chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she grabbed a 5ml vial of Tubersol, thinking it was Fluzone Quadrivalent, inadvertently administering 0.5mL of Tubersol to patient, no advesre event; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2019SA295021 (same reporter).  This case involves a 48 year old patient who received 0.5 ml dose of TUBERCULIN TEST [TUBERSOL] instead of a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot C5588AA and expiration date 17-Jun-2021) via an intramuscular route in the left deltoid on 22-Oct-2019.  Medical history not reported and no other vaccines were received by patient.  It was an actual medication error case due to Wrong product administered.  No adverse event was reported at the time of reporting.  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.
Information has been received from a certified medical assistant referring to a patient of unknown age. On 06-JAN-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # J011342, expiration date 29-MAY-2015, dose unknown). No adverse effect was reported. This is one of several report received from same source. Additional information has been requested.
This spontaneous report was received from a certified medical assistant worker and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Soar throat; Chills; Tired; Runny nose/ Felt like nose flu; Arm sore; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age (Age: 27; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm sore on 04Jan2021, soar throat on 07Jan2021, chills on 07Jan2021, tired on 07Jan2021, runny nose/ felt like nose flu on 07Jan2021 Outcome of events was unknown.    Information on the lot/batch number has been requested.
The first symptoms I had were a sore throat and a fever. I took TYLENOL for the fever of 101.1. By the next day the fever had gone down. I completed a COVID 19 home test the next morning and received a strong positive. I spoke with the doctor on Tuesday, and I got the PAXLOVID prescription. The symptoms improved and almost went away. I began to get a productive cough. It brought up a lot of material. The symptoms gradually faded. I still have the cough, but it is no longer productive. I do feel I have recovered from my symptoms outside of the cough.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 05-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
1hr p/vax pt noted to be apneic & cyanotic,  responded to stimulation;was listless for short period of time, but was WNL w/in 1hr;
Noted rash on arms and chest 24 hours after receiving MMR Booster.  Treated with Triamcinalone 0.5% cream and Benadryl.  Prescription given for Prednisone if needed.
Liquid leaked out; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Liquid leaked out) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced UNDERDOSE (Liquid leaked out). On 05-Apr-2021, UNDERDOSE (Liquid leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that during the administration the plunger was being pushed down and some liquid leaked out, caller stated the patient received close to half of the dose. Concomitant medications were not reported. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24-May-2021 and does not contain any new information. On 22-Jul-2021: Follow up received on 22-Jul-2021 and contains no new information.
1 1/2 cm of induration-2 x 5 cm area of pink area surrounding site of vaccine.
Client was given her first HPV vaccine and the next day she had abdominal cramping but no menses. After no menses for two months, mother took client to the doctor, where client was...
DEATH, ABDOMINAL DISTENTION, CHF EXACERBATION. Narrative: Pt died after completion of COVID vaccine series. Pt in CLC at time of both vaccinations. Hospitalized for CHF exacerbation 01/05 COVID vaccine dose #1 01/01 c/o abdominal distention, diarrhea 01/08 c/o increased SOB and continued diarrhea/abdominal distention, sent to ED, low potassium, borderline elevation troponin, gaseous distention on CT, admitted to hospital, states SOB and leg swelling for a few weeks now (likely unrelated to vaccine) 01/21 discharged from hospital to CLC; during course, found to have severe hypokalemia and renal failure, abd ileus, treated for electrolyte imbalance 01/26 admitted to hospital with c/o coffee ground emesis & abdominal distention 01/27 COVID vaccine dose #2 moved to critical care mid hospitalization with like aspiration PNA and numerous complications 02/06 patient passed away after withdraw of care Unlikely that vaccine contributed to death but death likely due to comorbidities and advanced age. Patient did not have acute specific ADR at time of vaccine or between vaccinations and date of death that could be attributed to vaccine. Hospitalized prior to and after vaccinations. Numerous comorbidities including acute on chronic HF and kidney failure pre-disposed patient to death.
fine papular rash on abdomen treatment recommended: hydrocortisone cream and oral benadryl for itching as needed
Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT FAINTED A COUPLE OF MINUTES AFTER RECIEVING PFIZER VACCINE; WHILE SITTING IN THE CHAIR, HE SLID OFF & HIT HIS HEAD ON THE OPPOSITE CHAIR. DID NOT FULLY LOSE CONSCIOUSNESS. NO EPIPEN NEEDED, EMS CALLED & NORMAL VITALS. PATIENT REFUSED TREATMENT/HOSPITALIZATION.
Received TDAP shot on 9/14/09. Notified physician on 10/21/09 of continued limited range of motion/pain at the injection site and in my shoulder, excruciating pain when I raise arm higher than my shoulder or reach behind my back. Saw physician on 1/8/10 because of worsening condition. Performed x-rays, prescribed meloxicam and physical therapy. Went to physical therapy on 1/11, 1/13, and 1/18, but had to discontinue because the exercises were aggravating a urogynecological condition. (Underwent surgery on 3/4 and 3/31 for the urogynecological condition. Currently on 12-week limited activity restrictions). Saw orthopedic doctor on 4/13/10 who diagnosed frozen shoulder and prescribed Flexeril, Vicodin, and Relafen, as well as aqua-therapy. Going to neurologist on 4/15/10 for 2nd opinion because (after researching), I believe I am suffering from brachial neuritis.
62 year old female complained of a headache after receiving vaccine. Onsite EMS was called vritals  BP 166/98  100%O2 HR 98. She refused further eval and care.
complaining of dizziness unsteadiness on her feet and episode of syncope .  Patient states felt body aches, and the morning of presentation to the ER went to the bathroom to get ready for work and passed out does not remember the event but does remember afterwards feeling unsteady on her feet confused and having dizziness.  pt with symmetric strength and normal sensation on exam but with loss of balance and unsteady gait with ambulation.
Red rash at injection site, grew over time (lasted approx 3 days). Rash was red, warm and at times itchy.   Also developed a lump in injection arm armpit area that was about the size of a golf ball. Painful. Could not sleep on that side (left) or raise arm above shoulder height for 3 days.
74.7kg 69 yo WF with PMH: rheumatoid arthritis, hypothyroidism, fibromyalgia, Sjogrens Syndrome, hyperlipidemia and OSA presented to clinic for Moderna Covid19 vaccination.  Patient has multiple allergies.   Patient was given 0.5ml dose IM in left deltoid at ~1000.  (Lot # 013L20A)  Within ~30 seconds, patient complained of oral burning, chest burning 9/10, chest tightness, SOB, flushing and difficulty breathing.  Patient complained of palpitations.  EKG performed with no significant findings.  Treated with aspirin 81mg x 4 at 1025.  Described symptoms as similar to those she had in the past when exposed to seafood.   Note that BP seemed unstable.  EMS called to transfer to ED for rule out ACS.
This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with GARDASIL (lot #, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse affect reported. This is one of several reports received from the same reporter. Additional information has been requested.
received an expired dose of HAVRIX; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th June 2022, the patient received Havrix (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. On 6th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comment: The reporter stated that the patient received an expired dose of Havrix . The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
After receiving COVID vaccine, patient began to feel hot and flushed in her hands and ears  Vital Signs: BP 108/64 HR 56 O2Sat 99  Skin Signs: Warm and dry Other - Flush in hands and ears  Respiratory: Breath sound clear bilaterally  Initial treatment: Vitals taken at 1:25 PM. Monitor patient and reassess vitals. HR of patient presented irregular. 1:33 PM Vital Signs: 100/52 HR 97 O2Sat 97  Skin Signs: Warm and dry Other - Intermittent flush in hands  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Continue to monitor vitals 1:40 PM Vital Signs: BP 110/62 HR 80 O2Sat 99  Respiratory: Breath sound clear bilaterally  Follow Up Treatment: Patient states feels 'great', wants to go home. Appears normal. No flushing. Regular pulse. No change on standing. Home with husband.
Pt recv vax on 10/13/97; 20 min post vax pt exp hives on chest, immediately pt exp local rxn at vax site, 25 min post vax pt exp hoarse voice & dizzy; tx=ice, Benadryl
1.) Right axillary lymphadenopathy starting the morning following the injection (3/30/21) and not resolved at the time of this report.  Slight discomfort associated with the lymphadenopathy when right arm positioned or held close to body.  Took 200mg Ibuprofen before bed on 3/30/21 to help with discomfort.  2.) Body chills noted throughout the day on 3/30/21. Resolved as of 3/31/21.  Not associated with a fever. No treatment.  3.) Headache noted throughout the day on 3/31/21. Resolved as of 3/31/21. No treatment.
Patient was administered with Pentacel vaccine which was expired with no reported AE; instead of Adacel patient administered Pentacel with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00544726) and transmitted to Sanofi on 01-Apr-2021.  This case involves a 53 year old female patient who instead of adacel administered pentacel (Wrong product administered) and also was administered with pentacel vaccine which was expired (Expired product administered), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Patient received no concomitant vaccines.  Medical history, medical treatment, vaccination and family history were not provided.   On 01-Apr-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot U6615AB and expiry date: 29-Mar-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that, they intended to administer Adacel (Tdap) to the patient today (01-Apr-2021), but instead Pentacel, but only the DTaP-IPV component and not the Hib component, was inadvertently administered intramuscularly to the patient. In addition to that, the DTaP-IPV component of the Pentacel had expired on 29-Mar-2021. Facility was planning to re-vaccinate patient with Adacel. Reporter did not know the injection/administration site on the body where the vaccine was administered.  Product used : Used. First time product used: Yes  Still using product: No  It was a case actual medication error due wrong product administered and expired product administered. [latency: at the same time of vaccination] .  At the time of reporting, patient had no adverse event.  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.  There will be no information available on the batch number for this case.
Was feeling in full health prior to this vaccine so went in with my wife/ partner to get our 4th boosters.  Within 2 hours of receiving the vaccine, my left arm was noticeably sore.  Woke up with fever about 2 a.m. the next morning. The fever persisted and was low grade, but was intermittent for several days. Did my best to stay hydrated.  Deep exhaustion and fatigue. Slept a lot. Up to 18 - 20 hours per day.  Loss of smell for 3 - 4 days + (couldn't smell bacon cooking or coffee brewing. No specific treatment applied.  Intermittent, brief sharp headaches.  Brain fog  Anxiety  Tested negative on April 29, 2023 at approximately 10 am  Ongoing symptoms in recovery - fatigue, brain fog, anxiety
received first dose 6/21; This case was reported by a consumer and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. Vaccination facility details were provided for 1st dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as it was not available, which led to product supply issue. The patient was now in another country until July again but there was no Shingrix available. The patient asked if it was possible for it to be available in different country. The consent to follow up was requested.
Date for first shot: Consumer stated, "First shot was done on 06Apr2021."; I am having periods which I shouldn't have because I am very post menopausal; I started bleeding;  menopausal female; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 17Dec2021 14:00 (Lot number: 83030BD) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 06Apr2021, for Covid-19 Immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 23Dec2021, outcome "not recovered", described as "I started bleeding;  menopausal female"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Date for first shot: Consumer stated, "First shot was done on 06Apr2021.""; MENSTRUAL DISORDER (non-serious) with onset 23Dec2021, outcome "not recovered", described as "I am having periods which I shouldn't have because I am very post menopausal". The events "i started bleeding;  menopausal female" and "i am having periods which i shouldn't have because i am very post menopausal" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: all good; gynaecological examination: unknown results; smear cervix: unknown results. Therapeutic measures were not taken as a result of postmenopausal haemorrhage, menstrual disorder. Clinical course: The consumer reported that she was very healthy forever and she still believing, it's been 8 days now and pretty convinced that it's because of the shot, there is no other reason to this, she had been post menopausal for probably about 8 years. She was having a uterine ultrasound next week and she have to go to the hospital for that. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
he started acting a little goofy laughing; he got confused; he didn't know who his family; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 16:00 (Lot number: FC3184) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. The following information was reported: ABNORMAL BEHAVIOUR (non-serious) with onset 19Sep2021 17:00, outcome "recovered" (19Sep2021 17:20), described as "he started acting a little goofy laughing"; CONFUSIONAL STATE (non-serious) with onset 19Sep2021 17:00, outcome "recovered" (19Sep2021 17:20), described as "he got confused"; COGNITIVE DISORDER (non-serious) with onset 19Sep2021 17:00, outcome "recovered" (19Sep2021 17:20), described as "he didn't know who his family". The events "he started acting a little goofy laughing", "he got confused" and "he didn't know who his family" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abnormal behaviour, confusional state, cognitive disorder.  No follow-up attempts are possible. No further information is expected.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Reported Event: About 20-25 minutes after My son received the Pfizer vaccine, he started acting a little goofy laughing and then about 15-20 minutes after that he got confused he did not know who his family was it lasted for about 20 mins. I became concerned and took him to urgent care. At this time, he was all back to normal the doctor was not concerned and said it was a vaccine reaction. Doctor told me to report this to you guys.  The adverse events resulted in Emergency room/department or urgent care. The patient was not received treatment for the adverse events. Patient was diagnosed with COVID-19 prior vaccination. Patient had not tested for COVID-19 since vaccination  Follow-Up #01 (21Sep2021): Follow-up attempts are completed. No further information is expected.
Patient came to pharmacy the day after her vaccinations complaining of swollen red warm itchy arm.  Redness was not around injection site, but below the site. Redness almost appeared to look like a blood pressure cuff around her arm. Upon questioning, patient did state she had blood drawn from the same are the day prior to her vaccinations. Flu was administered on top and PNEUMOVAX administered about 1 inch below, both in the deltoid (patient preference not to inject into separate arms). Followed up with patient later in the afternoon. states she still has redness and a little swelling but does not appear to be getting any worse.
Pt came to our clinic for covid vaccine on 8/27/21 and filled out form indicating it was her first dose. She returned on 9/17/2021 for second dose. When entering into IRIS we noticed she had Pfizer vaccine on 4/8/21 at another facility. Our Marshallese interpreter contacted patient and she states she did not get a Covid vaccine at that facility. I contacted the facility and they have notes indicating she did indeed come for a vaccine on 4/8/21. So the administration error was that the 3rd dose given to soon but pt states it was only her second. Pt feels fine.