chrisvoncsefalvay/vaers-outcomes huggingface dataset:
@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient has a history of allergies - anaphylaxis. Vitals taken: b/p 197/116, hr 70, temp 97.5, 02 sat 99% on r/a. States she has HTN and takes meds. She did take her medication this morning. With meds she is around 140s/80s. Stayed with us for about 30 minutes. Repeat vs 186/104 hr 68, 98% RA. Still reporting anxiety but states she feels her b/p is high because she is anxious. She never experienced SOB, difficulty breathing. Stated at first a little bit of a scratchy throat but that went away shortly after. She stayed until she felt less anxious.
Received MMR and Varivax vaccines on 9/14/02. On 9/24/02 right eye began twitching. Rash on left leg at site of varivax.  Sent to hospital for testing.
A 21 year old, female patient (with no medical history) experienced her tongue turn brown, a dark brown, approximately 2 hours after she received FLUZONE (lot number U2529AA) intramuscularly in the left deltoid on 10 November 2007. There was no swelling and no other symptoms were reported. Benadryl was given. She did not have any illness at the time of vaccination and was not on any medications. At the time of the report, the patient's recovery status was unknown.
chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 55-year-old female patient received second dose of bnt162b2 (BNT162B2, brand:ELI,, Batch/lot number: 283), via Intramuscular on Left arm on 06Jan2021 03:30 PM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Penicillin, sulfa drugs and Hypothyroid, genital herpes. Concomitant medications included the patient received within 2 weeks of vaccination: levothyroxine, Valacyclovir. The patient previously took first dose of bnt162b2 (BNT162B2, brand: EK, Batch/lot number: 5730), by injection via Intramuscular on Arm Right on 16Dec2020 03:30 PM at single dose for covid-19 immunisation. Facility type vaccine was Hospital. No other vaccine in fourweeks. At approximately 12 hours post injection chills, body aches, headache, nausea, dry heaves, fatigue from 07Jan2021 03:30 AM. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
BAD BODY ACHES; TIREDNESS/FELT EXHAUSTED; NAUSEA; FEVER; HEADACHE; TENSION HEADACHE; DID NOT FEEL LIKE MY NORMAL SELF; TOOK 2 DAYS OFF WORK BECAUSE COULD NOT GET UP; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced did not feel like my normal self. On AUG-2021, the patient experienced took 2 days off work because could not get up. On AUG-2021, the patient experienced tension headache. On 09-AUG-2021, the patient experienced headache. On 10-AUG-2021, the patient experienced bad body aches. On 10-AUG-2021, the patient experienced tiredness/felt exhausted. On 10-AUG-2021, the patient experienced nausea. On 10-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 11-AUG-2021, and fever on 12-AUG-2021, had not recovered from headache, bad body aches, and tiredness/felt exhausted, and the outcome of took 2 days off work because could not get up, did not feel like my normal self and tension headache was not reported. This report was non-serious.
No adverse affects; improperly stored MMR II was administered; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 14-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (product storage error) (dose was not reported) lot # R027063, expiration date: 20-SEP-2020, subcutaneously for prophylaxis. There were no previous temperatures excursion. The vaccine was exposed at 70 Fahrenheit degrees for 4 days. Data digital logger was involved. No adverse effects were reported.
break through infection wtih Rapid antigen positive on 22Dec2021; break through infection wtih Rapid antigen positive on 22Dec2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single and administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included covid-19 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome not recovered. The patient underwent the following laboratory tests and procedures sars-cov-2 test (22Dec2021) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is expected. The case will be reassessed further upon receipt of additional information.
This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days). No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 22-AUG-2013. This is the one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
Patient received HPV vaccine on 10/23/07 and 12/31/07.  On 2/25/08 patient presented with breathing difficulty and was diagnosed with pulmonary embolism.   Sibling and mother subsequently diagnosed with Protein S deficiency and patient presumed to have this as well.  Patient began OCPs 10/07.  Pulmonary embolism likely related to underlying hypercoagualability and use of OCPs, but we are reporting just in case HPV could also have been a factor.  01/26/09 Reviewed hospital medical records of 2/25-3/4/2008. FINAL DX: bilateral pulmonary emboli w/left common iliac DVT. Records reveal patient experienced DOE x 3 weeks & acute SOB w/chest pressure on 2/25.  Fever & dizziness 2 weeks prior.  Frontal HA 1 week prior.  Seen by PCP 2/25 & found to have tachycardia, tachypnea, orthostatic BP.  Admitted to PICU. Cardio, vascular surgery, Heme, Pulm  consults done.  Tx w/anticoagulant meds.  D/C to home on continued anticoagulant meds w/thrombotic w/u to continue as outpatient in Hematology clinic.  4/24/09 Received Heme clinic med recs of 3/4/08-1/13/09. FINAL DX: PE assoc w/OCP Records reveal coumadin d/c 7/14/08 & covered w/lovenox to permit protein s testing.  Patient self d/c coumadin as of 1/13/09 & no further medical records available.
blood and mucus in the stool on 8 /20 and again on 8/28 no pain no fever
36 days have passed since the 1st dose; hives all over her body; itchy; heart was heavy; chest was heavy; heart was heavy; felt tired / so tired; high blood pressure over 200 mm hg; had chest pain; very low fever (99°F); pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure over 200 mm hg), CHEST DISCOMFORT (heart was heavy), CARDIAC DISCOMFORT (heart was heavy) and CHEST DISCOMFORT (chest was heavy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no adverse event history reported) since an unknown date.   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 (pain).   On 04-Mar-2021, the patient experienced CHEST PAIN (had chest pain) and PYREXIA (very low fever (99°F)).   On 05-Mar-2021, the patient experienced FATIGUE (felt tired / so tired), HYPERTENSION (high blood pressure over 200 mm hg) (seriousness criterion medically significant) and CARDIAC DISCOMFORT (heart was heavy) (seriousness criterion medically significant).   On 10-Mar-2021, the patient experienced CHEST DISCOMFORT (heart was heavy) (seriousness criterion medically significant) and CHEST DISCOMFORT (chest was heavy) (seriousness criterion medically significant). On 11-Apr-2021, the patient experienced URTICARIA (hives all over her body) and PRURITUS (itchy).   On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (36 days have passed since the 1st dose).   At the time of the report, CHEST PAIN (had chest pain), PYREXIA (very low fever (99°F)), FATIGUE (felt tired / so tired), HYPERTENSION (high blood pressure over 200 mm hg), CHEST DISCOMFORT (heart was heavy), URTICARIA (hives all over her body), PRURITUS (itchy), PRODUCT DOSE OMISSION ISSUE (36 days have passed since the 1st dose), CARDIAC DISCOMFORT (heart was heavy), CHEST DISCOMFORT (chest was heavy) and PAIN (pain) 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.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. The event of product omission is assessed as not applicable; Sender's Comments: This is a case of a 65-year-old female who missed due date for second week as it was 6 weeks since first dose in addition to the events (product dose omission). Based on the available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, causal relationship cannot be excluded. The event of product dose omission is assessed as not applicable
Patient received COVID-19 vaccine at 4pm, completed her 15 minute wait, felt fine and left. Called into the building 1 hr late (5pm) stating that she was having burning in her abdomen, up her chest, and into her jaw. She was told to go to the ER.
No additional adverse events; Nurse administered a dose of VARIVAX that had experienced temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided   On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) valid lot # U025205, expiration date 13-AUG-2023 for prophylaxis (strength, and route of administration were not provided). The vaccine underwent a temperature excursion (Product storage error). No additional details were available. The patient did not experience any adverse event.
urinary tract infection; Soreness in the shoulder; Kidney stone; Shoulder was black and blue; A spontaneous report  was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection, soreness in the shoulder, shoulder was black and blue and kidney stone.   The patient's medical history was not reported.  Concomitant medication was not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown dose, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient stated that he had a urinary tract infection after having the Moderna COVID-19 vaccine. The patient was given keflex but did not know if it would affect the vaccine. Patient had kidney stones two to three days before the second dose of the vaccine. Patient also reports a little soreness in the shoulder and that it was black and blue. He had the shot in his left arm and took Tylenol to help treat his symptoms.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome for the events urinary tract infection, soreness in the shoulder, shoulder was black and blue and kidney stone was unknown.; Reporter's Comments: Urinary tract infection is assessed as unlikely related to mRNA-1273  in the setting of newly diagnosed kidney stone. Based on the current available information and temporal association between the use of the product and the onset date of soreness in the shoulder and shoulder was black and blue, a causal relationship cannot be excluded.
RN witnessed the administration of the Moderna vaccine to this patient by a volunteer RN. After the administration of the vaccine, a small amount of vaccine dripped out of the patient's arm. The needle was then placed on the table without being capped and a miniscule amount of vaccine was still left in the syringe (approximately 0.02ml). After noticing this, the RN that had administered the vaccine was spoken with and taken out of circulation shortly thereafter.
patient jumped away/pulled away from pharmacist during administration. Pfizer was contacted and cdc/guidelines were presented.  Patient did not receive full dose. Patient did not have any treatment/adverse effects or symptoms. Patient was aware it was her fault for pulling away from administration.
Same issues after this booster shot as after the initial two (in April and May, 2021) :   1. VERY heavy period for a month non-stop (after initial shots I had the same and went to my family doctor)  2. Cartilage inflammation in the back (started after 1st shot, also reported to my pcp, and got much worse after the booster so I need surgery).
PAIN IN LEFT BREAST. PATIENT DESCRIBES AS A PAIN THAT FEELS LIKE ROCKS ARE IN HER LEFT BREAST. SHE FEELS IT MORE WHEN MOVING.
This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost voice), FATIGUE (extremely tired), INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ZOLPIDEM TARTRATE (AMBIEN) and HYDROCODONE for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced APHONIA (lost voice) and FATIGUE (extremely tired). On 31-Mar-2021, the patient experienced INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever), CHILLS (chills), ABDOMINAL PAIN (body aches), PYREXIA (shaking body) and HEADACHE (extreme headache). On 04-Mar-2021, FATIGUE (extremely tired) had resolved. On 06-Mar-2021, APHONIA (lost voice) had resolved. At the time of the report, INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever), CHILLS (chills), ABDOMINAL PAIN (body aches), PYREXIA (shaking body) and HEADACHE (extreme headache) outcome was unknown. Treatment information was not provided. This case was linked to MOD-2021-065181 (E2B Linked Report).; Sender's Comments: MOD-2021-065181:1st dose case.
Refrigerated Bivalent was opened and punctured between 9am -12 on 10/20/22.  On 10/21/22 a dose was given from that same vial between 9 and 10 am. The vial was stored in the fridge the whole time. The vial may have been left out of the fridge for a total of 40 minutes as a total of 3 doses were given on 10/20/22. Theses were in office doses so the vial was only taken out of the fridge to draw up the doses and then placed back in the fridge until a provider ordered another administration. Spoke with Moderna per CDC guidelines and they determined no excursion occurred. The Bivalent maintained its efficacy. Determined no repeat booster necessary.
Fatigue, headaches, muscle and joint pain, neck pain, nausea and nosebleeds. Had shot yesterday morning and still having these side effects
medication error Adacel was inadvertently given to a two year old patient. with no AE; Initial information received on 01-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient who reported medication error adacel was inadvertently given to a two year old patient with no ae while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "medication error adacel was inadvertently given to a two year old patient with no ae" (product administered to patient of inappropriate age) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error Adacel was inadvertently given to a two year old patient with no AE).  At time of reporting, the outcome was Unknown for the event medication error adacel was inadvertently given to a two year old patient with no ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Headache inj site soreness, back soreness, migraine, dry heaves  Narrative:
No Adverse Event. Patient is 10 yo autistic male. At time of IM injection patient pulled away from injection nurse while nurse still plunging and an unmeasurable amount was not injected into patient's arm. Both mother and father were witness and stated, "it's OK, at least he got some in there." Mother was understanding due to child's condition and stated, "it'll be alright, we'll be alright." Patient was calm post injection. No adverse reactions during 15 minute observation period. No treatment necessary. Dose 2 scheduled for 21 days per pharmaceutical/CDC guideline for Pfizer. Nurse Leader made aware.
It is like having raised chicken skin. Irregular bumps, larger than goosebumps. They look like chicken skin but all over the arms, torso and legs except for calves. They have not seemed to effect my breathing, my oxygen levels seem normal but I am tired. I had a light headache at the beginning. I believe my fatigue is related to the vaccine. I went for a walk yesterday and today I am more tired than yesterday.  I normally haven't had any time for exercising but I decided to go for a walk yesterday and felt fine but today I am just more tired and feel slow. So at first I thought the bumps were white but I had somebody look at the bumps and they said the bumps are pink. The COVID specialist at work said I may have COVID rash.  I waited 24 hours in hopes it would go away but they are still there. They are not itchy but they feel weird. It feels better when it is not touching something, it feels like whelps and there are many of them. They are pinkish white. I can provide photos if needed.