chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
shortly after the vaccine, the patient had a seizure while sitting on his chair for about 10 seconds and was feeling dizzy. He sipped some water and he felt better. paramedics came to check on him and he was stable.
Freezer temperature warm by atleast 2 degree C for 4 days; Possible administration of invalid dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
kindrix dtap #5 Ipv #4.  swollen arm and redness, warm to the touch
got real dizzy; her face is all red; Its like flushed; seems to be a little warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (got real dizzy), ERYTHEMA (her face is all red), FLUSHING (Its like flushed) and SKIN WARM (seems to be a little warm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested Covid positive on February.) in February 2021 and COVID-19 (Tested Covid positive on March but tested negative on April) in March 2021. Concurrent medical conditions included Hypertension.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (got real dizzy), ERYTHEMA (her face is all red) and FLUSHING (Its like flushed). 13-Apr-2021, the patient experienced SKIN WARM (seems to be a little warm). At the time of the report, DIZZINESS (got real dizzy), ERYTHEMA (her face is all red), FLUSHING (Its like flushed) and SKIN WARM (seems to be a little warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: (Inconclusive) Temperature 97.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included high blood pressure medications and cortisone shot in her low back.    Treatment medication was not provided.  Had first dose of the Moderna COVID-19 vaccine today, she stayed the 15 minutes and everything was fine but one hour later got real dizzy and her face is all red, it's like flushed and she seems to be a little warm but does not have a fever (temperature of 97.1). Had a cortisone shot in her low back so she does not know if it has something to do. Also tested positive for COVID on February and on March but tested negative on April and that's why she could get the vaccine.
Itching, rash, redness, and inflammation 4 days post injection  on Left shoulder and arm
p/vax pt devel fussiness & a fever of 103.2 R;pt hosp for 1 day;CBC count, urine & blood cultures, CXR & LP performed-results were not provided;pt recovered; A 15-day follow up report received 10/28/2002 adds: It was reported, "A nurse reported that a 2-month-old male received Hib-Titer, Rota Shield, DTaP (Aventis Pasteur S) and IPV (Aventis Pasteur SA) vaccines on 06/10/1999. Four days later, he developed fussiness andn a fever of 103.2 deg. F rectally. He was hospitalized for 1 day. A complete blood count, urine and blood cultures, chest x-ray and lumbar puncture were performed; however, the results were not provided. The infant recovered". From additional info received on 10/21/1999, it was reported that the vaccine was purchased with public funds rather than private funds as previously reported. Follow-up #1 (08/22/2002): During internal review of all files, it was deemed necessary to amend the report by upgrading this case to a 15-Day Alert Report, due to this being serious unlabeled.
Pt described diarrhea, constipation, fatigues and aches a few days after receiving the vaccine. Went to primary care physician who attributed it to vaccine.
Initial and follow-up information has been received from a physician and registered nurse concerning a 17 year old female with no pertinent medical history and no drug allergies/reactions who on an unspecified date was vaccinated with a first dose of GARDASIL (lot # 656050/0245U) injection . Concomitant therapy also given on the same date included PEDIARIX. After receiving the first dose of Gardasil, the patient experienced syncope which the registered nurse and physician felt was a vasovagal response not related to the vaccine. It was reported that the patient "does not like shots." Medical attention was sought in the physician's office. The patient was treated with oxygen to help her breathe and an electrocardiogram was performed (results not provided). Subsequently, the patient recovered. The physician felt that the event required intervention to previous serious criteria (Other Important Medical Event). Additional information is not expected. Follow up information indicated that approximately 2 to 5 minutes after vaccine administration the patient experienced a brief loss of consciousness (less than one minute) with spontaneous recovery. It was presumed to be a vasovagal reaction to the vaccination. No diagnostic laboratory studies were performed. On 02-AUG-2007, the patient recovered. The physician felt that the event required intervention to previous serious criteria (Other Important Medical Event). Additional information is not expected.
sore arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported.  A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9266), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included ovarian cancer stage iii from an, surgery from Sep2020 to an unknown date, hypertension, blood cholesterol, depression takes a mild antidepressant Venlafaxine 37.5mg twice per day, blood pressure measurement from 1979 to an unknown date. Concomitant medication(s) included metoprolol; simvastatin; venlafaxine taken for depression. The patient previously took lynparza for ovarian cancer stage iii. Consumer said that her main concern is that she is currently taking a cancer management treatment, Lynparza. She said she has been on this medication prior to receiving the vaccine. She said it takes away some of her immune system, and wants to know how it could affect the vaccines efficacy or if she has to stay isolated. Caller states she had a big surgery in Sep2020 and they wanted her to wait to heal from that before starting the Lynparza and she began taking it on 04Nov2020. The patient experienced sore arm on Feb2021. Outcome of the event was unknown. Description of Product Complaint: Vaccine Supplemental Form completed in additional context. Caller on the line who had the 1st dose of the Pfizer COVID vaccine on 11Feb2021 and the 2nd dose on 04Mar2021; states the caller is taking three medications and the medication is Lynparza and she is taking four tablets of Lynparza as a cancer maintenance pill; Caller asks if taking the Lynparza would lessen the Pfizer Vaccine immunization protection. States for the Pfizer COVID vaccine, the 1st dose lot is EL9266 and the 2nd dose has lot EN6205 and her patient card has no expiry date or NDC written on it. States she has been on other medicaitons for a while and takes a blood pressure medication Metoprolol 50mg, takes Simvastatin for cholesterol 40mg once per day by mouth, takes a mild antidepressant Venlafaxine 37.5mg twice per day; states she was on other blood pressure medications since 1979 and she was on and off of them since then and some of the blood pressure medications she was on just kind of quit working and it was many years ago and she has no names, dosages or lots, expiry dates or NDC numbers to provide. Caller states she sees her HCP on the 3rd next month and was seeing him once per month and how sees the HCP every 5 weeks. States her HCP said there is not enough information yet and he did not know if the Lymparza which lowers the immune system somewhat could have an affect on the Pfizer COVID vaccine. No follow-up attempts are needed. No further information is expected.
Confusion - vasovagal reaction. BP 131/62 (pulse 69), O2 sat 98%.
swollen lymph node in left armpit started 5/30/21 @ 1:30pm. Very sore to the touch
Vaccine error, the patient was given a Tdap instead of the Dtap that was due & ordered. CDC states because it is 5th dose it counts and no other action is needed.
BODY ACHES; CHILLS; This spontaneous report received from a consumer concerned a male 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 admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 at 10:45 AM for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 at around 18:30, the subject experienced body aches. On 11-MAR-2021 15to 20 minutes ago at the time of reporting, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and chills. This report was non-serious.
Patient still got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient still got COVID) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient still got COVID). At the time of the report, COVID-19 (Patient still got COVID) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient previously had 3 Moderna shots. No concomitant medication was reported.    Reporter said he knew a woman who lives next door who was very healthy because she walked a lot and patient has received 4 shots of the Moderna, but she still got COVID. He said "that shit didn't work". No treatment information was reported.   Reporter did not allow further contact
Red and sore day after vaccine.  continued to get redder and more inflammed.  spreading down arm
July 26th tested positive for covid, cough, sore throat, fatigue, fever, chills, malaise
Pleuritic chest pain and shortness of breath starting on the day after admission. Clinically suggestive of acute pericarditis. She has a history of this which was thought to be due to lupus.
Epstein-Barr symptoms have subtly disappeared, 3 weeks approximate after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Epstein-Barr symptoms have subtly disappeared, 3 weeks approximate after receiving the vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epstein-Barr virus associated lymphoproliferative disorder (Patient experienced  Epstein-Barr virus (EBV) for already 3,5 years.).    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Epstein-Barr symptoms have subtly disappeared, 3 weeks approximate after receiving the vaccine). The patient was treated with NALTREXONE for Epstein-Barr virus infection, at a dose of 18 months. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Epstein-Barr symptoms have subtly disappeared, 3 weeks approximate after receiving the vaccine) had resolved.            No concomitant medications reported. Treatment information not reported.
Injection site was reddish purple, swollen and warm to touch.  Has one inch by 4 inch area with bruising in the center and redness with slight swelling and area warm to touch at 1500 on 10/15/14.
LRG reaction with erythema & edema below elbow.  Pt to start a course of oral prednisone.
10/25/2021 had 2nd Moderna shot. 10/26/2021 patient complained of palpitations that evening. 10/27/2021 patient stated she felt better. 10/28/2021  -Patient stated took a long walk and didnt feel good so went to Urgent Care. -She tested   -NEGATIVE-  for Covid at urgent care.   -she said they did several tests and mentioned it was idiopathic and it was to much to say over the phone.  But, she would follow up    with her doctor. -I spoke with her at 2pm and she was home and would schedule an appointment with her doctor
8/06/03: Pt was given 1st Hep B injection in left deltoid, c/o numbness in arm following injection. Had good pulse and ROM. After waiting 15 minutes pt reported arm felt better, completely better 2 hours later. 9/17/03: Pt received 2nd Hep B injection and c/o arm feeling weird, some tingling. Had difficulty lifting and moving arm for 1 hour.
pt became fussy and inconsolable roughly 3 hours after receiving Dtap, Hib,PCV7, and IPV.  Her right leg is sensitive to touch.  Her left leg has a 3 mm red area at the site of the Dtap in the left leg and a 1 cm red area to the HIB site on the left leg.  Her fever has climbed to 103.5 rectally.
This spontaneous case, initially received from other health professional on 10-Oct-2018, concerns a female patient of unspecified age. It was reported that, the reporter checked the temperature of the vaccine every morning at 7:00 am and it was found within the range 38-Fahrenheit. On an unspecified date, the fridge was left ajar and the multi-dose vial (MDV) of vaccine underwent first time temperature excursion. It was reported that, the excursion had occurred between 7:45 am and 1:37 pm for 6 hours. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252231 and expiry date: 31-May-2019) that underwent temperature excursion. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
This spontaneous report was received from a pharmacist via company representative regarding to his approximately 23 month old son. Patient's concurrent condition, medical history and concomitant medications were not reported. On 01-MAY-2007, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (lot #, expiry date not specified). On 04-APR-2008, the patient experienced a vesicular like rash on his right leg. The pharmacist had took his son to an unspecified pediatrician, who cultured the vesicles and reported that the patient had herpes zoster. The patient had been treated with anti-virals for the rash and on an unspecified date it was reported to have been recovered/resolved. On 27-APR-2010, the patient was administered with a second dose of (Oka/Merck) VARIVAX. There was no product quality complaint filed. Causality assessment was not provided. Additional information has been requested.
Arm really red and hard, it was swollen and hot, extremely fatigue, headache, body aches, cough
Pentacel was administered without ActHIB component with no AE; Initial information received on 10-Jun-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 month old female patient administered pentacel without acthib component DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 10-Jun-2021, the patient received a 0.5mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE once [lot UJ413AA,UJ389AB, expiry date: 09-Oct-2021 via an intramuscular route at right thigh for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue [Latency: on the same day].  It was reported that, Acthib was not reconstituted . Pentacel was administered without ActHIB component. Patient asks if it should be 0.5 ml NaCl saline solution used. Also, it necessary to wait to administer the ActHIB component. Nurse reported patient was given Pentacel without the HIB component  At the time of report no adverse event was reported.  It was not reported if the patient received a corrective treatment 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 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.
Child received IPV, DTaP, MMR and Varicella on 9/12/2007.  On 9/14/2007, child went to ER with swelling, reddness, "hardness" and pain in left arm.  He had no fever.  He was treated with an antibiotic.
Right thigh swollen, red, hot to touch, DTaP 3rd dose, given at this sight.  Child irritable, fever (102), child eat well, mother states child fine otherwise.
Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 08-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test positive: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
I started having headaches everyday that increased in intensity throughout the day and felt really sick. It hurt all over, but mainly in the back. I waited to call the doctor because I have seasonal allergies. My head would feel really tingling on the outside, I started experiencing a high pitched screaming sound in my ears and I felt foggy/off, along with memory issues. So after a month, I decided to call my doctor and we had a video call. She ordered an MRI, which hasn't been done yet. I had a CBC count done in the middle of April and it was normal. The headaches are getting better and I'm getting them about once a week versus daily. However, I did have a really bad headache yesterday that I would say was over a 10 on the pain scale, but it's better today.
Almost immediated  weakness within 3 or four hours, collapsed the next day, repeated falls, taken to Emergency Room on Thursday, March 25, 2021--admitted to Heart Hospital with heart failure, lung failure ( no history of lung problems), and severe sepsis, placed on ventilator until Saturday, March 27, 2021.  Died on March 28, 2021.
At about 26 hours after receiving the injection, I developed severe fatigue and chills.  I sat in my recliner fully reclined with a blanket over my body and slept for about 90 minutes.  Upon awakening, I felt fine - fatigue was gone and chills were gone.
I had my vaccination on 09/21/2022. On 10/23/2022 I woke up during the night with a sore throat that was so bad like razor blades.  I took an at home COVID-19 test which was Positive. I had a virtual visit with my doctor on 10/24/2022. They prescribed Paxlovid.