chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Get the shot, get shingles/Suspected Vaccination Failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Get the shot, get shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient interactive digital media. The patient stated that it was what you get when the physician said that at your age, you should have the shot for shingles and when you get the shot, you get shingles.  The patient stated that it was not fun and he/she wished he/she never have had the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Breakthrough case admission after 2 vaccines  Pfizer 2/25/21 Lot# EN6202;  Pfizer 3/18/21 Lot# ER2613
Pt. stated "I started feeling numbness on my face and weakness 10 minutes after getting vaccinated."  Vital signs taken BP 100/70, HR 76, O2Sat 99%, R 18.  At 12:37pm pt. is still having numbness of face.  EKG was done.  Normal sinus rhythm.  At 12:50pm pt. stated he wants to go to the hospital.  At 12:52pm pt. was transported to healthcare facility.
SECOND DOSE GIVEN TOO EARLY AND ADDITIONAL DOSE ADMINISTERED. FIRST DOSE ADMINISTERED 3/16/2021.  SECOND DOSE ADMINISTERED 3/31/2021. A THIRD DOSE OF PFIZER WAS ADMINISTERED AGAIN ON 4/28/2021.
aching all fingers, shoulders, both hands w/tingling in both hands; @ site had itching & erythema as large as hand;
Headache, Fever, NauseaVomiting, BODY ACHES Narrative:
She had chills, severe headache, the headache was forehead back of the neck jaw line and ear, fatigue, running nose and possible eye infection triggered also a sore arm at the injection site. Has had symptom s for 5  day and COVID tested. Seen primary today 10/23/2023  Dr.
15 to 20 minutes after shot patient felt worsening muscle pain - neck pain greater, shoulder pain greater, headache pain greater, she felt a little dizzy and felt a numbing band across head/eyes. She felt like her throat was a little constricted across front area. Pt was instructed to be seated - took her blood pressure and heart rate - Systolic 108/Diastolic 70/Heart Rate 80 -- called 911 for paramedics to evaluate her. Pt complained of some throat irritation/ constriction but no hives or itching.  EMS arrived quickly and said not to administer Benadryl injection.  They evaluated patient and said that they did not want to give her a shot of Benadryl after evaluating her.  They wanted to the patient to go to Hospital to be fully evaluated but patient declined. EMS told patient she could buy oral Benadryl and take that for allergy. SHe bought Benadryl at pharmacy and took 1 tablet. Called patient once she arrived home and she said she was lying down. Her headache and muscle pain still persists but her throat felt better. This was around 6:15 PM on Jan 5, 2010.   She was instructed by EMS to go to ER if not feeling better.
pt recvd vax;mom reports unconsolable crying 10-12 hrs; onset 4-5 hrs p/ inject;highest t 99 ax; apap given q 4 hrs;
Was itchy since a few hours after the shot. Noticed a rash one day after around the area of the shot.
Increased temperature of 102 at times. Migraine, light sensitivity, body aches, chills. temperature lasting only few hours, migraine headache lasting approx 12 hours and patient continues to have migraine headache at time of reporting. Patient seen by military provider no tx at this time. Pt instructed rescue primary PCP if symptoms persist or worsen.
pt recvd vax & states had a rxn to the DTP @ 6mos; mom states pt t105 was shaking & vomiting 15hrs p/vax was seen in ER:
This spontaneous report as received from a nurse on 04-NOV-2014 refers to an unspecified number of patient of unknown age and gender. The nurse reported that since 04-NOV-2014 an unknown doses of PROQUAD (injection, subcutaneous, strength, dose and lot# not reported), which underwent supported temperature excursions, had been administered. No adverse effects was reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient started having dizziness, light-headedness and headache 3 days after receiving the second dose of Moderna COVID-19 vaccine.  She thought it was vertigo and self medicated with meclizine which did not help.  She presented to my office 3 weeks (3/29/2021) later because the dizziness was not improving and she also reported other symptoms that had been occurring including nausea, blurred vision, one episode of double vision, pressure in her ears and headache.  An MRI of the brain was ordered which revealed a subacute infarction in the right frontoperiventricular white matter.
Started to have body aches and brain fogginess at noon 12 p 3/16/21 same day of second vaccine. Severe left arm pain and neck pain.   Several episodes of diarrhea and abdominal cramping.  Severe coccyx bone pain, lower back pain and knee pain at 6 pm 3/16/2021 My daughter who is 17 months old and who still breast feeds had several episodes of diarrhea  and gas pain causing crying for over an hour at 9 pm 3/16/2021 facial swelling bilaterally and hives unilaterally on left side of face  appeared next day 3/17/2021 at 8 am
Information has been received from a registered nurse concerning a 4 year old male patient with drug reactions or allergies to penicillin and no pertinent medical history who on 28-APR-2006 was vaccinated subcutaneously with an 0.5 ml dose of VARIVAX (Merck) (Lot # 652723/1128R, expiration date unavailable). There was no concomitant medication. On 02-MAR-2010, the patient was diagnosed with shingles. The distribution of the rash was right leg and hip. The patient was treated with acyclovir and fully recovered on an unspecified date. Lab diagnostics studies were not performed. Patient sought medical attention by an office visit. Additional information has been requested.
Rashes all over the body with medium to large size blots, redness and raised. The skin has a rough texture to the touch. Headaches, tiredness, chills, and light nausea. Lack of air, and chest pressure, with difficulties to swallow.
No documented hypertension.  average BP 106/60 or lower since I was age 21.  May 1 2021 BP 150/94 at home.  Rechecked BP next day 145/90.  Rechecked QD avg 130?s / high 80?s. PCP office on 9/8/21 118/80.   I have been monitoring my BP every day with new BP Unit.  Consistently 130?s/ 90?s.  Feels tachycardic when walking short distances.  No SOB or chest pain.
Reported on located rash and itchiness on the injection site about 12 minutes post vaccination, developed hives to the RUE to right side of chest, received Benadryl at 11:52am, and  Pepcid PO at 12:23pm, transported to a clinic at 12:25pm, reported throat tightness and received EPI at 12:37pm and solumedrol at 12:39pm, 2nd EPI administered around 12:44pm and called 911, ambulance arrived on 13:05pm and left to  ED at 13:09pm.
Pt came to pharmacy and asked for meningococcal shot on his paper. Pt asked for and received Group B. Pt returned later in the week to ask for MCV for school as he misunderstood requirements. MCV administered 1 week later.
COVID-19; Myasthenia flare; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) and MYASTHENIA GRAVIS (Myasthenia flare) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis. Concomitant products included PREDNISONE, PYRIDOSTIGMINE BROMIDE (MESTINON) and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia flare) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19) and MYASTHENIA GRAVIS (Myasthenia flare) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information include patient received an antibody infusion from an antibody provider, Zpac and albuterol sulfate.  Company Comment: A 53-year-old female patient who received mRNA-1273 experienced MYASTHENIA GRAVIS and COVID-19 6 days after the first dose of vaccine. No medical conditions were provided. Concomitant products included PREDNISONE,PYRIDOSTIGMINE and MYCOPHENOLATE. From the conmeds she is taking seems likely that the patient has a history of Myasthenia Gravis. Unlikely that the events are related to the vaccine. Very limited information has been reported at this time. Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient medical history, Lab investigations and hospital details; Sender's Comments: A 53-year-old female patient who received mRNA-1273 experienced MYASTHENIA GRAVIS and COVID-19 6 days after the first dose of vaccine. No medical conditions were provided.Concomitant products included PREDNISONE,PYRIDOSTIGMINE and MYCOPHENOLATE. From the conmeds she is taking seems likely that the patient has a history of Myasthenia Gravis. Unlikely that the events are related to the vaccine. Very limited information has been reported at this time. Further information is not expected.
This spontaneous report as received from a nurse practitioner refers to an 11 month old patient (gender unknown). On an unknown date, the patient was vaccinated with VARIVAX subcutaneous (dose not reported). It was reported that a patient was administered the first dose of VARIVAX (Merck) at 11 months old. No adverse events were reported. Additional information has been requested.
Extreme  redness and swelling of arm around injection site. Fatigue, really bad headache and fever of 100.5 to 101.7, nausea.
Respiratory problems after flu shot.  Coughing, pain deep in lungs, red eyes overall aching/pain. Coughing lasted for several hours until I took Benadryl.  Flu like symptoms lasted for 2 days.
they were going to administer to the patient via G-tube today; they were going to administer to the patient via G-tube today; This spontaneous report was received from a nurse referring to a 4 months old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 10-SEP-2021, the reporter was going to administer to the patient via G-tube with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) for prophylaxis (circumstance or information capable of leading to medication error and incorrect route of product administration).
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for COPD exacerbation w/pneumonia. Vaccination took place 2/5/09. According to physician relationship is 'None'.
It started with a lot of pain...which I expected, was red and hot to the touch and then a patch about 4-5 inches in height and 2-3inches wide went across my bicep and there was what looked like slight bruising and a water-mark effect around the redness.  I iced it the first and second day and by Sunday, 07/26/2020 it had cleared up.  I did speak to my doctor's office both 07/23/2020 and 07/24/2020 and they said to keep an eye on it and call back if any other symptoms arose.  They also asked me if I was short of breath which I was not.
Within a day or so after my 3rd Dose of the vaccine. I noticed several cysts in my right underarm and right breast about 3 or 4 in each area. This lasted for a few months then went away. About 2 months later they are back  nternal cyts  under my  arm 3 or 4 cysts and spread to the right breast that lasted for a few months they gradually went away. However about  2 months ago they have returned. I was scheduled to get  a Mammogram and was turned away as the issue has not resolved.
Diarrhea, headache, and body aches next day, 1/15/21.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      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.   The healthcare facility had an power outage on 01 April 2021. This dropped the temperature of the vials stored in freezer and refrigerator to -  Frozen vaccine 47 minutes -13.79 degree celsius Refrigerator 59 minutes 12 degree Celsius  This report refers to a case of Product administration error and product storage error, for mRNA-1273, lot # 003B21A, with no associated AEs.  Treatment information was not provided.  Concomitant medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2021-066742 (E2B Linked Report).; Sender's Comments: This report refers to a case of Product administration error and product storage error, for mRNA-1273, lot # 003B21A, with no associated AEs. MODERNATX, INC.-MOD-2021-066742:Crossed linked
terrible malaise; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "terrible malaise".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/02/2010 itching started. 10/03/2010 redness and blisters developed. 10/05/2010 redness continues with some discomfort and firm areas to touch. 10/06/2010 saw Dr. and was diagnosed as shingles. 10/07/2010 tingling sensation developed in groin area. Bacitracin Zinc Ointment applied for treatment.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE NON ST ELEVATION MI  5/15/2022 -- RECURRENCE OF SAME SYMPTOMS
12/29/20- Spoke to CG.  Received Pfizer COVID-19 vaccine, dose #1 on 12/23/20 @ 4pm.    Stayed in Observation area for 15 minutes without any problem.   Suddenly, on 12/26/20 (3 days after receiving the COVIID vaccine), CG felt "itching to throat, gum, mouth and body; itching head to toe", also noticed "lip, mouth swelling" as well as "wheezing".  Stated she has history of "asthma".  CG then self-medicated with "Claritin and Albuterol inhaler" without much  improvement on 12/26/20.  Then the next day, on 12/27/20, itching to throat and mouth is resolving but still had shortness of breath and itching body.  On 12/28/20, CG came to work but still experienced itching body and "hard to breath" when wearing surgical mask (required at work).  CG was sent home and saw primary care physician (PCP) via virtual visit.   Per PCP's evaluation, CG has had "delayed allergic reaction" to COVID-19 vaccine.  PCP recommended CG to continue with Benadryl and Albuterol inhaler until recheck on January 4 for re-evaluation and discussion on preparation of 2nd dose with steroid and EpiPen.   CG would like to complete the vaccination series to receive 2nd dose. As of today, 12/29/20- CG stated she still has shortness of breath and itching and will be off work until re-evaluation by PMD on Jan 4, 2021.   Reviewed CG?s consent form of COVID-19 Vaccine- Date received 12/23/20 @3:37pm.  Answer of NO to question ?Do you have a history of severe allergic reaction (e.g. anaphylaxis) to another vaccine or injectable medication??
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: COLD AND CLAMMY SKIN-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Mild
Little bit of a sore arm; Body achiness; I realized after I left the nurse gave my injection subcutaneously; This is a spontaneous report from a contactable consumer (patient herself). A 38-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine; formulation: solution for injection; Lot Number: ER8736; NDC number, UPC number and Expiry Date : Unknown), dose 2 via an unspecified route of administration administered in left arm on 20May2021 at 10:00 AM (at the age of 38 years) as dose 2, single for covid-19 immunisation. Medical history included migraine; patient stated that she had migraine since she was 13. So, probably like 25 years ago, 1995 or 96. Concomitant medication included propranolol taken for an unspecified indication at 10 mg twice a day from an unknown date and patient mentioned that she was on a really low dose. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0179) on 29Apr2021 (at the age of 38-years-old), as a dose 1, single for COVID-19 immunisation and there was no reaction on previous exposure to vaccine. Patient reported that she got the second dose of the Covid vaccine yesterday, she realized after she left the nurse gave her injection subcutaneously on 20May2021. She also reported that she had her vaccination done yesterday at 10 'O' clock. The body achiness about 2 am last night, the only, she has a sore arm, a little bit of a sore arm and then she had very mild just little bit of aching today but that's all. So, just normal kind of expected reaction to vaccine on 21May2021. There is no PQC reported. No therapeutic measures were taken as a result of the events. The patient has not received any treatment. The outcome of the events little bit of a sore arm and body achiness was not recovered and the event ''I realized after I left the nurse gave my injection subcutaneously'' was unknown at the time of the report.  Follow-up attempts are needed. Further information is requested.
Yesterday at night I had an acute chest pain, it last for al least 5-6 hours. The vaccine information statement that the pharmacy gave showed muscle pain, buy in my case a had a n extremally severe chest pain.   I just wanted to inform you, just in case you received similar symptoms from other people.  I am still in pain, but not compare with the one I felt yesterday.
Covid-19 positive test; Covid-19 positive test; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 18Mar2021 as dose 2, single (Lot number: EL3247), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 54 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. No known allergies. No other medical history. No covid prior vaccination. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2023, outcome "not recovered" and all described as "Covid-19 positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2023) Positive, notes: Nasal Swab, Flowflex Covid-19 Antigen home test. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure  (LOE) ,  Covid-19 cannot be ruled out.
After 2 days I had a metallic taste in my mouth for about a week.  My right calf was slightly swollen for 2 days after the metallic taste left.  Since then I have been experiencing severe inflammation in my back on both sides of my spine which is increasing my usual chronic pain level.
Information has been received from a consumer concerning her niece who on an unspecified date was vaccinated with GARDASIL.  The patient broke out in hives 3 days after first shot.  The aunt mentioned that her niece took diphenhydramine hydrochloride (BENADRYL) to help the hives.  She also stated that she would have her niece's parents call.  The patient's outcome is unknown.  No further information is available.
Approximately 1 week to 10 days later my son began to complain of fatigue, heart flutters and palpitations and nausea after physical activity.  Symptoms would come and go until finally making an appointment with a pediatric cardiologist who referred us to ER.  After visit to ER, my son was admitted into the hospital ICU cardiology unit.  He was diagnosed with myocarditis.  He was in the hospital for 5 days and is still under doctor's care.
CLIENT STATES SHE HAD REDNESS AND ITCHING THE NEXT DAY FOLLOWING THE VACCINE. STATES SHE APPLIED BENADRYL CREAM AND TOOK IBUPROFEN.
Normal injection site soreness and redness day after shot but goes away but a week and half later comes back but is itchy raised up and hot. Over the next two gets to be the size of two half dollars. Goes away with Benadryl cream and Hydro Cortizone cream use
PT referred to ED for SOB , chest tightness PT  reported covid exposure, fatigue, BA, HA before having vaccine- Pt says not asked if was sick before getting the dose and did not have to wait