chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna Bivalent vaccine was administered Beyond use by date to 6 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment medication information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698131 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698131:Same reporter
12DEC90 devel elevated weakness which began in feet & moved upwards; unable to walk, drops things; mild URI sx x 1 wk PTA; IGM-17DEC abn consistent w/GBS; plasmaphoresis x 5 exchgs;
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 12-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 13-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, and route of administration were not provided), lot #U039722, expiration date: 15-DEC-2023 (discrepancy: lot# reported also as U0397722 and this lot# is not valid for varicella virus vaccine live [oka/merck] [VARIVAX]) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
When I got home from getting the vaccination, my arm was sore. It felt like there was a rock inside of my arm and a lot of pressure. My symptoms lasted for about one day.
Lymphocyte abnormal; Neutrophil count abnormal; This is a spontaneous report from a contactable nurse (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN9581, Expiration Date: 31May2021) via intramuscular at single dose in deltoid left 30Jan2021 08:30 for COVID-19 immunization. The first dose was on 08Jan2021 at about 4:30 pm (Lot#: EL3246, Expiration Date: 30Apr2021) via intramuscular at single dose in deltoid left. Medical history was none. There was no additional vaccines administered on same date of the pfizer suspect. Prior vaccinations (within 4 weeks) was none. Concomitant medication was not reported. Patient stated she received both doses of the vaccine. She had blood work done afterwards and her neutrophil count and lymphocytes were abnormal on 20Feb2021. Patient asked if that was a normal response to getting the vaccine, if this was related to the COVID-19 vaccine. At this time, since she didn't know if it was related to the vaccine or not and if it was something to be concerned with, she would consider the events to be medically significant. She believed it was something to look into. Results of tests and procedures on 20Feb2021 included: lymphocyte percentage (normal range 20-50) was 54.8%; lymphocyte count 2.8, which was in the normal range; neutrophil percentage (normal range 50-70) 37.8%; neutrophil count (normal range 2-7.5) 1.9 mm; WBC 5.0. Patient also mentioned a test "hydrochroma", but she didn't print the results out. She has never heard of it before. Her level was like 1. The outcome of events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
5 doses were given from a vial exposed to several tempereature excursions; 5 doses were given from a vial exposed to several tempereature excursions; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several tempereature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several tempereature excursions) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial was exposed at minimum temperature of 199.9 degree Celsius for 30 minutes. Storage condition at the time of the excursion was refrigerated storage. No concomitant and treatment medications were reported by the reporter
clusters of small blisters; splotchy red rash; felt very unwell; headache; Fever; chills; exhausted; had little sleep; pain in my neck and left shoulder; pain in my neck and left shoulder; sore muscles; This is a spontaneous report received from a contactable consumer (patient). This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fish oil, Men's Multivitamin and "avmacol," all from unknown dates for unknown indications. The patent reported he started having pain in his neck and left shoulder; further described as like sore muscles, for which he was annoyed enough to take ibuprofen and use ice packs. On Sunday 07Mar (2021) the patient noticed there were clusters of small blisters all over his left shoulder and neck, overlaying a splotchy red rash; reporting they were mostly on the left shoulder, but started in the center of his chest and went all through to his back and stopped at his spine. The patient also reported the past very days he felt very unwell, enough to miss work. Aside from the rash/blisters, he had a headache, chills, and a fever that had come and gone, which measured 103.4 at it's worst. He reported taking dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) every six hours which he thought helped, and he reported using cold compresses for the rash, blisters. He stated he felt exhausted the whole time but had little sleep, which was helped by the dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol for a few hours. He reported today (as of 22Mar2021) was the first day in a few that he'd felt alive enough to report. The blisters/rash were about the same, "but the blisters." The events required a doctor or other healthcare professional office/clinic visit. The clinical outcomes of pain in my neck and left shoulder, sore muscles, cluster of small blisters, splotchy red rash, felt very unwell, headache, fever, chills, exhausted, and had little sleep were reported as recovering. It was also reported the patient was tested for COVID-19 post vaccination, and on 14Mar2021 had a negative nasal swab.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recv vax 16MAY96 & 1JUN96 pt devel rash w/large papules area of confluence head to toe including palms & soles of the feet;dx erythema multiforme;pt sibling allerg to amoxicillin reporter questioned whether pt had allerg rxn d/t ATB
Syringe without vaccine administered to patient, second administration occurred @ 1328 once medication error identified.
Patient became light headed, dizzy, hot and sweating. He was sitting and remained sitting and provided water and crackers. monitored for approximately an hour until the patient had someone pick him up.
temperature excursion for Shingrix being stored at -6.5°F for 5 hours; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional information received as follows: The age at vaccination was not reported.  Pharmacist called on Jan 6th 2019 to report a below temperature excursion for Shingrix being stored at 6.5°F for 5 hours, which led to incorrect storage of vaccine.  Consent to Follow up was not given.  Batch number for Shingrix was provided.
vaccine reaction-passed out.   c/o worsening headache and feels tire. states broke out sweat, stomach pain, HA, leg cramping and passed out (for about 30sec according to husband) on Mon. took Advil several days. last Advil 0600. J&J vaccine on 5 Apr.  61 yo f w/spouse c/o ongoing headache w/concerns for single episode of 'passing out' approx 48hrs pta approx 30-45 sec per spouse at bedside; Pt states nighttime episode w/preceding leg crampings, sweating, dizziness, sat on footstool and per spouse passed out but caught by spouse and avoided injury; spontaneous recovery w/o further issue from that episode, spouse denies any post-syncope seizure-like activity/urinary incontinence/tongue biting; Pt and spouse concerned.  for cerebral venous thrombosis; Pt has sig hx of prior neurosurgery for posterior/occipital schwannoma around 2017, successfully removed, w/o further findings or complications on f/u (last DEC 2020) to include repeat imaging at that time  Pt states has been taking advil OTC for ha but no sig relief at this time; Pt defers need for medications at time of provider evaluation; Pt denies any fevers/ns/chills, cp, sob, palpitations, dyspnea, abd pain/cramping, current nvd, prior syncope, fam hx of MI/SCD/dysrhythmias.
Initial misuse report received from a healthcare professional on 28 MAY 2013. It was reported that ADACEL was given to a patient at an age of 10 years. No adverse event was reported. Documents held by sender: none
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K016966, expiration date reported as 10-MAY-2017 (dose, route and site of vaccination were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 56.8 degrees Fahrenheit fro 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
I had a sore throat, fever for a day, loss sense of taste and smell. I tested myself day 1 and 2 for COVID-19 and tested negative. On day 3, I tested positive for COVID-19. I took Tylenol for my symptoms because my doctor said that my symptoms were so mild that I didn't need a prescription. It took at least 2 months for my smell to come back.
The next day after the vaccine I had fever of 102, I stay in bed all day. The next day fever went down, I was tired for a couple of days and stay in bed.
Student with complaint of pain and numbness in right arm and right leg. Call to parent, parent picked up and sought medical care.
2-3 inch purplish area around injection site. Solid mass of 5 cm in diameter noted under skin. Area is warm to touch, with a stinging sensation. Lymph nodes in groin were swollen and painful. Had fever of 101.9 at highest for 3 days.
Soreness and pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness and pain at the injection site) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness and pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness and pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Redness around both injection sites developed 3/18. She had pain of the area as well. No itchiness. No rash elsewhere. No wheezing, trouble breathing, lip/tongue swelling or lip/tongue itching. The redness and pain resolved 3/20.
Post vax, the pt developed chickenpox on her face, back of her throat, underwear line, and underline of her torso. The pt was treated with Benadryl, Tylenol, calamine lotion and Aveeno bath.
Approximately 10 days after vaccine, developed dime sized rash in the region of the injection site. Within 3 days it had spread to cover most of my upper arm, then on the 4th day it started to go down slightly. I used steroid cream and took benadryl.
I observed the aboved named guest becoming pale.  Guest stated she was weak and dizzy.  Guest was assisted from her chair to the floor with her legs elavated.  EMS was activated.  Vitals were taken.  HR: 87, RR: 15, BP: 122/82 SPO2: 99% RA;  County EMS arrived on-scene.  Para-medics checked guest and spoke with father.  Father refused further treatment or transport to hospital, but stated he would bring his daughter to the family Primary Care Physician just around the corner of our current location.  Father signed Refusal of Care form both with County and Ambulance Companies.  Guest was escorted to her fathers car without further issue or incident.
Patient have rapid heartbeat, fever, ache chills, fatigue; fever; ache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Patient have rapid heartbeat, fever, ache chills, fatigue), PYREXIA (fever), PAIN (ache), CHILLS (chills) and FATIGUE (fatigue) in a 66-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Patient have rapid heartbeat, fever, ache chills, fatigue), PYREXIA (fever), PAIN (ache), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, HEART RATE INCREASED (Patient have rapid heartbeat, fever, ache chills, fatigue), PYREXIA (fever), PAIN (ache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (High) heart rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.
no reaction initially; removed bandaid (red color, put on after injection) two days later. Noticed slight hardening at the site. March 7: Pale red blotch where bandaid had been,.  Slight itchyness.  March 9: approx 2 inch diam. slight hardness under the skin, blotchy patch same.
Information has been received from a public health nurse concerning an 11 year old Caucasian male who on 1/10/99 was vaccinated with the 2nd dose of Hep-B in the left deltoid. On 1/11/99, approx. 21 hours, post vax, the pt experienced hives on the upper torso, front and back. Subsequently, the pt recovered. No further information is available.
This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was 62-year-old) as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications included Singulair. The patient stated that she got the COVID-19 shot a couple weeks ago, had a 102.3 fever on an unspecified date. The patient stated she was concerned about shortness of breath that she experienced for 12 hours after. Wanted to know if she could do anything else besides her inhalers. Wanted to know if she could take an extra Singulair pill that has to do with the lungs, or she should take other drugs such as Pulmicort and Levalbuterol tartrate. Therapeutic measures were taken as a result of shortness of breath. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.
The clinician that diluted the vial diluted with 0.8 cc saline provided, not 1.8 cc.
On August 28, 2023, a RN was preparing to administer a Menveo-meningococcal vaccine to a patient. She noted that there were 2 component/powder-Vial 1 and one Vial 2 component left in Menveo box. In inventory, it showed that there was 0-Menveo vaccine left after she administered that dose. After reviewing the barcode, 4 doses had been previously administered. Those 4 doses had been administered by 2 others RNs. Each RN was questioned about mixing vials, but neither can remember if they had mixed vial 1 and vial 3. Dr. was notified of incident and his recommendation was to contact parents of each patient and let them know that each patient is covered on Meningococcal C, Y and W -135 but not cove Dr. was notified of incident and his recommendation was to contact parents of each patient and let them know that each patient is covered on Meningococcal C, Y and W -135 but not covered on Group A, which is not needed unless traveling outside of the country No adverse reactions noted.
Patient stated shortly after returning from pharmacy her arm began swelling and was very tender. By next AM  it was swollen to size of baseball and could not even wear jacket. Patient began having "fiery" pain on neck and chest and rash around injection site and on trunk. Ran temp of 100.3 until Sat PM but still has rash about 2 inches around injection site. Patient took Benadryl for rash.
Onset of numbness and weakness in lower extremities. Developed unstable gait. Fell two times and presented to emergency department for evaluation due to worsening symptoms. Symptoms progressed to include paralysis of breathing functions, was admitted to intensive care, placed on vent, progressed through supportive care stage was transferred to rehabilitation facility and subsequently discharged to outpatient care. Currently in process of returning to work on part time basis in restricted position.
pt recvd flu vax & devel edema, erythema, pruritus @ inj site;
After receiving my vaccine my arm hurt a lot. I walked out to the waiting room to sit for 15 mins as directed. I felt a little weak while sitting down. I started to feel dizzy, and I remember almost my entire arm hurt. Next thing I remember is waking up and I was slouched over. Someone was asking if I was okay. It took me a minute to realize where I was. I was very sweaty, lightheaded and dizzy. I had also peed my pants. I was instructed to lay down. After about 5 mins of feeling dizzy, tired, sweaty and disoriented I finally started to feel more normal and less sweaty. The entire next day I felt extremely lightheaded and fatigued. By 9/17/21 I felt back to normal with only arm pain.
Hives; Headache; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0153) via an unspecified route of administration in the right arm on 07Apr2021 at 17:15 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unspecified indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP69SS), via an unspecified route of administration in the left arm on 16Mar2021 at 17:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 17:30, the patient experienced hives and headache. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcomes of the events hives and headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.