chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles 3 to 4 months after 2nd dose / Suspected vaccination failure; Shingles (full blown case); Rash on forehead; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 3 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Shingles 3 to 4 months after 2nd dose / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles (full blown case)) and rash (Verbatim: Rash on forehead). The outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-MAR-2023 The physician stated in his office at the time of reporting that a patient (no identifying factors for patient) in their mid-80's, had a full blown case of shingles 3 to 4 months after the 2nd dose of Shingrix, with a rash located on the patient's forehead.  The GlaxoSmithKline field representative did not had any further information about this incident, no information about the vaccination facility other than the doctor stated the vaccination did not occur in the doctor's office and the doctor did not know where the patient received the vaccine, no information about the date it occurred and no information about the patient. The consent to follow up with the healthcare professional was obtained. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
The site of her neck where she got the tick bite flayed up; Arm started hurting; The site of her neck where she got the tick bite flayed up; Having headache every single day; She could sleep for 10 hours, wake up for an hour and sleep for another 10 hours; Feels exhausted; Cannot keep her eyes open; Mangione's on neck; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), MUSCULOSKELETAL DISCOMFORT (The site of her neck where she got the tick bite flayed up), HEADACHE (Having headache every single day), SOMNOLENCE (She could sleep for 10 hours, wake up for an hour and sleep for another 10 hours) and FATIGUE (Feels exhausted) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting), MUSCULOSKELETAL DISCOMFORT (The site of her neck where she got the tick bite flayed up), HEADACHE (Having headache every single day), SOMNOLENCE (She could sleep for 10 hours, wake up for an hour and sleep for another 10 hours), FATIGUE (Feels exhausted), OCULAR DISCOMFORT (Cannot keep her eyes open) and MUSCULOSKELETAL STIFFNESS (Mangione's on neck). On an unknown date, the patient experienced ARTHROPOD BITE (The site of her neck where she got the tick bite flayed up). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), MUSCULOSKELETAL DISCOMFORT (The site of her neck where she got the tick bite flayed up), HEADACHE (Having headache every single day), SOMNOLENCE (She could sleep for 10 hours, wake up for an hour and sleep for another 10 hours), FATIGUE (Feels exhausted), OCULAR DISCOMFORT (Cannot keep her eyes open), MUSCULOSKELETAL STIFFNESS (Mangione's on neck) and ARTHROPOD BITE (The site of her neck where she got the tick bite flayed up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Tylenol
Sudden nausea, diarrhea, sweating, headache for 24 hours.
PRESSURE ON THE BRAIN WHEN I LAY DOWN WITH MY HAND PRESSED AGAINST IT, SHORT TERM MEMORY LOSS, LEG PAINS AND OPPOSITE SHOULDER PAIN. FEELS LIKE SOMETHING MAY BE IN MY THOUGHT
SWELLING OF UPPER ARM AROUND INJECTION SITE.  PAIN RADIATING TO SHOULDER FROM INJECTION SITE.
Within 24 hours of administration experienced noticeable swelling under right arm/armpit (appears to be potentially lymph node related) as well as injection site pain.
Patient called 4/23/18 stating that she is having bad reaction to 1st dose of SHINGRIX. She said it started bothering her a few hours after the vaccine was given on 4/20/18. She put ice on it and took TYLENOL and that her arm was warm to the touch and area raised. Over the course of the weekend, the area has gotten larger (the size of baseball), she has fever, shivering, fatigue, dizziness. Today she is unable to move arm and has numbness below the elbow. I recommended that the patient go to ER/Urgent Care. Patient states that she will have daughter take her to Urgent Care/ER in the morning.
severe joint pain in both knees, hard to walk started a week after the vaccine.  For a week unable to walk, and now daily severe pain, difficulty working due to being a healthcare professional.  Heat and Ice daily.   outcome remains the same continue with severe bilateral knee pain.
Patient was apprehensive about getting vaccine, immediately after receiving vaccine he started to experience vasovagal syncope. I laid him down on his back and lifted his legs onto a chair. He regained consciousness within 10 to 15 seconds. I had him lay down for about 5 minutes till he was comfortable enough to sit. He sat for an additional 5 minutes before being able to walk and leave on his own. I gave him some water while he was on the ground and he was able to leave on his own.
Pt experienced recurring pain in both shoulders and elbows similar to when shot with a needle. This was experienced some time after the 3rd vaccination was administered. The most recent mention of symptoms was 2 weeks ago. Not mentioned prior because pain was minimal. Pt has fear of increased symptoms and pain level with continuation of vaccinations.
On 06/23/2022 I took a home COVID-19 test which was positive because I had severe sore throat, throat pain, cough and runny nose. I called my doctor and started Paxlovid on 06/24/2022. I do not currently have any symptoms.
Temporary loss of consciousness for a couple of seconds. Loss of vision, trouble breathing, perspiration, and confusion lasting ~15 minutes.
12/28/2020 weakness, fatigue, chills, tongue swollen, left arm pain at injection site 12/29/2020 fever 101.00 headache, loss of appetite, weakness, fatigue, dizziness, throat swollen
Gout flare; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 09:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included gout, asthma and overweight. Concomitant medications included varicella zoster vaccine rgE (CHO) (SHINGRIX) in the right arm for unknown indication on 14Apr2021, ibuprofen (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (MANUFACTURER UNKNOWN) for unknown indication from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021, the patient experienced gout flare. The clinical outcome of the event gout flare was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
03/16/2021- 1ST DOSE MODERNA COVID-19 VACCINE 04/14/2021- 2ND DOSE MODERNA COVID-19 VACCINE 08/11/2021 - ONSET OF COVID-19 SYMPTOMS 08/12/20201- PATIENT TESTED POSITIVE FOR COVID-19, PCR TEST.
Approximately 9 days following first injection I noticed that my left arm was sore near injection site.   I looked at my arm and saw a red spot near injection site which had not been there earlier.   The soreness and redness lessened over the next five days until completely gone.    I messaged my doctor's office Doctor;  They put me in touch with the Brigham & Women's hospital vaccine line.   I called them & spoke with a nurse who told me not to let this event prevent me from Second Shot.   Therefore I got the second shot on March 3.
painful skin irritation; radiating pain in his left shoulder and down his left leg; radiating pain in his left shoulder and down his left leg; radiating pain in his left shoulder and down his left leg; This case was reported by a other health professional via sales rep and described the occurrence of skin irritation in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced skin irritation, radiating pain, shoulder pain and leg pain. On an unknown date, the outcome of the skin irritation, radiating pain, shoulder pain and leg pain were unknown.   It was unknown if the reporter considered the skin irritation, radiating pain, shoulder pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had radiating pain in left shoulder and down his left leg.  The patient told doctor he thought he had shingles, but doctor saw the patient and diagnosed him with painful skin irritation and confirmed that it was not shingles.  The patient had refused the second dose of Shingrix vaccine at the time of reporting. No further information was available.
Arm pain and headache within a couple hours of vaccine.  Body shivers at 11:15pm-12:15am.  Woke up at 5:15am and was dizzy, lightheaded, nauseated and really bad headache.  Very lethargic also.  I took Motrin and went back to sleep, when I woke up I was no longer dizzy and nauseated but I still have the headache and lethargy and arm pain.
This spontaneous report as received from a other health professional refers to a unspecified number of patients of unknown age. It was reported that unspecified number of patients received improperly stored RECOMBIVAX HB, 2.5 microgram/0.5 milliliter, on an unspecified day. No adverse effects were reported. This is one of several reports. Additional information has been requested.
Pt. was transferred to local ED after accidently fell off barstool at home and landed on her left side. Pt. was c/o severe left hip pain. After x-ray  found to have Left femoral shaft fracture. Pt. was transferred to higher level of care for ortho. In the ER record there is no documentation of pt. having any s/s or c/o's following the 2nd Covid vaccine.
vial was initially stored in the refrigerator on15Feb2022/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days; administered with vaccine that has been stored in the refrigerator for more than 30 days/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine that has been stored in the refrigerator for more than 30 days/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on15Feb2022/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine that has been stored in the refrigerator for more than 30 days/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on15Feb2022/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine that has been stored in the refrigerator for more than 30 days/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on15Feb2022/1 patient was administered with vaccine that has been stored in the refrigerator for 34 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vial was initially stored in the refrigerator on 15-Feb-2022 at 5:15 pm and patient was administered with vaccine that had been stored in the refrigerator for 34 days.  No patient had reported any adverse events so far.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up received, contains reporter details, patient information and dose information was added and event verbatim was updated. On 26-Mar-2022: Follow-up received contains no new information.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Oct-2013. The patient experienced tested positive for strain A flu which started on 24-Feb-2014. The patient recovered from the event of tested positive for strain A flu on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 17-Apr-2014 from a health professional: Vaccine start date, expiry date added. Patient details added.
Complaining of left arm rash that went down to elbow area. Looked blotchy and warm to touch, denies pain.
I'm having pain in the lower rear of my head and upper back of my neck.  Pain worsens during sleep.  Almost not able to roll over at night because the pain is so bad.  This has been going on since 12/21/2021 which is 1 week after the vaccination.  This has occurred every night since 12/21/2021.  Rear of my head and upper back of my neck are also sore during the day but not as bad as during the night.  When I drive, it is hard for me to turn my head to the left or to the right.  I have to turn my whole body to see to the left and to see to the right.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 01-DEC-2015 at time- 11:57, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.6 and 1.7 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
This case was reported in a literature article and described the occurrence of severe bullous eruption in a 5-month-old subject of unspecified gender who was vaccinated with Hib (manufacturer unspecified), SYNFLORIX, poliomyelitis, unspecified, Rotavirus vaccine and DT absorbed. Concurrent medical conditions included Diffuse Cutaneous Mastocytosis diagnosed at 3 months based on the peau d?orange appearance of his skin with positive Darier sign. Total tryptase was 64ng/ml with mature fraction of 3.1ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Concurrent medication included therapy with H1 and H2-antagonists and topical sodium cromoglycate. On an unspecified date, the subject received unspecified dose of Hib (unknown route, unknown manufacturer), unspecified dose of Pneumococcal vaccine (unknown route, unknown manufacturer), unspecified dose of Poliomyelitis vaccine (unknown route, unknown manufacturer), unspecified dose of Rotavirus vaccine (unknown route, unknown manufacturer) and unspecified dose of DT (unknown route, unknown manufacturer). 1 day after vaccination with DT, Hib, Pneumococcal vaccine, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The author considered the events were life threatening. At the time of reporting the events were resolved.
Sever muscle pain in arm vaccine administered in.  Also, pain extends into shoulder, jaw and neck.
3 days later the patient began having twitching symptoms in her right eyelid.  This continued for 10 days before completely going away. She is currently asymptomatic.
normal pressure hydrocephalus; still really sick; Migraine not responsive to meds,; Cannot stay awake; Shakes (tremors); Extremely tired and weak; Everything hurts all over; Extremely tired and weak; felt like a bomb went off in my body, Unpleasant symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (still really sick), FEELING ABNORMAL (felt like a bomb went off in my body, Unpleasant symptoms), NORMAL PRESSURE HYDROCEPHALUS (normal pressure hydrocephalus), MIGRAINE (Migraine not responsive to meds,) and SOMNOLENCE (Cannot stay awake) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease and Fibromyalgia. Concomitant products included ONDANSETRON, OMEPRAZOLE, LEVOTHYROXINE and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (felt like a bomb went off in my body, Unpleasant symptoms). On 20-Mar-2021, the patient experienced MIGRAINE (Migraine not responsive to meds,), SOMNOLENCE (Cannot stay awake), TREMOR (Shakes (tremors)), ASTHENIA (Extremely tired and weak), PAIN (Everything hurts all over) and FATIGUE (Extremely tired and weak). On an unknown date, the patient experienced ILLNESS (still really sick) and NORMAL PRESSURE HYDROCEPHALUS (normal pressure hydrocephalus). The patient was treated with SUMATRIPTAN at an unspecified dose and frequency and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency. At the time of the report, ILLNESS (still really sick) and SOMNOLENCE (Cannot stay awake) had not resolved, FEELING ABNORMAL (felt like a bomb went off in my body, Unpleasant symptoms) and NORMAL PRESSURE HYDROCEPHALUS (normal pressure hydrocephalus) outcome was unknown and MIGRAINE (Migraine not responsive to meds,), TREMOR (Shakes (tremors)), ASTHENIA (Extremely tired and weak), PAIN (Everything hurts all over) and FATIGUE (Extremely tired and weak) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drug was OTC Excedrin.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up valid case On 10-Aug-2021: Significant Fu Appended: Medical history Chronic Lyme disease and fibromyalgia were added. Additional events Feeling abnormal, Normal pressure hydrocephalus and Sickness were added.
on IS (immunosuppression- prednisone and myfortic); I had the sars-cov-2 total antibody test 11Feb2021, resulted negative for antibodies; This spontaneous case is report from a contactable other hcp. This is a report based on information received by Pfizer from Biontech Se 15874, license party for {BNT162B2}. A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Dec2020 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 10Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; prednisone (PREDNISONE), route of administration, start and stop date, batch/lot number and dose were not reported for immunosuppressant drug therapy; mycophenolate sodium (MYFORTIC), route of administration, start and stop date, batch/lot number and dose were not reported for immunosuppressant drug therapy. Medical history included autoimmune hepatitis from an unknown date and unknown if ongoing Bx documented AIH (autoimmune hepatitis) on IS (immunosuppression-Prednisone and Myfortic). The patient's concomitant medications were not reported. The patient had the sars-cov-2 total antibody test 11feb2021, resulted negative for antibodies (sars-cov-2 antibody test negative) and immunosuppresion(immunosuppression- prednisone and myfortic) (drug interaction) on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Feb2021. The outcome of the events were unknown.