chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness; Swelling; Itching; Pain in the arm; Heat in the arm; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itching), PAIN IN EXTREMITY (Pain in the arm ) and FEELING HOT (Heat in the arm) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itching), PAIN IN EXTREMITY (Pain in the arm ) and FEELING HOT (Heat in the arm). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itching), PAIN IN EXTREMITY (Pain in the arm ) and FEELING HOT (Heat in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-003300 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-003300:
It was reported that the patient experienced a local reaction the next day after the vaccination with a slightly raised, red rash the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm, radiating from the vaccination site. The patient also had muscle soreness. The patient was treated with Benadryl and Excedrin, which alleviated her symptoms. From additional correspondence received on 04/20/2001, it was reported that the patient recovered from this experience. This case is closed.
2 places that are in the size of a silver dollar that are red, the spot on her back was getting larger; a reaction on her body; very itchy, or itchy like crazy; looks like rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (2 places that are in the size of a silver dollar that are red, the spot on her back was getting larger), VACCINATION COMPLICATION (a reaction on her body), PRURITUS (very itchy, or itchy like crazy) and RASH (looks like rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.   No Medical History information was reported.  Concurrent medical conditions included Drug allergy. Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) and CLONAZEPAM for Product used for unknown indication, LEVOTHYROXINE SODIUM (SYNTHROID) and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (2 places that are in the size of a silver dollar that are red, the spot on her back was getting larger), VACCINATION COMPLICATION (a reaction on her body), PRURITUS (very itchy, or itchy like crazy) and RASH (looks like rash). At the time of the report, ERYTHEMA (2 places that are in the size of a silver dollar that are red, the spot on her back was getting larger), VACCINATION COMPLICATION (a reaction on her body), PRURITUS (very itchy, or itchy like crazy) and RASH (looks like rash) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a lot of allergy to medications (unspecified). The patient put on an itch cream (unspecified) to help treat. The spot on back was getting larger. The patient said spot was not very large in the morning, but it got larger in the afternoon.
Leg that was injected, turned pale and stayed pale for 1 hour, approx. 3 hours, post vax. Infant was very quiet/sleepy during this time.
I became anemic; my hemoglobin dropped pretty significantly. I give blood for every 6 weeks to a clinic, and my donation was declined due to low iron levels. I called my doctor the next day to call for an examination. They took blood work and noticed my low levels were low. I have been going to receive doses of IV iron; I had to receive 3 doses to have a follow-up examination of bloodwork to see if I need to receive any additional IVs in the future.
This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient second dose received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164, Expiry date: not reported), via an unspecified route of administration on 28May2021(age at vaccination: 43-year-old) as dose 2, single for covid-19 immunization. Medical history was none. The patient had no known allergies. The patient's concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EW0171), on 07May2021 for covid-19 immunization. The patient was not diagnosed with covid prior to vaccination and was not tested for covid-19 post vaccination. The patient did not receive any other vaccine within four weeks and did not receive any other medications in two weeks after the vaccination. On 29May2021 (following day after vaccine), the patient had chills and fever which subsided on 30May2021. And around 3 weeks later on 14Jun2021, the patient had noticed an oval rash on her chest with some discoloration, resembled ring worm. A few weeks after that her body developed little rashes on chest, trunk and legs. So she went to the dermatologist on Friday 09Jul2021 and was diagnosed with Pityriasis Roses. She was asked if she recently had a fever or was sick, she didn't remember that she had recently received the covid 19 vaccine and had a fever after until she got home. The patient did not receive any treatment for the events. The patient visited doctor or other healthcare professional office/clinic visit due to adverse events. The events were non-serious. The outcome of the events was recovering.
On 2-2-2015 pt. had arm pain. On 2-6-2015 pt. had extreme arm and shoulder pain, couldn't breathe. Was transported by ambulance to hospital. Pt. was never well, and died on April 10,2015 at hospital.
Almost immediate muscle weakness that moved to aches  within 1-2 hours.  Nausea and total body neuralgia, chills, headache, muscle weakness and aches for 24-30 hours following the injection.  No symptoms relieved by tylenol until 24hours post injection.  Some relief from Aleve 8 hours post injection but not near total relief from headache, neuralgia and muscle aches. I was unable to do any activities of daily living but lying about for an entire day....very unlike myself in my entire life. It is now almost 48 hours post injection and I still have muscle aches and some shakiness but can function without medication. I still have low level headache, nausea (I am able to eat but feel nauseated)and sore muscles.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2021 as dose 2, single (Lot number: EW0183) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid started on 20Dec2022 and stopped on 25Dec2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received COVID-19 Vaccine previously. No known allergies. No other medical history.
welling under the left arm down to the elbow, pain to the touch and rash down the left arm through the elbow (underside of the arm)
ACUTE NON ST ELEVATION MI ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Information has been received from a registered nurse concerning a female patient who on an unknown date, was vaccinated with GARDASIL (dose, route and lot number not reported). The nurse reported that on an unknown date, her friend's daughter experienced adverse event after getting GARDASIL. On an unknown date, the daughter's ovaries became "necrotizing" so it had been removed by a surgeon. At the time of the report the patient's outcome was unknown. Upon internal review the ovaries became "necrotizing" was determined to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a consumer and refers to a 15 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). It was reported that the patient experienced fever for two days. The outcome of the event pyrexia was resolved and the causal relationship between the event and vaccination with M-M-R II were not reported.
12 hours after receiving the second dose, lost feeling from her waste down.  Went to the hospital and later was sent home.  Two weeks later she had fluid building up in her stomach, had testing done at the hospital,  liver had 10% function left.  Over the next six weeks her organs shut down while being in the hospital the whole time, she died on June 29th 2021.  She never drank Alcohol or smoked.  This has been very devastating to myself and my brother.
Dizziness-12:05, fever-7:01, headache, nausea
Unlike the other times, she has been having very strong effects; First dose received on 07-Apr-2021 and second dose on 03-Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unlike the other times, she has been having very strong effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 07-Apr-2021 and second dose on 03-Oct-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 002B21A and 012H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 07-Apr-2021 and second dose on 03-Oct-2021). On an unknown date, the patient experienced VACCINATION COMPLICATION (Unlike the other times, she has been having very strong effects). On 03-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 07-Apr-2021 and second dose on 03-Oct-2021) had resolved. At the time of the report, VACCINATION COMPLICATION (Unlike the other times, she has been having very strong effects) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-404313, MOD-2021-404712 (Patient Link).
Patient received Gardasil vaccination & sat in waiting area..got lightheaded & pale & fainted about 5 minutes after receiving injection. Was VERY pale. Almost looked like she had a seizure, but came to quickly so not sure if it was. Laid on exam table. BP was 102/60. Oxygen sat was 99%. No other treatment was necessary.
rash form a band around her arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2021, the patient received Shingrix. On 31st March 2021, less than a day after receiving Shingrix, the patient experienced rash. On 3rd April 2021, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's brother in law. The patient received a dose of Shingrix (unknown whether first or second). The reporter did not know the lot number and expiry date. The patient experienced rash form band on arm which resolved in few days. The reporter did not consent to follow up and permission to contact HCP (health care professional) not granted. This case has been linked with US2021085431, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021085431:same reporter
Pt received first dose on 7/29/21, and 2nd dose should have been scheduled for 8/19/21. However, pt received vaccine 6 days before recommeneded 2nd dose on 8/13/21. Pt was recommended to receive a booster sometime in September pending CDC's recommendations for non-immunocompromised pts.
Sharp chest pain in one location.  Persistent dull/ache in another chest location.  Tachycardia.  Fatigue.   Weak sensations in both arms.  Sharp chest pain from 8/26/21-9/16/21.  Dull/ache in chest from 9/15/21 - current.  Tachycardia is inconsistent but is still present currently.  Fatigue from 8/26/21-current.  Weak sensations in both arms has not happened since 9/16/21.
Could not abate pain from back by conventional means so I made an appt. and was seen on 12/2. After a physical my PCP sent me home with 5 day course of Prednisone. As of 12\8 the pain is still present and I have not recovered. Checked back with PCP and was referred to a physical therapist. No word on when I start.
T 105 (R), rash, aching all over, very sick. Has been getting APAP q4h. Pt c/o back hurting.Pt is tilting head to the side. Mom will take to MD & call back.Pt went to MD 21Mar91 DX:Throat infect-MD said not related to vax.Pt on antibiotics.
Developed hi-degree A-V block, requiring permanent pacemaker placement. 10/23/03 Pt complained of SOB on exertion. Heart rate was slow at 47 beats/min. 10/30/03 EKG revealed "profound bradycardia." Pt referred to cardoiologist. Pacemaker placed in 11/03.  Nurse follow up on 05/27/04 states: "Review of medical record confirms diagnosis of AV block."
Adverse effect of other bacterial vaccines, subs encntr on 2016-10-19. Adverse effect of vaccines and biological substances, init on 2016-11-14.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Pain, swelling, erythematous raised area 3-3.5" diameter on L upper arm at site of injection at site of 2nd anthrax shot. Redness and swelling occurred 2 days post vaccine; increased and ? on day 3 and 4.
Myalgia Redness, Chills, Narrative:  Other Relevant History:
Swelling and severe pain, redness and itching where the vaccine was given. Headache, hard to swallow and joint pain.
w/in 24hr of vax pt devel an inj site rxn characterized by a softball sized area of redness, swelling & warmth;pt recovered;this is 1 of 5 pt from this facility to have an adverse exp p/vax;
Redness started about 2 days after vaccine given. Redness around injection site, some slight swelling. Still using arm, relieved by cool compresses. Redness 3 inches long and 2 inches wide, 2-3 mm nodule under injection site.
L arm injection site red, warm, indurated Narrative:  referred to PCP  Other Relevant History:
Missed 42 day dosing window; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 42 day dosing window) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 42 day dosing window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 42 day dosing window) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.   Reporter did not allow further contact
FEVER, COUGH, SOB, VOMITING, LOSS OF TASTE AND SMELL
I got COVID; I got COVID; This is a spontaneous report from a contactable nurse (patient). A 24 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 15Jan2021 08:00 (Batch/Lot number was not reported) at age of 23 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. The patient had no medical history. There were no concomitant medications. The patient got covid in Aug2021.  The outcome of the event was resolving. No treatment received. There was no COVID prior vaccination or COVID tested post vaccination. No other vaccine received in four weeks. No other medications received in two weeks.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Within 48 hrs of 2nd Fluzone, the pt had the first & only febrile seizure (T=103) of her life. It lasted less than 5 min. Pt was taken to ER. Had normal exam & labs. Saw Dr on 2/17, no neurologic deficits, fever & totally nml exam.
Pt. received the Pfizer vaccine for first dose.  when she came back for the 2nd dose, she was inadvertently given Moderna as the 2nd dose.  It was discovered later in the day when we were checking on the status of the vaccines.
This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-MAY-2017, the patient was vaccinated with a dose of improperly stored ARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1706USA002688:
Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sore lymph nodes in neck and groin, achy, tired, no appetite
Pt allegedly fainted for less than 5 seconds. By the time the examiner entered the exam room Pt was conscious.
Initial report received from a consumer on 08may06. A four year old male child with a medical history of pervasive development disorder, developed profuse sweating, felt warm, appeared to sleep more deeply and wet the bed which began in the evening of the day he received the injection of IPOL, lot number Y1067-2 (expiry date 22Nov07) in the left arm on 17May06. Per reporter, who is the pt's mom, her son had no illness at the time of vaccination. The symptoms lasted for one week. Per mom, the child had recovered, however still has sporadic bed wetting episodes. Follow up information received on 12Jun06 from a health care professional. It was reported that the pt received the IPOL vaccination on 17Apr06. His mother did not notify the physician of any adverse reactions until 10May06. The pt was seen in the physician's office on that day, but by that time his symptoms had already subsided. No further treatment was provided. Further information is not expected.
Pt collapsed at pre school 24 hours receiving immunizations. Pt said I cant see, flailed arms, then lost consciousness. Event lasted 5 minutes per mom. Pt was taken to ER blood glucose and head CT normal. EKG normal, FU with PCP.
Information has been received from a physician referring to a 1 years old female patient. The patient's concomitant medications included montelukast, cetirizine hydrochloride (ZYRTEC), a daily multivitamin, two topical steroids for atopic dermatitis, clobetasol propionate (also reported as clabetesol) and fluocinolone acetonide (DERMA-SMOOTHE) /FS TOPICAL OIL. Her current condition included atopic dermatitis. The patient was allergic to milk, dust and dogs. Her historical drugs and historical conditions were not reported. On 05-FEB-2015, the patient was vaccinated with M-M-R II (dose, lot number and expiration date were unknown), subcutaneously for prophylaxis. On an unknown date in 2015, the physician reported that the patient's mother believed the patient developed a mild case of the measles, including a fever lasting 5 to 7 days after receiving the M-M-R II and developed a rash (reported as the patient had atopic dermatitis and easily developed a rash). On 11-MAR-2015, the patient came to medical practice and was diagnosed with fever, contact dermatitis, otitis media and influenza. There were no lab diagnostics or studies performed. The physician reported the patient had fully recovered from all reported symptoms. The causality assessment between the events and M-M-R II was not reported. Upon internal review, measles was determined to medically significant.
Complained of headache and feeling, jittery.  She admits to having hypoglycemia.  We gave her orange juice and she improved.
Patient received Tdap vaccine on 11/2/18. Woke up on 11/3/18 with a huge bump on her shoulder, increased fatigue, fever 99 and then 100.5. Torso, neck and head able to move. No headache, no limited ROM. Encouraged ice pack on arm, NSAIDs 600mg at the time of call and again before bed. Advised patient to follow up if ongoing localized pain and back and neck muscle tenderness.
Presented to clinic pediatrics (Dr.) on 8-11-2008 with rash consistent with zoster on his (L) leg. Rash had been present for approximately 5 days at that time. Started on ZOVIRAX tid by Dr. Subsequently developed headache/aseptic meningitis and was admitted to hospital overnight. Patient has recovered fully with no sequelae. I was the on call MD for admit.   9/29/08 Case closed w/records that accompanied report. FINAL DX: aseptic meningitis Records reveal patient experienced vesicular rash while out of country 10 days prior to admit.  Saw PCP 4 days prior to admit, dx w/shingles & tx w/antiviral meds.  Day prior to admit, awoke w/severe HA, nausea/vomiting, low grade fever.  In ER, had stiff neck.  LP done.  Tx w/IVF.  Improved & d/c to home.
I now have issues with my heart. Have already had one surgery and now have another one scheduled.  I have not had any of these issues prior to this shot. I can barely breathe just to walk in my home.