chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruise down left arm; sweats; hives on her face down to torso and back; rash down left arm; fever; chills; nausea; shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (shortness of breath), CONTUSION (bruise down left arm), HYPERHIDROSIS (sweats), URTICARIA (hives on her face down to torso and back) and RASH (rash down left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient had COVID in December 2020 or January 2021.).    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced DYSPNOEA (shortness of breath). On 24-Jul-2021, the patient experienced CONTUSION (bruise down left arm), HYPERHIDROSIS (sweats), URTICARIA (hives on her face down to torso and back), RASH (rash down left arm), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at a dose of unknown. At the time of the report, DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweats), PYREXIA (fever) and CHILLS (chills) outcome was unknown and CONTUSION (bruise down left arm), URTICARIA (hives on her face down to torso and back), RASH (rash down left arm) and NAUSEA (nausea) had not resolved.        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.   Concomitant product use was unknown by the reporter.
8cm x 7cm area of erythema, slight bogginess, warmth -- NONtender.
p/vax arm red/inflamed & swollen from elbow to shoulder w/reduced mobility;seen in clinic;some improvement;
p/vax pt exp raised, red at inj site; cranky & irritable for 3 days;  tx: tylenol
Right armpit lymph nodes swollen; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; Soreness, right arm; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; the swelling is ongoing on the thumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 18:00 (Lot number: FJ6396) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Covid vaccine: 17Mar2021, Lot Number / Expiry Date: EN6208, Route, Anatomical Location: left arm), administration date: 17Mar2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Second Covid vaccine, Lot Number / Expiry Date: EW0150, Route, Anatomical Location: left arm , No. of Previous Doses: one, Date: 07Apr2021), administration date: 07Apr2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Jan2022, outcome "unknown", described as "Right armpit lymph nodes swollen"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 28Jan2022, outcome "recovering" and all described as "Right thumb, pointer finger, tingling and swollen, swelling inside forearm."; PAIN IN EXTREMITY (non-serious) with onset 28Jan2022, outcome "recovered" (28Jan2022), described as "Soreness, right arm"; PARAESTHESIA (non-serious) with onset 28Jan2022, outcome "recovered" (30Jan2022), THUMB SUCKING (non-serious) with onset Jan2022, outcome "not recovered" and all described as "the swelling is ongoing on the thumb".  Additional Information: Vaccine Administered at Military Facility: No. Any AE(s) require a visit to Emergency Room: No and Physician Office: No. No prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations. No relevant tests were performed.  No follow-up attempts are possible. No further information is expected.
2 hours after receiving vaccine - pt started feeling warm and achy all over - fever of 101.9 degrees F couldn't sleep all night. Patient took MOTRIN & drank ginger ale. She fell in the house. She saw her doctor 6 days and fell in the office. She's feeling better now.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: recommended patient seek medical attention to be evaluated by doctor
Arm turned red, swelled up to size of lemon. Became inflammed and very itchy.
This spontaneous report as received from a consumer refers two female patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (dosage regimen were not reported) for prophylaxis. On an unknown date, the patient experienced chicken pox (varicella). The outcome of varicella was unknown. The relatedness between the drug and the reported event were not reported. Additional information has been requested.
Volunteered on March 1st to help with vaccines- I filled syringes with the Moderna vaccine.    On  3/6/2021 at 11:24 AM I presented  with dizziness, slurred speech, a feeling of my lip dropping to the right, and weakness in left upper extremity.  Called my daughter whom arrived within 10 minutes. After asking me some questions and exercises she  said my strength in the left upper extremity was weak compared to the right.  My daughter took me to ER, at check in I said I think I had a stroke. I was admitted, and neurology was consulted. In the ER they called it a TIA, and after imaging a  diagnosis of stroke was made.    Acute frontoparietal infarct, ASA/plavix, lipitor, PT/OT, Neurologist follow up.    After discharge I have been meeting with PT/OT following exercises. Met with my PCP and continued medications Aspirin 81 mg, atorvastatin 80 mg, clopidogrel 75 mg. Still have muscle aches, and pain in the left upper extremity- especially 3rd and 5th digits.
Rash on face and torso, erythema. Anaphylaxis; delayed onset. Did not happen until 2/11/10. Was treated at hospital with EPIPEN and SOLUMEDROL.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Aug 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 4, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Aug 4, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration: May 7, 2021.
mom reported that later evening following adm of vax pt's face turned blue then spinal tap & blood work done; temp was 101 R on arrival;
Itchiness, hard lump/swelling, and large red circle all at injection site. No symptoms prior. Began on day 8 past injection.
Onset swelling and redness at vaccine site the day after injection-treatment recommended ice, BENADRYL-Resolved without further treatment, within few days.
Vaccine given 1 day early, earliest due was 1/5/23 and vaccine was given 1/4/23.
I'm estimating that it was in the late afternoon the day after my vaccination, the tinnitus in both ears became much louder, with the left ear particularly loud.   It makes it difficult to sleep, even with a sound conditioner.    On March 28, I sent a message to my primary physician, indicating the increased level of tinnitus and wondering if I should not take the 2nd dose in four weeks.  He replied that tinnitus was not a side effect of the vaccine based on clinical trials and he would like me to get the 2nd dose.  He said I could run it by an ENT. I saw an ENT, on April 8.  She determined that I have minor hearing loss typical for my age and said that is likely the cause(cont.)
Right sided trigeminal neuralgia; This is a spontaneous report from a contactable physician. A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the right arm, on 09Jan2021 13:30 at a single dose for COVID-19 immunization. at a clinic Patient was generally healthy, though has history of migraines, symptoms were not typical of migraine and dairy allergy that has resolved, no current allergies. Patient is not pregnant. Concomitant medication included colecalciferol (VITAMIN D), calcium, sumatriptan, cetirizine hydrochloride (ZYRTEC), and fish oil, vitamin e nos (OMEGA 3). Patient previously took  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9899), intramuscular at the left arm, on 19Dec2020, 09:15. The patient experienced right sided trigeminal neuralgia  on 10Jan2021 06:00, began 17 hours post 2nd dose vaccine and lasted 24 hours in duration. No history of this condition. Self resolved. Most likely diagnosis confirmed by neurology colleague, though definitive testing was not able to be done due to short duration of symptoms.  No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient recovered from the event.
9/21/17 approximately 10:50 AM the child experienced syncope with LOC after Tdap and meningococcal. Once recovered, she felt weakness again when ambulating W/O LOC. She had a HA and was sent to ER via EMS.
This spontaneous report was received from a licensed practical nurse, who is also the patient, 39 or 40 years old female patient. Concurrent conditions included antiphospholipid syndrome, ankylosing spondylitis, juvenile idiopathic arthritis, autoimmune thyroiditis, Sjogren's syndrome, and albumin urine. Additionally, the patient's medical history included a hysterectomy and a disability due to a fractured hip in 2003 and osteopenia; the patient had been in a wheelchair. On an unspecified date in 2006, the patient was vaccinated with PNEUMOVAX 23 (dose number, route of administrations, anatomical location, and lot # and expiration date not reported). Concomitant therapies included aspirin (manufacturer unknown) and SYNTHROID. After vaccination, also approximately in 2006 (reported as "believed this occurred in 2006") the patient developed an abscess which ended up in a cellulitis (location was unspecified), consequently, the patient was hospitalized for 4 or 5 days. At the reporting time, the outcome of abscess and cellulitis was unknown. The causal relationship between vaccination with PNEUMOVAX 23 and the events was not reported. Upon internal review the event of cellulitis was considered medically significant. Subsequently, the patient experienced adverse events while on therapy with lisinopril (manufacturer unknown) (captured in MARRS # 1606USA000913). Additional information has been requested.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were orally vaccinated with improperly stored doses of ROTATEQ dose was not reported, lot # L004453 with expiration date: 16-APR-2015 and K010222 with expiration date: 12-MAY-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Generalized tonic clonic seizure lasting 7 minutes, followed by second GTC seizure lasting 3 minutes, followed by third GTC seizure lasting 45 seconds.
rash on the right arm / the rash was really red; the rash was swollen; the rash was itchy; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced red rash, swelling arm and itchy rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the red rash, swelling arm and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash, swelling arm and itchy rash to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient received the first dose of vaccine and experienced a rash on the right arm which required treatment with both oral and topical Benedryl. The rash was large, swollen, itchy, and really red. The reporter consented to follow up. The pharmacist did not provide further details during the call.
She is itching all over and it's bad itching.; Started to break out in hives all over her body/ Hives was reported as worsened; Ear was puffy and itchy; Ear was puffy and itchy; This is a spontaneous report from a contactable consumer (patient grandmother). A 13-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left upper arm on 27May2021 12:30 (Batch/Lot Number: EW0182) as single dose for covid-19 immunisation at the age of 13-year-old. Medical history ongoing depression. Concomitant medications included dimenhydrinate (DRAMAMINE) taken for an unspecified indication from an unspecified start date to 23May2021; fluoxetine (FLUOXETINE) taken as antidepressant therapy from an unspecified start date and ongoing. Her mom says she takes allergy pills Benadryl, clarified to be the CVS Allergy relief brand (Lot# P123696, Exp date: Jan2024). The consumer reported her granddaughter received the COVID Vaccine yesterday at 12: 30. Last night her granddaughter started to break out in hives all over her body. It is on her arms, legs, belly, back, all over. She came in her room last night saying her ear was puffy and itchy. Her granddaughter is itching all over and it's bad itching. she applied Hydrocortisone Cream to the spots to help the itching and the itching is better. The hives have gotten worse. She mentioned she has recently done her grand-daughters laundry and washed her bedding/clothing in Tide. Caller contacted the patients mom and found out she normally does not use Tide. Therefore, she does not know if its from the shot itself or the change that occurred with the use of Tide. The outcome of itching all over was recovering. Outcome of other events was not recovered.
On Monday after receiving the high-dose flu vaccine on the previous Friday afternoon via intramuscular injection in her left arm, pt began experiencing severe illness symptoms that persisted and worsened through the rest of the week. These symptoms included a fever of 101-102, chills, excessive sweating, nausea, vomiting, diarrhea, chronic headache, severe weakness (to the point she was unable to stand or raise herself out of bed on 2-3 occasions), coma-like sleepiness (could not stay awake for more than a few minutes at a time and would sleep deeply without awakening or even stirring at all for hours and hours at a time). Another symptom, either separate or resulting from aforementioned, was severe loss of appetite - was unable to eat more than a bite or two 2-3x/day for 3+  days. As of the following Friday (1 week after the injection), pt was still suffering most of these symptoms , especially exhaustion and nausea.
Hormonal changes.  Severe PMS, cystic acne, and menstruation began 2 weeks early in my cycle that is never off.
This spontaneous report as received from a physician refers to a 17 year old female patient. The patient did not have any concurrent conditions, pertinent medical history or drug reactions or allergies. The patient's concomitant medication included unspecified birth control therapy. On 17-NOV-2016, the patient was vaccinated with her first dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not specified) for human papillomavirus (HPV) vaccination. On 05-JAN-2017, the patient was vaccinated with her second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not specified) for HPV vaccination. On 16-MAR-2017, the patient was vaccinated with her third dose of GARDASIL 9(dose and route of administration were not provided, lot # M007728, expiration date: 21-MAR-2018), for HPV vaccination. On 16-MAR-2017, immediately after being vaccinated with the third dose of GARDASIL 9, the patient had a syncopal event that lasted for a few seconds. The physician stated that she gave the patient juice and crackers. No laboratory diagnostics studies were performed. At the time of the report, the patient was fully recovered from the syncopal event. The relatedness between GARDASIL 9 and the syncopal event was not reported. Additional information has been requested.
Patient had syncopal event about 5-7 minutes after vaccination. She came to within a minute or two, but was very anxious and visibly upset. She stopped shaking within another minute or two and had calmed down enough to sit up upright. She drank a few sips of water and said she was feeling better.  EMS as called as a precaution and arrived in about 15 minutes.  Patient's BP was normal (120/80) and blood sugar within normal range.
The patient presented to the hospital followed by multiple specialists for severe pulmonary hypertension, autoimmune hemolytic anemia, acute kidney injury, coagulopathy (elevated dimer). Other multi inflammatory system disorder: acute gastrocolitis and inflammatory spinal arthritis. We were consulted as vascular surgery for findings of bilateral iliac artery dissections. Unclear if this is related to the vaccine or incidental finding during his hospital stay.
12/18/1999 Woke up and noticed a swollen gland behind one ear, by afternoon the other side was also swollen. No fever, today the glands are still swollen. No fever. Today the glands are still swollen and now his throat is getting sore. The glands are a little larger than a pea.
Patient's niece states patient developed cold approx 24 hours after receiving ZOSTAVAX. They feel it is because immune system has been lowered in response to ZOSTAVAX.
Headache, NauseaVomiting, Arm pain, alternate chills/sweating Narrative:
This spontaneous report as received from a registered nurse refers to a 4 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was unknown. On 27-AUG-2014 the patient who was intended to receive (Oka/Merck) VARIVAX was inadvertently vaccinated with ZOSTAVAX (single dose), subcutaneous. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approx 6 wks /p vax pt c/o of pain @ vax site.Site was red,hard &swollen.Pain &swelling inc when using arm.Pain,swelling & loss of muscle strengh cont until Mar91 /p 1month of anti-inflammatory drugs.
After the first dose I developed extreme abdominal pains; Mucus/ Diarrhea; Nausea; Heartburn; I realized gluten was causing it and cut out wheat from my diet. I have felt much better and tried eating gluten again but cant. Now I am gluten intolerant.; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) in the left arm on 25Aug2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, after the first dose, the patient developed extreme abdominal pains, mucus and diarrhea as well as nausea and heartburn. This lasted every day for about 2 weeks. She had never experienced this before. She realized gluten was causing it and cut out wheat from her diet. She had felt much better and tried eating gluten again but could not and now (at the time of this report) she was gluten intolerant. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events abdominal pains, mucus, diarrhea, nausea and heartburn was resolved on an unknown date in 2021; while that of realized gluten was causing it and cut out wheat from her diet, felt much better and tried eating gluten again but could not and now (at the time of this report) she was gluten intolerant was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) in the left arm on 16Sep2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.
Patient has been in hospital since 3/14/2022 for klebsiella UTI.   5/9/2022 While on the unit, she began having a seizure and experienced gaze preference with limb weakness.  While getting a STAT Head CT patient had another seizure and was intubated on arrival to NCC. Continuous EEG was started.  Patient is still intubated at this time and still has weakness, impaired corneal reflexes and a upward gaze preference.
FELT WARM; CRAMPS IN LEG AND BUTT AREA; This spontaneous report received from a parent concerned an 18 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, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced cramps in leg and butt area. Treatment medications included: acetylsalicylic acid/caffeine. On 13-APR-2021, the subject experienced felt warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cramps in leg and butt area, and had not recovered from felt warm. This report was non-serious.
mom reported diff w/resp;5:15 on 4JUN referred to ER;5JUN96 mom reports pt had fever of 103.5 in ER w/labored resp;pt is doing well today