chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed dose; Patient received first dose in May2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose in May2021) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose in May2021). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose in May2021) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        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.   No concomitant and Treatment medications were reported.
Severe itching, hotness & red at injection site - this symptom started on Day 8 following vaccine (it is now Day 9).
(R) arm, edema, red, warm, peeling - 2" from site of injection down to elbow. Could not straighten arm out. T 99, was itchy. Was put on antibiotic, was to call/come back PRN.
No additional adverse effects were reported; the patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gander. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 23-JUL-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot# T008698, was established as valid, with expiration date: 04-JUN-2021) 25/0.5 (units not provided) vial (upon internal validation process, the formulation was established as prefilled syringe) (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccines was exposed was 62.2 degrees of Fahrenheit and the time frame was reported as 3 hours 50 minutes. No previous temperature excursion was reported. A digital data logger was involved. No additional adverse effects were reported..  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA009779: US-009507513-2007USA010267: US-009507513-2007USA010269:
On 10/22/2021, child received a COVID-19 vaccine prior to the recommended 21-41 days after the initial COVID-19 vaccine. While transcribing COVID-19 vaccines to UAC, MC noted COVID-19 vaccine had previously been given to the child on 10/13/2021. PCP NP was notified of findings and recommended to notify DCS Medical and UMP medical. As per Regional Director of Nursing, a medication error was to be documented along with an SIR. Child is currently safe and stable.
lost my sense of taste about three days ago; This spontaneous case was reported by an other and describes the occurrence of AGEUSIA (lost my sense of taste about three days ago) in a patient of an unknown age and gender 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 AGEUSIA (lost my sense of taste about three days ago). At the time of the report, AGEUSIA (lost my sense of taste about three days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Profuse sweating, numbness in hands, burning feeling in arms, severe diarrhea. Symptoms alleviated within 24 hours.
Hematoma at the site, ITP with platelets of 1000 noted on 10/11/14.
Severe onset of dizziness, then the next day as well and on the third day nov. 2 I was taken to ER with severe vomiting and vertigo and unable to stand.  Diagnosed with Viral Labyrinthitis.  3 days later lost part of my hearing in right ear.  Under treatment now for 8 weeks with ENT for Meniers disease.  Still with hearing loss and constant loud ringing in my right ear.  Waking up with severe vertigo.  Injection was mandated by mom job. Injected given in right arm.
Her leg is sore; Legs weak; Muscle ache; Joint pain from her knees down to her feet; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her leg is sore), ASTHENIA (Legs weak), MYALGIA (Muscle ache), ARTHRALGIA (Joint pain from her knees down to her feet) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K28 and 039K28) for COVID-19 vaccination.     The patient's past medical history included Jaundice, Heart murmur, Bile duct stent insertion and Aortic valve replacement in 2000. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-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 PAIN IN EXTREMITY (Her leg is sore), ASTHENIA (Legs weak), MYALGIA (Muscle ache), ARTHRALGIA (Joint pain from her knees down to her feet) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, PAIN IN EXTREMITY (Her leg is sore), ASTHENIA (Legs weak), MYALGIA (Muscle ache) and ARTHRALGIA (Joint pain from her knees down to her feet) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness around the injection site) had resolved.
This spontaneous report as received from a pharmacist refers to a 70 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 05-MAR-2018 the patient was administered a dose of PNEUMOVAX 23 in an unspecified arm from lot N030847 expiry date 09-JUN-2019, 0.5 ml, once by intramuscular route for prophylaxis. Later in the day on 05-MAR-2018, patient developed redness at the injection site. On 06-MAR-2018, patient developed swelling from the injection site down to the elbow of the vaccinated arm, described as very swollen(joint swelling), edematous, like there is fluid accumulating under the skin (skin oedema). Treatment included application of ice to the affected area and unspecified NSAIDs. The outcome of injection site erythema, skin oedema, joint swelling and injection site swelling was reported as not recovered. Causality assessment was not provided by reporter.
redness at the injection site, looks as if someone puched arm; Pain at injection site, looks as if someone puched arm; tired and fatigued; looks as if someone puched her in the arm; chills; nausea; manic symptoms, feels like drank 10 cups of coffee; Anxiety; unable to sit still; unable to sleep; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 34L52, expiry date 6th July 2023) for prophylaxis.   Previously administered products included LEVAQUIN with an associated reaction of manic symptom (received dose of Levaquin in 2017 and experienced manic symptoms). Concomitant products included venlafaxine hydrochloride (Efexor).   On 30th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th May 2022, 12 hrs after receiving Shingrix, the patient experienced manic symptom, anxiety, restlessness and sleeplessness. On 31st May 2022, the patient experienced chills and nausea. On an unknown date, the patient experienced injection site erythema, injection site pain, fatigue and pain in arm. The patient was treated with paracetamol (Tylenol) and clonazepam. On an unknown date, the outcome of the injection site erythema, injection site pain, manic symptom, anxiety, restlessness, sleeplessness, fatigue and pain in arm were not recovered/not resolved and the outcome of the chills and nausea were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, manic symptom, anxiety, restlessness, sleeplessness, chills, nausea, fatigue and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: The pharmacist was reporting on behalf of the patient.  The reporter reported that the patient received first dose of Shingrix into right deltoid, and approximately 12 hours later, the patient experienced manic symptoms, anxiety, unable to sit still, and unable to sleep.  The pharmacist reported that the patient still had manic issues at the time of the reporting. The pharmacist also reported that the patient experienced redness and pain at the injection site, but was unsure it that had resolved. AE (adverse event) filed. The patient had a red, sore arm near injection site. The patient reported it looks as if someone punched her in the arm.  The patient was taking Tylenol for this.  The patient reported that she experienced chills and nausea the day after the Shingrix vaccine and also reported that she was very tired and fatigued. The patient reported that manic symptoms. The patient reported that she felt like she drank ten cups of coffee. The patient reported that when she lays down she can not sleep, patient was restless.  The patient's doctor just prescribed her Clonazepam at bedtime to the end of the week to alleviate symptoms. The patient reported that she currently taking Effexor. The patient reported that she had an adverse reaction to Levaquin in 2017 in which she also experienced manic symptoms. The patient gave consent to follow up with HCP (Health care professional).
Pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in left arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provider by the reporter.
Warm/hot rash; Itchy rash; pink/red rash; Triangular 5.5x5" rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash), VACCINATION SITE ERYTHEMA (pink/red rash) and VACCINATION SITE RASH (Triangular 5.5x5" rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Immunization: Shingrix. Past adverse reactions to the above products included Local reaction with Shingrix.    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 VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash), VACCINATION SITE ERYTHEMA (pink/red rash) and VACCINATION SITE RASH (Triangular 5.5x5" rash). At the time of the report, VACCINATION SITE WARMTH (Warm/hot rash), VACCINATION SITE PRURITUS (Itchy rash) and VACCINATION SITE ERYTHEMA (pink/red rash) outcome was unknown and VACCINATION SITE RASH (Triangular 5.5x5" rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
pt recv vax & exp projectile vomiting, limp, ? sz activity, trouble breathing, ? stop breathing for a few seconds, dazed w/in 4hr of vax; fever 101-102 approx 2 days;
This was reported to me by RN.  Pt received his 2nd dose of Moderna 4/9/21.  First dose was administered on 4/2/21.
3/8: Admitted to hospital dx chest pain;  3/9 transferred to a different hospital, dx gallbladder necrosis. Hospital course: 74 y.o. female admitted on 4/8/2021 for abdominal pain. Notable PMHx: aortic valve replacement, HTN   On morning of admission, patient woke up with severe epigastric pain.  Describes pain as a pressure.  Has had vomiting.  Had bowel movement after pain started.  Patient came to the emergency room.  Patient received an antiemetic and Demerol.  Patient has continued to have pain in got a dose of morphine as well.  Pain eased some but was still 7/10.  In the ER, blood pressure was very elevated with systolic in 200s.  Cardiac enzymes negative.  EKG look good with normal sinus rhythm.  Patient has aortic valve replacement and is on Coumadin with INR goal of 2.5-3.5.  INR was elevated at 4.3.  D-dimer was negative.  Amylase and lipase negative.  Creatinine normal at 0.9.  Chest x-ray done which showed no acute disease.  On the floor, we ordered a CT abdomen.  It did show gallstones, but nonobstructing.  It showed kidney stones in the renal pelvis, but none obstructing.  No other inflammation or signs of bleeding.  Blood pressure came down after medicines in the ER.  Did have some lower blood pressures through the afternoon evening which was felt to be a combination of blood pressure low in medicines in the ER and pain medication.  From 11:00 p.m. onward blood pressures were controlled.   Patient continued to have severe abdominal pain.  Hemoglobin down to 9.0 from prior 12.4 yesterday.  Creatinine up from 0.9 yesterday to 1.8.  White count up from 8.3 yesterday to 14.4.  INR from 4.3 yesterday to 4.2.  Coumadin was held yesterday.   CT abdomen was repeated. CT abdomen was read as worrisome for necrotic gallbladder and small bile leak Contacted transfer line at hospital.  Surgery accepted and wanted transfer to go through the ER. Patient has PCN allergy.  Surgery said that if reaction was not severe, they wanted Invanz given before she left.  Patient says that she had a itching rash in the 70s.  No trouble breathing or swallowing.  No other reaction.  Dose of Invanz ordered.  IVF were increased.  HPI from hospital: 74 y.o. female who presents with Chief Complaint Patient presents with? Abnormal Scan   Patient presents via EMS as a medical transfer from hospital after having gallbladder necrosis seen on CT imaging.  She was given IV Invanz there.  General surgeon was contacted by that facility and he accepted the patient for transfer to this facility.   Apparently, the patient began having abdominal pain yesterday. Timing of onset was gradual.  Severity is rated as severe at maximum intensity. Quality is described as aching abdominal pain.  Symptoms have been improved after IV pain medicine.  Symptoms worsen with nothing, and improve with IV pain medicine.     History was provided by patient, EMS, transfer paperwork and EMR, and I spoke with treating doctor in general surgery who accepted the patient for transfer.
has pins and needles in his left leg sometimes his arm, right leg by his knee he has numbness
Immediately following vaccine felt tingling, slightly pre-syncopal, exacerbated autonomic issue. Feeling week. Stayed seated in chair where vaccine received until initial feeling passed (about 5 minutes) then stayed in observation area for 30 minutes.
Initially, the night of January 18, the left arm was somewhat sore as expected. The next day, within about 24 hours after the injection, I felt slightly queasy, somewhat weak, what we called on the farm, being "off our feed." The left arm was increasingly painful, although I slept reasonably well that night. On the second day after the injection (Wednesday, January 20), the left arm was even more painful, I was actually nauseous, weak,  and in the afternoon had a temperature of 99.8 (my normal temperature is 97.4). I had some abdominal pain for a few weeks before the injection and that pain had increased. But by bed time (about 10:30 p.m. CST) the temperature had returned near normal and I was feeling much better. Today, Thursday, January 21, I felt normal, no general weakness and minimal abdominal pain, and there was only very slight soreness in the left arm. My wife (81 years old with a history of nut allergies and asthma) received an injection at the same time I did and had minimal side effects from the Moderna vaccine with the same Lot Number. I note the EUA Fact Sheet says the Modern vaccine is still being studied so I hope is a small contribution.
"pt recv vax 17NOV96 & on 4FEB97 pt devel a rash on proximal thigh described as pustular w/an erythematous base, & a temp of 101;"
Pain at injection with radiation down to forearm. Patient seen in office again on 12/19/2013, given NSAIDS and hydrocodone/APAP to use as needed for pain.
no adverse event occurred. this report is for administration error of extraneous third dose of heplisav, whereas only 2 doses one month apart are indicated by current guidelines. 2 dose series was completed a month ago.
Medication administration error: Adolescent was 17 yrs old at time of administration.  No adverse events reported after vaccination.
Clinic Lead did not use Qualified Container and Packout for the initial vaccine transfer of 10 doses of Moderna. Moderna was transferred from one site to another site (travel time total 15 min).
Dizziness (for about 6 hours, only when I would turn around. Went away after I slept) Runny/stuffy nose (48 hours)  Tiredness (48 hours)
Information has been received from a registered nurse (R.N.) in a physicians office concerning a 13-month-old male who on 28-MAR-2007 was vaccinated with a subcutaneous "first dose, single dose vial" of ProQuad (lot # 656160/1396F). Concomitant therapy included a dose of Comvax and a dose of Vaqta. The nurse reported that the patient developed "fine red pin-point on the trunk of his body". The patient's parent notified the office of the experience on 09-APR-2007. The patient sought unspecified medical attention. It was unspecified if the patient recovered. No product quality complaint was involved. No more information is expected.
Patient fully vaccinated (Moderna), but not boosted admitted to the hospital with COVID-19 and associated hypoxia. Patient was discharged on 12/27/21.
I am not sure if after the first shot or second shot but my period was delayed for 4 months. When I did get it, was pretty heavy and lasted longer. The next period was delayed by 1.5 months and again heavy. My cramps started all over again which I haven?t experienced in last 20 years
Initial report received from a Consumer on 26 November 2013. A 72-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (Lot number, route and site of vaccination were not reported), on 23 October 2013. On 23 October 2013, after receiving vaccine the patient experienced severe pain at injection site. Then about 24 hours after administration of vaccine began experiencing severe pain in arm from shoulder down to hand. Pain has been persistent and he was not able to move arm in full range of motion. Pain had been so severe and he was only getting about 2 to 3 hours of sleep at night because pain in arm will wake him up. Also the patient does not have any strength in arm. Corrective treatment was not reported. At the time of this report the outcome of adverse events was not resolved. Documents held by sender: none. Follow-up information received from healthcare professional on 18 August 2014. The patient received FLUZONE HD vaccine in left deltoid. It was reported that, the patient received annual flu shots without incidents. The patient did not perform any laboratory investigations and did not receive any other vaccinations within 4 weeks prior to vaccination. The patient had no illness at the time of vaccination. The patient is allergic to acetyl salicylic acid and iodine. It was reported that, the patient and his brother or sister did not experience any adverse events to prior vaccination.
bad headache; fever (100F); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and PYREXIA (fever (100F)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (bad headache) and PYREXIA (fever (100F)). At the time of the report, HEADACHE (bad headache) and PYREXIA (fever (100F)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 99/76 mmHg Low. On 25-Mar-2021, Pyrexia: (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment medication was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and PYREXIA (fever (100F)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (bad headache) and PYREXIA (fever (100F)). At the time of the report, HEADACHE (bad headache) and PYREXIA (fever (100F)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 99/76 mmHg Low. On 25-Mar-2021, Pyrexia: (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment medication was not provided.