chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very red rash with bumps, warm to the touch, pharmacist recommended taking Benadryl.  The rash enlarged in size and became infected.  Went to Urgent Care Facility on 06/08/2014.
Patient is a 73 y.o. female with a history of breast and lung cancer under observation, atrial fibrillation on warfarin therapy, diastolic heart failure, hypertension, dyslipidemia, CVA, depression and COPD  who presents with sweating and clamminess, poor appetite, cough and weakness and positive for COVID-19.  Her symptoms started on Monday 10/18/21 with profuse sweating, weakness, sore throat and cough.  She notes that these seemed to get better but on 10/21/21 she felt clammy and her sore throat was significantly worse.  She has not experienced shortness of breath during this time but she does note that she has not been ambulating much because she feels weak.  In the ED she was evaluated and fou Additional information for Item 18: nd to have oxygen saturation at 87% and was placed on 2L of O2 via nasal cannula and was at 95% O2 saturation.  Workup found positive COVID-19, elevated CRP at 3.2, hypokalemia at 3.0.  AST was normal at 18, CBC was within normal limits.  She was given 40 meq of potassium for hypokalemia.
Redness, swelling, and warmth at site of injection of Prevnar vaccine.  Sites were carefully recorded at time of injection with 3 vaccines yesterday.
Inconsistent periods. Menstrual bleeding for 3 weeks. Then following month heaving menstrual bleeding. Then following month missed period. Then following month period lasted for 1 week.
Sore Throat; General "sickness; Fever; Fatigue; A spontaneous report was received from a Healthcare Professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever,sore throat,fatigue and general sickness.  The patient's medical history was not reported. Concomitant medication was not reported.  on /jan-2021,Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 01-FEB-2021, The patient experienced  fever, sore throat, fatigue and general "sickness". No laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events sore throat,sickness,fever,fatigue  is Unknown.
2 days post vax, pt developed a lumpy itchy rash on abdomen, arms and legs.  The rash lasted 2-3 weeks.
Day of vaccination left arm at site was sore for 3 days. Soreness went away and returned 9 days late. Also, has had headache for several days.
Patient came in for his first Janssen dose (0.5ml) but Patient was administered a Moderna Booster dose (0.25ml). Patient was offered an additional moderna half-dose to complete a full dose today or a Janssen dose (0.5ml). Waiting on patient's decision and pt informed all dose will be reported on his covid card.
secretions and vomitting at 11pm...suctioned.  2:25 am 6/30 vent alarm.   pt pale,  bp 72/38  pulse 46 , cyanotic lips, limp, resps 11.  pt passed at 2:30
red patch from shingle shot site to under arm; This case was reported by a consumer and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had red patch from shingle shot site to under arm. The patient asked if there was anything to worry about.
On Friday patient woke up with severe chest pain. He had to be taken to the emergency room. His troponin levels were above 1300 which indicated a heart attack so they admitted him to the hospital overnight. However, the blood work indicated an infection and Ibuprofen was the only medicine that helped with the pain.  While at the hospital a series of tests were done to find out what was going on. Once the patient was stable enough he left the hospital and he is now undergoing more tests and getting his medical records transferred to the doctors here. We are still in the process of finding out the exact issue and will hopefully get some answers soon.
Systemic: Chills-Mild, Systemic: Other- Dizziness; symptoms lasted 1 day
Severe dulling of hearing in both right and left ears. Feeling of nasal/sinus congestion. Sudden onset within 2 hour period
My heart went into A-fib and was racing for almost a week.   Beating really really hard.  I was traveling at the time and didn't have my llo recorder remote available to track symptoms but the same day I returned home, my doctor called me to tell me my heart was in A-fib (03/17/2021).
9/28/00; red skin under arm (X2) and both breasts, also groin area with "some" itching, temperature 100.9F (oral). Client stated redness has decreased in 12 hours; encouraged to see PCP. On 9/29/00, client states rash is only under breasts today and is afebrile; going to PCP and has been self-medicating with Benadryl.
No adverse event; Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    Patient was never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 11 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Patient 1 out of 11
JOINT PAIN; THROBBING HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced joint pain, and throbbing headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing headache, and joint pain. This report was non-serious.
Mom reports vomiting and diarrhea starting 5/22/13 - 5/31/13. Fever and rash starting 5/31/13 and evaluated at medical center and was told a reaction to MMR and started on steroid x 4 days BID. Mom states rash resolving today: 6/3/13.
Body aches - 1800 hrs Chills - 2000 hrs Recorded body temp, oral, of 102.4 F at 2125 hrs Extra Strength Tylenol, 1000 mg, at 2130 hrs Recorded body temp, oral, of 103.2 F at 2245 hrs Recorded body temp, oral, of 104.2 F at 2315 hrs, Pulse 110 BPM Ibuprofen, 1200 mg, at 2316 hrs, immediate cold shower for 15 - 20 mins Recorded body temp, oral, of 102.3 F at 2350 hrs Monday March 8th Recorded body temp, oral, of 101.5 F at 0015 hrs Recorded body temp, oral, of 96.4 F at 0700 hrs Body felt sore until Wed 10th Breathing - can take full breaths, however, discomfort felt when breathing in and out. Feeling similar to minor burns, chemical or thermal, in upper respiratory tract.  Pulse Ox - consistently 98 - 99 percent Pulse has returned to normal levels with RBPM at 68
patient was accidentally given the Daptacel and Ipol liquid portions only and not given the ActHIB powder portions of the Pentacel injection/ no AE; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA172647 (same reporter).  This case involves a 8 weeks old female patient who experienced patient was accidentally given the DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL] liquid portions only and not given the ACTHIB powder portions of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine (lot UJ082AA, expiry date 13-Oct-2020) via intramuscular route in the right thigh on 28-May-2019.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.   It was an actual medication error due to inappropriate reconstitution technique.  It was reported that patient was accidentally given the Daptacel and Ipol liquid portions only and not given the ActHIB powder portions of the Pentacel injection.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
The pt experienced a localized reaction, with swelling to the left arm and warmth, but no itching.
On 12-8-19, pt started with fever, rash, fussiness.  Fever subsided on 12/9/18 with improvement of rash, PO intake. Mom reported possible  pain in shoulder area due to fussiness taking  shirt off.
Bladder infection; This is a spontaneous report from a Pfizer-sponsored program. A 77-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient reported that she took the COVID 19 vaccine and came down with a bladder infection. The doctor put her on a different medicine because the tumor has grown. It is on her liver now. She said to go on the 22nd for a PET scan and will see what was going on. The Ibrance didn't work. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Presented with localized urticaria approximately 1" below immunization site (RA) with parameters of approximately 3'' x 2". Presence of urticaria began to subside during 30 minute observation time. Patient was released under the care of father and advised to seek additional medical care. At time of release presence of urticaria had mostly subsided.
The wrong dose for the first Moderna Bivalent COVID booster was given at 0.25mL dose (Lot: AS7146B) on 10/14/2022. The other 0.25mL was administered today on 11/21/2022 (Lot: 061F22A)
For the first few days I experienced normal side effects. Now I have troubles catching my breath at times and I have very little energy. I used to be fairly active but now it is a struggle to get out of bed some days. I doze off randomly and am just worried that this is my life now.
8 days after receiving the first shot of COVID I developed a small hard bump at the injection site.  3 days after that, a rash appeared in the same spot.  It is about 3" across and high, red, hot, a little bumpy.  It doesn't hurt or itch unless I touch it.
Varicella zoster like rash (shingles) in left posterior L1L2 dermatomal distribution for 2 days prior to evaluation in clinic. otherwise healthy, no fever or pain.
Throat constriction could not swallow; Throat constriction could not swallow; Blood pressure high 225/170; It wasn't right on site; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration in right arm on 01Mar2021 09:15 as first dose single for covid-19 immunisation. Medical history included migraines, fibromyalgia, arthritis, Known allergies to tetracycline, Iodine, Ecklonia Kurome, degenerative joint and Osteoarthritis. Concomitant medications included sumatriptan, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET), rosuvastatin calcium (CRESTOR) all are taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfacetamide and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient experienced throat constriction could not swallow/blood pressure high 225/170 on 08Mar2021 02:00. Patient received the 1st dose of the Pfizer vaccine on 08Mar2021. She had adverse events after the 1st dose and was rushed to the ER, but they were able to stabilize her. She is wondering if she would be a candidate for the 2nd dose which is scheduled on 12Apr2021. She also mentioned that she had a check-up, and she was told that she can get the 2nd dose. She was asked to bring her EpiPen with her and take some antihistamine prior to getting the 2nd dose. She was asking maybe Pfizer has some advice for her as well. Patient ended up being taken in the ambulance to ER with an adverse reaction. It was a delayed reaction. It was not right on site on an unspecified date in Mar2021, right after I had the shot that it was a delayed reaction and I ended up in emergency in the ER. As per the reporter seriousness criteria reported as medically significant. Patient received treatment of IV drip methylprednisolone sod succ (Solution-MEDRO) for adverse events. The patient underwent lab tests and procedures which included blood pressure: 225/170 on 08Mar2021. The outcome of the event vaccination site discomfort was unknown and not recovered for other events.  Information on Lot/Batch number was available. Additional information has been requested.
This spontaneous report was received from a Registered Nurse (RN) concerning on her son of unspecified age. The patient's pertinent medical history and drug reactions or allergies were not provided. In the early 1970's, the patient was vaccinated with a dose of measles (manufacturer unspecified)(route, dose, lot # and Exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. Th RN reported that on an unknown date her son developed measles (time frame from vaccination was unspecified). No treatment information was reported. The outcome of measles was reported as recovered/resolved on an unspecified. Additional information is not expected.
I have had extreme pain and loss of function in my left arm from shoulder throughout my arm ever since my vaccine.  I?ve had to spend a lot of money out of my pocket for numerous doctor?s visits and physical therapy sessions, and the pain is so bad that I can never go a day without thinking about it or experiencing it.  I have some improved mobility after numerous times physical therapy sessions, but still have weakness and extreme pain in my entire arm and shoulder.  It?s impacted my mental health in addition to my physical health, and I can barely sleep at night.  I filled out reports early on and have had no follow up other than texts about my symptoms.  It now seems like this will be a lifelong issue for me and I want to be contacted and receive compensation.  I am very upset.
about 2 weeks with raised red bumps, injections site warm and swollen with a knot, most raised bumps on both arms down to around fingers and toe knuckles area and around elbows.
Had first vaccine January 22, 2021 and second 1 February 22, 2021.  On approximately March 29, 2021 developed a right ptosis of her eyelid.  Was seen by ophthalmology.  Had positive acetylcholine antibody studies suggestive of myasthenia gravis.  Was referred to neurology and confirmed.  Patient had concerns whether Covid vaccine somehow contributed to this
Pt is here today for COVID-19 immunization per federal guidelines/written order. See immunization activity for details. Pt was observed post-immunization for a minimum of 30 minutes due to previous history of immediate allergic reaction to a vaccine or injectable therapy and/or history of anaphylaxis with evidence of difficulty breathing, difficulty swallowing, throat tightness, lightheadedness and dizziness. Anaphylaxis Management Standing Order protocol initiated. Physician/APP notified of patient condition. Additional orders received: verbal per Dr 50mg/1mL given IM in left deltoid. BP 148/94, heart rate 105, 96% on 3 liters O2 COVID-19 (MRNA) VACCINE. Allergen added to patient's Allergies. VAERS reporting completed as appropriate. Benadryl given at 1:22pm, Lot 6020400 Exp 09/2021. First set of vitals taken at 1:24pm. Second set taken at 1:53pm, 98% O2 on 3 liters, heart rate 97, BP 130/83, respirations not labored. Patient states relief of symptoms, feels normal. Per verbal from Dr  patient stable and ok to go home, advised her to take Benadryl 30 minutes before next vaccine appt. Patient discharged in stable condition with daughter. COVID-19 post-vaccination Patient Instructions added to After Visit Summary for patient to review in her MyChart account.
Hospitalized;  COVID-19 positive;  fully vaccinated.   Brief Overview: Admission Date: 8/23/2021 Discharge Date: 8/26/21   HOSPITAL PROBLEMS   1.  Stage IV pressure wound on coccyx, infected 2. Covid 19 infection 3. Stage IV pressure wound on left heel 4. Pressure injury of left elbow, unstageable 5. Parkinson's dementia 6. BPH 7. Atrial fibrillation PRESENTING PROBLEM   Chief Complaint Patient presents with ? WOUND PROBLEM     wounds to left heel and coccyx tested positive for staph 8/13. Has been on doxycycline with worsening to wounds. Pt also tested positive for COVID today. Has been vaccinated         HOSPITAL COURSE   Patient is a 81 y.o. male with history of Parkinson's dementia who was recently admitted for rehab after sustaining a fall with left femur and humerus fracture.  While there he developed pressure ulcer on his heel, elbow, and coccyx.  This started smelling foul and wound culture was growing MRSA.  He was started on doxycycline there.  His wounds continued to worsen and he presented to hospital.  He was admitted and started on Vancomycin.  Wound consult was performed with recommendations for wound management including dressings.  He was additionally evaluated by therapy with recommendations for SAR.  He was tolerating oral intake, VSS, and was felt stable for discharge.  He was discharged for therapy and wound care.   He was discharged on doxycycline to complete antibiotic course.     Of note, patient did test positive for Covid-19 prior to presentation to hospital.  He was asymptomatic and did not require any treatments for Covid.  He was previously vaccinated.     Follow-Up:              - Ongoing wound care management              - Post-hospitalization follow-up including doxycycline course completion.
Got flu shot at clinic at about 10:39. Returned at about 4:10 P with c/o hives to throat. Has visible redness to throat. No difficulty breathing. Reluctant to go to ER despite instructions. Called Dr's office, was seen at 4:30 PM. States rash started about noon. With itching. States rash gone this AM. Client states was offered BENADRYL and refused. Got RX for PREDNISONE but didn't start.
1. Swelling - erythematous Patches 2. The pt was unable to lift her arm 3. Bruising in multiple areas of her Right arm. 4. Nausea, weakness
Patient presented to the ER due to dizziness for the last 3 days. The patient recently tested positive for Covid-19. Subsequently he missed a day of dialysis. On presentation to the emergency department he was noted to be hypotensive tachycardiac but afebrile saturating well on room air. His elevated kidney creatinine. Inflammatory markers were elevated including D-dimer, ferritin, LDH, and procalcitonin. Troponin was within normal limits and lactic acid was 2. CBC shows hemoglobin and hematocrit of 12.6 and 37.8 respectively and had no leukocytosis. Chest x-ray shows mild pulmonary vascular congestion with patchy infiltrates/airspace disease in bilateral lungs. Nephrology was cardiology were consulted. Patient states for the last 3 days he has been very dizzy. The patient recently tested positive for Covid (has been vaccinated but no booster). Subsequently he missed a day of dialysis. Chest x-ray shows mild pulmonary vascular congestion with patchy infiltrates/airspace disease in bilateral lungs. He received Remdesivir.
Low grade fever 100.2; chills; malaise; This is a spontaneous report from COVAES. A 44-year-old male contactable consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EP6955), via an unspecified route of administration on 24Mar2021 at 13:30 as single dose in left arm for covid-19 immunization. The patient medical history included mild food allergy to soy and tree nuts. Historical vaccine included bnt162b2 on 03Mar2021 (at 13:00 PM, vaccine location=Left arm, dose number=1, lot number=EL3247). Concomitant medications included cetirizine hydrochloride (ZYRTEC) from Mar2021 and multi vitamin. On 24Mar2021 at 21:00, the patient experienced low grade fever 100.2, chills and malaise. The patient did not received treatment for the events. The outcome of the events was recovering   Information on the suspect expiry date has been requested.
It started with headache and body ache, joint pains. My urine was dark and I was itching from head to toe. I felt like I had heartburn and indigestion, I had nausea. I waited a few days and called the doctor and was told to go to the ER. They took blood and my liver was failing, I was admitted to the hospital and hospitalized for 7 days. It took several months for me to feel normal again.