chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She also knows of a woman who was having issues with blood clot. She is not sure which vaccine she took also.; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (She also knows of a woman who was having issues with blood clot. She is not sure which vaccine she took also.) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (She also knows of a woman who was having issues with blood clot. She is not sure which vaccine she took also.) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (She also knows of a woman who was having issues with blood clot. She is not sure which vaccine she took also.) outcome was unknown.            No concomitant medications was reported.  Patient could not provide the vaccination information because could not find the vaccination card. Patient did not knowhowmany doses of the Moderna vaccine she had.  No treatment medications was reported.  Company comment: This is a spontaneous case concerning a female patient with no reported relevant medical history, who experienced the unexpected and serious (due to medically significant and hospitalization) event of thrombosis. The event occurred after of a dose of Covid-19 vaccine with mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient with no reported relevant medical history, who experienced the unexpected and serious (due to medically significant and hospitalization) event of thrombosis. The event occurred after of a dose of Covid-19 vaccine with mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Urticaria - 12 y/o boy - known controlled allergic rhinitis, intermittent asthma and ADHD. Daily meds: FLONASE, Montelukast, Vyvanse. GARDASIL 9 #1 on 06/07/16. # 2 on 08/09/16. On am of 08/10/16 - diffuse urticaria from waist up. Rx with oral BENADRYL.
sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 19May2021 as dose 2, single (Lot number: EW0183) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jan2020 (unspecified if ongoing), notes: tested positive once and the first time was Jan2020; "COVID", start date: Apr2020 (unspecified if ongoing), notes: got delta in late Apr2020 and not yet vaccinated. Lasted until 1st, dose of Pfizer vaccine May2021; "monkey pox" (unspecified if ongoing), notes: Got in this Jun and had monkey pox and felt like getting better after 3 weeks; "Long COVID" (unspecified if ongoing), notes: long Covid and lost sense of smell and all the symptoms with 1st round of Covid and were mild sympts; "Covid-19" (unspecified if ongoing), notes: They had Covid several times; "Hydrocele like a build of lymphatic fluid in the" (unspecified if ongoing), notes: Hydrocele like a build of lymphatic fluid in the scrotum. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; MELATONIN; PEPCID AC; REISHI MUSHROOM; TURKEY TAIL MUSHROOM; VITAMIN C [ASCORBIC ACID]; MAGNESIUM. Vaccination history included: BNT162b2 (Manufacturer: Pfizer, NDC: Unknown, Lot: EW0175, Expiration: Unknown), administration date: 27Apr2021, when the patient was 40-year-old, for Covid-19 immunization, reaction(s): "diarrhea", "Illness". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sickness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive. They got vaccinated in May2021 and got sick between vaccinations.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201204867 similar report from same reporter;
The patient called 8/1/14 and said she had a reaction and went to the ER. Her symptoms she stated were a really sore arm she can't move easily, fever, headache, swollen lymph node, trouble swallowing. She was also being treated for other conditions also.
Developed a chronic skin rash, which biopsy revealed to be Lichen Planus. May have developed sooner but I didn't notice until mid-May.  Initially began on wrists, hands, and ankles. Rash proceeded to spread over all extremities, shoulders, spine, and is the worst on the anterior bilateral upper thighs. Rash is small, raised red/purplish color. Only itches when it is newly spread. Then it doesn't itch.  Treated with Fluocinonide 0.05% topical ointment 7/27/21. Then added Pimecrolimus 1% on 9/7/21 due to continues to spread. Also prescribed Triamcinolone cream 0.1% to use after supply of Fluocinonide is gone.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 PNEUMONIA R09.02 HYPOXIA 4/30/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 FEVER OF UNKNOWN ORIGIN R09.02 HYPOXIA 4/30/2023 FEVER OF UNKNOWN ORIGIN J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC R09.02 HYPOXIA 4/30/2023 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 MALIGNANT PLEURAL EFFUSION R09.02 HYPOXIA 4/30/2023 MALIGNANT PLEURAL EFFUSION J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 BENIGN ESSENTIAL TREMOR R09.02 HYPOXIA 4/30/2023 BENIGN ESSENTIAL TREMOR
around 1PM felt a tightness in throat, SOB & began coughing w/diaphoresis;went to ETU because was @ hosp & wanted MD eval;given DPH w/relief;MD did not feel it was anaphylaxis @ all;VS stable throughout;
The patient is a health care worker (Physician) who experienced an onset of severe generalized headache, severe head to-toe myalgias and profound malaise with onset of 24-48 hours staus post influenza vaccine.  The patient has no medical history of note- headache was not positional, no hypersensitivity to light, no nausea, vomiting, or occular abnormality. No relief with Tylenol, Motrin or sleep. Onset head to-toe myalgias, no sore muscles. Muscles not painful to touch. No dark urine or stool color. The patient reports even " feel" hurts him. Profound malaise, no stamina or endurance. The patient had to run a marathon and the severity of malaise exceeded the weakness S/P the marathon. Denies fever, cough, URTI, diarrhea. Triad of headache, myalgias and fatigue they all have lasted about 2 weeks.
E87.1 - Hypo-osmolality and hyponatremia R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction D69.6 - Thrombocytopenia, unspecified J18.9 - Atypical pneumonia
Testing positive for Covid longer than two weeks after both doses/Tested positive for Covid virus, after being fully vaccinated; testing positive for Covid longer than two weeks after both doses/Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. This report is 12th of 37, reports.   A 69-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 06Feb2021 as single dose, and received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EJ1686) via an unspecified route of administration on 16Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing asthma and ongoing hypertension. The patient's concomitant medications were not reported.  The patient tested positive for covid longer than two weeks after both doses/tested positive for covid virus, after being fully vaccinated on 27Jul2021.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Jul2021. Caller stated that, they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Caller called because she had some concerns, and the health department was tracking breakthrough cases in that area. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/event, different patient
10 minutes after receiving the intramuscular Covid-19 Moderna vaccination patient started to feel tingling sensation on the right side of her face, arm and leg and a  dizzy.  She also had a metallic type taste in her mouth.   When called to the area client was talking and had no signs or symptoms of distress.  Was speaking without difficulty and ambulating without difficulty.  She reported that she had not taken her blood pressure (hypotensive) medication today nor had she eaten anything.  The issue was resolving quickly  while speaking with her.  Lung sounds clear, heart rate normal.  124/72  84  20  (TPR).  Denied headache, weakness or numbness.  Client improved while speaking with her and was released to home with her daughter who was directed to stay with her the rest of the day and call 911 for any medical emergency.
On 2/24/01 the pt became fussy and by 2/26/01 the pt had developed a total of 40-50 lesions. No other symptoms were reported. subsequently, om 03/09/01, the patient recovered. No further information is available.
1533: Patient notified staff of tingling in right shoulder at injection site and denied respiratory problems, shortness of breath or swelling in the mouth. Upon further questioning patient stated she was anxious. Offered patient option to sit out front, monitored for the duration of her 30 min with mask off. 1536: Patient was still at chair and notified staff her tongue was beginning to feel thick. 1537: Patient brought to emergency area. Significant throat edema noted, uvula not visualized. Lung sounds clear to auscultation. 1542: 50mg Benadryl administered by RN, PA, RN. O2 administered via simple face mask at high flow 10L/min, 1550: 0.3mg Epinephrine administered IM by RN via Right vastus lateralis site. Patient's throat remained edematous, but uvula visualized and posterior pharynx visualized with patent airway after epinephrine. VS:1540: O2 sat 92, HR94, VS:1550: O2 sat: 98, HR 75  BP: 162/92, VS: 1555: O2 99%, HR 70, BP 162/88. Staff consult with Dr. He is aware of patient's status and advised EMS transport and approved patient treatment plan along with anaphylaxis algorithm. EMS Arrived 1557. Staff advised patient to go with EMS for transport to Emergency Room. After examination, EMS gave patient option to drive with husband. Patient elected to go with husband in their own car to ER. EMS transported patient in wheelchair to car with husband. Patient upon departure stated "my tongue has stopped feeling like it's swelling." No visible shortness of breath, ambulating well independently. A/O X3. Patient tolerated EPI well and was stable and calm through out time here. Husband was sitting next to her in emergency area also calm. Patient and husband stated she has not used her EPI pen in 10 years and probably used it about 10 years before that as well.  She states she frequently takes 5-6 Benadryl 25 mg tabs for allergic reactions to bug bites.
Sore injection site, fatigue, low grade fever, sore armpit ( radiating to left breast ).  Fatigue. And Temperature lasted approximately 24 hours. Pain in at injection site and armpit pain lasted 3 days.
Rash appeared 2 days  after shot lightly.  Strong heavy rash at 10 days after shot continuing 5 more days.  Fever 104.5 degrees X 72 hrs starting 9 days after shot.  Irritability intermittently x 5 days starting 10 days after shot
lt ulnar nerve palsy @ day 8;diffuse peripheral sensory neuropathy @ 3wk;moderate lt peroneal nerve paralysis;+ EMG;+NCV;some improvement @ 2mo;
Patient was accidentally given a vaccine that had expired on 02/06/2023.  Patient did not experience any adverse events.  Patient will come back to the pharmacy to receive a non-expired second dose.
This spontaneous prospective pregnancy report was received from a nurse refers to a female patient of unknown age. Information regarding her medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 29-APR-2016, the patient was vaccinated with M-M-R II (lot # L029266, expiry date: 04-AUG-2017). Other suspect therapies included VARIVAX. Nurse reported that the patient was unaware that she was pregnant at the time of vaccination, and discovered her pregnancy on 03-MAY-2016. Her LMP and EDD were reported as 01-APR-2016 and 06-JAN-2017, respectively. Nurse reported that due to this time frame, she thought that the patient was already pregnant at the time of vaccination. Outcome of patient's pregnancy was not reported. No adverse effect was reported. Additional information has been requested.
chills; Body aches - mainly on left side - arm and leg - muscle and joint; Body aches - mainly on left side - arm and leg - muscle and joint; Arm sore at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MYALGIA (Body aches - mainly on left side - arm and leg - muscle and joint), ARTHRALGIA (Body aches - mainly on left side - arm and leg - muscle and joint), VACCINATION SITE PAIN (Arm sore at injection site) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020 at 5:30 PM, the patient experienced MYALGIA (Body aches - mainly on left side - arm and leg - muscle and joint), ARTHRALGIA (Body aches - mainly on left side - arm and leg - muscle and joint) and VACCINATION SITE PAIN (Arm sore at injection site). On 20-Jan-2021, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Jan-2021, CHILLS (chills) had resolved. At the time of the report, MYALGIA (Body aches - mainly on left side - arm and leg - muscle and joint), ARTHRALGIA (Body aches - mainly on left side - arm and leg - muscle and joint) and VACCINATION SITE PAIN (Arm sore at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-061872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: No specific follow-up information recorded. On 31-Mar-2021: No new information On 12-May-2021: NNI
Swelling and redness (L) thigh from knee to groin and 10 cm wide.
swollen lymph nodes, runny nose,  nausea, jittery, chest and bronchia congestion,  low energy  NO headache,   NO cough,    NO fever  took benadryl  at 12 noon - relieved some symtoms slightly
Information has been received from a physician concerning her mother who on 06-APR-2009 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Coughing up mucus/Coughing through the night; Wheezing; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Coughing up mucus/Coughing through the night) and WHEEZING (Wheezing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     The patient's past medical history included No medical history.    On 27-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Other) at an unspecified dose. On an unknown date, the patient experienced COUGH (Coughing up mucus/Coughing through the night) and WHEEZING (Wheezing). At the time of the report, WHEEZING (Wheezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Other) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Other), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-162367 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162367:Linked to Husband case
Fever, nausea, hyper salivation, fatigue, several episodes of blacking out/passing out/collapsing, inappetence, night sweats, pain at injection site, swollen joints. Not touched by Tylenol or Meloxicam
We held our vaccine clinic. I had one designated nurse assigned to provide the vaccine to each resident on the roster. The nurse, gave us 3 extra doses that were left over from the previous clinic. After patients vaccinated, we made a zealous attempt to find 3 individuals for the 3 extra doses we had so that we did not waste them. Our nurse attempted to help find patients interested in the vaccine and she went to unit. She asked Patien (who was just vaccinated in the morning) if she wanted the vaccine. Patient accepted the vaccine, and the nurse administered the vaccine, not knowing that she already received it.
Shoulder pain/weakness shortly after injection progressively getting worse now with limited range of motion continuing today 11/24/2020. Body aches/ chills and general not feeling well starting at 5pm on 11/10/2020 and continuing until morning of 11/12/2020.
Shortness of breath, tingling starting bottom left foot, then spread through extremities like electrical shocks.  Numbness/tingling in arm, went to hospital many times and different locations.  I have had multiple abnormal ekgs, bloodwork that is off, high d dimer.  Chest pains, heart palpations, wake up in the middle of the night with chest pains.  Testing shows my spike antibody from the vaccine is off the charts over 150.
Slight sore arm (resolved much quicker than with 1st dose); fever, headache, extreme shivers-never experienced those before-lethergy. Improvement began mid-morning next day and I was almost normal by late afternoon.
Information has been received from a registered nurse concerning an 18 year old female with asthma and no known allergies or adverse drug reactions reported. On 08-JAN-2007, the patient was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (yeast) (lot#655165/1425F). Concomitant therapy included hormonal contraceptives (unspecified) and albuterol. On 09-JAN-2007, the patient developed a rash on her back and chest. The patient sought unspecified medical attention. The patient was being treated with BENADRYL. At the time of this report, the patient had not recovered from the event.
Booster for Janssen   Lip swelling  Itchy rash Chapped lips
Patient received immunization on 1/31/18 in the deltoid. Patient reported adverse reaction of swelling and redness of bicep on 2/1/18 at 6:45pm. Counseled patient to seek medical attention from a provider.
I had extreme fatigue, headache, nausea, sore throat and a fever after I received my first booster. On 08/13/2022 I tested positive for COVID-19 at an urgent care center. I had a fever, cough, body aches, chills, tired, not appetite, headache which lasted a week. As of today, I continue to have a headache that I can't get rid of.
Chest pain, heart was racing, breathing was difficult, abnormal temperament, weak/tired. Lasted about 6 days. Periodic rapid heart rate with some chest pain on the left side continues. Everything else has subsided. Making a doctor appointment for a heart check.
Redness and hot at injection site whole arm swollen and tender up to top of shoulder. 4/20/08 Fever 012 which has not ameliorated with Tylenol 36 hrs. 0900 am shortness of breath for 36 hrs. Better 4-21-08 9:00 PM.
1 of 9 pts immunized from same lot# 366-949; not the same vial; who exp induration & poss erythematous nodule approx 2 inches in diameter @ inj site; nodule persisted 6-8wks;
Redness, hardness at injection site started on 10/24/2022 after receiving vaccines at  Pharmacy at  on 10/23/22 Cellulitis at injection site, left arm
3 min following vaccine administration pt was sitting on exam table and suddenly became pale, diaphoretic, and c/o feeling nauseous. She immed laid down and felt better within 5 min - *had not eaten or had anything to drink this am prior to appt*.
Patient typically suffers from Chronic Migraines despite being on topiramate, IMITREX and receiving BOTOX for migraines. She has migraines around 28 to 29 days per month. On the evening of the SHINGRIX vaccination, patient claims she had the worst migraine she has ever had and felt very lightheaded and dizzy. She said she nearly went to the Emergency room as a result. She also had about 6 inches of redness around the injection site which has subsided since the day of the injection. She has also recovered from the severe migraine/lightheadedness/dizziness and continues to experience regular migraines.
CONFIRMED COVID 19; DIZZINESS; VOMITING; LOSS OF TASTE; LOSS OF SMELL; DIARRHEA; FEVER; HYSTERECTOMY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, alcohol use, seasonal allergy, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, amlodipine for hypertension, acetylsalicylic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, dulaglutide, ergocalciferol, hydrochlorothiazide, and lisinopril. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 09-APR-2021, the subject experienced hysterectomy. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced loss of taste. On 10-APR-2021, the subject experienced loss of smell. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced fever. Laboratory data included: Blood sugar abnormal (NR: not provided) not reported. On 13-APR-2021, the subject experienced confirmed covid 19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, had not recovered from dizziness, loss of taste, loss of smell, fever, and diarrhea, and the outcome of confirmed covid 19 and hysterectomy was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Patient called 2 days after vaccination said she was in bed next day could not move arm-swelled up size of golf ball next day was still swollen red to touch 3rd day was better sore and red.
pt recv vax 17MAR97 & JUL97 pt G98 titer test was negative;