chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bloody diarrhea; foul-smelling stools; abdominal urgency for 1 month; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Apr2021 (Lot Number: ER6955), at the age of 55-year-old, as dose 2, single for COVID-19 immunization. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks. Medical history included hyperthyroidism and hypercholesterolaemia and COVID-19 prior to vaccination. The patient was not pregnant. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=8731, as reported) via an unspecified route of administration on 28Mar2021, at the age of 55-year-old, at single dose for COVID-19 immunization. The patient had known allergies to methimazole: she previously took methimazole and had allergy. On 10Aug2021 the patient experienced bloody diarrhea, foul-smelling stools, abdominal urgency for 1 month. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was administered for the events. It was reported that the patient recovered with lasting effects from the events. Abdominal urgency recovered with sequelae in Sep2021, the other events recovered with sequelae on an unspecified date. The patient was tested for Covid-19 post vaccination on 07Sep2021 and the test result was negative.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 54-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 09-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patient, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Within three hours of the injection, patient had runny nose, runny  and glassy eyes, cough, and malaise. Within 12 hours, patient was in bed with myalgias, cough, headache, and somnolence.
Suspected Vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had both shingle shots and still got shingles. The patient further stated that anyone could get shingles after vaccine. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided. The follow-up would not be possible as no contact details were available.
left arm and whole left side of  body on fire,  headache and achy body parts, arm swelling, and myalgias.
red and warm reaction at the injection site; red and warm reaction at the injection site; mild soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (mild soreness at the injection site), INJECTION SITE ERYTHEMA (red and warm reaction at the injection site) and INJECTION SITE WARMTH (red and warm reaction at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced INJECTION SITE PAIN (mild soreness at the injection site). On 23-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red and warm reaction at the injection site) and INJECTION SITE WARMTH (red and warm reaction at the injection site). On 11-Jan-2021, INJECTION SITE PAIN (mild soreness at the injection site) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (red and warm reaction at the injection site) and INJECTION SITE WARMTH (red and warm reaction at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided no treatment taken
Intense hives that developed over 48 hours into a rash of hundreds of hives on bottom of feet, tops of feet, ankles, back of calves, inner thighs, and under arms near biceps. Hives were symmetrical in nature and mirrored a ?covid rash? or urticaria. Swelling intensified even while on Benadryl. Only steroid began to help diminish redness after 24 hours on 80mg of prednisone.   Began 3/10, worsened exponentially until taking prednisone on 3/13. Now (3/14) healing but still experiencing itchiness and red bumps.
Anaphylaxed to her first dose / allergic reaction; Vaccine was given 3/20/2020 / 6 month window / has already passed; This case was reported by a physician and described the occurrence of anaphylactic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the anaphylactic reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported for 1st dose of vaccine. The age at vaccination was not applicable for 2nd dose of vaccine. The patient was anaphylaxed to her first dose of Shingrix.  The reporter planned to do allergy testing to the vaccine and then give the vaccine in an incremental challenge. The reporter inquired about the non irritating concentration of the vaccine. The reporter asked since the 6 month window for getting the 2nd vaccine has already passed whether there was need to get 2 more vaccinations. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Localized erythema and swelling to left deltoid, maculopapular rash and hives noted.
Became extremely ill 30 hours after vaccine. Couldn't feel body. Then on Dec 30 a incidental clot in subclavian was found without symptom.
Local reaction: 5 x 4 cm raised erythematous mass with central puncta.
lower pelvic pain that progressed into severe pain over the next day; pain with bowel movements; difficulty to sit; weight loss; 4 hours after injection developed again the severe pain; pelvic mass; This is a spontaneous report from a contactable Physician (for herself).   A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 43-years-old , as single dose for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing (known allergy Latex - contact) and COVID-19 infection (prior to vaccination, the patient was diagnosed with COVID-19). The patient was not pregnant and was not pregnant at the time of vaccination. The patient received first dose of BNT162B2 (lot number EL1284), on 07Jan2021 12:00 PM, vaccine location Arm Left and experienced lower pelvic pain that progressed into severe pain over the next day, pain with bowel movements, difficulty to sit, weight loss, resulted in hospitalisation for one day for suspected pelvic mass. Facility where the most recent COVID-19 vaccine was administered: Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included daily multivitamin. The patient received 2nd on 28Jan2021 and 4 hours after injection, she developed again the severe pain experienced after the first injection require pain management. Underwent laparoscopic surgery for removal of pelvic mass and lysis of adhesions of intestines. Prior to the 1st vaccine on 07Jan2021 I had no pelvic pain or intestinal issues, no prior surgery and had maintained a very active lifestyle. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based from known drug safety profile and temporal occurrence, the causal association of the reported events in relation to suspected drug  BNT162B2 cannot be totally excluded.  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
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age (the sister is a nursing student at the nurse practitioner's office). On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot # not reported). It was reported that the patient was being followed at a hospital for an autoimmune disorder after receiving GARDASIL. The outcome of the autoimmune disorder was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Severe nausea; Bowel pain; Constipation; Diarrhea 5 times in 24 hours; This is a spontaneous report from a non-contactable other hcp. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), intramuscular on the right arm on 20Jan2021 15:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to sulfa from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced severe nausea, bowel pain, constipation followed by diarrhea 5 times in 24 hours following vaccine administration on 20Jan2021 22:30. No treatment was received for the events. The outcome of the events was recovering.
he had the second dose of Pfizer's covid vaccine and it gave him a headache, body aches and bone pain that all went away within two days.; he had the second dose of Pfizer's covid vaccine and it gave him a headache, body aches and bone pain that all went away within two days.; covid vaccine and it gave him a headache, body aches and bone pain that all went away within two days.; On 16May, he began to feel very dizzy and in the early morning he rose from dizziness; This is a spontaneous report from a contactable consumer. A 43-year-old male consumer (patient) reported for himself that, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical and concomitant medication history were not reported. Historical vaccination included 1st dose BNT162B2 (COMIRANTY) for COVID-19 immunization. It was reported that, on an unknown date, the patient had the second dose of Pfizer's covid vaccine and it gave him a headache, body aches and bone pain that all went away within two days. On 16May2021, patient began to feel very dizzy and in the early morning rose from dizziness. The patient wanted to know what he can do to treat the dizziness or if he should wait for it to go away.   Follow-up attempts not completed. No further information expected.
Ears infection; Diarrhea; Weakness; High temperature; Shingles; Severe headache.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm in Feb2021 (at the age 65-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient was tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021, the patient had ears infection, diarrhea, weakness, high temperature, and shingles all in a week. On an unknown date in Mar2021, (also reported as the past two weeks) the patient experienced a severe headache. The patient was in the emergency on 28Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event severe headache, ears infection, diarrhea, weakness, high temperature and shingles was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
20 year old female presents for physical for college. Has lab, TB and TDap injection. Upon checking out, patient states she feels nausea and asks for the restroom. She turns and the next thing she remembers she is lying face down on the floor Vitals at time 111/68 P- 58 O2 sat 98%. No neurological defects on examination, Talking and alert X3 with c/o pain to Left upper eye and left upper lip. Areas cleansed with normal saline and steri strips placed. Patient monitored for greater than 30 minutes with last vitals 117/76 Pulse 80, 02 sat 98%. Patient up and ambulating with boyfriend out of facility home. Return to clinic 07/26/2019 for follow up.
intense headaches; tired for a couple of days; soreness on arm; felt very cold; electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast; This is a spontaneous report from a contactable other hcp (Nurse). A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. Medical history included covid-19 from Mar2021 to an unknown date. Concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced intense headaches, tired for a couple of days, soreness on arm, felt very cold, electrical impulses all over her body started appearing and like her blood is running inside all over her body and heart rate went a little fast. The nurse reported that some of her co-workers, about 5 of them, had previous COVID diagnosis last March also received the vaccine were fine and experienced only intense headaches and tired for a couple of days. She mentioned that one person, until now has headaches and takes Tylenol for it. None of them reported the same side effects as her. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection. The patient underwent lab tests and procedures which included heart rate: heart rate went a little fast. Therapeutic measures were taken as a result of intense headaches, tired for a couple of days, soreness on arm, felt very cold, electrical impulses all over her body started appearing and like her blood is running inside all over her body and heart rate went a little fast which included Tylenol, albuterol and mucinex. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness morning of 12/2/2010, resolved. Vomiting at 11am (resolved) but still feeling sick.
pneumonia; bad asthma; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included allergy to insect bite from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that her doctor never told her she was getting a steroid shot 4 days after the first dose. Held the 2nd dose for 2 weeks and the next appointment is on 05Apr2021. The patient have bad asthma and had pneumonia from it. The patient was very fit and healthy. Also got 2 flu shots in the past. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Vaccine triggered two new autoimmune diseases: psoriatic arthritis and raynauds. Also caused Vitiligo to come back that was previously in remission.
presenting with fever, hypotension, abdominal pain and diarrhea with chills and rigors x 2-3 days.  ED Course Vitals: Temperature: 36.3 °C (97.4 °F) | Heart Rate: 70 | BP: 108/53 | Respiratory Rate: 16  | SpO2: 99 %  |    | FIO2     | Weight: 54.4 kg (120 lb)   On arrival to ED, patient was afebrile at 97.4, vital signs stable with BP 108/53. Labs notable for lactate 1.7 and 1.3, WBC 14.27 with neutrophilic predominance, Na 129. 2x blood cultures were drawn. Patient received 1L LR and given 1g CTX + 750mg vanc. CXR and CT A/P were unrevealing.  # Pericardial effusion without signs of HF (EF 60%, normal ventricular fxn) TTE identified small circumferential pericardial effusion w/o e/o tamponade. Pulsus normal throughout admission. Etiologies could be due to ischemia or myocarditis. Troponins were elevated, normal anterior EKGs with posterior EKGs demonstrating diffusely flattened T waves in comparison to prior EKGs. Cardiac MRI with diffuse enhancement in myocardium suggestive of myocarditis but no evidence of pericarditis or ischemia; however, does not have evidence of dilated cardiomyopathy or heart failure. She was initiated on colchicine 0.6mg QD and remained on treatment despite lack of evidence of pericarditis due to treatment with colchicine prior to cardiac MRI and improvement in chest pain after initiation. Viral and rheumatologic work-up negative as above. She will follow-up with Cardiology for repeat TTE and decision regarding course of colchicine.
PATIENT STATES LEFT ARM BECAME RED AND ITCHY FROM THE SHOULDER DOWN TO THE ELBOW. (NOT WARM TO THE TOUCH)  THEN THE RASH (REDNESS) MOVED TO THE NECK AND UPPER BACK BUT WAS NOT ITCHY IN THOSE SITES. SHE APPLY HYDROCORTISONE AND IT HELPED   REDNESS /RASH STILL PROMINENT 48 HOURS AFTER SHOT ADMINISTERED
Tylenol and Extra Strength Excedrin for headache that lasted 8 to 10 weeks. No longer have continuous headaches. Fatigue, Muscle aches, Shoulders are killing me because of no strength, Cramps, Numbness and Tingling of Arms and Legs are all still ongoing today 10/28/2021
got blind; Hepatitis; heart inflammation; Eye problem; Kidney problem; 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 BLINDNESS (got blind), HEPATITIS (Hepatitis) and CARDITIS (heart inflammation) in a  patient of an unknown age and gender 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (got blind) (seriousness criterion medically significant), HEPATITIS (Hepatitis) (seriousness criterion medically significant), CARDITIS (heart inflammation) (seriousness criterion medically significant), EYE DISORDER (Eye problem) and RENAL DISORDER (Kidney problem). At the time of the report, BLINDNESS (got blind), HEPATITIS (Hepatitis), CARDITIS (heart inflammation), EYE DISORDER (Eye problem) and RENAL DISORDER (Kidney problem) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.  Patient reported "225 people got blind after vaccination. There are also other reports on hepatitis, eye problem, kidney problem, and heart inflammation. People are dying".  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Information has been received from a physician concerning a 18 year old female with cystic fibrosis who, in 2003, developed extensive disseminated varicella zoster virus (VZV) infection while immunosupressed post-lung transplantation (time frame not known) and eventually died from the VZV infection. The physician also reported that the pt had also developed meningitis and pneumonia. The pt was noted ot be on high dose prednisone and had not been vaccinated with varicella virus vaccine live. The physician did not know how the pt could have been exposed since she had been in the hospital. The physician noted that the hospital did have an isolate that had grown VZV. The physician was interested in confirming the strain of VZV in case of pt had been exposed to someone who was vaccinated with varicella virus vaccine live. Upon internal review, meningitis was considered to be an other important medical event (OMIC). Additional info has been requested. The autopsy report received on 2/18/04 states hypotension, bradycardia, cardiac arrest, pulmonary edema and bronchitis. Results of PCR testing revealed that the patient had wild-type VZV infection. The physician also reported that another patient developed herpes zoster after being vaccinated with varicella virus vaccine live (WAES #0312USA01103). Additional information has been requested.  No further information is available.