chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was reported. After receiving Shingles vaccine, the patient got shingles twice since then. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were provided as follows: The patient's sister reported the case. The age of vaccination was not reported. The patient experienced sore arm after receiving Shingrix. No further details were available. The reporter did not consent to follow up. This case has been linked to US2019175459, reported by the same reporter.
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
temporary facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 30Apr2021 14:00 (Batch/Lot number was not reported) (at the age of 41 years old) as unknown (dose number), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 02May2021, the patient experienced temporary facial paralysis. There was no treatment for the event. No COVID prior vaccination and patient had not been tested for COVID post vaccination. The outcome of the event was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tendonitis in right foot that lasted continuously from April until July 2021 and intermittently since July 2021. Tendonitis in right wrist continuously July 2021- present. Pain in right jaw July 2021. Tendonitis in left wrist and ankle April 2022 that continues.  A Fistula/abscess in the roof of my mouth that appeared in June 2021 that resolved with antibiotics. Primary care ordered blood work in July 2021 with a positive ANA and referred to doctor of Rheumatology.  He ran additional blood work and prescribed 400 mg of Hydroxychloroquine daily and continues to follow my care with check-ups every 3 - 6 months. At the last check up he prescribed physical therapy to help regain some mobility in my right wrist.
Presumed partial myelitis, clinical diagnosis. Underwent 3 days of high-dose IV methylprednisolone followed by PLEX x5 exchanges
Mid morning the next day I was woozy and became disorianted. If I recall correctly it passed with an hour or so.
I had a fever when I went to bed that night. I took some ibuprofen.  Around 1:30 I was awaken to go to the bathroom.  My arms and legs didn?t want work.  I stumbled to the toilet and got back to bed.  I tried to get up again around 4am.  My temp was 102.  I had an even more difficulty getting out of bed but I made it by using my walker.   My legs and arms are better today but they still feel stiff and I continue to use the walker.
5 days. Arm is  still painful with large warm, red knot at injection site.
It just felt weird; the side effect started 09MAR2021 he noticed a red rash about the size a tennis ball; The rash didn't itch , it felt little warm, the actual skin wasn't raised at all.; It has faded now to a very light pink color. Still discolored a little bit, not the way it was when he first noticed it ; It was about two colors brighter then a tomato; The rash is located Below the injection on my Upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It just felt weird), RASH ERYTHEMATOUS (the side effect started 09MAR2021 he noticed a red rash about the size a tennis ball), VACCINATION SITE WARMTH (The rash didn't itch , it felt little warm, the actual skin wasn't raised at all.), VACCINATION SITE ERYTHEMA (It has faded now to a very light pink color. Still discolored a little bit, not the way it was when he first noticed it ; It was about two colors brighter then a tomato) and VACCINATION SITE RASH (The rash is located Below the injection on my Upper left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (It just felt weird), RASH ERYTHEMATOUS (the side effect started 09MAR2021 he noticed a red rash about the size a tennis ball), VACCINATION SITE WARMTH (The rash didn't itch , it felt little warm, the actual skin wasn't raised at all.), VACCINATION SITE ERYTHEMA (It has faded now to a very light pink color. Still discolored a little bit, not the way it was when he first noticed it ; It was about two colors brighter then a tomato) and VACCINATION SITE RASH (The rash is located Below the injection on my Upper left arm). At the time of the report, FEELING ABNORMAL (It just felt weird), RASH ERYTHEMATOUS (the side effect started 09MAR2021 he noticed a red rash about the size a tennis ball), VACCINATION SITE WARMTH (The rash didn't itch , it felt little warm, the actual skin wasn't raised at all.), VACCINATION SITE ERYTHEMA (It has faded now to a very light pink color. Still discolored a little bit, not the way it was when he first noticed it ; It was about two colors brighter then a tomato) and VACCINATION SITE RASH (The rash is located Below the injection on my Upper left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
8 days after his first shot (7/3/22) he had a high fever (~103) and a red raised rash around his injection site (see attached). The rash was hot to the touch and he said it was itchy. The fever resolved in 24 hours and the rash resolved with a few days. Tylenol was used for his fever only on 7/3/22.
Itchy bumps on neck that later progressed to face. Swelling at injection site that was size of palm of her hand. Patient saw primary care dr on 3/7/2011 and he "wanted to let it play out" so pt would get immunity from vaccine. Patient was using aloe on spots and taking Benadryl for itching. Dr added Pepcid to regimen for itching relief.
Pain in right arm, and shoulder pain. Pt can't lift arm as high as usual. Pain started 5/7/13 and has been getting a little worse as of 5/13/2013.
At 3:10 PM, he complained of lower back pain. At 8:30 PM, he urinated blood and at 9:00 PM, was taken to the emergency room. He was diagnosed with a bladder infection.
I started having difficulty swallowing foods felt as if my throat was closing up I went to the doctor prescribed Pepcid for Gerd. At the time I was experiencing dry mouth barely no saliva went to the ER diagnosed with Dysphagia. I'm waiting for a follow up with another doctor to check my Esophagus. I haven't been able to work in a month. As of today I'm having really bad heart burns in my chest.
Patient came in had Hep B, PCV 13, PENTACEL and ROTARIX around 3PM parents state no acute illnesses prior to vaccine. Around 9 PMN started having diarrhea and vomiting. Took to Emergency Room and Doctor stated that it was due to vaccine. Unknown if reported.
Soreness all over this past week (today 12/10). Over weekend, developed a rash to face, neck, shoulders, and chest - FRI - rash noted to face. C/O chills this weekend.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Jun2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Dec2021 at 10:00 as dose 3(booster), single (Lot number: 33130BA) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (07May2022) Negative, notes: Tested negative 8 days after I began my Paxlovid treatment; (09May2022) Positive, notes: 2 days later I tested positive again. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical closure: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment (Ibuprofen from 28Apr2022 to 02may2022 and Prednisone from 29-Apr2022 to 05May2022). The patient previously received a COVID-19 Vaccine. Tested negative 8 days after she began her Paxlovid treatment. From 29Apr2022 to 03May2022 2 days later she tested positive again and had completely different symptoms and felt worse than she did the first time around.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on reported information, causal association of event vaccination failure, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
After getting a company work assignment, my wife and I purchased the current flu vaccinations from a local drugstore.    Three days later, at 3:00 A.M., I was awakened by extreme pain in my neck.  The pain was such that I could not move, even the slightest, as even a movement tiny as a hair would create super intense pain in my neck.  Actually, it was a bit frightening because of not being able to move; even the tiniest movement brought excruciating pain to my neck.  After a time the intenseness subsided, however, the next few days movement in my neck was restricted by pain.  To this day (4 years later) I do not have the free neck movement I enjoyed prior to this experience.  A few months later I went to a dermatologist to check on some red blotches in different areas of my body.  I had had these skin blotches for many years without knowing what they were.  The dermatologist took one look and advised me I have eczema.  He gave me some topical cream to apply to the blotches.  A few days later in discussing this event - flu shot with eczema - a colleague at work described a similar situation with one of his family members.  He said they were advised to never get another flu shot again as it could be severe the next time.  Since that event in 2001, I have discontinued getting flu  shots for fear of re-experiencing such intense pain in my nect again in addition to fear of losing move free movement in my neck.  I do not know the specifics about the vaccine, i.e., manufacturer, type, or even the nurses who gave the shots.    I only submit this in order to help others with similar eczema symptoms as well as seeking information so that I may avoid similar experiences in the future.
After receiving a flu shot and Pneumovax-23 vaccine injection the same visit my arm/shoulder were very sore, a day later my bicep was red swollen and it still very painful. I receive a flu shot annually and never had this happen.
Redness, pain and swelling at site x 3 days.  fever chills on day x1 .
a patient was given a expired dose of Daptcel vaccine/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old patient who was given a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (fourth dose) lot C5281aa, expiry date:05-Oct-2019 via intramuscular route in the right thigh on 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA) and HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  Doctor Visit on 07-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Inactivated Influenza Vaccine received October 17, 2003 between 12 and 1:00 PM.  Approximately 1 hour later patient was sitting in chair on our driveway talking to a friend when he experienced a moderately strong dizzy spell which lasted about 15 minutes and then subsided.  No other adverse symptoms noted.  Patient did not feel it necessary to contact either the clinic or the doctor.
Information was received on 19-APR-2017 from an attorney in the from of an initial legal complaint regarding a female patient (age not reported).  Medical history, concurrent condition and concomitant therapy was not reported. On 07-JUL-2011 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-JUN-2016 the patient was treated for four outbreaks of painful blisters that were diagnosed as shingles that had caused post-herpetic neuralgia. Post-herpetic neuralgia is a painful and chronic condition caused by the residual nerve damage after the contracting shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical treatment. As a further proximate result the patient suffered and will continue to  suffer significant medical expenses, pain and suffering, and other damages.  Additional information has been requested.
She got the second dose two weeks apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
This case was reported by a physician via sales rep and described the occurrence of pallor facial in a 16-year-old male patient who received BEXSERO. Concomitant products included GARDASIL and MENACTRA. On 26th May 2016, the patient received BEXSERO .5mll. On 26th May 2016, less than a day after receiving BEXSERO, the patient experienced pallor facial, dizziness, syncope vasovagal and fall. On an unknown date, the outcome of the pallor facial, dizziness, syncope vasovagal and fall were recovered/resolved. It was unknown if the reporter considered the pallor facial, dizziness, syncope vasovagal and fall to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The field representative mentioned that the doctor reported that, the patient experienced pale face with dizziness, vasovagal syncope and fall to the floor after receiving a dose of BEXSERO vaccine.
The patient is a 76 year old female who presents with chest pain. Woke up in middle of the night on 9/25/2023 with muscle soreness at the top of right back.  Applied heat, went back to bed but then woke up with sternal pain triggered by deep inspiration, radiates to her back and to epigastrium. Anterior neck hurts with inspiration, too. Feels like she was punched in the chest and the back.  Pain not worsened by walking. No cough. No dyspnea.    Very compliant with her Eliquis.  Received Spikevax 9/21/23.  Rapid COVID Ag = negative. Chest x-ray normal. EKG - Sinus rhythm. LBBB unchanged. ESR = 2, CRP = 32.9 (normal <8), CBC normal. Troponin =5 (normal <47).  On 9/26/23 pain 70% improved.
Employee received flu vaccine at 1330 and returned to office at 1410 with red blotchy areas on arms and trunk (sternal area).  Neck also red, and employee c/o itching and scratching at skin. Employee denied SOB or any other symptoms. Oxygen sats 98-100%. B/P 140's over 80's. Employee given 25mg benadryl at 1420 and within one half hour, symptoms started improving. Employee pruritis improved, and redness on neck and trunk improved. Employee monitored for one hour after reaction and symptoms improved. VS remained stable.  Employee declined going to ER and went home as was her preference. Spoke with employee for update 4 hours after incident and she denied pruritis and stated redness was resolved. Employee planned to take benadryl as indicated on box x 24 hours.
Patient has not received her 2nd dose in 52 days after her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose in 52 days after her 1st dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose in 52 days after her 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose in 52 days after her 1st dose) had resolved.            No Concomitant and Treatment medication was provided. Patient had scheduled Gall Bladder surgery on 15-SEP-2021
Please refer to the H&P for full details.  This is a 63 y.o. male with PMHx of HTN and HLD who presented to the ED with chest pain    NSTEMI Type 2 Myocarditis Patient was seen by her PCP on 5/12 with c/o chest pain found to have elevated troponin 0.06 (0.03 upper limits of normal) otherwise EXG and CXR nl and was recommended to come to the ED. Patient reports the chest pain started ~1.5 weeks ago, initially resolved, however began to have discomfort again 4d PTA. She describes the sensation as a dull ache with radiation to the neck and her right shoulder. No history of heart disease. Risk factors for this pt include HTN, HLD and tobacco use. On admission HS-Tn elevated at 230 and EKG shows NSR, no ST/Twave changes. ECHO shows EF 60%. Received ASA and nitro in the ED.  -monitor on telemetry  -cardiology consulted, angio on 5/14 showed normal coronaries, cardiac MRI with evidence for myocarditis per discussion with cardiology - final read is pending at dc - colchicine started   Moderate aortic stenosis  Noted on ECHO, no significant change in the aortic valve pathology or aortic root dimension compared to prior in 2017   HTN  Normotensive in the ED  -continue amlodipine and lisinopril    HLD  Last lipid panel on 12/1/2020 with LDL 109 -continue statin - increased to high dose 80 mg   Tobacco abuse Current everyday smoker of at least 1 ppd -cessation discussed   Tremor: Continue home med   Aortic root dilation - 4.0 cm. Monitor.
Syncopal episode. Pt felt it coming on, describes blackout. Rapid improvement, less than one minute.