chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated orally with improperly stored ROTATEQ (dose, frequency and indication were not reported, lot number# (K022995 expiration date: 22-JUL-2016, L008057 expiration date: 01-FEB-2016, K004432 expiration date: 27-JAN-2016, K023537 expiration date: 22-JUN-2016, L04453 expiration date: 27-MAY-2016, L008054 expiration date: 30-NOV-2016). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Threw up all the way home. Heart racing uncontrollably. Severely sick for 10 days still recovering - by far worse than any flu. The event has resulted in a working disability hopefully temporarily.
A nurse reported that an approximately 25 year old male was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis and subsequently tested positive for the hepatitis B surface antigen. The subject's medical history, concurrent conditions, and concurrent medications were not reported.  The subject had exposure to blood on 03/28/03.  The source blood was "negative for hepatitis B".  On 04/07/03, the subject received his first injection of Engerix-B (Lot # ENG5285B6).  On 04/09/03, a hepatitis B surface antigen titer was "positive".  The reporting nurse considered the positive hepatitis B surface antigen titer to be possibly related to Engerix-B administration.
No redness or swelling. Weakness with extension and downward pressure of left arm tingling occasionally first three fingers let hand began 20th September 3 days after receiving flu shot. Initially pain radiating to elbow yesterday and today down to fingers.
five dime sized, red "splotches" on her left arm near the injection site.; fatigue; sore injection site; This case was reported by a consumer via call center representative and described the occurrence of red blotches in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3F3FP, expiry date unknown) for prophylaxis.   On 24th August 2020, the patient received the 1st dose of Shingrix. On 24th August 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 25th August 2020, the patient experienced fatigue. On 26th August 2020, the patient experienced red blotches. On 27th August 2020, the outcome of the injection site pain and fatigue were recovered/resolved. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in left arm. The reporter stated that, after vaccination with 1st dose of Shingrix, the patient experienced five dime sized, red splotches on her left arm near the injection site, injection site sore and fatigue. The reporter stated that the red splotches were on going. The reporter consented to follow up.
Extreme Diarrhea, Urinary incontinence for approximately 12 hours.
they gave the DTAP-IPV component to a child but forgot the ActHIB part; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 8 months old female patient who received only DTap/IPV part of the Pentacel DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Pentacel- lot UJ015AAA, Dtap IPV Lot U6218AA, ActHIB- Lot UJ015AA (Expiry date 26-Oct-2020) on 15-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13).  It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that DTAP-IPV component to a child but forgot the ActHIB part). When she was asked to clarify for the ActHIB NDC number, she mentioned that there were two stickers on the vial with different NDC numbers.  It was unknown whether any adverse events occured.  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.
cellulitis-like rxn on entire arm including injection site .  ptnt received pneumococcal vaccine on 6/18/2007 and presented to 1060 with cellulitis-like rxn on 6/20/2007.  Treatment: benadryl
A 15 YEARS OLD CUSTOMER WAS REGISTERED BY MOTHER TO RECEIVE PFIZER COVID 19 VACCINE AND WAS GIVEN BY A NURSE.  THERE IS NO ADVERSE REACTIONS REPORTED SO FAR.
On December 18, 2022, I woke up with a sore throat. The following day it was so severe I was unable to swallow. I called the doctor, and they ran some tests. They ran several tests that all were negative. I was recommended some over-the-counter medications. I used a spray for my throat to numb it. I remained sick until January 1, 2023. Another symptom during this time was runny nose and fatigue. As of today, I still have a residual cough.
a rapid heartbeat for 1 minute and a half approximately then this symptom subsided; This is a spontaneous report from a contactable consumer via medical information team. A 67-year-old female patient received bnt162b2 (Pfizer-Bionetch, COVID-19 vaccine, Solution for injection, Batch/Lot Number: EN6201 and expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 (age at vaccination 67-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation.The patient medical history included asthma ongoing, digestive disorder ongoing , anxiety ongoing, had allergy. Concomitant medications included salbutamol (VENTOLINE [SALBUTAMOL]) taken for asthma, oxazepam taken for anxiety, cimetidine (TAGAMET [CIMETIDINE]) taken for digestive disorder. The patient previously took FLU vaccine. It was reported that patient experience with the first Covid shot she took it on Feb 19, at hospital and they were aware that she had allergy so they took very good care but after received the injection and they tell you to go out and sit for little because they have some papers to prepare and give, while sitting there did notice my heart rate begin to increase, I had a fast heartbeat but it only lasted I say about a minute or minute and a half then it subsided, but what happened was she felt like it's nothing to report but after I get home maybe should told them have a fast heart and they had a room for those who have allergy, sat for half hour, was fine, maybe thought, better report it, called my primary care physician and she said you have to report it to your provider that gave you the shot, didn't the call the hospital or anything and other than that fine but it was unusual. she had flu vaccine and shingles and all I never experience that but this one she experienced a fast heart rate for a minute or so and I think sat there and it did subsides and I felt that it may be wasn't anything so I thought I better give you call and ask you should I take my second vaccine I need some professional information on what to do. No treatment was received for the event. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that the patient received 4 dose of GARDASIL injection. On 15-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (strength and lot# unknown) injection, 0.5 ml, intramuscular. On 09-APR-2013, 06-JUN-2014 and 09-AUG-2014 the patient was vaccinated with the second, third and fourth dose of GARDASIL (strength and lot# unknown) injection, 0.5 ml, intramuscularly. No adverse effect reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: 0151), in left arm, on 24Apr2021 as dose 2, single (Lot number: EL00171), in left arm, on 11Dec2021 as dose 3 (booster), single (Lot number: 33130BA), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor" (unspecified if ongoing), notes: Breast cancer survivor; "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (03Jul2022) Negative; (05Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient got a rebound from using wonderful Paxlovid medicine. I felt good after 5 days, tested negative, but 2 days later tested positive again with symptoms (extremely runny nose). Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid , Treatment start date: 28Jun2022, Treatment stop date: 03Jul2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/19/2023 MELENA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/19/2023 HX OF URINARY BLADDER CANCER I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/19/2023 CANCER METASTATIC TO MEDIASTINUM
Progressive bilateral pruritic rash; Severe flu-like symptoms; Severe nausea; headache; myalgia; fatigue; chills; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ovarian cancer. Concurrent medical conditions included non-hodgkin's lymphoma.   On 1st August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced nausea, headache, myalgia, fatigue, chills and influenza-like symptoms. In August 2019, the patient experienced itchy rash. On an unknown date, the outcome of the nausea, headache, myalgia, fatigue and chills were recovered/resolved and the outcome of the itchy rash was not recovered/not resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the nausea, headache, myalgia, fatigue, chills, itchy rash and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient experienced severe flu-like symptoms for 3 days following the vaccine including severe nausea, headache, myalgia, fatigue and chills. The reporter never took her temperature to see if she had a fever. The symptoms resolved after 3 days. The week before the reporting date, the patient experienced progressive bilateral pruritic rash. The reporter was not sure if it was related to Shingrix.  This was related to patient.
Patient is a 44-year-old female with PMHx significant for DM and HTN who presented to the ED due to worsening dyspnea over the past 3 days that acutely worsened last night. Of note, pt tested positive for COVID-19 8 days ago and is s/p vaccination x 2 without a booster. Upon arrival to the ED, the patient was noted to have an SpO2 of 100% on RA, normotensive, and afebrile. Routine labs revealed DKA and she was started on an insulin gtt. She arrives to the ICU in no acute distress breathing comfortably on room air.
cold; This is a spontaneous report from a contactable physician reporting for himself. A male patient of an unspecified age (reported as "aged 64") received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: not provided),  via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included hypertension and borderline diabetes. The patient's concomitant medications were not reported. The patient called on 08Jan2021 after receiving second dose on 07Jan2021. He is concerned he has not had a single side effect from the second vaccine. Patient reported that a doctor said "if you get side effects its good because you're body is building antibodies". Patient's toddler daughter had a cold that he caught between the two immunizations. Patient stated that he felt well yesterday during immunization and could honestly answer the questionnaire that he was not ill. Patient asked if he should have antibody testing done two weeks after his second dose to check his immunity. Outcome of the event was recovered on an unspecified date.  Information on lot/batch number has been requested.
FEVER UP TO 100.7 DF, LETHARGY, BODY ACHES, CHILLS, HEADACHE LASTING FROM FRIDAY UNTIL WEDNESDAY
c/o - SOB;  palpitation.    VS 142/85; HR62
extreme headache, extreme fatigue & malaise, dizziness, lightheadedness, diarrhea.   Started 21 hours after injection (next day) -- and symptoms continue unchanged  as of this report ( 7+ days) (ongoing)
Information has been received from a health care worker concerning a 9 month old patient who on an unspecified date was vaccinated orally with the second dose of ROTATEQ (dose and lot# not reported). No adverse symptoms noted. Additional information has been requested.
Information was received from a nurse who reported that on an unspecified date, an unspecified patient may have received an improperly stored dose of one of the following vaccines but she is unsure which of the lot numbers the unspecified patient received: ZOSTAVAX (lot # M037655, expiration date 29-NOV-2017); or VARIVAX (lot #M048200, expiration date 07-DEC-2018 or lot #M015731, expiration date 30-MAR-2018) (route of administration not provided). No adverse effect reported. No additional information was provided. Temperature excursion: In the range (-14°C to -10°C), Time frame: 2 hours and 30 minutes, Previous temperature excursion: No, Data logger involved: Yes. Additional information has been requested.
Central neurological cluster of symptoms  (dysosmia, fatigue, brain-fog, headache) , cardiorespiratory cluster of symptoms (difficulty breathing/shortness of breath, elevated heart rate).
High fever, ranging between 102 and 104 degrees. Unable to move arm without severe pain. Unlike anything I've felt before. Started 11/29/17 in evening. Continues to present. Taking TYLENOL for fever.
got sick after the flu shot and have been sick for a month now; Initial information received on 10-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.  This case involves a patient of unknown age and gender who got sick after the flu shot and have been sick for a month now after receiving influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date - not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient got sick after the flu shot and have been sick for a month now (illness) (unknown latency) following the administration of influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events   Reportedly,  It's funny I got sick after the flu shot and have been sick for a month now I will never get another flu shot.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
administered a PENTACEL today/The expiration date of the administered PENTACEL is 09Oct2023 with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 months old and unknown gender patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] which was expired on 09oct2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2023, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (expiry date: 09-Oct-2023) (with an unknown strength, lot number) via unknown route in unknown administration site for immunization.  On 20-Oct-2023, the patient was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine which was expired on 09oct2023 with no reported adverse event (expired product administered) (latency: same day).  It was reported, Nurse stated that one of their practices administered a PENTACEL today, 20Oct2023, to 3-month-old patient. The expiration date of the administered PENTACEL is 09Oct2023. Nurse was asking about revaccination recommendations. This situation is reported as a medication error due to administration of an expired vaccine. The nurse refused to provide any facility/clinic information. She also said that she does not have any patient information aside from the age.   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 and Regulatory Authority 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.
blurry vision; nausea; itchiness on back, bottom, belly / itching in nose where tubing for oxygen goes; unable to eat; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on back, bottom, belly / itching in nose where tubing for oxygen goes), FEEDING DISORDER (unable to eat), VISION BLURRED (blurry vision) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, AMLODIPINE, OXYCODONE, PARACETAMOL (TYLENOL) and OXYGEN for an unknown indication.    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 PRURITUS (itchiness on back, bottom, belly / itching in nose where tubing for oxygen goes), FEEDING DISORDER (unable to eat) and NAUSEA (nausea). On an unknown date, the patient experienced VISION BLURRED (blurry vision). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness on back, bottom, belly / itching in nose where tubing for oxygen goes), FEEDING DISORDER (unable to eat), VISION BLURRED (blurry vision) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a health professional concerning an 11 year old male who on 30-OCT-2000 was vaccinated with a first subcutaneous dose of Varivax (Lot# 634514/0539K). On 10-SEP-2006 the patient experienced chickenpox. Subsequently, the patient recovered. Medical attention was not sought. Additional information is not expected.
AFTER RECEIVING VACCINE, DEVELOPED DIZZINESS, FEELING HOT, BROUGHT TO OBS VIA W.C. AND ASSISTED TO STRETCHER. VSS THROUGHOUT OBSERVATION. AFTER A FEW MINUTES, PATIENT REPORTS SYMPTOMS IMPROVING. ESCORTED TO EXIT WITH NO ISSUES ONCE SYMPTOMS RESOLVED AT 0841. 0828 BP 145/99 HR 80 SATS 97% ON RA 0832 BP 159/91 HR 88 SATS 98% ON RA 0840 STANDING BP 143/83 HR 90 SATS 99% ON RA
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Double Ear infections- they don?t respond to standard antibiotic treatment. Each time, I ended up on 2 or 3 different antibiotics, steroids, and nasal sprays. 10/26/21, 12/5/21, and 3/6/22
Fluzone High-dose and was administered to a patient post-excursion with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 77 years old male patient and reporter reported that the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] was administered to a patient post-excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2023, the patient received a unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, expiry date, formulation: not reported and Frequency: once; lot UT8072AA) via intramuscular route in unknown administration site as immunization and was administered after post-excursion with no reported adverse event (poor quality product administered) (same day latency).  Reportedly: Fluzone High-dose Quadrivalent was exposed to Low temperature reached: - 6.4°C. Duration out of labelled range: 3 hours and 50 minutes Human error was unknown, the extended stability data was not cover the excursion, Administered to a patient: YES, Previous excursion: None   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 and Regulatory Authority 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.
Diarrhea x 1 month, watery dark green stools about 6 x 1/day. No blood.
On the second day I started to feel some mild pain in my left eye. By Monday my eye was swollen and painful.
6 minutes post vaccine the patient indicated that she felt her throat closing. Paramedic observed visible hives on chest and stridorous air bilateral wheezing lung sounds. Paramedic administered 0.3 mg Epinepherine and 50 mg Benadryl IM in right deltoid and conducted cardiac monitoring. Patient was transported to  Hospital via ambulance.