chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden onset of arterial blood clotting after Moderna Vaccine:  February 25, 2021 was the first Moderna vaccine. About March 11, 2021, approximately  2 weeks after the First Vaccine shot ,slight muscle soreness in legs and a little less energy occurred. The 2nd Moderna shot was on March 26, 2021, symptoms rapidly escalated to shortness of breath, coldness in limbs, leg pain, cramping, feet swelling, heart pounding resulting in 2 visits to the ER. During the 2nd ER visit I was admitted to hospital on April 3, and after more tests, then scheduled for for emergency surgery on April 5, 2021.  The April 5th surgeries involved  thrombectomies in both the right and left leg due to sudden onset of arteriolar blood clotting and the installation of a distal aortic stint. April 6th an additional throbectomy was performed on the left leg. Discharged from hospital on April 22, 202 and went to Inpatient rehab at the Rehab Institute and went home on May 4th,2021. A high fever developed at home and on May 15, 2021 a  3rd ER visit resulted in hospitalization and emergency radical debridement surgery to remove gangrenous tissue in the lower left leg, specifically  the removal of the gastrocnemius and soleus muscles. June 11, 2021 was the Hospital discharge date. No hardening of the arteries or plaque was ever found. Dr. found no cause for the sudden onset of arterial blood clotting. Dr., hematology, ran selected genetic tests that are valid in the presence of blood thinners and found no genetic reasons for the sudden onset of clotting. There is no familial history of any blood clotting disorder.
mom states pt devel whelps on abdo & chest @ 0200, w/ ?resp distress & swelling of the lips p/receiving DTP; Whelps remain visible 9 hrs p/onset; no resp distress or audible wheezing noted;
This spontaneous report as received from a licensed practical nurse refers to an 11 year old male patient. None pertinent medical history, drug reactions or allergies were reported. On 30-JUL-2014 the patient was vaccinated with GARDASIL, 0.5ml, lot number K006449, intramuscular in one arm (reported as "age") (strength, dose number and expiration date were unspecified). Other suspect therapies included TDAP, MENACTRA that were administered in the other arm on the same day. On 30-JUL-2014, 10 or 15 seconds after GARDASIL was administered, the patient zoned out, he turned white, was still and was posturing. The patient stated that he could see and hear the whole time and just could not talk. The outcome of turned white, was still and was posturing was reported as recovered in 15 seconds or so and the patient was completely awake and oriented for the three events on 30-JUL-2014. The result of a finger stick blood sugar obtained on 30-JUL-2014 after the adverse events was 105 (units not reported). The relationship between GARDASIL and the events as not reported. Additional information has been requested.
Breakthrough case admission after three vaccines moderna 5/7/21 Lot# 016B21A;  Moderna 6/4/21 Lot# 033C21A;  Moderna 12/6/21 Lot# 058H21A
syringe was not attached tight enough; vaccine leaked during giving the shot because the syringe was not attached tight enough; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (syringe was not attached tight enough) and UNDERDOSE (vaccine leaked during giving the shot because the syringe was not attached tight enough) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DEVICE CONNECTION ISSUE (syringe was not attached tight enough) and UNDERDOSE (vaccine leaked during giving the shot because the syringe was not attached tight enough). At the time of the report, DEVICE CONNECTION ISSUE (syringe was not attached tight enough) and UNDERDOSE (vaccine leaked during giving the shot because the syringe was not attached tight enough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter also mentioned he has not having any symptoms but his friends experience it.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: No new information.
Started meds 10/10/02 in morning developed a rash that night, small, red itchy bumps on trunk, arms, and legs.
Expired vaccine given to patient/The vial was punctured on, 28DEC2021, and used for up to 17 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/The vial was punctured on, 28DEC2021, and used for up to 17 hours post puncture) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/The vial was punctured on, 28DEC2021, and used for up to 17 hours post puncture). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/The vial was punctured on, 28DEC2021, and used for up to 17 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported .  The vial was punctured the previous day, on 28 Dec 2021, and used for up to 17 hours post puncture.No patients have reported any side effects from this dose.  No treatment information was provided.
Arm soreness; felt cold and had chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and CHILLS (felt cold and had chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, FINASTERIDE, OLMESARTAN, SIMVASTATIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), VITAMIN D NOS and PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness) and CHILLS (felt cold and had chills). At the time of the report, PAIN IN EXTREMITY (Arm soreness) and CHILLS (felt cold and had chills) outcome was unknown.        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.   Treatment information was not provided for first dose events.   This case was linked to US-MODERNATX, INC.-MOD-2021-067204 (Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2021-067247 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Event added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067204:Crosslinked (family member)
This spontaneous report as received from a pharmacist refers to 3 patients of unknown age. On 28-OCT-2013 the 3 patients were vaccinated with a dose of PNEUMOVAX23 (lot# J005067 exp date 17-JAN-2015) separately (dose and route unknown) that was exposed to 68F for 60 hours, an excursion that was found to be unsupported by in-house stability data. No adverse symptoms reported. Additional information has been requested.
Loss of appetite; Diarrhea; nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included IBD and Autoimmune disorder.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (Vomiting). At the time of the report, DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.            Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Soreness at the injection site lasting approximately 2 days Itchy red rash at the injection site - ongoing (approximately 10 days so far) What feels like a bump under the skin at the injection site  I've not yet sought treatment.
VACCINE WAS STORED IN FREEZER LONGER THAN MANUFACTURER RECOMMENDED, CAUSING ITS ADMINISTRATION TO BE BEYOUND THE USE DATE.
Patient was given the 2nd Pfizer vaccine 8 days before the recommended time between the 1st and 2nd dose. Patient has been notified of the vaccine administration error.
Pt had pain @ inject site, swelling @ inject site, 13 x 17 cm area of erythema @ inject site; When pt was seen @ MD had fever of 101.2; rx suprax  2 days later swelling had greatly dec;20MAR92;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 at 15:00 as dose 3 (booster), single (Lot number: wh90730), in left arm and on 10May2022 at 14:00 as dose 4 (booster), single (Lot number: fm7553) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Bee Sting" (unspecified if ongoing), notes: Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (Sep2022) Positive, notes: Rebound- Positive Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 09Sep2022, Treatment stop date: 14Sep2022, Indication: Treatment of COVID-19.
left arm is swollen; Left arm red; Left arm tender; left arm sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm sore arm), PERIPHERAL SWELLING (left arm is swollen), ERYTHEMA (Left arm red) and TENDERNESS (Left arm tender) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm sore arm). On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (left arm is swollen), ERYTHEMA (Left arm red) and TENDERNESS (Left arm tender). At the time of the report, PAIN IN EXTREMITY (left arm sore arm), PERIPHERAL SWELLING (left arm is swollen), ERYTHEMA (Left arm red) and TENDERNESS (Left arm tender) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
No adverse symptoms; the patient was administered a dose of improperly stored PROQUAD; This spontaneous report was received from a nurse concerning a 4 years old patient. No concurrent condition or medical history was reported. Concomitant therapy included sterile diluent (manufacturer unknown).       On 13-JUL-2020, the patient was administered a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# S022917, expiration date 19-JAN-2021; dose and frequency were not reported) as prophylaxis (product storage error). The temperature was reported as 9 degrees Celsius to 25 degrees Celsius (18.5 degrees Celsius). The time frame was reported as 20 minutes. No previous temperature excursion was reported. There was a call because of data logger. Properly stored sterile diluent (manufacturer unknown) (Lot# S030249, expiration date 02-JUN-2022) was used to reconstitute improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No adverse symptoms were reported (no adverse event).   This is one of two reports received from the same reporter.
Fever of 100.1 deg. F., seizure with 48 hrs. Pt receiving 2nd dose of DTaP and Haemophilus B.
Janssen adminstered to a 17 year old and only approved for 18 years and older.  Patient would not turn 18 until May 22 of 2021 and vaccine was given on April 8, 2021.  This clinic has shifted from all Pfizer to all Janssen for several dates and the registrar and vaccinator missed that this patient was not yet 18.   Unknown if this was identified at time of vaccination.  Age discrepancy was identified.
right after her arm was sore for a little bit; pain in her back.; hears thumping and heart pounding  in her head/ears; hears thumping and heart pounding  in her head/ears; she did feel numb in her arm; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration, administered in arm right on Sunday 25Apr2021 at 1:00 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer reported that right after her arm was sore for a little bit and she felt out of it. She reported that she did feel numb in her arm and this went away. She reported the next day something happened in her lower back. She stated she was outside weeding for about 10 minutes and had to take three advil that day because of the pain in her back. She stated she was nervous about the shots and does not want to take the second dose. Consumer also reported that when sleeping she hears thumping and heart pounding in her head/ears that wakes her up. She did not know if that was a heartbeat or blood pressure. She stated she did not want to call her HCP until she talked to someone and asked about myocarditis. On an unspecified date, the patient experienced right after her arm was sore for a little bit, pain in her back, hears thumping and heart pounding in her head/ears, she did feel numb in her arm. Therapeutic measures were taken as a result of event pain in her back and included treatment with take three advil. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical  history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 vial of 1, (lot # K000328; Exp. date: 06-MAR-2014) (dose and strength not provided). No co-suspect or concomitant therapies provided. The sterile water diluent lot number was reported as H021469. The reporter stated that sterile water diluent vials (NDC 0006-430901) were under filled and when reconstituted with ZOSTAVAX did not produce the required 0.65 ml of medication. The unit was under filled and was given to the patient. The ZOSTAVAX lyo cake and vial appeared normal. No AE (adverse event) symptoms reported.  The patient did not seek medical attention. Product quality complaint involved. This is one of several reports from the same source. Additional information has been requested.
-Painful injection site, huge bruise for almost 2 weeks, minor cold symptoms & fatigue for 2 days - 4/16, woke up & started to get out of bed, had major vertigo - I have NO idea if this is related to the vaccine; had to stay in bed most of the day, unable to walk without assistance   - a nurse recommended meclizine 25mg, started taking otc dissolvable meclizine on Sunday, along with benadryl, started doing Epley maneuver daily - gradually started getting better, but needed to stay home from work all week; was able to work from home, but didn't drive at all 4/21- Was able to speak to a telehealth doctor, she prescribed oral meclizine, 25mg, 3x a day, plus a prednisone steroid pack. started Meclizine on 4/21, started prednizone on 4/22. started seeing results by 4/24 4/25 saw Dr., he examined me, suggested it may have been a minor viral infection in my left ear, should go away by itself. Did Epley 2X in office 5/3 still having minor episodes of vertigo, but not disabling
No Adverse Event; HCP calling  to report a temperature excursion. Vaccine was administered after temperature excursion.; This spontaneous report was received from other health professional refers to a patient of unknown age and gender.      The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # W029553, expiration date: 14-MAR-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.         On 19-JAN-2023, administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was exposed for temperature excursion of 6.9 degrees Fahrenheit (F) for 15 minutes (product storage error). Previous temperature excursions of 7.1F for 30 minutes, and 11.6F for 1 hour. No additional adverse event (no adverse event).; Sender's Comments:  US-009507513-2304USA002131:
very fine rash on face & trunk;flu like sx, feel tired this was very first shot;pt from Mexico;t100 on 30SEP96;swollen lt side neck @ MD office;h/a x 1 wk;fever x 2d & rash x 2d;
Hives on abdomen arms legs and palms of hands. I have not seen a doctor. I have been taking an antihistamine every 4 hours.. hives stared 16 days after the vaccine not sure if it's related but have not had any diet changes. Have had hives about 20 years ago and have not since now
Blood in stool; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 17-Jun-2021, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant). On 15-Jun-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, HAEMATOCHEZIA (Blood in stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced pain at the injection site the day he received the vaccine and stopped the following day (15 Jun 2021). Patient also noticed blood in his stools on 17 Jun 2021. Consumer did not take any medications to treat his symptoms and is not taking any concurrent medications. No further treatment information was provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
patient was given pfizer vaccine 7/21/21, when she came in 8/10/21 for second dose was discovered she received janssen vaccine 3/4/21 at another facility
body aches, chills (no fever) and extreme fatigue onset 12 hours post vaccine lasted for 1 day.
1st dose of Covid vaccine was administered on 1-13-2021, eight days later on 1-21-2021 patient went to her Rock Steady Boxing class for her Parkinson's, she noticed that her arm was itching at the injection site on her right arm.  When looked at it there was a red streak about 3 inches long and at least 1 inch wide radiating down from the injection site there were also hives in the red area.  Since then patient has experienced an itching that started in her head and the itching radiates down to the injection site, this has happened a couple times.  Then most recently patient has had itching all over her body, as of 1-29-2021 the redness and hives around injection site while not as red has spread it's about 6 to 7 inches long by 4 inches wide.  She has called her Doctors office the nurse there told her to call the County Health Dept who administered the vaccine.  I spoke with someone at HD on 1-29-2021 on behalf of patient (my Mom) as she was having problems reaching a person to speak with.  She told me that we needed to report to V-Safe the reactions she is having and that she would need to call her Doctor,  as they could not give recommendations on whether she should have the 2nd vaccination she is scheduled to get on 2-10-2021.  That Doctor should advise her if she should get the 2nd vaccination.  She is calling her Doctors office again on Monday.  In the mean time since this all started she has been taking Benadryl and also using hydrocortizone on the area of skin that is red and has hives around the injection site.
PT developed itching & extensive swelling of the entire upper arm w/in 24 hrs of injection; rx'd w/benadryl & ice packs; resolved;
This spontaneous report as received from a registered nurse refers to a 62 year old male patient. On 18-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J001006, subcutaneous. Nurse reported that the patient presented to the pharmacy on 18-JUL-2013 with right sided flank pain as well as the twitching of nerves. Physician related these symptoms to patients recent work on machinery and patient was administered the ZOSTAVAX. Patient reported that as of 22-JUL-2013 or 23-JUL-2013 he had a "mild case of shingles" which was not painful. There was no laboratory studies performed. The outcome of events was unknown. Additional information has been requested.
Left chest pain similar to pericarditis in my medical history from 2005/06. Additionally, experienced body aches, headache, chills, fever and sweating episodes for several days.
It was a little fever, itchy throat and headache. They last about 4-5 days. I met my family physician virtually and he advised I take Tylenol and to rest.