chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Thursday, 3/18, I woke up at 3:30 am extremely dizzy with everything moving around me.  Sitting up was better but upon laying down, the extreme dizziness returned.  I was still dizzy when I finally fell back asleep.  In the morning, I nearly passed out & was in a cold sweat when I got up.  Gatorade helped. My PCP's office said it was probably a vaccine reaction.  I continued to feel rather light headed & neck pressure & by Tuesday, 3/23, I had a lot of body aches, diarrhea, I was definitely light headed & felt like I could pass out.  Over the next days, my blood pressure was very unstable.  This random blood pressure issue continued  & then the Premature Ventricular Contractions (PVC's) began to increase in spite of the Metropolol.  They became very frequent causing light headedness & neck pressure.  On 4/12, I went to the ER because my blood pressure was 185/50, heart rate 92.  Every 3rd beat was a PVC.  The cardiologist changed me to Verapamil 120 mg/day.  My condition deteriorated especially in the 3 days prior to the ablation.  I was short of breath with weak extremities.  The ablation was done on 5/25 & the Cardiologist said I was having PVC's every 2 seconds.  I am currently recovering from the procedure.  Prior to the 2nd vaccine shot, my PVC's were well controlled by Metropolol to 18% from the 21% in February 2019 prior to taking Metropolol.  My blood pressure was consistently normal as well.
Two days post vax, the pt developed an injection site reaction characterized by swelling, redness, and itching. She recovered after several days.
experiencing a very bad headache today.; This is a spontaneous report from a contactable consumer reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a very bad headache on 22Feb2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Confirmed Breakthrough   COVID-19 (Pfizer) 1 05/21/2021 Pfizer EW0158   COVID-19 (Pfizer) 2 06/01/2021 Pfizer    COVID-19 (Pfizer) 3 06/11/2021 EW0158   COVID-19 (Pfizer) 4 6/22/2021 Pfizer
Patient has infection at the site of injection. There was redness and swelling at the site of injection. Her primary care provider treated the side with antibiotic.
First Phizer-BioNTech vaccine given on 9/17/2021 In the morning given at the clinic. No reactions. Second Phizer-BioNTech vaccine given on 10/28/2021 in the morning given at the pharmacy. Adverese reaction.  1.The first few months were leg pains, extreme fatigue heart palpitations, increased anxiety. 2.The months following intailed joint pain, muscle pain, heart palpitations, muscle spasms, gi irregularity, menstral problems, left rib pain, chest pain, back pain, back ache, headaches, sensitivity to foods, sensitivity to medicine, neck pain, sleeping problems, increased anxiety, depression.   -Currently expiriencing all the syptoms listed above 10/24/2022
C/o feeling itchy on arms, neck, knee. No rash noted at injection site or on arms. Blotchy essential noted neck right clavicle area. Denies pain, SOB, dizziness, nausea. P76. Checked by EMT. EMT instruct ti take oral benadryl when she gets home. Client stated that perfums,perfume, lotions can set off itchy feeling when shesmells perfume.
Dry cough, shortness of breath, chest pain, headache, conjunctivitis. Dry cough - 3 hours after, shortness of breath/chest pain 4 hours after, headache and conjunctivitis 5 hours after injection.
7 Hrs after initial injection, severe body aches, severe headache, fatigue and weakness and next morning bad chills....lasted till approximately 3:30 pm the next day 12-30-2020. Some light headiness after that but other symptoms  abated after I slept the whole day. Fatigue appears to be an on-going issue sine my initial Covid-19 positive test at holiday.
FLUZONE administered 11/22/11. Redness/itching at injection site x 7-10 days. Random and periodic hives, itching/swollen hands since vaccinated. Came to pharmacy today w/ swollen (R) eye and upper lip. Pt. denies any allergies, or trouble breathing.
Pfizer COVID vaccine incorrectly diluted with normal saline in multi dose vial with preservative. Correct diluent should be normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Medical person called the morning of 08/03/21 and spoke to patient on the medical team at Pfizer who gave the same information. Patient was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Headache, Arthralgia, NauseaVomiting, chills, fatigue
Began not feeling well at end of December. Began having cough and cold like symptoms. Went in to PCP and was prescribed Paxlovid and symptoms began to resolve and around day 4 or 5 began to feel better
On the 18th I had a stuffy nose and was very weak. I had a slight fever around 99.4 to 99.6 for 3 days. I completed an at home COVID-19 test on 12/20/2022 and I took another PCR test on December 21, 2022, at the pharmacy. I was prescribed molnupiravir and started to take it on December 21st. I was feeling better by day 4 but still had a stuffy nose and a dry cough. I recovered after 4 days. I am still testing positive as recent as yesterday.
Mild but persistent numbness/pain around injection site of 2nd dose (left arm); Mild but persistent numbness/pain around injection site of 2nd dose (left arm); This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 31Mar2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 11:30, the patient experienced mild but persistent numbness/pain around injection site of 2nd dose (left arm). Not debilitating or overly impactful but always present. Concerning for future arm mobility/use in older age. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 events mild but persistent numbness/pain around injection site of 2nd dose (left arm) was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 17 year old female patient who started GARDASIL on an unknown date. The patient has no relevant medical history, and past drug includes no prior reactions to GARDASIL. On 01-DEC-2009 the patient was vaccinated with her third dose of GARDASIL (lot # 661703/0651X) in the right deltoid. Concomitant therapy included hormonal contraceptives (unspecified). After getting this injection, the patient reported feeling faint to the nurse who was still in the room, the nurse observed the patient to have tonic-clonic movements. The patient's blood pressure and pulse were monitored and reported to be normal, she was observed by the physician to be doing well and he felt that she was okay to go home. On 02-DEC-2009 a follow-up phone call was made to the physician's office stating that the patient had a severe headache, back ache and neck pain. He did not get to speak directly to the patient or her mother. Upon internal review, seizure/convulsion was determined to be an other important medical event. Additional information has been requested.
Information has been received from a Registered Nurse concerning a 21 year old male student who on 01-APR-2009 at 8:30 at a well visit was vaccinated with the second dose of PNEUMOVAX (lot # 659922/1667U), via subcutaneous in the right arm. On 01-APR-2009 1-2 hours after vaccination of PNEUMOVAX, the injection site became red, tender and swollen "area the size of a baseball" as per the patient. The patient was treated with ice packs and triamcinolone acetate 0.1% twice a day. The symptoms subsided after 3-4 days (approximately 05-APR-2009). The patient was reported as recovered. A signed informed consent form was not obtained. No further information is available.
Right groin 2 CM lymph nodes swelling  2 days post Pfizer vaccine.  Headache and muscle soreness  at injection site few minutes after the vaccine
Initial information received on 12-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (LPN).This case involves a patient (age and gender was not reported), who experienced one patient, received expired dose/ no ae reported, while he/she received vaccine PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used. 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.
the patient was administered improperly stored VAQTA; second dose administered outside prescribing information; This spontaneous report was received from a medical assistant and refers to a 58 year-old male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not provided.  On 01-JUL-2020, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) injection, intramuscularly (exact dose, lot #, expiration date and anatomical location were not reported). On 31-AUG-2020, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # S023220, expiration date 20-OCT-2020, intramuscularly (exact dose and anatomical location were not reported) which was improperly stored. The second dose was administered outside of the prescribing information. The vaccine underwent excursion above 9 degrees Celsius for 66 hours. No previous temperature excursion was reported. Digital data logger was involved.
Pt recvd 3 doses of Hep-B 26JUL90, 26AUG90, & 27FEB91 & following 3rd dose exp a severe h/a & diarrhea;
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender,. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored does of PROQUAD (rHA) (lot # M011662 with expiration date 08-SEP-2017, dose unknown, subcutaneous. The vaccine was improperly stored at 40.1 degree Fahrenheit for 50.5 hours. Data logger was involved. There was no prior excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
patient was given an expired dose of Ipol / No AE; Initial information was received on 24-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 23 year old female patient who received an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL].  The patient's past vaccination(s) included POLIO VACCINE INACT 3V (VERO) (IPOL) which was recieved 20 years ago. The patient's medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot P1A461M, expiry date-03-May-2020) (Interval Dosage : 24-Jul-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an 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 and Module VI of the 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.
Hives on lips, face, chest, head, arms, throat; Pain in arm so much that if arm moves; Rash on stomach, back, chest; Feels like throwing up.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on lips, face, chest, head, arms, throat), PAIN IN EXTREMITY (Pain in arm so much that if arm moves), RASH (Rash on stomach, back, chest) and NAUSEA (Feels like throwing up.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-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 URTICARIA (Hives on lips, face, chest, head, arms, throat), PAIN IN EXTREMITY (Pain in arm so much that if arm moves), RASH (Rash on stomach, back, chest) and NAUSEA (Feels like throwing up.). At the time of the report, URTICARIA (Hives on lips, face, chest, head, arms, throat), PAIN IN EXTREMITY (Pain in arm so much that if arm moves), RASH (Rash on stomach, back, chest) and NAUSEA (Feels like throwing up.) outcome was unknown.            Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Had redness about 3cm in diameter initially. Then next day, dramatic swelling and redness left anterior thigh. Has 10-12cm induration and erythema prominent at margin. Suspect hematoma after secondary possible celulitis.
8 x 7 cm red, warm, edematous at deltoid (left) which was injection site. Antibiotic treated. Recheck 2 days and resolved.
After the vaccination, only my arm hurt, but on Monday I woke up with a red eye and with pain and on Thursday my eye became redder and it did not blink and at around 11:00 AM my mouth was bent on one side. I went to the emergency hospital and they gave me medicine because my nerve had become paralyzed. They gave me two types of pills and to use drops for dry eye. I went to another doctor and she told me it was a virus in the eye. It's been 1 week now and my mouth is still on my side.
I was diagnosed with a sinus infection 03/10/2023. I couldn't sleep due to coughing so much, and the draining of my sinuses. I'm still experiencing symptoms and was prescribed cefdinir an antibiotic to take for 10 days.
A two month old patient accidentally received two injections of Fluzone QIV NP that were intended for family members instead of 2 month vaccine, no AE; A two month old patient accidentally received two injections of Fluzone QIV NP that were intended for family members instead of 2 month vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via consumer/non-health care professional via Agency (Reference number- 00786864) and transmitted to Sanofi on 27-Sep-2021.  This case involves a 2 month old male patient who accidentally received two injections of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that were intended for family members instead of 2 month vaccine (Wrong product administered and Product administered to patient of inappropriate age)  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 27-Sep-2021, the patient received a 0.5 ml (dose 1 and 2) of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7325LA, expiry date: 30-Jun-2022, Solution for injection in pre-filled syringe) via intramuscular route in the left thigh for prophylactic vaccination twice.  It was a case of an actual medication error due to Wrong product administered and Inappropriate age at vaccine administration (latency same day).  It was reported "Doctor states that a two-month-old patient accidentally received two injections of FLUZONE QIV NP (no preservative) that were intended for his family members instead of his 2 month vaccines that were scheduled on 27SEP2021. Doctor asked if there was any information regarding FLUZONE QIV NP in patients of this age and also asked if she should report this to the Vaccine Adverse Event Reporting System (VAERS) as well. Doctor asked if she should hold off on the patient's intended vaccinations so that it could be determined if the FLUZONE QIV NP were responsible if the patient developed any adverse events. Doctor states that patient is still in her office and has not experienced any adverse events thus far"  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.
This spontaneous report as received from a Registered Nurse refers to approximately 5 patients. The patients were vaccinated with the first dose of GARDASIL (route, dose and lot # were unknown) on unspecified dates "years ago" and inquired when to receive the second dose. No adverse symptoms reported. Additional information is not expected.
53 Y female with HTN, sleep apnea on CPAP qhs, premenstrual dysphoric disorder on celexa, h/o L knee replacement at outside hospital 7/2020 who was in hospital until 12/22 when noted onset of L knee pain, and 2 pustules at inferior end of healed L knee incision.  She presented to ED today due to worsening pain and L knee swelling.  Knee xray showed large left knee joint effusion. Pt was seen in ED by ortho, arthrocentesis performed with aspiration of 60 cc thick purulent synovial fluid.   LEFT KNEE ARTHROPLASTY INFECTION - no s/sx sepsis.  Admitted per ortho team.  S/p L knee I&D with vancomycin powder on 12/28. - Appreciate ortho recs: WBAT - Knee Cx grew MSSA.  Blood Cx on 12/23 was negative. - Appreciate ID recs: Stopped IV Vanc.  Continue IV Cefazolin and started BID Rifampin.   6 Weeks of therapy would put duration of therapy from 12/28/21 - 2/8/21.  PICC line placed and outpatient IV therapy arranged. - PT rec: HHPT.       COVID- Recent URI about 2 weeks prior to admission.  COVID test 12/17/21 negative.  S/sx largely resolved except for mild residual dry cough.   -Repeat COVID test on 12/26/21 positive this admission, though URI symptoms were resolving. -Case d/w ID  regarding need for inpt COVID isolation given sx were mild, onset 12/11, usual isolation would be 10 days (thourgh 12/21).  Per Dr., when she tested for COVID on 12/17, ~6 days after onset of sx, test should have had high yield and returned positive if her URI sx were due to COVID, unless test was poorly performed.  Query possibility of new asymptomatic community COVID infection after onset of viral URI.  Recommend COVID isolation x 10 days from positive test 12/26/21. - Given pt uses CPAP at night for osa, placed in airborne isolation. - Was borderline hypoxic without significant respiratory symptoms initially but this resolved and now satting fine on RA. - 12/30: d/w Dr. of ID and got CTA chest to r/o PE.  CT completed and showed no PE and no infiltrate. - 12/31: d/w another Dr.  of ID who recommended 3 day course of IV Remdesivir (but no steroids) (per named trial) to reduce risk of progression of COVID. - Finish 3 day course or Remdesivir today.  Should remain in isolation after discharge through 1/5/22.
his first dose on 17Feb2021. 10 days later he got covid; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wants to reschedule his Pfizer second covid vaccine shot as he has gotten his first dose on 17Feb2021. On 27Feb2021 then 10 days later, he got COVID and is still sick. The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Headache, Arthralgia, Diarrhea, Rigors, fatigue
Fever, muscle aches, and chills began 6:30pm January 22, 2021. At 11:30pm that evening, fever reached 102.7 with continued muscle aches, chills, along with mild headache, mild nausea, and fatigue.