chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms (fever, chills, aches, fatigue, headache); redness, swelling, warmth and firmness at injection site
Macular -Papular rash on posterior aspect of neck, just inferior to hair line.
Developed welt on abdomen / Was very itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed welt on abdomen / Was very itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (Developed welt on abdomen / Was very itchy). At the time of the report, URTICARIA (Developed welt on abdomen / Was very itchy) had not resolved.            No concomitant medication provided. No treatment information mentioned.  Patient developed welts on the abdomen and it was very itchy.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses VAQTA which had lot # M003011 with expiry date: 15-NOV-2017, (dose and route not reported). No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 3-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 15-APR-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Lump on my colon bone; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Lump on my colon bone) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Lump on my colon bone). At the time of the report, SKIN MASS (Lump on my colon bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
he noted multiple ( about 10) bumps on his right lower leg; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 57 years old male patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and reported that he noted multiple (about 10) bumps on his right lower leg.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included JAPANESE ENCEPHALITIS VACCINE (JAPANESE ENCEPHALITIS VACCINE).  On 14-Aug-2019, the patient received a dose of suspect RABIES (HDC) VACCINE lot PID603M and expiry date: 02-Oct-2020 via intramuscular route in the right deltoid.  On an unknown date, following the vaccination the patient experienced nodule.  (Other relevant tests included no lab data.)  Final diagnosis was nodule.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  List of documents held by sender: none.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Seizure-Mild
Rash, itchiness, migraines body soreness, nausea, chills
0.3 ML OF JANSSEN WAS GIVEN AS A 2ND COVID BOOSTER (4TH DOSE) MISTAKENLY IN PLACE OF PFIZER.
No additional AE; HCP called to report patient received expired dose of MMR II.; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUN-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #U014655, expiration date: 07-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 27-JUN-2023, HCP called to report patient received expired dose of MMR II. Case Number 02416785. No Additional AE/No PQC.
This spontaneous report as received from a licensed vocational nurse and a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL (lot # K010215 with expiration date 05-MAY-2017, lot # K006117 with expiration date 14-JAN-2017 and lot # K010574 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sore spot from where vaccines were given (both were given on same arm 3 weeks apart).  Then 2 days of flu-like symptoms I.e. chills, some fever, etc.  This went away, except for the sore spot.  Around early May,  that soreness stayed and now at night lying horizontally the pain now goes to my neck.
I received my 1st dose of Pfizer COVID-19 vaccine  on 04/21/2021. My adverse event started right after getting my 1st dose. I got my period on 04/15/2021-04/20/2021. Approximately after 15 days  I got my period back again on 04/30/2021-05/07/2021. This was very odd for me and I wasn't sure what was happening with me. I thought it just happened maybe next month will be normal. I  didn't call or visit my doctor because I thought it will resolve  it by itself.  After each of the vaccines  my eyes will get yellow discharge, pain, redness and swelling.  Sometimes it happens on the right eye, the left eye,   both of my eyes.  I just rinse my eyes with warm water and it goes away within few days.  On 11/30/2022-12/13/2022 I had the longest period which  was for 14 days. I still didn't   visit   my doctor if it had continued then I will have gone to my doctor as for now I am ok.
Hives on underside of left arm; Painful, burning and stinging; Still raised rash with same symptoms; Painful, burning and stinging; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 04May2021 at 12:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included (Facility name) chronic muscle pain, hip and knee. Pain resulting from Jan2020 school bus rear ended automobile in which she was passenger. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 13Apr2021 at 11:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient previously also received cefalexin (KEFLEX), vancomycin (MANUFACTURER UNKNOWN), clindamycin hydrochloride (CLEOCIN), desloratadine (LORETA), for unknown indication on an unknown date and experienced drug allergy. On 04May2021 at 17:00, Tuesday evening, the patient experienced hives on underside of left arm, painful, burning and stinging, still raised rash with same symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event hives on underside of left arm, painful, burning and stinging, still raised rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Following symptoms also experienced after the first dose of Shingrix, 3 months prior, but not reported: sleepy, body aches, lethargy, low grade fever, chills, slight nausea, no appetite, lasting 24 hours
Was having minor symptoms of dizziness related to Bell's Palsy prior to flu vaccination. Within 24 hrs, of receiving her flu shot she eveloped severe vertigo. She was given Acyclovir and Diazepam.
Information has been received from a consumer reporting on her 10-year-old female daughter with no pertinent medical history or allergies who on 13-MAY-1998 (when she was 14 months old) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 625378/0066H). There was no concomitant medication. On 04-OCT-2007 the patient was diagnosed with shingle. The patient sought unspecified medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Follow-up information received on a barely legible medical record indicated there are no childhood records on the patient. On 04-OCT-2007 the patient had an office visit and her chief complaint were blisters on the left upper back (herpes zoster on left upper back). The patient was treated with acyclovir 500 mg for 21 days and ibuprofen 600 mg (frequency and duration illegible). Additional information has been requested.
Radiating pain from shoulder to neck and down into elbow. Inability to raise arm past 90 degrees, 24 hours after receiving injection. Ibuprofen & ice to area provide little relief. Nausea for 1st week because of pain. Pain has not subsided since rec'd shot.
Covid test date=14Jan2022, Covid test result=Positive; Covid test date=14Jan2022, Covid test result=Positive; am extremely fatigued all the time; I'm losing a lot of hair; gaining weight; I have intermittent severe breast pain; I am having pain from my left ovary just like when I normally ovulate on that side.; I have not had my menses since Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 06:45 (Lot number: EW0171) at the age of 50 years as dose 3 (booster), single, administered in arm left, administration date 18Jan2021 17:00 (Lot number: EL3248) as dose 2, single and administered in arm left, administration date 18Dec2020 17:45 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing); "Raynaud's Vasculitis" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; TYLENOL; ASPIRIN [ACETYLSALICYLIC ACID]; METFORMIN. Past drug history included: Wellbutrin, reaction(s): "known allergies: Welbutrin", notes: known allergies: Welbutrin, latex. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 14Jan2022, outcome "unknown" and all described as "Covid test date=14Jan2022, Covid test result=Positive"; MENSTRUATION DELAYED (non-serious) with onset Nov2021, outcome "not recovered", described as "I have not had my menses since Nov2021"; FATIGUE (non-serious) with onset 21Dec2021, outcome "not recovered", described as "am extremely fatigued all the time"; ALOPECIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I'm losing a lot of hair"; WEIGHT INCREASED (non-serious) with onset 21Dec2021, outcome "not recovered", described as "gaining weight"; BREAST PAIN (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I have intermittent severe breast pain"; PAIN (non-serious) with onset 21Dec2021, outcome "not recovered", described as "I am having pain from my left ovary just like when I normally ovulate on that side.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of menstruation delayed, fatigue, alopecia, weight increased, breast pain, pain.  Clinical Course: Patient did not have COVID prior vaccination and tested COVID positive post vaccination. Patient did not take other vaccine in four weeks. Facility type vaccine: Hospital.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and covid-19 and BNT162B2.
After having 3 doses of Moderna (last one 9-21-21), I started having intermittent spotting - 8 years past menopause.  I went to my doctor and had a vaginal ultrasound and an endometrial biopsy.  All tests negative.  I then read that women can have irregular bleeding with COVID-19 vaccinations so I believed that to be the case.   I had a 4th dose  with Pfizer on 4/1/22.  A few weeks later, I had intermittent spotting again.  As of today 5/31/22, I still have intermittent spotting.  It isn't heavy and it is mostly brown in color, but I wanted to report that it is still happening.
Redness, swelling and warm to touch. 10x8cm. Advised to ice and apply warm compresses, observe area of erythema circle with marker, advised, mother to watch for extension, fever, pain and increased swelling.
August 24, 2021: Eczema on both feet. September 15, 2021: Started topical steroid cream. It took a month until both feet were cleared. December 6, 2021: Collapsed after a soccer match. Extremely fatigued. Heartrate was over 100 bpm until the next day. December 27, 2021: Complained about being more fatigued than usual with heart palpitations. Called his pediatrician. January 6, 2022: Office visit with pediatrician; ran tests; all came back normal. January 18, 2022: Cardiologist found an anterior mediastinal mass. January 19, 2022: Diagnosed with T-cell lymphoblastic lymphoma.
Information has been received from a licensed practical nurse (LPN), concerning a female patient who was vaccinated (date and dose unspecified) with the second dose of Gardasil. The nurse reported that the patient experienced nausea for approximately 24 hours after the vaccination was administered, though she had not experienced nausea with the first dose. At the time of this report, the nurse confirmed that the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a licensed practical nurse (LPN), concerning a 23 year old female, with seasonal allergies and a hypersensitivity to tetracyclines, who on 22-FEB-2007 was vaccinated in the left deltoid, with the second dose of GARDASIL (Lot #654741/0013U). Concomitant therapy included EFFEXOR XR, NUVARING, MSD, CLARITIN, FLONASE and trazodone HCl. There was no illness at the time of vaccination. The nurse reported that t he patient experienced nausea for approximately 24 hours after the vaccination was administered, though she had not experienced nausea with the first dose. At the time of this report, the patient had recovered. Follow up information indicated that the patient experienced dizziness (date of onset not specified), along with the nausea. The date of recovery was noted as 26-APR-2007, although nausea was originally reported with a 24 hour duration. The nurse clarified that the patient did not require a physician's office visit or an ER visit. No further information is expected.
local rxn @ site of inj w/swelling & redness w/in 48hr p/vax extended up to elbow;no systemic sx;
Tightness in chest, chest pain, shortness of breath, pounding heart. Worst of symptoms lasted for about two days. Symptoms resolved on their own.
allergic reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-BioNTech COVID-19), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (hospitalization) with onset 2021, outcome "unknown", described as "allergic reaction". The patient was hospitalized for hypersensitivity (start date: 2021). Additional information: Reporter stated:"I received the Pfizer vaccine 2021 I think I was hospitalized the same day for an allergic reaction."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a nurse via call center representative and described the occurrence of pain in a 83-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 11th May 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On 14th May 2018, the patient experienced rash. The patient was treated with ZYRTEC. In May 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the rash was unknown. The reporter considered the pain and rash to be related to SHINGRIX. Additional information was received as follows: The health care professional (HCP) reported that the patient began to experienced pain on 12th May 2018 or 13th May 2018. The pain lasted for about 3 to 4 days then resolved. The patient also developed a delayed pink rash (no vesicles) that started that on 14th May 2018 or 15th May 2018. The HCP was unsure if it had since resolved. The HCP instructed the patient to take ZYRTEC.
Anxious, shaky BP 180/100, 130/92, HR 98, O2Sat 98 1:03pm pt. felt ok to leave.
Tiredness, difficulty breathing, soreness at injection site, diarrhea, muscle soreness, back pain, joint pain, fatigue, fever.    This vaccine was worse/harder on my body then actually being tested positive for COVID-19.
approx 30 minutes after receiving the vaccine, client started c/o feeling facial heat and generalized facial rash. He denies difficulty breathing, throat closure, or lip tingling and swelling.Client was given Benadryl 50mg Im to L Deltoid at 2:41pm. 3:00pm client reports feeling well. Wife 10-15 minutes away. He was released to his wife for her to drive him home. client reports to having a similar episode after an allergy shot 4-5 yrs ago. He was given Benadryl and prednisone.
he read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (he read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (he read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (he read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications reported.  no treatment medications reported.  Reporter read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine.  Company comment: Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
2nd Shot - First 24 hrs - Fever 102, Chills, Aches, Headache, Nausea, fatique, Swollen Arm, Red, warm and Itchy Patch Next Day Small fever, Swelling, Sore, red, Itchy Arm, Headache