chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected Vaccination failure; Three times for me; Pain was unbelievable; 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.   The patient's past medical history included shingles.   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 suspected vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the suspected vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the suspected vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingle three times and had two shots. Pain was unbelievable. So the patient suggested to get the shot. The patient further stated that he/she amazed the doctor. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available. This case has been linked to US2022AMR009087, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR009087:same reporter, other patient
VACCINE GIVEN WAS EXPIRED, PROVIDER NOTIFIED AND PT WILL BE REVACCINATED WHEN PROPER DOSING IS RECEIVED AT CLINIC.
CHILLS; FEVER; MASSIVE HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, headache, and nausea on 2021. This report was non-serious.
Fluzone High- Dose to be administered to a 67 year old man, MA administered Flublok Quadrivalent instead, no AE; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 67 years old male patient who received 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1905, Exp. Date 21-May-2021 via unknown route in unknown administration site) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], on 27-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  It was reported that MD order was for Fluzone High- Dose to be administered to a 67 year old man. The MA administered Flublok Quadrivalent instead.  No adverse effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I had a chest cold, runny nose, cough. My cough was terrible. I took cough syrup to compress the cough so I can sleep.
2 oral cancers, one squamous cell and the other adenocarcinoma; Right hemi-maxillectomy; Clean margins, no cancer growth in bone, follow-up CT 9/8/2021 to check for recurrence.
One week after my injection I started to be axilarry pain on my right side, and felt a lymphnode that was swollen.  About 5 hours later my right arm (at injection side) started to become inflamed and hard as a rock (and painful).  No itching or redness, but warm tot he touch.
I started to get really dry and flaky skin. I went to the dermatologist and when they gave me medication but it got worse.  They gave me  triamcinolone, a topical cream but it got worse .  I went to my dermatologist and I was diagnosed with a fungal infection and given fungal cream to treat it. A lot of it has cleared out, but I still need to apply the cream. The rash has gone, and they told me to use it for 4 weeks.
Rash on face yesterday with spread to extremities, chest, abdomen, back this morning.
Patient started feeling dizzy soon after vaccination.  While waiting after dose, sitting in chair begin loosing consciousness.  He begin breathing heaving and fainted.  Lost consciousness for less than a minute.  He regained awareness on his own.  Emergency service was called and local fire chief responded and check pulse and BP.  Were normal .  Patient declined ambulance to hospital.   Patient was feeling ok next day.
Administered vaccine to Mom, and then her 2 children.  Immediately after vaccination, patient was observed to be fine talking to her child, and on phone.  After giving her 2nd child dose I walked back to pharmacy to resume duties.  About 2 to 3 minutes after returning to pharmacy department, daughter approached me and said her mom was not feeling right.  I asked patient what symptoms she was having. She explained she was not feeling right.  She was sweating.  I asked if she could breathe okay.  I called 911.  and kept monitoring her until their arrival.  We gave her a cold compress for the sweating and gave her water.  After 5 minutes ambulance arrived and she was taken to Aria Hospital.
Patient received J&J vaccine and should have received 2nd dose of  Pfizer. monitored patient and without adverse reaction.
Parsonage Turner syndrome.... Limited movement of right arm.. Currently undergoing rehabilitation for the last month.
8 days after the vaccine I developed itchiness and a red rash at the spot of injection
For 48 hours after the second shot, I was extremely fatigued, running a high fever, cold sweats, major headache and chest pains.  I have been experiencing random heart palpitations and shortness of breath.  My family doctor encouraged me to report this.
Self-limited swelling of cosmetic facial fillers. Saw her Dermatologist for this too
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (albumin status, dose number, exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses of M-M-R II experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000918: US-009507513-1709USA000920: US-009507513-1709USA000917: US-009507513-1709USA000919.
Pain and soreness in joints (shoulder, hips and hands) began immediately next day after injection. I expected some soreness, but the pain increased day after day and I still am experiencing the pain and stiffness. I have gone to my primary physician, he ran blood tests and found no answers in the bloodwork. My question is, how long will this pain and soreness last? It has now been over two months.
Woke with night terrors every night for 12 days, starting 2 days after immunization with ProQuad.  Each episode lasted 15 - 20 min.  Accompanied by  tremors, and sweating.
received first dose at seventeen years of age; concerned and freaked out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at seventeen years of age) and FEELING ABNORMAL (concerned and freaked out) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at seventeen years of age) and FEELING ABNORMAL (concerned and freaked out). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at seventeen years of age) and FEELING ABNORMAL (concerned and freaked out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not reported by reporter. Treatment information is not provided
Rash on chest  given OTC told to take OTC Tylenol and or Motrin along with Benadryl.
In addition to having a headache on and off since my second dose, I have now lost my sense of taste and smell.
tightening of neck muscles, including swallowing muscles; Sore arm; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EWO150) via an unspecified route of administration in the left arm on 07Apr2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included occasional irregular heartbeat and caffeine allergy. The patient previously took epinephrine (MANUFACTURER UNKNOWN) for unknown indication and from unknown date and experienced allergy. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), curcuma longa (TURMERIC) and multi vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 19:30, six hours after the first dose, the patient experienced tightening of neck muscles including swallowing muscles, sore arm and fatigue. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events tightening of neck muscles including swallowing muscles, sore arm and fatigue was recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 4:02 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 07-Feb-2022 at 4:02 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 16:02:08.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Symptoms started at 5:15 PM the next day, about 20 hours after vaccination  - Vomiting - High heart rate - Suspected seizure (symptoms differed from the past instances) - Loss of coherence (intermittent for 2 hours)  Ambulance brought her to hospital, where she was in ER and later admitted. She is still at hospital under observation at this time, with no discharge date set.
Swollen lymphoid; Early unset period by 2 weeks; Fatigue; Continued pain in arm post4 days; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Oct2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. Concomitant medications were not reported. On an unknown date in Oct2021, the patient experienced continued pain in arm post 4 days, swollen lymphoid, early onset (also reported as unset) period by 2 weeks and fatigue. The events resulted in emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events continued pain in arm was resolved on an unknown date in Oct2021; while that of the events swollen lymphoid, early onset period by 2 weeks and fatigue were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Worsening SOB; cough; This is a spontaneous report from a contactable healthcare professional via COVID-19 Adverse Event Self-Reporting Solution .     A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration on 22Mar2021 as a single dose for COVID-19 immunization.  Medical history included psoriatic arthritis and asthma from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Concomitant medications included acetylsalicylic acid (ASA), taken for an unspecified indication, start and stop date were not reported; secukinumab (COSENTYX) taken for an unspecified indication, start and stop date were not reported; gabapentin (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; lysine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; meloxicam (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; nicotinic acid (NIACIN) taken for an unspecified indication, start and stop date were not reported; cyproheptadine hydrochloride (PERIACTIN) taken for an unspecified indication, start and stop date were not reported; calcium, magnesium (MANUFACTURER UNKNOWN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  The patient previously took lidocaine and experienced drug allergy.  The patient experienced worsening shortness of breath (SOB)  and cough on 23Mar2021 with outcome of unknown.  Details were as follows: On 23Mar2021, the patient experienced worsening SOB and cough. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The clinical outcome of worsening SOB and cough was unknown.   No follow-up attempts are needed. No further information is expected.
I would say it started the week of the 12th. I was achy and dizzy. My stomach was upset, and I threw up once in a while. I thought it was the stomach flu, but it wouldn't go away. So, I went to get a COVID-19 test. We went on that PAXLOVID and that took care of it. I didn't really have an appetite. I couldn't get over how achy I was. I went to the emergency room because thought I was having a heart attack; this was before we tested positive. They did an EKG and chest x-ray. they gave me some fluids. Then I came home.
My left elbow, wrist and pinky finger was in extreme pain. My left middle finger swelled up and was painful. I was unable to make a fist for 2-1/2 was. Also my left outer knee was extremely painful and a week later my knee cap. My left ankle swelled and my left toes hurt. I started to form nods on my left pinky and middle finger. I was in such extreme pain I would scream especially at night. A week later my right fingers started to hurt and my right pinky swelled. I felt like I aged 30 years with rheumatoid arthritis. I was hiking 4 miles in the mountains and running upstairs until that shot. I didn?t have health insurance until Aug 1 and finally saw the doctor on Aug 3 and started steroids and pain meds. The steroids and the swelling went down and I FINALLY am starting to feel normal.
Patient has not had an adverse event. This is to report a third dose given too early. Patient's mom stated she received the second dose 3 weeks after receiving the first dose. The vaccine card also indicated that. After giving the dose and finishing up the paperwork, it was discovered the patient received the first dose July of 2021.  This resulted in the patient receiving her booster dose too early.
extreme fatigue, shortness of breath with exertion, weakness in arms and legs with tremors. occasional word finding problems , and cognitive fog.  Startle reflex.
A report has been received from a Health Professional concerning a 12 year old, female patient. No concomitant medication or relevant medical history has been reported. The patient had been receiving nasal FLUMIST started on 20-Sep-2012. On 25-Sep-2012, five days after receiving FLUMIST vaccine, the patient came to doctors office with symptoms of congestion and muscle aches. He was subjected to swab test and turned to be positive for Influenza vaccine A and diagnosed with flu-like symptoms. The patient was retested on 02-Oct-2012 and the result came to be Negative for Influenza. The patient recovered from the event of positive for influenza A on 02-Oct-2012 and the outcome of the event of flu-like symptoms was unknown. The report was considered to be non-serious by the reporter.
This spontaneous report as received from a pharmacy student refers to a 62 years-old female patient. On 25-OCT-2013, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX lot # J004268, expiration date 12-JUL-2014. On an unspecified date, approximately in October 2013 (since she received ZOSTAVAX), the patient experienced, intermittent red speckles and constant itchiness since she received ZOSTAVAX. No lab diagnostics studies were performed. The patient was seen by her unspecified family physician who referred her to an unspecified dermatologist who told her that she had eczema, however the patient did not have these symptoms prior to receiving ZOSTAVAX. Further, the patient did not feel that the prescribed unspecified eczema cream was helpful, so she used calamine lotion for itch relief. VZVIP packet sent. The outcome of the events was unknown. Additional information has been requested.
large swollen area at the injection site four days after 2nd shot received.  I went to my primary physician and was given an antibiotic for the condition.
After vaccination I no longer have a sensation that tells me I have to urinate until; I only know my bladder is full when it I have a dull pain; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in in Arm Left on 23Feb2021 (at the age of 66-year-old), at an unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not had COVID prior vaccination. Patient did not have other vaccine in four weeks. Patient has not tested covid post vaccination. On an unspecified date the patient experienced after vaccination i no longer have a sensation that tells me i have to urinate until. Patient did not receive treatment for the adverse events. Adverse event resulted in physician office visit. Outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
It was reported in a published article, that a 31 month old male patient who was vaccinated with a dose of VARIVAX (manufacturer unknown) on an unspecified date, 2.5 weeks prior to evaluation (PTE). The patient was diagnosed with a recurrence of benign cranial sixth nerve palsy (left) (date unspecified). The patient had a history of benign cranial sixth nerve palsy (left) after vaccination with HIB (OMPC) (manufacturer unknown, WAES#0905USA02200). Lab test included magnetic resonance imaging (MRI) and Acetylcholine Receptor Antibody (AchRab). The results were not provided. The patient was recovering but incomplete while on the last follow up visit. Various etiologies proposed as possible mechanisms responsible for benign sixth nerve palsy, including variant ophthalmologic migraine, atypical myasthenia gravis, inflammation secondary to viral infection or an idiosyncratic vaccine response. The cause of case with recurrence is unclear. For a child presenting with new onset sixth nerve palsy, the author recommended a thorough history and physical examination to evaluate for any other neurological symptoms or signs followed by magnetic resonance imaging (MRI) of the brain with and without contrast. The decision to perform a lumbar puncture as well as serum myasthenia gravis testing, Lyme testing and anti-Gq1b testing should be made on a case-by-case basis. Parents should be instructed that the majority of cases of benign sixth nerve palsy do not recur. However, the minority of instances that recur are still benign. Additional information had been requested.
Pt. was red, sore & warm at injection site. Area approx. 3 x 2 in diameter. Sore for 3 days.
General body/joint soreness, fatigue, chills, low-grade fever, headache, loss of appetite -- so far none I would consider serious/severe, but enough to interfere in regular activities.