chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reports that she was approximately 8 weeks pregnant at the time of her #2 COVID vaccine on 1/27/21. She reports she had a normal prenatal US at 7 weeks. She reports on 1/27/21, she had vaccine side effects of fever/chills, headache, and nausea. She notes on 1/29/21 most of her vaccine side effect symptoms resolved, but she is still suffering from headaches. She also notes that her morning sickness was gone on 1/29/21. She reports she called her OB, he brought her in for a repeat US on 2/1/21.  Notes that she has two healthy children and suffered a miscarriage in May 2020.
Patient complained of swollen and painful joints, swollen neck glands, arm pain and red bump at site of injection.
Menstrual Cycle went completely away, like it disappeared/hasn't seen anymore cycles; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN5318 and expiry: 31May2021), via an unspecified route in left arm on 12Feb2021 11:30 (at the age of 30-years-old) as 2 nd dose, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a clinic and vaccine was not administered at a (name) facility. No additional vaccines administered on same date of bnt162b2. The patient received first dose of bnt162b2 (lot:EL1284,expiry:30Apr2021) on 21Jan2021 at 11:00 (at the age of 30-years-old) for COVID-19 immunisation and experienced a small allergic reaction, left side of her lip was swollen and became numb from 21Jan2021 to 22Jan2021, recovered. The patient went home, she put ice on it and it was gone the next day. The patient had no medical history and no concomitant medications. The patient previously took a Flu Shot in Jan2021. The patient reported that her menstrual cycle went completely away, like it disappeared in Feb2021. The patient got her cycle on 19Feb2021, and it only stayed on for three to four days, when it normally stays for five to six days. After that, her period has disappeared, she hasn't seen anymore cycles. The patient clarified that she was a natural cycle person, she didn't have irregular cycles. Her periods came on regular all of the time, this was just since she got the vaccine. The bloodwork pregnancy test and pregnancy test on unspecified dates were negative. Apparently this just came up and she thinks it was from the vaccine. Clarified that she was not pregnant. Asked if what hormones were in the vaccine that may have caused the disappearance of her cycle. No treatment for the event (none for cycle). The event required Physician Office visit but no emergency room visit. The outcome of the event was not recovered.
Fever, angioedima, intractable hiccups, elevated troponin Visited emergency room Admitted to hospital for 3 nights
Information has been received from a physician concerning a 6-month-old female with no pertinent medical history and no drug reactions/allergies who was vaccinated at 2- and 4-months of age with 2 doses of Rotateq. Subsequently the patient experienced rotavirus disease and was hospitalized for 24 hours for dehydration. She was treated with IV fluids. Subsequently, the patient recovered. There was no product quality complaint. The event was considered to be an other important medical event by the reporter. Additional information has been requested.
swollen lymph in armpit breast- the very first occassion/ before booster vaccine for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 at 11:00 as dose 2, single (Lot number: EW0175) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (ongoing), notes: Migraines; "Mood disorder" (ongoing). Concomitant medication(s) included: BUPROPION oral taken for affective disorder, start date: 2018 (ongoing); SUMATRIPTAN oral taken for migraine, start date: 2016 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER8737; Route of administration: Intramuscular; Anatomical site of injection: Left arm; Vaccine administration Time: 10:30), administration date: 02Apr2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "swollen lymph in armpit breast- the very first occassion/ before booster vaccine for covid".  Additional Information: Patient does not required the initiation of new medication/other treatment/procedure.
I had the 2nd shot at 9 am on Friday. Around 2 am, I had trouble breathing. I felt as though I could not get enough air and had to take very deep breaths. At 2:30 am my lip began to tingle and go numb. I took one Benadryl and eventually I was able to breathe normally.
This is a spontaneous report from a contactable consumer. This consumer reporter for a 77-year-old female patient. A 77-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number unknown) via an unspecified route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE (age at vaccination: 77 years) for COVID-19 immunization. Medical history and concomitant medications were not reported. She was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Known allergies were unknown. It was reported that it had been vaccinated with the Pfizer Covid vaccine earlier this year. On 03Aug2021, she became sick with 103F fever. On 04Aug2021, patient underwent sars-cov-2 and tested positive for COVID using quick test. She was currently waiting for more accurate Covid test result. On an unspecified date in 2021 she had been short of breath and was very weak. No treatment was received. The patient underwent lab tests and procedures which included fever resulted as 103 Fahrenheit on 03Aug2021, more accurate Covid test result as unknown results on an unknown date covid test type post vaccination: unknown, covid test result pending, sars-cov-2 test resulted as positive on 04Aug2021. The clinical outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
A bump  at the site of administration of the vaccine; A 3 inch rash at the site of administration of the vaccine; This spontaneous case was received on 24-Sep-2020 from other non-health professional via agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849, expiry date: 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with cases: 202004697, 202004698, 202004699, 202004706, 202004701, 202004702, 202004703, 202004704, 202004705, 202004678 and 202004700 (same reporter).  Additional non-significant information received on 06-Jan-2021 from other non-health professional via agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two additional reporters added. Reference numbers added. No changes in narrative.  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.
7th pregnancy, 5 miscarriages, 1 live birth 10/2017. Current baby due 4/7/2020. Received TDaP at 28 week OB appointment. Pt has no history of gestational diabetes or pre-eclampsia, but does have moderate hyperemesis gravidarum with metabolic disturbances that is currently well-managed with zofran pump and phenergan.   Approximately 1 hour after injection, pt began suffering from moderate vertigo symptoms including dizziness and minor disorientation. Pt took 4 hour nap after returning home (3pm-7pm) on 1/15/20.  When pt awoke on 1/16/2020, she had increased vertigo symptoms with visual disturbances. Pt was advised to go to Urgent Care by a provider at OBGYN.   While at Urgent Care, provider noticed lower than average blood pressure (95/60) and mild tachycardia and ordered a urinalysis and blood glucose check. Blood glucose was 106 approximately 2 hours after pt had consumed a peanut butter sandwich. Based on UA results and in consultation with Dr., pt. was advised to go to Labor & Delivery Triage at hospital for IV fluids  Upon arrival at L&D Triage, pt was offered a glass of water which she was unable to hold down. Pt. was given antivert x2 orally after 90 minutes, and was then started on 2L of normal saline. Pt. reported decrease in vertigo symptoms within 60 minutes of antivert being administered.   Pt was discharged with a prescription for antivert. Pt took an additional dose of antivert at 8:00 PM on 1/16/19.   Pt awoke to no vertigo symptoms on 1/17/2020
LARGE RED HOT SWELLING 6" BY 6" ON UPPER ARM.  HOT HARD AND ITCHY.
PATIENT EXPERIENCED HEADACHE, MUSCLE ACHES, SWEATING, JOINT PAIN, LOSS OF BOFILY FUNCTION THAT REQUIRED EMT SERVICES.
PATIENT RECEIVED EXPIRED MODERNA COVID 19 VACCINE ON 3/31/22, VACCINE EXPIRED ON 3/27/22.
After being fully vaccinated with the moderna vaccine in March, patient subsequently presented to the ED on 7/11/2021 secondary to symptomatic COVID.
Patient reports soreness and redness around injection site, body aches, subjective fever.  All symptoms began within 12 hours of vaccination and continued for at least 48 hours.  Acetaminophen and Ibuprofen provided some relief for several hours after each dose.
Pfizer-BioNTech COVID- 19 Vaccine  Patient experienced nausea and palpitation approximately 2 hours post COVID-19 vaccine dose #2. Presented to emergency department and found to have new onset atrial fibrillation with rapid ventricular rate (pulse 155), and dehydration. Patient treated with metoprolol 5 mg IV and aspirin 325 mg orally, and subsequently converted to normal sinus rhythm. Patient admitted for observation and discharged with resolution of symptoms on 1/29/2021.
Slept for two hours; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for two hours) and FATIGUE (Tiredness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept for two hours) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (Slept for two hours) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-094738 (Patient Link).
Received TDaP and Menactra at about 8:40am 12/17 and developed a fever later that day.  Overnight Monday 12/17 experienced some trouble breathing, fever 101.2 axillary, vomiting, and rash on face.  Recovered on own without incident and is OK now per mom.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE, start date: 27May2022, stop date: 05Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (25May2022) positive; (08Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound Covid after Paxlovid 25May2022. Initial symptoms 24May2022 with positive test 25May2022.Pt had improved symptoms and negative test in between. Then followed by worsened symptoms and positive Covid PCR test 08Jun2022. Prescribed 2nd Paxlovid course.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
vertigo/still has vertigo when  lays down; dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/; felt "wobbly", "like after drinking 3 glasses of champagne"; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/still has vertigo when  lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo/still has vertigo when  lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne"). At the time of the report, VERTIGO (vertigo/still has vertigo when  lays down), DIZZINESS (dizziness/became dizzy when stand up/became dizzy when bend down/became dizzy when lay down/dizziness would last approximately 10 seconds and then resolve/) and BALANCE DISORDER (felt "wobbly", "like after drinking 3 glasses of champagne") outcome was unknown.        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.   No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: TCR : e-mail address updated.
Pericarditis; Couldn''t Breathe; the booster dose of the Covid 19 Vaccine; This is a spontaneous report from a contactable physician.   A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in left arm on 04Oct2021 (Batch/Lot Number: FF2587) as dose 3 (booster), single (at the age of 75 years old) for COVID-19 immunisation.  The patient had no medical history.  There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 on 26Dec2020 (Batch/Lot Number: EK9231) and dose 2 on 19Jan2021 (Batch/Lot Number: EK9231) for COVID-19 immunisation at the age of 75 years old. The patient experienced the booster dose of the Covid 19 Vaccine. States he has had what he thinks is a side effect from the booster shot. The patient stated that he has pericarditis.  States it started a week ago Sunday, so on 31Oct2021.  He was in the emergency room for 24 hours.  States he could not breathe and it was serious. He had around 30 blood test.  He had EKG's, ultrasounds, echocardiograms, CT Scans; states he had around 35 tests in all. No prior vaccinations (within 4 weeks).  The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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.
Mild chest pain that comes and goes; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EW0161), via an unspecified route of administration on 22Apr2021 14:30 as dose number unknown, single for COVID-19 immunisation. Medical history included known allergies: Penicillin. Patient concomitant medications were reported as none. She was not pregnant at the time of vaccination. She did not take any other vaccine in four weeks and other medications in two weeks before COVID-19 vaccine. She was not tested with COVID-19 prior and post vaccination. On 23Apr2021, the patient experienced mild chest pain that comes and goes. Patient did not receive any treatment for event. The seriousness of the event was reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
pt had been give the immunization and asked to wait in the waiting area, about 5 minutes later his sister yelled that they needed help. he had said he felt faint and then passed out falling to the side and out of the chair, she states that she saw him "seize" when he hit the ground, but stated that he did not hit his head. When I came upon him his eyes were open and he was able to answer questions. he stated that he did not have any problems breathing, but felt dizzy. He was very clammy so we took his bp and it was 142/65 pulse 64, gave him an ice pack and had him stay laying down. He sat up after awhile and took a few sips of water but started to feel light headed again so we had him lay back down. His bp went down to 105/58 pulse 61, but then came back up to 136/81 pulse 75 as he was starting to feel better. He started to get more color in his face and feel less clammy so I stayed sitting up. We put him in a chair eventually and the EMTs arrived shortly later. They did and evaluation, but as they were talking about whether or not to take him to the hospital he passed out again. The EMTs said he was probably having some anxiety to needles. He then said that he had passed out giving blood once.  They took him to the hospital for further evaluation.
Permanent red, itchy, inflamed bump immediately after influenza vaccine at injection sight. A year and a half later it spread on skin an inch away from first location. Seen doctor and was given steroid shot to decrease inflammation and itchiness. Did not see any results or follow ups.
pt recv vax & devel an inj site rxn characterized by redness & blisters, which extended down arm;
Headache, Myalgia, Fever, Palpitations,  CHILLS, SWEATING Narrative:   Other Relevant History:
Error: unauthorized age group (17-year-old, Moderna EUA approved only for persons 18 years and older at time of administration. Parent signed consent form with incorrect DOB indicating age greater than 18 years). Event discovered and forwarded for reporting. Signs and symptoms: None known. Diagnosis and treatment: None known. Outcome: No adverse reaction reported.
approx 12hr p/vax awoke w/pain, edema & inflammation @ inj site & entire arm had pain;24hr p/vax exp h/a, neck pain & extremity aching & pain;also loss of appetite & fatigue;sx lasted 4-5 days pt took OTC Ibuprofen to rx sx;
A boy was vaccinated with Rabipur and developed neuroparalytic reaction. He was admitted to hospital for the last six days (before report on 6/3/04). We are awaiting further information. Addendum 7/13/04: A 10-12 year old boy was bitten by a dog at the neck. He was given Rabipur as per doctor's advice and after the 4th dose the boy developed encephalitis (paralytic rabies?). The patient left the hospital without notice on 7/7/04. The same dog bit another 6 persons and they neither sought any medical advice nor did they develop any sickness until 7/7/04. Assessment: unchanged.
1/21/09 woke in AM with redness size of baseball then increased to size of softball per dad. 1/23/09 seen in office induration centrally with 16x11 erythematous urticarial Rx.
Case number PHEH2014US013453 is an initial spontaneous report from a medical assistant received on 27 Jun 2014. This report refers to a 13-year-old female patient. The patient received MENVEO (batch number: M13047) intramuscularly on 25 Jun 2014. On the same day, ten minutes after vaccination, the injection site swelled, became red and hot to the touch. On 26 Jun 2014, the injection site expanded to six inches large and the patient was unable to move her arm. She had taken ibuprofen on 26 Jun 2014 and it did help limit some pain. The physician has not seen this patient since MENVEO was administered. Patient's mother states that the swelling, pain and limb-limiting movement has significantly improved but has not completely healed. Outcome of the other events were not reported. Seriousness and causality of the events was not reported.
Rapid onset headache, lasted 1 hour 30 minutes, given water by clinic staff
Mild post vaccinial encephalitis with transient L Bell's palsy face/arm/leg weakness now resolved (lasted 2-3 days). General rash-likely to vaccinia (erythematous macules on back and upper chest; itching x 2-3 days). Phophobia, headche occipital region Oncelf x 2 weeks.
Extreme pain in right knee joint which has had a total knee replacement  which was done almost 2 years ago.  The pain subsided after about 2 days.  I always have some discomfort of this knee, but the pain I experienced after the vaccine was much different.
14 hours post Gardasil 9 vaccination. Developed Chills without fever and Nausea. Brought home from school.