chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022; No adverse event; administered with vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 93-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2022, 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 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022).    Concomitant drugs were not reported. It was reported that the bivalent vial of 2.5 ml was initially stored in refrigerator on 09-Nov-2022 and post puncture was stored in room temperature for 20 hours. The vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022 1 dose at 11:00 am and 2 doses at 01:00 pm. The vial did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-674354, US-MODERNATX, INC.-MOD-2022-674357 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674354:same reporter US-MODERNATX, INC.-MOD-2022-674357:same reporter
This spontaneous report as received from a nurse refers to a 62 year old patient of unknown gender. No medical history provided. On 09-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot #J000492, exp 19-JAN-2014). The vaccine had been improperly stored at minus 5C since 16-APR-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 15-Nov-2015 and Pregnancy (Live, full-term birth) on 14-Oct-2017.    On 06-Apr-2021 at 10:39 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 30-Apr-2021. On 06-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth w/o Complications. No negative effect has been noted with my recently born child. The baby was born after the first dose and 4 days before the second dose. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   This case was linked to MOD-2021-237236, MOD-2021-237236 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Updated events after second dose.
At first, I thought my arm was just sore from injection.  However, it got much worse throughout the day and I had much difficulty using my left arm (where injection was given.) I was unable to dress, drive, moving certain ways brought such severe pain, I could not function.  Pain to tears.  I have never had arm or shoulder pain.  If the arm stayed still, it did not hurt.  Any movement in certain ways brought on severe pain that would last for several minutes.  The months of November and December, I took Aleve & Advil and rubbed my arm with sports creams.  Late December, I asked my physician for guidance and we decided on Physical Therapy.  I went to Rehab and they evaluated me and treated with exercise, steroid patch, and some sort of pulse therapy-Also steroid cream.  Also, I had great difficulty sleeping.  That lasted through January.  Had I had a job with manual labor, I would not have been able to work.  Thankfully, I was able to function, and am now much improved-probably 80% back to norman.  I spent close to $1000 at physical therapy, as my deductible had not been met.  I had no health issues before this and would consider myself to be in excellent health.  The pharmacist who administered the vaccination took his time and seemed to know exactly what he was doing.  I, in no way, blame him.  Something went absolutely wrong thought and I do feel the need to report this.  I am very RELUCTANT to receive any more shots in my arm.
fever/fever never surpassed 102 degrees, it was primarily low-grade over a 20 hour period; chills; Fatigue; Pain at injection site was present but considered mild to moderate; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 3248), via an unspecified route of administration in right arm on 30Mar2021 at 11:30 AM (at the age of 50 years old) as single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 10mg; levocetirizine dihydrochloride (XYZAL) 5mg; vardenafil 5mg. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration in right arm on 09Mar2021 at 02:30 PM (at the age of 50 years old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 30Mar2021 at 23:30 approximately 12 hours post dose patient experienced spiked a fever that started with extreme chills. The fever never surpassed 102 degrees; it was primarily low-grade over a 20 hour period. The chills lasted several hours. Fatigue still presents going on 48 hours post-dose. Pain at injection site was present but considered mild to moderate. These symptoms persisted throughout the day on Wednesday, 31Mar2021. The specific fever referenced did not subside until approximately 20 hours later, the late evening of Wednesday, 30Mar2021. He was symptomatic with immediate chills and fever sometime around midnight on Wednesday, 01Apr2021 and the fever persisted throughout the day on Wednesday, April 1st. After the fever subsided late evening on Wednesday, 31Mar2021 immediately went to sleep (at approximately 9pm). The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): negative on 01Dec2020, sars-cov-2 test (Nasal swab): negative on 17Feb2021. No hospitalization required. The reporter considered events as non-serious. Therapeutic measures were taken as a result of all events and included treatment with Prednisone/Atarax. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Reports intermittent fluttering sensation in right ear and constant ringing in left ear that started 2 days after receiving second dose of vaccine. Referred to PCP for further evaluation.
"High fever with body aches and chills fever 103 degrees, uncontrolled shivering swollen/painful glands."
inadvertently administered an extra dose of Havrix to a patient; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adolescent male patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was physician assistant. The age at vaccination was not reported. The reporter inadvertently administered an extra dose of Havrix to the patient. No details about previous doses were provided. The reporter consented to follow up through Email.
Pain and swelling in arm and vomiting all day with a headache and sweating with no fever
Janssen COVID-19 Vaccine EUA. Woke up at 1:20 am, with chills, shaking, shivering, dizzy.  Hard to get up to get an extra blanket beside the bed.  About 5 minutes of teeth chattering and shaking while trying to warm up under extra blankets.  Then about 20minutes of general cold discomfort (shaking stopped).    Then woke up with a headache this morning. No other symptoms - no rashes, no muscle pain, etc.
This case was reported by a pharmacist and described the occurrence of injection site induration in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced injection site induration and injection site redness. The subject received ENGERIX B and experienced red induration at the injection site. At the time of the report no other details were provided. At the time of reporting the injection site induration and injection site redness were unresolved. The pharmacist reported another adverse event with ENGERIX B, see case A0848459A.
Within 24 hours patient has a severe rash all over her skin. From her face to her feet. Very blotchy, red, and itchy. She also had swollen lips and eyes. We visited the ER and she received an oral steroid.
temperature excursion; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had temperature excursion while receiving vaccines [ADACEL], [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and HIB (PRP/T) VACCINE [ACT-HIB] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (lot - C582AA) for Product used for unknown indication.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UJ603AAA via unknown route in unknown administration site for immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C59700A via unknown route in unknown administration site immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ597AAA via unknown route in unknown administration site immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5816AA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect IPV (VERO) lot V1A011M via unknown route in unknown administration site immunization.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7093AA via unknown route in unknown administration site immunization.  On an unknown date the patient had temperature excursion (product temperature excursion issue) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion).  At time of reporting, the outcome was Unknown for the event temperature excursion.
Resident received vaccine around 10am. She called after 2pm that afternoon reporting she had fainted and her arm was sore and red. She was told to call her primary care. Her primary care was off but the RN told her to ice her arm and rest. She reports no fainting today and her arm feels better. I instructed her to call primary care if she fainted again or developed any other symptoms.
Case number PHEH2013US024858, is an initial spontaneous report received from a pharmacist on 25 NOV 2013. This case refers to a male patient of unknown age. Past medical history and concomitant medication were not reported. It was reported that, the patient had received FLUVIRIN 2013/2014 (batch number: not reported) intramuscularly on unknown date in OCT 2013 and then again vaccinated with FLUVIRIN 2013/2014 intramuscularly on 20 NOV 2013. No adverse event was reported following this administration error.
Intense nausea (no vomiting) shortly after 2nd dose of vaccine, lasting about 32 hours Acute arm pain at injection site, lasting about 24 hours Headache Fatigue/Lethargy
Patient was given 0.5ml booster dose instead of 0.25ml booster dose. Patient was informed, did not report any adverse reactions and had no further concerns at this time.
felt a tight pinching feeling in the left side " elbow pit"; purple looking bruise; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 14:30 (Lot number: FC3181) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot number: FA6780, Administration time: 10:30 AM, Dose number: 1, Vaccine location: Left arm), administration date: 22Jul2021, when the patient was 50 years old, for Covid-19 immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 21Aug2021 12:30, outcome "not recovered", described as "felt a tight pinching feeling in the left side " elbow pit""; CONTUSION (non-serious) with onset 21Aug2021, outcome "not recovered", described as "purple looking bruise". Therapeutic measures were not taken as a result of paraesthesia, contusion.  Additional information: Patient did not have any vaccine in four weeks. Prior and post vaccination patient was not tested for Covid. Patient did not had any allergies and medical history.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Patient started experiencing tingling in mouth area within 5 to 10 minutes of receiving vaccine. Patient is aware of beginning symptoms of anaphylaxis since she has experienced in the past.  Patient also started feeling her eyes swell. Patient has an Epipen and was unsure if she should use or wait longer. I contacted 911 to dispatch a paramedic since we would need to contact them anyway if she decides to use her epipen. Paramedics came within 5 to 10 minutes and took her to evaluate/treat.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to cases 2018SA271976, 2018SA271980, 2018SA271981 and 2018SA271982 (Same reporter). This case involves a patient (age range reported as 16-68 years old) (gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ011AG and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on 25-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccines were in transit to long. It was unknown if any adverse event was occurred or not following the vaccination. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Patient stated that she got really sick - fever, ache, nausea, vomiting, fatigue
6JUN91 developed fever (not measured), joint pain & swelling in ankles, wrists, fingers & armpits; On 9JUN91 devel rash generalized over entire body; To ER;
About three days after I received the second shot, my upper arm around the vaccination site became itchy.  Over the next couple of days, there was a rectangular area (maybe 3 X 6 inches) that was slightly swollen and red, with a minor rash.
Frozen L shoulder on 03NOV2016 at 1400. Given CELEBREX and is now doing physical therapy. Physical therapy has improved symptoms.
aches; vomiting the day following vaccination for about 12 hours; Severe UTI on the second day; Fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 02Mar2021 15:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. Medical history included Diabetes II. Concomitant medications included Metformin, Rybelsus, Glipizide, Atorvastatin, B12 (Cyanocobalamin). The patient previously took Motrin (ibuprofen) and experienced drug hypersensitivity, Erythromycin and experienced drug hypersensitivity, bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number- EL8982) administered in right arm on 09Feb2021 for COVID-19 immunization. On 04Mar2021 15:00, the patient experienced fever, aches, vomiting the day following vaccination for about 12 hours, severe UTI on the second day. If COVID prior vaccination and COVID tested post vaccination was reported as no. The patient did not receive treatment. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Developed a fever around 100-101 and headache around 10:30pm (approx 13 hours after vaccination). Fever has persisted until the following day (3/10 as of 11:30am) and headache has worsened. I also have other mild flu like symptoms like some sinus drainage but they have remained mild
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The pharmacist informed that on 14-AUG-2014 the patient was inadvertently vaccinated with an expired PNEUMOVAX 23 injection 25, 0.5 ml, lot # J009827, expiration date: 10-AUG-2014 (route was not reported). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
The evening  after the vaccination, the patient felt very dizzy and was having heart palpitations. He has a history of heart rhythm problems, and he contacted his doctor. He is in atrial fibrillation. The patient states that the doctor does not think it is the result of the vaccine, but we are reporting in case this is an issue that is being tracked.
A few days after the shot I experienced persistent swelling and pain in the hard palate directly behind the incisors, extending back about an inch. It was as if I'd burned my mouth with hot coffee. Pain was intense enough to wake me at night and make eating solid food difficult. I had to use topical benzocaine to get through meals.   The episode lasted a full week before subsiding.
Syncope post vaccine, fell out of chair. Pt had been NPO, has been known to syncope with blood draws. Pt came back within seconds.
Got sick; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (Got sick) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product MACITENTAN tablet for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included RIOCIGUAT (ADEMPAS) and WARFARIN SODIUM (COUMADIN) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and MACITENTAN (Oral) 10 milligram once a day. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The patient got sick after Moderna booster shot and developed the same event after second dose.  The treatment medication was not provided.
Wrong drug given. Patient received the adult Pfizer vaccine instead of the pediatric version. No adverse reaction reported.