chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have pain and swelling in the joints of my fingers.; I have pain and swelling in the joints of my fingers.; Inflammation in the sole of both feet; Backside of the knee hurts; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm right on 04Apr2021 at 14:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. Allergies to medications, food or other products was reported as not that the patient knows of. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 14Mar2021 at 14:30 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 14:00, the patient experienced pain and swelling in the joints of the fingers. The patient also had inflammation in the sole of both feet and backside of the knee hurts. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain and swelling in the joints of the fingers, inflammation in the sole of both feet and backside of the knee hurts were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient experienced lump at injection site and redness of approximately 6 inches in diameter around site.  Area also felt itchy and warm.  Patient has taken ibuprofen and states that the area is "tolerable".  Redness and warmness still apparent on 10/8/10, but not getting any worse.
still have a headache 1 week after my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (still have a headache 1 week after my vaccine) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (still have a headache 1 week after my vaccine). At the time of the report, HEADACHE (still have a headache 1 week after my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  patient's lab test data not reported. No concomitant medication information was provided. No treatment information was provided.
Swollen lymph node above clavicle, headache, neck and jaw pain, extreme fatigue. all symptoms for 2 days and ongoing.
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 03May2021 at 12:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis A in 1978, heart murmur. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included colecalciferol/ calcium carbonate/ magnesium oxide (CAL MAG D) for unknown indication from an unspecified date, unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 12Apr2021 at 12:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 14:00, the patient experienced fever up to 100.3 (unspecified units) for 24 hours, fever lingered at 99.5 (unspecified unit) for 36 hours. Chills, nausea, joint pain in every joint. Exhaustion and elevated resting heart rate (normally 66) at the time of reporting 88 continued for 4 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, nausea, joint pain in every joint, exhaustion and elevated resting heart rate was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Rcvd vaccine 2nd period.  Waited appropriate amt time in observation.  Started feeling flushed, scratchy throat during day.  Came back 6th period.  Sent to clinic for observation.  Mom notified, feeling better.
started to feel bad; arm is stiff, heavy, and has lost mobility; unbearable pain in the arm; feels like the bone is broken from the intense pain that she has, it feels like a cramping of the arm; arm is stiff, heavy, and has lost mobility; pain in all the joints of the body; pain and fever have not let her sleep; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started to feel bad), MUSCULOSKELETAL STIFFNESS (arm is stiff, heavy, and has lost mobility), PAIN IN EXTREMITY (unbearable pain in the arm), MUSCLE SPASMS (feels like the bone is broken from the intense pain that she has, it feels like a cramping of the arm) and MOBILITY DECREASED (arm is stiff, heavy, and has lost mobility) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced INSOMNIA (pain and fever have not let her sleep). On 02-Apr-2021 at 7:00 PM, the patient experienced MALAISE (started to feel bad), MUSCULOSKELETAL STIFFNESS (arm is stiff, heavy, and has lost mobility), PAIN IN EXTREMITY (unbearable pain in the arm), MUSCLE SPASMS (feels like the bone is broken from the intense pain that she has, it feels like a cramping of the arm), MOBILITY DECREASED (arm is stiff, heavy, and has lost mobility), PYREXIA (fever) and ARTHRALGIA (pain in all the joints of the body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, MALAISE (started to feel bad), MUSCULOSKELETAL STIFFNESS (arm is stiff, heavy, and has lost mobility), PAIN IN EXTREMITY (unbearable pain in the arm), MUSCLE SPASMS (feels like the bone is broken from the intense pain that she has, it feels like a cramping of the arm), MOBILITY DECREASED (arm is stiff, heavy, and has lost mobility), INSOMNIA (pain and fever have not let her sleep) and ARTHRALGIA (pain in all the joints of the body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were reported for cholesterol, acid reflux and pills for severe arthritis.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: TCR form received on 16-MAY-2021 Contains No new information. On 27-Jun-2021: Follow up received on 27-Jun-2021 and contain non significant information.
(L) arm is edematous, red, warm to touch, no wheezing, no sob T-99.2, P-110, O2 Sat- 98%, B/P 90/51
Mother stated that after client showered today, Client noticed redness and a water filled bump to left arm at the injection site after removing the bandaid. Mother stated she placed ice to the arm and aloevera. Mother denied that client had a fever or any rash. Advised mother to take client to urgent care for an examination. Mother stated she would take client to a primary care clinic.
temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event; Initial information received on 27-Dec-2021 regarding an unsolicited valid non-serious case received from a patient.  This case involves an unknown demographics patient who experienced (product temperature excursion issue), temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event while receiving vaccines INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) (dose, formulation and strength not reported via unknown route in unknown administration site; lot - C5804AA, expiry: 03-Feb-2023, 17-Mar-2023) for Tuberculin test. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot UJ724AA, expiry: 30-Jun-2022 and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ759AD, expiry: 30-Jun-2022 via unknown route in unknown administration site (dose, formulation and strength not reported) as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event" (product temperature excursion issue) (unknown latency) following the first dose intake of TUBERCULIN TEST, INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Caller states that a temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged. The highest temperature reached was 70.0F(Fahrenheit). The products involved were unopened: FLUBLOK QUADRIVALENT, TUBERSOL, and FLUZONE HIGH-DOSE QUADRIVALENT. Caller asked for stability information for these products."  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV), TUBERCULIN TEST (TUBERSOL) and QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion occurred for a total of 86 hours and 30 minutes because the refrigerator was unplugged with no reported adverse event.
On set of tingling in left pinky finger started about one week after second injection. Symptoms have gotten worse and now have traveled to ring finger, hand, arm, leg, foot and toes all centralized to the left side. She is experiencing dizzy spells and headaches that last days at a time.  We are in the third to forth week of this and she has been taken to her pediatrician who is consulting with a neurologist. No word back yet.  We do not know if there will be permanent damage at this time. 9/18/08-records received-presented to PCP on 9/8/08- C/O left arm and leg numbness for past 2 weeks. Started with left pinky and progressed to arm. Left leg becomes numb and tingly. Headache off and on for few months some dizziness a month ago. PE normal. Seen in PCP office on 9/11/08-C/O recurrent headaches and recurrent numbness.  To see neurologist.
Patient felt unwell - dizzy and tired on the evening of April 5, 2021.  She went to bed and died in her sleep, likely early in the morning April 6, 2021.  Medical Examiner recorded her cause of death "Sudden Cardiac Death associated with Mitral Valve Prolapse
Pt with widespread  rash on body following booster dose of Moderna COVID-19 mRNA vaccine
A physican reported that a female pediatric solid organ transplant pt received her first dose of Prevnar on 31-DEC-2001. On 08-JAN-2002, the child was hospitalized for a single episode of hemoptysis. The reported noted that within "the last several weeks" the child had developed an "intermittent" cough. A chest X-ray performed on admission was consistent with infiltrate or atelectasis. A second chest X-ray performed within 24 hours of admission showed "remarkable improvement suggesting atelectasis to be the cause of this radiographic abnormality." Other laboratory findings were unremarkable. The child "remained stable" and was discharged within 24 hours of admission. The reporter indicated that there was no obvious etiology to the hemoptysis and considered the events to be "definitely not related" to Prevnar administration. No further information was available at the date of this report. Follow up info was received from the physician on 2/22/02. The child's medical history includes Alagille syndrome and liver transplantation. Concomitant medications included Ditropan, Bactrim, and Prograf. The physician provided an event onset date of 1/8/02 and indicated that the child recovered.
1300 Pt received vaccine.  At 1305, Pt c/o throat feeling like moss was growing, described as something thick inside. Pt rated sensation between mild and moderate. Pt denied SOB, pain, swelling in throat  and itching. Pt had previous reaction to the first and second Pfizer vaccines, swelling of throat and itching. Was given Benadryl with last vaccine. At 1310 MD called. Dr. called and made aware of previous reaction and intervention, SBAR given. Per MD, since Pt able to swallow water and saliva, speaking in full sentences and has no other s&s, can monitor for an additional15 more mins and DC Pt to home if no new or worsening symptoms occur, if worsens send Pt to ED. After Pt was being monitored for appx 20 more mins reported symptoms subsiding and  felt good to go home. Verbal discharge instructions given, 911 for emergencies. Pt verbalized understanding and ambulated independent.  DC home at 1335.
States noted redness, lump and warmth at site within 24 hours. Persisted x 5 days. Also pain at site.
Systematic error: Client was fed down the wrong lane and seated at a vaccination station that had Pfizer COVID vaccine.  Pt. needed second dose of Moderna COVID vaccine.
Patient stated that she is on chemotherapy and her body didn't respond to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST (Patient stated that she is on chemotherapy and her body didn't respond to the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST (Patient stated that she is on chemotherapy and her body didn't respond to the vaccine). At the time of the report, SARS-COV-2 ANTIBODY TEST (Patient stated that she is on chemotherapy and her body didn't respond to the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Antibody test: low (Low) 40.         Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: FUP received  included no new information.; Reporter's Comments: This report refers to a case of Antibody test after mRNA-1273 vaccination with no associated AEs.
Syringe blew off and vaccine leaked out on the floor; Syringe blew off; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Syringe blew off and vaccine leaked out on the floor) and DEVICE CONNECTION ISSUE (Syringe blew off) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced UNDERDOSE (Syringe blew off and vaccine leaked out on the floor) and DEVICE CONNECTION ISSUE (Syringe blew off). On 05-Mar-2021, UNDERDOSE (Syringe blew off and vaccine leaked out on the floor) and DEVICE CONNECTION ISSUE (Syringe blew off) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: NNI; Reporter's Comments: This case concerns a 22-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot #  unknown), reporting (device connection issue and underdose) without any associated adverse events. Event occurred the same day as vaccine administration. Events considered resolved.; Sender's Comments: same reporter, same event
grand mal sz @ 320PM on 13JAN97;hosp 2nd sz occurred in hosp @ 11PM on 13JAN97;tx w/phenobarbital;had CT scan of head done for precaution, as pt had fallen on 11JAN97;
Progressive Central Artery Occlusion, Ophthalmic Artery Occlusion, and Hemispheric Intracranial Thrombosis after COVID-19 mRNA Vaccine; Progressive Central Artery Occlusion, Ophthalmic Artery Occlusion, and Hemispheric Intracranial Thrombosis after COVID-19 mRNA Vaccine; Progressive Central Artery Occlusion, Ophthalmic Artery Occlusion, and Hemispheric Intracranial Thrombosis after COVID-19 mRNA Vaccine; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTERIAL OCCLUSIVE DISEASE (medically significant), OPHTHALMIC ARTERY OCCLUSION (medically significant), CEREBRAL VENOUS THROMBOSIS (medically significant), outcome "unknown" and all described as "Progressive Central Artery Occlusion, Ophthalmic Artery Occlusion, and Hemispheric Intracranial Thrombosis after COVID-19 mRNA Vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal relationship between the reported events ARTERIAL OCCLUSIVE DISEASE ,OPHTHALMIC ARTERY OCCLUSION and CEREBRAL VENOUS THROMBOSIS  cannot be excluded based on temporal association.  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.
Pt called on 04/22/2002 and reports she had to leave work due to feeling dizzy, headache and felt chilled but no fever. pt denies any local reaction other than some soreness of left deltoid where TD was given. Advised her to take Tylenol and see MD if symptoms worsen. Pt's symptoms resolved.
3 doses of PNEUMOVAX-23 were given yesterday which had expired; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 05-OCT-2020 (reported as yesterday), the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (once, injection, lot number S026366, expiration date 17-SEP-2020; dose and route of administration were not provided) for prophylaxis (expired product administered).   The vaccine had not undergone a temperature excursion, and it was supported by the memo up to 1 month after expiration, so it did not require additional evaluation from the escalation team. Device was not available for evaluation (obtain was reported as false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA002558: US-009507513-2010USA002548:
Information has been received from a pharmacy technician concerning a female in-house hospital patient with no drug reactions/allergies, who on 28-OCT-2010 was vaccinated in her right deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667405/0884Z). It was unknown if the patient had received PNEUMOVAX 23 in the past. The patient experienced erythema, 5 inches x 8 inches area at the injection site. No treatment was required. The reaction did not prolong her hospital stay. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. An "unnamed" laboratory test was performed (no result was provided). This is one of two reports received from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-OCT-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
5 months after getting the last shot patient lost all hair all over the body it happened over a matter of 2 days. Alopecia prior to the shot was never this bad patient would get a bald spot in their head here or there and then it would grow right back. Still had a full head of hair prior to the shots after the 3rd shot patient started to lose hair and then all of a sudden lost all hair in 2 days.
Sharp chest pains, chills, short of breath, body aches, fatigue, headaches.
Shortness of breath and chest pain due to new onset type 1 diabetes mellitus presented as DKA - started on iv fluids and insulin drip. Transitioned to basal and prandial insulin with sliding scale dosing as needed. Patient discharged home in improved and stable condition. ED visit to hospital admission within 6 weeks of receiving the COVID Vaccine.
Patient said he started feeling dizzy ~10 AM the day after his first dose. He took a nap and woke up at 3 PM to find the dizziness was gone.