chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an serious observational study case, initially received on 31-Oct-2018, concerning a 26-year-old, pregnant female, subject of Body mass index: 21.3, weight: 120 lbs and height: 63 inch. This is the subject's first pregnancy. The father did not receive any medications prior to conception. The subject did not have any paternal or maternal history with major congenital malformation. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 07-Mar-2018. The gestational age of the subject was 31 weeks. On 20-Jun-2018, the subject underwent nuchal translucency and no major congenital malformation was noted. On 20-Jun-2018, the subject underwent first trimester screening and no major congenital malformation was noted. On 04-Sep-2018, the subject underwent targeted ultrasound and no major congenital malformation was noted. On 10-Oct-2018, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, anatomical location and expiry date: not reported). On an unknown date, after administration of suspect vaccine, the subject's pregnancy status was collected, and intrauterine Growth restriction (IUGR) was noted. The subject's estimated date of delivery was reported as 29-Dec-2018. At the time of this report, the outcome of the event intrauterine growth restriction was not reported. This case was linked to the original case: 201805222.
Otherwise healthy 7 year old white male presents to primary care provider approximately 48 hours after vaccines with an area of 6.5 cm X 8 cm erythema, induration, edema. It is pruritic and has been increasing in size over the last 24 hours. Lesion with tiny fluid filled areas in the center of lesion.
Symptom: Lightheadedness around 5 minutes after vaccination Treatment: laid down for ~15minutes Outcome: felt better
Left arm from collar bone to elbow red, swollen, warm to touch with streaking reported by mother.  Child was given p.o. Tylenol for symptoms.  Mother seeking appt. with PCP today (7/30/08)
RED RASH ACROSS ENTIRE BODY. VERY ITCHY FOR ABOUT 1 WEEK AFTER RECEIVING VACCINATION.
headache; upset stomach; muscle aches; Tiredness; ill; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced headache, upset stomach, muscle pain, tiredness and unwell. On an unknown date, the outcome of the headache, upset stomach, muscle pain, tiredness and unwell were unknown.   It was unknown if the reporter considered the headache, upset stomach, muscle pain, tiredness and unwell to be related to Shingrix.  Additional information was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced headache, upset stomach, muscle pain and tiredness. The patient was not seriously ill; however the patient was wondering if the patient would be contagious.
Patient presented to our community vaccine clinic held at middle school on 12/08/2021 for his first dose of Pfizer.  At the time patient was 12 years old, however, his mother entered his recorded his age on the form as 11.  Subsequently, patient was inoculated with the 5-11 dose of Pfizer rather than receiving the 30 mcg dose.  The error was not caught until today after we were reconciling and filing our intake registration forms in the clinic.  I did call and advise his parents that he unfortunately was under dosed, however, there was nothing that needed to be done to correct the error.  Patient did receive both doses and finished his initial dose series on 1/20/22.  I did advise Father that his son would be eligible for his booster dose on 6/20/22.  No adverse reactions were reported from dad post vaccinations.
COVID vaccine breakthrough case. Pfizer 4/20/21 EW0164, 8/26/21 EW0173, and boosted Moderna 12/3/21 024C21A.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1 , single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Jan2022 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Breast Cancer" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: Aug1999; PROVIGIL [CHORIONIC GONADOTROPHIN], start date: May2007; LAMOTRIGINE, start date: Feb2011. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 02May2022 at 10:00, outcome "recovered" (09May2022) and all described as "Covid-19". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: 11 days after first dose Covid-19 symptoms re-occurred. Symptoms were worse the second time. Paxlovid treatment reported with start date as 21Apr2022 nd stop date as 26Apr2022 with indication as Treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
When do burnig pain go away; This case was reported by a consumer via call center representative and described the occurrence of pain burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain burning. On an unknown date, the outcome of the pain burning was not recovered/not resolved.   It was unknown if the reporter considered the pain burning to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccination indication. The patient received Shingrix vaccine and experienced burning pain. The patient said that it had burning for a month and asked when the burning pain would go away. No other information was available.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAY-2016, the patient was vaccinated with for prophylaxis with a dose of ZOSTAVAV (lot #, dose, route and site of administration were not reported) that expired on an unspecified date in 2014. No adverse effect was reported. Additional information has been requested.
Shoulder pain that got progressively worse over the course of several weeks resulting in marked decreased range of motion. Missed work, visit to his doctor.
experinceing all the side effects; This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had all the side effects. The reporter asked how long would this last.
Diffuse rash the day after vaccination not responsive to diphenhydramine that lasted less than 1 week.
Burning skin, itching with no rash, extreme fatigue, no appetite, thirst, called Pharmacy in Sept to see if known factor, said it could be related to injection being in nerve areas, wait and see, however in Oct sysmptoms still continue so called medical Dr and had blood work done in series to detect anything going on with symptoms of ongoing, diagnosed low white blood cell count and referred to Hematologist, I lost work time in Dec due to fatigue and not being able to do by job as Dental Hygiene, wanted to go to bed and sleep so fatigued, no appetite etc.
A very distinct rash where I got the vaccine. It took almost a week to appear. The rash is in the shape of a triangle outlining my deltoid muscle. It was puffy for a few days and now it is a red outline around my muscle.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single 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"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
An hour after I received the 2nd Pfizer dose, I felt a lot of pressure in my neck which moved up to my ear canals which felt like they filled with fluid. My ear canals began to bubble and crackle like I was on an airplane with a cold. I felt pressure in my sinuses and up to my head. I took Day Quil the rest of the day to try to clear my ears & took Ny Quil that night. The pressure and bubbling & crackling in my ears was gone after that.
Had shots and still got shingles\ suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots and still got shingles, at least it was not as bad if did not get the Shingles shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
pt recvd vax OCT89 & 4 wks later devel an erythematous maculopapular rash; also had arthralgia of large joints, myalgia & fatigue; DEC89 devel fever to 40, h/a, dizziness, sweats, paresthesia, weakness that prevented ambulation, acute viral
Patient's arm is red with blisters where vaccination was given. Patient was given VALTREX to treat the shingles.
Patient received Janssen vaccine at 4pm and began having itchiness and redness at injection site at 4:10pm.  At 4:23 patient was given an ice pack to apply to the area and 50mg of benadryl PO. Patient did not have SOB. At 4:28pm rash was still spreading to underarm and chest.  Discussed possible future use of epinephrine due to history of anaphylaxis to spider bite, but patient had no SOB and emergency services was called at 4:34pm to assess patient. EMS arrived at 4:50pm and determined patient to be stable. Patient was given another 50mg Benadryl dose to take with him and instructions to call EMS if symptoms worsened.
I have had so much joint pain that remains despite therapy; This is a spontaneous report from a contactable consumer reported for a patient. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number & Expiry date not reported) via unspecified route of administration on unspecified date in Mar2021 as dose number unknown, single for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. It was reported that patient took covid shot in March 2021. I have had so much joint pain that remains despite therapy. Patient enquired are you having reports of this or ways to resolve this. The Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 19-AUG-2014 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular, (lot # not reported) that underwent a temperature excursion. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
patient was 11 years & 5 months old and received 12 year old dose. No side effects or adverse reactions.
PATIENT STATED DR DIAGNOSED VIA PICTURE OF ARM HAVING CELLULITIS FROM INJECTION. ANTIBIOTIC GIVEN.
first dose January 2020, late for second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. No patient's identifiers provided. No lot number and expiration date provided. No specific vaccination date provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter did not consent to follow up.
Patient first dose was Pfizer second dose was Maderna. He is aware that the vaccine serious is complete.
did not show any efficacy on her immunity response, hense she did not seroconvert to either the first two doses of MMR II due to the vaccine being ineffective; did not show any efficacy on her immunity response, hense she did not seroconvert to either the first two doses of MMR II due to the vaccine being ineffective; This spontaneous report was received from a female patient of unknown age referring to herself. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose detail, route, lot # and expiration date were not reported) for prophylaxis.   On an unknown date, the patient was vaccinated with the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose detail, route, lot # and expiration date were not reported) for prophylaxis because she explained it did not show any efficacy on her immunity response, hence she did not seroconvert to either the first two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) due to the vaccine being ineffective (vaccination failure and seroconversion test negative)  The patient also commented that other unspecified vaccines did not have any efficacy on her immunity, so she did not seroconvert to other unknown vaccinations she had previously received as well.  The outcome of  both events was not reported. The causality assessment between both events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported either.
1203 presents w/chills, tremors VS t99.4, P92 thready, R22, BP 90/60; 1220 t102.4; 1305 p103;
Ongoing exhaustion after, minor but persistent flu like symptoms (no fever however),  minor shortness of breath (persistent, but not life threatening and potentially related to high pollen) . My injection  site has become raised, itchy, and warm to the touch. There is tenderness also around the injection site.
tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for six patients. This is the 3rd of six reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was tested positive on an unknown date for covid-19 between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home on an unknown date. Those patients were tested every day. One patient was administered the second dose and then somebody said, "Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, "we're under the impression that you wait 90 days if you have been given antibodies after that to give the second dose". One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest of who were hospitalized did not receive their second injection. Caller asked, "What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of events was resolved on an unknown date.   Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is expected only 7 days after the second dose. 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. ,Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient
Swelling at injection site about the size of a pencil eraser (normal), then continued to grow throughout Sunday and Monday to the size of a very large grape. Monday my armpit lymph node became swollen and very painful. Saw the doctor Tuesday and she explained there was a clot of blood that has built up in my arm and that I needed to keep warm compresses on it in hopes of it breaking up.
Cyanosis, vomiting, fever (39.5 degrees C/103.1 degrees F), tachycardia, stridor.
HUGH RASH ON THE RIGHT SIDE OF MY FACE   MY OPINION  SHINGLES   VERY  NASTY LOOKING VERY ITCHY AND A LOT OF PAIN
Patient with probably allergic proctocolitis to egg/milk 3 months without symptoms, bloody, diarrhea 2 days after Pedarix/Prevnar/HIB without dietary changes, resolved approximately 24 hours.
Nurse that fainted after the vaccine; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer.  A patient of unspecified age and gender received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was a nurse who received the vaccine and did a live press conference on TV 15 minutes later and, as a result, she fainted. The event outcome was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer and described the occurrence of injection site pain in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (refer case US2018GSK230780). On 11th December 2018, the patient received the 2nd dose of SHINGRIX. On 12th December 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, general body pain, headache and shivering. On an unknown date, the outcome of the injection site pain, general body pain, headache and shivering were unknown. It was unknown if the reporter considered the injection site pain, general body pain, headache and shivering to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. After vaccination, the patient presented with injection site pain, body aches, headache, and shivering. The patient was asking, how long the side effects will last.
approx 5hr later had uncontrollable crying for @ least 2hr-last hr seemed to have a hard time breathing;father did artificial resp & then finally quit crying & breathing back to nl;
Increasing and ongoing nerve pain in right leg, which started around mid-month, May, 2021.  Still assessing the cause.
body aches; nausea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "body aches"; NAUSEA (non-serious), outcome "recovered", described as "nausea".  Additional information: Symptoms began 6 hours after injection and lasted for 12 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large area of erythema - 9x8" and induration 8/10". Benadryl 50 mg po, patient had taken Ibuprofen 800 mg 1 hour prior to being seen. She describes getting similar rxn to dT in past.
9/17 PATIENT RECORDS BREAKING OUT IN RASH AND HEADACHE, HAD A HIP INJECTION (UNKNOWN MEDICATION) ON 9/17, AND RASH RETURNED ON 9/20, ON 9/24 PATIENT REPORTS HAVING RASH (LESSENED) AND LOW BLOOD PRESSURE (STATES approximately 120/approximately 60 MMHG), DIZZINESS, UPSET STOMACH AND GENERAL DISCOMFORT. PATIENT DID NOT TAKE HER BLOOD PRESSURE MEDICATION ON 9/24.