chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore left arm; nausea; fatigue (slight); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2021 14:30 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Aortic stenosis" (ongoing); "TAVR Valve", start date: 22May2018 (unspecified if ongoing); "Atrial fibrillation" (ongoing); "Edwards Sapien 3 bovine TAUR Model 9600 TFX-23MM Serila" (unspecified if ongoing); "Cholesterol management" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for transcatheter aortic valve implantation (ongoing); ATORVASTATIN [ATORVASTATIN CALCIUM] taken for blood cholesterol (ongoing); SOTALOL taken for atrial fibrillation (ongoing). Vaccination history included: Bnt162b2 (Lot number: EN6200 at 14:30 intramuscularly in left upper arm as dose 1, single), administration date: 16Feb2021, when the patient was 72 years old, for COVID-19 immunisation, reaction(s): "Sore left arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Mar2021, outcome "unknown", described as "sore left arm"; NAUSEA (non-serious) with onset 14Mar2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 14Mar2021, outcome "unknown", described as "fatigue (slight)". Therapeutic measures were not taken as a result of vaccination site pain, nausea, fatigue.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Patient had not been tested for COVID-19. Events was experienced in the afternoon of 14Mar2021.  No follow-up attempts are possible. No further information is expected.
VERY SORE RIGHT ARM, SWOLLEN LYMPH NODES UNDER RIGHT AXILLA, FEVER, CHILLS
Patient got Covid after the 1st dose; Patient got Covid after the 1st dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Virus " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Patient got Covid after the 1st dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She got up to go to bathroom came out and passed out; Lost her appetite; all she wanted to do was sleep; Daughter thought patient's sugar was low; Her muscles hurt; Head was splitting - had a severe bad headache; She got ill about 4 or 5 hours after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), ILLNESS (She got ill about 4 or 5 hours after 2nd dose) and BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 test positive (Patient reported that she tested positive for COVID-19.) on 30-Dec-2020.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (She got ill about 4 or 5 hours after 2nd dose). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low), MYALGIA (Her muscles hurt) and HEADACHE (Head was splitting - had a severe bad headache). At the time of the report, LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), ILLNESS (She got ill about 4 or 5 hours after 2nd dose), BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low), MYALGIA (Her muscles hurt) and HEADACHE (Head was splitting - had a severe bad headache) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information provided.   This case was linked to MOD-2022-437428 (Patient Link).
Fever, chills, body aches, headache, extreme fatigue, nausea and diarrhea
Nasal hemorrhage beginning with blowing the nose.  Blood on the tissue indicated the problem, after which it was difficult to stop with pressure.  Make shift plugs worked for perhaps 15 minutes at a time, after which they failed to singularly work.  Applying an external ice pack to the upper nose in combination with a make shift internal plug stabilized the bleed, as long as the plug was in place.  Slept the first night with the plug in place.  Leakage continued through the following day, 11/22.  Leakage continued the night of 11/22 behind a make shift plug, with a large clot forming in the upper nasal cavity that was extracted over 15 minutes with saline solution and sucking, eventually spitting it out.  Leakage continued on and off  to a lesser extent through 11/24, at which point it has ceased thus far.
Answered a couple of questions incorrectly -received shingles shot from Pharmacy. Dr. is my interist not the doctor that administer the shot. Having pain in left arm where I received the shot. Nothing the first week but last two weeks it is getting worse. Throbbing mainly after use, like golf, tennis or working out at gym.
Immediately once the shot pulled out of her arm, she was dizzy. Walked slowly to the post vaccine area and spoke with the volunteer MD that was there.  The nursing students stayed with her and gave her apple juice. She has felt dizzy ever since.   Dizziness has eased up as far as severity goes, but she feels like it stays with her longer than it should have. Had to miss work last week a few days because of this.
Pain under both arms since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain under both arms since yesterday) 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 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain under both arms since yesterday). At the time of the report, PAIN IN EXTREMITY (Pain under both arms since yesterday) had not resolved.            No concomitant medications were reported.  Non drug treatment include Ice.   This case was linked to MOD-2021-033149 (Patient Link).
Developed reflux sx, facial swelling, eyes itching, SOB, wheezing.
Pt had a sore arm night of 9/21 and had flu like symptoms on 9/22. She started feeling better by Monday 9/23, however by the evening of Tuesday 9/24 her arm was more sore. She took Tylenol and went to bed but woke up at 2am Wed 9/25 with an extremely painful arm. Her arm is extremely painful with any movement and she has limited mobility in the arm. She also reports shooting pain with any sudden movements and is concerned about nerve issues. Patient reports her arm is tender to touch above the injection site, but states there is no swelling/bump/redness. She does have RA, which has manifested with the same symptoms, and she thinks that it may have been triggered by the shot but we are not sure at this point. I counseled patient to take some more Tylenol and recommended she go to an urgent care or see her physician so that they can take a look at her arm more closely.
patient given Menactra on 7/6, but was not quite 16 years old/came back today and was given another dose with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00690055) and transmitted to Sanofi on 20-Jul-2021.  This case involves an unknown age and unknown gender patient for whom it was reported "patient given menactra on 7/6, but was not quite 16 years old/came back today and was given another dose" (inappropriate schedule of vaccine administered) while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date: not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was case of actual medication error due to inappropriate schedule of vaccine administered (Latency: on the same day).  It was reported that, "Caller printed a certificate expires 14-Sep-2021. Caller has an appointment on 28-sep-2021 to get another injection. It is it ok that she is waiting longer than 8 weeks to give another injection. It is it ok that she is waiting longer than 8 weeks to give another injection".  Details of laboratory data not reported.  At time of reporting, the outcome was unknown for the event patient given menactra on 7/6, but was not quite 16 years old/came back today and was given another dose.  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 the 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.  There will be no information available on the batch number for this case.
The patient was brought to the ED by EMS on 10/16/23 for weakness and a cough. In the ED, patient was found to be borderline febrile with a temperature of 100 F. A rapid COVID PCR test performed in the ED resulted positive. Ultimately, the patient was admitted 10/16/23 - 10/26/23. Discharge diagnoses included suspected sepsis secondary to UTI and COVID positive, among other diagnoses.   Of note, the patient has received the Pfizer Monovalent COVID vaccine (given 3/7/2021; 4/4/2021; 12/6/2021; 8/16/202) and the Pfizer Bivalent COVID vaccine (given 12/7/2022).
She immediately fainted and then convulsed. This lasted about 5 minutes after the injection. Nurses gave her soda and crackers and she recovered within 20 minutes. Upon returning home, 45 minutes after the event, she vomited.
Patient c/o diffuse itching without rash or swelling identified.  Gave Benadryl 25mg PO with improvement.  Patient discharged with epi-pen and instructed on use.
This spontaneous report as received from a registered nurse refers to an 11 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 17-DEC-2002, one day after the patient's first birthday, the patient was vaccinated with a dose of M-M-R II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information has been requested.
pt recvd vax; red swollen rt leg; hard lump in rt leg; given apap & dph;
Seizures, Multiple.  Sent to hospital, diastat administered, hospitalized x 3 days. 11/13/09 Medical records received for date 4/23/05 to 4/25/05. DX: Prolonged afebrile seizure. Complex partial seizures. Presented to ER with parents c/o starring to right. Parent states pt had URI, low fever, irritable. Pt. starring to rt. upon arrival. Later in ER RUE, RLE began jerking, head toward rt. approx 5min. Assessment: fever(+), vomit(+), loose stool(+), otherwise WNL.
her entire body is itching/Her entire body has been itching for 22 days; felt pressure on her chest on her way home; Entire body tired; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (her entire body is itching/Her entire body has been itching for 22 days), CHEST DISCOMFORT (felt pressure on her chest on her way home) and FATIGUE (Entire body tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067FZ1A, 044A21A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PRURITUS (her entire body is itching/Her entire body has been itching for 22 days) and CHEST DISCOMFORT (felt pressure on her chest on her way home). In December 2021, the patient experienced FATIGUE (Entire body tired). At the time of the report, PRURITUS (her entire body is itching/Her entire body has been itching for 22 days), CHEST DISCOMFORT (felt pressure on her chest on her way home) and FATIGUE (Entire body tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (her entire body is itching/Her entire body has been itching for 22 days), CHEST DISCOMFORT (felt pressure on her chest on her way home) and FATIGUE (Entire body tired) to be related.    The reporter was a Public health program manager.  Concomitant medication of the patient was not reported.  The patient was still having the symptoms. Her entire body was itching so much that the itching cream was not working.   As per the pharmacist, the adverse events were probably the side effects from the vaccine. Her next appointment with her doctor was in next month.  Treatment information for rest of the events were not reported by the reporter.
FEVER 101F, WEEKNESS, CHILLS, BODY ACHES, NAUSEA, HEADACHE, SWOLLEN GUMS
Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Additional Details: Patient fainted after approxiamtely 5 minutes of Moderna administration. Patient was unconscious for approxiamately 30 second and then regained consciousness.
Last shot administered 6/9/16. Symptoms started in July 2016. Started w/burinig sensation in feet/heels. Moved throughout body to shoulders, toes, fingertips, etc. Hands began to tremor/shake. Tremors occur in hands consistently throughout the day and are 30sec - 2min in duration.
devel crying lasting several hr non-stop; mom unsure of temp, but states had a high fever; thigh became very red, swollen, bruised for approx 2 days p/recv vax; tc to FMD; DT recommended for future doses;
The Hib vaccine was expired.  I did not notice it until the patient had left.  A new copy of their immunization record was sent to Mom and explained to Mom what had happened.  They are moving so I wanted them to have a current, accurate record.
PATIENT LOOKED AT WIFE AND SAID I DON'T FEEL RIGHT, AS I WAS CALLED BACK TO THE CAR HIS HEAD BEGAN TO ROLE FORWARDS, THEN IN A CIRCULAR MOTION.  HIS EYES ROLLED BACK IN HIS HEAD AND HE MADE A GASP FOR BREATH THEN PASSED OUT.  EPI PEN WAS IMMEDIATELY ADMINISTERED.  PATIENT BECAME MORE RESPONSIVE, LAID SEAT BACK IN CAR.  PATIENT SWEATING , COULD NOW SPEAK TO ME BUT STILL SOMEWHAT DISORIENTED.  VERY FAINT PULSE.  911 WAS CALLED AND COOL WET PAPER TOWEL PLACED ON HIS NECK AND OBSERVED UNTIL 911 ARRIVED WITHIN 5-10 MINUTES.  PATIENT TRANSPORTED TO ER DUE TO VERY LOW PULSE EVEN AFTER EPI ADMINISTRATION.  PATIENT REMAINED AT ER UNTIL 1:30 PM FOR MONITORING.  THEY TRULY FELT IS WAS A VASOVAGUL REACTION.  PATIENT WAS OUTSIDE WORKING IN YARD AT 6:30PM WHEN I CALLED TO CHECK ON HIM, HAS NO RECOLLECTION OF RECEIVING SHOT OR EPI PEN, JUST SAID HE REMEMBERS MEDICINE FEELING "HOT" GOING DOWN HIS ARM.
Reddening and burning of top of ears.  Blood pressure became erratic.  Going from dangerously low to dangerously high. lowest reading 80/50  highest reading 200/100.  Still erratic
chest pain/pain on both sides of my chest; stiffness in my back and neck to a point I couldn't move my neck in any direction; stiffness in my back and neck to a point I couldn't move my neck in any direction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 17-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 07:45 (Lot number: FE3592) at the age of 17 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose: 1, Batch/lot number: EW0186, Anatomical Location: Arm Left, Time: 01:30 PM), administration date: 21Aug2021, when the patient was 17 years old, for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 24Sep2021, outcome "recovering", described as "chest pain/pain on both sides of my chest"; MUSCULOSKELETAL STIFFNESS (non-serious), MOVEMENT DISORDER (non-serious) all with onset 24Sep2021, outcome "recovering" and all described as "stiffness in my back and neck to a point I couldn't move my neck in any direction". Therapeutic measures were not taken as a result of chest pain, musculoskeletal stiffness, movement disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: Aleve and ibuprofen. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. Since second shot, the patient has been experiencing most to all symptoms. It's been 5 days and was still feeling most of them, but biggest concern was chest pain. It has been constant since patient has got shot, and the pain comes in waves. The patient was experiencing pain on both sides of chest but more so commonly on right side. The patient felt pain when tried to move, and when breath or stretch too much. It not so bad that it was enabling ability to do things, it was just not normal nor comfortable in any way. Other than that, the only other odd thing patient had experienced 1-2 days after was a stiffness in back and neck to a point that couldn't move neck in any direction.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician via company representative refers to an older female patient of unknown age. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date, the patient had positive pap smear. The outcome of positive pap smear was unknown. The physician stated that he wants to do a biopsy on the patient. The patient sought medical attention. Additional information has been requested.
Vaccination arm (left arm) became very sore, visible redness at injection site, intermittent fever & chills, some nausea. Lasted about 6 days.
I contracted Covid-19 again.  Was diagnosed positive on July 7th, 2021; I contracted Covid-19 again.  Was diagnosed positive on July 7th, 2021; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: CR8727) via an unspecified route of administration, administered in left arm on 30Mar2021 at 12:00 (at the age of 55-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included asthma. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 06Jul2021 at 07:00, the patient contracted covid-19 again, was diagnosed positive on 07Jul2021. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included rapid test nasal swab: negative on 22Jun2021, positive on 07Jul2021. Events resulted in emergency room/department or urgent care. No treatment received for the events. The clinical outcome of events was recovered on unspecified date in Jul2021.  Follow-up attempts are completed. No further information is expected.
Pt developed tense, painful erythema, swelling and induration encompassing 2/3 of the circumference of the upper arm which abated slowly over several weeks. Treated with IV antibiotics in hospital for about 7 days and then with home IV antibiotics until 11/6/02.
grandmother reports client achey all over-Fever 101 deg in 1st 24 hrs after receiving shots at our clinic 12-19-07 - 12-21-07 -still achey but feels some better fever decreased 99 deg with Tylenol/Advil every 4-6 hrs per grandmother's report today -12-26-07 pc from pt grandmother recovered 12-22-07 with no problems.
sick for 2-3 weeks after getting each vaccine; chills; fever; cant do anything; low white cell count "lower end of the normal"; suppressed autoimmune system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: EN6205), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6206, Vaccination Anatomical site: Left arm), administration date: 2021, for COVID-19 Immunization, reaction(s): "Chills", "Tiredness", "just did not feel her self", "Headache". The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "cant do anything"; CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "low white cell count "lower end of the normal""; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick for 2-3 weeks after getting each vaccine"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "suppressed autoimmune system". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller received 2 primary series of Pfizer COVID vaccine and 2 boosters shot, last one on 07May2022. She stated she has gotten sick for 2-3 weeks after getting each vaccine; chills, fever, can't do anything, no ER visits. She did call Pfizer after the first vaccine and reported it. She has low white cell count "lower end of the normal", suppressed autoimmune system and it takes her longer to recover when she gets sick. Caller wanted to know can she get her next booster dose before 6 months. Patient have the low white blood count cell and suppressed immune system after each dose.  No follow-up attempts are possible. No further information is expected.