chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2SEP92 pt recvd 1st MMR on 8SEP & 9SEP pt had febrile seizures; pt had pre-existing hx of afebrile & febrile seizures, fever lasted from 9SEP to 10SEP;
Persistent 102+F fever unresponsive to Tylenol. Diffuse overwhelming weakness unable to even open a water bottle. Severe chills, body aches, and headache. Nausea and feeling of vomiting. Pain at injection site. Symptoms started as exhaustion and body aches approximately 7-8 hours after receiving vaccination. Symptoms became more severe as time progressed through the night. Still having moderate to severe symptoms almost 24 hours after receiving vaccination.
PLATELET COUNT WAS VERY LOW 20K; BRUISES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 was not reported, 1 total administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, 3 weeks after the vaccine the patient experienced bruises. On 26-APR-2021, the patient experienced platelet count was very low 20k and was immediately advised to go to the hospital emergency room . She was given steroids at first and was tested covid positive in respiratory panel test so steroids were stopped. The patient had no other symptom. On 24-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. Laboratory data included: Blood test (NR: not provided) Platelet count very low 20k. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Has antibodies for covid, COVID-19 antigen test (NR: not provided) Negative, PCR (NR: not provided) Negative, and Respiratory viral panel (NR: not provided) Covid positive. Hematologist sent the patient home with low dose steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises and platelet count was very low 20k was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210457211-COVID-19 VACCINE AD26.COV2.S -platelet count very low. This event(s) is considered un assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Received the Bivalent Booster for 2nd dose instead of Primary dose vaccine.
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 03-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 37 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013888:
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix (received 1st dose on 16th January 2021). On an unknown date, the patient received the 2nd dose of shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination.
Nurse calling for TE evaluation on frozen products states products have been administered; no adverse event; This spontaneous report has been received from a nurse, concerning 5 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions and allergies were not provided. Concomitant medications included sterile diluent.  On an unknown date, the patient was administered vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (valid lot number W004029 [expiration date 01-AUG-2023]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis. The vaccine was exposed to the temperature excursions: 6 degrees Fahrenheit (F) up to 14 degrees F with average 8 F for 18 minutes (min), 14 F up to 46 F with average 18.40 F for 45 min (product storage error). No previous temperature excursion was reported. No additional adverse event (AE) details.; Sender's Comments:  US-009507513-2206USA002231: US-009507513-2206USA002264:
Pt called and spoke with the pharmacist on duty stating that she had tenderness at the injection area. The patient also had "red spots" around the injection site.  The patient did go to the ER to have the area looked at.
Breakthrough case admission after 2 vaccines Pfizer 4/9/21 Lot# Ew0150;  Pfizer 4/30/21 Lot# Ew0164;
was positive for Covid-19 in June 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (was positive for Covid-19 in June 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In January 2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (was positive for Covid-19 in June 2022). At the time of the report, COVID-19 (was positive for Covid-19 in June 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant information were reported by the reporter.  No treatment information were reported by the reporter.
Patient experienced an ischemic stroke per spouse.  Stated this happened 3 days after receiving pfizer bivalent injection.  It was the 4th shot he has received, prior were all moderna covid 19 shots.  Patient had two surgeries for the brain clot.  One was to clear out the carotid artery brain clot, and then a second one that required an incision to clear the carotid out again for the patient.  He went into afib as well at some point in time, and is now on therapy for that, but can have one of two elective surgeries to come off of the blood thinner he is required to take for controlled afib currently.  Time course started at 9:30pm on 10/16/22 where the local fire department/rescue squad transported him to hospital, and then on 10/17/22 he was transferred to different hospital where he stayed from 10/17/22 to 10/27/22, then progressed to a rehab clinic where he stayed until 11/4/22.   He is learning to recognize things again currently, speak more fluently, but is continuing to have ongoing issues from it that could take 6 months to a year to finely tune more, but will never more than likely be 100% again.
She was picking up her medicine and had a conversation with me and I asked her if she had a shingle vaccine, she said I gave it to her about a month ago. She said she had some rash around her neck and stuff. She said that she had autoimmune disease before and she think it made her sensitive to things when she is sick. She doesn't think anything serious and she said it went away 2 days after. She said she will come back to get the second shot.
Client observed vomiting when asked client voiced that she had same reaction with the first dose and had notified her physician.  Client seen and assessed by EMT and VS are as followed BP 214/148, HR 86, O2 97%.  Client advised to go to ER but declined and voiced that her husband would take her.
Headache, Arthralgia, Fever, Chills, Injection site pain Narrative:  Other Relevant History:
SINUS INFECTION; JOINT ACHING ON BOTH  FEET AND ANKLES; LUMP ON INJECTION SITE; SORE INJECTION ARM; REDNESS AT INJECTION SITE; REALLY ROUGH LOWER BACK PAIN; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has no known allergies and also has no covid in past and not tested positive for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced really rough lower back pain. On 17-MAY-2021, the subject experienced lump on injection site. On 17-MAY-2021, the subject experienced sore injection arm. On 17-MAY-2021, the subject experienced redness at injection site. On 18-MAY-2021, the subject experienced joint aching on both feet and ankles. On an unspecified date, the subject experienced sinus infection. Treatment medications (dates unspecified) included: amoxicillin trihydrate/clavulanate potassium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really rough lower back pain on 16-MAY-2021, and was recovering from sore injection arm, lump on injection site, redness at injection site, joint aching on both feet and ankles, headache, and sinus infection. This report was non-serious.
Headaches/neck pain/fever/myalgias; eval serum sickness type illness w/fever/abn LFT's; resolved over 6 wks;
He is feeling hopeless; Following Monday, he started being depressed; Patient felt dizzy after receiving 1st dose; his heart raced up(heart rates went up); He was also warm on that day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient felt dizzy after receiving 1st dose), HEART RATE INCREASED (his heart raced up(heart rates went up)), FEELING HOT (He was also warm on that day), DEPRESSED MOOD (Following Monday, he started being depressed) and FEELING OF DESPAIR (He is feeling hopeless) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Patient felt dizzy after receiving 1st dose), HEART RATE INCREASED (his heart raced up(heart rates went up)) and FEELING HOT (He was also warm on that day). On 29-Mar-2021, the patient experienced DEPRESSED MOOD (Following Monday, he started being depressed). On 05-Apr-2021, the patient experienced FEELING OF DESPAIR (He is feeling hopeless). At the time of the report, DIZZINESS (Patient felt dizzy after receiving 1st dose), HEART RATE INCREASED (his heart raced up(heart rates went up)), FEELING HOT (He was also warm on that day), DEPRESSED MOOD (Following Monday, he started being depressed) and FEELING OF DESPAIR (He is feeling hopeless) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included BP medication, Acid reflux medication, Arthritis medication.
Initially had small, localized reaction 1-2 days after vaccine. Included redness and soreness at vaccination site.  It then went away. One week later, on 2/19/2021,  I noticed itching at the vaccination site and a raised, warm red spot the size of a quarter. The redness has continued to grow with occasional itchiness. Now , almost 14 days post vaccine,  the redness is the size of a tennis ball. No pain at site. Been treating itchiness with steroid cream.
starting to itch; Minor pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (starting to itch) and VACCINATION SITE PAIN (Minor pain at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Minor pain at the injection site). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (starting to itch). At the time of the report, VACCINATION SITE PRURITUS (starting to itch) and VACCINATION SITE PAIN (Minor pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
no adverse event; vaccine used which were beyond the 30-Day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date).    Concomitant products were not reported.  It was reported that patient received monovalent dose that was administered beyond 30 day beyond use date. The use by date of lot 042J21A was reported as 17-Feb-2022.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Significant Live Follow up received narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
They stated that they did not feel well for 3 days after the vaccine but was fine after; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (They stated that they did not feel well for 3 days after the vaccine but was fine after) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (They stated that they did not feel well for 3 days after the vaccine but was fine after). At the time of the report, MALAISE (They stated that they did not feel well for 3 days after the vaccine but was fine after) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   1 patient involved. They had the 1st 2 vaccines in early 2021 and then the 3rd one at the end of 2021. They did not feel well for 3 days after the vaccine but was fine after. They did not indicate which dose they had this reaction to. Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Pt desrcibes a large raised/sore bump that developed into a black/blue mark around the injection site. Pt describes developing hives all over on 11/27.
urticaria type of rash; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 27Oct2020 at single dose for immunization. Medical history was none. There were no concomitant medications. The patient experienced urticaria type of rash on 29Oct2020 with outcome of unknown. Additional information: no other symptoms, took allegra to relieve rash symptoms.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arm; vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (Sore arm) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Alcoholic from 31-Mar-2011 to 12-Feb-2021 and Pregnant on 08-Sep-2020. Concurrent medical conditions included Anemia and Thalassemia. Concomitant products included IRON from 17-Feb-2021 to an unknown date for Anemia, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for Nausea, PRENATAL S from 17-Feb-2021 to an unknown date for Pregnancy.    On 28-Apr-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 02-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 28-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. On 28-Apr-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Pregnancy test: positive (Positive) Positive. On 28-Apr-2021, Prenatal screening test: normal (normal) normal. On 24-May-2021, Cytogenetic analysis: normal (normal) Normal. On 26-May-2021, Amniocentesis: normal (normal) Normal. On 08-Jun-2021, Ultrasound scan normal: normal (normal) normal. On 21-Jul-2021, Blood glucose: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   This case was linked to MOD-2021-227709 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Initial Additional-1 : VAERS, AE details, Dose 2 Details, Patient medical history were reported. On 30-Jul-2021: Follow-up information received contains Significant information:Pregnancy Information updated, Patient details updated, Lab test and Concomitant product updated
Some weeks after vaccination I started feeling shortness of breath. When I walked from the parking lot to my work desk it was hard and when I arrived at work my co-workers could hear me grasping for air, I felt winded, and it never happened before. Also, another episode when the elevator broke down I could not go the flight of stairs without having to stop and catching my breath.  Since the weather is better I decided to start walking in the park for exercise but I realized I did not have the strength nor the capacity to breathe. I amafraid at night because sometimes when I lay down I can't breathe.
Palpitation felt after getting vaccine.  122/72, HR 90, O2Sat 98%. 9:45am: Stated that patient is feeling better per husband.  Transportation was refused, voiced that if patient is still having palpitation will take patient to hospital himself as he lives close by
Client was lightheaded post vaccine--breathing was not in distress. Client was diaphoretic and pale. Raised clients legs , propped her head up and applied ice packs to her neck. Client recovered in 10 minutes. No 911 call or meds received. Client walked out of clinic feeling "normal".
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po  vital signs stable
Pt was a 31 week preemie with hx of NEC D/C from NICU 3 weeks prior to event. He was on O2 NC; ostomy bag; NG feeds on AB monitor 24 hours after vaccination Pt became apneic at home and was pronounced dead at local ER.
swelling, hardness in shoulder around vaccine site, pain when site is pushed or arm raised, very little otherwise
The pt had a seizure on 12/18/01, 6 hours post vax. She was admitted to the hospital for observation and further testing. Neurologist to comment. Still in the hospital on 10/19/01. Per 1 year follow up: Pt did not recover. Pt continues with a seizure disorder. She is followed by neurologist on Phinobarb and Vulparic acid. Pt also see another MD at the hospital.
Woke up at 2:30 am and was incoherant, difficulty walking and was assisted to bathroom, chills, headache.  Next morning had soaked through pajamas with sweating.