chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 13  y.o. 4  m.o. patient here to receive the vaccine(s) as ordered today. The VIS(s) were given to the caregiver and contraindications screened.  Education was provided to the patient/consenting adult and all questions answered.   Patient has been screened for eligibility for the Vaccines for Program at this office visit.  She is eligible for vaccine due to the following criterion: no health insurance.   The patient is instructed to wait for 15-20 minutes after the injection to watch for any side effects or syncopal symptoms.   The patient did not tolerate the procedure well.  The patient had the following syncopal symptoms: paleness, dizziness, brief loss of consciousness, and jerking movement.  The patient was sitting in the back seat of her mother's car when the incident occurred after receiving Tdap, MCV4, and HPV.  The patient regained consciousness immediately following the incident.  She was awake, alert, and oriented X 3.  At 11:20 am the vital signs were the following:  99%,B/P: 89/51, P: 62.  According to the patient, she had not eaten or drunken anything since last night. The patient was given a juice and asked to drink it slowly.  She was laid down in the car with her feet elevated above her heart level.  The patient's color returned and her vital signs at 11:42 am were the following: B/P 108/61 and P 70.  The patient denied feeling dizzy, faint, or light headed.  Mother instructed to notify future providers about the episode so they can give her vaccines lying down.  Also instructed the mother and patient to always eat and drink before receiving vaccines.  They verbalized understanding of the same.       PPE used during this procedure: Face Shield / Goggles, Procedural Mask, Gown, Gloves.
SMV/IMV thrombosis; constipation; bacteria filled abscess in abdomen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 at 13:15 as dose 3 (booster), single (Lot number: FF2590) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not listed on medical record, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 31Mar2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Other), administration date: 17Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: MESENTERIC VEIN THROMBOSIS (hospitalization, medically significant, life threatening) with onset 01Nov2021, outcome "not recovered", described as "SMV/IMV thrombosis"; ABDOMINAL ABSCESS (hospitalization, medically significant, life threatening) with onset 01Nov2021, outcome "not recovered", described as "bacteria filled abscess in abdomen"; CONSTIPATION (hospitalization, life threatening) with onset 01Nov2021, outcome "not recovered". The patient was hospitalized for mesenteric vein thrombosis, constipation, abdominal abscess (hospitalization duration: 20 day(s)). The events "smv/imv thrombosis", "constipation" and "bacteria filled abscess in abdomen" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (03May2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of mesenteric vein thrombosis, constipation, abdominal abscess.  Clinical Course: The patient tested for covid post vaccination. no known allergies and no other medications were received with in two weeks of covid vaccination.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that the vaccines were stored in a freezer and one to 2 vials were taken and place in fridge each day as needed. It was reported that no treatment was given to the patients
pt recvd vax 10JAN95 mom cont to give APAP q 4 hrs until 1600 hrs @ 2230 pt awoke crying, t103.5 p/taking temp; pt started having generalized sz w/eyes rolling back-lasted 7-8mins; appeared tired, pale p/sz but o/w fine; seen in ER;
Tongue - sore on tip. Lips - looks like chicken pox. Temperature - low grade. Noticed 9/19/12.
A parent reported that son (now 6 years age) received his fourth dose of Orimune along with DPT  (manufacturer unknown) vaccines on 04/27/1999 when he was 4 year old. On 05/04/99,he developed chickenpox with fever. Additional information received from the child's pediatrician stated. "I honestly do not believe that the above stated vaccines brought about varicella. the child was just incubating the natural virus when coincidentally he got these immunizations and a few days later he came down with varicella." The child recovered.
The follicular lymphoma that has been completely stable for eight years transformed into an aggressive B-cell lymphoma. My doctor at facility was perplexed regarding why this happened, and I was never healthier in my life.
On Nov 4th I had three raised welts on right elbow that were itchy thought might be bug bites. The next morning I had welts along my waistline l believed to be hives later that evening from my arm pit to my waist I had a rash, I also had welts/hives on both elbows and forearms. The evening of Nov 6th around 4pm my right shoulder where the vaccine was injected became swollen and red hot to the touch and slightly painful. Today the morning of Nov 7th rash on left side of torso is gone I am left with welts/hives on both elbows/forearms and the large red swollen area at the injection site.
This spontaneous report was received from a 23 year old female consumer enrolled in a market research program concerning unspecified patients. The concurrent condition, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. It was reported that "the vaccine killed girls". The reporter denied taking this vaccine it from her doctor the whole life and would continue to do so. The action taken was not applicable. The causality was unspecified.
Day after receiving vaccine child had low grade fever and rashy face.  Day two after receiving patient had low grade fever, rash on abd and Left leg.
No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 6-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 7th of 15 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live follow-up document received includes patient demographics (initial and DOB), vaccine administration date was updated. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 1
Initial report was retrieved on 14 August 2012 from the scientific literature. Verbatim from the report: "PURPOSE: In studying the safety of vaccine for H1N1 given during pregnancy, spontaneous abortion (SAB) is one of the important points to consider. Because women may receive the vaccine any time during their pregnancy, evaluation of the effect of the vaccine on SAB should only take place after vaccination and in the risk window for SAB, that is, the first 20 weeks of gestation. In addition, when such studies are conducted through pregnancy registries where recruitment occurs after pregnancy recognition, the accrued subjects are left truncated in the sense that they are not followed from the start of pregnancy. METHODS: As previously reported, left truncation needs to be properly handled using survival analysis methods to avoid bias. In the context of time-dependent vaccine exposure, a time-dependent covariate Cox model can be used to simultaneously take into account the left truncation and the vaccine exposure timing. RESULTS: In this communication, we illustrate the approach using the Vaccine and Medication in Pregnancy Surveillance System data. We explain in details how the model is fitted using different software. CONCLUSIONS: We recommend survival analysis methods together with collection of necessary data to study the effects of vaccine on SAB." This report utilized preliminary data from the Vaccine and Medication in Pregnancy Surveillance System H1N1 vaccine which included 677 pregnancies. The report focused on 198 women who were enrolled in the study before 20 weeks gestation. Of the 198 women, 158 were exposed to the H1N1 at different stages of their pregnancies and an unspecified amount of time after vaccination five of the patients had spontaneous abortions. Of these patients, one patient was exposed to the vaccine during the period from their last menstrual period to date of conception and four were exposed during the first trimester. No further information was provided at the time of the report. The patient's outcomes were not reported. Documents held by sender: none.
Pain, edema, erythema, cellulitis requiring antibiotics 02/15/2017.
2" red raised area on L arm.  Applying cold pack and giving TYLENOL.
As soon as I received the injection in my left arm, I felt a tingling/numbness sensation that started to go down to my fingers. I waited the 15 mins, then started to drive home. Then my heart started to race uncontrollably. The numbness then continued to my neck and travel up to the left side of my face- lips, cheek, eye.  Felt like I had dental work done. Called the Dr. the next day. She gave me anti-viral medications and a steroid (but I didn?t take the steroid.)  Luckily, the symptoms started to subside by Friday, 3/19.
Site: Pain at Injection Site-Mild, Systemic: Bell's Palsy-Severe, Systemic: one month post vaccination patient woke up with stroke like symptoms-Severe
8/18/03 Office visit for fever 101-103, petechiae on legs and arms for 2 days. BOM persistent from 8/6/03 and diagnosed with thrombocytopenia (cath UA, CX, CBC/Blood CX, LP and CX. Rocephin 1gm IM). Admitted to hospital. Office recheck from hospital discharge on 8/21/03. Diagnosis - sepsis, OM, thrombocytopenia. Prescribed Omnicef. Office recheck 8/28/03 ITP 2 hours to MMR. 60-day follow up on 11/21/2003: "Vaccine recipient did recover from adverse events that were reported for this vaccination.  Seen 09/04/2003 follow up: ITP resolving.  Seen 09/10/2003 Diagnosis with upper respiratory and doing well." The hospital d/c records received on 1/23/04 confirms diagnosis of fever and thrombocytopenia.
Product storage error; Vial was not shipped frozen/ temperature excursion; The dose was given beyound 30days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was not shipped frozen/ temperature excursion), EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Product storage error) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was not shipped frozen/ temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was not shipped frozen/ temperature excursion), EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Vial was not shipped frozen/ temperature excursion) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The dose was given beyound 30days) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication were provided.  The patient had NKDA (No Known Drug Allergy).  The office was not aware that vial was not shipped frozen; staff put vial back into freezer when arrived morning of 16-Jun-2021. Transport temperature was 2-8 degree Celsius for couple of hours.   Patient had no signs or symptoms of any adverse reaction to the injection site.  No treatment medication were provided.   This case was linked to MOD-2022-539787 (Patient Link).
Erythema of extremities noted half hour after administration of vaccine. Urticaria became generalized over entire body.
sore arm; 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.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller reports she received pfizer vaccine last Sep. After the 1st shot she was fine, just a sore arm. But then 4 days after her 2nd dose she developed reactive arthritis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201222794 similar report from same reporter;
Nausea followed by chills, fever of 101.3 and a SEVERE headache
Patient experienced moderate hives after receiving the Shingrix vaccine. Took Benadryl + symptoms improved
Pain in right and left leg. Pain started at hip and run down to toes. Pain was not shooting pain but was a constant pain. On a pain scale of 1-10, pt reports pain was around 20. Pain woke patient up from sleep and was strong enough that patient muscles locked up. Patient began trembling from the pain. Pain lasted about about 24 hours. Pain was so strong that patient could not think. Pain caused patient to become weak and lethargic.
Arm is swollen; Arm is hot; Arm is red; have a terrible pain; muscle pain in her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 045AUA) for COVID-19 vaccination.     Concomitant products included GLICLAZIDE (MICROZIDE [GLICLAZIDE]), LOSARTAN POTASSIUM (COZAAR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VORTIOXETINE HYDROBROMIDE (TRINTELLIX), Colanapin and ALLOPURINOL (ELAVIL [ALLOPURINOL]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder). At the time of the report, PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder) outcome was unknown. Not Provided          Treatment details included Tylenol Extra strength.
Arm and body pain that does not go away with medication, inflammation, leg pain left side of body feels hot and arm is starting to feel numb/weak and it is spreading to face and the rest of the left side of the body.
So on the day that I got the vaccination around 4pm that evening she started to see lights, was having double vision, and was dizzy. Went to bed woke up the next day got ready for work and on her way to work she blinked her eyes and stated she lost 50% of her vision in left eye and couldn't see.  Drove to work which is the hospital where she got her shot everyone was telling her that she needed to see a doctor right away. Went to an urgent care. Went to hospital to look at her eye  did different test told her it was 50%.Told her the regna and macular had detached. They did surgery on her left eye the same day.
This spontaneous report as received from a nurse practitioner via healthcare worker refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patients received improperly stored RECOMBIVAX HB injection 10 Y, lot # K026666 with expiration date: 22-OCT-2016; (strength, dose number, dose and route was not reported). Concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received a pediatric dose of Hepatitis A in error. Did not discover until patient had left office. Patient left office in normal, stable condition. Spoke to PCP about this error who assured me that the patient would be okay. Called mother to let her know of mistake and explain that it was given in error, but there should be no adverse reactions..
CHILLS WITHIN 7 HOURS; FEVER 101.5 WITHIN 7 HOURS; HEADACHE LASTED FOR 48 HOURS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and was unable to perform follow up to request batch/lot number.  No concomitant medications were reported. On MAR-2021, the subject experienced chills within 7 hours. On MAR-2021, the subject experienced fever 101.5 within 7 hours. On MAR-2021, the subject experienced headache lasted for 48 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.5 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache lasted for 48 hours on MAR-2021, and the outcome of chills within 7 hours and fever 101.5 within 7 hours was not reported. This report was non-serious.
Localized redness of MMRV injection site 6-8 cm, red splotches on face cold compresses applied to L arm, red splotches resolved obs X L arm redness faded.
Pain, erythema, inflammation, soreness, redness, arm feels very heavy, bumpiness, large area about 4-5 inches long, 2-3 inches wide.
First day I experienced sore arm; fatigue; the third day my vision became blurry and I could not see that morning, later on in the day I regained my vision back; the third day my vision became blurry and I could not see that morning, later on in the day I regained my vision back; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Aug2021 15:00 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Family history included: "High blood pressure" (unspecified if ongoing); "Diabetic" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Aug2021, outcome "recovered", described as "First day I experienced sore arm"; FATIGUE (non-serious) with onset 20Aug2021, outcome "recovered", described as "fatigue"; VISION BLURRED (non-serious), VISUAL IMPAIRMENT (non-serious) all with onset Aug2021, outcome "recovered" and all described as "the third day my vision became blurry and I could not see that morning, later on in the day I regained my vision back". Therapeutic measures were not taken as a result of pain in extremity, fatigue, vision blurred, visual impairment.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient not been tested for COVID-19 since the vaccination. Patient had no allergies. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient received second dose of Pfizer / Biontech COVID-19 Vaccine via intramuscular on 10Sep2021 3:00 pm.  No follow-up attempts are needed. No further information expected.
Patient reported to medical clinic 2 hours post-vaccination to report hives on face, chest, and upper limbs. No SOB or life-threatening response. Treated with Benadryl 50mg . Symptoms resolved within 45 minutes of medication administration.
Swelling, Redness and pain at site of vaccine (left arm) after vaccines.  Swelling was more serious than previously experienced with vaccines.