (LEXAPRO), ACETYLSALICYLIC ACID (ASPIRIN 81), CURCUMA LONGA, PIPER NIGRUM (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]), FISH OIL, ASCORBIC ACID (VITAMINE C), VITAMIN D NOS and TIEMONIUM METHYLSULPHATE (VISCERAL) for an unknown indication.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (low grade fever). On 01-May-2021, the patient experienced RASH (rash on right hand / rash then went to right arm). On 02-May-2021, the patient experienced HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling) and DERMATITIS CONTACT (contact dermatitis). On an unknown date, the patient experienced RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night), PERIPHERAL SWELLING (hands feel swollen) and FEELING HOT (Hands feel warmth). At the time of the report, HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling), RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night), DERMATITIS CONTACT (contact dermatitis), PERIPHERAL SWELLING (hands feel swollen), FEELING HOT (Hands feel warmth), RASH (rash on right hand / rash then went to right arm) and PYREXIA (low grade fever) outcome was unknown.            Treatment information included steroid cream   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Significant follow up ; Events Added
Lightheaded, sweaty Seen by onsite EMT No interventions required Pt. released @12:58 recorded by RN.
COVID-19; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20220152301.
ED 3/7/2021 MC MC  Source Organization Encounter Summary     78 y.o. Male; born Jan. 03, 1943January 03, 1943Encounter Summary, generated on Apr. 02, 2021April 02, 2021  Reason for Visit  Reason Comments Shortness of Breath   Fever   Encounter Details  Suspected COVID-19 virus infection (Primary Dx)  ED Provider Note   Patient Chief Complaint   Shortness of Breath and Fever  History of Present Illness  78-year-old male, PMH is documented below, presenting to the emergency department with fever, cough and shortness of breath. Patient reports that he has been ill since Tuesday. He developed a productive cough bringing up some clear sputum. States he has some shortness of breath with exertion. He denies any chest pain. He denies any palpitations, lightheadedness or syncope. No headache or neck stiffness. States that he has been afebrile until today. Patient had a temperature of a 101° for EMS he has also been having some diarrhea. States he has no loss of taste and has chronic loss of smell. He has not come into contact anybody with COVID-19. Denies any history of DVT or PE. No lower extremity pain or swelling. Patient had his 1st Covid vaccination, but has not received his 2nd.  Office Visit 5/7/2021   Family Medicine Cough +1 more Dx Cough Reason for Visit
Dose 1 April 8/2021 on April 10/2021 in the morning around 8:00AM I felt fatigue, I had a rash neck, and my face. and I took phenazone to reduce the swelling. April 10/2021 in the morning I had leg pain and trouble breathing. Because I got J&J I went to ER to check blood clot and I did not have any. October 21/2021 I begin feeling fatigue on Oct 23/2021. I had fever, chills on October 23/24/25. I took plenty of rest. I spoke with my doctor she told me to take Tylenol and drink plenty of liquid. I started feeling better as of the October 26/2021.
did pass out while getting the shot/ fainted after 1st shot; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information team and 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 an unspecified date in Apr2021 (Batch/Lot number and Expiration date were unknown) as the 1st dose, single dose for COVID-19 immunization. Relevant medical history included cardiogenic syncope from an unknown date and unknown if ongoing and cardiac arrest one time. The patient's concomitant medications were not reported. The reporter stated that the patient (reporter's wife) received the first dose of the Pfizer COVID-19 vaccine and did pass out while getting the shot on an unspecified date. The reporter stated that it was not from the vaccine itself, but the patient had a condition known as cardiogenic syncope, that when she got blood drawn, she tends to faint; she even went into cardiac arrest one time. The reporter would like to know the efficacy of the vaccine after receiving one dose to make a determination if the risk of the patient having the cardiogenic syncope again was worth the need to receive the second dose or not. It was further reported that the patient had cardiogenic syncope, and fainted after 1st shot on an unspecified date. The reporter stated that this was not due to medication, but due to the cardiogenic syncope, which was present prior to receiving the vaccine. The reporter would like to know the efficacy rate of receiving only 1 vaccine (dose). The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The event syncope is likely due to the underlying cardiogenic syncope and is unrelated to suspect product BNT162B2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
caller reported Flushing, redness around face  and nauseous. Advised that Number for IMT (Incident management Team)will be activated. Caller declined.  Advised to return to observation room where shot was given. Caller stated she would. Called her 5 minutes and left a message to call back if symptoms also persist or worsens
have been experiencing heart palpitations/flutter on and off for about 6-7 hours; have been experiencing heart palpitations/flutter on and off for about 6-7 hours; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL3247), via an unspecified route of administration administered in left arm on 19Feb2021 13:15 at single dose for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included clarithromycin (CLARITIN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), and statin for cholesterol. The patient previously took the first dose of bnt162b2 (Batch/Lot Number: EL3247), administered in left arm on 27Jan2021 09:15 for COVID-19 immunisation. Patient was not pregnant. Facility type vaccine was clinic. No other vaccine received in four weeks. The patient has been experiencing heart palpitations/flutter on and off for about 6-7 hours on 23Feb2021 04:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was not recovered.
Petechiae on arms/legs, bruising on legs/arms/back, headache, fatigue, general feeling of malaise, joint pain on first day, yellowing eyes, dark urine
My mother passed away/death cause: natural causes; This is a spontaneous report from a contactable consumer for patient (reporter's mother).   A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 74 years old, via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  Medical history included Stage 4 metastatic lung cancer, Diabetes type 2, Hypertension. Other medications in two weeks was Yes, while unspecified. The reporter reported that my mother passed away/death cause: natural causes on 05Apr2021 07:00.  4 days after receiving this vaccine. No treatment received. An autopsy was not performed. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Information on batch/lot number has been requested.; Reported Cause(s) of Death: My mother passed away/death cause: natural causes
Patient gives hx of bilateral arm pain and back pain. Rx ibuprofen 800 mg.
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle to DHS staff and then to health system and the staff administering vaccine. Because of this delay, some monovalent vaccine throughout health system was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent Immunization meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
MOC states pt had blood in stool starting day after Rota given at 2 month and 4 month visit.
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 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 17th January 2023, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th January 2023, 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: 17-Jan-2023 Reporter's Comments: Nurse reported that a patient was inadvertently administered an expired dose of Bexsero. The reporter consented to follow-up via email. Additional Supportive Information: The patient inadvertently received an expired dose of Bexsero, which led to expired vaccine used.