chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA: hospitalized with acute hypoxemic respiratory failure due to COVID-19. Patient received remdesivir, steroids, supplemental oxygen, anticoagulation, and antibiotics. Discharged to home medically stable.
8/8/21: Patient was sent to clinic by PCP to request orders for bamlanivimab infusion-Pt reports testing positive at a testing center on Wednesday and has been symptomatic for 7 days. Pt states she also brought husband to Clinic due to COVID like symptoms and husband was recommended to go to the ED due to hypoxia. Presents to ED with SOB. She states over the last 5 days she has had symptoms of generalized myalgias, fevers, nausea, vomiting and diarrhea. 8 8/8/21: Patient received rapid COVID test at clinic which resulted as negative. 8/8/21: Patient tested COVID positive upon admission  8/12/21: Pt discharged home
Dizziness, weakness, had to stop usual activities at school and went home. Was pale and clammy when the mother picked him up from school, the symptoms resolved after about 24 hours.
devel sz w/fever & subsequently afeb,9 days p/being vax w/MMR/HIB/Varivax;currently under care of neurologist,being treated w/Dilantin;
Fever, painful arm, severe headache, chills, muscle aches, initial nausea
left shoulder pain. Patient told to ice area of pain 4-5times per day for 20 minutes each and to take Ibuprofen 800mg TID with food.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered impoperly stored LIQUID PEDVAXHIB for prophylaxis lot #R005118 and expiration date 28-NOV-2020 (strength, dose, frequency and route of administration were not reported).  No adverse effects were reported.  The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-09507513-1901USA007858:
Black and blue bruising at the site that went away 5 days later but pt now has a red spot at the site. 2nd shot due the 13th Feb
pt recv vax Friday & broke out in rash Sunday noc;also joint pain kept pt awake;Monday morning severe bleeding of gums;the rash was on hip & thighs  no itch;cheeks felt hot, but temp never taken
A physician reported that an infant received Acel-Imune, IPV and Comvax on 8/25/99. That evening the infant developed an injection site reaction characterized by a red mark at the injection site. The MD noted that this event was related to Acel-Imune.  IPV and Comvax were administered in the opposite arm. This is 1 of 5 pts from this facility who had an adverse event following receipt of Acel-Imune. The reported indicated that 5 pts experienced an adverse event; however, only 4 pts have been identified. Additional information received on 11/23/99 from the MD indicated that the infant recovered.
My arm has been feeling sore the past two days, only at the injection site, but today oí noticed a red circle around it when it suddenly felt itchy. I can feel heat radiating from the area, making it uncomfortable but not painful.
Chest pain, heart palpitations, crippling joint pain, muscle pain and daily fever (from 103.5 first 3 days to 101 daily since). Headaches won't go away even with Imitrex. Diarrhea. No treatments given. I'm scheduled for blood work and EKG next week. I was told to go to hospital if it escalates prior to my appointment. My rheumatologist was upset I got the vaccine, because I am so sensitive to all vaccines. I had COVID-19 1 month ago. PCP didn't want me to get booster. As of today, I received the vaccination. I had to decide between this outcome or losing my job. Now vaccination not mandated. And now I'm ignored because it's just a side effect.
Patient received the first dose of the Moderna COVID-19 vaccine and patient states that after a few day of receiving the vaccine he developed a rash around the injection site. Symptoms he said he experienced were as stated " felt like it was a mixture feeling like a rug burn, it was swollen and sensitive to touch". Patient went to the local hospital/ urgent care and was seen and evaluated, the rash was marked with a sharpie pen to make sure it was not getting worse. If the rash gets bigger or worse was told by hospital team to return to see them .
Shivers that continued to get stronger almost to a convulsion .  Body aches and fever. Body aches and fever lasted until 11 pm 3/26/21.
Rash on lower left arm - lasted almost 7 days. Tingling and numbness is still going on randomly each day.
Rash, itching, subcutaneous recommended antihistamine regime ice if really itchy,
This spontaneous report as received from a physician refers to a patient of unknown age. On 10-APR-2013 the patient was vaccinated early with VAQTA dose 2. Therapy with VAQTA was started on 10-DEC-2012. Dosage and route were not provided. No adverse effects were reported. Additional information has been requested.
Chest pain. Pt is a smallpox re-vaccinee who reports the onset of intermittent, non-radiating, sharp chest pains with onset approx. 10 days following his smallpox vaccine.  His initial episode was centered on the left side of his chest and felt like a "vise grip." He rated the pain intensity as a level 8-9 on a pain scale of 0-10. The episode lasted about 20 seconds. His 2nd episode occurred between Day 10 and Day 17, and was not as severe in intensity (2/10). The pain was located along the left sternal border. The pain that episode is described as "a sharp needle" and lasted only a few seconds. These symptoms were recorded on the on-line Smallpox Diary. After experiencing his second episode of chest pain, pt contacted the clinic and was told that if his chest pain was recorded, some would contact him. Pt continues to have brief, intermittent episodes of sharp chest pain varying in intensity and location, but always located on the left side. On the average, these episodes continue to occur 1-4x/month and never last more than 1 minute. The pain is not associated with exertion, breathing, or positioning. He has not experienced any accompanying symptoms like palpitations, SOB, cough, dizziness, or peripheral edema. After experiencing an episode that "took him to his knees" in August, pt sought medical evaluation at his primary care clinic. His evaluation has included an ECG, an echocardiogram, one set of cardiac enzymes, and an exercise stress test.
HIB TITER administered 3JAN91 & 8MAR91; Following administration, pt devel vomiting, diarrhea, & fever to 101; No rxn when DTP #3 recvd alone; MMR administered 9JUL91;
I had a fast heart beat that started about an hour to half hour after my shot. My heart rate was at 120 BPM and I called 911. The highest my hear rate  went was 140 BPM. The paramedics but me on an EKG and my heart rate dropped to 116 BPM. I was not admitted to the hospital, and after the paramedics left I was able to go back to sleep.  I had heart palpitations for the next 8-10 days after the vaccine. I saw a cardiologist and they didn't find anything out of the ordinary, and then I saw an allergist and I'm following up with him soon.
Extremally exhausted; like even I go up the steps, it takes me a lot time/very tired/very fatigued; a very bad headache; very weak; loss of appetite; still very sickly; have chills as well; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 03Oct2023, this case now contains all required information to be considered valid.  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.  A 66-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 04Oct2023, outcome "not recovered", described as "Extremally exhausted; like even I go up the steps, it takes me a lot time/very tired/very fatigued"; HEADACHE (non-serious) with onset 04Oct2023, outcome "not recovered", described as "a very bad headache"; CHILLS (non-serious) with onset 04Oct2023, outcome "unknown", described as "have chills as well"; DECREASED APPETITE (non-serious) with onset 04Oct2023, outcome "unknown", described as "loss of appetite"; ILLNESS (non-serious) with onset 04Oct2023, outcome "not recovered", described as "still very sickly"; ASTHENIA (non-serious) with onset 04Oct2023, outcome "unknown", described as "very weak". Additional information: Patient was fully vaccinated from before. The patient got extremally exhausted, a very bad headache, very weak, loss of appetite. She left work and came home and slept for 6 hours and today, was still very sickly, very tired, loss of appetite and headache is very slight today. She was extremally exhausted like even the patient go up the steps, it takes her a lot time. Patient did have chills as well. Patient stated "I guess we could it still persisting today because I still have the fatigue and slight headache".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
no adverse event; VARIVAX was administered after the excursion: 30 F for 30 min; This spontaneous report was received from medical assistant (office manager) and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-JAN-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U020244, expiration date: 28-JUN-2023, (dosing schedule and route of administration were not reported) for prophylaxis. Administered dose of vaccine was exposed to temperature 30 F for 30 minutes. No previous temperature excursion was noted. No additional adverse event (AE) was reported.
Suspected vaccination failure; developed shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter
PATIENT RECIEVED SHOT IN LEFT ARM BEFORE SITTING DOWN IN THE WAITING AREA  FOR 15 MINUTES WHILE WAITING FOR 3 FAMILY MEMBERS TO RECIEVE VACCINATIONS. ABOUT 10 MINUTES AFTER RECIEVING THE VACCINATION, PATIENT STARTED WHEEZING AND STRUGGLING TO CATCH BREATH AND SAID SHE FELT THAT HER THROAT WAS TIGHT. AT 2:16PM, PHARMACIST ADMINISTERED ONE EPIPEN TO THE LEFT LEG. PARAMEDICS CAME AND CONTINUED THEIR ASSESSMENT BEFORE TAKING PATIENT TO THE HOSPITAL.
chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use.  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.
AFTER INJECTION - MORE THAN HALF OF VACCINE LEAKED FROM SITE - WITNESSED BY 2 RNS.  NO ADVERSE EVENT AFTER REDOSE PER CDC AND PROTOCOL.
Missed menstrual cycles; late menstrual cycles; heavy menstrual cycles; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL0142 and expiration dates were not reported), via unspecified route of administration in the right arm on 04Jan2021 at 12:00 as dose 1, single for COVID-19 immunization at Workplace clinic. The patient medical history reported patient had covid prior vaccination. Concomitant medications included birth control in two weeks. The patient had no know allergies. Covid tested post vaccination reported as yes. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 the patient experienced missed menstrual cycles, late menstrual cycles and  heavy menstrual cycles. The patient underwent lab tests and procedures which included PCR (Polymerase chain reaction) test: negative on 21Jun2021, nasal swab: result unknown (Covid prior vaccination) on an unknown date. The patient did not received treatment for the adverse event. The outcome of the events was unknown  Follow-up attempts are completed. No further information is expected.
The pt experienced erythema and vesicles. Diagnosed with cellulitis at the ER Visit. Treated with Diclox.
Patient developed fever, chills at home 6 hours after vaccination. Patient progressed to extreme sleepiness and started to slur words and had difficulty focusing. Symptoms seemed to resolve after  giving ibuprofen and fluids. Patient slept okay that night and was alert the following day. Around 5 pm the following day patient had difficulty staying awake, went to bed and started running a fever will chills. patient developed severe fatigue, began to experience mental confusion,. Progressed to patient unable to carry on a conversation or perform simple tasks. Patient delirious , symptoms identical of those she exhibited in May 2018 when she was hospitalized for sepsis. Family together made the decision to call 911 because she was becoming unresponsive. She was transported to hospital by ambulance.
Received the vaccine at 12:35pm and at 12:44pm noticed a hive on my neck and a mild rash across the top part of my chest. I felt a flushing sensation and started to notice some difference when swallowing. Within a few minutes my lips began to tingle. After getting some fresh air and sitting with the EMS my symptoms were starting to improve but not resolved. I was given a dose of Benadryl (pill form) and within 15 minutes all symptoms started to improve. Within 30 minutes all symptoms resolved. Total time, I spent about 45-50 minutes before leaving the station. I would also like to note that when I was given the injection I did experience some bleeding, which seemed a little more than normal. It was ok within a minute or two. Since, I have a small bruise where the injection was given.
ED to Hosp-Admission  Discharged   10/27/2021 - 10/29/2021 (2 days)  HPI: Very pleasant 84-year-old gentleman with a past medical history of coronary artery disease with last intervention several years ago, previous CABG, previous stenting, CKD stage III who presented to Hospital with bright red blood per rectum and significant drop in hemoglobin resulting in anemia.     Hospital Course: Patient was hospitalized for GI bleed but incidentally tested positive for COVID-19 in the setting of vaccinations x2.   Patient underwent colonoscopy which did not reveal source for bleeding.  He does have underlying diverticula so it is quite possible that a self-limited diverticular bleed might have been the etiology of the bleed.  He can follow-up with gastroenterology as an outpatient if needed.  Please recheck hemoglobin in 3 to 5days.     Due to bleeding as above, he has been recommended to avoid NSAIDs.  Furthermore, I am going to stop Brilinta and recommend that PCP evaluate the need for dual antiplatelet therapy.  I do not see an indication.   Patient is asymptomatic from COVID-19 and I do not think he warrants further hospitalization in regards to this.  Would recommend quarantine time of 10 days for asymptomatic patient
Extreme shaking of entire body for 90 minutes and extreme pain in entire body and joints for 90 minutes.
I developed Shingles two weeks after receiving my first vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP075333), via an unspecified route of administration, administered in arm left on 31Mar2021 at 13:30 (01:30 PM) (at the age of 63-year-old) as dose 1, single for COVID-19 immunization. Medical history included GERD and known allergies: PCN. The patient concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 10Apr2021, the patient experienced I developed shingles two weeks after receiving my first vaccination. AE resulted in doctor or other healthcare professional office/clinic visit. Adverse event: I developed Shingles two weeks after receiving my first vaccination and wondering if this is a side effect. Just read an article regarding herpes rash as a side effect. The patient received Antiviral and topical cream as a treatment medication for the event. Outcome of the event was recovering.
pt recv vax; denies any pain; felt achy; flu like sxs; dull ache in lt arm; had flu shots before w/ no problems;
Moderna COVID-19  Vaccine EUA soreness at injection site lasted for 2 days after injection no treatment
pt recvd vax as a child & @ age 20 and 23 recvd 2 addtl doses & @ age 25yrs had a titer drawn & was found to have a lack of response for MMR; No further details were provided;
Pt woke up the next morning with fever, chills T-99 degrees, and aches that lasted for 5 wks. She also has had her upper teeth ache and complains she now has whiskers growing out of her (R) cheek about silver dollar sized.
Moderate anaphylaxis 1 hour after the injection  which lasted for approximately 10 minutes.  Heart pain and shortness of breathe which started within 15 minutes of the injection. The heart pains lasted 8-10 days. Headache, fatigue and shooting muscle pains throughout the body starting 2 hours after injection and lasting 8-10 days.
The patient was given the Hepatitis A vaccine in error. A hepatitis B vaccine had been ordered by the provider.  No signs or symptoms of adverse reaction noted. The  medical assistant was given remedial training and will have vaccines checked prior to administration. The ordering provider was informed and discussed with the mother. She addressed any concerns/questions and possible side effects with the mother.
Patient developed erythematous; indurated, slightly edematous: patch surrounding DTaP vaccine site approx. 24 hrs after administration. Was seen in office 48 hrs after vaccine was given. Had 17cm x 14 cm area of erythema with 8cm x 7cm area of induration and slight edema, no tenderness. Erythema blanches on palpation. No fever, no difficulty breathing.
pt recvd 1st dose of Hep B vax on 19SEP90 & later devel alterations in smell & taste described as metallic.On 19OCT90 pt recvd 2nd dose & sx worsened.