chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site warmth; Injection site Itching; Injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site Itching) and VACCINATION SITE SWELLING (Injection site swelling) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site Itching) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site Itching) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications reported. Treatment medication  included Benadryl.   This case was linked to MOD-2021-070802 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 contains no new information.
Pregnancy through IVF due date 8/12/21 Approximately an hour after receiving the vaccine, I started having severe vaginal bleeding (more than 1 pad per hour) with large blood clots consistent with a miscarriage. The heavy bleeding lasted for approximately 5 hours and then lightened to a medium period rate, by the next morning it was just spotting and as of today (12/13) I am still experiencing some spotting.  An ultrasound and HCG test showed that there is still one healthy embryo. A second ultrasound will be taken on 12/15 to confirm. It is uncertain if there had original been multiples or what caused the bleeding. A tissue sample was not taken.
2 patients received full dose Moderna COVID-19 vaccine when they should have received the booster dose; The patients subsequently received a full 0.5ml (100mcg) dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 patients received full dose Moderna COVID-19 vaccine when they should have received the booster dose) and ACCIDENTAL OVERDOSE (The patients subsequently received a full 0.5ml (100mcg) dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD26 (JNJ 78436735).    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 patients received full dose Moderna COVID-19 vaccine when they should have received the booster dose) and ACCIDENTAL OVERDOSE (The patients subsequently received a full 0.5ml (100mcg) dose). On 05-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 patients received full dose Moderna COVID-19 vaccine when they should have received the booster dose) and ACCIDENTAL OVERDOSE (The patients subsequently received a full 0.5ml (100mcg) dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. The patient had received Johnson and Johnson vaccines in March 2021. The patient had subsequently received a full 0.5ml (100mcg) dose as they were receiving the first dose in their Moderna COVID-19 series.
Information has been received from a physician concerning an 18 year old female who was vaccinated with first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included sertraline HCl (ZOLOFT) and hormonal contraceptives (unspecified). Subsequently, a week after the vaccination, the patient developed a rash. It was reported that the patient went to the emergency room due to shortness of breath. The patient was not admitted. Subsequently, the patients symptoms "cleared up." Additional information has been requested.
This spontaneous report was received from a 79-year-old male patient who was reporting on himself. The patient's medical history included bladder cancer, prostate cancer and vaccination with PREVENAR (a year and a half ago in approximately 2015). The patient's concurrent conditions included Achilles tendon tear. The patient did not have any known drug reactions or allergies. On 01-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 for prevention of pneumonia (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included unspecified NSAIDS and EXCEDRIN. In approximately May 2017, also reported as "afterwards", the patient could not lift his arm for 3 days and it was painful and swollen. On an unknown date in approximately May 2017, reported as "shortly after receiving the vaccine", the patient had unspecified bloodwork conducted at his physicians office which resulted in "high alanine aminotransferase (ALT) level of 207 (units not provided) and it dropped to 175 (units not provided) a week later" in approximately May 2017. The patient also noticed that his pulse was elevated in the 80's for about a week after getting the vaccine in approximately May 2017. It was unknown if the patient received a treatment for the events. The outcome of high ALT level was reported as recovering. The outcome of other events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: Admission Date: 7/16/2022 Discharge Date: 7/17/2022  PRESENTING PROBLEM: Hypokalemia  Microcytic anemia  Septic shock  Hypotension, unspecified hypotension type   HOSPITAL COURSE: Patient is a 65 y.o. female who presents today with complaints of awakening at 0330 with sudden onset of shakiness with chills which continued for a couple of hours. She contacted her PCP after 8am and was instructed to go to ER for further evaluation. She states prior to presentation she developed a headache which was typical of her chronic known migraines associated with nausea. She took her home med of Nurtec and headache improved. Upon arrival to the ER she states that her headache continued but resolved completely shortly after receiving toradol in the ED. Regarding her rigors, she states that it has been intermittently occurring over the past few weeks and has been seeing her PCP regarding this. She is also awaiting referral to hematologist for iron deficiency anemia. She reports that yesterday she was at her baseline health, without any complaints of nausea, shortness of breath, cough, fever, diarrhea, dysuria. Today she denies any neck pain, light sensitivity.    In the ED her vital signs showed a low blood pressure which upon review of office visit VS her SBP typically runs 110-120s. She was given 2L of NS but continued to be hypotensive; therefore, Levophed was started. Labs revealed an elevated WBC with intermediate procalcitonin levels and normal lactic acid. Hemoglobin was 7.9 ( she denies any bloody or black colored stools). UA was normal and chest xray did not show any sign of infiltrate. COVID 19 was positive. Due to no meningeal signs LP was deferred. Per ED provider her exam was benign including no abdominal pain and clear lung sounds.  Patient was admitted on IV antibiotics and given 1 unit of packed red blood cells for her symptomatic anemia.  We were able to wean her off Levophed readily.  Her hemoglobin improved to 9.0.  She had no further headaches or other signs or symptoms of SIRS.  She was anxious to go home and after a dose of Venofer 200 mg IV she was discharged home to follow-up with her primary care provider.  She was to resume her regular medications as previously ordered.  She could return to diet and activity as tolerated.  She understood these instructions and was discharged home in stable condition.
Rash began day of exam red & raised. Began on the patient's back & spread to the face, neck, & lower extremities. No fever.
chest tightness; neck swelling; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (chest tightness) and SWELLING (neck swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness) and SWELLING (neck swelling). At the time of the report, CHEST DISCOMFORT (chest tightness) and SWELLING (neck swelling) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
A report has been received from a physician concerning an 8 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Reporter reported that they gave expired FLUMIST on 15-Jan-2014. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious.
Pt called and stated he developed fever > 101 degrees post immunization with FLUZONE HD. Pt complained of feeling like he was going to "die". Took Ibuprofen and TYLENOL - was better the morning (11/18/15).
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: 23May2022; CLARITIN [CLARITHROMYCIN]; VITAMIN B COMPLEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had COVID-19 treatment with anti-viral drug. Treatment start date was 29Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025696 Same patient, different product and event;
7X4 CM REDDENED, WARM AND SWOLLEN AT LEFT DELTOID WILL FOLLOW SEE NURSE PRACTIONER TODAY.
8/23/04 received Varicella and MMR. Presents today with 101 temp, decreased appetite, rash with pustules at site of injection
T103.7 ax, weakness, shaking in hands & legs, irritability;adverse event lasted approx 24hr;pt seen by MD tx for sinus infect;CBC & lead test;mom reports no sx still exist;
On 7/5/22 I felt pain in my right rib cage. When I woke up the next day it was centered on my spine. At about 10 am I went to urgent care and they tole me to go to the E.R. They did a chest X-ray first, then a CT Scan. They then drew blood and and EKG. The doctor came in and told me they found 2 blood clots and I had to stay over night. I received 2 shots of Heparin. I am now taking Eliquis. I am scheduled to see a Hematologist on 8/12/22.
Case received primary Covid Pfizer series and booster, and was hospitalized for Covid and died of Covid.  Hospitalized at Hospital, Dr. Hospitalization: w* Pneumonia due to COVID-19 virus Assessment & Plan Tested pos 10/2. Treating with dexamethasone, and baricitinib initiated October 9 after review of emergency use authorization with family, her surrogate decision makers in her confused state. She has had decreasing tolerance of wearing high flow nasal cannula increased agitation, and signs of distress, and interruptions of high flow nasal cannula resulted in worsening hypoxia. Discussed more than one occasion the average experience of patients her age to have high likelihood of death if mechanical ventilation and intubation were used for respiratory failure Given her progressive difficulty, difficulty tolerance of intervention, family including her son, has elected for proceeding with a comfort care approach and allowing visitors. Versed has been helpful for agitation after morphine seem to be aggravated hallucinations and agitation.   Acute respiratory failure Assessment & Plan Due to covid. Not on oxygen at baseline. On 4L at admit.  Progressive hypoxia requiring high flow nasal cannula to maintain oxygen saturation greater than 90%. CAUSE OF DEATH: 1.        COVID-19 pneumonia.  Patient transition to comfort care plan on the evening of October 10 with development of progressive hypoxia, intolerance of high flow nasal cannula as discussed below family surrogate decision makers agreed not to pursue mechanical ventilation and intubation.  Patient was restless, moaning and attempting to remove the high flow nasal cannula.  We maintain this until family could visit, and discontinuation of oxygen support, patient became increasingly obtunded, and received Ativan and Dilaudid boluses for periods of agitation, restlessness or moaning with good effect. Patient died at 1058.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, 1 ml, lot # M023892, expiration date 15-SEP-2017 (route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. Temperature and time frame of incorrect storage were unspecified. Additional information has been requested.
A petechial rash developed on my bilateral palms of hands, left greater than right, on 01/10/2021.  There was no rash noted on my feet or body habitus.  When the lesions became darker and more punctate , decision was made to seek medical attention.  There was no history of trauma, fever, or skin injury. I saw my Internist, on 01/14/2021 for evaluation and treatment.
Post vax, the patient complained of erythema, induration, and warmth to the area of injection. Dx: Allergic reaction to Pneumovax.
Injection site very sore including muscle use of arm.  Started about an hour after shot received.  Shot itself virtually painless at injection time.  Ibuprofen taken helped diminish pain.  36 hours later still sore but much reduced pain.  Physically active use of arm  I think helped reduction in pain.    Expect after 48 hours to be pain free I hope.
This spontaneous report as received from a pharmacist referred to himself/herself. On 27-FEB-2013 pharmacist administered one client with ZOSTAVAX (dose reported as "just a small amount", Lot #, route and duration were unspecified) in the left arm. Pharmacist stated while administering the vaccine to patient today (27-FEB-2013), the needle came apart and most of the vaccine ran down the client's arm and some squirted onto the pharmacist oneself too. No adverse effects reported. It was unspecified whether pharmacist had sought medical attention or not. The outcome was unknown. This is one of several reports that received from the same source. Additional information is not expected.
Pt has pain in forearm even after 10 days of vaccines. Also pain in biceps in arm (right arm).
Orthostatic hypotension; neurological sequalae; foggy brain; This is a spontaneous report from contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender (age within 30-49 years old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced orthostatic hypotension, neurological sequalae, and foggy brain on unspecified date which were post 10-day administration. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Constant itching in injection site that continues today, startup of Shingles out breaks started in May 2021 and continue today. Increased arthritis pain.
Within a few hours of injection,  my arm became very painful  and ached and painful to touch and pain was so great that I could not raise my arm  over my head.  Had to go straight to bed unable to eat or drink.  Terrible headache and nausea was constant.   Stayed in bed for twenty-two straight hours.  Only able to consume one small popsicle and few sips of sweet tea during that whole time.  Here it is two days later and I still have no appetite.  Was almost ready to go to ER for fluids.  I am still feeling nausea and weakness 2 days later.
Slightly lightheaded immediately after injection. 6 hours after injection; rapid onset of intense headache, intense chills, body aches, nausea. Most concerning symptoms; rapid breathing, rapid heart rate, fever reached 102.6 when I took Tylenol to reduce it.
No adverse effect reported.; a patient received improperly stored PROQUAD on 5/13/2019.; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On 13-MAY-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant Human albumin (rHA); lot # R018778 with expiration date auto calculated as 29-DEC-2019 (also reported as 23-JUL-2020); strength, dose detail and route were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Temperature and time of the vaccine exposed was unknown. There was no previous temperature excursion. No adverse effect reported. Data logger was involved.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The reporter was an internal medicine manager. No concomitant medications were reported. The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State. The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment medications were reported.
Edema and rash begun at injection site. Moved down arm almost to arm bend. Extreme it hing. Treated with cortisone topical cream.  Edema and rash gone by Tuesday, Feb 2. Slight itching remains.
vaccine was given at 20 days instead of 28 due to error in grits and system not catching early fill.
depressed; acquaintance of his was depressed, had anger spells was not the same; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same). At the time of the report, DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Night of vaccine had severe body aches, back pain, leg pain severe until legs went numb, then arm pain severe until also numb, chest pains/ trouble breathing.  Following days had pains in arms and legs as if a tourniquet was left on and I cycled through severe pain and being numb. 5 days in I lost my vision (super blurry and seeing double) and lost complete control of arms and legs on top of headache and chest pains. Vision came back a couple hours later but the leg pains/ numbness continued even now. It feels as if my circulation has been cut off.