chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that 4 to 5 days after receiving his vaccine he developed a painful spot on the right side of his back, Today he is calling stating that this has now developed into a rash and is very painful. The rash goes in a line across the right side of his back from where the painful point began, Patient is contacting his provider to seek treatment for rash/SE.
Received yellow cap 0.2mL/10ug instead of 0.25ml/25 ug dose-Lower than authorized dose
Dizziness, Diarrhea, Bradycardia, hypokalemia Narrative:
mental cloudiness; Febrile; fatigued; generalized aches; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration in the left arm (also reported as left deltoid) on 02Mar2021 12:15 as single dose for COVID-19 immunization. Medical history included obstructive sleep apnea (OSA), hypertension (HTN), obesity from and hypothyroidism. The patient had no known allergies. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID), estradiol and hydrochlorothiazide, losartan potassium (LOSARTAN HCT). No other vaccine in four weeks. The patient experienced mental cloudiness, febrile, fatigued and generalized aches on 03Mar2021. The patient received treatment for the events including Tylenol and work absence. No COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event mental cloudiness cannot be completely excluded based on temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to  patient past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to  patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 021F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to  patient past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to  patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The CDC Expiration date was reported as 26-Mar-2022. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date and no additional information was provided. Date Stored in Standard Freezer for the lot 021F21A was 2 degrees F high, -1 degrees F low on 30-Nov-2021.  No treatment medications were reported.   This case was linked to MOD-2022-614356 (Patient Link).
The patient had received the Moderna  vaccine booster when she was not eligible to receive as she is 15 years old.   She was vaccinated with  Pfizer COVID vaccine on 5/21/21 (age 14 for first vaccination) at pharmacy in. Her second Pfizer dose was on 6/11/21. Per her mother, she did not have any side effects from either Pfizer vaccines.  Her mother came to the office to possibly get Moderna booster after learning that there were some doses left from a open vial used to vaccinate the office staff earlier in the day.  The patient was brought in by the mother to also get booster if it were still available. The patient received a  Moderna Booster on 11/12/21 at about 3:45 PM in the left deltoid. She was healthy with no medical concerns or illness at time of vaccination with Moderna. Her mother signed consent for vaccination for her.   The staff has been in close communication with mother since discovering that she was not officially a candidate for Moderna Booster due to her age.     Per mom, patient tolerated vaccination well without concerns. She states that she did have some mild dizziness around 18 hours post- vaccination which lasted about 2-3 hours. Her mother states that she has dizzy spells chronically which resolve with hydration and electrolyte drinks so she is not convinced that dizziness was from Moderna vaccination. She complained of a mild pain at injection site which resolved on its own. Patient  denies any other symptoms.  She did NOT require any medical follow up (i.e. doctors office visit, ER/UC) after Moderna Booster vaccination.
Shock-like pains in back and abdomen started on the day of first dose of Moderna COVID-19 vaccine.  Also had fatigue, headache, extreme right arm pain. Fatigue, headache, and arm pain subsided, but shock-like pains continued over several weeks and have traveled to other parts of the body. These pains have been felt in the back, abdomen, chest, legs, feet, ankles, toes, fingers, and wrist. They occur on and off throughout the day and in the last two weeks, tingling has also been noticed in legs and feet. Muscle spasms have also occurred in feet and legs in the last week. I have seen a cardiologist and a neurologist. I completed an echocardiogram, heart monitor, and MRI. Those results have returned normal, but neurologist believes this is neuropathy that was triggered by the vaccine.
Headache, Fever, NauseaVomiting, Fatigue, Chills Narrative:
10-1 Received shot. 10-2 Sore. 10-3 Swollen - hot red. 10-4 More swollen, hot, red, breathing shallow used inhaler went to school nurse where I work said wasn't right call Dr. 10-5 Red, more swollen, headache, stomach ache, hot, breathing shallow. Went to Dr. said cellulitis gave KEFLEX.
pt recvd vax & exp dizziness; resolved the same day; the next day 19OCT93 blacked out briefly; 2 to 3 days p/vax exp SOB, chest pains, h/a & low grade fever; pt indicated glands were swelled;
Pt recvd 2nd dose of vax pt devel vertigo exp vision problems &  was sick the day p/vax; pt had a CAT Scan performed p/2nd dose;
I had to use my rescue albuterol twice the day following the vaccine, the following morning I ended up in our emergency room after experiencing breathing difficulty diagnosed as a likely asthma exacerbation due to an immune response secondary to the vaccine I received on Monday, 2/1/2021.  On Friday 2/5/2021, I was placed on a 28 day tapered dose of prednisone. As of this morning, 2/6/2021, my symptoms of labored breathing are lessened, yet continue. I?m extremely fatigued, sweating continuously, and overall do not feel well yet.
This spontaneous report was received from a Licensed Vocational Nurse, referring to an unspecified number of patients older than age 26 years old. Genders, medical history or concurrent conditions were not reported. Concomitant medication was not reported. On unknown dates, the patients were administered doses of GARDASIL (lot number, dose, route and strength were not provided). The reporter also stated that her clinic routinely vaccinated patients older than age 26 years with GARDASIL. No adverse effect was reported and there was not product quality complaint involved. Additional information has been requested.
Patient received a bivalent booster.  Patient was scheduled for the 2nd dose of the Pfizer Monovalent vaccine of his primary series.  In error, the patient received the bivalent booster.   No adverse events.  Patient was observed and appeared stable prior to leaving this facility.
dizziness; dysphoria; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; DYSPHORIA (non-serious), outcome "unknown".  Additional information: patient reported that he was involved in a recent clinical trial but he didn't know whether he was in the study.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recvd Engerix-B & devel nausea & dizziness immed following dose;
Subconjunctival hemorrhage. Petechiae. Headache. Cardiac insufficiency. SOB. Syncope. Fever. Splinter hemorrhages.
Stroke; prev dose 1 administration date: 10Apr2021/ dose 2 administration date: 05Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 at 10:00 as dose 2, single (Lot number: LR8727) at the age of 62 years, in left arm for covid-19 immunisation; influenza vaccine (FLU), on 05Dec2021 as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; ALPRAZOLAM. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Administration time: 10:00, lot number: 338358D, Administration location: Left arm), administration date: 10Apr2021, when the patient was 61-year-old, for Covid-19 immunization; Flu (DOSE 1), for immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Dec2021 at 10:00, outcome "unknown", described as "prev dose 1 administration date: 10Apr2021/ dose 2 administration date: 05Dec2021"; CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 20Jan2022, outcome "recovering", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)). The event "stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown results; Echocardiogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (28Jan2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: Patient age group was reported as (18-64 Years). Patient received BNT162b2 on 10Apr2022 at 16:00 as dose 3, single (lot number: unknown) in left arm for covid-19 immunisation. Vaccination facility type reported as other pharmacy. Patient had not received any other vaccine in four weeks. Patient did not have covid prior vaccination and did not have any known allergies. Covid tested post vaccination. AE treatment was MRI, CT, ECHO, ECG therapy.
HEADACHE, DIZZINESS, OFF BALANCE, CONSTIPATED, INCREASED BLOOD PRESSURE, EMERGENCY ROOM
Systemic: Fainting / Unresponsive-Mild, Additional Details: The pt fainted for a few seconds and recovered. Parents were on seen and told me that it happenned to her before. i gave her benadryl just in case. patient apreared to me very stressed from her mom watching her dusring the vaccination process and laughing at her. i gave her benadryl just in case and watched her for 25 min. she said nothing hurts and everything normal
pushed down the fluid leaked out of the syringe around the hub and onto the patient's arm / no AE; pushed down the fluid leaked out of the syringe around the hub and onto the patient's arm / no AE; plunger was pushed down the fluid leaked out of syringe / no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown demographics who had an incomplete vaccination of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ288AA, Expiry date unknown) via unknown route in unknown administration site.  It was an actual medication error case due to vaccine underdose.  It was also a case of syringe leak and Exposure via skin contact.  The patient was given injection and when plunger was pushed down the fluid leaked out of the syringe around the hub and onto the patient's arm. Syringe was disposed of after injection.  At the time of reporting no adverse reaction was reported.  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 Directive and Module VI of the Practices. 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.
fever 101; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever 101) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in October 2020 and Fever (Fever ran for 16 days) in October 2020. Concomitant products included APIXABAN (ELIQUIS), BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), ROSUVASTATIN CALCIUM (CRESTOR) and CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills). On 26-Feb-2021, the patient experienced PYREXIA (fever 101). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and PYREXIA (fever 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever 101) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in October 2020 and Fever (Fever ran for 16 days) in October 2020. Concomitant products included APIXABAN (ELIQUIS), BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), ROSUVASTATIN CALCIUM (CRESTOR) and CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills). On 26-Feb-2021, the patient experienced PYREXIA (fever 101). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and PYREXIA (fever 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The diluent used for the Yellow Fever Vaccine expired on 6/21.  The patient was contacted to return for a valid Yellow Fever dose 28 days after the initial dose.  She reported no adverse effects.
The patient developed a red welt on arm right below injection site approximately  2 weeks after the vaccine. They reported some bruising on outside of the welt, it appears red, and feels hot  and hard to touch, tender and itchy. The welt has not worsened. The patient reports her husband accidentally elbowing her in the arm preceding the adverse event.
Patient s/p second Pfizer COVID vaccine 4/17/21. Presents to ED 4/28 with slurred speech & left hemiplegia.  CT imaging revealed R MCA CVA. Patient s/p thrombectomy for CVA.  CT also had question of L transverse venous sinus thrombosis.  On 4/29, patient went for MRI which confirmed multiple anterior and posterior circulation strokes and nonocclusive left transverse dural vein thrombus.  Platelets at the time of presentation are normal.  Heparin drip initiated 4/29  after consult with hematology (patient also high bleeding risk due to HHT). IF CT head stable 4/30, Patient will be transitioned to oral anticoagulation with close monitoring by hematology given bleeding risk.
Patient received his Moderna vaccine and immediately (10-15 seconds) appeared to be seizing.  His muscles were tensed, tonic clonic, he was pale, hot to the touch, and excessively sweating.  However, the fire department reported it as a syncopal episode.   The fire department paramedics came and monitored him until his family came to pick him up.  His pulse was 57, blood pressure was 102/54, respirations 20, glucose 116, pulse of 96.  Patient denied treatment to the hospital and requested to go with his parents.  His dad is a physician.
Date of Evaluation: 1/22/2022                                  Date of Injury: 1/22/2022 Time of Trauma page: 18:27                                                Time of Evaluation: 18:40 Trauma Code: Level 3   Chief Complaint:  Trauma, Unwitnessed Mechanical Fall   Source of Information:  Daughter   Mechanism of Injury/Details of Event:  This is a 86y.o. female seen by Trauma Surgery for unwitnessed mechanical ground level fall 2 days ago. Patient was found by daughter in the bathroom. Daughter and daughter's husband were carrying patient for past two days and noticed today that patient had enlarging Right thigh.  It is unknown if patient hit head but mental status appears baseline. Patient does have obvious ecchymosis on Right posterior thigh. Patient has biphasic DP and TP pulses in the right leg. She is grossly in pain. Hgb was 6.4 with creatinine 2.06. Patient's past medical history is unknown. Patient also noted to be hypotensive and tachycardic on presentation which corrected with 500ml bolus. Troponins and CPK elevated
Left entire thigh swollen 1" larger than right, pain with walking, painful to touch.
THE VACCINE ADMINISTRATION WAS DONE 13 DAYS AFTER THE BEYOND USE DATE (BUD). ONCE RECEIVED, VACCINES MUST BE STORED REFRIGERATED FOR UP TO 10 WEEKS. THESE VACCINES WERE RECEIVED ON JANUARY 26, 2022 AND THE BUD WAS APRIL 5, 2022. HOWEVER, UPON RECEIPT THE STAFF CONFUSED THE DATE AND DOCUMENTED THE BUD AS MAY 4, 2022.
Full body rash. The rash kept appearing and disappearing. Rash was itchy, blotchy, and red. Rapid heart rate and high BP. Chest pains. Nausea, Menstrual cycle did not start on time and has been irregular. I bled heavily for 30 days, which started on April 29, 2021. My period skipped in June 2021. I went to the Emergency Room on June 28, 2021. I went to see a cardiologist on July 6, 2021 and I have seen him several times since then.
Unknown.  Patients husband came pharmacy at ~ 12pm 11/02 mentioning that his wife had passed away in the evening. Pharmacist manager is a friend of the family and relayed on information on to myself that was running a flu clinic at that location today. 11/9/06 Received Death Certificate which reveal COD as ischemic heart disease and HTN with insomnia, hypothyroidism and chronic bronchitis as contributing factors.
Information has been received from a registered nurse concerning a 10 year old female with attention deficit hyperactivity disorder who in August 1996, was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included methylphenidate HCl (CONCERTA). On 02 OCT 2001, the patient experienced 20 to 30 lesions, some with blisters and was afebrile. She was seen in the physicians office on 03 OCT 2001 and was diagnosed with varicella. It was reported that no treatment was needed. Subsequently the patient recovered. Additional information has been requested.
Incorrectly reconstituted with bacteriostatic Nacl. Patient contacted and provided additional dose.
Pt experienced large induration, warmth and redness at injection site - right arm. Pt was treated with Keflex.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 53-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th May 2018, several hours after receiving SHINGRIX, the patient experienced swelling (serious criteria disability), malaise (serious criteria disability), fever (serious criteria disability), headache (serious criteria disability), tingling (serious criteria disability), appetite lost (serious criteria disability), erythema (serious criteria disability) and dizziness (serious criteria disability). On 16th May 2018, the outcome of the swelling, malaise, fever, headache, tingling, appetite lost, erythema and dizziness were recovered/resolved. The reporter considered the swelling, malaise, fever, headache, tingling, appetite lost, erythema and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The healthcare professional (HCP) reported that the patient experienced extreme swelling, redness, malaise, dizziness, headaches, loss of appetite and tingling in the face. The patient also got a fever of 103 degree F and stated that these side effects were started a few hours after receiving the vaccination and were severe for the next 2 days. It took a total of 6 days events to resolve. The HCP reported that this was disabling to the patient because the day the patient got the vaccine, she had to leave work early as well as take a day off from work. There were days where she could not get out of bed.
Information has been received from a medical assistant concerning a "9 to 14" year old female who was vaccinated with a dose of Gardasil. Subsequently, the patient experienced tingling and numbness in her arm, nausea and it was reported that the patient's "face turned white." Her blood pressure was satisfactory. The "patient was in the office for an hour to an hour and a half and then was sent home." The patient outcome was unknown. Additional information has been requested.
Pt states went home after receiving vaccine had headache, fever, muscle pain. Felt better after 1 hour.
Lt/ arm swollen like baseball - hard, hot, red, weakness of arm.  Md advised to take benadryl, advil.  Pt took meds for one week.