chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives all over body including abdomen, back, neck, face, eyes, scalp. Symptoms started 4/9, 2 days after vaccination. Took benadryl for itchiness. Symptoms was severe on Saturday 4/10. Benadryl could not control hives. Went to urgent care because hives were so severe and causing body ache.
Rash Narrative:  Received 1st dose on 1/20/21. Approximately 1 week later,  developed itchy rash at site of injection, extending slightly below site. The next day rash had progressed to cover the bicep. Described as red, itchy, burning and hot. No fever or chills reported. Sought care at a walk in clinic on 1/29/21. Cellulitis suspected so prescribed cephalexin. Patient took 2 doses, and rash was starting to resolve so stopped cephalexin. On 2/3/21 rash continues to improve, though slight redness with minor itching. Also reports possible worsening of droop from pre-existing Bells palsy she developed after flu shot in 2019. No known prior covid infection.
chills, diaphoresis, fatigue, congestion, rhinorrhea, sore throat, cough, abdominal pain, diarrhea, dysuria, urinary frequency/urgency
I started feeling super nauseas and lightheaded and I couldn't walk 10 minutes after taking the vaccination. I waited for nurse to check me, she called doctor and I was given a sweet candy thinking it was my diabetes but that did not work so they took me in a wheelchair to the next building and the clinic took over. They checked my fluids, and I was given IV fluids, they checked my vitals, and I was given a shot for the headache, they monitored me for about an hour and then I was released.
PAIN ON LEFT SHOULDER; PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 56 year old female. 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 and batch number: 185020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced pain in left arm. On 13-MAR-2021, the subject experienced pain on left shoulder. On 23-MAR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on left shoulder, and pain in left arm. This report was non-serious.
got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be possibly related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that they would tell you Guillain Barre syndrome was very rare, but the reporter knows the patient who had Guillain Barre syndrome. The reporter stated that he/she would never take the Shingles shot because it could cause Guillain Barre syndrome (GBS). The shot tells you that in the fine print. This case was 1 of the 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208072:same reporter US-GLAXOSMITHKLINE-US2021AMR208069:same reporter US-GLAXOSMITHKLINE-US2021AMR208071:same reporter
Patient was given influenza and pneumococcal vaccines. Within 10 minutes after administration, patient became severely anxious, holding chest and stating he could not breathe. Oxygen saturation dropped to 84% and patient was placed on oxygen. Patient was severely hypertensive (225/115) and very wheezy and nauseous, beginning to vomit. Patient given 25 mg IV Benadryl; BP, anxiety, and breathing improved afterward.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021 at 1:33 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 1:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 76.47. No concomitant medications were reported. On 28-Feb-2021, excursion time was 9 AM, temperature was 27 and 1 PM, temperature was 26. Total doses given for the day was 152, condition of vaccine prior to administration was not frozen. The vial was initially moved to the fridge on 24-Feb-2021 and beyond use date was 26-Mar-2021. 20 vials were sent to clinic on 27-Feb-2021. Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 PM: 46, 1 PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. No treatment medications were reported.
Approximately 3 hours after receiving the vaccine, patient had a sudden onset of severe dizziness, blurry vision, nausea, vomiting and fatigue.  She contacted our office and was advised supportive care with OTC pain relievers and anti-emetics.  Her symptoms began to resolve after 6 hours.  Patient was contacted the next morning and reported complete resolution.
pt recv vax & devel an inj site rxn characterized by redness, swelling & a rash;the inj site rxn extended down the arm;
The patient is a 34y.o.  female PMH of depression, anxiety, recent COVID-19 infection who presents for evaluation of worsening anxiety.   Patient reports a 5 day history of worsening in her anxiety. She woke up on Monday morning, experiencing severe anxiety. This occurred every morning for the past few days, however yesterday persisted throughout the day prompting her visit to the ED. Patient was seen for follow-up today.  She reports that she is feeling much better than yesterday.
high grade fever; chills; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high grade fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Dose given on 10/2/07. Came to office 10/8/07 arm red, swollen at injection site. Placed on antibiotic.
This spontaneous report was received from a 46 year old female patient reporting on herself, via Pfizer Inc. The patient's current conditions included Crohn's Disease, decreased immune responsiveness and a medical history of pneumonia. On 11-NOV-2015, the patient sought for vaccination to prevent pneumonia, so she went to a pharmacy and asked for it. It was not confirmed if she was vaccinated with PNEUMOVAX 23 injection, 25 mcg/0.5 ml (route, dose number, frequency and site of vaccination were not provide) or PREVNAR 13  (dose, frequency, route, dose number and site of vaccination were not provided) or both of them at the same time. Concomitant therapies included FLUARIX and LOMOTIL. Additional information has been requested.
Redness and swelling at site of injection 3 inches in diameter.  Warm and tender to touch.
Flu IM 11/14/01. Same day 11/14/01, red, swollen, painful right arm. Advised Ice and Ibuprofen.
Tinnitus (hissing moderately - intense in both ears) going on 4 days.
Patient with facial tics as a child which resolved through teenage years. Restarted and have continued within 1 week after second dose of Pfizer covid vaccine.
Racing heart; breathing was a little more difficult; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 16:30 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; MONTELUKAST. The following information was reported: HEART RATE INCREASED (non-serious) with onset 24Nov2021 12:00, outcome "recovered" (Nov2021), described as "Racing heart"; DYSPNOEA (non-serious) with onset 24Nov2021 12:00, outcome "recovered" (Nov2021), described as "breathing was a little more difficult". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, dyspnoea.  Additional information: Patient had not diagnosed with COVID-19 prior to vaccination. Patient had not tested for COVID-19 since the vaccination. The lab data includes Heart rate, it was over 100 for about 5-6 hours and began about 20 hours after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 06/12/2021 in the afternoon I felt like I had a pimple or ingrown hair in my back shoulder blade area. By the 06/13/2021 -the next day- it was a large cyst size lump and it was bright red and I was having fever and chills. 06/14/2021 I went to DR and started on antibiotics and had an abscess and since then it's been going down but it's still an abscess. I am going to a surgeon this week to see if they can cut the cyst.
Induration injection site with some swelling noted to (Rt) deltoid - no erythema
This spontaneous report as received from a 65 year old female patient, regarding herself via company representative. Patient's pertinent medical history included Hashimoto's disease, brain aneurysm, high blood pressure and colon surgery. Patient's drug reactions/allergies included an unspecified pain pills when she had during her colon surgery. Approximately in September 2015 (reported as "last fall"), the patient was vaccinated with 1 dose of ZOSTAVAX, intramuscularly (IM) (strength, lot number and expiration date was not provided). Concomitant therapies included thyroid medication, statin. Approximately in September 2015 (reported as since receiving the vaccine), the patient had experienced shingles. The patient had stated that she had experienced shingles 3 times after getting the ZOSTAVAX vaccine. She also stated that "she knows it was coming because she feels the itching, burning feeling. The patient sought medical attention for the events via telephone. Patient was treated for the events. The outcome of shingles was reported as not recovered. The causality of the events was not reported. No product quality complaints (PQC) was reported. Additional information is not expected as the reporter refused to follow-up.
Patient woke up day after vaccine administration with pain/soreness at injection site but resolved after a couple of days. However, patient stated that on Friday morning after vaccine administration, he woke up with strong pain in his left arm/shoulder. He stated he could barely lift his arm and had very limited range of motion. Patient did not report adverse event to pharmacy immediately, we were made aware of adverse event a week after vaccine administration. Patient states that as of today, he can lift his arm about 135 degrees from resting position and the pain is decreasing.
On Wednesday, at approximately 1:30 pm I stared experiencing severe vision issues. It was like I was looking at a Picasso painting. If I looked at computer screen, the image was broken into pieces. When I walked outside and looked at a tree, the left side seemed to disappear and the right was in sections. It was as if my eyes were looking at images in multiple/disjointed images. It was not blurry. It was just multiple images. This distortion lasted for almost 30 minutes and then started to  go away so after an hour of first experiencing the vision symptoms. About two hours later, my vision was 100% normal. Four hours later I started to get a stiff neck and a basic "cold". My temperature was normal but the next two days I had a stiff neck and slight headache. No other visual issues. I did not seek medical attention because by the time I got to the hospital (my wife drove) my main concern---vision---was fine. It was scary.
Onset day 1, cough, fever, rhinorrhea, cervical adenopathy, headache, fatigue, no rash. Gradual progression Day 16 hospitalized for low back pain, diarrhea, vomiting. Prescribed IV's. Gradual improvement - symptom free 30 days post shot.
Information has been received from a physician via a company representative referring to a female patient of unknown age. No pertinent or historical conditions were reported. On an unknown date the patient was vaccinated with GARDASIL 9, one shot/three dose series (strength and route unknown). There was no concomitant medication reported. On an unknown date, the patient experienced injection site pain and some dizziness while on therapy with GARDASIL 9. The adverse experiences had resolved on an unknown date and the patient was fine and would continue the series. Causality between events and GARDASIL 9 was not reported. Additional information has been requested.
I experienced heavier than normal periods and night sweats for about three months after getting the Moderna vaccine. Normal periods have resumed and I no longer have night sweats.
Cancer; Multiple Sclerosis; immunocompromised; Lymphocytopenia; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Cancer), MULTIPLE SCLEROSIS (Multiple Sclerosis) and IMMUNODEFICIENCY (immunocompromised) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 042L20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant), MULTIPLE SCLEROSIS (Multiple Sclerosis) (seriousness criterion medically significant), IMMUNODEFICIENCY (immunocompromised) (seriousness criterion medically significant) and LYMPHOPENIA (Lymphocytopenia). At the time of the report, NEOPLASM MALIGNANT (Cancer), MULTIPLE SCLEROSIS (Multiple Sclerosis), IMMUNODEFICIENCY (immunocompromised) and LYMPHOPENIA (Lymphocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: low (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist called on behalf of a patient that was immunocompromised and received three full doses of the Moderna COVID19 vaccine. Last dose was in August. The patient had some lab test done (HCP did not have any supporting document for this) and said that her antibody levels are low, she did not feel protected and wanted to get a booster. Reason of immunocompromise: Cancer and Multiple Sclerosis, Lymphocytopenia. No date of diagnosis available. HCP said that patient wrote down cancer in her file after the first dose, so she did not know if this was something that she was currently under. No consent for follow up gathered.  Company Comment  This case concerns a 54-year-old female patient with no reported medical history, who experienced the serious unexpected events of Neoplasm malignant, Multiple sclerosis (AESI), and Immunodeficiency. The events occurred on an unspecified date after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old female patient with no reported medical history, who experienced the serious unexpected events of Neoplasm malignant, Multiple sclerosis (AESI), and Immunodeficiency. The events occurred on an unspecified date after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.
Information has been received from an office manager concerning 8 patients who were vaccinated with PNEUMOVAX ( lot # 662599/1076X). It was unspecified if this was the first or second dose for the patients. Subsequently the patients developed "very severe" injection site reactions. The patients sought medical attention in the office. In follow-up, the office manager indicated that one of the patients was a female who had a mild reaction to the PNEUMOVAX vaccination. The patient had redness around the injection site. This is one of several reports form the same source. Additional information has been requested.
Headache; Stomachache; Mild fever of 100.1 degrees Fahrenheit by oral thermometer; Fatigue; General Malaise; Mild diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 at 19:00 as dose 3 (booster), single (Lot number: FL8094) at the age of 6 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 04Dec2021, when the patient was 5-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 07Nov2021, when the patient was 5--old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered"; MALAISE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "General Malaise"; HEADACHE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered"; DIARRHEA (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Mild diarrhea"; PYREXIA (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Mild fever of 100.1 degrees Fahrenheit by oral thermometer"; ABDOMINAL PAIN UPPER (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Stomachache". The events "headache", "stomachache", "mild fever of 100.1 degrees Fahrenheit by oral thermometer", "fatigue", "general malaise" and "mild diarrhea" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, abdominal pain upper, pyrexia, fatigue, malaise, diarrhea.  Additional information: Facility type vaccine: Pharmacy or Drug Store. Other vaccine in four weeks: No. Other medication in two weeks: daily vitamins, daily children's Claritin or Benadryl. No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
third dose was administered.   dose 1:  01/06/21 dose 2:  01/27/21 dose 3:  02/19/21
Vomiting and diarrhea and low-grade fever with hives over trunk and extremities and ear lobes. Onset 12 hours, post vax. Treated with Pedialyte and bland diet. Return if rash progresses treat with Benadryl.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). There were no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Aug2023 at 12:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient was sneezing and had a runny nose yesterday and today she was stuffy and it's yellow. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Arm pain, swelling, redness, itching and difficulty lifting left arm. Patient missed appointment for evaluation. Itching still present after 5 days, but swelling and redness have subsided after 5 days.
He was given this vaccine at the age of 15 when it is recommended for 18 years and older. His mother is aware and asked for him to have this vaccine
spasms in the inner elbow down to the hand. Both hands are extremely sore and loss of strength.
Dose 1 01/25/2021 moderna lot # 029K201  Pt died from CVA complications on 8/18/2021- NOT  a covid or vaccine related death
8-10 clear, yellow stools/per day starting 48 hrs. after patient received ROTARIX vaccine, continuing to today's date (7-14-15) for a total of 13 days with diarrhea. Seen for issue by APRN.
Rash on right part of the anus. Severe acid reflux, burning and consistent chest pain.