chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Extreme body aches; Extreme headache; Diarrhea; Chest pain; Blue palms; Fatigue; This is a spontaneous report received from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 17Nov2021 at 10:00 (Lot number: FF2593) at the age of 27 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: FH8027, Administration site: Left arm, Administration Time: 09:45), administration date: 27Oct2021, when the patient was 27 years old, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Fever"; PAIN (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Extreme body aches"; HEADACHE (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Extreme headache"; DIARRHOEA (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Diarrhea"; CHEST PAIN (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Chest pain"; SKIN DISCOLOURATION (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Blue palms"; FATIGUE (non-serious) with onset 17Nov2021 at 11:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Fatigue". Therapeutic measures were not taken as a result of pyrexia, pain, headache, diarrhoea, chest pain, skin discolouration and fatigue. Relevant laboratory tests and procedures are available in the appropriate section.   Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: Nasal swab (01Nov2021) negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Loose stools; Arm was hurting; vomiting; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stools), PAIN IN EXTREMITY (Arm was hurting), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Thyroid disorder. Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIARRHOEA (Loose stools), PAIN IN EXTREMITY (Arm was hurting), VOMITING (vomiting), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). On 29-Mar-2021, DIARRHOEA (Loose stools), PAIN IN EXTREMITY (Arm was hurting), VOMITING (vomiting), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
ARM FEELS HEAVY; VEIN THAT NEVER SEEN BEFORE; FELT FLUISH; SORE ARM, ARM WAS HURTING AGAIN AND HAND HURTS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021, the subject experienced sore arm, arm was hurting again and hand hurts. On 12-MAY-2021, the subject experienced felt fluish. On 26-MAY-2021, the subject experienced arm feels heavy. On 26-MAY-2021, the subject experienced vein that never seen before. The action taken with covid-19 vaccine was not applicable. The patient recovered from felt fluish on MAY-2021, and had not recovered from sore arm, arm was hurting again and hand hurts, arm feels heavy, and vein that never seen before. This report was non-serious.
ED visit for reported bradycardia - treated and released. Hospital admission after 3 episodes of bright red blood per rectum . Severe diverticulosis in the sigmoid and distal descending colon. Treated and discharged. ED visits and hospital admissions within 6 weeks of receiving the COVID vaccine.
shingles on her face; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles on her face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles on her face). At the time of the report, HERPES ZOSTER (shingles on her face) outcome was unknown.            No concomitant and treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow up received and does not contain any new information.
Sore Throat (right side) on 4/2/2021 One ulcer on palatoglossal arch (right side)
arm soreness around the injection site; petechial rash on the underside of toes on both feet; This is a spontaneous report received from a contactable consumer, the patient. A 25-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 12:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included aplastic anemia (treated successfully with equine atg) on an unknown date. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications within the two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. On 19Mar2021 at 17: 00, the patient experienced arm soreness around the injection site and a petechial rash on the underside of toes on both feet. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome of the events soreness around the injection site and a petechial rash on the underside of toes on both feet was recovering. No follow-up attempts are needed. No further information is expected.
patient took claritin. rash was severe, lots of red splotching all on left arm
Pt came for Covid vaccine and DOB was incorrect. Vaccine had not been approved for 14yo's at that time. DOB given was incorrect which would have put child at age 16 at the time when he was actually 14.  Pt received dose #2 on 04/24/2021 with the same DOB given. Today parent presented vaccine card with DOB changed from incorrect year to correct year and asked for it to be changed in our system.  Pt is currently 15.
(this information is in response to a telephone message I received from your organization on 3/11/2022) stomach discomfort described as a burning feeling.  Doctor prescribed a 20 day course of sucralfate 1gm to be taken twice daily. 3 days of that course remains.  I feel that symptoms have eased, but not completely absent.  I will follow up with Doctor at end of medication course.
she passed out three times after recieving second dose of moderna vaccine; she reports that a "hell night" for her following her 2nd dose.; she fell two times after the second dose.; vomiting; she also experienced a "very strong headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ESTRADIOL, NORETHISTERONE ACETATE (COMBIPATCH) for an unknown indication.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache). At the time of the report, LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment medication  was not provided .   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up information included no new information.; Sender's Comments: This case concerns a female patient of unknown age, with relevant medical history of kidney disorder, who experienced the expected events of vomiting and headache and the unexpected events of Feeling abnormal, fall and Loss of consciousness. The events occurred on an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The events were considered related to the vaccine per the reporter's assessment. The events vomiting and headache are consistent with the current understanding of the mechanism of action of the study medication. The medical history, of kidney disorder, use of concomitant medication levothyroxine and estradiol/norethindrone acetate, remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event Loss of consciousness was automatically upgraded as serious as per IME list. However, based on reporter´s assesment, information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious.
Chills, fever (up to 102), HA, myalgia, nausea, gross hematuria (worse with 2nd dose). Symptoms lasted 48-60 hours. The gross hematuria gradually improved over 6-7 days approximately.
I began having notable palpitations after my 2nd vaccine in January. Palipitations continued getting worse until I began having SVT episodes in late May 2021. I was officially diagnosed with SVT and will need a cardiac ablation.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". 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.  Clinical information: The patient did not receive other medications or products within 2 weeks of starting COVID-19 treatment and the patient previously receive a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client experienced unusual rash approx. 24 hr after receiving the following vaccines: Dtap, Hib, PCV7 and MMR. Rash described as diffuse "bumps" on legs, back, arms and torso. Some of them were red and became "itchy" with time. Eval by FNP completed with unknown diagnosis. Symptoms resolved in approx 1 week with treatment.
Patient self-reported TIA approx. 40 mins after receiving 1st dose of moderna vaccine.  Pt states she did not go in for diagnostic imaging or medical care, but knows what a TIA "feels like," as she has had approx. 6 in her lifetime (self-reported, only 1 TIA found on her medical record).
missed 2nd dose appointment; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medicines was not reported by reporter  treatment information was not provided
Pt was inconsolable per mom the evening after the vaccinations. Upon presentation to PCP 03/29/2017 pt was positive for single red induration on the ULT. Treating with TYLENOL.
symptoms of feeling warmth over the head and ears; heart beat started to beat very fast; quoted," bum ,bum, bum and almost like tachycardia"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (symptoms of feeling warmth over the head and ears), HEART RATE INCREASED (heart beat started to beat very fast) and TACHYCARDIA (quoted," bum ,bum, bum and almost like tachycardia") in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced FEELING HOT (symptoms of feeling warmth over the head and ears), HEART RATE INCREASED (heart beat started to beat very fast) and TACHYCARDIA (quoted," bum ,bum, bum and almost like tachycardia"). At the time of the report, FEELING HOT (symptoms of feeling warmth over the head and ears), HEART RATE INCREASED (heart beat started to beat very fast) and TACHYCARDIA (quoted," bum ,bum, bum and almost like tachycardia") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent two separate temperature excursions. In the first excursion the vaccine was exposed to temperature between 46 to 77 degrees Fahrenheit for 4 hours. The second temperature excursion details were unknown. There was no adverse effect reported. Data logger was not involved. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013513: US-009507513-1701USA013514:
Effusive Constrictive Pericarditis After Covid-19 Vaccination; This is a literature report.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation.The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19. The following information was reported: PERICARDITIS CONSTRICTIVE (medically significant), 4 days after the suspect product(s) administration, outcome "recovering", described as "Effusive Constrictive Pericarditis After Covid-19 Vaccination". The event "effusive constrictive pericarditis after covid-19 vaccination" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102.7 Centigrade; Chest X-ray: noncontributory.; C-reactive protein: 17.18 mg/dl; Echocardiogram: Showed a small fibrinous circumferential pericardi, notes: effusion with no evidence of cardiac tamponade; however, there was an interventricular septal bounce suggestive of effusive-constrictive pericarditis; Electrocardiogram: revealed diffuse T wave inversions; autoimmune workup: Negative; Negative; Magnetic resonance imaging: This diastolic septal bounce was also seen, notes: along with a pericardial enhancement measuring up to 0.2 cm in thickness; Nucleic acid test: negative; Troponin: negative x2; White blood cell count: 13.6, notes: unit:Thou/uL. Therapeutic measures were taken as a result of pericarditis constrictive.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event Pericarditis constructive  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
MMR and Varicella Vaccine ordered today.  MA gave MMRV and Varicella vaccine.   Patient received double dose of varicella.  Error was discovered after patient left clinic.  CDC Vaccine Information Line contacted to discuss/learn of any possible complications of which none where identified.  Contacted mom to inform of error.
The finger tips getting numb was with the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FMWBO) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset Nov2021, outcome "unknown", described as "The finger tips getting numb was with the first dose". Additional information: In the beginning the patient finger tips were getting numb. She has had two doses. The finger tips getting numb was with the first dose and they did not think anything about it and over looked it. After the second dose is when other side effects started and the finger tips getting numb increased really bad. Caller unable to provide specific date on when her daughter finger tips were getting numb. The second dose was on 05Dec2021. Her daughter did not start having side effects or did not mention it to caller until the beginning of Jan2022. Prior Vaccinations (within 4 weeks), and other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were none. AE(s) following prior vaccinations were none. Family Medical History Relevant to AE(s) was not provided.  Follow-up attempts are completed. No further information is expected.
Friend had shingles 4x even with the shot/Suspected vaccination failure; Had shingles 4x even with the shot; This case was reported by a consumer via interactive digital media and described the occurrence of 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Nov-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient's knew that the patient who has had shingles 4 times even with the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.