chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patient of unknown age and gender. On an unknown date in 2012, the patients were vaccinated with a dose of LIQUID PEDVAXHIB (lot numbers were reported as H010726 and H013038, expiry date, dose and route were not reported) that had a temperature excursion of 26 Fahrenheit for 17.5 hours and unsupported. No concomitant medications were reported. This is one of the 2 reports received from the same reporter (MARRS-1212USA007932). Additional information has been requested.
Severe injection site pain for the first two days + fatigue. Flu like symptoms started on the second day and it got worse each day (body ache, joint pain, stuffed nose, severe headache, upset stomach, diarrhea, coughing.
Patient states the day following the vaccine administration he started to feel "off" during the day.  That evening he developed chills.  During the night he believes he had a high fever, woke up lying on his floor and states he had difficulty getting up.  He doesn't know how he got on the floor.  He did not take his temperature but says he felt very warm.  He was nauseated and his arm was very sore.  He states he was "delirious".  The following morning he felt a little better, and as the day progressed he eventually felt more like himself.
BLOOD CLOT; This spontaneous report received from a consumer via news concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient developed a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Received flu vaccine on 10-18-10. 10-25-10 presented to hospital with "hives et itching". Received 60mg PO x1 of ORAPRED et discharged to home with instructions for allergic reactions. Presented at Center on 10-25-10 for an acute appt with provider. Area was erythematous, soft, et without drainage. Pt also displayed s/s of sore throat. Amoxicillin 400/5 1.5 tsp BID x 10 days given rx given to parent at time of exit.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PROQUAD and VARIVAX for prophylaxis (dosage regimen was unspecified) on the same day. No adverse symptoms reported.
Pt had brief, sudden lapse of conscious activity with generalized stiffening and shaking of his head and extremities. His eyes were closed most of the time and his head was jerking backward. No lose of bowel/bladder. Lasted 2 min.
Pt returned to clinic 48 hrs post Td vaccination c/o redness, swelling,pain at injection site (L deltoid) beginning 12/15/2005. Denied lymphadenopathy, fever, or chills. Pt's mother was instructed to ice area, take tylenol prn for pain control, and call/return to clinic if symptom worsens or does not resolve.
Patient said that she had muscle pain an redness the first night, the next day the redness spread down the arm past the elbow and was itchy and warm to the touch, reaction has improved but still red and itchy as of 11/3/16.
Following the second dose I had a very bad cold for two months; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 80 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Following the second dose I had a very bad cold for two months".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient told nurse she was due for her 3rd ( booster ) dose and when this was being entered into , it was discovered that she had received COVID 19 vaccines on 1/29/21, 4/7/21 and 4/28/21 at Medical Clinic and only the date of 4/7/21 was in our system.  The COVID 19 dose the patient received on 11/16/21 was her 4th dose according to .
Awoke at 6:30AM with chills and fever of 102. Took tylenol to reduce fever. Stayed in bed all day until 5 PM. Kept taking tylenol every 3 hours . Fever was gone at 5pm but still felt very lethargic.  The next morning I was feeling fine.
expired dose of Daptacel was given to patient on 24SEP2019/no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old female patient who received expired 0.5 mL dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254AA, expiry date-18-09-2019 Frequency = once via unknown route in the right thigh on 24-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation; and POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Headache, Sedation, Arthralgia, Fever, Chills, Pain/Itching @ injection site Narrative:  Other Relevant History:
I had congestion; sore throat; diarrhea; fever; and cough lasting 6 days. I took nothing for it.
54 year old male presented for Moderna Covid vaccine. This is First dose. MA retrieved me for evaluation of patient due to complaints. Possible reaction to Moderna Covid vaccine 1st dose. Administered at 9:15am. Started feeling symptoms 10 min after vaccine. His blood pressure dropped to 50/36. Patient mentions complaints of associated dizziness and feeling hot. Denies prutitis, denies dyspnea, denies GI distress. Has  not eaten today. RBS 128. Pt placed supine.  Treated with EPI 0.3mg as prophylaxis.  9:32 am administered. EMS was called to the clinic to evaluate pt and transfer to ER The patient stabilized and elected to not be transferred to the hospital.  BP at 9:35 89/55;  After epi  9:40: 93/61 BP stabilized to 127/74 at 9:50 am   Pt endorses having similar reaction when he had his MI.   per provider Possible vaso-vagal response, but treated as if anaphylaxis due to temporal relationship to vaccine.  Recommend second vaccine with Pfizer under close observation.  Pt to FU with PCP
Narrative:  30 minutes after patient received J&J COVID-19 vaccine, patient stated they felt warm. Vitals were obtained. Vitals unremarkable except temperature was 99.1 F. Cold pack was applied and water given to pt to drink. PCP examined pt and determined pt was in no need of immediate  medical attention. Patient at no time reported or displayed that they were in distress. Patient then proceeded for scheduled PCP appt.
Moderna dose administered after recommended 12-hour punctured beyond-use-date (BUD) but before recommended 24-hour room temperature unpunctured BUD.
No other AEs; received 2 doses of vaccine on same day; This spontaneous report was received from an office manager referring to a 10 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-AUG-2021, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot # T025370, expiration date 01-DEC-2022) via unknown route for prophylaxis (extra dose administered). This was patient's second vaccine in a series of 2. No other adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This spontaneous report as received from nurse practitioner via company representative and refers to a 36 week old female patient. On 09-SEP-2014, the patient was vaccinated with the first dose of ROTATEQ series (dose, lot and expiration date not reported). On the same day (09-SEP-2014), the patient was concomitantly vaccinated with poliovirus vaccine inactivated (unspecified) (dose, route, lot and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
A large raised/red rash appeared on my upper arm around the site of the injection a week after I got the vaccine. It is sometimes itchy but not too bad. It has a large eliptical like shape. I first noticed it on Wednesday night and it can still be seen today (four days later). It is now smaller/less raised/less red than when I first noticed it. I didnt report it on the vsafe app because I didnt notice it until after I stopped reporting to the app. I have not seen a doctor about it.
Pt called within 5 minutes of leaving, she experienced tingling, and numbing on left side of face.  Pt took a Benadryl orally, she stated she has had allergic reactions previously to other medications.  Pt went to ER, Labor and Delivery and was admitted when her tongue began to swell, tingling and numbing.  After discharge pt expeirenced diarrhea and lump at injection site.
arm pain next day; lightheadedness and fogginess about 1 hr post vaccine which resolved within 15 min; lightheadedness and fogginess about 1 hr post vaccine which resolved within 15 min; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 86 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 15:15 (Batch/Lot number: unknown) at the age of 86 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), FEELING ABNORMAL (non-serious) all with onset 03Mar2021 16:30, outcome "recovered" (03Mar2021 16:45) and all described as "lightheadedness and fogginess about 1 hr post vaccine which resolved within 15 min"; PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "recovered", described as "arm pain next day". Therapeutic measures were not taken as a result of dizziness, feeling abnormal, pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Joint range of motion decreased; Limbs stiffness; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), MUSCULOSKELETAL STIFFNESS (Limbs stiffness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No medical history provided by the reporter.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). On 23-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and MUSCULOSKELETAL STIFFNESS (Limbs stiffness). On 23-Apr-2021, VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and MUSCULOSKELETAL STIFFNESS (Limbs stiffness) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
nearly killed me; could not run which I do often for more than 20 yards without heart jumping out of chest; My heart went into defibrillation for more than ten seconds at a time; Initial information received on 04-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced nearly killed me, could not run which I do often for more than 20 yards without heart jumping out of chest and my heart went into defibrillation for more than ten seconds at a time while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient reported that this shot nearly killed me (near death experience (onset date and latency: unknown). This event was assessed as medically significant. His/her heart went into defibrillation for more than ten seconds at a time this happened for more that three days in a row (unevaluable event, onset date and unknown latency). The patient  could not run, which he do often, for more than 20 yards without his/her heart jumping out of his/her chest (losss of personal independence in daily activities, onset date and unknown latency, seriousness: disability). He/she had yet to test it again.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (My heart went into defibrillation for more than ten seconds at a time, nearly killed me).  At time of reporting, the outcome was Unknown for the event my heart went into defibrillation for more than ten seconds at a time, was unknown for could not run which I do often for more than 20 yards without heart jumping out of chest and was Unknown for the event nearly killed me.; Sender's Comments: Sanofi Company Comment dated 04-Jan-2022:  This case involves a patient of unspecified demographics who experienced "nearly killed me"  and "My heart went into defibrillation for more than ten seconds at a time." Further information regarding previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed
GARDASIL 9 was administered to a pregnant patient; No additional AE reported; Information has been received from a medical assistant referring to a female patient of unknown age. The patient was pregnant (estimated last menstrual period (LMP), estimated date of conception (EDC) and estimated date of delivery (EDD) were unknown, fetus number was one). Information of concomitant medication, pertinent medical history and drug reactions/allergies was unknown.     On 27-MAY-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose detail, frequency, route, lot# and expiration date were unknown) for prophylaxis (Vaccine exposure during pregnancy). The pregnancy outcome was outcome pending. The fetal outcome was unknown. No adverse event was reported.
he had some arm tenderness in the upper muscle; incredibly tired; a slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 Immunization, reaction(s): "little bit arm tenderness"; Flu shot (his symptoms are normal and nothing more than when you receive a flu shot.). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "he had some arm tenderness in the upper muscle"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "incredibly tired"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "a slight headache".  Additional Information:  Patient stated he received the second dose of the Pfizer COVID vaccine yesterday and had some arm tenderness in the upper muscle, incredibly tired and a slight headache that was tolerable. Caller stated his symptoms were normal and nothing more than when you received a flu shot. Caller states his wife says you were not suppose to take Tylenol or Advil before receiving the vaccine and his daughter says you were not suppose to take Tylenol or Advil after the vaccine. Caller would like to know who is correct and if you can take Tylenol or Advil before or after vaccination and if it will affect the efficacy of the vaccine. Patient would also wanted to know if arm soreness, tiredness, and headache are common side effects of the vaccine?. Patient and his wife had 2nd dose of Pfizer vaccine yesterday. Other family members would also get Pfizer vaccines. Said after 1st dose had little bit arm tenderness. After 2nd dose had little arm tenderness and a slight headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blood blister in my hand/ Seemed like a blood clot; depressed; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (Blood blister in my hand/ Seemed like a blood clot) and DEPRESSION (depressed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced BLOOD BLISTER (Blood blister in my hand/ Seemed like a blood clot) and DEPRESSION (depressed). At the time of the report, BLOOD BLISTER (Blood blister in my hand/ Seemed like a blood clot) and DEPRESSION (depressed) outcome was unknown.            Patient is unhappy and stated the life is damaged. Patient thought blood blister thing was going to bleed and went to different doctors and they said "cover it in case it bleeds" and said not to worry about  The patient  took picture of this thing, it's huge.  Patient had no doubts that Moderna vaccine caused the blister  No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-333559, MOD-2021-333582 (Patient Link).
patient became sick; This spontaneous report as received from a physician refers to a patient of unknown age. The patient's concurrent conditions included auto-immunity illness. Thepatient's medical history and concomitant medications were not provided.  On an unknown date the patient was vaccinated with an unidentified Merck hpv vaccine (name and lot number not provided). On an unknown date, after the vaccination, the patient became sick.    The outcome of malaise, the action taken with the vaccines and the causality assessment were not provided.
Staff member reported to his supervisor that he started with lung pain, headache, and soreness at injection site. He called off of work and went to see his doctor who diagnosed him with body aches post COVID-19 vaccine. He is to be home until 10/24 to which he can return to work. To my knowledge there has been no hospitalization post vaccine.
Erythematous, moderate area on right anterior thigh for 2 days. 8cm x 12cm at 2 days post vaccination. No fever, some tenderness, no streaking. Unable to access duration of event as pt's phone disconnected.
This is a spontaneous report from a contactable nurse reporting for two patients. This is the first of two patients. This report was received via a sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, headache, sore arm and temperature of 101 all on an unspecified date with outcome of unknown. The patient actually went to the emergency room.