chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 11May2022, outcome "unknown", COVID-19 (medically significant) with onset 11May2022 at 13:00, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Negative; (07May2022) Negative; (11May2022) Positive. Therapeutic measures were taken as a result of covid-19. c clinical Course : Antiviral treatment of Paxlovid for COVID were started from 29Apr2022 to 03MAy2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recvd 1st dose of Recomb on 25JAN91 & 3 days p/vax devel cold sores around mouth; pt did recvd 2nd dose of Recombivax;
NauseaVomiting, Cold sweats, abdominal pain,  Narrative:
Cold like symptoms, extreme anxiety started the week of 12/11/11, OCD, debilitating intrusive thoughts with confessions and a diagnosis of strep on 12/17, dilated pupils, loss of math skills.
APPROXIMATELY 10 MINUTES OR SO AFTER RECEIVING SECOND DOSE OF MODERNA, PT EXPERIENCED A SEIZURE. PT'S MOTHER WAS NEXT TO THE PATIENT. THE PATIENT REMAINED SEATED IN HER CHAIR THROUGHOUT THE DURATION OF THE SEIZURE.  MOTHER STATED THAT THE PATIENT HAS A HISTORY OF SEIZURES AND IS ON MEDICATION FOR THEM. SHE HAD ALREADY HAD MORNING DOSE AND STILL NEEDED EVENING DOSE. MOTHER DECLINED EMS SERVICES AND TOOK THE PATIENT HOME AFTER A 30 MINUTE OBSERVATION PERIOD AT THE PHARMACY. THE PATIENT WAS CONSCIOUS AND MOVING A FEW MINUTES AFTER THE SEIZURE OCCURRED.
cough, diarrhea, low-grade fever and shortness of breath  Admission: Current   8/20/2021 - present (5 days) COVID-19 Principal problem      History of Present Illness     Patient is an 75 y.o. male.  Pt presents via community referral for MAB infusion for recent COVID infection. Pt is fully vaccinated and doing well. Pt states that earlier in week he was outside leaf blowing and kicked up some dust and started coughing, he initially thought that this was the cause of his symptoms but by the next day he was feeling very poorly and was seen in the urgent care. Urgent care did COVID swab and his swab resulted as positive on 8/18. Pt was notified and d/t his hx of bone marrow transplant, obesity, T2DM, and age he was a candidate for MAB infusion. Pt agreed and was placed on list for infusion. Facility was consulted to help facilitate infusion. Pt was screened at home via telephone and notes that he has a niece that lives nearby and helps him, as well as family and many friends that are willing to help him if needed. Pt denies recent falls and states that he bowls on a league and is always active.    Pt will be enrolled in facility for MAB infusion and continued following for several days to ensure improvement in symptoms. Pt was agreeable. Currently endorsing fatigue, loss of taste/smell, cough, SOB, chest tightness, mild nausea, lack of appetite, fevers, and body aches.
Extremely sore arm for 2 days, then went away. Exactly 7 days after injection site started itching very bad, then pain at site and then a red raised spot the size of baseball near and on the shoulder of the vaccinated arm. Redness went away after 2 days and pain slowly going away.
Immediately following vaccine administration the patient's arm began to bleed and the arm at the site of administration began to swell up. The patient's arm developed a large lump under the skin.  The patient stated it was not painful.  The patient waited in the pharmacy for 15 minutes with no further reaction. The swelling of the patient's arm began to decrease within the 15 minutes after administration. On 11/30/15 the patient was contacted for follow up.  The patient stated that her arm was not swollen anymore but that there was a bruise at the site of injection.
seizure; fainted (syncope); This case was reported by a other health professional via other manufacturer and described the occurrence of seizure in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENQUADFI (batch number U7924AAC, expiry date unknown) for prophylaxis.   On 15th August 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and MENQUADFI (intramuscular). On 15th August 2022, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant and other: serious as per reporter) and syncope (serious criteria GSK medically significant and other: serious as per reporter). On 15th August 2022, the outcome of the seizure and syncope were recovered/resolved.   It was unknown if the reporter considered the seizure and syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-OCT-2022 Reporter's comment: Less than a day after receiving Bexsero and Menquadfi vaccine, the patient had developed a serious event of seizure and fainted (syncope). It was not reported if the patient received a corrective treatment for the events. The reporter considered the seriousness criteria as medically significant for both events.  The case listedness was reported as unlisted. The reporter had consented to follow up. It was unknown if the reporter considered the seizure and syncope to be related to Menquadfi.
Patient states two days after vaccine her are was swollen, reddened, she was nauseated and did not feel well.  Patient not sure if it was the vaccine or another virus.  she did test for covid and was negative
This spontaneous prospective pregnancy report was received from a physician via a company representative and refers to a 17 year old female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 08-APR-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot #, expiration date, exact dose and route of administration were not reported). Dates of the first and the second dose of vaccine were not provided. On an unspecified date in June 2016, the patient called the physician's office to report that she was pregnant. The last menstrual period (LMP) date was 20-APR-2016 and estimated date of delivery (EDD) was 25-JAN-2017. Pregnancy gestation was unspecified. The pregnancy outcome was pending. Additional information has been requested.
Given combination vaccine containing Hep B & Hep B wasnt due. Vaccine (Hep B) before minimum interval; This non-serious case was received during the monitoring on 11-APR-2022 with the following Primary ID 2194488-1. The original narrative from the sender is as below:  Pt was given combination vaccine containing Hep B & Hep B wasnt due. Vaccine (Hep B) before minimum interval.
Pretty sick after the vaccine; Super tired; Headache; Big rash on my torso that itches; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced sickness, tiredness, headache and itchy rash. On an unknown date, the outcome of the sickness, tiredness, headache and itchy rash were unknown.   It was unknown if the reporter considered the sickness, tiredness, headache and itchy rash to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that after the shingrix vaccine patient got pretty sick and being super tired and headache and also reported that seven days after the injection patient experience big rash on torso that tches and patient was asking is this normal. The reporter consented to follow up.
Headache, NauseaVomiting,  lightheadedness, fatigue, backache, sore arm Narrative:
lymph node in (R) supraclavicular Loss a became moderately tender & swollen within 24 hours of vaccine
Parent described continuous shrieking since evening of vaccine.  Disturbed sleep, no fever, no improvement with tylenol.  Calmed slightly in office and nursed on breast.
Menstrual spotting randomly between cycles,  between 2-7 days the past few months up to February.
Rash broke out on left arm about 38 hours after shot. Today rash has spread to under both arms, around neck and in groin area. Taking  Claritin & Tylenol.  Contacted doctors office and following their prescribed treatment.
I started having tinnitis about a week after receiving the shot. It wasn't until the past couple of days I read others with  vaccine have also had this symptom following. Still having the tinnitis today and will likely need to schedule a doctor's appointment soon, if it doesn't go away.
METALLIC MEDICINE TASTE IN MOUTH CONSTANTLY; STRANGE FEELING IN CHEST; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's past medical history included: chronic mild bronchitis, 1 level cervical fusion, 2 level laminectomy and 2 level discectomy ((fusion and laminectomy/discectomy cause chronic pain)), and concurrent conditions included: drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 11:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 55 years old. No concomitant medications were reported.  On NOV-2022, the patient experienced suspected covid-19 infection. On 23-NOV-2022 17:00, the patient experienced metallic medicine taste in mouth constantly and strange feeling in chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic medicine taste in mouth constantly, strange feeling in chest, and suspected covid-19 infection. This report was non-serious.
pt recv vax 7MAR90 pt recv vax & exp GBS & was seen by MD:the reporter felt that the GBS was not r/t the vax;pt exp were felt to be disabling;
Intradermal vaccination given in left forearm but did not wheal.  Repeat subcutaneous injection of vaccine given in left arm successfully.
Hives. Hives have been continuous. Painful. Told pharmacist. Was told need steroid shot.
COVID 19 Treatment/Was having headache, lost taste, smell, sneezing, terrible dry cough.Tested positive for Covid; COVID 19 Treatment/Was having headache, lost taste, smell, sneezing, terrible dry cough.Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment/Was having headache, lost taste, smell, sneezing, terrible dry cough.Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 RNA: (Jun2022) Positive; SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taken other medication in 2 weeks was methotrexate, levothyroxine, folic Acid, Tresiba, lisinopril, viibryd, atorvastatin and farxiga. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event: Was having headache, lost taste, smell, sneezing, terrible dry cough. Tested positive for COVID. Started Paxlovid got better was regaining taste and smell cough still there but much better. Symptoms came back worse than before on 21Jun2022. Took home test and was positive again for COVID. The treatment was  received for the adverse event was Paxlovid. Hospitalization Prolonged: No Device timestamp: 25Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Localized swelling, hives, redness, hot to the touch measuring 6 inches by 4 inches, itchy and sore
Developed swelling (edema) in both legs and groin.  It continues to worsen.  We have checked for blood clots, Heart problems, tumors, and vascular problems, and urine and blood tests.  All have come up negative for a cause of the swelling.
This case was reported by a healthcare professional and described the occurrence of low grade temperature in an 8-year-old female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  The healthcare professional reported the specific age of the subject as 8 years, 7 months and 10 days.  The subject's medical history included pertussis exposure on 31 October 2007.  Concurrent medical conditions, reported on 7 November 2007, included a urinary tract infection "for the last 5 weeks which was unresolved."  The subject had no adverse events following receipt of previous immunizations.  On 5 November 2007 at 1:00 p.m., the subject received 5th dose of BOOSTRIX (.5 ml, unknown, left arm).  Concurrent vaccination on 5 November 2007 included SANOFI, MMRII, Merck, and VARIVAX, Merck.  The healthcare professional did not believe the other vaccines given were co-suspects.  As a result of the BOOSTRIX administration on 5 November 2007, the subject experienced a vaccination error.  On 6 November 2007, 1 day after vaccination with BOOSTRIX, the subject experienced low grade temperature, vomiting, stomach cramps, lethargy, and no appetite.  The subject was seen at a physician's office.  The healthcare professional reported that she believed the subject was having flu like symptoms and was really getting the flu.  At the time of reporting the events were unresolved.
Myocarditis symptoms - fluttering heart, excessive heart rate while at rest of 157 (confirmed via fitness Watch)
Mother of patient says redness, knot warmth to the left arm started the day after the vaccine was given. It lasted "awhile".  She says it went away then came back - decided to come see the dr.
her body felt like it was on fire; she developed an itchy, rash across her back and her body; Initial information was received on 02-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 34 year-old female patient who developed itchy, rash across her back and her body felt like it was on fire (rash pruritic) and (feeling hot), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Jan-2019, the patient received (once) dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in Jan-2021, the patient developed an itchy, rash across her back and her body felt like it was on fire (rash pruritic) and (feeling hot) either that evening or the next evening following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "The caller is requesting the ingredients for FLUBLOK of the 2019/2020 flu season. She said that she had a reaction to it. The caller stated that she received Flu Blok Quad on 1/30/2019. Either that evening or the next evening she developed an itchy, rash across her back and her body felt like it was on fire. Those symptoms resolved in less than a day. The rash was not treated. She would like to obtain a flu vaccination this flu season and would like the ingredient".  Details of laboratory data were not reported.  The rash was not treated and it was unknown if patient received any corrective treatment for feeling hot.   On an unknown date, patient had recovered from the events.  There will be no information available on batch number for this case.
I got a concussion and with the stitches they gave me a tetanus vaccine. My arm since has hurt a great deal. I cannot move it. I have a very large lump and my skin is red. I also got a fever and horrible body aches afterwards, though Im not sure if that was caused by the shot or the concussion. Keeping Ice on it helps, but does not clear it up in any way. I am on day 2 and the area has only gotten worse.
Breakthrough case admission after two vaccines Pfizer 1/14/22 Lot# FE3594;  Pfizer 2/14/22 LOt3 FK9729
After receiving the injection she became nauseous and had stomach cramping. Also complained of dizziness. After taken to a cold room and able to sit down did recover a little.
Patient has been extremely irritable and feverish since having the last staggered set of her 2 month shots. She has ran a fever of around 102 on and off since the 23rd. On 03/28/2011 I had to leave work early because she had been screaming for about 3 hours and the babysitter could not calm her down. We took her to Hospital on 03/28/2011 because we could tell something was exceptionally wrong with her. They tested her for a urinary tract infection which came back negative and sent us home because they couldn't see anything wrong. 2 days later (03/30/2011) I took her to her pediatrician because she was still not herself. During the visit her pediatrician said the most likely cause was from the vaccinations. She was only supposed to receive Hib#1, Prev#1, and Rota#2 but the Health Dept took it upon themselves to give her DTap, HepB, and Polio as well.
Swollen lips, headaches chronic,chills,fever  symptoms lasted 1.5 week
SWOLLEN IN ARM; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWOLLEN IN ARM) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (SWOLLEN IN ARM). At the time of the report, PERIPHERAL SWELLING (SWOLLEN IN ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.   This case was linked to MOD-2022-644994, MOD-2022-644996 (Patient Link).
He was not feeling well all next day, stayed in bed, the following day, he was delusional, and fell on the floor.  He was taken to hospital and diagnosed as Viral Meningitis. He reported that he slipped into coma at one point.   Hospitalized for 2 weeks.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017 (from 24-AUG-2017 to 07-SEP-2017), the patients were vaccinated with improperly stored doses of M-M-R II (recombinant human albumin) (lot # M040558, expiry date 03-OCT-2018; lot # M045401, expiry date 14-NOV-2018) (dose and route of administration were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit to 25 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA011198.
Child's arm (L) upper arm reddened, edema, pain - tx with ice, MOTRIN.
Patient states left upper arm swelling starting a few days post injection. Growing swelling into the forearm area. No redness, itching, temperature change, fever. Patient has done no self care. Just calling pharmacy to report swelling. Patient did not express any concerns for life-threatening symptoms. Referred patient to contact primary care physician or immediate care clinic as soon as possible.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours and also at a temperature of 31.3 degrees Fahrenheit for 11.5 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I felt fine after the vaccination, about 3 hours after the vaccination.  I had lower abdominal cramps.  They hit around 3:00PM.  I got that following morning and felt awful.  About an hour after being up my husband told me that I slumped over the kitchen table.  I was unresponsive, my pupils were dilated.  I was taken to Hospital by ambulance. I am extremely fit for my age.  I have a high pain tolerance.  The monitor in the ER was constantly saying I was in Brachy cardia.  They did a nuclear stress.  They found problems with my heart.  They prescribed medications.  They put me on a halter monitor.  They did an ablation the 20th of March.  They found a-fib. I never had signs before of any of this. The day before vaccination I walked 6 plus miles. I was admitted for observation overnight after the vaccine.